79C3C34C52B45572883A05D425EB0F82
Ethical Review of Biomedical Research in the CIS Countries (Social and Cultural Aspects)
http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
http://leaux.net/URLS/ConvertAPI Text Files/9A0542790DD3D2E7596BF9DA17DBB1E1.en.txt
Examining the file media/Synopses/9A0542790DD3D2E7596BF9DA17DBB1E1.html:
This file was generated: 2020-12-01 05:32:14
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator convicts:
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p.000225: solved problems, which were beginnings of bioethics principles and rules. They used method of experiment,
p.000225: observing disease activity and experimented on animals. At that time ethical approaches to experiments were formed.
p.000225: So, A.M.Filomafitckiy (11807-1849), the first Russian scientist, who made vivisection and surgery method as the base
p.000225: of physiology, said: “... Experiment made by inexperienced hand and aimlessly should be severely punished,
p.000225: especially if sufferings of an animal after blood operation are lengthened without any need, but experiments made
p.000225: by hands of a skillful and loyal observer are necessary for science and saving
p.000225:
p.000226: 226
p.000226:
p.000227: 227
p.000227:
p.000227: of mankind...” (11). D.S.Samoylovich (1744-1805), founder of the Russian epidemiology, self-tested plague infection
p.000227: and its course. There were negative examples. In the middle of the XIX century in Moscow foundling hospital they
p.000227: were searching for substitute of breast milk for children, and among others Libihovskiy beef broth was studied. As a
p.000227: result many children fell ill and so it was concluded to be harmful (8).
p.000227: One of the first who began to defend rights of prisoners on health and medical help was F.P.Gaaz (1780-1853). In his
p.000227: everyday practice he defended and implemented the slogan “hurry up to make good”, displaying humane attitude to most
p.000227: miserable people such as exiles, convicts, he supported them morally and gave medical and social help, took care about
p.000227: their children. He both worked with selfless devotion and attracted unselfish assistants being of different classes and
p.000227: generations.
p.000227: Moral position of N.I.Pirogov (1810-1881) displays principle of honesty in Russia. He paid special attention to medical
p.000227: mistakes. In contrast with existing in medical society opinion he believed that every honest man should be able to
p.000227: admit and proclaim his mistakes to warn against them not well- informed people (24). Many Russian physicians became his
p.000227: followers and were able to admit and analyze their mistakes. They were A.Y.Krasovskiy, C.P.Kolomina, F.I.Sinitsin and
p.000227: others.
p.000227: An issue of patient consent for surgery was discussed by physicians in the past. N.I.Pirogov remembered in the Old
p.000227: Doctor Dairy, that an inspector of medical institutions I.Rule required from doctors in the hospital not to do any
p.000227: surgery without patient agreement.
p.000227: The time since the end of the XVIII century till beginning of the XIX century one can state as a
p.000227: birth of public medicine. First medical papers, medical societies, public hospitals and chemist’s shops,
p.000227: charity organizations were founded in Russia. One of the forms of public movement was movement of narodniks, which in
p.000227: the 60-70’s of the XIX century became mass ideology of intelligence not of gentle birth trying to be spokesman of
p.000227: peasants. At the call of members of organization Narodnaya Volya (People’s Will) Russian teachers and doctors went
p.000227: willingly “close to the people” and went to work in the depth of Russia (13).
...
Searching for indicator prisoners:
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p.000069: of the research. In this context, the universal significance of the ethical component of the scientific research and
p.000069: its global effect on the development of ethical ideas and on the ways of their implementation at the
p.000069: general level of civilization in the history of humankind is quite obvious. From the theoretical viewpoint, it is
p.000069: impossible to speak about the history of medical ethics without considering interdependent processes of the
p.000069: development of various ethical concepts and an essential role of main landmarks in the history of world ethical
p.000069: practice that have determined a harmonious and comprehensive understanding of general ethical principles of the
p.000069: research.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000071: 71
p.000071:
p.000071: From the practical point of view, the history of biomedical research ethics is inseparable from
p.000071: understanding the essence and process of the biomedical research as such.
p.000071: According to the main research subject, the biomedical research may be divided into the following categories:
p.000071: • Research that physicians carry out on themselves (autoexperiments);
p.000071: • Research involving healthy people;
p.000071: • Research involving patients.
p.000071: In historical context, the concept of informed and voluntary consent of a research subject requires subdividing
p.000071: into separate groups within these categories
p.000071: Besides, both in healthy (e.g. prisoners and military men) and ill (e.g. persons with mental disorders or ill
p.000071: minors) research subjects, groups of vulnerable contingents should be distinguished, i.e. groups of persons who for
p.000071: social, legal, age-specific, intellectual, mental or other reasons have a limited capacity or do not
p.000071: have the capacity to make an independent, informed and voluntary decision to participate in a clinical research.
p.000071: It is also essential to distinguish different types of biomedical research depending on the character of the connection
p.000071: between the research goal and its actual clinical motivation.
p.000071: Research of the first type, defined in international documents as “therapeutic” (or clinical) biomedical
p.000071: research, implies the application of new diagnostic, therapeutic or preventive pharmaceuticals or methods, i.e.
p.000071: research conducted in the interests of a particular research subject.
p.000071: Research of the second type, defined as “non-therapeutic” (or non- clinical) biomedical research, does not
p.000071: imply actions in the interests of ill or healthy subjects. Biomedical research is carried out with the purpose of
p.000071: obtaining some scientific knowledge or studying how the human organism would respond to one or another condition or
p.000071: factor (pharmokinetic studies, studies in the field of normal physiology, in cosmonautics and sport, etc.).
p.000071: Each of the mentioned types of biomedical research forms and determines special ethical and legal
p.000071: relations. In historical context, the influence of ethical dialectics of each type of biomedical research on the
p.000071: current concept of bioethics is most essential.
p.000071: Thus, high moral principles of physicians (investigators) who conducted experiments on themselves gave rise to a symbol
p.000071: of heroic dedication - a “burning candle”, which personified the motto of medical profession “Aliis lucens uror”. The
p.000071: history of medicine knows many examples of heroic dedication to science, self-sacrifice and modesty. Often
p.000071: those experiments ended tragically and entered the chronicle of “tragic medicine” in the world history. Among
p.000071: devotees there are many physicians (investigators) representing peoples of the CIS countries, which is
p.000071: reflected in chapters describing the cultural and historical background of ethics development in each
p.000071: country. On the whole, the scientific feat of those people is of a supranational character, and arouses feelings of a
p.000071: deep respect and admiration. Their work served the purpose of scientific knowledge, saving people’s life and making
p.000071: achievements for the welfare of the humankind.
p.000071: Inhuman experiments on concentration camp prisoners carried out on an appallingly large scale and sanctioned by the
p.000071: state law of the Nazi regime arouse opposite emotions, and the very word “experiment” with regard to a human being has
p.000071: a dismal echo.
p.000071: However, the development of biomedical research is based not only on those polar, in terms of ethics, examples.
p.000071: International standards of implementation into the medical practice of new therapeutic, diagnostic and preventive
p.000071: pharmaceuticals and methods, as well as their scientific and moral resonance are reflected in historical stages of
p.000071: setting out legal concepts of bioethics.
p.000071: Currently, the list of international recommendations, declarations, codes, resolutions and other documents relating to
p.000071: bioethics is very extensive, and in the last decades it has a tendency to increase.
p.000071: One of the most important events in the history of bioethics in the XX century was the Nuremberg Code adopted by
p.000071: the International Military Tribunal in 1947. When commenting on this historical document, the world press emphasized
p.000071: that the accusatory sentence of the Nuremberg Trial “speaks on behalf of insulted human conscience”. The
p.000071: Nuremberg Code was the first document based on the “judgment of the victorious truth”, which declared the
p.000071: cardinal ethical principles with regard to an individual and stimulated the growth of public awareness and peoples’
p.000071: responsibility.
p.000071: Among international documents in which the ethical principles in medicine and their actual application were
p.000071: further developed, the Declaration
p.000071:
p.000072: 72
p.000072:
p.000073: 73
p.000073:
...
p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armed forces, prisoners and persons under arrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
p.000119: • Equal rights of patients and physicians to respect for their human dignity (Art. 14);
p.000119: • Mutual trust and mutual responsibility of the patient and the physician, patient is an active participant of the
p.000119: treatment process (Art. 16);
p.000119: • Compulsory consent from the patient for a medical intervention, except for cases provided by law (Art.
p.000119: 21);
p.000119: • Compulsory written consent from a patient, his/her close relatives or legal representatives for removal
p.000119: organs or tissues for diagnostic or therapeutic purposes; removal of organs and tissues for other purposes may not
p.000119: be carried out (Art. 23);
...
p.000189: regard to ethical criteria, consider moral and ethical problems arising in the course of clinical trials of
p.000189: pharmaceutical products and ensure the protection of patient’s rights.
p.000189: This Law contains important provisions concerning human rights in clinical trials of pharmaceutical
p.000189: products. In particular, it says that a patient gives his or her written consent to participate in a clinical
p.000189: trial of a pharmaceutical product and has the right to withdraw his or her consent at any stage of the research. Before
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
p.000189: out in such vulnerable patients as children without parents; military personnel; prisoners and persons under
p.000189: investigation in detention Centres; pregnant women (except for cases when clinical trials are designed specially
p.000189: for pregnant women and when the
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000191: 191
p.000191:
p.000191: necessary information can only be obtained in a clinical trial provided that the trail is not hazardous to a woman or
p.000191: to a fetus).
p.000191: Besides, the Law sets certain restrictions relating to clinical trials involving children. Thus the trials are
p.000191: only permitted if the investigational pharmaceutical product is specially indicated for use in children or to obtain
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
...
p.000225: A.M.Filomafitskiy, S.F.Hotovitskiy, F.I.Inozemtsev and others maintained this tradition. Their professional activity
p.000225: and civil position were based on moral ideals. They wrote works where they discuss qualities characterizing a
p.000225: doctor, ethical aspects of relations with society, patients and colleagues. In everyday activity they pointed and
p.000225: solved problems, which were beginnings of bioethics principles and rules. They used method of experiment,
p.000225: observing disease activity and experimented on animals. At that time ethical approaches to experiments were formed.
p.000225: So, A.M.Filomafitckiy (11807-1849), the first Russian scientist, who made vivisection and surgery method as the base
p.000225: of physiology, said: “... Experiment made by inexperienced hand and aimlessly should be severely punished,
p.000225: especially if sufferings of an animal after blood operation are lengthened without any need, but experiments made
p.000225: by hands of a skillful and loyal observer are necessary for science and saving
p.000225:
p.000226: 226
p.000226:
p.000227: 227
p.000227:
p.000227: of mankind...” (11). D.S.Samoylovich (1744-1805), founder of the Russian epidemiology, self-tested plague infection
p.000227: and its course. There were negative examples. In the middle of the XIX century in Moscow foundling hospital they
p.000227: were searching for substitute of breast milk for children, and among others Libihovskiy beef broth was studied. As a
p.000227: result many children fell ill and so it was concluded to be harmful (8).
p.000227: One of the first who began to defend rights of prisoners on health and medical help was F.P.Gaaz (1780-1853). In his
p.000227: everyday practice he defended and implemented the slogan “hurry up to make good”, displaying humane attitude to most
p.000227: miserable people such as exiles, convicts, he supported them morally and gave medical and social help, took care about
p.000227: their children. He both worked with selfless devotion and attracted unselfish assistants being of different classes and
p.000227: generations.
p.000227: Moral position of N.I.Pirogov (1810-1881) displays principle of honesty in Russia. He paid special attention to medical
p.000227: mistakes. In contrast with existing in medical society opinion he believed that every honest man should be able to
p.000227: admit and proclaim his mistakes to warn against them not well- informed people (24). Many Russian physicians became his
p.000227: followers and were able to admit and analyze their mistakes. They were A.Y.Krasovskiy, C.P.Kolomina, F.I.Sinitsin and
p.000227: others.
p.000227: An issue of patient consent for surgery was discussed by physicians in the past. N.I.Pirogov remembered in the Old
p.000227: Doctor Dairy, that an inspector of medical institutions I.Rule required from doctors in the hospital not to do any
p.000227: surgery without patient agreement.
p.000227: The time since the end of the XVIII century till beginning of the XIX century one can state as a
p.000227: birth of public medicine. First medical papers, medical societies, public hospitals and chemist’s shops,
p.000227: charity organizations were founded in Russia. One of the forms of public movement was movement of narodniks, which in
...
p.000271: information provided to the patient shall be logically completed with the informed consent form, which exhibits, if
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
p.000271: alterations of the drug introduction routes, its doses, and significant changes in number of the CT subjects. An ethics
...
p.000331: - independent ethical review;
p.000331: - insurance;
p.000331: - operational standard procedures.
p.000331: A number of other documents (decrees of the President of Republic Uzbekistan, decrees of the Cabinet of the
p.000331: Republic of Uzbekistan, orders and guidelines of the Ministry of Public Health) have been adopted for a further
p.000331: healthcare development (reforming the system of medical service, creating necessary material and technical conditions
p.000331: for providing healthcare at state and private medical institutions, etc.).
p.000331:
p.000332: 332
p.000332:
p.000333: 333
p.000333:
p.000333: Uzbekistan adopted basic international documents in the field of bioethics, such as
p.000333: 1. Declaration of Helsinki
p.000333: 2. Universal Declaration on Human Rights (1948)
p.000333: 3. The Universal Declaration on the Human Genome and Human Rights (1997)
p.000333: 4. Monaco Declaration (18 of July 2001),
p.000333: 5. International Declaration on Human Genetic Data (adopted by UNESCO General Assembly; 16 of Octobe, 2003
p.000333: 6. Universal Declaration on Bioethics and Human Rights (UNESCO, 2005)
p.000333: 7. United Nations Declaration on Human Cloning (8 of March 2005)
p.000333: 8. ECOSOS Resolution “Genetic privacy and non-discrimination” (21 of July 2004)
p.000333: 9. Resolutions of ECOSOS Commission for Human Rights:
p.000333: - Human Rights and Bioethics (25 of April 2003);
p.000333: - Principles of biomedical ethics with regard to the role of medical professionals, particularly
p.000333: physicians, in the protection of prisoners or persons under arrest against tortures and other cruel, inhuman or
p.000333: disgracing attitude and punishment (18 of December 1982);
p.000333: - Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of
p.000333: Mankind (10 of November 1975).
p.000333: In its activity the National Ethics Committee (NEC) of the Republic of Uzbekistan at the Ministry of Public Health of
p.000333: Uzbekistan uses also other international documents, such as
p.000333: 1. Final Act of the International Conference on Healthcare (New-York, 22 July 1946)
p.000333: 2. The Nuremberg Code (1947)
p.000333: 3. Universal Declaration on Human Rights 1948
p.000333: 4. Declaration of Helsinki (WHO, 1964, 2002)
p.000333: 5. European Agreement on Providing Medical Assistance to Persons Temporarily Residing in Other [Member] (Geneva, 17
p.000333: of October 1980)
p.000333: 6. Convention on Biological (Rio de Janeiro, 5 of June 1992)
p.000333: 7. Budapest Summit Decisions. Human Dimension (Budapest, 1994)
p.000333: 8. Agreement on Collaboration in Public Health Protection (Minsk, 26 of June 1992)
p.000333: 9. The Charter of Social Rights and Guarantees to the Citizens of Independent States (approved by the
p.000333: Inter-parliamentary Assembly of the Commonwealth of Independent States, 29 of October 1994)
p.000333: 10. Convention on Human Rights and Biomedicine (Council of Europe, 1996)
p.000333: 11. Note for Guidance on Good Clinical Practice (ICH, 1996)
p.000333: 12. WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
...
Political / Illegal Activity
Searching for indicator crime:
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p.000007: in the North America (1929-1933). Besides, recent changes of mortality rate, marriage ability and fertility shifts have
p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
p.000009: stability and to the whole process of reformation; however, there is a certain stabilization of the situation.
p.000009: Let us consider changes in resident population of the CIS countries and Turkmenistan in the period from 1991 to 2006.
p.000009: (Table 1).
p.000009: The presented data show the increase of population in Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan,
p.000009: Turkmenistan and Uzbekistan considering the change in the tendencies of population reproduction.
p.000009: The population in the CIS member-countries is about 5% of world population. The population density in
p.000009: the CIS countries varies from 6- 9 persons per sq. km in Kazakhstan, Russia and Turkmenistan to 126-129 persons in
p.000009: Armenia and Moldova. Thus, the average population density in the CIS countries is 13 persons per sq. km. For
p.000009: comparison: the population in the European Union (EU) makes 7% of world population, while the average density of
p.000009: population in the EU is 114 persons per sq. km. Over 66% of Belarus, Armenia, Ukraine, and 73% of Russia population are
...
Searching for indicator illegal:
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p.000163: Dr. V.V.Zikeev used formalized bone transplants for the treatment of pseudo-arthroses.
p.000163: During the war research institutions of Kazakhstan did not interrupt their activity; immediately after the war
p.000163: several medical research institutions were organized under the Academy of Sciences of Kazakhstan Republic: the
p.000163: Institute of Regional Pathology, the Institute of Clinical and Experimental Surgery, the Institute of Physiology.
p.000163: World-known academician Nikolai Dmitrievich Beklemishev – doctor of medical sciences, professor, honored scientist of
p.000163: Kazakhstan Republic and the winner of the State Prize – made a great input in the study and control of
p.000163: brucellosis. His monograph “Chronic brucellosis” was included as big section in the manual «Die brucellose des
p.000163: Menschen» that was edited and published in Berlin by J.Parms and in recommendations published by the World Health
p.000163: Organization.
p.000163:
p.000164: 164
p.000164:
p.000165: 165
p.000165:
p.000165: When Kazakhstan became independent country the public health sector in the country changed dramatically.
p.000165: The president of the state N.A.Nazarbaev declared the health of the population as the most important value in the
p.000165: country and formulated the specific goals of the policy – the improvement of the population health, support to the
p.000165: public health system and advocacy for the healthy lifestyle.
p.000165: Taking into consideration more strict demands and requirements for the quality of medical aid to
p.000165: population several social programmes were developed and approved in the country including the State Programme “The
p.000165: Health of Population”, “The program for the Control of Illegal Drug Use and Drugs Traffic”, the conception “On the
p.000165: development of Medical Sciences in Kazakhstan Republic”, the complex programme “The healthy lifestyle”, the State
p.000165: Programme “On reforms of Public Health System and its future development in 2005-2010” and other programmes.
p.000165: During the last several years new methods for treatment of patients were developed successfully in the
p.000165: Republic as well as new directions in medical sciences were created. Research studies were conducted on clinical
p.000165: efficacy of transplantations of pancreatic B-cells and embryonic liver cells. The National Genetic Register was
p.000165: organized. Public health authorities spend great efforts to implement the best results and discoveries of medical
p.000165: science into everyday practice of health care institutions. At the same time medical professionals like the Association
p.000165: of Physicians and Pharmacists of Kazakhstan (APPK) started very serious dialogue with the Government and society on
p.000165: such complicated issues as protection of human rights of participants of research studies and experiments.
p.000165: At all international conferences members of this Association stressed that the research activity should not harm the
p.000165: health and life of human beings. The importance of this problem found very positive response in the Government of the
p.000165: country. As a result in September 2005 the Commission on Bioethics was organized in frames of the National Coordination
p.000165: Council for Health Protection under Kazakhstan Government.
p.000165:
p.000165: 3.5.2. Legal Regulations
p.000165:
...
Political / Persecuted
Searching for indicator persecuted:
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p.000223: personnel charity that created the foundation necessary for helping the poor at the following times. It was forming
p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
p.000225: people social life organization on the basis of common views (19).
p.000225: Under church influence and with its participation care for people in need for medical and social help
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
p.000225: thousands of disabled, old people and orphans. In the 50’s of XVI century they attempted to place a part of care
p.000225: for people health, social support for sick and weak people on the state. Stoglav, a great council of Russian
p.000225: bishops held in 1551, together with tsar and boyar Duma ordered to found everywhere hospices for “leprous, aged,
p.000225: lying in boxes on the streets, carrying carts and sledges and having no place to sleep”. “Desyatina”, the tenth
p.000225: part of funds from sale of bread, cattle and from rent, was brought in to keep churches, monasteries, hospitals,
...
Political / Prosecuted
Searching for indicator prosecuted:
(return to top)
p.000165: – “On Physical Culture and Sports”, in 2002 – “On Medical and Social Rehabilitation of Persons with Drug Addiction”
p.000165: and “On Prevention and Control of Tobacco Use” and “On Sanitary and Epidemiological Protection of Population”.
p.000165: Several laws – such as “On Health Protection of Citizens”, “On the System of Public Health”, “On Medical Drugs” that
p.000165: were adopted in 2004-2005 – have the greatest importance in area of bioethics (2).
p.000165: Ethical problems of biomedical research in Kazakhstan were discussed actively since 2001 when according to
p.000165: initiative of the Association of Physicians and Pharmacists of Kazakhstan (APPK) and with the support from
p.000165: FECCIS and WHO the republican conference was organized and later
p.000165: – international conferences (in 2002 and 2005) under the common title – “High quality ethical practice for biomedical
p.000165: research in the Republic of Kazakhstan”.
p.000165: At present time there are definite trends for increase of attention to bioethical issues in the Republic
p.000165: of Kazakhstan not only from the state but from the general population too. These trends are reflected
p.000165: by the improvement of legal regulations in Kazakhstan.
p.000165: The article 29 of the “Constitution of the Republic of Kazakhstan” says that all Kazakhstan citizens have the right for
p.000165: health protection. The article 29 of the Constitution says that administrative persons that keep the secret on the
p.000165: facts and circumstances that are dangerous for population health and life can be prosecuted according to the Law (3).
p.000165: In July 2006 new version of the Law of Kazakhstan Republic “On Health Protection of Citizens” was
p.000165: approved. Requirements to preclinical studies and medical and biological experiments as well as to clinical trials
p.000165: or implementation of new methods and means of disease prevention, diagnostics, treatment and medical rehabilitation are
p.000165: described in the article 31 (4):
p.000165: - Preclinical studies and medical and biological experiments should be done in animals only.
p.000165: - Clinical trials in human beings can be done only with written informed consent or according to a special agreement
p.000165: between the person and health care institution after getting positive results of preclinical studies and medical and
p.000165: biological experiments in animals.
p.000165:
p.000166: 166
p.000166:
p.000167: 167
p.000167:
p.000167: - Clinical trials should be interrupted immediately according to the will of a person participating in such trials as
p.000167: well as in the situation that can be dangerous for the health or life of a patient.
p.000167: - The use of new methods and means of disease prevention, diagnostics, treatment and medical rehabilitation is possible
p.000167: only after positive results of clinical trials were obtained.
p.000167: According to the article 9 of the same law (“The competence of responsible institution”) the Ministry of Health of
p.000167: Kazakhstan has the right to:
p.000167: - determine the requirements for the use of new methods and means of disease prevention, diagnostics, treatment and
p.000167: medical rehabilitation;
p.000167: - determine the requirements for implementation of preclinical studies and medical and biological experiments as well
p.000167: as to clinical trials;
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.000007: conditions. Specific features in each State are determined by different styles of life in the CIS countries due to
p.000007: their historical, religious, cultural and ethnic development. All these factors resulted in a general fertility rate
p.000007: decrease, mortality growth and a fall of the health quality index. These processes affect negatively the demographic,
p.000007: labour and migration potential of the CIS countries.
p.000007: The last decade of the XX century was characterized by an essential aggravation of the demographic situation that could
p.000007: be defined as a crisis. High mortality rates had practically no precedents in the Eurasian peacetime history. The
p.000007: “excess mortality” in the period since 1989 was much higher than the mortality rate in the period of Great Depression
p.000007: in the North America (1929-1933). Besides, recent changes of mortality rate, marriage ability and fertility shifts have
p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
p.000009: stability and to the whole process of reformation; however, there is a certain stabilization of the situation.
p.000009: Let us consider changes in resident population of the CIS countries and Turkmenistan in the period from 1991 to 2006.
...
p.000031: for implementing such important ethical principles of biomedical research as
p.000031:
p.000032: 32
p.000032:
p.000033: 33
p.000033:
p.000033: respect to autonomy and individual dignity of a patient/subject as well as a principle of justice.
p.000033: Majority of constitutions of the CIS countries proclaim a person as a basic value (Art. 4, Constitution of Armenia;
p.000033: Art. 13, Constitution of Azerbaijan; Art. 2, Constitution of Belarus, Art. 3, Constitution of the Ukraine, Art. 2,
p.000033: Constitution of Russia; P.1, Art. 36, Constitution of Moldova, etc.). Free development of a person is
p.000033: protected by law and independent court. Person dignity is acknowledged as a special value to be protected by the state
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
p.000033: state becomes a guarantor for protection of personal rights and freedoms. Other directions of the state
p.000033: policy in social sphere are also extremely important for provision of human rights in the area of health care and
p.000033: biomedical research.
p.000033: 9 The Constitution of Kyrgyz Republic also mentions psychological tests in this list (Art.18 of the Constitution of
p.000033: Kyrgyz Republic). Since there is almost no special legal regulations within the regions of the CIS countries for such
p.000033: sphere of biomedical research as psychological studies this fact has a special value. Such constitutional statement can
...
p.000037: political, economic, social and cultural, ecological, demographic and other constituents of life of the Commonwealth
p.000037: countries that provides effectiveness, timeliness and demand for produced recommendations on harmonization and
p.000037: convergence of legislation of the CIS countries. Activity of IPA CIS in this respect is versatile and includes a range
p.000037: of spheres and areas determined with specifics and competence of permanent commissions such as commission on social
p.000037: policy and human rights, on legal issues, on science and education, on foreign policy issues, on defense
p.000037: and security, etc. In 1998 the Council of IPA CIS as the higher leading authority of the Assembly approved the
p.000037: declaration that emphasized solidarity of national parliaments with ideology
p.000037:
p.000038: 38
p.000038:
p.000039: 39
p.000039:
p.000039: of the Universal Declaration of Human Rights and stressed that since the moment of its proclamation the field of human
p.000039: rights exhibited considerable progress in general and that efforts in the field of human rights undertaken within CIS
p.000039: are also directed on provision of common respect for them, facilitation of strengthening of atmosphere of
p.000039: friendship and trust, effective implementation of multi-party agreements where a special place is given to the CIS
p.000039: Convention on Human Rights and Fundamental Freedoms adopted in Minsk in 1995.
p.000039: Criminal, penal procedure and penal enforcement model codes adopted by IPA CIS being a basis for development of similar
p.000039: codes in some of the Commonwealth countries should be considered as norms of general type establishing crucial
p.000039: requirements to an order of legal act execution in regard to main freedoms and rights of citizens in the Commonwealth
p.000039: countries. Statements of the given model codes were also reflected in initiation and creation of many legislator
p.000039: enactments in the CIS countries in the field of criminal law and criminal procedures. The model civil code adopted by
p.000039: IPA CIS has special values for establishing of new conditions for administration and management in all spheres of
p.000039: activities and its main statements were to some extent practically embodied in civil legislation of all CIS countries.
p.000039: Activity of the Permanent Commission on social policy and human rights of IPA CIS has a special value from the
p.000039: point of harmonizing influence on the health care field. After initiatives of the said commission model laws
p.000039: determining main statements for a complex welfare system were adopted, a list of international conventions recommended
p.000039: for immediate ratification by the CIS countries was developed, a set of model laws on rights of human beings related to
p.000039: category of vulnerable population groups was approved, such as a law On Basic Children Rights and On Additional
p.000039: Guarantees to Child-Orphans and Children without Parental Guardians, Guidelines On Childhood Protection in Member
p.000039: Nations of CIS (1998) as well as The Charter for Older People and other socially significant documents.
p.000039: In accordance with basic statements on protection of human rights and freedoms there are being prepared model
p.000039: laws related to both forming of domestic policy in the Commonwealth countries in the field of health care and
...
p.000075: of the CIS countries during last century and evaluate interrelating tendencies in the development of
p.000075: bioethics in the world, regional and national space. The moral basis of the medical profession since early
p.000075: times has been reflected in national traditions and worldview, which revealed itself in humanistic ideals of
p.000075: physicians-enlighteners of the past. (See Chapter 3 “Ethical Review System for Biomedical Research in the CIS
p.000075: Countries”). National cultures and ethical views relating to medicine alongside with penetration into and acceptance of
p.000075: world experience formed the foundation for medical activity in the CIS countries.
p.000075: However, we should mention that in the common historical canvas there are particular written evidences of moral and
p.000075: legal regulation with regard to biomedical research dating back to the first half of the XX century.
p.000075: Chronologically, the first case of legal regulation of medical activity that is available for our analysis is the case
p.000075: of Dr. Modlinsky (Sudebnye Dramy (Dramas in the Court) Journal, 1902, No. 2). On 15 of November 1901, the Moscow
p.000075: regional court, basing its judgement on Article 1468 of the Statute on punishment in Russia, with respect to “causing
p.000075: death by an obviously careless, but not legally prohibited, deed”, judged Modlinsky to be guilty of having performed
p.000075: surgery without obtaining the patient’s consent. Although there was no requirement for patient consent for medical
p.000075: interventions under the relevant medical code at that time, on 19 of November 1902 the Criminal Court of Appeal of the
p.000075: Senate of Russia endorsed the findings of the lower court, stating that “not obtaining the patient’s consent for
p.000075: surgery deprives medicine of its legal character and is the sign of overt neglect, giving the doctor’s deed the status
p.000075: of a criminally culpable act”. Already at that time, it had been accepted that a patient’s consent to a medical
p.000075: intervention should be sought (Tregubov “Ugolovnaia otvetstvennost vracha za vrachevanie bez soglasia bolnogo”
p.000075: (Physicians’ Criminal Liability for Treating the Patient without His Consent) St.-Petersburg, 1904, No. 12), and that
p.000075: the patient may make a conscious decision. According to the famous professor of criminal
p.000075: law, Tagantzev, “the patient’s consent is not always sufficient to prove that any particular case of medical
p.000075: practice is not indictable” (Pravo (Law) Journal, 1902, No. 12).
p.000075: An understanding of the ethical and legal issues with regard to organ transplantation and the necessity to obtain a
p.000075: written and documented consent from the donor and the recipient, as in a case described by the Dr B.V.Dmitriev in the
p.000075: beginning of the XX century (Medicinskoe Obozrenie (Medical Review) 1917, vol. LXXXVII, No. 13-14-15-16,), to a
p.000075: large extent reflects the modem view of the basic moral principles of biomedical research. Dr. Dmitriev sets out some
p.000075: other ethical norms of such surgical operation. The donor and recipient should be informed about potential consequences
p.000075: of the surgical intervention; there are requirements concerning the donor’s mental and physical health; the physician
p.000075: should guarantee that the harm done to the donor would be mild and transient. Dr. Dmitriev’s article contains
p.000075: a unique text, an early example of a carefully designed a patient’s informed consent form that is still valid today.
p.000075: It deserves to be quoted in full.
p.000075: “I, the undersigned E.R, by myself, without any external influences, offered a piece of my thyroid gland for
p.000075: transplantation. The piece would be of the size required for successful transplantation (approximately up to one eighth
p.000075: of the gland’s volume). I have had all the details explained to me and I am aware of all the risks I am subject to,
p.000075: i.e.:
...
p.000075: experiencing troubles related to the absence of the thyroid gland. I am also aware how a shortage of thyroid gland
p.000075: affects the human.
p.000075:
p.000076: 76
p.000076:
p.000077: 77
p.000077:
p.000077: Then I was told that although I will have analgesic medicine injected under the skin for pain relief, I will
p.000077: possibly feel some pain during the surgery and afterwards. And finally, it was explained to me, that in the case
p.000077: of successful operation or especially if the wound suppurates I will have a scar for life on my neck about 7.5-10 cm
p.000077: long. And, despite all the facts mentioned above, I agree to the surgery, and whatever happens, I will never have any
p.000077: claims either against the doctors who will perform the surgery, or the patient who will receive my thyroid gland. I am
p.000077: signing this paper in the presence of doctors B.V.Dmitriev, E.K.Vinakurova, M.P.Alexeev and the nurse
p.000077: E.V.Shevchenko (signature); we witnessed the reading and signing of this paper and hereby certify that E.P. is an adult
p.000077: and mentally capacitated person (signatures of doctors and nurse)”.
p.000077: This document dated 1917, contains all elements of current ethical concept relating to biomedical
p.000077: research: confidentiality, respect for a person’s autonomy, information about all risks associated with the
p.000077: research, freedom of a voluntary choice, verification of the research subject’s social and mental maturity.
p.000077: All statements in Dmitriev’s article base on a legal concept of a famous lawyer A.F.Kony who testified to the
p.000077: absence of criminal deed in the case of the sale of organs for treatment purposes in accordance with the contract
p.000077: between the donor (seller) and recipient (buyer). At the same time he noted that “under these circumstances the
p.000077: only ethical issue that might arise concerned the permissibility of such a deal in a situation where the
p.000077: “seller” was a minor, imbecile, or a person in a state of artificial excitation, and where the “buyer” was a
p.000077: person who acted through psychological compulsion, deception, seduction, promise of profit or suggestion by authority.
p.000077: On the whole, the analysis of legal and ethical principles referring to biomedical research existing in the tsarist
p.000077: Russia in the beginning of the XX century shows that humanistic concepts of a voluntary and conscious choice made by
p.000077: the research subject and confidentiality have been combined with a responsible and merciful attitude on the part of a
p.000077: physician-investigator, and reinforced with accepted moral and ethical norms and legislative acts in force.
p.000077: Turning to a more recent period in national history, the following stages of Soviet law development illustrate how the
p.000077: issues in ethical and legal regulation of medical and biological research were interpreted in the USSR.
p.000077: In the law of the Russian Soviet Federal Socialistic Republic (RSFSR) on 1 of December 1924 “On the Professional
p.000077: Activity and Rights of Health Professionals” the need to obtain the patient’s consent, in particular when surgery is
...
p.000079: The doctors in-charge of the institutions where the research is being conducted must report the results of the
p.000079: research”.
p.000079: As a whole, the Statute of 1936 was the first legal act of the Soviet health care system, which regulated the rules and
p.000079: conditions of the conduct of biomedical research, and defined the responsibility for observation of such
p.000079: regulations. As to its contents, the Statute illustrates a number of cardinal principles regulating the modem
p.000079: practice of biomedical research. However, the Statute did not declare the need to establish ethics committees, nor
p.000079: emphasize the need for independent ethical review, and the decisions on
p.000079: both professional and ethical aspects of the review were still the responsibility of the institutional organizations.
p.000079: On the whole, the significance of all these documents (considering their content and the time when they
p.000079: had been adopted) consists in the fact that the requirements concerning scientific justification and
p.000079: preliminary experiments on animals, research participants’ informed and conscious consent, high qualification of a
p.000079: physician-investigator and his responsibility in relation to research subjects fully coincide with modern norms of
p.000079: research ethics. The other important and positive aspect with regard to the analyzed documents is that the
p.000079: motivation to create those and their content has a protective legal character.
p.000079: At the same time, it should be noted that the Soviet legislation had a legal mechanism for the attribution
p.000079: of criminal liability for committing “crimes against Humankind”. (Decree of Presidium of the Supreme Council of the
p.000079: USSR on 19 of April 1943. Art. 1). There is an important historical document that reflected moral and legal
p.000079: understanding of experiments on live human beings – the protocols of a legal action conducted by the Military Tribunal
p.000079: of the USSR in Khabarovsk in 1949. It concerned the case of former Japanese military men accused of the development and
p.000079: use of biological weapons (“Indictment on the case of the former Japanese military men”; a supplement to Novoe Vremia
p.000079: (New Time) Journal, No 1, 1 of January 1950). The importance of the Conclusion adopted by the Tribunal in Khabarovsk is
p.000079: comparable with the importance of the Nuremberg Trials and the Code adopted there. In both cases the moral aspects of
p.000079: decisions concerned not only the individuals guilсссty of the crimes, but also the governmental policy and
p.000079: ideology which made these crimes possible.
p.000079: In the context of this Chapter the above documents are mentioned for the following purposes:
p.000079: • to eliminate informational vacuum existing in relation to the ethics of biomedical research in the former Soviet
p.000079: Union;
p.000079: • to clarify the reason of including the abovementioned documents into the international list on important documents
p.000079: of “pre-Helsinki” era to the CIOMS list;
...
p.000089: answer to the question “Does the physician have a moral right to hasten his patient’s death?”.
p.000089:
p.000090: 90
p.000090:
p.000091: 91
p.000091:
p.000091: Similar views we find in works of Armenian thinkers Mkhitar Hosha and Smbat Hundstabl (XIII c.). In “The Book
p.000091: of Laws” we read: “The physician who deliberately or through ignorance does harm to the patient’s health or, what
p.000091: is more, hastens the patient’s death, as well as the physician who educates a disciple, but does not give him proper
p.000091: knowledge deserves a severe punishment, up to death penalty”.
p.000091: This discussion started many ages ago is still topical nowadays. Neither lawsuits against physicians who
p.000091: support euthanasia thus violating one of the fundamental principles in The Hippocratic Oath (“To please no one will I
p.000091: prescribe a deadly drug nor give advice which may cause his death”), nor protests of public at large advocating
p.000091: traditional views do not guarantee that those who stick to more radical opinions will not triumph in the near future
p.000091: (alas!).
p.000091: Philosophical moral principles of the Hellenistic world had a great influence on the moral code of
p.000091: medieval Armenian medicine along with the highest values of the Christian ethics. The physician who violated The
p.000091: Hippocratic Oath and gave his patient “a deadly drug” was not merely reproached for that but treated as a
p.000091: criminal guilty of an innocent person’s death with all the corresponding consequences, as stated in the chapter “On
p.000091: Physicians Prescribing Deadly Drugs” in “The Book of Chrii”.
p.000091: In his treatise “The Usefulness of Medicine” Amirdovlat Amasiatsi, an outstanding Armenian physician (XV c.) writes:
p.000091: “The physician should be reasonable and have the sense of duty; he should be tolerant and ready to give advice. In no
p.000091: circumstance should he be a drunkard nor should he be greedy and mercenary-minded. He should love the poor and be
p.000091: merciful, faithful and god-fearing. If he does not understand the essence of the disease he should
p.000091: prescribe no drug in order not to stain his reputation. If the physician is ignorant it would be better not to call him
p.000091: to see a patient, and, in general, he should not be regarded as a physician.” These words showing an ideal image of the
p.000091: physician-humanist and his moral code are still essential for modern medicine that synthesized imperishable moral
p.000091: values set forth in medical systems of the East and the West.
p.000091: Today, each of the presented problems gives rise to many new questions. At the present stage of bioethics development
p.000091: we are more able to formulate the questions than to offer a comprehensive solution, and therefore most of them remain
p.000091: open.
p.000091: References
p.000091: 1. Amirdovlat Amasiatsi. The Good of Medicine. Yerevan, 1940, p. 9 (in Armenian).
p.000091: 2. Arevshatyan S.S. Early Armenian Translations and Their Cultural and Historical Significance. // Journal of
p.000091: History and Philology of Academy of Sciences of Armenian S.S.R. 1973, No 1, p. 23-37 (in Armenian).
...
p.000119: treatment process (Art. 16);
p.000119: • Compulsory consent from the patient for a medical intervention, except for cases provided by law (Art.
p.000119: 21);
p.000119: • Compulsory written consent from a patient, his/her close relatives or legal representatives for removal
p.000119: organs or tissues for diagnostic or therapeutic purposes; removal of organs and tissues for other purposes may not
p.000119: be carried out (Art. 23);
p.000119: • Confidentiality of patients’ personal data obtained in the patient— physician relationship; it is not permitted to
p.000119: disclose the patient’s personal information even after the patient’s death (Art. 24).
p.000119: An analysis and classification of fundamental statements of the Law of Republic Belarus on Healthcare and the Code of
p.000119: Medical Ethics show how the documents reflect topical principles and problems of biomedical ethics. The principle of
p.000119: human life sanctity (value) directs the physician’s activity towards all possible care for patients and implies
p.000119: that euthanasia is
p.000119: unacceptable:
p.000119: - “The physician should relieve sufferings of a dying patient by every available and legal means. Euthanasia as an
p.000119: act of an intentional taking of one’s life is not permissible at the patient’s or his/her relative’s
p.000119: request” (Art. 25 CME).
p.000119: - “Medical or pharmaceutical professionals are not permitted to perform euthanasia. A person who
p.000119: consciously induces the patient to euthanasia and/or performs euthanasia shall bear criminal responsibility
p.000119: according to legislation of Republic of Belarus” (Art. 38 of the Law on Healthcare).
p.000119: Priority of a person’s interests implies that interests and well-being of an individual should prevail over scientific
p.000119: and public interests:
p.000119: - “In his/her scientific and research activity the physician should be guided by the priority of the
p.000119: patient’s benefit over scientific interests; clinical trials and research may only be carried out in compliance with
p.000119: the rules established by law and with the patient’s consent” (Art. 36 CME).
p.000119: Principle of tolerance implies that all citizens, with no exception, are guaranteed that the individual’s integrity,
p.000119: principal rights and freedoms shall be respected:
p.000119: - “The main goal of physician’s professional activity is to save an individual’s life and health…
p.000119: regardless of the patient’s sex, age, nationality, social and financial status, political convictions and religion”
p.000119: (Art. 2, CME);
p.000119: - “Physician shall in every possible way contribute into protection of population health and to
p.000119: struggle against any forms of cruelty and disparagement” (Art. 5 CME).
p.000119: Equal rights and cooperation in physician-patient relationship as a cardinal principle of modern deontology
p.000119: implies the following:
p.000119: - “Physician and patient have equal rights to respect for their human dignity and may protect it according to
...
p.000159: also, its additional protocol on Biomedical Research has been signed;
p.000159: • First research (institutional) ethics committees for drug trials are established;
p.000159: • Specific law on biomedical research involving human subjects has been drafted and submitted to the Government;
p.000159: • Concept on the establishment of the two-tired network of research ethics committees on the regional level has been
p.000159: drafted (central research ethics committee and regional research ethics committees);
p.000159: • National council on bioethics stresses the importance of strengthening the system of ethical review of
p.000159: research protocols and advocates for the speeding up of the process of adoption of the specific law on biomedical
p.000159: research;
p.000159: • Teaching programmes in bioethics, including research ethics have been introduced on undergraduate as
p.000159: well as postgraduate level (programmes for residents and doctoral students as well as continuing medical
p.000159: education programmes for practicing physicians) of medial education/training.
p.000159: Is to be done:
p.000159: • Stimulation and speeding up the process of ratification of the law on biomedical research involving human
p.000159: subjects;
p.000159: • Introduction of sanctions in administrative and criminal code of Georgia for the infringement of the
p.000159: principles set out in the legislation related to the protection of research subjects;
p.000159: • Enforcement of the above mentioned concept on ethics committees (order of the minister of health or inclusion of
p.000159: the main statements of the concept in the draft law on biomedical research during the discussions at the parliament);
p.000159: • Education: undergraduate, postgraduate education; education of potential members of research ethics
p.000159: committees;
p.000159: • Establishment of central and regional ethics committees;
p.000159: • Setting up quality assurance system for research ethics committees.
p.000159:
p.000159: Finally, step-by-step we have to strengthen mechanisms, which will ensure that the rights and dignity of
p.000159: human research subjects are duly protected. This will be one more brick in the wall in the process of building
p.000159: democratic society, which doesn’t allows injustice to take place among people.
p.000159:
p.000159:
p.000160: 160
p.000160:
p.000161: 161
p.000161:
p.000161: 3.4.5 Perspectives and Forms of International Cooperation
p.000161:
p.000161: Georgia is the member of all international cooperation in the field of protection human rights in
...
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
p.000191: trials of pharmaceutical products involving subjects with mental disorders may only be carried out after
p.000191: obtaining a written informed consent from a legally authorized representative in accordance with applicable law.
p.000191: Protection of patients’ rights in biomedical research and other interventions in Kyrgyz Republic are
p.000191: also regulated by the following laws:
p.000191: - “On Narcotic and Psychoactive Drugs and Precursors” (No 66, 22 May 1998);
p.000191: - “On Donorship of Blood and Blood Components in Kyrgyz Republic” (No 951-XII, 3 July 1992);
p.000191: - “On Tuberculosis Prevention in Kyrgyz Republic” (No 56, 18 May 1998);
p.000191: - “On Prevention of Diseases Caused by Iodine Deficit” (No 40, 8 February 2000);
p.000191: - “On Citizens’ Medical Insurance in Kyrgyz Republic” (No 208, 28 December 2006);
p.000191: - “On HIV/AIDS Prevention in Kyrgyz Republic” (No 149, 13 August 2005);
p.000191: - “On Citizens’ Reproductive Rights” (No 5, 13 January 2000).
p.000191: Statements of civil, administrative and criminal codes set the responsibility in case of violating
p.000191: patients’ rights in medical interventions and in case of violating the legally established order of practice in
p.000191: healthcare and biomedicine.
p.000191: 3.6.3. Education in Bioethics
p.000191:
p.000191: Today Kyrgyz Republic has several institutions for a higher medical education: the Kyrgyz State Medical Academy,
p.000191: Medical Faculty of the Kyrgyz-Russian (Slavic) University, Medical Faculty at the International University of
p.000191: Kyrgyzstan and Medical Faculty at the Osh State University.
p.000191: The State Standard of Education in Kyrgyz Republic does not include bioethics as a separate subject. Nevertheless,
p.000191: bioethics has been introduced into the syllabus of the Kyrgyz State Medical Academy and is taught to
p.000191: undergraduate students. The course in bioethics consists of lectures (36
p.000191: h) and practical seminars (18 h). One of the course topics is “Ethical and Legal Control of Biomedical Research”.
p.000191: Bioethics is also taught at Chairs of Clinical Medicine and Pediatrics of the Medical Faculty at the Kyrgyz- Russian
p.000191: (Slavic) University (lectures – 19 h and seminars – 19 h). Bioethics is not taught at the postgraduate level.
p.000191: Presently, there is no state system of teaching GCP to members of ethics committees. However courses on basic and
p.000191: clinical pharmacology provide information on clinical trials and GCP principles to students at all faculties of the
p.000191: Kyrgyz State Medical Academy.
p.000191: Two staff-members from the Department of Basic and Clinical Pharmacology of the Kyrgyz State Medical
...
p.000229: medical community. Thoroughly, providing great number of examples he showed the destitute position of an average
p.000229: practicing doctor, his vulnerability. And at the same time he stressed the high requirements that the
p.000229: community imposed over a physician (5, 6).
p.000229:
p.000230: 230
p.000230:
p.000231: 231
p.000231:
p.000231: V.A. Manassein (1841-1901), a noted general practitioner, editor of “The Doctor” magazine, a person who won a
p.000231: name of a ‘knight of medical ethics’, ‘conscience of medical community’ stressed the necessity for a doctor to
p.000231: comply with medical confidentiality even at the expense of his own benefits. A contrary position was expressed by a
p.000231: denoted lawyer A.F. Kony (1844-1927), who considered that in situations of grave threat needs of the society should
p.000231: prevail over the ban to disclose patients’ secrets. At the same time he advocated the idea of sticking to medical
p.000231: confidentiality after a patient’s death. A.F. Kony also stipulated the conditions which allowed active euthanasia both
p.000231: legally and ethically.
p.000231: In he beginning of the XX century it was acknowledged that relationship of physicians with the community require
p.000231: dramatic revision especially when it comes to correlation of a doctor’s right to perform medical assistance essential
p.000231: for a patient and consent of the latter to have it in terms of observing or violating the principle of physical
p.000231: integrity (“Court newspaper”, 1901, №№ 51, 52) and also about the legal grounds and limits of criminal responsibility
p.000231: for the harm caused to patients health (‘Law”, 1902, №51). The issue to what extent the patient’s consent for medical
p.000231: treatment should be based upon his conscious understanding of the nature of this treatment especially if it is
p.000231: performed not only for the benefit of a patient but out of experimental needs. Prominent law experts A.F. Kony, N.G.
p.000231: Tagantsev, I.G. Sceglovitov, S.N. Tregubov and others come to join this discussion. According to Professor of Criminal
p.000231: Law N.G. Tagantsev “patients consent is incapable of setting impunity to all medical cases”. The fundamental principles
p.000231: of biomedical research in connection with thyroid gland transplantation were described from both legal and ethical
p.000231: sides in 1917 in an article by B.V. Dmitriev, a physician who worked for a machine factory in Kolomna and whose
p.000231: expertise was based on the consultation that the author obtained from A.F. Kony (12). Considering legal aspect of
p.000231: a doctor’s right for transplanting organs and tissues B.V. Dmitriev asked: “Whether a physician is granted
p.000231: any right to cause even minute and fleeting harm to a healthy person for the sake of another human being? Whether he is
p.000231: competent to decide in every particular situation if the benefit for one patient compensates for the harm done to the
p.000231: other, having the widest sense of the words benefit and harm in mind, that means not only in relation to physical
p.000231: health of these individuals but taking into account a complex of spiritual and physical strength of both?”.
p.000231: In response to these concerns Doctor Dmitriev stated the main provisions of implementing a medical
p.000231: research, the most essential of which are providing information and obtaining a conscious consent (of a donor in this
p.000231: case) which fully complies with the modern requirements. The same article provides a text of the first Russian
...
p.000257: in accordance with the most progressive international standards in this field.
p.000257: Legislation initiatives in the sphere of protection of patients’ rights40, activity directed to adaptation of
p.000257: international guidelines, as well as transformation of the positions of international declarations and conventions
p.000257: in the sphere of biomedicine into the domestic legal acts, give us the reason to expect the strengthening and
p.000257: development of the institute of ethical review in our country.
p.000257:
p.000257: 3.8.3 Education in Bioethics
p.000257:
p.000257: Issues on education of medical ethics and deontology in medical schools and colleges of the USSR were
p.000257: started to discuss in the 60’s of the XX century after the 1st All-Union Conference on issues of medical
p.000257: deontology in 1969 being a kind of triggering point for revival of talks on them. The final resolution, in particular,
p.000257: said: “The Conference would like to draw attention of the Chief Agency on Educational Facilities of the Ministry of
p.000257: Health of the USSR on necessity to implement medical deontology into education process”.
p.000257:
p.000257:
p.000257: 40 For example, Draft Law “On legal basis of bioethics and its guaranties”, “On reproductive rights of citizens”,
p.000257: “On additions to Criminal Code of the Russian Federation regarding to criminal liability for conducting
p.000257: medical trials involving human subjects without their voluntary consent” and others.
p.000257: Many medical schools developed medical oaths based on the Hippocratic Oath. In 1971 the Presidium of the Supreme Soviet
p.000257: of the USSR approved an official text of the Oath of Medical Doctor of the Soviet Union.
p.000257: In 1976 the Ministry of Health of the USSR approved interdepartmental curriculum on medical ethics (deontology)
p.000257: for higher medical and pharmaceutical educational facilities. The curriculum distributed the course along the
p.000257: entire educational process basing on that “concepts of morals and morality, development of higher feelings and medical
p.000257: ethics is an integral part of the entire educational process and should be implemented in various aspects during all
p.000257: years of training at all departments“.
p.000257: The curriculum stipulated one lecture for the 1 year students: “Medical ethics and medical
p.000257: deontology, their role for formation of a medical doctor and pharmacist” (Introduction for the subject);
p.000257: 5 lectures for the 2 year students: “Soviet health care as qualitatively new system“ (Department of
p.000257: Social Hygiene and Health Care Management), “Main peculiarities of deontology development at different stages of
...
p.000329: participant.
p.000329: To protect patients’rights and dignity,Article 25 prohibits propagandizing, including information in mass media,
p.000329: methods of prevention, diagnostics and treatment, as well as pharmaceutical products unless they undergo trials.
p.000329: The law “On Protection of Citizens’ Health” is closely linked with the law of the Republic of Uzbekistan “On Protection
p.000329: of Consumers’ Rights”. The title reflects the essence of the law – to protect consumers of any services (general,
p.000329: community, trade services, etc.) including medical ones. According to the Law, “a consumer is a citizen (natural
p.000329: person) who purchases, orders or has an intention to purchase or order goods or a service for personal use or a private
p.000329: non-profit household”.
p.000329: A consumer of medical services is a patient having certain rights defined by the Law. It is difficult
p.000329: enough to put a patient on the same level as the consumer of general, community or trade services. To provide a
p.000329: comprehensive protection of a patient’s rights a special law is needed, however, in the absence of such a
p.000329: law, provisions of the law “On Protection of Consumers’ Rights” are applied.
p.000329: It is noteworthy that in the events of a damage to a patient’s life and health the guilty part (medical professionals)
p.000329: are liable to criminal prosecution or to disciplinary or financial sanctions as prescribed by Articles 989 and 1022 of
p.000329: the Civil Code of the Republic of Uzbekistan. According to the Articles mentioned, the person who has suffered undue
p.000329: harm and/or moral damage
p.000329:
p.000330: 330
p.000330:
p.000331: 331
p.000331:
p.000331: resulting from an intervention is entitled to fair financial compensation estimated according to the
p.000331: conditions and procedures prescribed by law.
p.000331: Currently, there are but single instances of suits brought by patients or their relatives against medical institutions.
p.000331: Uzbekistan has little experience in considering such complaints at court, because citizens are not properly informed
p.000331: about their rights. The lack of knowledge in this field negatively affects physician-patient relationships and the
p.000331: treatment efficiency. It is physicians’ professional duty to know patients’ and physicians’ rights and
p.000331: responsibilities. Incidentally, while the patient may be ignorant of his rights and responsibilities relating to
p.000331: medical care, the physician usually has this knowledge but intentionally conceals it from the patient,
p.000331: which is a disadvantage to both the patient and the physician.
p.000331: To involve medical professionals in educational activity aiming at informing patients about their rights, as
p.000331: well as physicians’ rights is one of urgent tasks for the healthcare system of Uzbekistan. .
p.000331: Ethical norms considering special features in relationship with patients from various age and social groups should have
...
Political / nomad
Searching for indicator nomadic:
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p.000177: (Inventory).
p.000177:
p.000177:
p.000178: 178
p.000178:
p.000179: 179
p.000179:
p.000179: 3.6. KYRGYz REPUBLIC (A.z.zurdinov, U.M.tilekeeva, B.A.Alisherov)
p.000179:
p.000179: 3.6.1. Historical and Cultural Background
p.000179:
p.000179: Kyrgyz Republic is a country in the middle part of Central Asia; most of it is located in the Tenir-Too
p.000179: mountainous region. The territory of Kyrgyzstan is equal to 198.5 thousands sq. km; nearly 90% of the territory is 1500
p.000179: m above the sea level. According to 1999 census, the population is 4.8 million people including 3.1 million of
p.000179: ethnic Kyrgyz. About one third of Kyrgyzstan population (35%) lives in urban areas and 65% are rural population
p.000179: (1999).
p.000179: Kyrgyzstan is a multinational unitary state. The country is divided into seven administrative regions: Batken,
p.000179: Zhalal-Abad, Naryn, Osh, Talass, Chuisk, Issyk-Kul. The capital of Kyrgyz Republic is Bishkek, the form of
p.000179: government – republic.
p.000179: The land of Kyrgyzstan, like all Central Asia, is one of the most ancient places of human civilization. Archeological
p.000179: studies show that primitive men settled there in the time of the Stone Age. Kyrgyz ethnos that was known in Central
p.000179: Asia since the first millennium BC retained its self-name to our time. First politically organized communities in the
p.000179: territory of the present-
p.000179: day Kyrgyzstan appeared in the II century BC when southern agricultural regions joined the State of Parkan.
p.000179: During the IV and III centuries BC early Kyrgyz formed part of powerful unions of nomadic tribes that were a
p.000179: serious problem for China. It was the time when the Great Wall of China began to be built. During the II and I
p.000179: centuries BC a part of Kyrgyz tribes got away from the power of Hunnu State and moved to Enisei (the Kyrzys meaning of
p.000179: “Ene-sai” is the Mother-River) and Baikal (Rich Lake) regions. There they founded their first state Kyrgyz Kaganat that
p.000179: became the centre of the Kyrgyz consolidation and the centre of their culture where their written language
p.000179: developed. Runic inscriptions still can be seen on stone monuments. Invaders destroyed the state but they could not
p.000179: destroy people’s memory, although the written language was lost.
p.000179: During the V century the transition from nomadic to settled lifestyle began in the North of Kyrgyzstan. First written
p.000179: sources mentioning Kyrgyz tribes inhabiting Tian Shan date back to the X century.
p.000179: Petroglyphs of Saimaly Tash, one of the oldest and biggest collections of rock pictures, demonstrate a high level of
p.000179: Kyrgyz civilization. The Burana Tower and Uzgen architecture complex are examples of an amazing mastery of architects
p.000179: and builders.
p.000179: From the middle of the IX century to the beginning of the X century AD the Great Kyrgyz Khanate extended to the South
p.000179: Siberia, Mongolia, Baikal, the Upper Irtysh, Issyk Kul and Talas. This period was not only the time of conquests but
p.000179: also time of an active trade with China, Tibet and peoples of South Siberia and Central Asia. It was the period when
p.000179: after defeating the Uighur Kaganat the Kyrgyz for the first time entered the Tian Shan territory. In the X century,
p.000179: however, the Kyrgyz domination had shrunk to South Siberia, Altai and South-West of Mongolia and in the XI and
p.000179: XIIcenturies to Altai and Sayan Mountains. Nevertheless, parts of Kyrgyz tribes scattered over a large territory
p.000179: participated actively in numerous historical events in Central Asia. They managed to keep their ethnic
p.000179: independence and became the centre of attraction for other ethnic groups. The final stage of ethnogenesis related
p.000179: Kyrgyz people to Oirot (Kalmats), Naiman and other peoples of Central Asia.
p.000179: Starting from the XIII century Kyrgyz people had to fight wars of independence from different invaders. In
p.000179: the second half of the XV century Kyrgyz tribes joined in an independent khanate that embraced a major part of Kyrgyz
p.000179: people. The Great Silk Road was very important for Kyrgyzstan. The town of Osh – the main city in the south of the
p.000179: present-day Kyrgyzstan
p.000179: – due to its favorable geographic location was a transit town in the Fergana line of the Great Silk Road.
p.000179: In 1863 the North Kyrgyzstan and in 1876 the South Kyrgyzstan were incorporated into the Russian Empire. After the
p.000179: Great October Revolution Kyrgyz people, as other peoples of former tsarist Russia entered the Soviet Republic
p.000179: In 1918 Kyrgyzstan formed a part of Turkistan Autonomous Soviet Socialist Republic. In 1924 the Kara-Kyrgyz
p.000179: Autonomous Region within the Russian SFSR was established. In 1926 it was transformed into the Kyrgyz Autonomous
p.000179: Republic, and in 1936 – into the Kyrgyz Republic. On 31 of August 1999, Kyrgyzstan declared its independence.
p.000179: We know that myths and legends form the base of every culture. Nomadic life-style and the loss of written
p.000179: language of early Kyrgyz people
p.000179:
p.000180: 180
p.000180:
p.000181: 181
p.000181:
p.000181: stimulated the rise of a special philosophy that revealed itself in poetic folklore. It has accumulated the
p.000181: basic problems of human existence, mental and philosophic activity and spirituality.
p.000181: To reconstruct spiritual life of the Kyrgyz ancestors, we should mention an epic poem “Manas” that depicted
p.000181: historical events and ethnographic details, different aspects of the Kyrgyz life, worldview and national outlook
p.000181: from the III century BC (the Hunnu period) and to the beginning of the XX century. As a concentrated representation
p.000181: of folk philosophy, “Manas” is both the result of creative thinking across generations and the evidence of ancient
p.000181: Kyrgyz civilization. In fact, “Manas” is a moral code of the nomads and still a source of morals and humanism,
p.000181: as it describes customs and moral traditions, philosophical and aesthetic views, moral principles and norms
p.000181: of behaviour. With regard to its moral significance, “Manas” may be compared to Confucian Pentateuch. Like
p.000181: Confucian ethics, “Manas” depicts a model of putting the world into good order. Much attention is given
p.000181: to the struggle against chaos, which is expressed through regulation of human relationships, i.e. by establishing norms
p.000181: of behaviour, the system of prohibitions and social stratification.
...
p.000183: addresses his warriors:
p.000183: “Do not thou slaughter their cattle more that thou need for food, A foe today may be kinsman tomorrow,
p.000183: Do not thou harm them”.
p.000183: The early Kyrgyzstan was located on the crossroad of the Great Silk Road routs, which made it “a bastion of
p.000183: religious syncretism” where representatives of different confessions could coexist. This is, perhaps, the
p.000183: reason for a remarkable tolerance in the Kyrgyz in relation to other confessions and cultures of people
p.000183: inhabiting Kyrgyzstan.
p.000183: “The Beneficial Knowledge” by Jusup Balasagyn (XI c.) is another treasure of the Kyrgyz. The treatise was so
p.000183: perfect that in China it was titled “The Code of Decent Men”, in Iran – “The Book of Shahs” and in Turania
p.000183: – “The Book of Precepts for Rulers”. For Turkic peoples “The Beneficial Knowledge” “was as much important as “Lay of
p.000183: Igor’s Warfare” for Slavic peoples” (Naum Grebnev).
p.000183: “The Beneficial Knowledge” covers problems of sociology, ethics, aesthetics, theology and social psychology. It
p.000183: presents a sum of knowledge in different fields of science and culture of that time. The treatise presents a
p.000183: comprehensive system setting forth and analyzing philosophical problems relating to sense and meaning of human life. It
p.000183: defines human duties and norms of behaviour in the community and reflects “moral and ethical ideals with regard to
p.000183: life-style, culture and ideology of settled Turkic peoples still retaining the memories about their nomadic
p.000183: civilization” [13].
p.000183: According to “The Beneficial Knowledge” just and fair laws are the cardinal mechanism ensuring stability in the
p.000183: society, and everyone, be it a ruler or a subject should follow the laws.
p.000183: Law rules the world – we shan’t forget this, It is a sign of humanity inherent in people.
p.000183: In its character, “The Beneficial Knowledge” is an ethical and didactic poem written with the purpose to show the way
p.000183: towards learning the wisdom
p.000183: of government, every-day life and relationships between people on different occasions. Jusup Balasagyn describes
p.000183: qualities necessary for viziers, military commanders, secretaries, ambassadors, penmen and copyists,
p.000183: treasurers, cooks, cup-bearers, scientists, physicians, dream interpreters, magi, astrologers, merchants,
p.000183: cattle-breeders, craftsmen and others. He also writes how people should behave, reflects on human
p.000183: responsibilities and duties, virtues and vices. For Balasagyn sees “dissolution of morals and depreciation
p.000183: of spiritual values as one of the worst vices of his time” [8].
p.000183: A peculiar feature of “The Beneficial Knowledge” is that the author allows the reader to himself to gain an
p.000183: understanding of sense of life, of virtues and vices. Jusup Balasagyn argues that everyone should know and observe
p.000183: moral norms and rules of behaviour. “The Beneficial Knowledge” is a peculiar moral code of its time. Over a long time
p.000183: Kyrgyz ethnos had been existing in form of clans. Relationships within the community had been forming during
p.000183: a long historical period. Changes, if any, occurred due to the influence of external environment forming the worldview:
p.000183: the sense of sharing needs and interests of other people, feelings of mutual aid and collectivism. Kyrgyz people
p.000183: survived in crisis situations only due to spiritual and genetic health of their ancestors. People retained and
p.000183: developed clan traditions, upbringing practices, code of ancestral honour. Clan honour for Kyrgyz people is one of
p.000183: the most essential concepts. Every Kyrgyz had his ancestors, his land and his clan. Each clan had its hierarchy
p.000183: at the head of which was the most respected clan member. Collectivism, mutual aid, empathy, respect for other
p.000183: people – those were the qualities inherent in Kyrgyz mentality.
p.000183: Cultural and historical sources reveal respect to women in nomadic tribes, however there were conflicting
p.000183: traditions with regard to this issue. It is noteworthy that women had a high social status in Kyrgyz society [6].
p.000183: Ethical ideas in works by Kyrgyz thinkers. Spiritual culture of Kyrgyz people reflected in philosophical and poetic art
p.000183: of akyns20 is characterized by the search for perfection. Problems of upbringing and education, of humanism
p.000183: and love for people have a significant place in philosophical poetry of Kyrgyz thinkers, and therefore there
p.000183: is every reason to consider
p.000183: 20 Akyn is an improvising poet and singer in the Kazakh and Kyrgyz cultures. Akyns played and important role in terms
p.000183: of expressing people’s thoughts and feelings, exposing social vices, and glorifying heroes.
p.000183:
p.000184: 184
p.000184:
p.000185: 185
p.000185:
p.000185: it as a code of moral and ethical norms on human behaviour in Kyrgyz culture. Some scientists associate
p.000185: this special attention to moral issues with an access to Chinese sources known for their interest in ethics. The
p.000185: history of development of ethical and philosophical ideas in Kyrgyz culture may be divided into three stages. The first
p.000185: stage is associated with names of late medieval Kyrgyz thinkers: Asan-Kaigy (XV c), Tolubai Synchi and Sanch- Synchi
p.000185: (XIII c) [3]. Kyrgyz people justly call them legendary thinkers, folk sages (akylmanam). We know about these
p.000185: Kyrgyz thinkers from folk legends. Only fragments of their sayings survived to our time.
...
p.000185: 21 Zamanism – philosophical teaching about frailty and an inevitable tragic end of the world
p.000185:
p.000186: 186
p.000186:
p.000187: 187
p.000187:
p.000187: leader expressing expectations of Kyrgyz people through his poetry inspires their hopes.
p.000187: Problems of justice are very essential for Kalygul. Being a judge, he proclaims a kind of ethical code comprising
p.000187: universal values and norms of human behaviour: honesty, unselfishness, justice, mutual respect.
p.000187: Criticizing the state system of their time as a form of social inequality akyns offered a moral characteristic of
p.000187: behaviour in different social strata. Akyn-democrats tended to give a realistic picture of the world. Thus
p.000187: Toktogul Saltyganov presents his ethical views through opposing the good to the evil. Jenijok taught that every man
p.000187: should strive for self-perfection from his young days [7].
p.000187: Akyn-zamanists were spiritual elite of Kyrgyz society and true patriots. Their laments were neither the echo of
p.000187: feudalism nor an attempt to stop the development of the society. Those were the thoughts about the traditional culture
p.000187: that in their time was at a deadlock and could not find way out of it; thoughts about the future of Kyrgyz people. They
p.000187: understood well a close connection between the destiny of their people and the integrity of ethno- cultural space.
p.000187: Today we may rightly say that zamanism is a special king of creative work of poetry initially establishing in set
p.000187: verbal formulae a system of moral and ethical priorities of nomadic peoples. Zamanists lived in the epoch of
p.000187: disintegration of traditional Kyrgyz community, and therefore efforts were required to form an integrated Kyrgyz
p.000187: nation. They realized the hardship of that mission and used for that purpose moral norms and rules of behaviour that
p.000187: did not lose their significance to our days.
p.000187: The next stage in ethics development is associated with names of akyn- democrats Toktogul Satylganov (1864-1993),
p.000187: Togolok Moldo (1860-1942), Jenijok (1860-1918), Varna Alykulov (1884-1949). In contrast to their predecessors,
p.000187: they actively expressed ethical views of oppressed sections of Kyrgyz population.
p.000187:
p.000187: References
p.000187: 1. Abramzon S.M. Kyrgyz People and their Ethno-Genetic, Historical and Cultural Contacts. Leningrad, 1971, p. 152 (in
p.000187: Russian)
p.000187: 2. Akmoldoeva Sh. B. Spiritual World of the Early Kyrgyz (Analyzing Epos). “Manas” and Concepts of Geneva
p.000187: Conventions. Bishkek, 1999, p. 211 (in Russian)
p.000187: 3. Amanaliev A. From the History of Kyrgyz Philosophy. Frunze, 1863 (in Russian).
p.000187: 4. Asan-Kaigy. In: Anthology of Kyrgyz Portry. Bishkek, 1999 (in Kyrgyz)
p.000187: 5. Valikhanov Ch. Collected Works. Vol. 1-5. Alma-Ata, 1961-1972 (in Russian)
p.000187: 6. Kurmanjan the Mountain Queen and Her Time. Bishkek, 2002 (in Russian)
p.000187: 7. Jenijok. Poetic Works. Frunze, 1982 (in Kyrgyz)
p.000187: 8. Jusup Balasagyn “The Beneficial Knowledge”. Frunze, 1988, p. 339 (in Russian)
p.000187: 9. Kalygul Bai Uulu In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
...
Searching for indicator nomads:
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p.000179: Great October Revolution Kyrgyz people, as other peoples of former tsarist Russia entered the Soviet Republic
p.000179: In 1918 Kyrgyzstan formed a part of Turkistan Autonomous Soviet Socialist Republic. In 1924 the Kara-Kyrgyz
p.000179: Autonomous Region within the Russian SFSR was established. In 1926 it was transformed into the Kyrgyz Autonomous
p.000179: Republic, and in 1936 – into the Kyrgyz Republic. On 31 of August 1999, Kyrgyzstan declared its independence.
p.000179: We know that myths and legends form the base of every culture. Nomadic life-style and the loss of written
p.000179: language of early Kyrgyz people
p.000179:
p.000180: 180
p.000180:
p.000181: 181
p.000181:
p.000181: stimulated the rise of a special philosophy that revealed itself in poetic folklore. It has accumulated the
p.000181: basic problems of human existence, mental and philosophic activity and spirituality.
p.000181: To reconstruct spiritual life of the Kyrgyz ancestors, we should mention an epic poem “Manas” that depicted
p.000181: historical events and ethnographic details, different aspects of the Kyrgyz life, worldview and national outlook
p.000181: from the III century BC (the Hunnu period) and to the beginning of the XX century. As a concentrated representation
p.000181: of folk philosophy, “Manas” is both the result of creative thinking across generations and the evidence of ancient
p.000181: Kyrgyz civilization. In fact, “Manas” is a moral code of the nomads and still a source of morals and humanism,
p.000181: as it describes customs and moral traditions, philosophical and aesthetic views, moral principles and norms
p.000181: of behaviour. With regard to its moral significance, “Manas” may be compared to Confucian Pentateuch. Like
p.000181: Confucian ethics, “Manas” depicts a model of putting the world into good order. Much attention is given
p.000181: to the struggle against chaos, which is expressed through regulation of human relationships, i.e. by establishing norms
p.000181: of behaviour, the system of prohibitions and social stratification.
p.000181: “Manas” is called a “cultural encyclopedia” of Kyrgyz people. It ranks among outstanding monuments of world
p.000181: culture, such as “Iliad” and “Odissey”, “Mahabharata”, “Epic of Gilgamesh”, “Kalevala”, “Rigveda” and many
p.000181: others. The Turkic epic poem “Manas” differs from west European, Slavonic and other epic poems not just in its
p.000181: volume. It covers a long historical period and gives a detailed genealogy and a distinct biographical line of
p.000181: athlete Manas – the central hero of the epic poem – from the moment of his birth to his death including the description
p.000181: of main events of his life. Poems, songs and legends passed across the generations served as a teaching
p.000181: material in folk pedagogics. The unique nature of oral folklore allows people to pass their moral knowledge to
p.000181: future generations within a family and within a clan thus ensuring continuity of spiritual life and
...
Political / person under arrest
Searching for indicator arrested:
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p.000267: topical post-graduate education, establishment of the bioethics grade.
p.000267:
p.000267: 3.8.4. System of Ethical Review
p.000267:
p.000267: The Russian legislation in the field of ethical and legal provision for biomedical research is represented with a range
p.000267: of documents. First of all, it is the Constitution of the Russian Federation (Art.21), which states: “… no one can be
p.000267: made undergo medical, scientific or other experiments without his/her consent.” Beside, there is the Basics of the
p.000267: Legislation of the Russian Federation on Protection of Health of Citizens where Article 43 considers issues on
p.000267: application of new methods of prevention, diagnostics, treatment; medical agents, immunobiological agents and
p.000267: disinfecting agents and biomedical research conduct. However, this article is declarative to a large extent: rights
p.000267: of citizens involved in biomedical studies stipulated there do not have any mechanisms of implementation and
p.000267: enforcement, including the ones via ethical review of applications for research conduct. At the same time,
p.000267: in accordance with this document children of age below 15 can participate in studies of new medicinal agents, methods,
p.000267: etc, only in case of vital indications though in real life this statement is constantly breached that is inevitable and
p.000267: determined with realia of medical practice development and scientific progress. Article 29 of this document prohibits
p.000267: involvement into studies of those arrested or convicted though, in some cases these persons can benefit from
p.000267: their participation in clinical biomedical research. In this respect the Russian legislation differs from
p.000267: European norms that allow in case of specific and clearly defined conditions to hold studies with involvement of
p.000267: those categories of citizens. Another document regulating possibility for conduct of biomedical studies in the Russian
p.000267: Federation is the Law on Psychiatric Care where Article 5 proclaims the right of a person with mental disorder to
p.000267: consent or to refuse of participation in such studies though necessity for such action is not stipulated. The Law on
p.000267: Pharmaceutical Products analyzes quite profoundly those norms regulating research on new
p.000267: medicinal agents but, regretfully, it covers only one though rather important sphere of biomedical research – studies
p.000267: of pharmaceuticals. This law as it is shown by the text is written basing on an assumption that each study is premised
p.000267: with an examination held by an ethical committee but either status, or authority, or order of creation, or composition
p.000267: of ethical committees are not stipulated by the Law; there only guidelines that “the ethical committee acts at the
p.000267: federal executive authority which competence covers state control and surveillance in the sphere of pharmaceuticals”
p.000267: (Art. 37). There is also no such mechanism for creation and activities of such organization in any other Russian legal
p.000267: document. The National standard of the Russian Federation GOST R52379-2005 “Good Clinical Practice” adopted in 2006
...
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p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armed forces, prisoners and persons under arrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
p.000119: • Equal rights of patients and physicians to respect for their human dignity (Art. 14);
p.000119: • Mutual trust and mutual responsibility of the patient and the physician, patient is an active participant of the
p.000119: treatment process (Art. 16);
p.000119: • Compulsory consent from the patient for a medical intervention, except for cases provided by law (Art.
p.000119: 21);
p.000119: • Compulsory written consent from a patient, his/her close relatives or legal representatives for removal
p.000119: organs or tissues for diagnostic or therapeutic purposes; removal of organs and tissues for other purposes may not
p.000119: be carried out (Art. 23);
p.000119: • Confidentiality of patients’ personal data obtained in the patient— physician relationship; it is not permitted to
...
p.000331: - independent ethical review;
p.000331: - insurance;
p.000331: - operational standard procedures.
p.000331: A number of other documents (decrees of the President of Republic Uzbekistan, decrees of the Cabinet of the
p.000331: Republic of Uzbekistan, orders and guidelines of the Ministry of Public Health) have been adopted for a further
p.000331: healthcare development (reforming the system of medical service, creating necessary material and technical conditions
p.000331: for providing healthcare at state and private medical institutions, etc.).
p.000331:
p.000332: 332
p.000332:
p.000333: 333
p.000333:
p.000333: Uzbekistan adopted basic international documents in the field of bioethics, such as
p.000333: 1. Declaration of Helsinki
p.000333: 2. Universal Declaration on Human Rights (1948)
p.000333: 3. The Universal Declaration on the Human Genome and Human Rights (1997)
p.000333: 4. Monaco Declaration (18 of July 2001),
p.000333: 5. International Declaration on Human Genetic Data (adopted by UNESCO General Assembly; 16 of Octobe, 2003
p.000333: 6. Universal Declaration on Bioethics and Human Rights (UNESCO, 2005)
p.000333: 7. United Nations Declaration on Human Cloning (8 of March 2005)
p.000333: 8. ECOSOS Resolution “Genetic privacy and non-discrimination” (21 of July 2004)
p.000333: 9. Resolutions of ECOSOS Commission for Human Rights:
p.000333: - Human Rights and Bioethics (25 of April 2003);
p.000333: - Principles of biomedical ethics with regard to the role of medical professionals, particularly
p.000333: physicians, in the protection of prisoners or persons under arrest against tortures and other cruel, inhuman or
p.000333: disgracing attitude and punishment (18 of December 1982);
p.000333: - Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of
p.000333: Mankind (10 of November 1975).
p.000333: In its activity the National Ethics Committee (NEC) of the Republic of Uzbekistan at the Ministry of Public Health of
p.000333: Uzbekistan uses also other international documents, such as
p.000333: 1. Final Act of the International Conference on Healthcare (New-York, 22 July 1946)
p.000333: 2. The Nuremberg Code (1947)
p.000333: 3. Universal Declaration on Human Rights 1948
p.000333: 4. Declaration of Helsinki (WHO, 1964, 2002)
p.000333: 5. European Agreement on Providing Medical Assistance to Persons Temporarily Residing in Other [Member] (Geneva, 17
p.000333: of October 1980)
p.000333: 6. Convention on Biological (Rio de Janeiro, 5 of June 1992)
p.000333: 7. Budapest Summit Decisions. Human Dimension (Budapest, 1994)
p.000333: 8. Agreement on Collaboration in Public Health Protection (Minsk, 26 of June 1992)
p.000333: 9. The Charter of Social Rights and Guarantees to the Citizens of Independent States (approved by the
p.000333: Inter-parliamentary Assembly of the Commonwealth of Independent States, 29 of October 1994)
p.000333: 10. Convention on Human Rights and Biomedicine (Council of Europe, 1996)
p.000333: 11. Note for Guidance on Good Clinical Practice (ICH, 1996)
p.000333: 12. WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
...
Political / political affiliation
Searching for indicator party:
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p.000035: Care of the Republic of Tajikistan No.118, 10 of March 2005, etc.
p.000035:
p.000036: 36
p.000036:
p.000037: 37
p.000037:
p.000037: usually, perform ethical examination of research projects are created and work subjected to central executive
p.000037: authorities (usually these are ministries regulating activities in the sphere of health care, labor, social policy,
p.000037: etc.; in some of the countries these are national academies of sciences). There are also regional and local ethical
p.000037: committees at scientific medical Centres as well as committees at professional medical societies. In some of the
p.000037: countries the research ethics committees have a function of consulting higher state authorities on issues for
p.000037: development of policies in health care as well as resolving conflicts associated with routine medical practice.
p.000037: Participation of all CIS countries in the process of moral and ethical professional resolution of medical practical and
p.000037: research activities appears to be important. Many of the Commonwealth countries have already adopted or are developing
p.000037: ethical codes for medical and pharmaceutical workers, have approved national oaths for medical school graduates,
p.000037: ethical codes for medical doctors15. These codes and oaths provide higher vs. the legal enactments ethical
p.000037: standards for behavior of representatives of medical profession and are related to both relationships of doctors with
p.000037: their patients, with third party persons and to intracorporate relations.
p.000037: Analyzing trends in development of ethical and legal control of biomedical activities in the Commonwealth
p.000037: countries one cannot but mention influence of religious tradition on this process. For instance, in some
p.000037: of the Central Middle Asia countries daily practice of medical workers and researchers to a large extent is based on
p.000037: norms of the Koran, Shariat, Hadises. An important role as a guideline for national policy formation in the field of
p.000037: ethical examination development of biomedical studies as well as for protection of the rights of patients and study
p.000037: subjects is played by the Code of Islam medical ethics. Countries with prevailing Orthodox religious tradition showed
p.000037: that a significant role for ethical consideration of medical science and practices is dedicated to Basics of the Social
p.000037: Concept of the Russian Orthodox Church (2000) containing official position on many of the most arguable bioethical
p.000037: issues.
p.000037: 15 For instance, The Code of Medical Ethics of Armenia, The Ethical Code of Medical Doctor of Georgia, The Ethical
p.000037: Code of Pharmacists of the Kyrgyz Republic, The Ethical Code of Nurse of Russia, The Oath of Medical Doctor of Russia,
p.000037: The Medical Ethics Code of Russia. In Uzbekistan the code on bioethics issues is under development, in Kazakhstan they
...
p.000037: States, which as one of the main objectives takes development of mechanisms for interstate regulation of respect for
p.000037: human rights in the region. IPA CIS as an agency for inter- parliamentary cooperation accumulates information on
p.000037: political, economic, social and cultural, ecological, demographic and other constituents of life of the Commonwealth
p.000037: countries that provides effectiveness, timeliness and demand for produced recommendations on harmonization and
p.000037: convergence of legislation of the CIS countries. Activity of IPA CIS in this respect is versatile and includes a range
p.000037: of spheres and areas determined with specifics and competence of permanent commissions such as commission on social
p.000037: policy and human rights, on legal issues, on science and education, on foreign policy issues, on defense
p.000037: and security, etc. In 1998 the Council of IPA CIS as the higher leading authority of the Assembly approved the
p.000037: declaration that emphasized solidarity of national parliaments with ideology
p.000037:
p.000038: 38
p.000038:
p.000039: 39
p.000039:
p.000039: of the Universal Declaration of Human Rights and stressed that since the moment of its proclamation the field of human
p.000039: rights exhibited considerable progress in general and that efforts in the field of human rights undertaken within CIS
p.000039: are also directed on provision of common respect for them, facilitation of strengthening of atmosphere of
p.000039: friendship and trust, effective implementation of multi-party agreements where a special place is given to the CIS
p.000039: Convention on Human Rights and Fundamental Freedoms adopted in Minsk in 1995.
p.000039: Criminal, penal procedure and penal enforcement model codes adopted by IPA CIS being a basis for development of similar
p.000039: codes in some of the Commonwealth countries should be considered as norms of general type establishing crucial
p.000039: requirements to an order of legal act execution in regard to main freedoms and rights of citizens in the Commonwealth
p.000039: countries. Statements of the given model codes were also reflected in initiation and creation of many legislator
p.000039: enactments in the CIS countries in the field of criminal law and criminal procedures. The model civil code adopted by
p.000039: IPA CIS has special values for establishing of new conditions for administration and management in all spheres of
p.000039: activities and its main statements were to some extent practically embodied in civil legislation of all CIS countries.
p.000039: Activity of the Permanent Commission on social policy and human rights of IPA CIS has a special value from the
p.000039: point of harmonizing influence on the health care field. After initiatives of the said commission model laws
p.000039: determining main statements for a complex welfare system were adopted, a list of international conventions recommended
p.000039: for immediate ratification by the CIS countries was developed, a set of model laws on rights of human beings related to
...
p.000233: themselves into health care, integrity of academic and practical medicine – became determining aspects of the Soviet
p.000233: health care.
p.000233: After the revolution of 1917 medical ethics in the USSR underwent it way of development and was influenced by a range
p.000233: of factors.
p.000233: Medicine started to be perceived from a position of class, individualistic bourgeois medicine being matched against
p.000233: collectivist and proletarian, which led to neglecting a personal value of a human being and it absolute humility to
p.000233: social use. In terms of ethics and morality key significance also belonged to class approach. It was promoted that
p.000233: medical ethics represented corporate and class ideology alien to the working class needs. In contrast to medical ethics
p.000233: common ethical norms of communist morality were pushed forward. These conditions altered social perception of a medical
p.000233: doctor. In the early years of the Soviet regime a physician was seen as representing hostile bourgeois class and
p.000233: should have been tolerated as a specialist but was allowed to practice only under rigid supervision of
p.000233: the working class. Subsequently, physicians suffered political and ideological pressure. Unfortunately, repressions
p.000233: against medical professionals were started time and again and they were accused of poisoning and killing both
p.000233: common citizens and party and state leaders. Priority trends in medicine and health
p.000233:
p.000234: 234
p.000234:
p.000235: 235
p.000235:
p.000235: care were determined not by logical development of science and essential needs but were rather dictated by economic
p.000235: policy, ideology and conformist ideas.
p.000235: Repressive measures taken against genetics, pedology; campaigns restricting research in physiology, psychology
p.000235: and other areas that impeded and even set back many promising academic and applied directions of science can
p.000235: serve us a good example.
p.000235: There was a target to stipulate ideology for a physician of a new type. The contrast in moral portrait of doctors in
p.000235: capitalist and socialist societies is rendered in the lines by first People’s Commissar for health care N.A. Semashko:
p.000235: “Certainly among foreign physicians there are doctors who perceive there duties the way their humane profession
p.000235: suggests them. But is it a rule and what is an exception? This would depend on the ground where these phenomena bud.
p.000235: Capitalistic ground is rocky and not suited to growing humanistic ideas. If in a capitalistic society “dog eats dogs”,
p.000235: how can we speak of any humanistic feelings? All this finds its way into a physician’s behavior… It is clear that the
p.000235: problems of the so called medical ethics are solved completely differently in our country and in the
p.000235: capitalist world. Ethics for a soviet physician means the ethics of our socialist Motherland, the ethics appropriate
...
p.000337: Physician-investigator should safeguard the patient’s right to withdraw his/her consent to participate in a research at
p.000337: any time and for any reason.
p.000337: This draft project of the law has been submitted to the Legislative Chamber of Uzbekistan Parliament; it
p.000337: has been discussed, and will be adopted in 2007.
p.000337: Alongside the patients’ rights, the Law “On Medical Practice” implies patients’ responsibilities. Thus, Article 47
p.000337: states that the patient should
p.000337: - to show tact and respect towards medical professionals;
p.000337: - to give comprehensive information necessary for the diagnostics and treatment of a disease;
p.000337:
p.000338: 338
p.000338:
p.000339: 339
p.000339:
p.000339: - to follow the physician’s prescriptions after having given consent to a medical intervention;
p.000339: - to comply with the routine of the healthcare institution;
p.000339: - to collaborate with the physician in the process of treatment;
p.000339: - to inform the physician without delay about a change in his/her health condition in the process of diagnostics and
p.000339: treatment;
p.000339: - to apply to the physician immediately if there is a suspicion of a disease or a disease posing hazard of a wide
p.000339: spreading;
p.000339: - to avoid any actions that may infringe other patients’ rights.
p.000339: It is essential to include into the draft project of the Law provisions on the physician’s rights and responsibilities
p.000339: that enhance the rapport with the patient, as both the patient and the physician become partners having reciprocal
p.000339: rights and responsibilities, and the right for one party, is the responsibility of another one.
p.000339: The Law “On Medical Practice” will facilitate the regulation of independent ethical review and safeguard the
p.000339: protection of rights and dignity of Uzbekistan citizens in biomedical trials.
p.000339: Legislative measures undertaken in Uzbekistan will be able to protect individuals, the society and humankind as a
p.000339: whole against undesirable or sometimes harmful consequences from the implementation of new biomedical
p.000339: technologies.
p.000339:
p.000339: 3.11.3. Education in Bioethics
p.000339:
p.000339: Problems of teaching bioethics arouse much discussion at all international forums on bioethics.
p.000339: According to UNESCO Ethics Education Programme (EEP), for the biennium 2004-2005 the activities in the area of ethics
p.000339: teaching have primarily focused on East and Central Europe. During 2006-2007 priority has been given to
p.000339: South-East Europe and part of the Arab region (Gulf region).
p.000339: To facilitate the development of new relations in Uzbekistan healthcare that would more adequately comply with
p.000339: current political and social conditions, all Uzbekistan institutes of higher medical institutions and
p.000339: universities (faculties of law, philosophy and biology) introduced regular courses on bioethics into the syllabi
...
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p.000007: decrease, mortality growth and a fall of the health quality index. These processes affect negatively the demographic,
p.000007: labour and migration potential of the CIS countries.
p.000007: The last decade of the XX century was characterized by an essential aggravation of the demographic situation that could
p.000007: be defined as a crisis. High mortality rates had practically no precedents in the Eurasian peacetime history. The
p.000007: “excess mortality” in the period since 1989 was much higher than the mortality rate in the period of Great Depression
p.000007: in the North America (1929-1933). Besides, recent changes of mortality rate, marriage ability and fertility shifts have
p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
p.000009: stability and to the whole process of reformation; however, there is a certain stabilization of the situation.
p.000009: Let us consider changes in resident population of the CIS countries and Turkmenistan in the period from 1991 to 2006.
p.000009: (Table 1).
p.000009: The presented data show the increase of population in Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan,
p.000009: Turkmenistan and Uzbekistan considering the change in the tendencies of population reproduction.
...
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
p.000025: efficiency of social assistance programs by weight of amounts received by families beyond the poverty line in total
p.000025: amounts of social support).
p.000025: 1.2 Ethical and Legal Issues
p.000025: in the Field of Biology and Medicine (o.I.Kubar, B.G.Yudin, A.E.nikitina, E.Yu.Vladimirova)
p.000025:
p.000025: Characterizing trends of legal and ethical control in the sphere of practical health care and biomedical
p.000025: research in the CIS member states it is necessary to emphasize a multilevel system of factors determining common
p.000025: pattern of directions, characteristics, features and mechanisms of national and international, retrospective and
p.000025: perspective influence. A rationale for forming of the given community is geographical closeness, unity of political
p.000025: history of the pre-Soviet and Soviet periods, contingency and interpenetration of cultures and traditions, forming
p.000025: extreme ethnical, cultural and religious multiplicity making countries in the region different.
p.000025: By itself such multiplicity leads, in particular, to the following - the set of actual ethical norms being a basis for
p.000025: medical care in the region countries is a historical foundation and a clear reflection of tolerance concepts both to
p.000025: cultural differences as they are and to their particular carriers. Moreover, in this case we can talk not just about
p.000025: tolerance but also about respectful relationship to differences of that kind.
p.000025: One more factor, which should be taken into account when explaining closeness of ethical and legal basis of health
p.000025: care, is that other countries in the region inherited legal base that was established in the Soviet period of their
p.000025: history. It should be noted that the legal system existing in the USSR in the field of medicine and health care,
p.000025: first, was of declarative nature, and, second, paid insufficient attention to issues of protection of rights and
p.000025: dignity of both patients and participants of biomedical research.
p.000025: Therefore, after the USSR breakup and appearance of new independent states they faced tasks of development of new legal
p.000025: framework in the field of practical and experimental biomedicine. All CIS countries in different forms proclaimed such
p.000025: basic norms of state development as adherence to principles of a social state, which policy is directed for creation of
...
p.000031: Ukraine; and it is only Georgia that actually ratified it. At the same time, acknowledgement of high authority of the
p.000031: Convention in this or that form is generally common for virtually entire bioethical community in all CIS countries.
p.000031: The international enactments mentioned above became a basis for legal regulation of biomedical research and
p.000031: their ethical review in all CIS countries (detailed analysis of legal participation of a particular country in any of
p.000031: international documents – recommendation influence, ratification, adaptation to national legislation, etc. –
p.000031: is presented in our book in corresponding chapter for each specific state). A crucial issue emphasizing profound
p.000031: importance of international documents regulating this sphere is a fact of priority of international law
p.000031: approved by all Commonwealth countries. International cooperation in the field of bioethics is implemented also
p.000031: through formation of regional programs and Centres of bioethics and research ethics with involvement of
p.000031: international organizations being leaders in this field. A convincing example of such cooperation is a setup of
p.000031: national committees of bioethics with UNESCO support in some of the Commonwealth countries and planned scientific and
p.000031: educational activities of the UNESCO office in Moscow and some other countries in the region
p.000031: being held in context of national, social and cultural, historical and political traditions and utilization of the
p.000031: world experience in the field of bioethics.
p.000031: In 2001 animportant bioethical resource, the Forumfor Ethics Committees in the CIS (FECCIS), was established in the
p.000031: region. The FECCIS is one of five regional forums created within the framework of the WHO project, the Strategic
p.000031: Initiative for Developing Capacity in Ethical Review (SIDCER). Sharing main priorities of the WHO SIDCER project on
p.000031: protection of the rights and dignity of research subjects in all countries in the world basing on respect to cultural,
p.000031: religious and national differences the FECCIS seeks the main task of facilitating development of bioethics in the
p.000031: region of the CIS countries, paying specific attention to ethics of biomedical research involving human
p.000031: subjects. During all its years of existence (2001–2007) the Forum activities were directed on development of regulatory
p.000031: and methodical basis on research ethics; development and implementation of education programs for members of
p.000031: ethical committees; development of information space and extensive dialogue with various parties involved in ethical
p.000031: review of biomedical research that, certainly, facilitated harmonization of both regional and global
...
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
p.000033: state becomes a guarantor for protection of personal rights and freedoms. Other directions of the state
p.000033: policy in social sphere are also extremely important for provision of human rights in the area of health care and
p.000033: biomedical research.
p.000033: 9 The Constitution of Kyrgyz Republic also mentions psychological tests in this list (Art.18 of the Constitution of
p.000033: Kyrgyz Republic). Since there is almost no special legal regulations within the regions of the CIS countries for such
p.000033: sphere of biomedical research as psychological studies this fact has a special value. Such constitutional statement can
p.000033: become a basis for independent regulation of the given type of experiments.
p.000033: 10 Art. 16 and Art. 24 of the Constitutions of Kyrgyz Republic and the Republic of Moldova, respectively.
p.000033: The right for protection of health and its state support are legally fixed in all Commonwealth countries (Art. 34 of
p.000033: the Constitution of the Republic of Armenia, Art. 41 of the Constitution of the Republic of Azerbaijan, Art. 45 of the
p.000033: Constitution of the Republic of Belarus, Art. 37 of the Constitution of Georgia, Art. 29 of the Constitution of the
p.000033: Republic of Kazakhstan, Art. 34 of the Constitution of the Kyrgyz Republic, Art. 36 of the Constitution of the
p.000033: Republic of Moldova, Art. 41 of the Constitution of the Russian Federation, Art. 38 of the Constitution of the
...
p.000037: solidarity. Translating the given point at the language of conflicts of interests that appear at the pace of scientific
p.000037: and technological progress in any sphere of human activities (including biology and medicine), one can notice
p.000037: crystallization of the main advantage of a social state being acknowledgement of the role of ethics for resolution of
p.000037: conflicts and interpretation of ethical principles as state control mechanisms.
p.000037: However, it is worth stressing that in order to protect social rights of citizens only legal mechanisms and procedures
p.000037: for prevention of breaching of these rights are far from being sufficient. Along with aforementioned versatile
p.000037: state activities aimed on development of conditions for execution of these rights and freedoms as well as readiness of
p.000037: society for their conscious perception and compliance are required.
p.000037: This process takes prolonged gradual movement on development of a complex mechanism for protection of
p.000037: human rights and constitutes of legal, administrative, economic and humanitarian means. Such objective is
p.000037: implemented in the most consistent fashion by the Inter-Parliamentary Assembly of the Commonwealth of Independent
p.000037: States, which as one of the main objectives takes development of mechanisms for interstate regulation of respect for
p.000037: human rights in the region. IPA CIS as an agency for inter- parliamentary cooperation accumulates information on
p.000037: political, economic, social and cultural, ecological, demographic and other constituents of life of the Commonwealth
p.000037: countries that provides effectiveness, timeliness and demand for produced recommendations on harmonization and
p.000037: convergence of legislation of the CIS countries. Activity of IPA CIS in this respect is versatile and includes a range
p.000037: of spheres and areas determined with specifics and competence of permanent commissions such as commission on social
p.000037: policy and human rights, on legal issues, on science and education, on foreign policy issues, on defense
p.000037: and security, etc. In 1998 the Council of IPA CIS as the higher leading authority of the Assembly approved the
p.000037: declaration that emphasized solidarity of national parliaments with ideology
p.000037:
p.000038: 38
p.000038:
p.000039: 39
p.000039:
p.000039: of the Universal Declaration of Human Rights and stressed that since the moment of its proclamation the field of human
p.000039: rights exhibited considerable progress in general and that efforts in the field of human rights undertaken within CIS
p.000039: are also directed on provision of common respect for them, facilitation of strengthening of atmosphere of
p.000039: friendship and trust, effective implementation of multi-party agreements where a special place is given to the CIS
p.000039: Convention on Human Rights and Fundamental Freedoms adopted in Minsk in 1995.
p.000039: Criminal, penal procedure and penal enforcement model codes adopted by IPA CIS being a basis for development of similar
...
p.000049: Today, however, we can if to use the term by the German sociologist, M.Weber, talk about routinization of this
p.000049: very process of technological upgrades when new technologies do not break into manufacturing activities, into lives
p.000049: of people, but are placed into preliminary prepared “cells”. In other words, new technologies are “custom-made”. More
p.000049: often this sequence is built in order directly opposite to the common way: development of a new technology starts only
p.000049: when and because there is already a demand for it.
p.000049:
p.000049: Phenomenon of “technoscience”
p.000049: Today in the beginning of the XXI century we have all grounds to say about qualitatively novel stage in
p.000049: development not only of science but its interaction with the society as well. One of the ways expressing it
p.000049: is establishment of a new type of interaction between science and technology that was called technoscience. For
p.000049: instance, the English sociologist Barry Barnes wrote: “The term technoscience now is widely used in academic
p.000049: sphere and is related to such activity within which framework science and technology form a kind of a mixture or a
p.000049: hybrid… technoscience should be perceived as specifically modern phenomenon” (B.Barnes. Elusive Memories of
p.000049: Technoscience. – Perspectives on Science: Historical, Philosophical, Social. Vol. 13, Issue 2 – Technoscientific
p.000049: Productivity, Summer 2005, pp. 142-165). The most evident sign of technoscience is considerably more profound
p.000049: than before built-in pattern of scientific cognition into activities on development and promotion of new technologies.
p.000049: According to the German sociologist and political scientist, Wolf Schäfer: “Technoscience is a hybrid of science-based
p.000049: technology and technology-based science. Global phone communications and genetically modified products are
p.000049: para-scientific things: their invasion into our world is due to complex interweaving of particular human
p.000049: interests with modern understanding of electricity, on one hand, and genetics, on the other.” (W.Schäfer. Global
p.000049: technoscience: the dark matter of social theory.Univ. of Maryland conf. on globalizations, April 2002.
p.000049: www.bsos.umd.edu/socy/conference). Here, as you can see, our attention is drawn to the fact that technoscience is not
p.000049: only the tightest link between science and technology, but also such symbiosis that includes also human aspirations and
p.000049: interests.
p.000049: However, relationships of science and technique in this symbiosis are internally contradictive. On one
p.000049: hand, science is a generator of new technologies and due to stable demand on these new technologies science
p.000049: enjoys some, and sometimes quite generous support. On the other hand, production of new technologies dictates
p.000049: demand on science of specific, if you wish limited, single-sided type, therefore, many potentials of science being
p.000049: used this way are still outstanding. Roughly speaking, science is required neither to explain, nor to
p.000049: understand things – it is quite sufficient that it makes possible to alter them effectively.
p.000049: Besides, it assumes understanding of human cognitive activities including the scientific one, as an
p.000049: activity being secondary to some extent, subjected to practical transformation, changing of both the world
...
p.000059: an owner of knowledge was an individual scientist. Idea of his personal responsibility corresponded to
p.000059: such state of affairs. In biotech companies there appears corporate ownership of gained knowledge. Space of
p.000059: personal responsibility shrinks dramatically. But at the same time there emerges idea of collective (corporate)
p.000059: responsibility or accountability to the society. From the point of view of ethics there appears a new type
p.000059: of a moral subject (“businessman scientist”), for whom similarly doubled ethos is characteristic. In English
p.000059: publications oppositions of these two ethos’s features is sometimes fixed in terminological sense as a relation of
p.000059: personal responsibility and corporate accountability for the society.
p.000059: From the R.Merton’s point of view scientific society ethos includes the following principles:
p.000059: 1. “Communism (collectivism)” – knowledge as a result of scientific activity is a public domain. Any scientific
p.000059: knowledge is built upon results of previous studies. Therefore, a scientist should comprehend himself as a
p.000059: member of scientific society who is able of implementing his destiny only cooperating with other. His duty is
p.000059: to share unselfishly his scientific results with other scientists and publish them in publications available to the
p.000059: public.
p.000059: 2. “Universalism” – assessment of importance of scientific achievements of a scientist should be based exclusively upon
p.000059: their objective assessments, irrelevantly to his nationality, association with this or that scientific
p.000059: institution, personal features, religious or political views.
p.000059: 3. “Disinterest” – scientific research shall be motivated only with a desire to arrive at the truth. It is
p.000059: necessary to exclude all non-scientific interests – economical, political, religious, and etc.
p.000059: 4. “Established skepticism” – researchers must be critical to results of work not only of others but also of their own.
p.000059: Only basing on systematical criticism scientific ideas can get rid of errors and come closer to the truth. A duty of a
p.000059: scientist is to question constantly obtained results.
p.000059: These aforementioned four Merton’s principles form scientific society ethos. The word “ethos” underlines the fact that
p.000059: principles are, at the same time, ethical standards for self-perfection of a scientist and methodological rules
p.000059: providing arrival at the truth.
p.000059: What is specificity of scientific ethos as a corporate activity at the market of knowledge and technologies?
p.000059: In other words, what is specificity of scientific society ethos where a hybrid of a scientist and a businessman is a
p.000059: subject?
p.000059: Ethos of this two-faced Janus is also similarly two-faced. Since science does not terminate to be science, than
p.000059: self-consciousness of scientists retains moral and methodological importance of principles formulated by Merton.
p.000059: However, these principles in cases when “a scientist” starts to play a role of a businessman are limited and appended
p.000059: with a system of other principles. This system was for the first time described by the American sociologist of
p.000059: science, Jan Mitroff, at the 70’s of the last century when a policy of commercialization in various
p.000059: spheres of scientific studies was launched. To some extent, these principles are directly opposite to the
p.000059: ones stated
p.000059:
p.000060: 60
p.000060:
p.000061: 61
p.000061:
p.000061: by Merton. In regard to reality of biotechnological science the Mitroff’s principles can be stated as
p.000061: follows:
...
p.000061: and the most important condition for successful struggle for health of every single individual and the humanity as a
p.000061: whole.
p.000061: In the XXI century the words of one of the founders of bioethics, Claude Bernand, he said at the end of the XIX
p.000061: century, sound quite fatefully: “a doctor of future is a doctor-experimenter” that convincingly coincides with novel
p.000061: capacities of modern medical science and practice not only to prevent and treat diseases but also to control human
p.000061: life.
p.000061: An issue of community of the biomedical research in the CIS region from the point of view of philosophical
p.000061: consideration of community of knowledge assumes, first of all, addressing characteristic of biomedical research on the
p.000061: basis of integral scientific, social and value-vision phenomenon.
p.000061: Since in the context herein there is no objective to describe structure and order of conduct as it is that is resolved
p.000061: in many of special methodical and regulatory documents we permit ourselves to utilize commonly accepted in
p.000061: international practice definitions and concepts that, by itself, demonstrates supranational scale in the CIS members
p.000061: states and makes possible to form some perspective characteristics and prognoses.
p.000061: However, both in any sphere of human activity and in the sphere of biomedical research to forecast future in a
p.000061: correct way it is necessary to have memory of the past and knowledge of the present. In this connection,
p.000061: consideration of main stages of establishment of biomedical research in the analyzed regional space at stages of
p.000061: its varying political and economical development gains fundamental value being governed with historical frames
p.000061: selected within the aspect of the given publication.
p.000061:
p.000062: 62
p.000062:
p.000063: 63
p.000063:
p.000063: To retain integrity of perception of materials herein as when defining common elements of ethical and legal trends in
p.000063: the sphere of biology and medicine there will be used similar parameters of chronological and logical consideration due
p.000063: to priority of their influence.
p.000063: Thus, from the point of view of historical community based on common ideological and social and economic
p.000063: inheritance of the countries in the region we should distinguish a set of important elements determining both
p.000063: closeness of positions in the region in regard to international participation in biomedical research and their
p.000063: specificity. First of all, one should note that the USSR had a regulated state system of organizing,
p.000063: examination, registration of medical use products that included regulatory and methodical requirements and standards
p.000063: for study conduct. From administrative point of view the system was purely “vertical” assuming a whole set for
p.000063: management, approval and setup only at the All-Soviet level excluding possibility for independent approving
p.000063: and executive structures to conduct biomedical research in individual republics of the former Soviet
p.000063: Union. Regulations determining this order were clearly determined and strictly controlled. Studies could be
p.000063: conducted only at clinical sites of the Pharmacological Committee being a central approving authority, and a
...
p.000073: 1833) и Claude Bernand (France, 1865).
p.000073: Dr. S. Fluss, the Scientific Councilor at the Council for International Organizations of Medical Sciences (CIOMS), in
p.000073: his historical analysis of materials relating to the ethics of medical research involving human subjects developed in
p.000073: the XX century, before the Declaration of Helsinki, mentions about 15 documents adopted in Germany (1900, 1931), USSR
p.000073: (1936, 1949),
p.000073: Netherlands (1955), Great Britain (1962-63) and Sweden (1963).
p.000073: Among significant international documents adopted in the period before the Declaration of Helsinki, we should mention
p.000073: the International Code of Medical Ethics (WMA, London, 1949). It states: “the physician shall act in the patient’s best
p.000073: interest when providing medical care that is to improve the patient’s physical and mental health”. Declaration of
p.000073: Geneva Adopted by the 2nd General Assembly of the World Medical Association (Geneva, Switzerland, September 1948)
p.000073: defined the physician’s duty: “The health of my patient will be my first consideration”.
p.000073: These canons of the physician’s behaviour entered the Preamble of the Declaration of Helsinki, which proves the
p.000073: significance of the abovementioned documents.
p.000073: Below is the chronology list of main documents aiming at developing ethical principles of biomedical research:
p.000073: • International Covenant on Civil and Political Rights adopted by the General Assembly of United Nations (UN, 1996)
p.000073: to enforce the “Universal Declaration of Human Rights” (General Assembly of United Nations, 1948);
p.000073: • International Ethical Guidelines for Biomedical research Involving Human Subjects (CIOMS in collaboration with
p.000073: WHO, Geneva, 1982);
p.000073: • International Guidelines for Ethical Review of Epidemiological Studies, СIOMS (Geneva, 1991);
p.000073: • Declaration on the Human Genome Project. Adopted by the 44th World Medical Assembly (Marbella, Spain, September
p.000073: 1992);
p.000073: • International Ethical Guidelines for Biomedical research Involving Human Subjects (СIОМS, Geneva, 1993 – an
p.000073: updated version of Guidelines adopted in 1982);
p.000073: • Declaration on the Promotion of Patients’ Rights in Europe (World Health Organization, WHO Regional Office
p.000073: for Europe, Amsterdam, 1994);
p.000073: • Convention for the Protection of Human Rights and Dignity with Regard to the Application of Biology and Medicine:
p.000073: Convention of Human Rights and Biomedicine (Council of Europe, Strasbourg, 1996 and its Additional Protocols);
p.000073: • Guidelines for Good Clinical Practice (GCP) developed by the International Conference on Harmonization
p.000073: of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) (Brussels, Washington,
p.000073: Tokyo, 1996);
p.000073: • Guidelines and Recommendations for European Ethics Committees
p.000073: (European Forum for Good Clinical Practice (EF GCP), Brussels, 1997);
p.000073: • The Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997);
...
p.000105: progressing day by day, it cannot stay unchanged, and only one thing remains constant – high moral, ethical
p.000105: and professional standards demanded from the physician”.
p.000105: After the disintegration of the Soviet Union and declaration of Azerbaijan independence, the reformation of the
p.000105: healthcare system began. Professional education, creation of a new pharmaceutical market, etc, and, naturally, the main
p.000105: principles of medical ethics (the physician’s duty and responsibility, relationships with patients, colleagues and
p.000105: society) underwent a strong correction. Academicians Z.A.Alieva, A.T.Amiraslanov, A.A.Namazova et al. made a great
p.000105: contribution into the development of bioethics.
p.000105: An important milestone in the history of Azerbaijan was the year of 1999, when, on the initiative of UNESCO, the
p.000105: Presidium of National Academy of Sciences established the Committee on Bioethics and Technology Ethics (Decree
p.000105: 9/1).
p.000105: 3.2.2. Legal Regulations
p.000105:
p.000105: Health is one of a few subjective human values without which many other comforts and values lose their significance.
p.000105: Today every democratic country acknowledges the importance of human rights protection in all spheres of social
p.000105: life. Within last years, the National Assembly of Azerbaijan adopted legislative acts setting forth political,
p.000105: economic, social, cultural, scientific and medical measures for maintaining and strengthening physical and mental
p.000105: health of every person and providing medical care in case of loss of health. When drawing up the documents the
p.000105: experience of other countries was used, and the following legal norms based on international legal norms were adopted:
p.000105: - UN Convention on Children’s Rights (Decree of the National Assembly of Azerbaijan Republic. No 236; 21 of July 1992)
p.000105: - Law on Sanitary-and-epidemiologic Well-being of Population (10.11.1992)
p.000105: - Law on Preventing the Spread of the Disease Caused by HIV in Azerbaijan (16.04.1996)
p.000105: - Law on Pharmaceutical Activity (05.11.1996)
p.000105: - Law on Health Protection (26.07.1997)
p.000105: - Law on Medical Insurance (1997)
p.000105: - Law on Radiation Safety (30.12.1997)
p.000105: - Law on Children’s Rights (19.05.1998)
p.000105: - Law on Transplantation of Human Organs and Tissues (28.10.1999)
p.000105: - Law on Immunoprophylaxis of Infectious Diseases (14.04.2000)
p.000105: - Law on Tuberculosis Control in Azerbaijan (05.02.2000)
p.000105: - Law on Psychiatric Care (12.06.2001)
p.000105: - Law on Narcological Service and Control (29.06.2001)
p.000105: - Law on Nutrition of Newborns and Infants (17.06.2003)
p.000105: - Law on the State Care for Patients with Diabetes (23.12.2003)
p.000105: - Law on Iodination of Sodium Chloride for the Mass Prevention of Iodine Deficiency.
p.000105: - Law on Donorship of Blood, Blood Components and Blood Donor Service (03.05.2005)
...
p.000119: human life sanctity (value) directs the physician’s activity towards all possible care for patients and implies
p.000119: that euthanasia is
p.000119: unacceptable:
p.000119: - “The physician should relieve sufferings of a dying patient by every available and legal means. Euthanasia as an
p.000119: act of an intentional taking of one’s life is not permissible at the patient’s or his/her relative’s
p.000119: request” (Art. 25 CME).
p.000119: - “Medical or pharmaceutical professionals are not permitted to perform euthanasia. A person who
p.000119: consciously induces the patient to euthanasia and/or performs euthanasia shall bear criminal responsibility
p.000119: according to legislation of Republic of Belarus” (Art. 38 of the Law on Healthcare).
p.000119: Priority of a person’s interests implies that interests and well-being of an individual should prevail over scientific
p.000119: and public interests:
p.000119: - “In his/her scientific and research activity the physician should be guided by the priority of the
p.000119: patient’s benefit over scientific interests; clinical trials and research may only be carried out in compliance with
p.000119: the rules established by law and with the patient’s consent” (Art. 36 CME).
p.000119: Principle of tolerance implies that all citizens, with no exception, are guaranteed that the individual’s integrity,
p.000119: principal rights and freedoms shall be respected:
p.000119: - “The main goal of physician’s professional activity is to save an individual’s life and health…
p.000119: regardless of the patient’s sex, age, nationality, social and financial status, political convictions and religion”
p.000119: (Art. 2, CME);
p.000119: - “Physician shall in every possible way contribute into protection of population health and to
p.000119: struggle against any forms of cruelty and disparagement” (Art. 5 CME).
p.000119: Equal rights and cooperation in physician-patient relationship as a cardinal principle of modern deontology
p.000119: implies the following:
p.000119: - “Physician and patient have equal rights to respect for their human dignity and may protect it according to
p.000119: current legislation” (Art. 14 CME).
p.000119: Principle of physician’s and patient’s autonomy following from the above statement reveals itself in recognizing the
p.000119: autonomy of the physician:
p.000119:
p.000120: 120
p.000120:
p.000121: 121
p.000121:
p.000121: - “Physician shall bear responsibility for all his/her professional decisions and has the right to reject
p.000121: any attempts of pressure from colleagues, patients and other persons if their requests contradict ethical
p.000121: principles, professional duty and law.” (Art. 11 CME).
p.000121: Secondly, the principle of autonomy implies the patient’s autonomy:
p.000121: - “Patient is an active participant of the treatment process” (Art. 16 CME).
p.000121: - “Patient has the right to choose the physician. In case of a disagreement with the physician the
...
p.000161: share the experience and to build the harmonized relations in the bioethics in the frame of international
p.000161: informational, legal and research space.
p.000161: 3.5. REPUBLIC oF KAzAKHStAn
p.000161: (А.B.Sadykova, B.Е.Sarymsakova)
p.000161:
p.000161: 3.5.1. Historical and Cultural Background
p.000161:
p.000161: Kazakhstan is a country with very rich historical and cultural past time. Being geographically located in the Centre of
p.000161: Eurasia Kazakhstan was on the crossroad of ancient world civilizations, on the cross of transportation arteries,
p.000161: social and economic, cultural and ideological relations between East and West, South and North, between
p.000161: Europe and Asia, between the largest states of Eurasian continent. At different phases of the history states with
p.000161: original cultural history were organized and developed at the territory of Kazakhstan; the modern Kazakhstan is
p.000161: the inheritor of this cultural history. In the middle of XV century Kazakhs united in the unique khanate but after
p.000161: the death of khan Tauke and invasions of Djungars the country disintegrated and was divided into 3 “zhuzes”
p.000161: (sub-countries) each of which was practically independent of others. The khan of Jounger Zhuz applied to Russia for
p.000161: protection – so since that time the incorporation of Kazakh territories started.
p.000161: In 1866 all Kazakh territories were under the political power of Russia but some part of Older Zhuz and Middle Zhuz was
p.000161: incorporated into the Czinn Empire.
p.000161: In 1917 «Alash-Ordy» declared its autonomy.
p.000161: In 1920 Kirgyz Autonomic Republic was organized as a part of the Russian Federation.
p.000161: In 1925 the republic received the name of Kazakh Autonomic Republic with the capital in Almaty and in 1936 it was
p.000161: transformed into Kazakhskaya Soviet Socialist Republic.
p.000161: In 1956 some part of republican territory was adjoined to Omskaya province and Altaysky krai.
p.000161: On 16th of December 1991 Kazakhstan became independent republic. The official name of the country is the
p.000161: “Republic of Kazakhstan” (RK). Astana is the capital of the country, Almaty – the biggest city of the country. The
p.000161: territory of Kazakhstan is equal to 2,717,300 sq. km.
p.000161: The population size of the country (data of 2006) is equal to 15.3 million citizens. Around 53% of the population is
p.000161: urban citizens. There are over
p.000161:
p.000162: 162
p.000162:
p.000163: 163
p.000163:
p.000163: 120 nationalities in Kazakhstan, among them Kazakhs – 58.9%, Russians
p.000163: – 25.9%, Ukranians - 15,2%, and Uzbeks, Germans, Tatars, Uygurs and representatives of other nationalities.
p.000163: Medicine as a part of population culture is the result of practical and scientific selection of methods for the
p.000163: treatment of different diseases. It is well known that even ancient healers used infusions, decoctions, blood-
p.000163: lettings and other traditional methods of treatment (1).
p.000163: Multiple archeological findings on the territory of Kazakhstan proves the existence of drug therapy, surgery,
...
p.000195: the ancient world (Herodotus, Strabo, Thucydides, Plato, Joseph Flavius, Dio Cassius, Jordanes etc.). Farming
p.000195: was a prime activity of the Dacians. 72 fortresses were discovered.
p.000195: The Dacians had medical concept according to which at treating it was necessary to take into consideration the state of
p.000195: a body in general, including mental state. Their medical knowledge for that period was excellent.
p.000195: 4 large Dacian communities existed in the first part of the 2nd century
p.000195: B.C. Each community had the army and institution of money. The union and strengthening of Dacia happened in the
p.000195: time of king Burebista (+80
p.000195: - 44 B.C.) Dechebal (87-106) was the last Dacian king. In 106 Dacia was conquered by the Romans and turned to be a
p.000195: province. That was the last province of the Roman Empire. It was followed by Roman epoch (106-
p.000195: 271) with the Romanization of Dacian population, the Latinization of the
p.000195: language and evangelization. There was the ethnogenesis of Romanians (from “Romans”) later.
p.000195: Development of feudal relationship was attested in the X century. Three principalities were formed in the one-time
p.000195: Dacian territory: Transylvania, which felt under the reign of Hungarians (Hungarians are Finno-Ugric trans- Ural tribes
p.000195: settled here by the end of the IX century) in the beginning of the X century, Ţara Românească (or Walachia, Muntenia);
p.000195: Ţara Moldovei. The first written diplomas mentioning political and military strength of Ţara Românească and
p.000195: Moldova are referred to the years 1330 and 1359, respectively.
p.000195: During the Middle Age Moldova kept suffering from raids of the Tatars, the Turks, the Hungarians and the Poles.
p.000195: Historical Moldova covered the territory between Eastern Carpathians, woody Carpathians, the Dniester, the Black
p.000195: Sea and the Danube under Roman 1 of Moldavia (1392-1394). Geographic location of the territory was favorable as
p.000195: to the nature and life resources and at the same time unfavorable as to geopolitical strategic aspect. The country
p.000195: was located in the strategic pass connecting Eastern and Western Europe, being situated between the Carpathians and the
p.000195: Black Sea. The Silk Road, i.e. the longest commercial route connecting the Far East with the western European countries
p.000195: was there in the Middle Age. Since the first centuries AD and until now great states, trying to preserve the influence
p.000195: here had strategic interests in common. Our people have never been involved in wars of aggression but only defensive
p.000195: ones. Such state of affairs left a deep track in the spiritual life of the country. Spirituality of the inhabitants,
p.000195: philosophic thoughts are of the patriotic and the humanist nature. The ideas of the Italian Renaissance were taken here
p.000195: caught on with some works of some local cultural figures.
p.000195: Ştefan cel Mare şi Sfânt (Stephen the Great and Holy) (1457-1504) ruled Moldova during the most
...
p.000197: Divan or The Wise Man’s Parley with the World; Metaphysics; General Brief Logics; Research of the Nature of Monarchies;
p.000197: The History of the Growth and Decay of the Ottoman Empire; Geographical, Ethnographical and Economic Description of
p.000197: Moldavia; The Life of Constantine Cantemir; Events from the Life of the Cantacusins and the Brunkovyans; The System or
p.000197: the State of Muhammad Religion; The Hieroglyphic History. Works of Cantemir on the history of the Ottoman Empire
p.000197: were considered classic research and were translated into English, German, and French. Voltaire called this
p.000197: work his reference book on the East. His works are of high value until today.
p.000197: Constantin Virnav is one of the scientists-medics of the XIX century, whose activity as the doctor and civilian
p.000197: had a great significance for development of the public health care and medical ideas in the area. He is
p.000197: the first doctor of medicine in Moldova (he defended his dissertation in 1836 in the city of Buda, Hungary). He is the
p.000197: author of numerous scientific researches. His ethical ideas, application in treatment practice are especially valuable.
p.000197: Zamfir Ralli Arbore was a doctor, the Encyclopaedist, writer and public figure, graduate of the Saint Petersburg
p.000197: Medical and Surgery Academy, a person of encyclopedic learning. During his student years he jointed the
p.000197: narodnik movement and was jailed in St. Peter and Paul Fortress. He went back to Bessarabia. Later, being afraid
p.000197: of new prosecution of the tsar’s secret political police he settled in Romania. He is the author of numerous
p.000197: scientific researches. His encyclopedias are highly valuable. He was an excellent humanist and moralist. He
p.000197: supported active propaganda of high moral values on different levels.
p.000197: Anatolie Kotovski – leading doctor, reformer of the mental health service in Bessarabia, scientist, public figure who
p.000197: made plenty for the development of the social medicine of Moldavia. Many of rules considered bioethical today
p.000197: were applied to his activity.
p.000197:
p.000198: 198
p.000198:
p.000199: 199
p.000199:
p.000199: Toma Chorbe is considered as one of the great doctors-humanists, founder of sanitary and epidemiologic service
p.000199: in the area. He won the name of the unmercenary doctor rightfully. He advocated strongly spreading and efficient
p.000199: introduction of ethic norms and values in medicine.
p.000199: Nicoale Testemitanu is an outstanding scientist, public figure and manager of modern medicine, Doctor of
p.000199: Medicine, professor. He served as: Chief of the Traumatic Surgery Department of the Republican Territory Hospital,
p.000199: the Minister of Public Health, President of the Chisinau State Medical Institute, Chief of the Department
p.000199: of Public Health and Social Medicine Department. He is the most prominent organizer of national medicine
p.000199: of the second part of the XX century. His works on organization of public health care examining medical ethics and
p.000199: deontology are especially valuable. He strongly supported introduction to the practice of moral medical principles. In
p.000199: this respect his everyday activity was a bright example.
...
p.000227: birth of public medicine. First medical papers, medical societies, public hospitals and chemist’s shops,
p.000227: charity organizations were founded in Russia. One of the forms of public movement was movement of narodniks, which in
p.000227: the 60-70’s of the XIX century became mass ideology of intelligence not of gentle birth trying to be spokesman of
p.000227: peasants. At the call of members of organization Narodnaya Volya (People’s Will) Russian teachers and doctors went
p.000227: willingly “close to the people” and went to work in the depth of Russia (13).
p.000227: Conditions existing in Russia after abolition of serfdom such as quick development of capitalism and
p.000227: industrial and urban growth changed medicine very much. In the second half of the XIX century medicine became
p.000227: scientific and based on experimental methods. Medicine was differenced and integrated. Owing to scientific and
p.000227: technical progress many discoveries were made in biology and medicine, they changed conceptions of etiology and
p.000227: pathogenesis of diseases, diagnostics and treatments methods were improved. At this time many outstanding
p.000227: scientists, who gave us lessons of morality, lived, and scientific medical schools were established. They
p.000227: could not exist without succession between generations of researchers of traditions of handling not only knowledge and
p.000227: ideas but skills of research and truth comprehension, way of thinking and work, peculiar cooperation and creative work.
p.000227: The Pirogov’s medical association became a Centre of public medical thinking in Russia in the beginning of the
p.000227: 80’s. It grew from narrow professional community of physicians into a specific forum of Russian
p.000227: intelligence discussing social, political and moral problems. Its founders and leaders were famous
p.000227: physicians N.V. Sklifosovskiy, S,S, Korsakov,
p.000227: A.Y. Krasovskiy, F.F. Arisman, E.A. Osipov, G,E. Rain and others. The association held Pirogov’s congresses where
p.000227: the most urgent problems of medicine health protection such as fight against epidemics, management of medical
p.000227: care, medical organization at the front and home front and others were discussed. Congresses sent to the
p.000227: government decisions and applications and though most of them were not answered some of them were
p.000227: followed by orders. They were: decision on foundation of the Women Medical Institute (1902), manifest of corporal
p.000227: punishment abolition for all peasants in Russia and some others. Many times the Pirogov association discussed ethic
p.000227: issues such as status of physicians in Russia, problems of private practice and treatment payment, physicians’ mutual
p.000227: aid, physician right to treat without patient and his relatives’ consent and others (12).
p.000227: One more considerable page of Russian public medicine history has moral accent and is connected with struggle
p.000227: of progressive public persons for women rights and their political emancipation, the right for higher medical education
p.000227: and independent practice. Progressive university professors, scientists and writers supported these demands.
p.000227: Supporters of equal rights for women were S.P. Botkin, I.M. Sechenov, A.L. Krasovskiy, P.F. Lesgaft,
p.000227: V.L. Gruber, etc. They opened the door of their classes for first women and give them equal opportunities with men.
p.000227: Progressive media magazines and newspapers such as Medicine bulletin, Modern medicine, Saint-Petersburg
p.000227:
p.000228: 228
p.000228:
p.000229: 229
p.000229:
p.000229: Bulletin wrote about a need for the country to have women-doctors, about their role in propagation of hygiene,
p.000229: necessity of treatment of women whose shame often “results in great evil in medical practice”. Foundation of the Higher
p.000229: Women Medical Courses (1872, 1876) was the beginning of higher women medical education in our country, thus, Russia
p.000229: left behind almost all European states, besides Switzerland and the USA (the College of 1864). Courses could exist
p.000229: only on private donations. Means were collected in favor of the Courses. Zemskiy doctors sent part of their
p.000229: salary in favor of the courses. Association of mutual aid of women-doctors founded in 1890 was very useful. In 1897
...
p.000233: was well demonstrated at the WHO conference on primary medical and sanitary care issues in Alma-Ata in 1978.
p.000233: It is important stress the role of country medicine in public health care system setup after October 1917. Almost all
p.000233: of its main trends – such as free service and accessibility, preventive trend, involving the community, the citizens
p.000233: themselves into health care, integrity of academic and practical medicine – became determining aspects of the Soviet
p.000233: health care.
p.000233: After the revolution of 1917 medical ethics in the USSR underwent it way of development and was influenced by a range
p.000233: of factors.
p.000233: Medicine started to be perceived from a position of class, individualistic bourgeois medicine being matched against
p.000233: collectivist and proletarian, which led to neglecting a personal value of a human being and it absolute humility to
p.000233: social use. In terms of ethics and morality key significance also belonged to class approach. It was promoted that
p.000233: medical ethics represented corporate and class ideology alien to the working class needs. In contrast to medical ethics
p.000233: common ethical norms of communist morality were pushed forward. These conditions altered social perception of a medical
p.000233: doctor. In the early years of the Soviet regime a physician was seen as representing hostile bourgeois class and
p.000233: should have been tolerated as a specialist but was allowed to practice only under rigid supervision of
p.000233: the working class. Subsequently, physicians suffered political and ideological pressure. Unfortunately, repressions
p.000233: against medical professionals were started time and again and they were accused of poisoning and killing both
p.000233: common citizens and party and state leaders. Priority trends in medicine and health
p.000233:
p.000234: 234
p.000234:
p.000235: 235
p.000235:
p.000235: care were determined not by logical development of science and essential needs but were rather dictated by economic
p.000235: policy, ideology and conformist ideas.
p.000235: Repressive measures taken against genetics, pedology; campaigns restricting research in physiology, psychology
p.000235: and other areas that impeded and even set back many promising academic and applied directions of science can
p.000235: serve us a good example.
p.000235: There was a target to stipulate ideology for a physician of a new type. The contrast in moral portrait of doctors in
p.000235: capitalist and socialist societies is rendered in the lines by first People’s Commissar for health care N.A. Semashko:
p.000235: “Certainly among foreign physicians there are doctors who perceive there duties the way their humane profession
p.000235: suggests them. But is it a rule and what is an exception? This would depend on the ground where these phenomena bud.
p.000235: Capitalistic ground is rocky and not suited to growing humanistic ideas. If in a capitalistic society “dog eats dogs”,
p.000235: how can we speak of any humanistic feelings? All this finds its way into a physician’s behavior… It is clear that the
p.000235: problems of the so called medical ethics are solved completely differently in our country and in the
...
p.000237: implemented. Apart from that the declared idea of free service brought up consumptive attitude to medicine among
p.000237: citizens, lowered public responsibility for their health issues, deteriorated medical activity of citizens. There was
p.000237: indicated a multilevel approach in medical service provision for different groups of patients. With the growing
p.000237: differentiation and narrow fields of medical activity and no relevant integration processes there occurred
p.000237: “fragmentation” of medical responsibility, weakening of the inner moral control mechanisms, perception of a patient
p.000237: as one whole was lost. In these conditions the controversy between the declared moral principles of medical
p.000237: service and the way they were put into practice became outstanding. Staples of medical ethics alongside with legal
p.000237: standards became increasingly irrelevant to real life social practices. In medicine moral strain became ever
p.000237: increasing; such vital principles as humane and respectful attitude to a patient, medical confidentiality were
p.000237: violated. Increasing intensity of flaws in the field of ethics resulted in decline in medical doctors’ prestige
p.000237: and influence in society, aroused disaffection with their work among doctors, affected the moral climate in the
p.000237: society in general (10).
p.000237: All these issues developed alongside with lack of regulatory framework in the environment of legal and ethical
p.000237: unpreparedness of the citizens to work in new economic situation on the one hand and the growing application of new
p.000237: medical technology on the other.
p.000237: Political, economic and social reforms in the XX century 90’s badly affected all areas of social and spiritual life of
p.000237: people. Unfortunately they were not scientifically proved and never underwent ethical evaluation. The following
p.000237: years demonstrated that immoral economy does not prove effective. But above all – drastic large scale changes
p.000237: in the country significantly influenced the state of mind and mentality of the general public suffering
p.000237: through the pressure of social changes. Because of being psychologically unprepared for the current events, for the
p.000237: suddenly acquired freedom both individuals and certain social groups showed deadaptation
p.000237: which was demonstrated through manifested sense of social destitution and injustice, extraneity to novel social norms,
p.000237: culture and values, awareness of helplessness and alienation (2). The results of the social surveys
p.000237: demonstrated “collapse’ of such traits, traditionally characteristic of the Russians, as friendliness, warm
p.000237: heartedness, sincerity, self-forgetfulness” alongside with the evidently growing manifests of aggressiveness
p.000237: and cynicism (23). All this drastically affected medicine and health care, the medical community and the
p.000237: eventual patients. Availability of not only technology intensive methods of diagnostics and treatment but also
p.000237: common routine manipulations, vitally essential medications dramatically dropped. A far more important role in the
p.000237: market economy environment now belonged to private commercial firms, companies and foundations, which
p.000237: implemented research of new medications and promoted them in the pharmaceutical market as part of their
p.000237: business activity, often being driven by the idea of profit and seeing pragmatic solution to problems at the expense
p.000237: of ethics and morality as priority.
p.000237: Changes in the social and political life of Russia, setback from principles of socialism made creating health care
p.000237: model in the new environment a burning issue. And the most complicated task was to work out new
p.000237: approaches at the same time retaining the entire positive that with no doubt the previous experience of health
p.000237: care development in Russia contained. In this respect the most critical issues are those related to fair
p.000237: distribution of limited resources in health care, determining priorities of allocation, organizing supervision
p.000237: of these processes.
p.000237: It became evident in early 90’s that without ethical framework integrating into the world community would not be
p.000237: possible. Publications on issues of bioethics started to occur (I. Frolov, B. Judin, P. Tistchenko, I. Silujanova,
p.000237: N. Sedova, E. Mikhailovska-Karlova, V. Orlov, V. Vlasov, A. Ivanjushkin,
p.000237: A. Zilber, R. Korotkikh, M. Jarovinskiy and others) Great impact was made by the Human magazine (editor in chief B.
p.000237: Judin).
p.000237: The 90’s in Russia saw the set up of infrastructure in bioethics, 5 Central Committees on Bioethics
p.000237: were organized. First in 1993 there was established the Russian Academy of Science National Committee on
p.000237: Bioethics. It was followed by the Committee of Presidium of Russian Academy of Medical Science, Committee of Russian
p.000237: Medical Association (RMA), Committee of Medical Doctors’ Association, and Committee of the
p.000237:
p.000238: 238
p.000238:
p.000239: 239
p.000239:
p.000239: Russian Federation Public Health Ministry. After the RF Act On Medical Agents and in compliance with article 37 of this
p.000239: act there was established the Ethical Committee of Federal Agency for Control over Medical Agents (prior to that
p.000239: ethical evaluation of clinical research protocols was carried out by the Special Board of RMA National
p.000239: Committee). In the same 2000 year a spearhead of health care professionals set up the Independent Multidisciplinary
p.000239: Committee on Ethical Evaluation of Clinical Research which was aimed at answering various requests and appeals on
p.000239: voluntary basis. Local and regional ethical committees are set up with lower activity but their number gradually grows
p.000239: (22).
p.000239: The current stage is characterized by booming information and communication technology, rapid
p.000239: development of market economy, drastic changes in demography, persistent urbanization process, and trends towards
p.000239: development of open society. Signs of two controversial tendencies: globalization on the one hand and on
p.000239: the other – increased attention of people to their national and cultural traditions.
p.000239: After seventy years of atheism as state ideology and withdrawal from those ideas and values that the society was
p.000239: governed by, the caused moral vacuum in Russia failed to be compensated with a more or less integral
p.000239: framework of secular ideas and values clear and conventional to people and capable of appealing to people and give them
p.000239: hope. A distinguishing feature of the Russian society is that conventional factors invariably play significant role in
p.000239: many walks of social life, adherence to traditional ideological and social values which saw little influence
p.000239: of the changing social and economic systems, political regimes as well as fresh social and ideological paradigms for
p.000239: development declared in the recent decades of the XX century. Under any state system – monarchical or collective type,
p.000239: totalitarian or liberal – an impact of a number of constants which determine a civilization portrait of Russia is
p.000239: feasibly evident. Among them a crucial role belongs to religion, first and foremost the Orthodox Christian Church which
p.000239: by masses of population is perceived not only as an institution with the main function of not just disseminating the
p.000239: ideas of Christianity but mostly as preserver of the Russian national values and traditions (by different social
p.000239: studies three fourths of believers who are almost half of the population in Russia are Orthodox Christians). The same
p.000239: can be said about the Islam – second confession in Russia in terms of adherents’ number and influence (about 19% among
p.000239: believers) (20).
p.000239: Today religious organizations prove active in most different fields: religion itself, education, health care,
p.000239: culture, charity and mercy, business and economic. Changes occurring in the society and the Church demanded for a
p.000239: comprehensive philosophy that would reflect general attitude of the Church to issues of state and the Church
p.000239: relations and concerns of the modern society on the whole.
p.000239: At the Anniversary Episcopal Assembly in 2000 the Basic Social Conception of Russian Orthodox Church was
...
p.000263: pharmacologists, psychiatrists).
p.000263: Majority of medical academies and universities has the amount of academic hours complying with the curriculum
p.000263: stipulated one – 36 hours, two – shrank it insignificantly up to 32 hours, and in one academy – to 19 hours.
p.000263: More than a half of medical educational facilities in Russia managed in their curriculum to move the classes from 1st
p.000263: year students to more trained ones up to the pre-graduates at their last year training (Volgograd, Kursk, Ryazan,
p.000263: St-Petersburg Pediatric Medical Academy).
p.000263: An important feature of the modern stage of development of biomedical education in medical education facilities is
p.000263: its close organizational and methodical association with coaching in jurisprudence and medical law. It is not by
p.000263: chance that one of the main magazines publishing articles and other materials on bioethics-related topics is
p.000263: Medical Law included into the list of magazines recommended by the Higher Attestation Commission for publication of
p.000263: results of dissertation research.
p.000263: Special departments on medical law were established in two Moscow facilities (Moscow Medical Academy named after
p.000263: Sechenov I.M. and Moscow State Medical and Dentistry University), in 11 cities the law training is
p.000263: provided in the departments, which titles mention law. In 7 cases these are departments of humanitarian and
p.000263: social and economic field: bioethics, philosophy, political sciences, economics, sociology, psychology and pedagogics;
p.000263: in 4 cases – forensics medicine.
p.000263: Four universities set up the educational process on jurisprudence at humanitarian departments
p.000263: (humanitarian sciences - 2, social and humanitarian - 2), four – at departments of forensics medicine and
p.000263: four – at departments of public health and health care. In Astrakhan they decided to involve professors of three
p.000263: departments: philosophy, public health and forensic medicine.
p.000263: Objectives of bioethics and law coaching are to identify, formulate and bring to students those norms of
p.000263: morals and law that will protect their patient and, at the same time, will not hinder innovations in medicine and,
p.000263: moreover, beneficial use of modern diagnostic and medicinal technologies. Achievement of this goal is based on complex,
p.000263: interdisciplinary approach to the educational process as it is required by the essence of bioethics.
p.000263: Bioethics as it is should be in the Centre integrating common efforts of men of law, forensic medicine specialists,
p.000263: philosophers and other representative of humanitarian departments and, naturally, clinicians and health care
p.000263: managers as well as university administration for training and education of future specialists. Some actions
p.000263: in this respect are performed (Moscow State Medical and Dentistry University, etc.). Maybe, it makes sense to
...
p.000281: its independence.
p.000281: Tajikistan is a mountainous landlocked country in Central Asia. Afghanistan borders to the south,
p.000281: Uzbekistan to the west, Kyrgyzstan to the North, and China to the east. The total area of Tajikistan Republic is
p.000281: 143.1 thousands of square km, and it has a population of 7,163,506 citizens. Tajikistan consists of 4 administrative
p.000281: divisions: 2 provinces (Sughd in the north and Khatlon in the south), 1 autonomous province (Gorno-Badakhshan
p.000281: - Pamir), and disrtricts of republican subordination around Dushanbe.
p.000281: Tajikistan is an agrarian-industrial country and has a considerable potential. Lengthy wars caused
p.000281: devastations and human losses, which resulted in a dramatic economic recession. However, during the last peaceful
p.000281: years the economics and living standard have notably increased.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000283: 283
p.000283:
p.000283: The Tajik people have a rich and ancient culture. Since antiquity to the period of feudalism moral and
p.000283: ethical issues took an important place in religious and philosophical outlook. Until the IX century it had
p.000283: been developing in the context of Iranian philosophy, and later, since the 9th to the XV century in the
p.000283: context of Arabic philosophy. Due to the ethnic, language, social and political commonality in antiquity and the early
p.000283: Middle Ages particularly close relations were between East-Iranian (ancestors of the Tajiks) and West-Iranian
p.000283: (ancestors of the Persians) people. The Tajik- Persian philosophical thought had also a connection with Indian and
p.000283: Greek philosophy. However the closest links connected the Tajik culture and spiritual and philosophic outlook
p.000283: with cultures of Turkic peoples of Central Asia and Azerbaijan. There was a mutual enrichment of cultures, spiritual
p.000283: values and scientific achievements.
p.000283: Religious and philosophical ideas of Tajik ancestors roots back to an ancient monument of spiritual
p.000283: culture “Avesta” the holy canon of Zoroastrism (Mazdeism) containing not only religious dogmas but also
p.000283: ideas on cosmogony, philosophy, morals and law. The characteristic feature of Zoroastrianism is dualism, i.e. the view
p.000283: that two fundamental concepts exist, such as good and evil, and the struggle between these is the pivot and content of
p.000283: the universe. Zoroastrianism formulated a ternary ideal of the righteous man (“good thoughts”, “good words” and
p.000283: “good deeds”) opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked words” and “wicked deeds”). The
p.000283: Zoroastrian idea about infinite time as an initial substance gave rise to zervanism – a teaching in the framework of
p.000283: which a materialistic trend developed that denied the creation, and god as the creator of the universe, and
p.000283: affirmed the belief in the eternity of the world. In the end of the slave-owning system and in the beginning of
p.000283: feudalism, Manichaeism (Mani, 215-276) and Mazdakism (Mazdak, the end of the V - the beginning of the VI century)
p.000283: became very influential. Those philosophical trends assimilated the Zoroastrian ideal about the struggle
p.000283: between the good and the evil. The social doctrine of Mazdakism proclaimed ideas of justice and equality.
p.000283: The earliest written evidence that peoples of Central Asia had a good knowledge of mathematics and astronomy is
p.000283: “Avesta” containing data on the movement of celestial bodies, the system of time count and some mathematical rules.
p.000283: In that period, early states in Central Asia achieved a high
p.000283: level of material production and culture: crafts, agriculture, architecture and art. That was the time when many
p.000283: written monuments of religious, political and scientific thought were created, many of which were destroyed during the
p.000283: invasion of the army of the Arab Caliphate (VII-VIII centuries).
p.000283: During the VIII-XV centuries philosophical, social and political ideas were developing in the atmosphere of
p.000283: Arabian conquests and a forcible spreading of Islam. Spiritual cultures of Iranian and Arabic peoples became most
p.000283: closely linked. During the VIII-IX centuries, in Maverannahr (the right bank of Amudarya) and Khorosan the tendency to
p.000283: the territorial, language and cultural integration broken by the Arabian conquest had been growing. During the period
p.000283: of the Samanids rule (874-1005 AD), the Tajiks developed as a nation with its State system and
p.000283: literary language. In the IX-XI centuries, Central Asia was one of the most important centres of oriental
p.000283: science. That was the time when astronomical observatories, “Houses of Wisdom” and libraries were built.
p.000283: Scientists from Central Asia translated and commented the scientific heritage of ancient Greece and India and
p.000283: wrote original works on mathematics, astronomy, mineralogy, applied mechanics, physics, chemistry and medicine.
p.000283: Mohammed ibn Musa al-Khorezmi, Abdul Marvazi, Usman Balhi al-Fergani (IX c.), Abul-Vefa al-Buzjani, Abulmahmud Hudjani
p.000283: (X c.) and many others made an essential contribution to science. In the XI-XIV centuries Khorezm, Bukhara,
p.000283: Merv, Gazna and other towns, and later, in the XV century, Samarkand with the Ulugbek’s observatory,
p.000283: were outstanding scientific centres. The names of Biruni (X-XI c.), Omar Khayyam (XI-XII c.), al-Djurjani
...
p.000285: five centuries. He was the author of works on philosophy (e.g. commentaries on Aristotle’s “Poetics”), wrote lyrical
p.000285: poetry, and some poems have survived to out time. Ibn Sina’s “Book of Healing” was the highest achievement of the
p.000285: medieval philosophy, particularly, as it tried to reconcile rationalistic thinking and religion. A great
p.000285: number of his works were translated into Latin in the second half of the XII century.
p.000285: “Book of Healing” in 18 volumes included “Logic”, “Poetics”, “Rhetoric”, “Physics” (in eight
p.000285: chapters; the sixth chapter was entitled “On the Soul”) and “Metaphysics”. Dominique Gundisalvi from
p.000285: Toledo completed the latter in 1180.
p.000285: Following Aristotle, Abu Ali Ibn Sina classified knowledge into theoretical and practical trends, and
p.000285: attributed ethics, economics and politics to the practical area. He considered problems of essence and existence in the
p.000285: light of Neoplatonism.
p.000285: The starting point of Aristotle’s ethical teaching was the theory that social life of human beings is realized
p.000285: in actions and in their interaction. Already in the first paragraph of “Great Ethics” Aristotle wrote that to act in
p.000285: social life, one should have certain ethical qualities and be a worthy man. To be a worthy man means to have virtues.
p.000285: Therefore, the one who intends to act in social and political life should be a virtuous man. Substance and form cannot
p.000285: exist independently, they are interconnected. In the so called “dispute of universalia”– one of the fundamental
p.000285: problems in medieval scholasticism – Abu Ali Ibn Sina followed Aristotle’s theory of interrelation of substance and
p.000285: form and believed that universalia exist both in things and in human mind. The latter elicits universalia from
p.000285: things, and even ante things (ante res) and after things (post res). Ibn Sina did not doubt that the world is
p.000285: intelligible and stressed the importance of logic considering it as an introduction to every science. With regard to
p.000285: psychology, Ibn Sina also
p.000285: followed Aristotle and distinguished the vegetable, animal and rational soul. He gave a special attention to
p.000285: the human soul and did not deny its immortality, not in the direct, but in the philosophical sense, i.e. he
p.000285: did not believe in metempsychosis. Neoplatonic ideas of Aristotle are present also in those philosophical views of Abu
p.000285: Ali Ibn Sina that contain elements of Sufism. Aristotle’s philosophy developed by Abu Ali Ibn Sina and his followers
p.000285: (including Omar Khayyam) was very popular in the orient. The teaching of Ibn Sina contained some materialistic elements
p.000285: (the idea of the eternal material world, sensualist elements in the theory of cognition, etc.). Ibn Sina’s talent shows
p.000285: itself most fully in the analysis of Neoplatonism philosophy. His works “Book of Healing” and “Book of Salvation” are
...
p.000285: Some works by Ibn Sina show us his adherence to certain aspects of Sufism and mystical symbolism. Famous for its
p.000285: encyclopaedic character, his philosophy served for reconciliation of religious views and rationalistic sciences, which
p.000285: alone would suffice to consider him an original philosopher. Avicenna had a noticeable influence on views of
p.000285: Thomas d’Aquin and Albert the Great – the two prominent medieval philosophers. Agiographic texts abound in
p.000285: evidences on remarkable abilities of Hadji Naseeruddin Obaidullah Ahmar from Maverannahr (1404-1490), a religious
p.000285: figure, who worked miracles to protect order, justice and the oppressed. His actions
p.000285:
p.000286: 286
p.000286:
p.000287: 287
p.000287:
p.000287: showed his mercy to the oppressed and sternness towards oppressors and their accomplices who forgot the moral norms of
p.000287: Sharia. His style of behaviour demonstrated norms of righteousness, good deeds and ethical conduct.
p.000287: Abu Ali Ibn Sina was very popular among European scholastics (especially in the XIII c.). In the Middle
p.000287: Ages separate chapters from Avicenna’s “Book of Healing”, such as “Logic”, “On the Soul” and
p.000287: “Metaphysics” were translated into Latin, and Christian philosophers all over Europe considered themselves
p.000287: either followers of admirers of Abu Ali Ibn Sina.
p.000287: Ethical views of another great Tajik scientist, thinker and political figure of the XIII century Naseeruddin
p.000287: Tusi on the essence and norms of morals we find in his work “Ahloki Nosiri” composed of two parts: “On the fundamentals
p.000287: of morals” and “Doctrine of the purpose”. For him ethics as a science of behaviour is an essence of not only innate but
p.000287: also of acquired qualities, and being a product of social relations it may change according to social events. The
p.000287: author describes factors causing ethical changes.
p.000287: Ar-Razi proceeded from the materialistic tradition of Democritus who recognized natural regularities of nature
p.000287: and society and affirmed the cognoscibility of the world. Advanced ideas of Biruni who opposed the
p.000287: natural-science approach to the religious worldview were widespread. During the IX-XIV century, kalam, a scholastic
p.000287: philosophy of Islam that emerged in the VIII century, gained popularity and was opposing progressive views of Ibn Sina
p.000287: and his followers. Kalam defenders (Gazalii Fahruddin Rosi) advocated the idea of the Creation and believed that the
p.000287: world depends on the divine will. In the XI century, the teachings of Ismailism (a philosophical doctrine of Ismailism
p.000287: based on Neoplatonic and Aristotle’s views) became very influential (Nasir Hisrov). In their teaching on the
p.000287: harmony of the universe the Ismailis likened the constitution of the universe (“macrocosm”) to the constitution of
p.000287: human body (“microcosm”).
p.000287: Continuous internal wars in khanates of the Central Asia over XVI-XIX centuries resulted in the decline of productive
p.000287: forces, and living conditions of working masses changed for the worse. During that period, reactionary clergy was
p.000287: extremely influential, and repressed any scientific thought. The main attention was given to Muslim theology and
p.000287: ethics. The influence of the Sufi doctrine and literature with biographies of Sufi sheikhs and moral regulations of
p.000287: various Sufi Orders was particularly strong. Progressive
p.000287: tendencies and anti-feudal views were expressed in works by Tajik poets and thinkers, such as Binoi (1453-1512), Vasifi
p.000287: (1485-1551), Hiloli (executed in 1529), Saiido Nasafi (died in 1707 or in 1711), Bedil (1644-1721) and others. Their
p.000287: works reflected interests of working people and their protest against a feudal exploitation.
p.000287: Starting from the second half of the XIX century, the Russian Empire had a favourable influence on the development of
p.000287: philosophical and socio- political thought of the Tajik and other peoples of the Central Asia. Under the influence of
p.000287: Russian culture, democratic and enlightening views paved the way to Marxist-Leninist ideology. The involvement in the
p.000287: sphere of economic and scientific interests of Russia, despite an imperial policy of tsarism, facilitated the
p.000287: process of the implementation in Tajikistan of new and more developed agricultural and industrial machinery, transport
p.000287: equipment, new methods of farming and new crops. In the period from the end of the XIX to the beginning of the XX
p.000287: century, Russian culture influenced the development of the Tajik philosophical, scientific and engineering thought.
p.000287: Ahmad Donish, Hodji Halif, Hodji Jusup, Yakubi Farang, Hairat, Somi, Sobir, Asiri, Siddiki, Aini and others advocated
p.000287: ideas of national progress and social justice and criticized medieval feudal system. Scientific centres of Moscow,
p.000287: Leningrad and other cities were helpful in rising Tajik philosophers. The study of the history of Tajik philosophy and
p.000287: teachings of ancient peoples of the Central Asia was also very important. S.Aini, A.A.Semenov, A.M.Bogoutdinov,
p.000287: Z.Sh.Radzhabov, M.Boltaev, G.A.Ashurov, M.Dinorshoev, M.Radjabov and others analyzed in their works problems of the
p.000287: unity of the national and the international in the history of Tajik culture and philosophy, revealed special
p.000287: regularities of their development, the character of interaction with other philosophical trends and unmasked
p.000287: reactionary nature of Europocentric and Asiacentric concepts. Tajik scientists carried out studies in the
p.000287: sphere of dialectical, historical materialism and philosophy of natural sciences; they analyzed laws and categories of
p.000287: materialistic dialectics, objective regularities of historical development and conscious human activity,
p.000287: problems of education, formation of socialist nations, methodology of modern science, etc. (S.Umarov, M.S.Asimov,
p.000287: S.B.Morochnik, V.I.Pripisnov, M.Gafarova, A.Tursunov, I.Sharipov, S.A.Radjabov, K.Sabirov, M.Kamilov). The works on
p.000287: scientific atheism analyzed problems of developing a scientific and materialistic worldview, causes for
p.000287: survival of religious views and ways
p.000287:
p.000288: 288
p.000288:
p.000289: 289
p.000289:
p.000289: to overcome the problem; gave a critical analysis of various religious concepts (A.Bazarov, R.Madjiev). There
p.000289: were also new studies in the field of sociology, ethics and aesthetics.
p.000289: The late eighties and early nineties were marked with complicated and contradictory events, the most significant
p.000289: of which was a disappearance of such a state as the USSR on the map of the world. Instead, about 15
p.000289: new independent states appeared, and Tajikistan among those. Thus, within a short historical interval Tajikistan
p.000289: moved from one historical period to another; the state and power structure changed, as well as its
p.000289: attributes. The former political system was destroyed, which resulted in the change of ownership patterns and social
p.000289: relations.
p.000289: The development of Tajikistan as an independent secular republic in the post-Soviet space was accompanied
p.000289: with economic, political and social instability. A significant support from the international community was
p.000289: directed to the needs associated with the civil was (1992-1995) and its consequences. Emergency measures of
p.000289: providing medicines, vaccines, bandaging material taken by the international community made an essential contribution
p.000289: into the solution of healthcare problems. At the same time, there was a need in more thorough structural changes that
p.000289: would help to overcome existing problems and facilitate the development of safe mechanisms for providing
p.000289: healthcare and safeguarding patients’ rights.
p.000289: As current biomedical researches are carried out at a large scale and at many Centres, they affect interests of many
p.000289: people and many countries. New problems emerge, because “rich” countries carry over their biomedical research to other,
p.000289: “poorer” countries, and use the results of the research at home, as, “poor” countries cannot afford to use the research
p.000289: findings for economic reasons. To eliminate this injustice, the medical community took certain measures. The WMA
p.000289: Declaration of Helsinki and the additional Protocol to the CE Convention on Human Rights and Biomedicine require
p.000289: that in the countries where a biomedical research is planned the permission should be sought from state structures, and
p.000289: interests of people who live there and who are potential research subjects should be considered.
p.000289: The involvement of Republic of Tajikistan, as an independent state, in international research projects
...
p.000293: rights;
p.000293: - legal assistance in any case of discrimination referring to health condition;
p.000293: - compensation for a caused harm;
p.000293: - making an appeal in the event of wrongful decisions or actions of healthcare professionals;
p.000293: - independent medical expertise in case of discordance with the decision of the State expertise.
p.000293: The healthcare legislation in Tajikistan includes Constitution norms, Tajikistan law “On the Protection
p.000293: of Population Health” and other national legislation acts, international regulations adopted by
p.000293: Tajikistan, international treaties and normative documents issued by state structures. All these documents state that
p.000293: the society and government are responsible to contemporaries and future generations for the health level of the
p.000293: Tajikistan population. The current legislation is regulating social relations in the sphere of healthcare covering a
p.000293: wide range of issues from a harmonious physical and spiritual development and the improvement of heredity to social and
p.000293: legal protection of the patient. The laws aim at improving conditions of work, life and rest, resolving
p.000293: ecological problems, developing the quality of medical care and promoting a healthy life-style.
p.000293: The first steps of the independent Tajikistan were accompanied with economic crisis in all fields including healthcare.
p.000293: Economic, political and social recession affected indices of the population health. Most urgent were problems
p.000293: concerning food, water supply, sanitary situation, the growth of
p.000293: infectious diseases (typhoid, malaria, tuberculosis, diphtheria, acute viral hepatitis) acute respiratory
p.000293: diseases, anemia, diseases caused by iodine deficit and reproductive health. Despite instability in
p.000293: political and socio- economic life during the first years of independence, Tajikistan Government took comprehensive
p.000293: measures on the protection of the population health. During that period, Tajikistan ratified important
p.000293: international documents referring to the protection of human rights such as the Convention on the Elimination of All
p.000293: Forms of Discrimination against Women (ratified in 1993), Convention on Children’s Rights (ratified in
p.000293: 1993). Presently, the following documents form the legislative basis in healthcare:
p.000293: - Constitution of Republic of Tajikistan (RT) (1994)
p.000293: - RT law “On AIDS Prevention” (No 904; 23 of December 1993)
p.000293: - RT law “On Donorship of Blood and its Components” (No 901; 23 December 1993)
p.000293: - RT law “On the State Sanitary Inspection” (No 987; 20 of July 1994)
p.000293: - RT law “On the Protection of Population Health” (No 419; 15 of May 1997)
p.000293: - RT Labour Code (1997).
p.000293: - Family Code (1997).
p.000293: - RT law “On Narcotic Drugs, Psychotropic and Precursors” (No 874, 10 of December 1999)
p.000293: - RT law “On Pharmaceutical Products and Pharmaceutical Activity” (No 39; 6 of August 2001)
p.000293: - RT law “On Psychiatric Care” (No 90, 2 of December 2000)
p.000293: - RT law “On Reproductive Health and Reproductive Rights” (No 72; 2 of December 2002)
p.000293: - RT law “On Private Medical Practice” (No 60; 3 of December 2000)
p.000293: - RT law “On Salt Iodination” (No 85; 2 of December 2002)
...
p.000307: Sanitary and Epidemiologic Well-Being of the Population”, “On Healthcare”, “On Protection of People from
p.000307: Ionizing Radiation”, “On Measures against Tuberculosis”, “On Implantation of Pace-makers”, “On the Animal World” and
p.000307: “On Veterinary Medicine” and a number of other laws and Decrees of the Ukrainian Cabinet of Ministers,
p.000307: President’s Decrees and orders of the Ministry of Health. Noteworthy is the order of the Ukrainian Ministry of Health
p.000307: No 66 on February 2006 “On Rules of Conducting Clinical Trials of Pharmaceutical Products and Reviewing
p.000307: Materials of Clinical Trials”.
p.000307: With all this considerable number of regulating documents, there is no legislation in the sphere of human
p.000307: genome with regard to both general and specific principles. Almost unregulated is one of the most significant bioethics
p.000307: fields - in vitro research on embryos. Article 19 of the law “On Transplantation of Organs and Other Anatomical
p.000307: Materials” stipulates that it may be possible to use fetal material for transplantation, while issues relating to
p.000307: research on embryos and creation of human embryos for research purposes are not regulated.
p.000307: One of stimulating events that should facilitate the process of legal regulation in the sphere of biomedical
p.000307: research was signing of Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the
p.000307: Application of Biology and Medicine: Convention on Human Rights and Biomedicine in March 2002. This implied
p.000307: assuming political obligations to introduce relevant norms into national legislation (signing and ratification of an
p.000307: additional Protocol on biomedical research is meanwhile a more remote perspective). Today, on the instructions of the
p.000307: Cabinet on
p.000307: the necessity to ratify the Convention efforts are underway towards the development of a relevant legal and
p.000307: normative basis. There was an attempt to adopt a complex law on human rights and biomedicine by analogy with the
p.000307: Convention but the institutions where the draft law was submitted for consideration decided that it required an
p.000307: essential revision.
p.000307:
p.000307: 3.10.3. Education in Bioethics
p.000307:
p.000307: There are 17 institutes of higher medical education of the 4th level of accreditation (undergraduate level) and 3
p.000307: institutes for postgraduate training located in 14 provinces of Ukraine.
p.000307: Starting from 1990s some bioethics problems began to appear in the course of undergraduate and postgraduate training of
p.000307: medical professionals, biologists, social workers and veterinaries, and eventually special training modules and courses
p.000307: in bioethics have been designed.
p.000307: In 2004 the Ministry of Health approved an elective course in bioethics for students of the 5th year at medical
p.000307: universities and institutes of the 4th level of accreditation. The course consists of lectures (10 academic hours),
p.000307: practical seminars (17 academic hours) and students’ individual work (54 academic hours)
p.000307: Although the elective course in bioethics was adopted as a special course for institutes of higher
...
p.000309:
p.000309: Deontological Aspects of Physician’s Activity” (18 h) for clinical residents; “Philosophy of Medicine” (36 h) for
p.000309: PhD students and PhD candidates; “Organization and Performance of Ethical Review of Biomedical Research” (36 h) for
p.000309: physicians and members of ethics committees at research institutes and institutes of higher medical education in
p.000309: Ukraine.
p.000309: A considerable experience in teaching bioethics has been accumulated at National Medical University named
p.000309: after A.A.Bogomolets and at Ukrainian Medical College (Kiev). A programme on experimental studies of bioethics
p.000309: basic principles was launched in 2000 at Ukrainian Medical College at National Medical University named
p.000309: after A.A.Bogomolets and has been successfully functioning since then. Within the framework of teaching
p.000309: seminar the following activities are carried out during every academic year:
p.000309: • Individual work – analysis of actual bioethical problems and situations; assistance in the preparation of
p.000309: a computer presentation; report presentation and a follow-up discussion;
p.000309: • Regular public open lectures by leading Ukrainian and Russian scientists on actual ethical problems
p.000309: relating to biomedical technologies;
p.000309: • Visiting teaching seminars on the basis of the Institute of Experimental and Theoretical Biophysics at the Russian
p.000309: Academy of Sciences (town of Pushchino, Russia)
p.000309: In Kiev compulsory courses in bioethics are also taught at the National Technical University (Department of
p.000309: Political Sciences, Sociology and Social Work), Academy of Labour and Social Relations (Department of
p.000309: Practical Psychology and Social Work), T. Schevchenko National University (Faculties of Ethics and Aesthetics,
p.000309: Biochemistry and Science Methodology), at the National Agrarian University et al.
p.000309: In the western region of Ukraine bioethics is taught in the context of fundamental principles of
p.000309: Christian moral (Ivano-Frankovsk Medical Academy, Lvov Theological Academy, Lvov State Academy of Veterinary
p.000309: Medicine named by S.Z.Gzhitsky, Lvov State Medical University named after D. Galitsky, The Western Branch of
p.000309: Interregional Academy of Personnel Management et al.). Thus Lvov Medical University offers an elective
p.000309: course in bioethics for students in the 3rd year at every faculty. There are also seminars (16 h) for
p.000309: physicians and teaching staff held at the Department of Healthcare Organization and Management. To provide the
p.000309: teaching process with methodical materials, The Training and Methodical Centre for Bioethics was established at the
p.000309: University.
p.000309: Institutes of higher education in Kharkov became methodical centres of teaching bioethics in the Eastearn Ukraine.
p.000309: Since 2004 the Department of Valeology at the Faculty of Philosophy of Kharkov National University named after
p.000309: V.Karazin has been offering a special course “Bioethics as the Ethics of Health” (90 hours). The course
p.000309: was designed for students of the 2nd year who are trained as teachers in valeology. At all faculties of Kharkov
...
p.000325: In 2003, the Islamic Republic of Iran and UNESCO instituted the Avicenna prize for the development of modern
p.000325: bioethics in science. The role of Avicenna in the development of current bioethical views runs all through the book
p.000325: “Avicenna and the Ethics of Science Technology Today” published
p.000325:
p.000326: 326
p.000326:
p.000327: 327
p.000327:
p.000327: by UNESCO in 2006. Avicenna’s life and works invite us to think about the ethics of science. (“Avicenna and the Ethics
p.000327: of Science and Technology Today”. UNESCO, France, 2006, pp.1-18).
p.000327: The Moslem etiquette of attitude to the patient has been and is certainly influencing the content of professional
p.000327: ethics of Uzbekistan physicians. However, a transformation of the socio-economic development model that
p.000327: began after Uzbekistan had declared its independence in 1991, and, as a consequence, commercialization of
p.000327: medicine, resulted in a too rapid and radical transition to the principles of informed consent. In particularly
p.000327: difficult cases, Uzbekistan physicians prefer an indirect informing – they inform not the patient but his/her
p.000327: relatives. Physicians in countries with the domination of Roman Catholicism act in a similar way.
p.000327: Indeed, we find Moslem views on certain dilemmas of modern biomedical ethics have much in common with
p.000327: views of other orthodox religions. Islam having undergone many trials by the Soviet atheism and political extremism
p.000327: provides an ideological foundation for the development of bioethical values. However, it would be incorrect
p.000327: merely to reduce Uzbekistan ethical norms to Islamic ones. Uzbekistan is a secular state, and Islam adherents form
p.000327: but one of society segments, and religious norms are but one of the components of biomedical ethics in Uzbekistan. Many
p.000327: ethical and medical rules of social life exist not only in form of religious dogmas but also as traditions, rituals and
p.000327: folklore, which helps to observe the norms across generations.
p.000327: Biomedical ethics in Uzbekistan is open to world tendencies, such as globalization and westernization that have a
p.000327: strong impact on Uzbekistan science. Achievements in the field of informed consent, reproductive behaviour,
p.000327: etc. prove the response to world tendencies. The protection of universal human values, as well as traditional values is
p.000327: a key issue of the contemporary medical ethics in Uzbekistan.
p.000327: Thus, the Uzbekistan model of biomedical ethics is at the stage of intensive development. The intensity
p.000327: of research development in this field is predetermined by ethical tendencies in Uzbekistan education and
p.000327: philosophy existing throughout the history of Uzbekistan (Zagyrtdinove
...
p.000333: Inter-parliamentary Assembly of the Commonwealth of Independent States, 29 of October 1994)
p.000333: 10. Convention on Human Rights and Biomedicine (Council of Europe, 1996)
p.000333: 11. Note for Guidance on Good Clinical Practice (ICH, 1996)
p.000333: 12. WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
p.000333: 13. Model Law of IPA CIS “On the Protection of Human Rights and Dignity in Biomedical Research in the CIS” (2005)
p.000333: 14. International Ethical guidelines for Biomedical research Involving Human Subjects (WHO/CIOMS, 13 of June 1993/2003)
p.000333: 15. Report of the International Bioethics Committee on the Possibility of Elaborating a Universal Instrument on
p.000333: Bioethics (13 of June 2003)
p.000333: 16. UNESCO Programme on Bioethics: Priorities and Perspectives (17 of October 1999)
p.000333: 17. Implementation of the Universal Declaration on the Human. Genome and Human Rights (17 of November
p.000333: 1999)
p.000333: A number of national laws of the Republic of Uzbekistan relating to the implementation of international agreements in
p.000333: healthcare imply a possibility of a joint regulation by the national Uzbekistan legislation and international norms.
p.000333: Article 1 of the Law “on the Protection of Citizen’s Health” (No 265-I; 29 of August 1996) states that “if
p.000333: an international agreement sets out rules others than those in the national legislation, norms of the international
p.000333: agreement are applied”.
p.000333: Substantiation of certain approaches to resolving bioethics problems is nowadays in the centre of political,
p.000333: philosophical and religious investigations that are to offer guiding lines in our rapidly changing world. Thus, the
p.000333: necessity to consider existing religious moral norms and cultural traditions in making decisions on key bioethical
p.000333: problems was discussed at the International Congress of Bioethics (Teheran, 2005). For the independent the
p.000333: Republic of Uzbekistan this issue is particularly topical. Despite the secular character of Uzbekistan, many residents
p.000333: are practicing Islam and other religions. The clause on the liberty of conscience in the Constitution of the
p.000333: Republic of Uzbekistan reflects the respect for the feelings of believers in our country, and therefore specific
p.000333: features of religious thinking are to be considered in
p.000333:
p.000334: 334
p.000334:
p.000335: 335
p.000335:
p.000335: adopting the Code of the Republic of Uzbekistan on Bioethical Problems (Mukhamedova Z.M. Islamic Bioethics in
p.000335: Historical Context. In: “Materials of the First National Congress on Bioethics”, Tashkent, 2005, pp. 98-100).
p.000335: It is necessary to note that nowadays there is a number of ethical codes interpreting teachings of the Koran and Sunnah
p.000335: with regard to complicated medical and biological problems. Thus, there are the Islamic Code of Medical
p.000335: Ethics48 and Islamic Bioethics49 correlating their statements with the Islam teachings: the Koran, Shariat and
p.000335: Hasid.50 These Codes are used in Kuwait, Egypt, Saudi Arabia, Iran, Pakistan and in other countries with Moslem
...
p.000339: that enhance the rapport with the patient, as both the patient and the physician become partners having reciprocal
p.000339: rights and responsibilities, and the right for one party, is the responsibility of another one.
p.000339: The Law “On Medical Practice” will facilitate the regulation of independent ethical review and safeguard the
p.000339: protection of rights and dignity of Uzbekistan citizens in biomedical trials.
p.000339: Legislative measures undertaken in Uzbekistan will be able to protect individuals, the society and humankind as a
p.000339: whole against undesirable or sometimes harmful consequences from the implementation of new biomedical
p.000339: technologies.
p.000339:
p.000339: 3.11.3. Education in Bioethics
p.000339:
p.000339: Problems of teaching bioethics arouse much discussion at all international forums on bioethics.
p.000339: According to UNESCO Ethics Education Programme (EEP), for the biennium 2004-2005 the activities in the area of ethics
p.000339: teaching have primarily focused on East and Central Europe. During 2006-2007 priority has been given to
p.000339: South-East Europe and part of the Arab region (Gulf region).
p.000339: To facilitate the development of new relations in Uzbekistan healthcare that would more adequately comply with
p.000339: current political and social conditions, all Uzbekistan institutes of higher medical institutions and
p.000339: universities (faculties of law, philosophy and biology) introduced regular courses on bioethics into the syllabi
p.000339: of undergraduate and postgraduate education.
p.000339: According to the State Standard of Education, at institutes of higher medical education bioethics is taught at two
p.000339: levels: 1st level --”Introduction to Bioethics” and 2nd level – “Biomedical ethics” for senior students (3rd year).
p.000339: In 1998, Tashkent Medical Academy (TMA) included the study of basic bioethical problems in the baccalaureate programme
p.000339: on social sciences and humanities. Since 2002 TMA is offering modules on bioethics for magistracy residents; in 2003
p.000339: the Faculty of Post-Graduate Education at the Tashkent Medical Academy included topics on bioethics into the
p.000339: programme for post-graduate education, and since 2004 bioethics is taught as an elective course.
p.000339: The Chair of Philosophy has designed a programme on bioethics and published a manual “Introduction to Bioethics”
p.000339: in Russian and Uzbek (2004). In 2005, an anonymous questionnaire on key bioethical problems was offered to medical
p.000339: students of the second year to assess the level of their training and the system of their values and general worldview
p.000339: [1].
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p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
p.000023: population, and where in the case of an essential improvement of the economic situation the extended reproduction may
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
p.000023: To summarize the analysis of the demographic situation, it is necessary to note that with regard to self-preservation
p.000023: the following public processes are crucial:
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
p.000023: mortality in able-bodied population, “rejuvenation” of some diseases, spread of alcoholism and drug addiction;
p.000023: - the change in consumption of genetically habitual food products, decrease in food calorie content for the
p.000023: considerable part of the society;
p.000023: - reduced access to social services in conditions of a large-scale commercialization, which negatively
p.000023: affects the quality of human resources, intellectual, scientific and physical potential of the country;
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000025: 25
p.000025:
p.000025: - the decreasing number of medical institutions; a level of the population morbidity and mortality still remains
p.000025: high; the number of handicapped people is increasing;
p.000025: - stratification of the society by income, when 10% of the most well- to-do population have incomes more than 10 times
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
...
p.000091: we are more able to formulate the questions than to offer a comprehensive solution, and therefore most of them remain
p.000091: open.
p.000091: References
p.000091: 1. Amirdovlat Amasiatsi. The Good of Medicine. Yerevan, 1940, p. 9 (in Armenian).
p.000091: 2. Arevshatyan S.S. Early Armenian Translations and Their Cultural and Historical Significance. // Journal of
p.000091: History and Philology of Academy of Sciences of Armenian S.S.R. 1973, No 1, p. 23-37 (in Armenian).
p.000091: 3. Vardanyan S.A. Medical and Biological Views of David the Invincible. / Philosophy of David the
p.000091: Invincible. Moscow, 1984, pp. 83-93 (in Russian).
p.000091: 4. David Anhaght. Works. Moscow, 1980, pp. 84, 77, 71, 49, 72, 44, 75,
p.000091: 61, 63, 65 (in Russian).
p.000091: 5. Oganesyan L.A. The History of Armenian Medicine. Yerevan, 1946, Vol. 1, pp. 85-127, 141-143 (in Russian).
p.000091: 6. Vardanyan Stella. History de la medicine en Armenia. Paris, 1999. pp. 43-52.
p.000091: 7. Vardanyan S. Medicine and Philosophy in Early and Medieval Armenia. In: Collection of Scientific Works.
p.000091: Yerevan, 2005, pp. 644-647 (in Russian).
p.000091: 8. Informed Consent. UNESCO Chair in Bioethics, Editor: Prof. Amnon Carmi. – Israel, 2003.
p.000091: 9. Davtyan S.A. The Problem of Implementing New Approaches in the Process of Teaching Traditional Ethics and Bioethics.
p.000091: In: The Process of Implementing New Teaching and Scientific Technologies. Yerevan, 2003, pp. 40-42 (in Armenian).
p.000091: 10. Davtyan S. The traditions, customs, culture, and mentality of the nation and problem of Eutanasia in Armenia.
p.000091: Eilat, Israel, 2002, p. 10.
p.000091:
p.000091: 3.1.2 Legal Regulations
p.000091:
p.000091: Biomedical research and, particularly, a clinical trial is a complicated process requiring not only heavy financial and
p.000091: intellectual costs, but also a competent approach to research planning in order to obtain eventually a safe and
p.000091: effective pharmaceutical product or method.
p.000091: The development and study of new pharmaceutical products is impossible without research involving
p.000091: human subjects, and here we face two main problems. On the one hand, we have to obtain reliable data on
p.000091:
p.000092: 92
p.000092:
p.000093: 93
p.000093:
p.000093: the efficiency and safety of any new drug or method, while; on the other hand we must not expose human subjects
p.000093: participating in the research to an excessive risk.
p.000093: Modern rules of conducting clinical drug trials are very strict both in relation to the protection of human
p.000093: rights of research participants and in relation to reliability of research results. The history of biomedical
p.000093: research knows many examples proving the importance of such an approach.
p.000093: In connection with the broadening of international contacts and the increasing exchange of drugs, it is
p.000093: necessary to have uniform requirements of conducting experiments on animals, laboratory studies and clinical trials.
p.000093: Today principles and procedures of biomedical research involving human subjects, particularly of clinical trials, are
...
p.000181: culture, such as “Iliad” and “Odissey”, “Mahabharata”, “Epic of Gilgamesh”, “Kalevala”, “Rigveda” and many
p.000181: others. The Turkic epic poem “Manas” differs from west European, Slavonic and other epic poems not just in its
p.000181: volume. It covers a long historical period and gives a detailed genealogy and a distinct biographical line of
p.000181: athlete Manas – the central hero of the epic poem – from the moment of his birth to his death including the description
p.000181: of main events of his life. Poems, songs and legends passed across the generations served as a teaching
p.000181: material in folk pedagogics. The unique nature of oral folklore allows people to pass their moral knowledge to
p.000181: future generations within a family and within a clan thus ensuring continuity of spiritual life and
p.000181: connection between epochs. Another equally efficient method of education was joining to folk customs and traditions.
p.000181: Epic poems embraced all sides
p.000181: Ethical views of the early Kyrgyz make up a system of values, norms and rules based on aspiration for happiness.
p.000181: Therefore, ethics of the ancient Kyrgyz may be defined as the ethics of positive eudemonism19, and their overall
p.000181: worldview as world- and life-asserting.
p.000181: Although the epic poem does not contain distinctly formulated precepts, moral lessons learned from centuries-long
p.000181: history formed a traditional system of moral values that has survived to our days:
p.000181: 1. unity and solidarity of the nation,
p.000181: 2. international accord,
p.000181: 3. national honour,
p.000181: 4. movement towards prosperity and well-being through a continuous labour and knowledge,
p.000181: 5. humanism, generosity, tolerance,
p.000181: 6. harmony with nature,
p.000181: 7. strengthening and protection of Kyrgyzstan state system.
p.000181: Ethical norms in “Manas” are based on four cardinal virtues (wisdom, patience, conscience and generosity) that are
p.000181: personified in images. They are opposed by four vices: laziness, wickedness, greed and arrogance. It is said that a
p.000181: clever person is always able by using one’s mind which is “the best of all treasures” to oppose positive qualities to
p.000181: negative ones and defeat the evil by kindness, wickedness by patience, greed by generosity. Hence, the person has to
p.000181: make every effort to improve his or her moral nature, to overcome evil elements and to change the surrounding world.
p.000181: Among human qualities most valued in Kyrgyz culture are health and longevity, diligence and valour, sense of duty and
p.000181: honour, modesty, self- control and wisdom. These virtues ensure a harmonious life of the individual [5]. Openness, love
p.000181: for children, hospitality, generosity, humanism, patience, firmness, goodwill, respect for old age and other qualities
p.000181: inherent in Kyrgyz people form the basis of moral and ethical principles of their life [1].
p.000181: Historical conditions dictated to Kyrgyz people the necessity to stand up for their freedom and integrity in the fight
p.000181: with stronger neighboring states. Severe war conditions required from men who were admitted to military
...
p.000187: leader expressing expectations of Kyrgyz people through his poetry inspires their hopes.
p.000187: Problems of justice are very essential for Kalygul. Being a judge, he proclaims a kind of ethical code comprising
p.000187: universal values and norms of human behaviour: honesty, unselfishness, justice, mutual respect.
p.000187: Criticizing the state system of their time as a form of social inequality akyns offered a moral characteristic of
p.000187: behaviour in different social strata. Akyn-democrats tended to give a realistic picture of the world. Thus
p.000187: Toktogul Saltyganov presents his ethical views through opposing the good to the evil. Jenijok taught that every man
p.000187: should strive for self-perfection from his young days [7].
p.000187: Akyn-zamanists were spiritual elite of Kyrgyz society and true patriots. Their laments were neither the echo of
p.000187: feudalism nor an attempt to stop the development of the society. Those were the thoughts about the traditional culture
p.000187: that in their time was at a deadlock and could not find way out of it; thoughts about the future of Kyrgyz people. They
p.000187: understood well a close connection between the destiny of their people and the integrity of ethno- cultural space.
p.000187: Today we may rightly say that zamanism is a special king of creative work of poetry initially establishing in set
p.000187: verbal formulae a system of moral and ethical priorities of nomadic peoples. Zamanists lived in the epoch of
p.000187: disintegration of traditional Kyrgyz community, and therefore efforts were required to form an integrated Kyrgyz
p.000187: nation. They realized the hardship of that mission and used for that purpose moral norms and rules of behaviour that
p.000187: did not lose their significance to our days.
p.000187: The next stage in ethics development is associated with names of akyn- democrats Toktogul Satylganov (1864-1993),
p.000187: Togolok Moldo (1860-1942), Jenijok (1860-1918), Varna Alykulov (1884-1949). In contrast to their predecessors,
p.000187: they actively expressed ethical views of oppressed sections of Kyrgyz population.
p.000187:
p.000187: References
p.000187: 1. Abramzon S.M. Kyrgyz People and their Ethno-Genetic, Historical and Cultural Contacts. Leningrad, 1971, p. 152 (in
p.000187: Russian)
p.000187: 2. Akmoldoeva Sh. B. Spiritual World of the Early Kyrgyz (Analyzing Epos). “Manas” and Concepts of Geneva
p.000187: Conventions. Bishkek, 1999, p. 211 (in Russian)
p.000187: 3. Amanaliev A. From the History of Kyrgyz Philosophy. Frunze, 1863 (in Russian).
p.000187: 4. Asan-Kaigy. In: Anthology of Kyrgyz Portry. Bishkek, 1999 (in Kyrgyz)
p.000187: 5. Valikhanov Ch. Collected Works. Vol. 1-5. Alma-Ata, 1961-1972 (in Russian)
p.000187: 6. Kurmanjan the Mountain Queen and Her Time. Bishkek, 2002 (in Russian)
p.000187: 7. Jenijok. Poetic Works. Frunze, 1982 (in Kyrgyz)
p.000187: 8. Jusup Balasagyn “The Beneficial Knowledge”. Frunze, 1988, p. 339 (in Russian)
p.000187: 9. Kalygul Bai Uulu In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 10. Moldo Kylych. Time of Sorrow. Manuscript No 56, Library of the Kyrgyz Academy of Sciences (in Kyrgyz)
p.000187: 11. Moldo Kylych Shamyrkan Uulu. Time of Sorrow. In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 12. Tolubai-Synchi. Ibid.
...
p.000283: between the good and the evil. The social doctrine of Mazdakism proclaimed ideas of justice and equality.
p.000283: The earliest written evidence that peoples of Central Asia had a good knowledge of mathematics and astronomy is
p.000283: “Avesta” containing data on the movement of celestial bodies, the system of time count and some mathematical rules.
p.000283: In that period, early states in Central Asia achieved a high
p.000283: level of material production and culture: crafts, agriculture, architecture and art. That was the time when many
p.000283: written monuments of religious, political and scientific thought were created, many of which were destroyed during the
p.000283: invasion of the army of the Arab Caliphate (VII-VIII centuries).
p.000283: During the VIII-XV centuries philosophical, social and political ideas were developing in the atmosphere of
p.000283: Arabian conquests and a forcible spreading of Islam. Spiritual cultures of Iranian and Arabic peoples became most
p.000283: closely linked. During the VIII-IX centuries, in Maverannahr (the right bank of Amudarya) and Khorosan the tendency to
p.000283: the territorial, language and cultural integration broken by the Arabian conquest had been growing. During the period
p.000283: of the Samanids rule (874-1005 AD), the Tajiks developed as a nation with its State system and
p.000283: literary language. In the IX-XI centuries, Central Asia was one of the most important centres of oriental
p.000283: science. That was the time when astronomical observatories, “Houses of Wisdom” and libraries were built.
p.000283: Scientists from Central Asia translated and commented the scientific heritage of ancient Greece and India and
p.000283: wrote original works on mathematics, astronomy, mineralogy, applied mechanics, physics, chemistry and medicine.
p.000283: Mohammed ibn Musa al-Khorezmi, Abdul Marvazi, Usman Balhi al-Fergani (IX c.), Abul-Vefa al-Buzjani, Abulmahmud Hudjani
p.000283: (X c.) and many others made an essential contribution to science. In the XI-XIV centuries Khorezm, Bukhara,
p.000283: Merv, Gazna and other towns, and later, in the XV century, Samarkand with the Ulugbek’s observatory,
p.000283: were outstanding scientific centres. The names of Biruni (X-XI c.), Omar Khayyam (XI-XII c.), al-Djurjani
p.000283: (XII c.), Naseeruddin Tusi, Shamsiddine Samarkandi, Djamaleddine Bukhoroi, Alishakh Buhoroi (XIIc.), Mohammed
p.000283: Samarkandi, Ansori (XIV c.) and others are associated with medieval towns. The leading scientists of the
p.000283: Samarkand scientific school were Kazi-zade ar-Rumi, Djemshid al-Kashi
p.000283: (XIV-XV c.), Ali Kushchi (XV c.), Abu Ali Ibn Sina and others.
p.000283: Ethics as a scientific trend had a significant place in works of prominent oriental thinkers, and Ali Ibn Sina
p.000283: (Abu Ali al-Husain ibn Sina-e Balkhi (Latinized Avicenna) one of them; a philosopher, musician, poet, physician,
p.000283: the follower of Aristotle, he was a scientist of encyclopaedic knowledge and one of the greatest minds of the Middle
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000019: Mortality by main groups of death causes in 2004
p.000019: Table 4
p.000019: Table 5
p.000019: Life expectancy in people of certain age1) in several CIS countries
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: 1) 2003.
p.000019: 2) 2000.
p.000019: 3) From neoplasm. 4) 1995.
p.000019: 5) 2001.
p.000019:
p.000019:
p.000019:
p.000019: 1) Life expectancy is the average number of additional years a person could expect to live if current mortality trends
p.000019: were to continue for the rest of that person’s life.
p.000019:
p.000020: 20
p.000020:
p.000021: 21
p.000021:
p.000021: The significant increase of the total mortality rate and the decrease of the life expectancy at birth, as shown above,
p.000021: affected different age and sex groups with different intensity. First, the increase of mortality concerned males more
p.000021: than females. This growing disparity resulted in the increase of the number of incomplete families and widows,
p.000021: aggravation of the existing disbalance (as will be shown below) in the sex structure, reduction of
p.000021: nuptiality and population reproduction potential, and in a growing difference of the lifespan between the sexes. In
p.000021: spite of substantiated expectations, the high mortality rate in the period of transition at the early nineteenth did
p.000021: not affect seriously those population groups that usually are considered as particularly vulnerable due to biological
p.000021: or social causes, namely children and elder people. Perhaps the most remarkable feature of this recent population
p.000021: health crisis became a significant increase of the mortality rate for age groups of gainfully employed population. The
p.000021: most drastic relative growth of the mortality rate for adult males was registered in the group of “blooming age” i.e.
p.000021: at the age of 35-49, which is most typical for Russia. As to females, the mortality changes had unequal intensity, and
p.000021: the increase of mortality here was less marked, but it affected exactly the “blooming” age group from 35 to 49 years.
p.000021: As we know, the population reproduction depends mostly on two factors: firstly – on the ratio of marriages and
p.000021: divorces; secondly – on the ratio between males and females at the fertile age. As to the first factor, in
p.000021: the conditions of the increasing youth unemployment, rapidly growing prices housing costs and uncertain prospects, the
p.000021: nuptial ratio has decreased in all nine countries from 4% (Azerbaijan) to 34% (Russian Federation). The decrease of the
p.000021: nuptial ratio for persons in the second marriage in all countries was even sharper. An average decrease of this index
p.000021: was 28%; only in Ukraine the increase of the nuptial ratio was registered, but in 1993 the fertility in this country
...
p.000033: It is truly important that virtually all CIS countries adopted branch laws related to issues of health care and patient
p.000033: rights – the Law of the Republic of Armenia On Medical Care and on Services for Population (1996), the Law of the
p.000033: Republic of Azerbaijan On Protection of Population Health (26.07.1997),
p.000033: 11 Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of Moldova,
p.000033: respectively.
p.000033:
p.000034: 34
p.000034:
p.000035: 35
p.000035:
p.000035: the Law of the Republic of Belarus On Health Care (1999), the Law of Georgia On Health Care (1997), the
p.000035: Law of the Republic of Kazakhstan On Protection of Population Health of the Republic of Kazakhstan (1991), the Law of
p.000035: the Kyrgyz Republic On Protection of Population Health of the Kyrgyz Republic (09.01.2005), the Law of the
p.000035: Republic of Moldova On Rights and Responsibility of Patient (27.10.2005), Basics of the Law of the Russian Federation
p.000035: On Protection of Citizen Health (22.07.1993), the Law of the Republic of Tajikistan On Protection of Population Health
p.000035: (15.05.1997), Basics of the Law of the Ukraine On Health Care (1992), the Law of the Republic of Uzbekistan On
p.000035: Protection of Citizen Health (29.08.1996). Legislation specifically related to protection of especially vulnerable
p.000035: groups of patients and subjects is of particular importance for regulation of biomedical activities including valuation
p.000035: of biomedical research. Virtually all countries adopted separate laws on psychiatric assistance to population,
p.000035: counteraction to HIV infection, donorship, transplantation, protection of children rights. These enactments reflect
p.000035: specificity of institutions of informed consent and patient confidentiality in some situations of biomedical int
p.000035: rventions as well as stipulate additional guarantees of rights of dependent groups of patients/ subjects. In many CIS
p.000035: countries laws and by-laws regulate various issues in the area of auxiliary methods of reproduction and genetic
p.000035: assistance to the population12. Two countries (the Russian Federation and the Ukraine)
p.000035: 12 For instance, in the Republic of Armenia – the Law of the Republic of Armenia On Reproductive Health
p.000035: and Reproductive Rights of Person, 12 of September 2002, in the Republic of Belarus – the Law of the
p.000035: Republic of Belarus On Safety of Gene Engineering Activities, 9 of January 2006, in the Republic of Kazakhstan – the
p.000035: Law of the Republic of Kazakhstan, 16 of July , 2004, N 565-2 On Reproductive Rights of Citizens and Guarantees of
p.000035: Implementation Thereof, in the Kyrgyz Republic – the Law of the Kyrgyz Republic, 20 of December 1999, On Reproductive
p.000035: Rights of Citizens, in the Russian Federation – the Order of the Ministry of Health of the Russian Federation. 26 of
...
p.000039: Convention on Human Rights and Fundamental Freedoms adopted in Minsk in 1995.
p.000039: Criminal, penal procedure and penal enforcement model codes adopted by IPA CIS being a basis for development of similar
p.000039: codes in some of the Commonwealth countries should be considered as norms of general type establishing crucial
p.000039: requirements to an order of legal act execution in regard to main freedoms and rights of citizens in the Commonwealth
p.000039: countries. Statements of the given model codes were also reflected in initiation and creation of many legislator
p.000039: enactments in the CIS countries in the field of criminal law and criminal procedures. The model civil code adopted by
p.000039: IPA CIS has special values for establishing of new conditions for administration and management in all spheres of
p.000039: activities and its main statements were to some extent practically embodied in civil legislation of all CIS countries.
p.000039: Activity of the Permanent Commission on social policy and human rights of IPA CIS has a special value from the
p.000039: point of harmonizing influence on the health care field. After initiatives of the said commission model laws
p.000039: determining main statements for a complex welfare system were adopted, a list of international conventions recommended
p.000039: for immediate ratification by the CIS countries was developed, a set of model laws on rights of human beings related to
p.000039: category of vulnerable population groups was approved, such as a law On Basic Children Rights and On Additional
p.000039: Guarantees to Child-Orphans and Children without Parental Guardians, Guidelines On Childhood Protection in Member
p.000039: Nations of CIS (1998) as well as The Charter for Older People and other socially significant documents.
p.000039: In accordance with basic statements on protection of human rights and freedoms there are being prepared model
p.000039: laws related to both forming of domestic policy in the Commonwealth countries in the field of health care and
p.000039: developing of common approaches to international cooperation of the states in this field. An important role for
p.000039: legislative regulation of special situations in the area of medical practice and their potential application
p.000039: to cases of
p.000039: biomedical studies and ethical review is assigned to the following model laws: On Sanitary and Epidemic
p.000039: Well-being of the Population, On Prevention of Spread of Diseases with Social Significance, the Concept on Formation of
p.000039: Legal Basics and Mechanisms for Implementation of Social State in the CIS Countries, the Charter of Social Rights and
p.000039: Guarantees for Citizens of Independent States (adopted by IPA CIS, 29.10.1994). Also many projects of model acts
p.000039: included into perspective plan of model law development are also important for formation of state policies of the CIS
...
p.000065: determined unique features inherited from the former USSR providing motivation for pharmaceutical companies to conduct
p.000065: biomedical research in the CIS countries. All analytical reviews from all representatives of world pharmaceutical
p.000065: industry interested in conduct of studies made in the beginning of the 90’s of the XX century noted their interest for
p.000065: conduct of biomedical research in this region, first of all, due to the following reasons:
p.000065: - existence of centralized specialized Centres capable of inclusion large number of patients into a study within short
p.000065: term;
p.000065: - epidemiology of infectious and non-infectious diseases in conditions of absence of treatment standards approved
p.000065: for foreign practices (“naïve patients”);
p.000065: - high scientific and medical potential of researchers and research Centres;
p.000065: - knowledge of foreign languages by leading specialists, high quality of documenting;
p.000065: - interest of all stakeholders involved into a research process (state authorities, researchers and research
p.000065: Centres, high degree of trust of patients to medical personnel);
p.000065: - perspectives of future pharmaceutical market and low competitive strength of local pharmaceutical industry.
p.000065: Naturally, these capacities were not evenly distributed in all CIS countries but general trends were explicitly present
p.000065: and determined attractiveness of this region.
p.000065: However, it is necessary to introduce significant correction in the course of events presented above that
p.000065: coincided in time with deep social and economic depression of the initial stage of independence of the CIS countries
p.000065: making them “vulnerable” countries in regard to conduct of biomedical research. This “vulnerability” was
p.000065: characterized with high dependence of all parties indicated above involved into a research process (state agencies,
p.000065: researchers and research sites as well as patients) as to facts of considerable
p.000065: conflicts of interests, direct and indirect pressure due to absence of tangible assets, medicines, work, etc.
p.000065: The mostly civilized response on present situation was transition explicitly marked in all CIS countries to the
p.000065: level of global international interaction in the sphere of biomedical researches (described in details herein
p.000065: in chapters regarded to the CIS member states). Currently the basis of legal regulation of biomedical research in all
p.000065: CIS countries is formed by a set of international legal and recommendation documents among which, first of all, one can
p.000065: emphasize previously mentioned (1.2) Guidelines for Good Clinical Practice (ICH GCP) of 1996. This document
p.000065: along with a set of documents regulating the order of ethical examination to a large extent determined domestic
p.000065: regulation in the sphere of biomedical research in the CIS member states and added to the aforementioned parameters of
p.000065: attractiveness of the region in regard to the biomedical research setup the following features:
p.000065: - compliance with international research standards;
p.000065: - predictability and openness of approval systems;
p.000065: - availability for monitoring, audit and inspection.
p.000065: Activities of IPA CIS and the CIS Council on Cooperation in the Field of Health Care contributed a lot into this
...
p.000067: principles proclaimed by fundamental international documents.
p.000067: The sphere of action of the present law is spread on state citizens participating in biomedical research
p.000067: and is applied in regard to all facilities and persons being related to conduct of biomedical research at the territory
p.000067: of the state as well as it stipulates that foreign citizens and persons with absent nationality being present at
p.000067: the territory of the state in case of participation in a biomedical study can enjoy all rights established with
p.000067: the given law equally to citizens of this state. Such statement is quite significant in regard to situation in the
p.000067: CIS region due to openness of borders and notable migration processes.
p.000067: In regard to harmonization both within CIS and at the international level it is important that the law
p.000067: unifies terminology in compliance with GCP-approved definitions creating attitude for mutual understanding and
p.000067: development of a united information field of biomedical research. Some articles of the law stipulate the state
p.000067: policy standard and rights of participants of biomedical studies. Separate chapters are dedicated to study safety and
p.000067: an ethical review system, a format of an informed consent and compliance with confidentiality requirements, therefore,
p.000067: corresponding to the core of all international enactments in the sphere of biomedical research. There is a separate
p.000067: chapter on special situations of the biomedical study conduct including articles regarding biomedical
p.000067: research involving vulnerable persons, research in emergency clinical situations, epidemiological and social
p.000067: studies. In general, force of the law covers all types of biomedical research involving human subjects including the
p.000067: ones with embryos in vivo, but excluding research on embryos in vitro. Liability for breaching the law is also
p.000067: stipulated.
p.000067: Beside regulatory model regulation there is a functioning union for executive authorities of the
p.000067: Commonwealth countries as the Council on Cooperation in the Field of Health Care mentioned above which
p.000067: has the interstate commission on standardization, registration and control of quality
p.000067: of medicinal agents, products for medical use and medical equipment in the CIS member states.
p.000067: By the order of the Council on Cooperation in the Field of Health Care the CIS Executive Committee prepared and
p.000067: submitted final information of regulatory and legal documents in the field of sanitary and epidemiological regulations
p.000067: and provision of sanitary and epidemiological well-being of population in the CIS member states as well as
p.000067: concerning agreements and decisions on provision of coordinated actions of the CIS member states in the field of
p.000067: standardization, registration and quality control of medicinal agents, products for medical use and medical
p.000067: equipment.
p.000067: Acknowledging logic of closeness of conditions and problems of biomedical study conduct in the CIS region
p.000067: the coordinated harmonized actions include not only authorized state agencies but also public entities (for
p.000067: instance, the FECCIS) and professional associations of manufacturers of medicinal agents and pharmaceutical companies
...
p.000069: impossible to speak about the history of medical ethics without considering interdependent processes of the
p.000069: development of various ethical concepts and an essential role of main landmarks in the history of world ethical
p.000069: practice that have determined a harmonious and comprehensive understanding of general ethical principles of the
p.000069: research.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000071: 71
p.000071:
p.000071: From the practical point of view, the history of biomedical research ethics is inseparable from
p.000071: understanding the essence and process of the biomedical research as such.
p.000071: According to the main research subject, the biomedical research may be divided into the following categories:
p.000071: • Research that physicians carry out on themselves (autoexperiments);
p.000071: • Research involving healthy people;
p.000071: • Research involving patients.
p.000071: In historical context, the concept of informed and voluntary consent of a research subject requires subdividing
p.000071: into separate groups within these categories
p.000071: Besides, both in healthy (e.g. prisoners and military men) and ill (e.g. persons with mental disorders or ill
p.000071: minors) research subjects, groups of vulnerable contingents should be distinguished, i.e. groups of persons who for
p.000071: social, legal, age-specific, intellectual, mental or other reasons have a limited capacity or do not
p.000071: have the capacity to make an independent, informed and voluntary decision to participate in a clinical research.
p.000071: It is also essential to distinguish different types of biomedical research depending on the character of the connection
p.000071: between the research goal and its actual clinical motivation.
p.000071: Research of the first type, defined in international documents as “therapeutic” (or clinical) biomedical
p.000071: research, implies the application of new diagnostic, therapeutic or preventive pharmaceuticals or methods, i.e.
p.000071: research conducted in the interests of a particular research subject.
p.000071: Research of the second type, defined as “non-therapeutic” (or non- clinical) biomedical research, does not
p.000071: imply actions in the interests of ill or healthy subjects. Biomedical research is carried out with the purpose of
p.000071: obtaining some scientific knowledge or studying how the human organism would respond to one or another condition or
p.000071: factor (pharmokinetic studies, studies in the field of normal physiology, in cosmonautics and sport, etc.).
p.000071: Each of the mentioned types of biomedical research forms and determines special ethical and legal
p.000071: relations. In historical context, the influence of ethical dialectics of each type of biomedical research on the
p.000071: current concept of bioethics is most essential.
...
p.000133: system of administrative and State control ensuring the protection trial subjects’ rights and interests.
p.000133: Presently, local ECs carry out ethical review, which includes the review of documents (research protocols,
p.000133: forms of individual registration cards, informed consent forms, etc.) relating to pre-registration (Phase I, II and III
p.000133: trials, generic bioequivalence studies) and post-registration (Phase
p.000133: IV) clinical trials in various fields of medicine (cardiology, oncology, gastroenterology, allergology,
p.000133: endocrinology, traumatology) including international multicentre trials.
p.000012: 12
p.000011: 11
p.000010: 10
p.000010: 10
p.000010:
p.000010:
p.000008: 8
p.000008:
p.000008:
p.000006: 6
p.000005: 5
p.000004: 4
p.000004: 4
p.000002: 2
p.000002: 2 1 1 1
p.000002:
p.000000: 0
p.000000: 1998 1999 2000 2001 2002 2003 2004
p.002005: 2005
p.002005:
p.002005:
p.002005: Multicentre clinical trials of pharmaceutical products in Belarus
p.002005: (1998-2005)
p.002005:
p.002005: When conducting ethical review ECs give a special attention to the protection of rights and interests of
p.002005: healthy volunteers involved in the Phase I clinical trials and in the clinical stage of bioequivalence studies. A
p.002005: special consideration is also given to research involving vulnerable groups (children, aged people, armed forces
p.002005: personnel, etc.).
p.002005:
p.000134: 134
p.000134:
p.000135: 135
p.000135:
p.000135: 9 8
p.000008: 8
p.000007: 7
p.000007: 7 6 6
p.000006: 6
p.000005: 5
p.000005: 5
p.000005: 5
p.000005:
p.000004: 4
p.000004:
p.000003: 3
p.000002: 2
p.000002: 2
p.000002:
p.000001: 1
p.000001:
p.000000: 0
p.000000: 1999 2000 2001 2002 2003 2004 2005
p.000000:
p.000000: Bioequivalence Studies of Pharmaceutical Products
p.000000: The review of documents referring to clinical trials, including the trial protocol, is performed by local ECs within
p.000000: 5-7 days. Without the approval from local ECs the Chairman of the Pharmacological Committee of the Health
p.000000: Ministry of Belarus may not approve the documents, and the trial may not be started. In the case of disagreement with
p.000000: the EC decision, the applicant (sponsor) may appeal against the decision to the NCBE.
p.000000: The activity of local ECs is regulated by respective normative and legal acts, the EC Statute and Standard Operational
p.000000: Procedures. These documents define the following:
p.000000: 1. Composition of the EC and membership requirements (qualification, etc.);
p.000000: 2. Operating schedule, contact telephones of the EC members, notification procedure;
p.000000: 3. A list of documents to be submitted to the EC for ethical review;
p.000000: 4. The procedure for ethical review of submitted documents;
p.000000: 5. Standard forms of the EC decisions;
...
p.000149: its own legislation independently.
p.000149: During aforementioned 70 years legislative activity in Georgia was restricted to the slight alteration or, at
p.000149: best, adaptation of the frame laws, provided by the central authorities (Moscow). As well as in other republics of the
p.000149: Soviet Union there was no tradition of training the legal professionals for the health care system in Georgia. Before
p.000149: re-establishment of Georgia’s sovereignty, the Law on Health Care, adopted in 1972 by Soviet Government, was in force.
p.000149: This document showed significant negligence of individual rights of patients. Almost none of the basic principles of
p.000149: ensuring patients’
p.000149: autonomy and self-determination (except the right to keep personal data confidentially) were even declared.
p.000149: The creation of national legislation is an essential condition for building the national and democratic state and a
p.000149: civil society. Adoption of Georgian Constitution (24 of August 1995) and Georgian Civil Code (26 of June 1997) is
p.000149: definitely significant step toward establishment of national state.
p.000149:
p.000149: 3.4.2 Legal Regulations
p.000149:
p.000149: Legislation of Georgia related to health, biomedicine and human rights comprise laws which regulate
p.000149: various aspects of medicine/health care: rights of patients and research subjects (including vulnerable groups; such
p.000149: as minors, persons with mental disorders, patients with HIV/AIDS etc.), duties and responsibilities of health
p.000149: care professionals, human organ transplantation, assisted reproductive technologies etc.
p.000149: From the above-mentioned laws the Law of Georgia on Health Care (adopted by the Parliament of Georgia in 1997)
p.000149: is considered to be the framework law, which determines the priorities and sets out fundamental principles of the
p.000149: health care legislation of Georgia. It covers full range of problems related to health, including issues related to
p.000149: protection of research subjects.
p.000149: In general, there are three major documents serving the legal basis for biomedical research involving human subjects.
p.000149: These legal texts are:
p.000149: • Convention on Human Rights and Biomedicine (Signed by Georgia in May 2000; Ratified by the Parliament in September
p.000149: 2002; Entered into force on 1 of March 2001);
p.000149: • Law of Georgia on Health Care (Adopted by the Parliament of Georgia in December, 1997);
p.000149: • Law of Georgia on Drug and Pharmaceutical Activity (Adopted by the Parliament of Georgia in 1995; Updated in
p.000149: 2001).
p.000149: The draft of specific law on biomedical research –“Law on Biomedical Research Involving Human Subjects” will be
p.000149: the fourth and the most comprehensive document regulating research on human subject. Draft “Law on
p.000149: Biomedical Research Involving Human Subjects” (originally drafted in 1999) has been reviewed by the expert
p.000149: appointed by the Council of Europe in 2000 and updated according to the comments provided.
p.000149:
p.000150: 150
...
p.000151: Biomedical Research involving Human Subjects, which is being submitted to the Government this year. The aim of the
p.000151: draft law is protection of the rights, health and life of a research subject of biomedical research and provision of
p.000151: safety and respect for dignity during the research. The draft law concerns any type of research aiming at obtaining
p.000151: information and broadening knowledge in the sphere of biomedicine, which serves the interests of human health
p.000151: protection and implies:
p.000151: • Physical intervention on human being;
p.000151: • Research on biological materials which initially were taken and stored with other purpose;
p.000151: • Intervention which doesn’t imply physical intervention on human being but can pose danger to mental health or
p.000151: psychological condition of human being;
p.000151: • Research on foetus and/or embryo in vivo (The Law does not apply to research on embryos in vitro.
p.000151: The draft Law on Biomedical Research involving Human Subjects is based on the following core principles:
p.000151: • Primacy of the human being;
p.000151: • Autonomy of research subjects: information, informed consent, confidentiality and privacy;
p.000151: • Scientific quality;
p.000151: • Minimizing risks and keeping adequate risk-benefit ratio;
p.000151: • Safety;
p.000151: • Protection of vulnerable groups;
p.000151: • Multidisciplinary review of ethical acceptability of research protocol and its approval by an ethics committee.
p.000151:
p.000152: 152
p.000152:
p.000153: 153
p.000153:
p.000153: Side by side with legislation certain impact on the ethical conduct of health care providers as researchers has ethical
p.000153: regulations, which could be considered as soft legal instruments. In April 2003 the Congress of Georgian Physicians
p.000153: endorsed the Ethics Code of Physician of Georgia. The code was developed by Georgian Health Law and Bioethics Society
p.000153: (GHLBS) and the Health Legislation and Bioethics Department of the National Institute of Health. The first version of
p.000153: the Code was discussed by the participants of the Congress and was submitted to further considerations to the National
p.000153: Council on Bioethics. The letter considered the document during its three different sittings and finally published the
p.000153: final text of the Code, which was adopted at the last session of the First Congress of Physicians of Georgia.
p.000153: The Ethics Code of Physician of Georgia is the first national code of ethics in the sphere of biomedicine. It includes
p.000153: specific provisions aiming at protecting research subjects. Particularly it says the following:
p.000153: “Patient’s interests are supreme in scientific research on human being. The research goals and its possible outcomes
p.000153: never interfere with the main mission of a physician – to serve for patient’s health and life.”
...
p.000187: ensuring every individual’s right
p.000187:
p.000188: 188
p.000188:
p.000189: 189
p.000189:
p.000189: to life, physical and moral inviolability; the right to freedom and safety, the right to a free development of one’s
p.000189: personality; right to dignity and freedom of private life, confidentiality of personal and family information et al.
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
p.000189: elderly persons, disabled persons, persons who had suffered from an emergency situation and residents of ecologically
p.000189: unfavorable regions (Art. 67, 68, 69, 70, 71).
p.000189: The Law on Pharmaceutical Products (March 2003) regulates clinical trials of pharmaceutical products.
p.000189: According to this Law, no clinical trials of pharmaceutical products in Kyrgyz Republic may be carried out
p.000189: without the permission granted by the authorized healthcare state institution of Kyrgyz Republic. Those guilty of
p.000189: violating rules of clinical trials, falsifying clinical results obtained in clinical trials of pharmaceutical
p.000189: products or conducting the trials without the permission granted by an authorized healthcare state institutions of
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
p.000189: necessary for an authorized healthcare state institutions of Kyrgyz Republic to make a decision about a clinical trial
p.000189: of a pharmaceutical product. The list includes an approval by the ethics committee of an authorized
p.000189: healthcare state institution of Kyrgyz Republic. Article 27 states that the ethics committee of an authorized
p.000189: healthcare state
...
p.000189: compliance with the principles of Declaration of Helsinki”. According to the Law, ethics board at an authorized
p.000189: healthcare state institutions of Kyrgyz Republic and at healthcare institutions carry out an expert evaluation with
p.000189: regard to ethical criteria, consider moral and ethical problems arising in the course of clinical trials of
p.000189: pharmaceutical products and ensure the protection of patient’s rights.
p.000189: This Law contains important provisions concerning human rights in clinical trials of pharmaceutical
p.000189: products. In particular, it says that a patient gives his or her written consent to participate in a clinical
p.000189: trial of a pharmaceutical product and has the right to withdraw his or her consent at any stage of the research. Before
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
p.000189: out in such vulnerable patients as children without parents; military personnel; prisoners and persons under
p.000189: investigation in detention Centres; pregnant women (except for cases when clinical trials are designed specially
p.000189: for pregnant women and when the
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000191: 191
p.000191:
p.000191: necessary information can only be obtained in a clinical trial provided that the trail is not hazardous to a woman or
p.000191: to a fetus).
p.000191: Besides, the Law sets certain restrictions relating to clinical trials involving children. Thus the trials are
p.000191: only permitted if the investigational pharmaceutical product is specially indicated for use in children or to obtain
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
...
p.000247: to the Necessities of life” adopted by the Order of Ministry of Health and Social Development (09.08.2005, No. 494).30
p.000247: This Act regulates issues relating to the individual case of application, according to the necessities of life, of a
p.000247: pharmaceutical product that is not registered in Russian Federation. This is a matter of non-interventional
p.000247: research. The decision about the use of a pharmaceutical product in this case is made via the Federal
p.000247: specialized medical commission; the protocol is documented and signed by the medical director of the director of the
p.000247: Federal specialized medical commission. This document emphasizes again the need to seek the patient’s voluntary written
p.000247: consent (in cases provided by law the consent from the patient’s legal representatives) to apply an
p.000247: unregistered pharmaceutical product. The physician should inform the patient about the pharmaceutical product, its
p.000247: expected benefit, safety and the degree of risk. The physician should also explain measures that will be taken in the
p.000247: case of unexpected effect of the pharmaceutical product on the patient’s health.
p.000247: The Article 29 of the Fundamental principles of Legislation also imposes the ban on biomedical trials involving persons
p.000247: under any form of detention or imprisonment.
p.000247: The strict character of legal norms relating to biomedical trials involving two categories of vulnerable subjects –
p.000247: minors and persons under detention or imprisonment – from the one hand is the sign of the law-maker’s intention to
p.000247: prevent the possibility of abuse of depending persons, from the other hand
p.000247: - it actually means the limitation of rights of mentioned persons to access to new medicines, diagnostic and
p.000247: prophylactic methods.
p.000247: At the same time it is to be taken into account that the Federal aw of the Russian Federation ”On Pharmaceutical
p.000247: Products” on 22 of June 1998
p.000247: 30 Order “On Applying Pharmaceutical Products according to the Necessities of life” adopted by the Order of Ministry
p.000247: of Health and Social Development (09.08.2005, No. 494) //Bulletin of normative acts of Federal Executive Authorities.
p.000247: No 36, 05.09.2005.
p.000247:
p.000248: 248
p.000248:
p.000249: 249
p.000249:
p.000249: N86-FZ fixes another approach towards some vulnerable contingents31. This document takes the central place in
p.000249: legal regulation of preclinical and clinical study of pharmaceutical products.
p.000249: The issues concerning rights of patients participating in clinical trials are touched on by the Article 40 of the
p.000249: mentioned law. The general rules of obtaining the informed consent for participating in research constituted by this
p.000249: article correspond in a whole with the discussed provisions of the Fundamental principles of Legislation. The
p.000249: noteworthy point is the more detailed description of information which should be given to subject, namely: 1)
p.000249: information on pharmaceutical products and nature of clinical trials of this drugs; 2) information on anticipated
p.000249: efficiency, the drug safety, and the degree of risks for the patient; 3) information on measures in the case of
p.000249: unforeseeable effects of pharmaceutical product on his health;
p.000249: 4) information on the terms of patient’s health insurance.
p.000249: The provision of the Law concerning the necessity of health insurance as well as insurance of civil liability of
p.000249: persons who carry out the study (items 3, 9 of the article 40, items 2 of the article 38) ensures an important
p.000249: additional guarantee of protection of subjects’ interests.
p.000249: At the same time, we cannot but mention an excessively “soft” approach to the question of terminating a clinical trial
p.000249: in the case of events that may be hazardous to the patient’s health. The Law states only that clinical trials may be
p.000249: terminated, while it should state that clinical trials must be terminated.
p.000249: Aiming at safeguarding the rights and interests of vulnerable contingents the Law forbids or
p.000249: limits their participation in clinical trials of medicines. Particularly clinical trials involving minors who
p.000249: don’t have parents, soldiers, persons under any form of detention or imprisonment is absolutely forbidden. The Law also
p.000249: sets up the limitation for the cases of clinical studies involving minors who have parents – such studies may be
p.000249: conducted only if pharmaceutical product is proposed for treatment of child diseases or if the aim of clinical trial is
p.000249: the getting the information about the best dosing of drug for therapy of minors. In latter situation the clinical trial
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
...
p.000269: a patient information and informed consent form (some ethical committees have a standard patient informed consent
p.000269: form, others observe that the informed consent being written in arbitrary way should contain all necessary
p.000269: elements); diaries and questionnaires (if stipulated by the protocol);
p.000269: description for all compensations for the study subjects (if stipulated); an insurance policy and certificate with
p.000269: clear indication of insurance terms and conditions, number of insured persons; signed and dated researchers’ CV’s;
p.000269: materials including promotional ones used to attract study candidates; all previous decisions produced by other EC’s
p.000269: (if any); a list of study sites; an approval from the Federal Service on Control in the sphere of Health Care and
p.000269: Social Development for conduct of this particular clinical study.
p.000269: Documents on the clinical study are to be examined by experienced specialists in the methodology of
p.000269: studying efficacy and safety of new medicinal agents, medical doctors with experience in clinical studies.
p.000269: Objectives of the ethical review prior to the study onset are to minimize risks for clinical study subjects if it is
p.000269: well justified, to provide fair selection of them, to provide control over complete and adequate informing the patients
p.000269: and obtaining the informed consent, confidentiality terms, protection for vulnerable population groups.
p.000269: When examining the clinical study protocol, specialists consider possibility of reaching study objectives with
p.000269: involvement of less amount of subjects, assess inclusion and exclusion criteria, early exclusion criteria from
p.000269: participating in the clinical study, conditions of the study termination, objective control methods, expected
p.000269: adverse events and inconveniences for patients.
p.000269: Reviewing the Investigator Brochure there are examined data on efficacy and safety, pharmacological, pharmaceutical and
p.000269: toxicological properties of the tested medical agent as well as data on results of previously conducted preclinical and
p.000269: clinical studies.
p.000269: Requirements for information on the study provided to a candidate subject are very strict. It must
p.000269: correspond to a level of understanding of those to be involved in the study, to be easy to read and not to
p.000269: contain many medical terms. This document must describe the following: study purpose and objectives; description of the
p.000269: tested medicinal article; concomitant treatment permitted or prohibited in the given the trial’s subjects. probability
p.000269: of random assignment in one of the study groups (including the control that might be treated with placebo. Explanations
p.000269: for all terms and concepts, for instance, placebo, is obligatory!); objectively expected benefit for the patient as
p.000269: well as inconveniences and objectively expected risks for both patients/healthy volunteers and a fetus or infants; all
p.000269: study procedures (especially accurately
p.000269:
p.000270: 270
p.000270:
...
p.000271: conditions when participation of the patient/healthy volunteer can be discontinued without his/her consent, suggested
p.000271: duration of the study, and approximate number of the subjects in different regions and in the given clinical site. The
p.000271: information provided to the patient shall be logically completed with the informed consent form, which exhibits, if
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
...
p.000277: biomedical research ethics. This document allows attaining common understanding of protection of human rights
p.000277: and fundamental freedoms in the sphere of biology and medicine application, to unite efforts of scientists
p.000277: and politicians from all CIS countries in the common legal and ethical environment for biomedical researches
p.000277: that covers all types of impacting a man, including studies on embryos in vivo. Along with that, the law
p.000277: enforcement is secured via creation of interstate and national systems of ethical review that is
p.000277: designed in accordance with ideology of the WHO program SIDCER and initiated by the Forum for Ethics Committees in
p.000277: the CIS.
p.000277: Currently we came to understanding that all biomedical projects held in the CIS countries shall undergo independent
p.000277: ethical review at the national level; there were established ethics committees forming a mechanism for provision of
p.000277: ethical review quality and research project safety through control at all stages of informed consent
p.000277: obtaining from candidate study subjects (in case of participation of subjects unable to provide such consent
p.000277: independently – from their legal representatives), ethical research support at all stages until project completion.
p.000277: Special situation of biomedical research conduct are specially controlled by ethical committees when study subjects are
p.000277: related to vulnerable population categories (due to their age, intellectual, mental, or social immaturity or
p.000277: vulnerability) or when studies stipulate obtaining information on genetic code of the study subject.
p.000277: Ethical committees of the CIS countries reached common understanding on necessity of ethical review, they
p.000277: approved common basics for their activities, and the next stage is building up the ethical control
p.000277: vertical system and making this process transparent both within the country and the Commonwealth that is possible
p.000277: through implementation of Acknowledgement program initiated by WHO and suggested for implementation in the post- Soviet
p.000277: countries by FECCIS. This program stipulated ethical committee certification that was a guarantee for
p.000277: compliance to highest quality standards of ethical review and development of a system of effective control
p.000277: over research activities in the country for the world community. Russia started preparation of ethical committees for
p.000277: participation in this procedure.
p.000277:
p.000278: 278
p.000278:
p.000279: 279
p.000279:
p.000279: Realization of significance of ethical review of biomedical studies facilitates attraction of grants from
p.000279: various funds and organizations to this field: these are foreign educational grants offered at the territory of Russia,
p.000279: for instance, by the Fogarty Fund, U.S. Civilian Research and Development Foundation (CRDF), or support for research
p.000279: projects in particular entities of the Russian Federation (for instance, a grant of the Academy of Sciences of the
...
p.000329: - receiving information about his/her rights and responsibilities and his/
p.000329:
p.000329: the activity of state structures, national enterprises, institutions and public unions in the field of healthcare
p.000329: (Kolesnikova L. Some Legal Aspects of Regulating Physician--Patient Relationship. Materials of the First National
p.000329: Congress on Bioethics with International Participation. Tashkent, 2005, pp. 58-59; Kolesnikova L. Relations of Doctor
p.000329: and Patient in the Light of Laws in Force in Uzbekistan: Clinical, Philosophical and Legal Aspects. Tashkent, 2006, pp.
p.000329: 129-135).
p.000329: Article 3 of the Law defines main principles of citizens’ health protection:
p.000329: - observance of human rights in the field of health protection;
p.000329: - availability of medical care for all social strata;
p.000329: - the priority of preventive measures;
p.000329: - social protection of citizens in cases of health loss;
p.000329: - the unity of medical science and practice.
p.000329: According to Article 13 of the Law, “…the State ensures the protection against discrimination irrespective of a disease
p.000329: the citizen has. Appropriate sanctions should be applied in the event of infringement of the provisions contained in
p.000329: this Article”.
p.000329: Nevertheless, in current practice of physician—patient relationship there are cases of marginalization and
p.000329: stigmatization, which shows itself in relation to most vulnerable social groups – drug and alcohol addicts, sex
p.000329: workers, etc. In the event of diagnosing an “improper disease” (venereal diseases, AIDS) a patient is labeled as
p.000329: “shameful”. A suspicious attitude of medical staff to patients with such a diagnosis infringes patients’ rights, which
p.000329: affects their moral and psychological state and, consequently, has a negative impact on the treatment efficiency.
p.000329: According to Article 24 of the Law, the patient has the right to:
p.000329: - respectful and humane attitude of medical staff;
p.000329: - choice of a physician;
p.000329: - medical aid (examination, treatment, etc.) provided in compliance with relevant sanitary requirements;
p.000329: - consultation by a medical specialist on the patient’s request;
p.000329: her health condition;
p.000329: - compensation in the event of a damage to his/her health;
p.000329: - access to a lawyer or another representative for the protection of his/ her rights.
p.000329: In case of infringement of a patient’s rights, his/her legal representative may make a complaint to any instance.
p.000329: Article 34 of the law “On the Protection of Citizens’ Health” permits to conduct biomedical research involving human
p.000329: subjects at state institutions after laboratory experiments and with informed consent from a research
p.000329: participant.
p.000329: To protect patients’rights and dignity,Article 25 prohibits propagandizing, including information in mass media,
...
p.000345: pharmaco-logical groups. Starting from 2001 the number of clinical trials has increased, which is mainly
p.000345: connected with new requirements relating to the registration of pharmaceutical products. It is noteworthy,
p.000345: that starting from 2001 all clinical trials have been conducted according to uniform guidelines complying
p.000345: with GCP for both domestic and foreign manufacturers. Clinical trials have been carried out at more than 60 medical
p.000345: institutions authorized by the Ministry of Public Health. During that period, 25 pharmaceutical products from both
p.000345: domestic and foreign manufacturers have been declined because of their low efficiency and/or expressed adverse effects.
p.000345: The first experience in actual application of ethical principles strictly according to GCP was gained in multicentre
p.000345: trials organized by large foreign pharmaceutical firms.
p.000345: To safeguard the protection of CT subjects, all documents relating to preclinical trials of toxicity and
p.000345: pharmaceutical activity of both new and generic pharmaceutical products should be most thoroughly studied
p.000345: and analyzed. Preclinical trials are conducted according to “Guidelines on
p.000345:
p.000346: 346
p.000346:
p.000347: 347
p.000347:
p.000347: Preclinical Trials of Pharmaceutical Products Safety” stating that placebo is used only to study pharmaceutical
p.000347: products for adjuvant therapy in patients with a mild or medium degree of a disease. Besides, there are
p.000347: special conditions for research participants from vulnerable groups.
p.000347: In 2001 paragraphs referring to CT ethics were included into the “Guidelines for Conducting Clinical Trials
p.000347: of Pharmaceutical Products and Expertise of Trial Materials”. Now, apart from the research Protocol and individual
p.000347: registration form, documentation submitted by the applicant to the NEC should include written informed consent forms
p.000347: signed by potential trial participants.
p.000347: The NEC activity in the sphere of implementing ethical principles into medical science and healthcare enhanced the
p.000347: quality of patient—physician relationship and of medical services provided by healthcare institutions. This
p.000347: also served to reduce the number of complaints from patients.
p.000347: The NEC coordinates its activity with the Centre of Science and Technology. The latter considers applied,
p.000347: fundamental and innovation grant projects relating to biomedical research after they were approved by the NEC.
p.000347: The NEC collaborates with the Higher Certifying Commission at the Cabinet of the Republic of Uzbekistan. According
p.000347: to the petition of the NEC Medical Council “On the Necessity to Conduct Ethical Review of Dissertation
p.000347: Works Involving Patients or Volunteers as Research Subjects” (Protocol No 25, 2002) the Commission considers
p.000347: dissertation works only after the NEC permission to carry out the research (including biomedical research with animals)
p.000347: was obtained.
p.000347: The NEC participated in the organization of the First National Congress on Bioethics with international participation
...
Searching for indicator vulnerability:
(return to top)
p.000065: biomedical research in the CIS countries. All analytical reviews from all representatives of world pharmaceutical
p.000065: industry interested in conduct of studies made in the beginning of the 90’s of the XX century noted their interest for
p.000065: conduct of biomedical research in this region, first of all, due to the following reasons:
p.000065: - existence of centralized specialized Centres capable of inclusion large number of patients into a study within short
p.000065: term;
p.000065: - epidemiology of infectious and non-infectious diseases in conditions of absence of treatment standards approved
p.000065: for foreign practices (“naïve patients”);
p.000065: - high scientific and medical potential of researchers and research Centres;
p.000065: - knowledge of foreign languages by leading specialists, high quality of documenting;
p.000065: - interest of all stakeholders involved into a research process (state authorities, researchers and research
p.000065: Centres, high degree of trust of patients to medical personnel);
p.000065: - perspectives of future pharmaceutical market and low competitive strength of local pharmaceutical industry.
p.000065: Naturally, these capacities were not evenly distributed in all CIS countries but general trends were explicitly present
p.000065: and determined attractiveness of this region.
p.000065: However, it is necessary to introduce significant correction in the course of events presented above that
p.000065: coincided in time with deep social and economic depression of the initial stage of independence of the CIS countries
p.000065: making them “vulnerable” countries in regard to conduct of biomedical research. This “vulnerability” was
p.000065: characterized with high dependence of all parties indicated above involved into a research process (state agencies,
p.000065: researchers and research sites as well as patients) as to facts of considerable
p.000065: conflicts of interests, direct and indirect pressure due to absence of tangible assets, medicines, work, etc.
p.000065: The mostly civilized response on present situation was transition explicitly marked in all CIS countries to the
p.000065: level of global international interaction in the sphere of biomedical researches (described in details herein
p.000065: in chapters regarded to the CIS member states). Currently the basis of legal regulation of biomedical research in all
p.000065: CIS countries is formed by a set of international legal and recommendation documents among which, first of all, one can
p.000065: emphasize previously mentioned (1.2) Guidelines for Good Clinical Practice (ICH GCP) of 1996. This document
p.000065: along with a set of documents regulating the order of ethical examination to a large extent determined domestic
p.000065: regulation in the sphere of biomedical research in the CIS member states and added to the aforementioned parameters of
p.000065: attractiveness of the region in regard to the biomedical research setup the following features:
p.000065: - compliance with international research standards;
p.000065: - predictability and openness of approval systems;
p.000065: - availability for monitoring, audit and inspection.
p.000065: Activities of IPA CIS and the CIS Council on Cooperation in the Field of Health Care contributed a lot into this
p.000065: process and its unification within CIS identifying unity of views on a range of factors determining modern realia of
p.000065: development of the CIS countries.
...
p.000229: infected with relapsing fever, G. N. Mikh and N.I. Mechnikov also suffered through severe illnesses. N.F. Gamaleja,
p.000229: N.I. Metchnikov, D.K. Zabolotnyi, M. Pettnkofer took pure culture of cholera vibrio. Such examples can be
p.000229: continued.
p.000229: In relation to experiments with other human subjects many researchers were guided by the respectful opinion of
p.000229: S.P. Botkin (1832-1889): “It is evident that trials with human subjects are permitted only in extraordinary cases
p.000229: when we can be sure of their harmlessness otherwise we resort to experiments with animals, conditions for
p.000229: our observations being significantly simplified”.
p.000229: In early XX century a book by V.V. Veresaev “Doctor’s notes” produced great social aftersound. It can be
p.000229: regarded as social and cultural assessment of many problems in medical ethics which are of concern even today in the
p.000229: rise of the XXI century. It contained sharp criticism towards a common practice of that time to neglect patients’
p.000229: rights and needs including subjects of biomedical research. V.V. Veresaev (1867-1945) provides ample evidence of
p.000229: cruel experiments with human subjects and puts under question the researchers’ reports that these trials were performed
p.000229: with those people’s consent. V.V. Veresaev was courageous to disclose and put under public scrutiny the secrets of
p.000229: medical community. Thoroughly, providing great number of examples he showed the destitute position of an average
p.000229: practicing doctor, his vulnerability. And at the same time he stressed the high requirements that the
p.000229: community imposed over a physician (5, 6).
p.000229:
p.000230: 230
p.000230:
p.000231: 231
p.000231:
p.000231: V.A. Manassein (1841-1901), a noted general practitioner, editor of “The Doctor” magazine, a person who won a
p.000231: name of a ‘knight of medical ethics’, ‘conscience of medical community’ stressed the necessity for a doctor to
p.000231: comply with medical confidentiality even at the expense of his own benefits. A contrary position was expressed by a
p.000231: denoted lawyer A.F. Kony (1844-1927), who considered that in situations of grave threat needs of the society should
p.000231: prevail over the ban to disclose patients’ secrets. At the same time he advocated the idea of sticking to medical
p.000231: confidentiality after a patient’s death. A.F. Kony also stipulated the conditions which allowed active euthanasia both
p.000231: legally and ethically.
p.000231: In he beginning of the XX century it was acknowledged that relationship of physicians with the community require
p.000231: dramatic revision especially when it comes to correlation of a doctor’s right to perform medical assistance essential
p.000231: for a patient and consent of the latter to have it in terms of observing or violating the principle of physical
p.000231: integrity (“Court newspaper”, 1901, №№ 51, 52) and also about the legal grounds and limits of criminal responsibility
p.000231: for the harm caused to patients health (‘Law”, 1902, №51). The issue to what extent the patient’s consent for medical
...
p.000277: and politicians from all CIS countries in the common legal and ethical environment for biomedical researches
p.000277: that covers all types of impacting a man, including studies on embryos in vivo. Along with that, the law
p.000277: enforcement is secured via creation of interstate and national systems of ethical review that is
p.000277: designed in accordance with ideology of the WHO program SIDCER and initiated by the Forum for Ethics Committees in
p.000277: the CIS.
p.000277: Currently we came to understanding that all biomedical projects held in the CIS countries shall undergo independent
p.000277: ethical review at the national level; there were established ethics committees forming a mechanism for provision of
p.000277: ethical review quality and research project safety through control at all stages of informed consent
p.000277: obtaining from candidate study subjects (in case of participation of subjects unable to provide such consent
p.000277: independently – from their legal representatives), ethical research support at all stages until project completion.
p.000277: Special situation of biomedical research conduct are specially controlled by ethical committees when study subjects are
p.000277: related to vulnerable population categories (due to their age, intellectual, mental, or social immaturity or
p.000277: vulnerability) or when studies stipulate obtaining information on genetic code of the study subject.
p.000277: Ethical committees of the CIS countries reached common understanding on necessity of ethical review, they
p.000277: approved common basics for their activities, and the next stage is building up the ethical control
p.000277: vertical system and making this process transparent both within the country and the Commonwealth that is possible
p.000277: through implementation of Acknowledgement program initiated by WHO and suggested for implementation in the post- Soviet
p.000277: countries by FECCIS. This program stipulated ethical committee certification that was a guarantee for
p.000277: compliance to highest quality standards of ethical review and development of a system of effective control
p.000277: over research activities in the country for the world community. Russia started preparation of ethical committees for
p.000277: participation in this procedure.
p.000277:
p.000278: 278
p.000278:
p.000279: 279
p.000279:
p.000279: Realization of significance of ethical review of biomedical studies facilitates attraction of grants from
p.000279: various funds and organizations to this field: these are foreign educational grants offered at the territory of Russia,
p.000279: for instance, by the Fogarty Fund, U.S. Civilian Research and Development Foundation (CRDF), or support for research
p.000279: projects in particular entities of the Russian Federation (for instance, a grant of the Academy of Sciences of the
p.000279: Republic of Tatarstan). They all facilitate wide spread of bioethical knowledge, realization of necessity for conduct
p.000279: of civilized ethical review of research projects in the sphere of medicine and provision of population safety during
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000049: According to the German sociologist and political scientist, Wolf Schäfer: “Technoscience is a hybrid of science-based
p.000049: technology and technology-based science. Global phone communications and genetically modified products are
p.000049: para-scientific things: their invasion into our world is due to complex interweaving of particular human
p.000049: interests with modern understanding of electricity, on one hand, and genetics, on the other.” (W.Schäfer. Global
p.000049: technoscience: the dark matter of social theory.Univ. of Maryland conf. on globalizations, April 2002.
p.000049: www.bsos.umd.edu/socy/conference). Here, as you can see, our attention is drawn to the fact that technoscience is not
p.000049: only the tightest link between science and technology, but also such symbiosis that includes also human aspirations and
p.000049: interests.
p.000049: However, relationships of science and technique in this symbiosis are internally contradictive. On one
p.000049: hand, science is a generator of new technologies and due to stable demand on these new technologies science
p.000049: enjoys some, and sometimes quite generous support. On the other hand, production of new technologies dictates
p.000049: demand on science of specific, if you wish limited, single-sided type, therefore, many potentials of science being
p.000049: used this way are still outstanding. Roughly speaking, science is required neither to explain, nor to
p.000049: understand things – it is quite sufficient that it makes possible to alter them effectively.
p.000049: Besides, it assumes understanding of human cognitive activities including the scientific one, as an
p.000049: activity being secondary to some extent, subjected to practical transformation, changing of both the world
p.000049: around and a man. Thus, reminding the said above, there is an opportunity for rethinking, or, being more
p.000049: specific – reversion – of the balance of science and technology established before. If traditionally this balance was
p.000049: perceived as technological application, utilization by someone and at some time produced scientific knowledge, now it
p.000049: turns out that the very activity for obtaining of
p.000049:
p.000050: 50
p.000050:
p.000051: 51
p.000051:
p.000051: such knowledge is built in into processes of creation and development of these or those technologies.
p.000051: It is interesting not only how such transformations take place in reality but also how they are comprehended. On the
p.000051: surface things seem to be the same: it is proclaimed that science is a leading force of the technological progress
p.000051: that, in turn, uses scientific achievements.
p.000051: This is the background for realization that so-called applied science deals with those problems that are
p.000051: determined with the very development of technologies, and, along with that, such “servicing” science becomes
p.000051: determinative both as to quantitative and financial or other supplies, and as to social recognition. As we already
p.000051: noted a regulator for scientific activity becomes not obtaining knowledge pretending to be the truth to some extent but
p.000051: gaining an effect that can be implemented into a technology in demand. One should say that also social expectations
p.000051: regarded to science today shows clear domination of demands for new effective technologies but not for explanation of
...
Health / Drug Dependence
Searching for indicator dependence:
(return to top)
p.000027: public attention that can be perceived as revival of medical ethics in the USSR. Medical deontology was
p.000027: 8 One should note that the term “deontology” is used with two different meanings. First, deontology is understood as
p.000027: a specific type of an ethical theory where a crucial definition is a concept of obligation; thus, personal actions are
p.000027: analyzed and assessed from the point of view to what extent they are fulfillment of a personal obligations by an
p.000027: individual. The most well known representative of deontological ethics is the German philosopher, I.Kant. In medical
p.000027: context this term is used with different, narrower meaning – deontology in this case implies a teaching on professional
p.000027: duties of medical workers in regard to their patients.
p.000027:
p.000028: 28
p.000028:
p.000029: 29
p.000029:
p.000029: included into curriculum of medical schools. At that, however, it was not distinguished as a separate subject – it was
p.000029: to be taught by those professors having classes on their medical fields. Therefore, within the study course there was
p.000029: simply no time to highlight medical deontology issues.
p.000029: A very important factor determining particularities and complexity of relationship development during a research
p.000029: process was characteristic for the entire medical community in the USSR paternalistic attitude among doctors
p.000029: and patients, peculiar standoff of health care professions (no public discussion on problems and errors, corporate
p.000029: spirit of medical workers) and strict vertical pattern of administration resulting in dependence of actions and making
p.000029: decisions.
p.000029: The common features being found at appearance and development of bioethics in the region are worth of specific
p.000029: attention. For a long time the region countries were out of global international dialogue on bioethics issues,
p.000029: therefore, they despite of their particular experience and specific approach to ethical issues in health care
p.000029: were not represented in the international bioethical society at a long run. Such isolation brought forth
p.000029: several considerable consequences: relatively poor development of major bioethical potential in the CIS countries and
p.000029: deficiency of capabilities for maintaining direct contacts with members of international bioethical community,
p.000029: in particular, due to limited knowledge of foreign languages for professional use and insufficient acquaintance with
p.000029: basic foreign publications.
p.000029: At the same time, within the community of the CIS countries there is a unique opportunity for international
p.000029: communication since not only majority of citizens but also specialists use a single instrument for communication, the
p.000029: Russian language. Development of bioethics in the CIS countries started about 20 years ago; one of the strongest
p.000029: impulses emerged after the first contacts of Soviet philosophers and medical researchers with their foreign colleagues
p.000029: at the end of the 1980’s. After the USSR break-up bioethics in the region developed in different conditions but, at
p.000029: that, there were present both stable cultural peculiarity and links among the region countries. The most important
...
p.000065: industry interested in conduct of studies made in the beginning of the 90’s of the XX century noted their interest for
p.000065: conduct of biomedical research in this region, first of all, due to the following reasons:
p.000065: - existence of centralized specialized Centres capable of inclusion large number of patients into a study within short
p.000065: term;
p.000065: - epidemiology of infectious and non-infectious diseases in conditions of absence of treatment standards approved
p.000065: for foreign practices (“naïve patients”);
p.000065: - high scientific and medical potential of researchers and research Centres;
p.000065: - knowledge of foreign languages by leading specialists, high quality of documenting;
p.000065: - interest of all stakeholders involved into a research process (state authorities, researchers and research
p.000065: Centres, high degree of trust of patients to medical personnel);
p.000065: - perspectives of future pharmaceutical market and low competitive strength of local pharmaceutical industry.
p.000065: Naturally, these capacities were not evenly distributed in all CIS countries but general trends were explicitly present
p.000065: and determined attractiveness of this region.
p.000065: However, it is necessary to introduce significant correction in the course of events presented above that
p.000065: coincided in time with deep social and economic depression of the initial stage of independence of the CIS countries
p.000065: making them “vulnerable” countries in regard to conduct of biomedical research. This “vulnerability” was
p.000065: characterized with high dependence of all parties indicated above involved into a research process (state agencies,
p.000065: researchers and research sites as well as patients) as to facts of considerable
p.000065: conflicts of interests, direct and indirect pressure due to absence of tangible assets, medicines, work, etc.
p.000065: The mostly civilized response on present situation was transition explicitly marked in all CIS countries to the
p.000065: level of global international interaction in the sphere of biomedical researches (described in details herein
p.000065: in chapters regarded to the CIS member states). Currently the basis of legal regulation of biomedical research in all
p.000065: CIS countries is formed by a set of international legal and recommendation documents among which, first of all, one can
p.000065: emphasize previously mentioned (1.2) Guidelines for Good Clinical Practice (ICH GCP) of 1996. This document
p.000065: along with a set of documents regulating the order of ethical examination to a large extent determined domestic
p.000065: regulation in the sphere of biomedical research in the CIS member states and added to the aforementioned parameters of
p.000065: attractiveness of the region in regard to the biomedical research setup the following features:
p.000065: - compliance with international research standards;
p.000065: - predictability and openness of approval systems;
p.000065: - availability for monitoring, audit and inspection.
p.000065: Activities of IPA CIS and the CIS Council on Cooperation in the Field of Health Care contributed a lot into this
p.000065: process and its unification within CIS identifying unity of views on a range of factors determining modern realia of
p.000065: development of the CIS countries.
p.000065: First of all, one should note that strengthening of health of the population as one of the main priorities
...
p.000081: the procedure of obtaining and documenting research subjects’ informed consent. The review is concluded with the EC
p.000081: decision relating to the proposed research project. The subject of the ethical review is the research compliance with
p.000081: ethical and legal requirements regulating biomedical research and set out in documents of various status and
p.000081: application sphere. Statements relating to a potential research subject’s voluntary consent to participate in
p.000081: the research, to providing adequate information on
p.000081: all aspects of the research and to confidentiality of all patient’s data obtained in the course of the research are of
p.000081: crucial importance.
p.000081: Here is seems reasonable to review main characteristics of these two elements of biomedical research ethics in the CIS
p.000081: countries and to determine perspectives for their development.
p.000081: When analyzing the situation in the CIS countries with regard to ECs activity and its compliance with standards of
p.000081: ethical review of biomedical research the following main problems should be mentioned:
p.000081: • usually there is no accurate distinction as to ECs functions, which creates potential conditions for the
p.000081: redoubling of the review and decisions;
p.000081: • ethical review conducted only at the level of the national EC (in some CIS countries) hampers the analysis of a
p.000081: specific character of a particular research centre and limits opportunities of a dynamic monitoring of ongoing
p.000081: research;
p.000081: • we cannot exclude cases of administrative and economic dependence of local EC on interests of research centres as
p.000081: they are highly motivated to conduct a research;
p.000081: • usually there is no legal system of appeal with regard to the EC decisions;
p.000081: • the lack of detailed regulations concerning EC financing;
p.000081: • the lack of state inspection of the EC activity;
p.000081: • the lack of demand for ethical review on the part of research subjects;
p.000081: • the lack of a regular state system for training EC members.
p.000081: The mentioned problems determine the leading trends in the development of the system of the EC performance and
p.000081: structure in the CIS countries:
p.000081: • to develop legislation ensuring the EC independent performance;
p.000081: • to separate power (responsibilities and rights) in the performance of EC on different levels (national, regional,
p.000081: local);
p.000081: • to create the system of EC interaction inside the country and on the international level;
p.000081: • to develop the demand for ethical review in all research subjects;
p.000081: • to eliminate informational vacuum with regard to issues of the protection of human rights and dignity in
p.000081: biomedical research;
p.000081: • to create an educational and informational programme on bioethics for medical professionals and other persons
p.000081: associated with the research;
p.000081:
p.000082: 82
p.000082:
p.000083: 83
p.000083:
p.000083: • to develop a special system for training EC members;
p.000083: • to introduce the practice of the state inspection and independent audit of EC performance;
p.000083: • to develop legal regulations for the EC economic activity.
...
Searching for indicator dependency:
(return to top)
p.000010: 10
p.000010:
p.000011: 11
p.000011:
p.000011: We should note that 1993 was one of the most hard years in the demography in the CIS countries, as the
p.000011: fertility rate decreased in all CIS countries (except Tajikistan). In comparison with 1986, when the highest fertility
p.000011: rate in the USSR for the last 50 years was registered, the fertility rate in 1993 in the CIS countries decreased by 33%
p.000011: (and by 8% in comparison with 1992, which is much enough in terms of annual oscillations) and was 13.5
p.000011: births per 1000 of population. The number of deaths in 1993 in the CIS countries was 3.6 million, and increased, in
p.000011: comparison with 1992, by 429,000. The general mortality rate increased by 14% and was 12.6 deaths per 1000 of
p.000011: population2.
p.000011: The growing share of elder people and a decreasing weight of children in the total population are typical for the
p.000011: majority of the CIS countries. This is connected with worldwide tendencies to population ageing and a drop in birth
p.000011: rate, as well as with the crisis at the end of the 20th century. In six of the CIS countries even the simple
p.000011: reproduction of population is not achieved,
p.000011: i.e. the total fertility rate (see below) is equal to or less than 2.1. These countries are Armenia,
p.000011: Belarus, Georgia, Moldova, Russia and Ukraine
p.000011: Belarus, Georgia, Russia and Ukraine are noted for the ratio of persons over 65 to the so called economically
p.000011: productive persons (at the age of 15-64), and Kyrgyz Republic, Tajikistan, Turkmenistan and Uzbekistan,
p.000011: where the age-dependency ratio is 2-3 times higher than in Belarus, Russia and Ukraine, stand out for that of children
p.000011: under 15.
p.000011: The greatest reduction of the able-bodied population in comparison with 1989 is observed in Georgia (by 20% for males
p.000011: and by 18% for females) and Ukraine (by 3,8% for males and by 4,9% for females). A significant increase of the
p.000011: able-bodied citizens (by 26-47%) is registered in Azerbaijan, Kyrgyzstan, Uzbekistan, Tajikistan and Turkmenistan
p.000011: The increase in the number of young people has a favorable effect on the increase of the total population, and the
p.000011: growing number of early marriages implies a perspective of a sooner birth of the first children and the increase of the
p.000011: total fertility rate.
p.000011: During last four years in the majority of the CIS countries no decrease of the fertility rate was registered. On
p.000011: the contrary, in 2003-2004 it has slightly increased. This process can be related to some stabilization
p.000011: in
p.000011:
p.000011: 2 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 23.
p.000011: social and economic situation in the CIS countries, as well as to the fact that people, born in the middle of 1980-s
p.000011: when the birth rate in Soviet Union was relatively high reached the fertility age.3
p.000011: At the beginning of 2005, the population size in the CIS countries was 279 million people (according to the Statistic
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000023: morbidity has increased dramatically. The most disturbing is the fact of the mental health worsening, since in recent
p.000023: ten years the rate of mental diseases in children doubled, that of moronity increased in 1.5 times and imbecility in
p.000023: 1.6 times. We have to recognize the growing number of disabled children; in the CIS countries there are about 1.5
p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
p.000023: addicts. Every five years the amount of drug addicts in the “youngest” group is increasing by 100%. The children
p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
p.000023: population, and where in the case of an essential improvement of the economic situation the extended reproduction may
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
p.000023: To summarize the analysis of the demographic situation, it is necessary to note that with regard to self-preservation
p.000023: the following public processes are crucial:
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
p.000023: mortality in able-bodied population, “rejuvenation” of some diseases, spread of alcoholism and drug addiction;
p.000023: - the change in consumption of genetically habitual food products, decrease in food calorie content for the
p.000023: considerable part of the society;
p.000023: - reduced access to social services in conditions of a large-scale commercialization, which negatively
p.000023: affects the quality of human resources, intellectual, scientific and physical potential of the country;
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000025: 25
p.000025:
p.000025: - the decreasing number of medical institutions; a level of the population morbidity and mortality still remains
p.000025: high; the number of handicapped people is increasing;
p.000025: - stratification of the society by income, when 10% of the most well- to-do population have incomes more than 10 times
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
...
p.000033: Republic of Tajikistan, Art. 49 of the Constitution of the Republic of the Ukraine, Art. 40 of the Constitution of the
p.000033: Republic of Uzbekistan).
p.000033: Majority of the CIS countries also declared in their constitutions the right for medical care in different forms
p.000033: (excluding three republics – Armenia, Azerbaijan and Uzbekistan: in these states guarantees of availability of
p.000033: health care for people are set at the level of branch laws regulating public relationships in the health care system).
p.000033: At the same time one should note that the issue of underfunding in regard to required amount of medical care today is
p.000033: still one of the most acute problems almost in all countries of the Commonwealth.
p.000033: States implement programs on population health protection, measures for environmental protection and provision of
p.000033: free access to reliable information on its status, living and working conditions, quality of food products
p.000033: and household goods, facilitate development of physical culture and sports, create opportunities for various
p.000033: forms of health insurance. Financial support is guaranteed to pregnant women11, mothers with small children and in
p.000033: case of children with disabilities – until they become older
p.000033: – to families with many children, persons with various diseases and drug abuse. The state provides special care
p.000033: for those who broke their health protecting state and common interests. An important issue is inclusion into the
p.000033: sphere of state policy and legal regulation of an issue of preservation of national gene pool.
p.000033: It is truly important that virtually all CIS countries adopted branch laws related to issues of health care and patient
p.000033: rights – the Law of the Republic of Armenia On Medical Care and on Services for Population (1996), the Law of the
p.000033: Republic of Azerbaijan On Protection of Population Health (26.07.1997),
p.000033: 11 Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of Moldova,
p.000033: respectively.
p.000033:
p.000034: 34
p.000034:
p.000035: 35
p.000035:
p.000035: the Law of the Republic of Belarus On Health Care (1999), the Law of Georgia On Health Care (1997), the
p.000035: Law of the Republic of Kazakhstan On Protection of Population Health of the Republic of Kazakhstan (1991), the Law of
p.000035: the Kyrgyz Republic On Protection of Population Health of the Kyrgyz Republic (09.01.2005), the Law of the
p.000035: Republic of Moldova On Rights and Responsibility of Patient (27.10.2005), Basics of the Law of the Russian Federation
p.000035: On Protection of Citizen Health (22.07.1993), the Law of the Republic of Tajikistan On Protection of Population Health
p.000035: (15.05.1997), Basics of the Law of the Ukraine On Health Care (1992), the Law of the Republic of Uzbekistan On
...
p.000055: advertising of a hydro power station or, for instance, a walking excavator would be senseless – advertising is
p.000055: appropriate only there and when it is targeted on mass consumer. And mass media utilizing this function makes possible
p.000055: to include it into the described circuit.
p.000055: At that, the term “mass media” is used in actually wide and, possibly, not very accurate sense. Mass media here is,
p.000055: actually, various technologies of working with information, informational support for the circuit. Generally speaking,
p.000055: this element – information and communication technologies
p.000055: – is considered by many authors as crucial for the society of knowledge. “Informational and communicational
p.000055: technologies – one of the supports for so widely discussed society of knowledge and economics of knowledge;
p.000055: other supports are growing importance of science, scientific knowledge as well as knowledge originating from culture
p.000055: sources.” (J.Spanberger et al. The knowledge-based society: measuring sustainability of the information society.
p.000055: Futura, 2002). Or it could be said as follows: the term “mass media” in this sense is related to all social and
p.000055: humanitarian technologies which are substantially important, necessary for functioning of the circuit.
p.000055: For instance, a special sphere of activity within the circuit is to bring to a consumer not only information about a
p.000055: newly developed technology but the technology itself. Let’s say, as per some estimation, when producing new medicinal
p.000055: agent its development (i.e., the laboratory) takes about one tenth of all financial expenditures, and all other costs
p.000055: are incurred for promotion of a drug up to the stage of a marketed product. Naturally, an activity for new technology
p.000055: promotion is also built upon technological basis, and at that at these stages the main role is played by social and
p.000055: humanitarian technologies. It indicates once again that development of some product – in this case, a medicinal agent –
p.000055: within the framework of technoscience is nothing else but a
p.000055:
p.000056: 56
p.000056:
p.000057: 57
p.000057:
p.000057: part of technological process and, thus, technoscience deals, first of all, not with objects as they are but with
p.000057: extensive circuits including, beside these objects, also joint, coordinated activity of various people and social
p.000057: structures.
p.000057: It does not matter how effective is advertising but one should not demonize it and consider as omnipotent. A
p.000057: consumer, generally speaking, is far from always being a puppet that is easy to manipulate. He has his own and not only
p.000057: dictated externally needs and preferences. Effectiveness of functioning of the technoscience circuit is, to a large
p.000057: extent, secured with built in mechanisms of identification of consumer interests and expectations. Due to use of
p.000057: social and humanitarian technologies these interests and expectations, in their turn, are brought to notice of
p.000057: the business and laboratory and become factors determining strategy of technology development.
p.000057: Further, it is necessary to mention another network where information circulates in the circuit. In this case we
p.000057: mean not mass but specialized information about desire of a businessman to invest in development of
p.000057: specific technologies, on one hand, and about technological possibilities and perspectives of this or that laboratory,
...
p.000089: pity on the half-alive philosopher and order either to heal or to kill me. Likewise, it would be right for a man who
p.000089: had reached old age to kill himself when he is delirious, confused and utters meaningless phrases”.
p.000089: David Anhaght did not share Stoic views on permissibility of suicides under conditions mentioned: “In this regard
p.000089: we say that no one should kill oneself – neither those who have the right to do this, nor those who don’t… Trials,
p.000089: whenever or wherever they happen, come to us not in order that we should kill ourselves, but so that we tried our soul.
p.000089: Like a good helmsman is tested not in still water, but in the stormy sea, the lofty soul goes to meet a trial”.
p.000089: Thus David Anhaght (the Invincible), in line with Nerses the Great, a prominent philosopher (V c.), gave a negative
p.000089: answer to the question “Does the physician have a moral right to hasten his patient’s death?”.
p.000089:
p.000090: 90
p.000090:
p.000091: 91
p.000091:
p.000091: Similar views we find in works of Armenian thinkers Mkhitar Hosha and Smbat Hundstabl (XIII c.). In “The Book
p.000091: of Laws” we read: “The physician who deliberately or through ignorance does harm to the patient’s health or, what
p.000091: is more, hastens the patient’s death, as well as the physician who educates a disciple, but does not give him proper
p.000091: knowledge deserves a severe punishment, up to death penalty”.
p.000091: This discussion started many ages ago is still topical nowadays. Neither lawsuits against physicians who
p.000091: support euthanasia thus violating one of the fundamental principles in The Hippocratic Oath (“To please no one will I
p.000091: prescribe a deadly drug nor give advice which may cause his death”), nor protests of public at large advocating
p.000091: traditional views do not guarantee that those who stick to more radical opinions will not triumph in the near future
p.000091: (alas!).
p.000091: Philosophical moral principles of the Hellenistic world had a great influence on the moral code of
p.000091: medieval Armenian medicine along with the highest values of the Christian ethics. The physician who violated The
p.000091: Hippocratic Oath and gave his patient “a deadly drug” was not merely reproached for that but treated as a
p.000091: criminal guilty of an innocent person’s death with all the corresponding consequences, as stated in the chapter “On
p.000091: Physicians Prescribing Deadly Drugs” in “The Book of Chrii”.
p.000091: In his treatise “The Usefulness of Medicine” Amirdovlat Amasiatsi, an outstanding Armenian physician (XV c.) writes:
p.000091: “The physician should be reasonable and have the sense of duty; he should be tolerant and ready to give advice. In no
p.000091: circumstance should he be a drunkard nor should he be greedy and mercenary-minded. He should love the poor and be
p.000091: merciful, faithful and god-fearing. If he does not understand the essence of the disease he should
p.000091: prescribe no drug in order not to stain his reputation. If the physician is ignorant it would be better not to call him
p.000091: to see a patient, and, in general, he should not be regarded as a physician.” These words showing an ideal image of the
p.000091: physician-humanist and his moral code are still essential for modern medicine that synthesized imperishable moral
p.000091: values set forth in medical systems of the East and the West.
p.000091: Today, each of the presented problems gives rise to many new questions. At the present stage of bioethics development
p.000091: we are more able to formulate the questions than to offer a comprehensive solution, and therefore most of them remain
p.000091: open.
p.000091: References
p.000091: 1. Amirdovlat Amasiatsi. The Good of Medicine. Yerevan, 1940, p. 9 (in Armenian).
p.000091: 2. Arevshatyan S.S. Early Armenian Translations and Their Cultural and Historical Significance. // Journal of
p.000091: History and Philology of Academy of Sciences of Armenian S.S.R. 1973, No 1, p. 23-37 (in Armenian).
p.000091: 3. Vardanyan S.A. Medical and Biological Views of David the Invincible. / Philosophy of David the
p.000091: Invincible. Moscow, 1984, pp. 83-93 (in Russian).
p.000091: 4. David Anhaght. Works. Moscow, 1980, pp. 84, 77, 71, 49, 72, 44, 75,
p.000091: 61, 63, 65 (in Russian).
p.000091: 5. Oganesyan L.A. The History of Armenian Medicine. Yerevan, 1946, Vol. 1, pp. 85-127, 141-143 (in Russian).
p.000091: 6. Vardanyan Stella. History de la medicine en Armenia. Paris, 1999. pp. 43-52.
p.000091: 7. Vardanyan S. Medicine and Philosophy in Early and Medieval Armenia. In: Collection of Scientific Works.
p.000091: Yerevan, 2005, pp. 644-647 (in Russian).
p.000091: 8. Informed Consent. UNESCO Chair in Bioethics, Editor: Prof. Amnon Carmi. – Israel, 2003.
p.000091: 9. Davtyan S.A. The Problem of Implementing New Approaches in the Process of Teaching Traditional Ethics and Bioethics.
p.000091: In: The Process of Implementing New Teaching and Scientific Technologies. Yerevan, 2003, pp. 40-42 (in Armenian).
p.000091: 10. Davtyan S. The traditions, customs, culture, and mentality of the nation and problem of Eutanasia in Armenia.
p.000091: Eilat, Israel, 2002, p. 10.
p.000091:
p.000091: 3.1.2 Legal Regulations
p.000091:
p.000091: Biomedical research and, particularly, a clinical trial is a complicated process requiring not only heavy financial and
p.000091: intellectual costs, but also a competent approach to research planning in order to obtain eventually a safe and
p.000091: effective pharmaceutical product or method.
p.000091: The development and study of new pharmaceutical products is impossible without research involving
p.000091: human subjects, and here we face two main problems. On the one hand, we have to obtain reliable data on
p.000091:
p.000092: 92
p.000092:
p.000093: 93
p.000093:
p.000093: the efficiency and safety of any new drug or method, while; on the other hand we must not expose human subjects
p.000093: participating in the research to an excessive risk.
p.000093: Modern rules of conducting clinical drug trials are very strict both in relation to the protection of human
p.000093: rights of research participants and in relation to reliability of research results. The history of biomedical
p.000093: research knows many examples proving the importance of such an approach.
p.000093: In connection with the broadening of international contacts and the increasing exchange of drugs, it is
p.000093: necessary to have uniform requirements of conducting experiments on animals, laboratory studies and clinical trials.
p.000093: Today principles and procedures of biomedical research involving human subjects, particularly of clinical trials, are
p.000093: most thoroughly elaborated, as biomedical research is an inevitable part of scientific activity aiming at
p.000093: developing a new drug or method or extending the list of indications for the application of a drug already known. Today
p.000093: the role of clinical trials has increased in connection with implementation of principles of evidence- based medicine
p.000093: into healthcare practice.
p.000093: The primary principle implies that individual clinical decisions on treatment of a certain patient should be
p.000093: based on strong evidenced scientific data which may be obtained in the course of a thoroughly planned and
p.000093: controlled clinical trials rather than on expert’s personal experience or views.
p.000093: Nowadays in conducting biomedical research the world community follows the rules stated in Guidelines on
p.000093: Good Clinical Practice. This document presents a set of regulations ensuring an unbiased evaluation and
p.000093: reliability of research outcomes, as well as protection of research participants. The protection of human
p.000093: rights is guaranteed by independent ethics committees that review documents relating to the clinical trial in view of
p.000093: evaluation of risks for patients and protection of their rights.
p.000093: As we know from the history of clinical trials, initially the organization and performance of those was lacking
p.000093: for an ordered and systematic approach, and there were problems regarding implementation of GCP guidelines
p.000093: in different countries. At the same time, it is clear that safe and reliable research outcomes may be obtained only if
p.000093: the rules are observed.
...
p.000099: and represent different social communities: physicians of different specialties, clinical pharmacologists, lawyers,
p.000099: nurses, representatives of culture, etc.
p.000099: Ethics Committee of Health Ministry of Republic of Armenia has the following responsibilities:
p.000099: - ethical review of clinical trials;
p.000099: - control of the trial process through a regular monitoring;
p.000099: - review of research protocol amendments;
p.000099: - protection of confidentiality.
p.000099: For a thorough and complete ethical review of clinical trials in Armenia the following documents are required:
p.000099: - research protocol,
p.000099: - informed consent form signed by the trial participant,
p.000099: - investigator’s brochure,
p.000099: - written information and promotion materials for potential trial participants
p.000099: - documents confirming investigator’s qualification.
p.000099: When reviewing the protocol of the clinical trial the following should be considered:
p.000099: - scientific justification of the trial goals and objectives;
p.000099: - data of pre-clinical studies;
p.000099: - results of previous clinical trials;
p.000099: - risk/benefit balance of the suggested treatment;
p.000099: - the justification of the treatment plan (dosages, duration of the treatment);
p.000099: - ethics of control choice (placebo, reference drug, no treatment);
p.000099: - criteria of recruitment of the trial participants (inclusion/exclusion criteria);
p.000099: - procedures of informing trial participants;
p.000099: - materials presented to the trial participant;
p.000099: - procedures of obtaining written informed consent to participate in the trial.
p.000099: In its activity Ethics Committee follows three main principles: scientific justification, risk/benefit balance,
p.000099: informed consent.
p.000099: Scientific justification. No scientific research can be considered ethical unless it has a comprehensive scientific
p.000099: justification. A poor justification may, at best, result in the loss of participants’ time, and, at worst, it may bring
p.000099: about an unwarranted risk. Ethics Committee has the right to reject the planned research if it repeats a similar
p.000099: research, and yields no new results.
p.000099: Risk/benefit balance. The main ethical requirement for clinical trials of new drugs is to gain benefit with the
p.000099: minimum risk for the patient. It is necessary to monitor clinical trials, and register all complications, not only
p.000099: physical but such as discomfort, invasion of participant’s privacy, etc. In many cases risks are unavoidable, but it
p.000099: must be minimum and under control.
...
p.000109: 10. Ethical Principles in Medicine. Part 2. Bioethical Aspects of Euthanasia. Methodical Manual. Baku,
p.000109: Republic of Azerbaijan, 2002, 32 p. (in Russian).
p.000109: 11. Ethical Standard Operational Procedures in Azerbaijan. “Ethics Committees in Russia and Other CIS Countries.
p.000109: International Seminar. St.- Petersburg, Russia, 2003, p. 15 (in Russian).
p.000109: 12. Medical Ethics. Baku, Republic of Azerbaijan, 2004, 100 p. (in Russian).
p.000109: 13. The Role and Meaning of Ethical Education of Medical University Graduates in the Protection of Patients’
p.000109: Rights in Biomedical Research. International Conference of CIS Countries. Kiev, Ukraine, 2004, pp. 23-25 (in
p.000109: Russian).
p.000109: 14. Ethical Education and Protection of Human Rights in Biomedical Research. Baku, Republic of Azerbaijan, 2004, pp.
p.000109: 65-67 (in Russian).
p.000109: 15. Moral and ethical aspects of healing. Azerbaijan Medical Journal, 2005, 1, p. 34.
p.000109: 16. Dictionary of Biomedical Ethics. Baku, Republic of Azerbaijan, 2007, 96 p. (in Russian).
p.000109:
p.000109: 3.2.4. The System of Ethical Review
p.000109:
p.000109: During the last years the issues of arranging conditions for the development of ethical review which is to
p.000109: safeguard rights and safety of patients and other persons involved into clinical trials are widely discussed.
p.000109: State regulation and control of drug quality is one of the principal ways to ensure protection of rights of individuals
p.000109: participating in trials.
p.000109: With that purpose, a Pharmaceutical Committee based on GCP principles was established at the Ministry of Health
p.000109: of Azerbaijan. Good clinical trials guarantee observance of ethical and other fundamental principles and
p.000109: requirements for organizing the research. Legal aspects are set forth in the “Law on Pharmaceutical Products”.
p.000109: In line with GCP principles, Azerbaijan Pharmacological Committee developed and endorsed a number of
p.000109: recommendations on the review of documents submitted for drug registration, on pre-clinical drug trials,
p.000109: on clinical drug trials, etc.
p.000109: Basic medical institutions with an adequate technical equipment and staff potential for conducting biomedical
p.000109: research were determined and appointed.
p.000109: The system of monitoring was developed. Basic medical institutions receive drugs through the Pharmacological
p.000109: Committee that approves the Research Protocol and then receives a report on results of trials. The drug is
p.000109: registered only after the survey of the review quality. This system is compulsory for every drug designed in
p.000109: Azerbaijan. There is also an effective system of licensing and accreditation. The Pharmacological Committee is planning
p.000109: a further development of normative documents and improvement of the existing system.
p.000109: Currently, comprehensive measures are taken to develop and implement international standards for ethical
p.000109: review – standard operational procedures.
p.000109: On UNESCO initiative, the International Committee on Bioethics was established in 1997, and national committees began
p.000109: to form.
p.000109: The Presidium of the National Academy of Sciences acknowledged the expedience of joining world scientific
p.000109: community in observing rules of bioethics when conducting biomedical and medical research and made the decision to
p.000109: constitute the Committee for Bioethics and Technology Ethics at the Presidium of the National Academy of Sciences.
p.000109: In 1999, following The Universal Declaration on the Human Genome and Human Rights adopted at UNESCO’s 29th
p.000109: General Conference, the Presidium of the National Academy of Sciences established the National Committee for
p.000109: Bioethics and Technology Ethics (Order No 9/1, 24.03.99).
p.000109:
p.000109: the Committee has the following structure:
p.000109:
p.000110: 110
p.000110:
p.000111: 111
p.000111:
p.000111: In 2003 the Committee developed guidelines regulating the work of ethics committees, their structure and
p.000111: management principles as well as rights and responsibilities of the committee members.
p.000111: Currently, the Committee works intensively at propagating ethical norms and principles and protecting fundamental human
p.000111: rights in Azerbaijan.
...
p.000129: of raising their professional knowledge and post-graduate education. Here the situation is more
p.000129: complicated as the system is yet to be developed, though there are some achievements. At the Academy for Post-Graduate
p.000129: Education of Belarus at least four aspects of education in biomedical ethics are considered, though time given to these
p.000129: issues is insufficient (2-4 h). The four aspects are:
p.000129: – raising professional level of specialists with higher and secondary special education in medicine and
p.000129: pharmacy through education in bioethics
p.000129: – introducing courses on bioethics into syllabi and teaching programmes for retraining specialists with higher and
p.000129: secondary special education in medicine and pharmacy;
p.000129: - teaching bioethics within a programme for training teaching staff of high qualification (postgraduates, doctoral
p.000129: students);
p.000129: – raising professional level of professionals who organize and carry out clinical trials so that they could be admitted
p.000129: to this activity.
p.000129: However, we do not have a separate course on bioethics at the graduate and post-graduate levels. We also lack a State
p.000129: system of teaching GCP and a systematic training for EC members. Training courses in ethical review of clinical drug
p.000129: trials are held at the Republican Centre of Expertise and Trials in Healthcare. The course is very short (2-4 hours).
p.000129: There are no dissertation boards, and no dissertation on bioethics has been defended, as the Higher Certifying
p.000129: Commission does not have this discipline on the list of specialties. The first dissertation on bioethics as a basis of
p.000129: the physician’s professional culture is planned in the section of “Culturology”. Therefore, currently the question of
p.000129: introducing differentiated specialized courses on bioethics for different categories of postgraduate audience is under
p.000129: consideration.
p.000129: We also use some other opportunities to raise graduates’ and postgraduates’ professional level in
p.000129: bioethics, particularly, international grants received on one’s personal initiative. Thus V.K.Kevra participated in
p.000129: an Educational Project at the Lithuanian National Committee on Bioethics;
p.000129: O.P.Aizberg attended the Seminar on Bioethical Problems in Narcology organized by the “AWEF—AIDS: East-West”
p.000129: Foundation (Kiev, 2006).
p.000129: The third level – providing bioethical knowledge for the population
p.000129: – is the most “deserted” field of work. A low level of public awareness affecting the public opinion and
p.000129: decision making with regard to vitally important issues – from informed consent to adoption of laws – requires
p.000129: taking immediate measures to change the situation.
p.000129: Here we have high hopes for the Project “Education in Bioethics and Promotion of Bioethical Knowledge in Belarus”
...
p.000149: civil society. Adoption of Georgian Constitution (24 of August 1995) and Georgian Civil Code (26 of June 1997) is
p.000149: definitely significant step toward establishment of national state.
p.000149:
p.000149: 3.4.2 Legal Regulations
p.000149:
p.000149: Legislation of Georgia related to health, biomedicine and human rights comprise laws which regulate
p.000149: various aspects of medicine/health care: rights of patients and research subjects (including vulnerable groups; such
p.000149: as minors, persons with mental disorders, patients with HIV/AIDS etc.), duties and responsibilities of health
p.000149: care professionals, human organ transplantation, assisted reproductive technologies etc.
p.000149: From the above-mentioned laws the Law of Georgia on Health Care (adopted by the Parliament of Georgia in 1997)
p.000149: is considered to be the framework law, which determines the priorities and sets out fundamental principles of the
p.000149: health care legislation of Georgia. It covers full range of problems related to health, including issues related to
p.000149: protection of research subjects.
p.000149: In general, there are three major documents serving the legal basis for biomedical research involving human subjects.
p.000149: These legal texts are:
p.000149: • Convention on Human Rights and Biomedicine (Signed by Georgia in May 2000; Ratified by the Parliament in September
p.000149: 2002; Entered into force on 1 of March 2001);
p.000149: • Law of Georgia on Health Care (Adopted by the Parliament of Georgia in December, 1997);
p.000149: • Law of Georgia on Drug and Pharmaceutical Activity (Adopted by the Parliament of Georgia in 1995; Updated in
p.000149: 2001).
p.000149: The draft of specific law on biomedical research –“Law on Biomedical Research Involving Human Subjects” will be
p.000149: the fourth and the most comprehensive document regulating research on human subject. Draft “Law on
p.000149: Biomedical Research Involving Human Subjects” (originally drafted in 1999) has been reviewed by the expert
p.000149: appointed by the Council of Europe in 2000 and updated according to the comments provided.
p.000149:
p.000150: 150
p.000150:
p.000151: 151
p.000151:
p.000151: It was submitted to the Government in 2000 and to the parliament of Georgia by the President in 2002.
p.000151: However, in 2005 it was taken back by the Government for further consideration against the background of the latest
p.000151: developments of the Council of Europe. In 2006 the draft law was reviewed by the working group based on the
p.000151: comments of the experts, including experts appointed by the Council of Europe. The draft law was the subject of
p.000151: debates during the international conference “The Council of Europe and Promotion of Research Ethics in East
p.000151: European States” organized by the Council of Europe and the Government of Georgia in Tbilisi in October
p.000151: 2006.
p.000151: Since the Convention on Human Rights and Biomedicine entered into force in Georgia it becomes the integral part
p.000151: of Georgian legislation, taking precedence over other laws and coming after the Constitution in the hierarchy of law.
p.000151: So, provisions of the Convention related to the research on human subjects is applicable to all relevant
...
p.000151: research and its ethical evaluation will have its Additional Protocol on Biomedical Research, which has been signed by
p.000151: Georgia but is not yet ratified.
p.000151: The law of Georgia on Health Care includes separate chapter – Chapter XIX “Biomedical Research”, in which basic
p.000151: principles regulating biomedical research are set out. Particularly according to the above-mentioned law:
p.000151: • aims, objectives, methods and possible outcomes of the research should be specified in the research
p.000151: protocol; research should be carried out only within the frames of the research protocol;
p.000151: • research protocol should be reviewed by independent body and ethics committee;
p.000151: • risks and benefits of the research should be assessed; risk associated with the research should not be
p.000151: disproportional to the expected benefits;
p.000151: • research subject should be fully informed about the details of the research (objectives, methods, potential
p.000151: benefits, risks, alternatives etc.);
p.000151: • research should not be started without informed consent of the research subject;
p.000151: • research subject has the right to refuse to participate in the research or withdraw from the research at any
p.000151: time despite already given written informed consent.
p.000151: The law also outlines general principles for the protection of incapable persons and minorities in the context of
p.000151: biomedical research.
p.000151: The law on Drug and Pharmaceutical Activity sets out the rules for organizing drug trials including trials in
p.000151: clinical phase when human beings are involved in the research programme. It requires that ethics committee to be
p.000151: created at the institution where the trial is to be carried out. Interestingly, this law specifically mentions
p.000151: recommendations set out in WMA Declaration of Helsinki to be the basis for conducting clinical trials on human beings.
p.000151: As already mentioned the most specific law on the protection of the research subjects will be the Law on
p.000151: Biomedical Research involving Human Subjects, which is being submitted to the Government this year. The aim of the
p.000151: draft law is protection of the rights, health and life of a research subject of biomedical research and provision of
p.000151: safety and respect for dignity during the research. The draft law concerns any type of research aiming at obtaining
p.000151: information and broadening knowledge in the sphere of biomedicine, which serves the interests of human health
p.000151: protection and implies:
p.000151: • Physical intervention on human being;
p.000151: • Research on biological materials which initially were taken and stored with other purpose;
p.000151: • Intervention which doesn’t imply physical intervention on human being but can pose danger to mental health or
p.000151: psychological condition of human being;
p.000151: • Research on foetus and/or embryo in vivo (The Law does not apply to research on embryos in vitro.
...
p.000153: Healthcare professionals have an opportunity to take short CME courses with credit hours. The course has been
p.000153: developed and submitted for accreditation by GHLBS. It offers the audience the variety of topical issues related to
p.000153: ethics inherent in doctor-patient relationship: basic principles of modern medical ethics; the rights of
p.000153: patients with the principles of modern medical ethics; active legislation of Georgia on patient’s rights; ethical
p.000153: basis of informed consent, regulations about informed consent in Georgian legislation; necessity of obtaining a written
p.000153: informed consent and protection of dignity of a patient, protect confidentiality and privacy in the process of teaching
p.000153: students and residents, role of Ethics committees, etc. There is one more programme specifically developed for
p.000153: doctoral students. This one day programme is focused on research ethics and covers
p.000153: all aspects of ethical and legal regulation of biomedical research.
p.000153:
p.000154: 154
p.000154:
p.000155: 155
p.000155:
p.000155: 3.4.4 The System of Ethical Review
p.000155:
p.000155: Below is given unofficial data collected about the drug trials being conducted in Georgia.
p.000155: In 1998-2002 12 internationally sponsored drug trials have been conducted in Georgia. About 15 medical
p.000155: centres participated in it and it included about two thousand people. As to the local trials, their
p.000155: total number is about 55, but number of participants is not so large.
p.000155: On the other hand several hundred biomedical researches are being conducted unnoticed. They are not related to
p.000155: drug experiments (which usually attract more public interest), however many of these researches include
p.000155: human subjects. Just to give idea about their number - in only one academic institution 50 research plans
p.000155: are approved annually. Most of experiments conducted or to be conducted in the framework of these research plans,
p.000155: involve human subjects, but yet only scientific merit of these studies are assessed without evaluating its
p.000155: ethical acceptability.
p.000155: It is expected that the number of international multi-centre biomedical research (mostly drug trials) will dramatically
p.000155: increase in this region and many thousand of people will participate in it. Therefore, the issue becomes very important
p.000155: and appropriate mechanisms should put on place to ensure that biomedical research involving human subjects is conducted
p.000155: in ethical manner and the rights and safety of research subjects are protected. The most effective and widely
p.000155: tested approach is mandatory ethical review of any research project that considers interventions on human beings. The
p.000155: first mention of ethics committee in legislation was appears in 1997 (the Law on Health Care). However, the first
p.000155: ethics committees were established in 2000.
p.000155:
p.000155: Ethics Committees in Georgia
p.000155:
p.000155: Three types of ethics committees exist currently in Georgia: National Council on Bioethics, research and clinical
p.000155: (medical) ethics committees. The table below schematically outlines all these ethics committees and the legal basis
p.000155: for their establishment and functioning.
p.000155:
p.000155:
p.000155:
p.000156: 156
p.000156:
p.000157: 157
p.000157:
p.000157: national Council on Bioethics
p.000157: National Council on Bioethics17, which is advisory body to the Minister of Labour, Health and Social Affairs, prepared
p.000157: several recommendations during the last two years. However, it could not avoid discussion of certain specific cases
p.000157: upon request of the minister or other officials within the Ministry. On of the most interesting text of the Council is
...
p.000157: institutions (basically hospitals) are about
p.000157:
p.000157: 17 Charter for National Council on Bioethics was approved with the Order of the Minister of Labour, Health and Social
p.000157: Affairs (Order # 157/0, 5 of July 2000).
p.000157: 18 Law on Health Care, Law on Patient’s Rights, Charter for Clinical Ethics Committees endorsed by the
p.000157: Order # 128/n of the Minister of Labour, Health and Social Affairs (2 of October 2000).
p.000157: the value of CECs. Several projects are on their way of implementation aiming at intensifying
p.000157: clinical/medical ethics committee movement in Georgia.
p.000157: First Research Ethics Committees
p.000157: The first research ethics committees in Georgia were introduced about 5-6 years ago. The idea of their establishment at
p.000157: the first stage was related to the fact that well-known foreign medical journals do not publish the articles
p.000157: representing results of biomedical research, without prior approval of the research protocols by ethics committee.
p.000157: Therefore, only narrow circle of citizens (few scientists interested in publishing results of their research in
p.000157: foreign journals) was informed about the existence of the above-mentioned committees in the “western world”.
p.000157: The legal basis for the establishment of ethics committees, which would be in charge of reviewing protocols of
p.000157: drug-trials, was the Law on Drug and Pharmaceutical Activity enforced in 1996.
p.000157: In 1995-97 the law regulating generally almost all fields of healthcare, was drafted. This document – The Law of
p.000157: Georgia on Health Care - was thought to be the framework law for ongoing healthcare reforming process in Georgia. The
p.000157: Law was enacted in 1997. It lays down the legal basis for the establishment of the research ethics committees, which
p.000157: shall carry out ethical review of all research protocols (not only research protocols related to drug testing). So,
p.000157: currently “a scientific research plan shall be considered and reviewed …by the ethics committee” (article 107; the Law
p.000157: of Georgia on Health Care).
p.000157: At the first stage due to the lack of appropriately trained professionals it was considered wise to establish ethics
p.000157: committees bearing the functions of hospital ethics committees as well as research ethics committees. So the first
p.000157: version of the draft regulation for the so-called Medical Ethics Committees (prepared according to the Presidents
p.000157: Decree #15 on 12 of January 1998) was prepared.
p.000157: In 1999 two separate documents were drafted – the first one lays down principles of establishment and operation of
p.000157: Medical (Hospital) Ethics Committees (already adopted by the Order of the Minister of Labour, Health and Social
p.000157: Affairs) and the second one will regulate the activity of Research Ethics Committees. According to latter document
p.000157: the two-tiered network of committees on the regional level will be created in Georgia. The central
p.000157:
p.000158: 158
p.000158:
p.000159: 159
p.000159:
p.000159: research ethics committee shall coordinate the activity of regional research ethics committees.
p.000159: Unfortunately the statute for the Research Ethics Committees has not been yet approved, because of the comments
p.000159: of the Ministry of Justice stating that establishment of the separate committees for research ethics is not
p.000159: required by existing legislation (law in force or the Presidents Order). Therefore, it is suggested to amend the draft
p.000159: law on “Biomedical Research Involving Human Subjects” (which is now before Parliament) by introducing in it basic
p.000159: statements from the above-mentioned draft statute.
p.000159: About 15 research ethics committees were established during the last 5-6 years, from which about 6 would function at
p.000159: the moment. They have been created at the institutions that used to participate in the multi-centre trans-national drug
p.000159: trials. Without having such committees they would not have been able to participate in such trials. Only few of them
p.000159: would have their own regulation/bylaw. The number of the members would vary from 5 to 11 (mostly their number is 5 as
p.000159: it is defined in the Law on Drug and Pharmaceutical Activity).
p.000159: Finally, the National Council on Bioethics would exceptionally review some research protocols that reflect
p.000159: international multi-central biomedical research, because still there is no central research ethics committee
p.000159: in Georgia that would be in charge of carrying out ethical review of multi- central studies.
p.000159: Below is given brief schematic summary of what have has done and what is to be done in Georgia for the protection of
p.000159: research subjects in the sphere of biomedicine.
p.000159: Has been done:
p.000159: • General legal framework outlining basic principles for conducting biomedical research involving human subjects is
p.000159: created (law on health care; adopted in 1997) and requirements for organizing drug trials are specified (law on drug
p.000159: and pharmaceutical activity; adopted in 1995),
p.000159: • Convention on Human Rights and Biomedicine is signed and ratified (entered into force in Georgia on 1.03.01);
p.000159: also, its additional protocol on Biomedical Research has been signed;
p.000159: • First research (institutional) ethics committees for drug trials are established;
p.000159: • Specific law on biomedical research involving human subjects has been drafted and submitted to the Government;
p.000159: • Concept on the establishment of the two-tired network of research ethics committees on the regional level has been
p.000159: drafted (central research ethics committee and regional research ethics committees);
p.000159: • National council on bioethics stresses the importance of strengthening the system of ethical review of
p.000159: research protocols and advocates for the speeding up of the process of adoption of the specific law on biomedical
p.000159: research;
p.000159: • Teaching programmes in bioethics, including research ethics have been introduced on undergraduate as
p.000159: well as postgraduate level (programmes for residents and doctoral students as well as continuing medical
p.000159: education programmes for practicing physicians) of medial education/training.
p.000159: Is to be done:
p.000159: • Stimulation and speeding up the process of ratification of the law on biomedical research involving human
p.000159: subjects;
p.000159: • Introduction of sanctions in administrative and criminal code of Georgia for the infringement of the
p.000159: principles set out in the legislation related to the protection of research subjects;
...
p.000161: incorporated into the Czinn Empire.
p.000161: In 1917 «Alash-Ordy» declared its autonomy.
p.000161: In 1920 Kirgyz Autonomic Republic was organized as a part of the Russian Federation.
p.000161: In 1925 the republic received the name of Kazakh Autonomic Republic with the capital in Almaty and in 1936 it was
p.000161: transformed into Kazakhskaya Soviet Socialist Republic.
p.000161: In 1956 some part of republican territory was adjoined to Omskaya province and Altaysky krai.
p.000161: On 16th of December 1991 Kazakhstan became independent republic. The official name of the country is the
p.000161: “Republic of Kazakhstan” (RK). Astana is the capital of the country, Almaty – the biggest city of the country. The
p.000161: territory of Kazakhstan is equal to 2,717,300 sq. km.
p.000161: The population size of the country (data of 2006) is equal to 15.3 million citizens. Around 53% of the population is
p.000161: urban citizens. There are over
p.000161:
p.000162: 162
p.000162:
p.000163: 163
p.000163:
p.000163: 120 nationalities in Kazakhstan, among them Kazakhs – 58.9%, Russians
p.000163: – 25.9%, Ukranians - 15,2%, and Uzbeks, Germans, Tatars, Uygurs and representatives of other nationalities.
p.000163: Medicine as a part of population culture is the result of practical and scientific selection of methods for the
p.000163: treatment of different diseases. It is well known that even ancient healers used infusions, decoctions, blood-
p.000163: lettings and other traditional methods of treatment (1).
p.000163: Multiple archeological findings on the territory of Kazakhstan proves the existence of drug therapy, surgery,
p.000163: neurosurgery. For example, the scull with marks of trepanation was found in Karagandinskaya province and the origin of
p.000163: this scull was dated by V-IV centuries B.C. Mortars for preparation of medical drugs from the same epoch were
p.000163: found not far away from Shymkent. Due to achievements of Arabic and Greek medicine, Kazakh healers’
p.000163: medicine in middle ages was characterized with deep knowledge in the area of disease prognosis, prevention and timely
p.000163: treatment. There are definite data that healers of that era used already laparathomy, abdomen punctures, and
p.000163: surgery for hernias and cataract surgery.
p.000163: The great scientist and healer Oteyboidak Tleukabyl uly (1397-1492) underlined the importance of combination use
p.000163: of traditional treatment with innovation methods and considered that such approach improved the diagnostics of
p.000163: diseases and increased the efficacy of treatment.
p.000163: In the middle of XVIII century when Kazakh territories began tom unite with Russia the first
p.000163: professional health care workers appeared on the territory of Kazakhstan and together with them the first
p.000163: health care institutions were created – such as hospitals and military medical units of the Siberian Cossack army.
p.000163: In 1827 and in 1831 several epidemics of smallpox spread in Kazakhs steps. To take urgent measures, khan Zhangir had
p.000163: sent Sarlybay Zhanibekov for medical studies to Orenburg and in 1828 Sarlybay returned to Kazakhstan as professional
p.000163: smallpox vaccinator and surgeon’s assistant. Since that time mass immunization of local population against smallpox
p.000163: started.
p.000163: In 1920 special anti-plague laboratories were organized to control social diseases in the country. In 1922 the
p.000163: Scientific Medical Council was created under the Commissariat of Public Health.
p.000163: On 10 of October 1925 the first scientific institution was founded in Kzyl-Orda – The Regional Institute of Sanitation
p.000163: and Bacteriology. In meant
p.000163: the organization of the national medical science of Kazakhstan. Konstantin Ivanovich Skryabin gave very valuable help
p.000163: in the process of medical science development; due to his initiative anti-helminthic unit was organized in the city of
p.000163: Kzyl-Orda, special laboratory in the city of Dzhambul, parasitological laboratory at the Institute of Zoology of the
p.000163: Academy of Sciences of the Kazakhstan Soviet Socialist Republic. Special scientific journal “Public Health of
p.000163: Kazakhstan” was founded in for dissemination of scientific knowledge and best practice; this journal played the
p.000163: distinguished role in the development of Kazakhstan’s science.
p.000163: In 1930s several research institutions were organized actively; these Centres began to develop
p.000163: scientifically based recommendations on prevention, early diagnostics and treatment of diseases.
p.000163: During the first years of the Great Patriotic War 112 military hospitals were organized at the territory of Kazakhstan.
p.000163: During the war in spite of very complicated situation medical scientists of Kazakhstan continued their research
p.000163: activity and enriched the practice with very important discoveries and patents that did not loose their
p.000163: actuality even after the war. Academician N.F.Gamaleya – the founder of the Russian microbiology
p.000163: – after experiments on himself developed the drug for the treatment of tuberculosis. Professor
p.000163: A.P.Polosukhin developed an effective drug for shock treatment; Dr. A. N. Syzganov proposed and scientifically
p.000163: based the use of salicylic acid and acidophilic cream for the treatment of infected wounds and frostbites;
p.000163: Dr. V.V.Zikeev used formalized bone transplants for the treatment of pseudo-arthroses.
p.000163: During the war research institutions of Kazakhstan did not interrupt their activity; immediately after the war
p.000163: several medical research institutions were organized under the Academy of Sciences of Kazakhstan Republic: the
p.000163: Institute of Regional Pathology, the Institute of Clinical and Experimental Surgery, the Institute of Physiology.
p.000163: World-known academician Nikolai Dmitrievich Beklemishev – doctor of medical sciences, professor, honored scientist of
p.000163: Kazakhstan Republic and the winner of the State Prize – made a great input in the study and control of
p.000163: brucellosis. His monograph “Chronic brucellosis” was included as big section in the manual «Die brucellose des
p.000163: Menschen» that was edited and published in Berlin by J.Parms and in recommendations published by the World Health
p.000163: Organization.
p.000163:
p.000164: 164
p.000164:
p.000165: 165
p.000165:
p.000165: When Kazakhstan became independent country the public health sector in the country changed dramatically.
p.000165: The president of the state N.A.Nazarbaev declared the health of the population as the most important value in the
p.000165: country and formulated the specific goals of the policy – the improvement of the population health, support to the
p.000165: public health system and advocacy for the healthy lifestyle.
p.000165: Taking into consideration more strict demands and requirements for the quality of medical aid to
p.000165: population several social programmes were developed and approved in the country including the State Programme “The
p.000165: Health of Population”, “The program for the Control of Illegal Drug Use and Drugs Traffic”, the conception “On the
p.000165: development of Medical Sciences in Kazakhstan Republic”, the complex programme “The healthy lifestyle”, the State
p.000165: Programme “On reforms of Public Health System and its future development in 2005-2010” and other programmes.
p.000165: During the last several years new methods for treatment of patients were developed successfully in the
p.000165: Republic as well as new directions in medical sciences were created. Research studies were conducted on clinical
p.000165: efficacy of transplantations of pancreatic B-cells and embryonic liver cells. The National Genetic Register was
p.000165: organized. Public health authorities spend great efforts to implement the best results and discoveries of medical
p.000165: science into everyday practice of health care institutions. At the same time medical professionals like the Association
p.000165: of Physicians and Pharmacists of Kazakhstan (APPK) started very serious dialogue with the Government and society on
p.000165: such complicated issues as protection of human rights of participants of research studies and experiments.
p.000165: At all international conferences members of this Association stressed that the research activity should not harm the
p.000165: health and life of human beings. The importance of this problem found very positive response in the Government of the
p.000165: country. As a result in September 2005 the Commission on Bioethics was organized in frames of the National Coordination
p.000165: Council for Health Protection under Kazakhstan Government.
p.000165:
p.000165: 3.5.2. Legal Regulations
p.000165:
p.000165: During the last decade several very important social laws were approved in Kazakhstan. In 1991 special law “On Health
p.000165: Protection of Citizens of
p.000165: the Republic of Kazakhstan” was adopted, in 1994 – “On Prevention of AIDS”, in 1997 – “On Psychiatric Aid
p.000165: and Guarantees of Patient Rights during Treatment”, in 1998 – “On Radioactive Safety of Population”, in 1999
p.000165: – “On Physical Culture and Sports”, in 2002 – “On Medical and Social Rehabilitation of Persons with Drug Addiction”
p.000165: and “On Prevention and Control of Tobacco Use” and “On Sanitary and Epidemiological Protection of Population”.
p.000165: Several laws – such as “On Health Protection of Citizens”, “On the System of Public Health”, “On Medical Drugs” that
p.000165: were adopted in 2004-2005 – have the greatest importance in area of bioethics (2).
p.000165: Ethical problems of biomedical research in Kazakhstan were discussed actively since 2001 when according to
p.000165: initiative of the Association of Physicians and Pharmacists of Kazakhstan (APPK) and with the support from
p.000165: FECCIS and WHO the republican conference was organized and later
p.000165: – international conferences (in 2002 and 2005) under the common title – “High quality ethical practice for biomedical
p.000165: research in the Republic of Kazakhstan”.
p.000165: At present time there are definite trends for increase of attention to bioethical issues in the Republic
p.000165: of Kazakhstan not only from the state but from the general population too. These trends are reflected
p.000165: by the improvement of legal regulations in Kazakhstan.
p.000165: The article 29 of the “Constitution of the Republic of Kazakhstan” says that all Kazakhstan citizens have the right for
p.000165: health protection. The article 29 of the Constitution says that administrative persons that keep the secret on the
p.000165: facts and circumstances that are dangerous for population health and life can be prosecuted according to the Law (3).
...
p.000167: only after positive results of clinical trials were obtained.
p.000167: According to the article 9 of the same law (“The competence of responsible institution”) the Ministry of Health of
p.000167: Kazakhstan has the right to:
p.000167: - determine the requirements for the use of new methods and means of disease prevention, diagnostics, treatment and
p.000167: medical rehabilitation;
p.000167: - determine the requirements for implementation of preclinical studies and medical and biological experiments as well
p.000167: as to clinical trials;
p.000167: - develop and approve the order and conditions of collection, conservation and transplantation of
p.000167: tissues and (or) organs (fragments of organs) from human to human, from the dead body to human and
p.000167: from animals to humans.
p.000167: According to the article 14 of this law every person has the right to receive the information on possible methods of
p.000167: treatment and consequences of clinical trials from public health institutions.
p.000167: According to the article 15 any person has a right to apply to independent experts for assessment of the quality of
p.000167: medical procedures that were offered to this person.
p.000167: The law “On Medical Drugs” approved on 13th of January 2004 contains articles 18, 19 and 20 that describe the
p.000167: order of development of biologically active substances and their preclinical studies or clinical trials of medical
p.000167: drugs. These articles were developed in the line with international experience (5):
p.000167: - the participation of the patient in clinical trials and (or) in testing of pharmaceutical substance or
p.000167: medical drug should be voluntary and is possible with his/her written informed consent only;
p.000167: - before clinical trials and (or) testing all information on the substance/ drug, on the contents of trials or tests,
p.000167: on safety and risks for patients health, on actions in the case of unforeseen effects of pharmaceutical substance or
p.000167: medical drug for the patient’s health as well as on patient’s health and life insurance should be provided to the
p.000167: patient;
p.000167: - the patient has a right to interrupt his/her participation in trials and (or) tests of pharmaceutical substance or
p.000167: medical drug at any phase of such trials or tests;
p.000167: - it is strictly prohibited to perform clinical trials and (or) tests of pharmaceutical substances or
p.000167: medical drugs with participation of: children and adolescents; pregnant women; military persons; imprisoned
p.000167: or incarcerated persons; non-competent persons.
p.000167: At the web-site www.medik.kz the Association of Physicians and Pharmacists of Kazakhstan has the page, where
p.000167: all legislative and regulatory documents in public health area. At present time specialists began to develop the Code
p.000167: of Republic of Kazakhstan “On Population Health and Public Health System” that will take into consideration all
p.000167: international legislative experience including legislative acts in area of biological and medical studies. For
p.000167: example, on 22nd of January 2007 the Frame Convention on Tobacco Control was officially ratified by the Republic of
p.000167: Kazakhstan; it is planned to bring laws of Kazakhstan in line with international documents that can ensure good
p.000167: clinical practice and improvement of activity of ethical committees [6].
p.000167: In 1995 according to initiative of the Association of Physicians and Pharmacists of Kazakhstan drafts of “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
p.000167: developed. In 2002 the Second Congress of Physicians and Pharmacists approved the text of “The Oath of Physician of the
p.000167: Republic of Kazakhstan” that was reflected in special Decree of the Government of the Republic of Kazakhstan No/ 1189
p.000167: published on 27th of November 2003 and in the article 50 of the Law of the Republic of Kazakhstan “On the
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan”.
p.000167: In 2006 according the law “On changes and additions to some legislative documents on public health of the Republic of
p.000167: Kazakhstan” the article 20 was supplemented with the following paragraphs:
p.000167: «it is prohibited to perform clinical trials and(or) testing of pharmaceutical substances or medical drugs with
p.000167: participation of:
p.000167:
p.000167:
p.000168: 168
p.000168:
p.000169: 169
p.000169:
p.000169: - persons before coming to age with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treatment of children diseases or when the goal of clinical trial is to collect data on the optimal dosage of this
p.000169: medical drug supposed for usage in children and adolescents. In the last case clinical studies of any medical drug in
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
p.000169: The article 43 of the Law of the Republic of Kazakhstan “On the System of Public Health” published on 4th
p.000169: June 2003 contains the juridical definition of scientific medical expertise; in this article it is indicated that
p.000169: objects of scientific medical expertise are as follows:
p.000169: - drafts of programmes of basic and applied scientific research;
p.000169: - republican targeted scientific medical programmes;
p.000169: - results of completed scientific medical programmes and projects;
p.000169: - scientific research that were nominated for the state awards of the Republic of Kazakhstan;
p.000169: - results of scientific medical programmes that are supposed to be implemented into public health practice.
p.000169: The order of scientific medical expertise is determined by the national authority in public health area.
p.000169: The article 42 “Expertise of medical drug” of the same Law says that the expertise of medical drug represents a study
p.000169: or a trial of medical drug
p.000169: for its safety, efficacy and quality and that physical, chemical and biological tests as well as clinical trials should
p.000169: be used for this process; besides all documentation for this medical drug should be assessed thoroughly; the order of
p.000169: all these tests and trials is determined by the national authority in public health area. Paragraphs 2 and 3 of the
p.000169: article 42 clarify that “assessment of safety, efficacy and quality of medical drugs should be performed by expert
p.000169: commissions via expertise of medical drug according to specification and other documents in the order determined by the
p.000169: national authority in public health area”. The expertise should be performed by institutions and persons that did not
p.000169: participate in the process of development and production of this specific medical drug.
p.000169: In 2005 two official documents were approved by the orders of the Ministry of Health №3493 and №3494 on 15th
p.000169: of March 2005: “On approval of instructions on clinical trials and studies and (or) tests of pharmaceutical substances
p.000169: and medical drugs in Kazakhstan” and №3489 on 14th of March “On approval of instructions on monitoring of adverse
p.000169: reactions produced by medical drugs”. These instructions were developed in accordance to international
p.000169: standards GLP and GCP.
p.000169: Mentioned legislative and regulatory documents formulated the unified requirements to planning, implementation,
p.000169: documentation and control of clinical trials in the Republic of Kazakhstan. They ensure the protection of
p.000169: rights, safety and health of persons participating in trials as well as reliability and good quality of data
p.000169: collected during such trials. The right for supervision of clinical trials was delegated to the National Centre for
p.000169: expertise of medical drugs, medical devices and medical equipment of the Ministry of Public Health of Kazakhstan.
p.000169: The important rule that was introduced in obligatory conditions for clinical trials was the necessity to obtain the
p.000169: inform consent of each participant of studies/experiments; this consent should be provided in the written form.
p.000169: The rule on the control of biological and medical studies was implemented for the first time in Kazakhstan. Special
p.000169: commission on ethics is responsible for these functions. The commission consists of specialists in public health and
p.000169: researches, representatives of non-governmental organizations who should protect the rights, safety and welfare of
p.000169: all participants and researches of trials or studies. The commission is responsible for ethical, moral and juridical
p.000169: assessment of all materials of clinical trials.
p.000169:
p.000170: 170
p.000170:
p.000171: 171
p.000171:
p.000171: The order regulates the development of standard operational procedures that should be prepared in the form of detailed
p.000171: written instructions.
p.000171: The serious progress in the field of protection of human rights of persons participating in clinical trials was the
p.000171: description by this Order of norms that allow the ethical commission to formulate the conclusion on possibility of
p.000171: clinical trials or on refusal. At the same time there is some controversy in this document, namely the delegation
p.000171: of monopolistic/exclusive right for conclusion on approval or disapproval of clinical trial to such institution as
p.000171: National Centre.
p.000171: For protection of rights of persons participating in studies or trials the article 35 clarifies that the person “can be
p.000171: included in the trial only after receiving of information”:
p.000171: 1) on medical drug and on the principles of its clinical trial;
p.000171: 2) on safety and efficacy of medical drug as well as on the potential risks for the health of the participant;
p.000171: 3) on actions to be taken in case of unforeseen effects of medical drug on the health of trials participant;
p.000171: 4) on terms of medical insurance of participant’s health”.
p.000171: The Order contains several annexes, including the standard form of informed consent; using this form the
p.000171: potential participant can refuse to participate or to continue the clinical trials of pharmaceutical
p.000171: substance or medical drug during any phase of the trial. This Order is comparatively big document because it contains
p.000171: detailed descriptions of application form and process, protocol of the study, the form of conclusion, the structure and
p.000171: contents of researcher brochure and so on.
p.000171: In this Order the special attention is given to the “Instructions on activity of ethical commission and on performance
p.000171: of ethical assessment of clinical trials”. This instructions clarifies the basic requirements to assessment of ethical,
p.000171: moral and legislative aspects of materials of clinical trials that can be done in patients. The principal goals and
p.000171: targets of the commission are described as follows:
p.000171: 1) protection of rights and interests of participants involved in clinical trials;
p.000171: 2) protection of rights and interests of researches;
p.000171: 3) assessment of importance and reliability of clinical trials goals;
p.000171: 4) ensuring the ethical, moral and legislative assessment of materials of clinical trials.
p.000171: The main principles of commission activity include independence, competence, pluralism, openness, high
p.000171: professional standards, internal believes “for good only and never to harm people”, interests of participant prevails
p.000171: over interests of any scientific research, positive effects are much greater in comparison with potential risks.
p.000171: It is anticipated that commissions to be organized under the responsible institution will have responsibility of the
p.000171: Republican Ethical Commission. Regional commissions will be organized under local authorities of the state system of
...
p.000177: and implementation of inspections of ethics committee in our country. Members of National and local ethics
p.000177: committees participated in workshops that were organized according to SIDCER programme
p.000177: «Recognition» - module 1 «Human Subject Protection» and module
p.000177: 2 «Standard Operational Procedures»; these workshops took place in Tashkent in November 2006. In June 2007 such
p.000177: workshop was organized in the Republic of Kazakhstan with the support from FECCIS, WHO and EFGCP. The international
p.000177: collaboration on different aspects of ethics and bioethics is also realized with UNESCO, WMA and other
p.000177: international organizations and agencies.
p.000177:
p.000177: References
p.000177: 1. «Densaulyk. Public Health of Kazakhstan». Almaty: «ТаuKajnar»,
p.000177: 2001, 432 pp.
p.000177: 2. Legislative documents of the Republic of Kazakhstan «On Health
p.000177: Protection of Citizens of the Republic of Kazakhstan» №111 of 19 May 1997;
p.000177: «On Psychiatric Care and Guaranties for Human Rights Protection during Psychiatric Care» N96 of 16 April 1997, the last
p.000177: revision date: 20.12.2004;
p.000177: «On Sanitary-Epidemiological Protection of Population Health» N361 of 4 December 2002, the last revision date:
p.000177: 07.07.2006, No 13705 in the State List (Inventory); «On Medical and Social Rehabilitation of Patients with Drug
p.000177: Addiction» N325 of 27 May 2002, the last revision date: 20.12.2004, No 12306 in the State List (Inventory); «On
p.000177: Prevention and Control of Tobacco Use» от 10 июля 2002 года N340 N340 of 10 July 2002, the last revision date:
p.000177: 11.12.2006, No 12697 in the State List (Inventory); «On the System of Public Health» N430 of 4 June 2003, the last
p.000177: revision date: 29.12.2006, № 15742 in the State List (Inventory); «On Physical Culture and Sports» N490 of 2 December
p.000177: 1999, the last revision date: 05.07.2006, No 4761 in the State List (Inventory).
p.000177: 3. «The Constitution of the Republic of Kazakhstan», adopted during the republican referendum on 30 August 1995,
p.000177: the last revision date: 07.10.1998, No 1 in the State List (Inventory).
p.000177: 4. «On Health Protection of Population». The Law of the Republic of Kazakhstan N170 of 7 July 2006, the last
p.000177: revision date: 07.07.2006, No 28793 in the State List (Inventory).
p.000177: 5. «On Medical Drugs». The Law of the Republic of Kazakhstan N522 of 13 January 2004, the last revision date:
p.000177: 29.12.2006 No 18187 in the State List (Inventory).
p.000177: 6. «On Prevention and Control of Tobacco Use». The Law of the Republic of Kazakhstan N340 of 10 July 2002, the last
p.000177: revision date: 11.12.2006, No 12697 in the State List (Inventory).
p.000177: 7. Law PK «The Oath of Physician of the Republic of Kazakhstan». The Resolution of the Government of the Republic of
p.000177: Kazakhstan №1189 of 27.11.2003.
p.000177: 8. «On the System of Public Health». The Law of the Republic of Kazakhstan N430 of 4 June 2003, the
p.000177: last revision date: 29.12.2006, № 15742 in the State List (Inventory).
...
p.000201: country is noticed: increase of academic hours in subject block for bioethics for students, doctoral
p.000201: candidates, applicants and residents, introduction of bioethical training for medical and nursery medical personnel of
p.000201: medical institutions of the Republic; publication of text-books and set of training materials; expansion of scientific
p.000201: research themes; holding of topical workshops; regular organization of round-tables with invitation of experts in
p.000201: gynecology, transplantology, resuscitation science, intensive care, biology, genetics, forensic medicine, psychiatry
p.000201: etc.; increase of student’s interest to bioethical issues through participation in student philosophic study
p.000201: groups, extending of international relations.
p.000201: Other advances were rather marked as well. However, the main achievement of this stage was foundation of true
p.000201: scientific bioethical school in our country.
p.000201: Prime bioethics development trends in the Republic of Moldova:
p.000201: 1) organization of training process in bioethics; 2) organizational and practical events; 3) scientific
p.000201: activity.
p.000201: Organizational and practical events include the whole set of activities: holding of different workshops and
p.000201: lectures in medical institutions, organization of programs on the Republic’s television and radio channels;
p.000201: presentation of books, information exchange with foreign organizations involved in bioethical issues; permanent
p.000201: advisory service for executives of medical institutions, drug stores, laboratories, sanitary and epidemiological
p.000201: stations on issues of documentation creation and set-up of bioethics committees; development and
p.000201: improvement of regulations, provisions, participation in adoption of laws; sample by-laws for bioethics committees
p.000201: under hospitals of our country were worked out.
p.000201: Main tasks of scientific activity: elaboration of comprehensive bioethical researches; intensification of
p.000201: researches on theoretical bioethics; examination of bioethical issues of clinical medicine (i.e. practical bioethics);
p.000201: identification set of issues of related subjects, where bioethics development
p.000201: is a catalyst of their demonstration; creation of practical teaching aids for bioethics intended for doctors majoring
p.000201: in other fields.
p.000201: It is possible to conclude that significant work was performed in the Republic of Moldova during rather short period of
p.000201: time as to development and introduction of bioethical knowledge as well as to research and solving of different issues
p.000201: in the sphere. That was the solid base for introduction and functioning of ethical review of biomedical research
p.000201: system.
p.000201:
p.000201: 3.7.2. Legal Regulations
p.000201:
p.000201: Regulations for clinical researches have been introduced in Moldova since the middle of the 90’s. Prime legal
p.000201: documents of the Republic of Moldova as to biomedical researches are as follows:
p.000201: 1. The Law of the Republic of Moldova On Pharmaceutical Products
p.000201: No. 1409 of 17.12.1997.
p.000201: 2. Law On the Rights and Responsibility of a Patient No. 263 of 27.10.2005
p.000201: Legal and ethical issues at clinical research are addressed in the Law of the Republic of Moldova On Pharmaceutical
...
p.000239: depend on doctor’s morality. Not giving preference to any of the health care organization models the Church
p.000239: considers that this service should work efficiently at its maximum and must be available to all members of society
p.000239: disregarding their financial and social status even with limited medical resources distributed. For such distribution
p.000239: to be fair the aspect of “vital requirements” should prevail over the aspect of “market relations”. The doctor should
p.000239: not see the degree of their responsibility for medical service in relation with financial reward and its amount only by
p.000239: this turning his profession into pure profit making. At the same time decent payment for medical professionals is seen
p.000239: as an essential task for the society and the state (26).
p.000239: Section 12 “Bioethical Issues” shows the official position of RCOC
p.000239: on a range of aspects which currently are concerning in the society and are brought about by blooming development of
p.000239: biomedical technology in late the
p.000239:
p.000240: 240
p.000240:
p.000241: 241
p.000241:
p.000241: XX century. These completely new challenges are once again comprehended and reinterpreted in the context of ideas of
p.000241: human life and personal dignity which are entrenched in the “Divine afflation”. It shows attitude of the
p.000241: Church to abortion, new reproductive methods, medical genetic methods of diagnostics, tissue and organ
p.000241: transplantation, reanimation and help to the parting, sexual issues. Moreover some sections of the social
p.000241: conception are devoted to the questions of marriage and family, psychological health, problems of drug and alcohol
p.000241: addiction, health care and the ecological environment (7).
p.000241: The current trend is towards younger age among religious groups of society. A study by VCIOM showed that 58% of young
p.000241: Russian citizens under the age of 25 refer to themselves as Orthodox Christians, a similar trend can be observed among
p.000241: adherents of the Islam.
p.000241: It should be particularly stressed that among young believers patriotic, pro-governmental ideas, believe that there is
p.000241: a necessity to restore the decent position of Russia in the world community, strive for order, strong power, collective
p.000241: like, collegial philosophies, support of the current government and antagonism to liberal western ideas
p.000241: prevail. A common trend among all young interviewees, disregarding distinctions in their philosophic and
p.000241: religious ideas, towards moral and spiritual values is demonstrated, for instance, the way they reacted to the
p.000241: concept of ‘morality’ (positive 87.9% among believers and 81.8% among non-believers, negative 12.1% and 18.2%
p.000241: respectively), ‘justice’(positive 96.6% and 94.3%, negative 3.4%
p.000241: and 5.7%), ‘faith’ (positive 97.1% and 85.9%, negative 2.9% and 14.1%),
p.000241: ‘prayer’ (positive 92.3% and 56.3%, negative 7.7% and 43.8%). A particular part of young believers and
p.000241: non-believers advocates the idea of paternal mode of relations, sticks to the idea of conventional patriarchal
...
p.000247: disinfectants, and conducting biomedical research29. The Article states that biomedical research may only be
p.000247: conducted at the institutions of public or municipal system of healthcare and should be preceded by preliminary
p.000247: laboratory studies. Besides, it is indicated that methods of disease prevention, diagnostics and
p.000247: treatment, as well as pharmaceutical products are not officially permitted but are under consideration
p.000247: according to the established procedure can be applied in the interests of a patient. Hence, we may conclude that
p.000247: Fundamentals of Legislation relate only to clinical (therapeutic) research. The mentioned Act also demands as an
p.000247: obligatory condition for biomedical research the written voluntary consent of a subject for participating in the study
p.000247: and guaranties his right to withdraw the consent at any moment of the study. Before the obtaining of consent for
p.000247: biomedical research the patient should be informed about goals, methods, side effects, possible risk, duration and
p.000247: expected results of the investigation.
p.000247:
p.000247: 28 Constitution of the Russian Federation, St-Pb, 1995.
p.000247: 29 Fundamental principals of Legislation of Russian Federation Concerning Public Healthcare?
p.000247: on 22 of July 1993// Rossiyskaya Gaseta, August 18, 1993. № 158.
p.000247: The given Article sets rather strict limitations on research involving minors (under 15 – in general
p.000247: cases, and under 16 in the case of drug addicts). In this case, the methods of disease prevention, diagnostics
p.000247: and treatment, as well as pharmaceuticals that are not officially permitted but are under consideration may only be
p.000247: applied for the treatment of minors if there is a direct threat to their life and with a written consent
p.000247: of their legal representatives. Here we should mention the Act “On Applying Pharmaceutical Products according
p.000247: to the Necessities of life” adopted by the Order of Ministry of Health and Social Development (09.08.2005, No. 494).30
p.000247: This Act regulates issues relating to the individual case of application, according to the necessities of life, of a
p.000247: pharmaceutical product that is not registered in Russian Federation. This is a matter of non-interventional
p.000247: research. The decision about the use of a pharmaceutical product in this case is made via the Federal
p.000247: specialized medical commission; the protocol is documented and signed by the medical director of the director of the
p.000247: Federal specialized medical commission. This document emphasizes again the need to seek the patient’s voluntary written
p.000247: consent (in cases provided by law the consent from the patient’s legal representatives) to apply an
p.000247: unregistered pharmaceutical product. The physician should inform the patient about the pharmaceutical product, its
...
p.000247: - it actually means the limitation of rights of mentioned persons to access to new medicines, diagnostic and
p.000247: prophylactic methods.
p.000247: At the same time it is to be taken into account that the Federal aw of the Russian Federation ”On Pharmaceutical
p.000247: Products” on 22 of June 1998
p.000247: 30 Order “On Applying Pharmaceutical Products according to the Necessities of life” adopted by the Order of Ministry
p.000247: of Health and Social Development (09.08.2005, No. 494) //Bulletin of normative acts of Federal Executive Authorities.
p.000247: No 36, 05.09.2005.
p.000247:
p.000248: 248
p.000248:
p.000249: 249
p.000249:
p.000249: N86-FZ fixes another approach towards some vulnerable contingents31. This document takes the central place in
p.000249: legal regulation of preclinical and clinical study of pharmaceutical products.
p.000249: The issues concerning rights of patients participating in clinical trials are touched on by the Article 40 of the
p.000249: mentioned law. The general rules of obtaining the informed consent for participating in research constituted by this
p.000249: article correspond in a whole with the discussed provisions of the Fundamental principles of Legislation. The
p.000249: noteworthy point is the more detailed description of information which should be given to subject, namely: 1)
p.000249: information on pharmaceutical products and nature of clinical trials of this drugs; 2) information on anticipated
p.000249: efficiency, the drug safety, and the degree of risks for the patient; 3) information on measures in the case of
p.000249: unforeseeable effects of pharmaceutical product on his health;
p.000249: 4) information on the terms of patient’s health insurance.
p.000249: The provision of the Law concerning the necessity of health insurance as well as insurance of civil liability of
p.000249: persons who carry out the study (items 3, 9 of the article 40, items 2 of the article 38) ensures an important
p.000249: additional guarantee of protection of subjects’ interests.
p.000249: At the same time, we cannot but mention an excessively “soft” approach to the question of terminating a clinical trial
p.000249: in the case of events that may be hazardous to the patient’s health. The Law states only that clinical trials may be
p.000249: terminated, while it should state that clinical trials must be terminated.
p.000249: Aiming at safeguarding the rights and interests of vulnerable contingents the Law forbids or
p.000249: limits their participation in clinical trials of medicines. Particularly clinical trials involving minors who
p.000249: don’t have parents, soldiers, persons under any form of detention or imprisonment is absolutely forbidden. The Law also
p.000249: sets up the limitation for the cases of clinical studies involving minors who have parents – such studies may be
p.000249: conducted only if pharmaceutical product is proposed for treatment of child diseases or if the aim of clinical trial is
p.000249: the getting the information about the best dosing of drug for therapy of minors. In latter situation the clinical trial
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
p.000249: carried out only after obtaining the written consent of legal guardians of these persons32.
p.000249: The latter Law states that all persons with mental disorders have to right for the preliminary consent or to refusal at
p.000249: any time to be used as a subject of trials of drugs and medical methods, scientific investigations or study
p.000249: process, video or photo or film shooting (item 2 of the article 2).
...
p.000253: standard “Good Clinical Practice. GOST- R 52379-2005 “ (National standard).
p.000253: Today the Rules of Clinical Practice have limited application caused by essential reorganization of the system of
p.000253: control and assessment of effectiveness and safety of products, processes and services, including those in medical
p.000253: sphere.
p.000253: The National standard that entered into force in April, 2006 is more meaningful document in this sphere.
p.000253: This act is the element of the system of technical regulation and develops the provisions of the Federal Law “On
p.000253: Technical Regulation”, which establishes the requirements for products, manufacturing, exploitation, storage,
p.000253: transportation, realization and utilization, service delivery, etc.
p.000253: The national standard is the Russian version of ICH GCP and by its status is recommending document. It establishes the
p.000253: ethical and scientific standard of the quality of planning and conducting research involving human subjects as well as
p.000253: the standard of recording and registering the study results.
p.000253: These standards may be applied not only to the studies of medicines, but also to “other clinical experiments, which can
p.000253: affect the safety and well- being of a subject”.
p.000253: The observation of the rules of the national standard is the guarantee of the validity of research results, safety of
p.000253: subjects and protection of their rights and health in accordance with the basic principles of Helsinki Declaration.
p.000253: Ignoring this standard actually means that the results of clinical research cannot be accepted as the evidence of drug
p.000253: effectiveness and safety. This fact serves as the stimulus of an effective compliance with the requirements of the
p.000253: present document.
p.000253:
p.000254: 254
p.000254:
p.000255: 255
p.000255:
p.000255: While analyzing the national standard, which in general is identical to ICH GCP, we should note two basic
p.000255: moments, which make it extremely important for development and functioning of the system of biomedical
p.000255: research ethical review in Russia.
p.000255: First, this document contains the definitions of all internationally accepted terms in sphere of clinical
p.000255: practice, including the definition of ethics committee.
p.000255: In accordance with item 1.29 of the national standard, the expert council of the organization/independent ethics
p.000255: committee is the independent body, which consists of medical professionals and persons, who are not engaged in
p.000255: medical sphere. This body provides protection of research subjects’ rights, safety and well-being and serves as
p.000255: guarantee of this protection, in particular via examination, approving of the study protocol, candidacy of researchers,
p.000255: research Centres, as well as materials and methods, which are used for obtaining and documentation of the
p.000255: informed consent of research subject.
p.000255: The document also emphasizes that the ethics committee can act at the level of organization, on regional, national or
...
p.000255: is the result of the ethical review at the national scale.
p.000255: The latter documents determine the order of work, the list of documents
p.000255:
p.000255:
p.000255: to be submitted, terms and procedure for the review of the documents, the procedure of making decisions, condition
p.000255: of their revocation and appeal, follow-up procedure, achieving and storage of documentation and other
p.000255: compulsory procedures.
p.000255: 38 The Letter of the Supreme Certifying Commission “On the Procedure of Biomedical Research Involving
p.000255: Human Subjects”//Bulletin of the Supreme Certifying Commission No 3, 2002.
p.000255: 39 “Uniform requirements for manuscripts submitted to biomedical journals”//Ann Intern Med – 1997 – Vol. 126
p.000255: – P. 36 - 47.
p.000255:
p.000256: 256
p.000256:
p.000257: 257
p.000257:
p.000257: Being guided by the principles of respect for human, the ensuring of the value of person, protection of rights
p.000257: and freedoms of individual and taking into account the insufficiency of studying of biological and social
p.000257: consequences of human cloning the above-mentioned law put temporary ban on the biomedical trial on human
p.000257: cloning.
p.000257: The attention of legislators to the ethical side of biomedicine is also demonstrated by the Draft Technical Regulations
p.000257: “On requirements for the safety of medicines, the processes of their development, manufacturing, production,
p.000257: testing, storage, transportation, realization, application and utilization”.
p.000257: In contrast to current federal laws, this bill proposes the more detailed regulation of process of the clinical
p.000257: drug research ethical review. It also constitutes research subjects’ rights and guarantees of these rights
p.000257: in accordance with the most progressive international standards in this field.
p.000257: Legislation initiatives in the sphere of protection of patients’ rights40, activity directed to adaptation of
p.000257: international guidelines, as well as transformation of the positions of international declarations and conventions
p.000257: in the sphere of biomedicine into the domestic legal acts, give us the reason to expect the strengthening and
p.000257: development of the institute of ethical review in our country.
p.000257:
p.000257: 3.8.3 Education in Bioethics
p.000257:
p.000257: Issues on education of medical ethics and deontology in medical schools and colleges of the USSR were
p.000257: started to discuss in the 60’s of the XX century after the 1st All-Union Conference on issues of medical
p.000257: deontology in 1969 being a kind of triggering point for revival of talks on them. The final resolution, in particular,
p.000257: said: “The Conference would like to draw attention of the Chief Agency on Educational Facilities of the Ministry of
p.000257: Health of the USSR on necessity to implement medical deontology into education process”.
p.000257:
p.000257:
p.000257: 40 For example, Draft Law “On legal basis of bioethics and its guaranties”, “On reproductive rights of citizens”,
...
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
p.000271: alterations of the drug introduction routes, its doses, and significant changes in number of the CT subjects. An ethics
p.000271: committee can approve amendments to the clinical study conduct only if presented changes do not lead to worsening of
p.000271: conditions for subjects.
p.000271: After the application review an ethics committee can make one of the following decisions: to approve study
p.000271: conduct; to approve a study with minor changes, and after they are introduced the EC decision on the study can be
p.000271: granted to an investigator with no need of repeated examination; to require amendments of study
p.000271: procedures and materials and to submit documents once again for examination; not to approve study conduct
p.000271: (indicating reasons for refusal, if necessary – with recommendations on elimination of identified defects).
p.000271: When reviewing amendments the EC decisions can vary as well: as an approval for amendments and continuance of the
p.000271: study, a request for additional information with or without the study suspension, non-approval of amendments. The EC
p.000271: decision has to contain
p.000271:
p.000272: 272
p.000272:
p.000273: 273
p.000273:
p.000273: how often the particular project shall undergo interim reviews. Usually in case of low risk for subjects ethical review
p.000273: during a study is performed once a year; if decreed population groups are involved into CT, in case of high risk due
p.000273: to peculiarities of a protocol, other decisions are possible (once every 1, 3, 6 months, with enrollment
...
p.000289: findings for economic reasons. To eliminate this injustice, the medical community took certain measures. The WMA
p.000289: Declaration of Helsinki and the additional Protocol to the CE Convention on Human Rights and Biomedicine require
p.000289: that in the countries where a biomedical research is planned the permission should be sought from state structures, and
p.000289: interests of people who live there and who are potential research subjects should be considered.
p.000289: The involvement of Republic of Tajikistan, as an independent state, in international research projects
p.000289: requiring ethical review to ensure the compliance with international regulations triggered the process of
p.000289: establishing in Tajikistan the Committee on Medical Ethics and developing the system
p.000289: of State registration of pharmaceutical products, medical facilities and other medical goods.
p.000289: For a further development of medical ethical review of scientific-research projects, the Ministry of Health established
p.000289: the Republican Committee on Medical Ethics at the Department of the Management of Medical Personnel and Science (Order
p.000289: No 250; 4 of June 2004). The first research project that had to undergo ethical review to ensure the compliance
p.000289: with documents setting international rules in ethics was a joint Tajik-American research on AIDS and hepatitis C in
p.000289: drug addicts.
p.000289:
p.000289: 3.9.2. Legal Regulations
p.000289:
p.000289: One of fundamental human rights is the right for life and health protection. Health is a natural, absolute
p.000289: and vitally important value taking the top position in the hierarchy of human values and in the system of such
p.000289: categories of human existence as interests and ideals, harmony and beauty, the meaning of life, happiness, creative
p.000289: labour and rhythm of life.
p.000289: The execution and efficiency of legal regulations depends on how much they correspond with moral requirements. Quite
p.000289: often legal regulations fix moral norms directly and reinforce them with legal sanctions. Thus, many legal norms
p.000289: prohibit actions that are hazardous to the society and human health.
p.000289: In healthcare, the integration of moral and ethical norms into the legal system should be a priority. Therefore, the
p.000289: moral and ethical components in the work of medical professionals should correspond to legislative principles
p.000289: referring to the protection of the patient’s rights and dignity. By now, the Committee on Medical Ethics at the Health
p.000289: Ministry of Republic of Tajikistan (HM RT) has worked out a number of important documents adapted to the needs of
p.000289: Tajikistan:
p.000289: • the Statement “On the Committee on Medical Ethics” (HM RT Order of No 118, 10 of March 2005);
p.000289: • “Ethical Aspects of Regulations for Clinical Practice in Republic of Tajikistan” (Supplement to the HM RT Order No
p.000289: 118, 10 of March 2005) and
...
p.000313: academicians in the fields of biology, medicine, philosophy, as well as representatives of Ministry of
p.000313: Health, Ministry of Environmental Safety, Ministry of Education and Science, Ministry of Justice and of Academy of
p.000313: Medical Sciences and Academy of Agrarian Sciences were invited to take part in the work of the Committee.
p.000313: In 2002 Bioethics Committee at the Presidium of Academy of Medical Sciences of Ukraine was established. In cooperation
p.000313: with Ministry of Health it developed model regulations for medical ethics committees at scientific and medical
p.000313: institutions in line with modern international requirements. During these years a number of public organizations
p.000313: having a concern in bioethics have emerged, and the implementation of the system of ethical review for biomedical
p.000313: research has begun on a large scale.
p.000313: Today we have the following system of ethical review. Firstly, there are different laws and by-laws regulating
p.000313: biomedical research. The order of conducting clinical trials of pharmaceutical products and reviewing materials of
p.000313: clinical trials has been developed in compliance with the Articles 7 and 8 of the Ukrainian Law “On Pharmaceutical
p.000313: Products”43 and in line with requirements of the Directive 2001/20/EC of the European Parliament and of the
p.000313: Council EC ICH GCP44 and Declaration of Helsinki45. It was approved by the Order of the Ministry of health
p.000313: of Ukraine No 6646. The responsibility for reviewing documentation on clinical drug trials rests with the State
p.000313: Pharmacological Centre of the Ukrainian Ministry of Health.
p.000313: General principles of conducting clinical trials:
p.000313: • According to the sponsor’s choice, clinical trials are mostly conducted at specialized medical
p.000313: institutions the list of which is submitted by the Centre in accordance with established procedure and approved by the
p.000313: Ministry of Health.
p.000313: • All clinical trials are conducted in compliance with ethical principles set by Helsinki Declaration, and on the
p.000313: condition that the basic requirements relating to the protection of research subjects (patients or healthy volunteers)
p.000313: are observed. Clinical trials may only be conducted if the expected benefit justifies the risk.
p.000313: • All clinical trials are conducted only after a compulsory review of trial protocol by ethics committees
p.000313: established to protect trial subjects’ rights, safety and well-being, and to guarantee the protection for the society.
p.000313: • Planning, conducting and reporting at all phases of clinical trials, including studies of bioavailability and
p.000313: bioequivalence, should meet GCP requirements adopted by the Ukrainian Ministry of Health.
p.000313: • Trial management, data handling, documentation and an assessment of results obtained in a trial should comply with
p.000313: requirements set in standard operational procedures.
...
p.000329: - receiving information about his/her rights and responsibilities and his/
p.000329:
p.000329: the activity of state structures, national enterprises, institutions and public unions in the field of healthcare
p.000329: (Kolesnikova L. Some Legal Aspects of Regulating Physician--Patient Relationship. Materials of the First National
p.000329: Congress on Bioethics with International Participation. Tashkent, 2005, pp. 58-59; Kolesnikova L. Relations of Doctor
p.000329: and Patient in the Light of Laws in Force in Uzbekistan: Clinical, Philosophical and Legal Aspects. Tashkent, 2006, pp.
p.000329: 129-135).
p.000329: Article 3 of the Law defines main principles of citizens’ health protection:
p.000329: - observance of human rights in the field of health protection;
p.000329: - availability of medical care for all social strata;
p.000329: - the priority of preventive measures;
p.000329: - social protection of citizens in cases of health loss;
p.000329: - the unity of medical science and practice.
p.000329: According to Article 13 of the Law, “…the State ensures the protection against discrimination irrespective of a disease
p.000329: the citizen has. Appropriate sanctions should be applied in the event of infringement of the provisions contained in
p.000329: this Article”.
p.000329: Nevertheless, in current practice of physician—patient relationship there are cases of marginalization and
p.000329: stigmatization, which shows itself in relation to most vulnerable social groups – drug and alcohol addicts, sex
p.000329: workers, etc. In the event of diagnosing an “improper disease” (venereal diseases, AIDS) a patient is labeled as
p.000329: “shameful”. A suspicious attitude of medical staff to patients with such a diagnosis infringes patients’ rights, which
p.000329: affects their moral and psychological state and, consequently, has a negative impact on the treatment efficiency.
p.000329: According to Article 24 of the Law, the patient has the right to:
p.000329: - respectful and humane attitude of medical staff;
p.000329: - choice of a physician;
p.000329: - medical aid (examination, treatment, etc.) provided in compliance with relevant sanitary requirements;
p.000329: - consultation by a medical specialist on the patient’s request;
p.000329: her health condition;
p.000329: - compensation in the event of a damage to his/her health;
p.000329: - access to a lawyer or another representative for the protection of his/ her rights.
p.000329: In case of infringement of a patient’s rights, his/her legal representative may make a complaint to any instance.
p.000329: Article 34 of the law “On the Protection of Citizens’ Health” permits to conduct biomedical research involving human
p.000329: subjects at state institutions after laboratory experiments and with informed consent from a research
p.000329: participant.
p.000329: To protect patients’rights and dignity,Article 25 prohibits propagandizing, including information in mass media,
...
p.000345: ombudsmen and a representative of the National Centre for Human Rights. Regional and local ECs established at regional
p.000345: centers (Samarkand, Bukhara, Andijan, Nukus) and large clinical sites at institutes of higher medical education and
p.000345: research institutes are also headed by eminent Uzbekistan scientists.
p.000345: The NEC reviews international research projects involving human subjects and makes its decisions about the
p.000345: project. The NEC of Republic Uzbekistan has been registered at American Centers for Information Disease Control
p.000345: (Atlanta) and American Centers for Disease Control and Prevention (NAMRO-3, Cairo).
p.000345: The NEC functions in conformity with Standard Operational Procedures (SOPs) designed in the process of a regular work.
p.000345: According to the NEC procedures, the documents should be reviewed within 7-30 days (expedited or regular review). Since
p.000345: the time of its establishment, the NEC has reviewed over 320 various projects including joint international
p.000345: research projects, research projects designed by Uzbekistan scientists and dissertations based on biomedical research
p.000345: involving human subjects.
p.000345: The NEC review also projects of clinical trials of pharmaceutical products, of medical equipment and other products for
p.000345: medical needs. Usually research projects meet ethical requirements, and the NEC makes positive decisions. Sometimes,
p.000345: however, there are cases when the NEC declines a project. This usually concerns clinical trials of a non-registered
p.000345: pharmaceutical product or of a new rout of a known drug administration when there is no approval by the Pharmacological
p.000345: Committee or the drug is hazardous to a patient’s
p.000345: health. Negative decisions are also made if the risk of complications or adverse effects is very high. The
p.000345: main criterion for an objective and reliable judgment about efficiency and safety of a pharmaceutical product
p.000345: is a clinical trial that ensures the safety of its participants. The Pharmacological Committee established in 1992
p.000345: at the Central Department for Control of Pharmaceutical Products and Medical Equipment within the Ministry
p.000345: of Public Health of the Republic of Uzbekistan conducts a scientific review of research projects. Acknowledging the
p.000345: importance of ethical review for a biomedical research the Pharmacological Committee closely collaborates with the NEC,
p.000345: which is very helpful with regard to such ethical problems as the protection of rights and interests of CT subjects. To
p.000345: obtain the permission for a CT the relevant documents are first submitted to the Pharmacological Committee that
p.000345: conducts its own review, and only after approval by the Committee the documents may be submitted to the
p.000345: NEC for the ethical review. Chairpersons of local ECs representing institutions that are planning to conduct
p.000345: clinical trials are present at the NEC meetings.
p.000345: In the period from 1992 to 2005 inclusive, the Pharmacological Committee reviewed 910 clinical trials of
p.000345: pharmaceutical products (312 of those were from domestic and 598 from foreign manufacturers) belonging to various
p.000345: pharmaco-logical groups. Starting from 2001 the number of clinical trials has increased, which is mainly
...
Searching for indicator influence:
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p.000025: high; the number of handicapped people is increasing;
p.000025: - stratification of the society by income, when 10% of the most well- to-do population have incomes more than 10 times
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
p.000025: efficiency of social assistance programs by weight of amounts received by families beyond the poverty line in total
p.000025: amounts of social support).
p.000025: 1.2 Ethical and Legal Issues
p.000025: in the Field of Biology and Medicine (o.I.Kubar, B.G.Yudin, A.E.nikitina, E.Yu.Vladimirova)
p.000025:
p.000025: Characterizing trends of legal and ethical control in the sphere of practical health care and biomedical
p.000025: research in the CIS member states it is necessary to emphasize a multilevel system of factors determining common
p.000025: pattern of directions, characteristics, features and mechanisms of national and international, retrospective and
p.000025: perspective influence. A rationale for forming of the given community is geographical closeness, unity of political
p.000025: history of the pre-Soviet and Soviet periods, contingency and interpenetration of cultures and traditions, forming
p.000025: extreme ethnical, cultural and religious multiplicity making countries in the region different.
p.000025: By itself such multiplicity leads, in particular, to the following - the set of actual ethical norms being a basis for
p.000025: medical care in the region countries is a historical foundation and a clear reflection of tolerance concepts both to
p.000025: cultural differences as they are and to their particular carriers. Moreover, in this case we can talk not just about
p.000025: tolerance but also about respectful relationship to differences of that kind.
p.000025: One more factor, which should be taken into account when explaining closeness of ethical and legal basis of health
p.000025: care, is that other countries in the region inherited legal base that was established in the Soviet period of their
p.000025: history. It should be noted that the legal system existing in the USSR in the field of medicine and health care,
p.000025: first, was of declarative nature, and, second, paid insufficient attention to issues of protection of rights and
p.000025: dignity of both patients and participants of biomedical research.
p.000025: Therefore, after the USSR breakup and appearance of new independent states they faced tasks of development of new legal
p.000025: framework in the field of practical and experimental biomedicine. All CIS countries in different forms proclaimed such
...
p.000029: Russian language. Development of bioethics in the CIS countries started about 20 years ago; one of the strongest
p.000029: impulses emerged after the first contacts of Soviet philosophers and medical researchers with their foreign colleagues
p.000029: at the end of the 1980’s. After the USSR break-up bioethics in the region developed in different conditions but, at
p.000029: that, there were present both stable cultural peculiarity and links among the region countries. The most important
p.000029: instrument influencing rates and pattern of the bioethics development is creation of special national facilities
p.000029: that having different structure and functions in some cases are entitled to adopt and implement mandatory decisions
p.000029: in the field of bioethics. Besides, all CIS countries have more or less main and similar resources for dynamic
p.000029: development of
p.000029: bioethics, and among them – teaching bioethics as a subject (mandatory or optional) in medical colleges and
p.000029: universities as well as at departments of philosophy in some of state universities; definite (though, in
p.000029: general, far from being sufficient) interest to ethical issues from the side of those working on legislation in the
p.000029: field of science and health care; development of corporate ethics and national associations on ethics;
p.000029: stimulating influence of research ethics; wider public interest to the bioethics issues being discussed in mass media.
p.000029: Besides factors of general social and economic development influencing peculiarity and unity of the situation in
p.000029: this sphere, global impact was provided by common cultural and educational environment based on both
p.000029: advanced humanistic traditions of medicine and on capabilities for interaction and mutual influence of
p.000029: different cultures in the given territorial and historical space. Such specifics exist despite considerable cultural
p.000029: and religious differences between populations of European and Central-Asian countries of CIS. In particular, it
p.000029: is necessary to mention influence of religious traditions in the Commonwealth countries on forming of bioethics
p.000029: models currently acting there as well as models of research ethics. Likeness in perception of moral and cultural values
p.000029: is built on the fact that among population of the CIS countries (mostly it is related to the Russian population) one
p.000029: can meet representatives of virtually all ethnical, religious and cultural groups existing in the region in general. It
p.000029: means that multiplicity that can be observed within the CIS countries to some extent repeats multiplicity of population
p.000029: of separate countries that is especially characteristic for scientific and medical creative environment formed during
p.000029: many years.
p.000029: It is really hard to overestimate a role, which is played by the factor of involvement of all Commonwealth
p.000029: countries in the process of global international interaction, for creation of single approaches to collaboration
p.000029: in ethical and legal sphere. It is related both to incorporation by the new independent states into their legal systems
p.000029: of a set of international ethical and legal acts which they joined to during existence of a single country, the USSR,
p.000029: and to modern involvement of the CIS countries into international legal and informational environment. It appears to be
p.000029: of tremendous importance that officially each of the countries declared adherence to all major norms and principles
...
p.000031: Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000) with additional document
p.000031: of 2002, Convention for the Protection of Human Rights and Dignity with Regard to the Application of
p.000031: Biology and Medicine: Convention of Human Rights and Biomedicine (Council of Europe, 1997) and adopted in addition
p.000031: thereof Additional Protocols including the Protocol on Biomedical Research, Universal Declaration on Bioethics and
p.000031: Human Rights (UNESCO, 2005), Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), International
p.000031: Declaration on Human Genetic Data (UNESCO, 2003) and a number of other documents which current total list includes
p.000031: more than 150 publications. Regretfully, among six CIS countries being current members of the Council of Europe such
p.000031: basic document as the Convention on Human Rights and Biomedicine are currently signed only by three – Georgia, Moldova,
p.000031: Ukraine; and it is only Georgia that actually ratified it. At the same time, acknowledgement of high authority of the
p.000031: Convention in this or that form is generally common for virtually entire bioethical community in all CIS countries.
p.000031: The international enactments mentioned above became a basis for legal regulation of biomedical research and
p.000031: their ethical review in all CIS countries (detailed analysis of legal participation of a particular country in any of
p.000031: international documents – recommendation influence, ratification, adaptation to national legislation, etc. –
p.000031: is presented in our book in corresponding chapter for each specific state). A crucial issue emphasizing profound
p.000031: importance of international documents regulating this sphere is a fact of priority of international law
p.000031: approved by all Commonwealth countries. International cooperation in the field of bioethics is implemented also
p.000031: through formation of regional programs and Centres of bioethics and research ethics with involvement of
p.000031: international organizations being leaders in this field. A convincing example of such cooperation is a setup of
p.000031: national committees of bioethics with UNESCO support in some of the Commonwealth countries and planned scientific and
p.000031: educational activities of the UNESCO office in Moscow and some other countries in the region
p.000031: being held in context of national, social and cultural, historical and political traditions and utilization of the
p.000031: world experience in the field of bioethics.
p.000031: In 2001 animportant bioethical resource, the Forumfor Ethics Committees in the CIS (FECCIS), was established in the
p.000031: region. The FECCIS is one of five regional forums created within the framework of the WHO project, the Strategic
p.000031: Initiative for Developing Capacity in Ethical Review (SIDCER). Sharing main priorities of the WHO SIDCER project on
...
p.000035:
p.000036: 36
p.000036:
p.000037: 37
p.000037:
p.000037: usually, perform ethical examination of research projects are created and work subjected to central executive
p.000037: authorities (usually these are ministries regulating activities in the sphere of health care, labor, social policy,
p.000037: etc.; in some of the countries these are national academies of sciences). There are also regional and local ethical
p.000037: committees at scientific medical Centres as well as committees at professional medical societies. In some of the
p.000037: countries the research ethics committees have a function of consulting higher state authorities on issues for
p.000037: development of policies in health care as well as resolving conflicts associated with routine medical practice.
p.000037: Participation of all CIS countries in the process of moral and ethical professional resolution of medical practical and
p.000037: research activities appears to be important. Many of the Commonwealth countries have already adopted or are developing
p.000037: ethical codes for medical and pharmaceutical workers, have approved national oaths for medical school graduates,
p.000037: ethical codes for medical doctors15. These codes and oaths provide higher vs. the legal enactments ethical
p.000037: standards for behavior of representatives of medical profession and are related to both relationships of doctors with
p.000037: their patients, with third party persons and to intracorporate relations.
p.000037: Analyzing trends in development of ethical and legal control of biomedical activities in the Commonwealth
p.000037: countries one cannot but mention influence of religious tradition on this process. For instance, in some
p.000037: of the Central Middle Asia countries daily practice of medical workers and researchers to a large extent is based on
p.000037: norms of the Koran, Shariat, Hadises. An important role as a guideline for national policy formation in the field of
p.000037: ethical examination development of biomedical studies as well as for protection of the rights of patients and study
p.000037: subjects is played by the Code of Islam medical ethics. Countries with prevailing Orthodox religious tradition showed
p.000037: that a significant role for ethical consideration of medical science and practices is dedicated to Basics of the Social
p.000037: Concept of the Russian Orthodox Church (2000) containing official position on many of the most arguable bioethical
p.000037: issues.
p.000037: 15 For instance, The Code of Medical Ethics of Armenia, The Ethical Code of Medical Doctor of Georgia, The Ethical
p.000037: Code of Pharmacists of the Kyrgyz Republic, The Ethical Code of Nurse of Russia, The Oath of Medical Doctor of Russia,
p.000037: The Medical Ethics Code of Russia. In Uzbekistan the code on bioethics issues is under development, in Kazakhstan they
p.000037: started to develop The Code on National Health and the Health Care System, in 2007 it is planned to adopt The Ethical
p.000037: Code of Medical Doctor of the Republic of Kazakhstan.
p.000037: Features mentioned above illustrating specific properties of legal and ethical regulation are, mostly, in accord
...
p.000039: 39
p.000039:
p.000039: of the Universal Declaration of Human Rights and stressed that since the moment of its proclamation the field of human
p.000039: rights exhibited considerable progress in general and that efforts in the field of human rights undertaken within CIS
p.000039: are also directed on provision of common respect for them, facilitation of strengthening of atmosphere of
p.000039: friendship and trust, effective implementation of multi-party agreements where a special place is given to the CIS
p.000039: Convention on Human Rights and Fundamental Freedoms adopted in Minsk in 1995.
p.000039: Criminal, penal procedure and penal enforcement model codes adopted by IPA CIS being a basis for development of similar
p.000039: codes in some of the Commonwealth countries should be considered as norms of general type establishing crucial
p.000039: requirements to an order of legal act execution in regard to main freedoms and rights of citizens in the Commonwealth
p.000039: countries. Statements of the given model codes were also reflected in initiation and creation of many legislator
p.000039: enactments in the CIS countries in the field of criminal law and criminal procedures. The model civil code adopted by
p.000039: IPA CIS has special values for establishing of new conditions for administration and management in all spheres of
p.000039: activities and its main statements were to some extent practically embodied in civil legislation of all CIS countries.
p.000039: Activity of the Permanent Commission on social policy and human rights of IPA CIS has a special value from the
p.000039: point of harmonizing influence on the health care field. After initiatives of the said commission model laws
p.000039: determining main statements for a complex welfare system were adopted, a list of international conventions recommended
p.000039: for immediate ratification by the CIS countries was developed, a set of model laws on rights of human beings related to
p.000039: category of vulnerable population groups was approved, such as a law On Basic Children Rights and On Additional
p.000039: Guarantees to Child-Orphans and Children without Parental Guardians, Guidelines On Childhood Protection in Member
p.000039: Nations of CIS (1998) as well as The Charter for Older People and other socially significant documents.
p.000039: In accordance with basic statements on protection of human rights and freedoms there are being prepared model
p.000039: laws related to both forming of domestic policy in the Commonwealth countries in the field of health care and
p.000039: developing of common approaches to international cooperation of the states in this field. An important role for
p.000039: legislative regulation of special situations in the area of medical practice and their potential application
p.000039: to cases of
p.000039: biomedical studies and ethical review is assigned to the following model laws: On Sanitary and Epidemic
p.000039: Well-being of the Population, On Prevention of Spread of Diseases with Social Significance, the Concept on Formation of
...
p.000045: ideology of new European education to a large extent is a gradual process of mastering the system of scientific
p.000045: knowledge, then without exaggeration one can say that the modern man (unlike a person in the Christian culture) is
p.000045: created “in the image and likeness of a scientist”.
p.000045: The leading position of science is retained and considerably strengthened gaining qualitatively new forms. Along
p.000045: with that, in the modern cultural situation science becomes more tolerant to other forms of cognition
p.000045: and comprehending of the reality. Ideas, concepts and practices that several decades ago were considered
p.000045: as superstitions are rehabilitated and gain status of fully-developed modern doctrines. In the whole world
p.000045: one can
p.000045: observe revival of archaic (shamanism, cabala and other esoteric practices) and creation of new non-scientific
p.000045: (and often anti-scientific) ideologies. Appear new bridges for cooperation between science and traditional religions
p.000045: appear.
p.000045: Another process is ongoing along with this paradoxical one. Science is still a mainstream for resolution of human
p.000045: problems, protection of a man against unfavorable natural impacts (for instance, diseases). But the mightier is
p.000045: scientific control over the nature, the clearer hazards are – that is, risks, related to development of science and
p.000045: scientifically-targeted technologies. Along with realization of these risks there are two directions being formed that
p.000045: influence in ideological sense establishment of procedures of ethical examination for biomedical studies. We are
p.000045: talking about ecological movement and bioethics. The ecological movement is concerned with diagnostics and
p.000045: prevention of begotten by scientific and technical progress risks related to biological survival of the humanity
p.000045: and biosphere as a whole. Bioethics elaborates its own technologies for identification and neutralization
p.000045: of those risks that the progress brings forth for the moral well being of a human.
p.000045: At that, it is paradoxical that in regard to the risks science has a triple position – it is one of the main risk
p.000045: producers, virtually the only developer of reliable methods for their assessment as well as it develops mechanisms for
p.000045: prevention of undesirable consequences or handling them – when they are present.
p.000045: Sources for these shifts that radically change waypoints and setup for the scientific search can be, at least,
p.000045: partially, found in events taking place about 4 decades ago. Those days at the end of the 60’s, young people, mostly,
p.000045: students in many Western countries initiated strong protesting movements that resulted in serious social unrest.
p.000045: Targets for attacks of the “new left” were key social institutions of bourgeois society and its culture; in
p.000045: this context science was also strongly criticized.
p.000045: Firstly, it was perceived as a power carrying the light of intellect and closely bound to ideals of free critical
p.000045: thinking and, therefore, democracy. One of bright mouthpieces of this position was the well-known sociologist of
p.000045: science, R.Merton (Merton R. Sociology of science: theoretical and empirical investigations. Chicago: Wiley,
...
p.000047: the Drucker’s ideas to some extent adding them with useful, from our point of view, results from other researchers.
p.000047: P.Drucker proceeded from that transformation of scientific knowledge into a main source of new technologies started as
p.000047: per historical measurements quite recently. He stated that yet in the XVIII century “no one even tried to talk over
p.000047: application of science for development of instruments of production, technologies and goods, i.e. about use of
p.000047: scientific knowledge in the field of techniques and technology. This idea matured only … in 1830 when the German
p.000047: chemist, Justus von Libikh (1803-1873), first invented
p.000047: artificial manure and then a method for storing animal proteins (P. Drucker. From Capitalism to Society of Knowledge.
p.000047: In: New Post-Industrial Wave in the West, edited by Inozemtsev V.L., M., 1999). According to Drucker that time the
p.000047: industrial revolution as a process of global transformation of the society and civilization on the basis of technical
p.000047: development began. At that, scientific knowledge took new, previously not characteristic role – as a factor actively
p.000047: influencing life of a man and society and dynamicizing it.
p.000047: In the context of technological application of science a research is not only an investigation of the
p.000047: world as it is, the natural world, but as transformation of this world, that is, as development of an
p.000047: artificial world (being more precise, worlds). And in such respect the research is a prototype of a technological
p.000047: method for learning and, moreover, vision of the world.
p.000047: This fact is of special importance for understanding how exactly biomedical technologies influence the
p.000047: very nature of a man. Now these technologies can wider and more effectively control existence of a man from
p.000047: stages prior to conception up to the death and even post-mortal existence (taking futurological ideas of “cryonics” as
p.000047: an example).
p.000047: Transfer from knowledge of reality to its artificial construction is associated with overestimation
p.000047: of truth status, which is more often substituted with ideas of “usefulness” and “effectiveness”. In technological
p.000047: context issues of truth and quality of knowledge are falling into background. One can say that in this context not
p.000047: research result by itself and not various interpretations of effects of a research system are of interest but the
p.000047: effect as it is – those transformations and conversions it provides. And while technological capacities
p.000047: hidden in experimental device and, in a wider meaning, in technological activities are being recognized,
p.000047: functions of science are being changed dramatically.
p.000047: At that, recognition of technological capacities of science is a mutual process, which includes both those
p.000047: involved in scientific activities and those of business and manufacture. As a result of the process
p.000047: people become not only more perceptive in regard to various new technologies but also, if one can say so, are
p.000047: “imbued” with technological mentality. Any serious problem they face starts being recognized and thought over
p.000047: as a significantly technological issue: initially it is distinguished as per canons set by technology, and then
p.000047: technological problems for its resolution are sought for and applied.
p.000047:
p.000048: 48
p.000048:
p.000049: 49
p.000049:
p.000049: Nowadays the technological role of science became dominating and many even think that the only function of
p.000049: science is development of new technologies. At that, the way of practical implementation of scientific
p.000049: knowledge and technologies based on it appears to be something like the following. First, a theorist and/or a research
p.000049: laboratory discover something. Then the result of this study during the process called as development (or elaboration)
p.000049: is implemented in new technologies. The following stages of a process are related to the fact that each such new
p.000049: technology is – with more or less problems – implemented in practice of manufacture or any other sphere of
p.000049: human activity. In other words, the traditional order of things is characteristic with the following: first a
p.000049: technology is created, and then markets to sell it are searched for. Talking about issues we mean particularly the
p.000049: notorious one of “implementation”, which caused breaking lances in the USSR times for many years and which does
p.000049: not have any satisfactory solution so far.
p.000049: Therefore, it makes sense to think over that the way the problem is defined is likely to be incorrect. In
p.000049: our established views appearance of any new technology looks like a move beyond the given and already mastered order
p.000049: of things. This word, “implementation”, seems to be here rather characteristic since it bears, beside other
p.000049: issues, a sense that there is some influence from outside breaching the groove, something extraordinary.
p.000049: Today, however, we can if to use the term by the German sociologist, M.Weber, talk about routinization of this
p.000049: very process of technological upgrades when new technologies do not break into manufacturing activities, into lives
p.000049: of people, but are placed into preliminary prepared “cells”. In other words, new technologies are “custom-made”. More
p.000049: often this sequence is built in order directly opposite to the common way: development of a new technology starts only
p.000049: when and because there is already a demand for it.
p.000049:
p.000049: Phenomenon of “technoscience”
p.000049: Today in the beginning of the XXI century we have all grounds to say about qualitatively novel stage in
p.000049: development not only of science but its interaction with the society as well. One of the ways expressing it
p.000049: is establishment of a new type of interaction between science and technology that was called technoscience. For
p.000049: instance, the English sociologist Barry Barnes wrote: “The term technoscience now is widely used in academic
p.000049: sphere and is related to such activity within which framework science and technology form a kind of a mixture or a
p.000049: hybrid… technoscience should be perceived as specifically modern phenomenon” (B.Barnes. Elusive Memories of
p.000049: Technoscience. – Perspectives on Science: Historical, Philosophical, Social. Vol. 13, Issue 2 – Technoscientific
p.000049: Productivity, Summer 2005, pp. 142-165). The most evident sign of technoscience is considerably more profound
p.000049: than before built-in pattern of scientific cognition into activities on development and promotion of new technologies.
...
p.000061: capacities of modern medical science and practice not only to prevent and treat diseases but also to control human
p.000061: life.
p.000061: An issue of community of the biomedical research in the CIS region from the point of view of philosophical
p.000061: consideration of community of knowledge assumes, first of all, addressing characteristic of biomedical research on the
p.000061: basis of integral scientific, social and value-vision phenomenon.
p.000061: Since in the context herein there is no objective to describe structure and order of conduct as it is that is resolved
p.000061: in many of special methodical and regulatory documents we permit ourselves to utilize commonly accepted in
p.000061: international practice definitions and concepts that, by itself, demonstrates supranational scale in the CIS members
p.000061: states and makes possible to form some perspective characteristics and prognoses.
p.000061: However, both in any sphere of human activity and in the sphere of biomedical research to forecast future in a
p.000061: correct way it is necessary to have memory of the past and knowledge of the present. In this connection,
p.000061: consideration of main stages of establishment of biomedical research in the analyzed regional space at stages of
p.000061: its varying political and economical development gains fundamental value being governed with historical frames
p.000061: selected within the aspect of the given publication.
p.000061:
p.000062: 62
p.000062:
p.000063: 63
p.000063:
p.000063: To retain integrity of perception of materials herein as when defining common elements of ethical and legal trends in
p.000063: the sphere of biology and medicine there will be used similar parameters of chronological and logical consideration due
p.000063: to priority of their influence.
p.000063: Thus, from the point of view of historical community based on common ideological and social and economic
p.000063: inheritance of the countries in the region we should distinguish a set of important elements determining both
p.000063: closeness of positions in the region in regard to international participation in biomedical research and their
p.000063: specificity. First of all, one should note that the USSR had a regulated state system of organizing,
p.000063: examination, registration of medical use products that included regulatory and methodical requirements and standards
p.000063: for study conduct. From administrative point of view the system was purely “vertical” assuming a whole set for
p.000063: management, approval and setup only at the All-Soviet level excluding possibility for independent approving
p.000063: and executive structures to conduct biomedical research in individual republics of the former Soviet
p.000063: Union. Regulations determining this order were clearly determined and strictly controlled. Studies could be
p.000063: conducted only at clinical sites of the Pharmacological Committee being a central approving authority, and a
p.000063: list of the clinical sites was centrally approved. The clinical site list included only research medical facilities
p.000063: with corresponding staff and technical capacities. Representatives of developing entities were prohibited from
p.000063: contacting directly with facilities and performers of clinical studies. Representatives of sponsoring entities
p.000063: including accredited foreign pharmaceutical companies had contacts only at the level of central approving authorities.
...
p.000071: minors) research subjects, groups of vulnerable contingents should be distinguished, i.e. groups of persons who for
p.000071: social, legal, age-specific, intellectual, mental or other reasons have a limited capacity or do not
p.000071: have the capacity to make an independent, informed and voluntary decision to participate in a clinical research.
p.000071: It is also essential to distinguish different types of biomedical research depending on the character of the connection
p.000071: between the research goal and its actual clinical motivation.
p.000071: Research of the first type, defined in international documents as “therapeutic” (or clinical) biomedical
p.000071: research, implies the application of new diagnostic, therapeutic or preventive pharmaceuticals or methods, i.e.
p.000071: research conducted in the interests of a particular research subject.
p.000071: Research of the second type, defined as “non-therapeutic” (or non- clinical) biomedical research, does not
p.000071: imply actions in the interests of ill or healthy subjects. Biomedical research is carried out with the purpose of
p.000071: obtaining some scientific knowledge or studying how the human organism would respond to one or another condition or
p.000071: factor (pharmokinetic studies, studies in the field of normal physiology, in cosmonautics and sport, etc.).
p.000071: Each of the mentioned types of biomedical research forms and determines special ethical and legal
p.000071: relations. In historical context, the influence of ethical dialectics of each type of biomedical research on the
p.000071: current concept of bioethics is most essential.
p.000071: Thus, high moral principles of physicians (investigators) who conducted experiments on themselves gave rise to a symbol
p.000071: of heroic dedication - a “burning candle”, which personified the motto of medical profession “Aliis lucens uror”. The
p.000071: history of medicine knows many examples of heroic dedication to science, self-sacrifice and modesty. Often
p.000071: those experiments ended tragically and entered the chronicle of “tragic medicine” in the world history. Among
p.000071: devotees there are many physicians (investigators) representing peoples of the CIS countries, which is
p.000071: reflected in chapters describing the cultural and historical background of ethics development in each
p.000071: country. On the whole, the scientific feat of those people is of a supranational character, and arouses feelings of a
p.000071: deep respect and admiration. Their work served the purpose of scientific knowledge, saving people’s life and making
p.000071: achievements for the welfare of the humankind.
p.000071: Inhuman experiments on concentration camp prisoners carried out on an appallingly large scale and sanctioned by the
p.000071: state law of the Nazi regime arouse opposite emotions, and the very word “experiment” with regard to a human being has
p.000071: a dismal echo.
p.000071: However, the development of biomedical research is based not only on those polar, in terms of ethics, examples.
...
p.000089: mountain, a cast bronze head of the goddess Anahit (nowadays in the British Museum), coins with portraits of Armenian
p.000089: tsars and rulers (starting from IV century B.C.), ornaments of a heathen temple and mosaic floor of a bath-house in
p.000089: Garni.
p.000089: Adoption of Christianity (III century) imparted new content and new trends to Armenian art. Antique steles were
p.000089: transformed into an entirely new sculpture style: “khachkary” (cross stones). These marvelous stone plates with tracery
p.000089: all over the surface surrounding carved crosses were erected as headstones or in honor of outstanding people or events.
p.000089: In medieval Armenian painting, alongside with frescoes, book illustrations (miniatures) are of great value. We find
p.000089: them in thousands of manuscripts starting from the VI century. Highly developed and widely spread art of
p.000089: Armenian miniature had its Centres (Van, Cilicia, Gladzor et al.). There were original schools representing different
p.000089: trends of one national style. Among miniaturists Toros Roslin (the XIII century) was particularly famous, in whose
p.000089: miniatures one may see many features of the Renaissance art.
p.000089: Armenian classical medicine that emerged in the great antiquity based on the experience of folk medicine during its
p.000089: centuries-old history had come a long way from empiricism to scientific knowledge. Being closely connected at the dawn
p.000089: of its development with the experience of traditional systems of the East (Mesopotamia, Egypt and India), later, in the
p.000089: period of establishing scientific basics of medicine, Armenian classical medicine had a beneficial impact from
p.000089: antique science. The influence of antique philosophers and physicians (Plato, Aristotle, Empedocles,
p.000089: Hippocrates and Galen) on the development of Armenian classical medicine was particularly strong. Due to the active
p.000089: translation from Greek language, during the period of the V- VII centuries texts of antique scientists had been
p.000089: translated into Armenian. Those texts inspired medieval Armenian physicians and naturalists, e.g. Grigor
p.000089: Magistros (X-XI c.), Mekhitar Heratsi (XII c.), Amirdovlat Amasiatsi (XV c.) et al.
p.000089: It is noteworthy that great Armenian philosophers (David the Invincible, Anania Shirakatsi et al.) placed high
p.000089: emphasis on the problems of good and evil, suffering and compassion, life and death. They considered those issues
p.000089: in light of Christian morals. Today Armenian Apostolic Church is continuing this tradition. Suffice it to say,
p.000089: that the Ararat Eparchy with its rich experience in propagating ideas of bioethics is planning to establish a Church
p.000089: Public Council for Medical Ethics. Armenian Apostolic Church takes a rather strict position on some problems of
p.000089: bioethics: it prohibits human cloning and cloning of human organs, euthanasia, artificial fertilization and abortion,
p.000089: which is considered as infringement of human life.
p.000089: In this context the views of David Anhaght (the Invincible) formulated in his works (“Definition of Philosophy”,
p.000089: “Commentary on Aristotle’s Analytics” and “Commentary on Porphyry’s Introduction”) are of much interest.
p.000089: David Anhaght took problems of medical ethics very much to heart. His ideas on the value of human life are of
...
p.000089: whenever or wherever they happen, come to us not in order that we should kill ourselves, but so that we tried our soul.
p.000089: Like a good helmsman is tested not in still water, but in the stormy sea, the lofty soul goes to meet a trial”.
p.000089: Thus David Anhaght (the Invincible), in line with Nerses the Great, a prominent philosopher (V c.), gave a negative
p.000089: answer to the question “Does the physician have a moral right to hasten his patient’s death?”.
p.000089:
p.000090: 90
p.000090:
p.000091: 91
p.000091:
p.000091: Similar views we find in works of Armenian thinkers Mkhitar Hosha and Smbat Hundstabl (XIII c.). In “The Book
p.000091: of Laws” we read: “The physician who deliberately or through ignorance does harm to the patient’s health or, what
p.000091: is more, hastens the patient’s death, as well as the physician who educates a disciple, but does not give him proper
p.000091: knowledge deserves a severe punishment, up to death penalty”.
p.000091: This discussion started many ages ago is still topical nowadays. Neither lawsuits against physicians who
p.000091: support euthanasia thus violating one of the fundamental principles in The Hippocratic Oath (“To please no one will I
p.000091: prescribe a deadly drug nor give advice which may cause his death”), nor protests of public at large advocating
p.000091: traditional views do not guarantee that those who stick to more radical opinions will not triumph in the near future
p.000091: (alas!).
p.000091: Philosophical moral principles of the Hellenistic world had a great influence on the moral code of
p.000091: medieval Armenian medicine along with the highest values of the Christian ethics. The physician who violated The
p.000091: Hippocratic Oath and gave his patient “a deadly drug” was not merely reproached for that but treated as a
p.000091: criminal guilty of an innocent person’s death with all the corresponding consequences, as stated in the chapter “On
p.000091: Physicians Prescribing Deadly Drugs” in “The Book of Chrii”.
p.000091: In his treatise “The Usefulness of Medicine” Amirdovlat Amasiatsi, an outstanding Armenian physician (XV c.) writes:
p.000091: “The physician should be reasonable and have the sense of duty; he should be tolerant and ready to give advice. In no
p.000091: circumstance should he be a drunkard nor should he be greedy and mercenary-minded. He should love the poor and be
p.000091: merciful, faithful and god-fearing. If he does not understand the essence of the disease he should
p.000091: prescribe no drug in order not to stain his reputation. If the physician is ignorant it would be better not to call him
p.000091: to see a patient, and, in general, he should not be regarded as a physician.” These words showing an ideal image of the
p.000091: physician-humanist and his moral code are still essential for modern medicine that synthesized imperishable moral
p.000091: values set forth in medical systems of the East and the West.
p.000091: Today, each of the presented problems gives rise to many new questions. At the present stage of bioethics development
...
p.000183: civilization” [13].
p.000183: According to “The Beneficial Knowledge” just and fair laws are the cardinal mechanism ensuring stability in the
p.000183: society, and everyone, be it a ruler or a subject should follow the laws.
p.000183: Law rules the world – we shan’t forget this, It is a sign of humanity inherent in people.
p.000183: In its character, “The Beneficial Knowledge” is an ethical and didactic poem written with the purpose to show the way
p.000183: towards learning the wisdom
p.000183: of government, every-day life and relationships between people on different occasions. Jusup Balasagyn describes
p.000183: qualities necessary for viziers, military commanders, secretaries, ambassadors, penmen and copyists,
p.000183: treasurers, cooks, cup-bearers, scientists, physicians, dream interpreters, magi, astrologers, merchants,
p.000183: cattle-breeders, craftsmen and others. He also writes how people should behave, reflects on human
p.000183: responsibilities and duties, virtues and vices. For Balasagyn sees “dissolution of morals and depreciation
p.000183: of spiritual values as one of the worst vices of his time” [8].
p.000183: A peculiar feature of “The Beneficial Knowledge” is that the author allows the reader to himself to gain an
p.000183: understanding of sense of life, of virtues and vices. Jusup Balasagyn argues that everyone should know and observe
p.000183: moral norms and rules of behaviour. “The Beneficial Knowledge” is a peculiar moral code of its time. Over a long time
p.000183: Kyrgyz ethnos had been existing in form of clans. Relationships within the community had been forming during
p.000183: a long historical period. Changes, if any, occurred due to the influence of external environment forming the worldview:
p.000183: the sense of sharing needs and interests of other people, feelings of mutual aid and collectivism. Kyrgyz people
p.000183: survived in crisis situations only due to spiritual and genetic health of their ancestors. People retained and
p.000183: developed clan traditions, upbringing practices, code of ancestral honour. Clan honour for Kyrgyz people is one of
p.000183: the most essential concepts. Every Kyrgyz had his ancestors, his land and his clan. Each clan had its hierarchy
p.000183: at the head of which was the most respected clan member. Collectivism, mutual aid, empathy, respect for other
p.000183: people – those were the qualities inherent in Kyrgyz mentality.
p.000183: Cultural and historical sources reveal respect to women in nomadic tribes, however there were conflicting
p.000183: traditions with regard to this issue. It is noteworthy that women had a high social status in Kyrgyz society [6].
p.000183: Ethical ideas in works by Kyrgyz thinkers. Spiritual culture of Kyrgyz people reflected in philosophical and poetic art
p.000183: of akyns20 is characterized by the search for perfection. Problems of upbringing and education, of humanism
p.000183: and love for people have a significant place in philosophical poetry of Kyrgyz thinkers, and therefore there
p.000183: is every reason to consider
p.000183: 20 Akyn is an improvising poet and singer in the Kazakh and Kyrgyz cultures. Akyns played and important role in terms
...
p.000195: language and evangelization. There was the ethnogenesis of Romanians (from “Romans”) later.
p.000195: Development of feudal relationship was attested in the X century. Three principalities were formed in the one-time
p.000195: Dacian territory: Transylvania, which felt under the reign of Hungarians (Hungarians are Finno-Ugric trans- Ural tribes
p.000195: settled here by the end of the IX century) in the beginning of the X century, Ţara Românească (or Walachia, Muntenia);
p.000195: Ţara Moldovei. The first written diplomas mentioning political and military strength of Ţara Românească and
p.000195: Moldova are referred to the years 1330 and 1359, respectively.
p.000195: During the Middle Age Moldova kept suffering from raids of the Tatars, the Turks, the Hungarians and the Poles.
p.000195: Historical Moldova covered the territory between Eastern Carpathians, woody Carpathians, the Dniester, the Black
p.000195: Sea and the Danube under Roman 1 of Moldavia (1392-1394). Geographic location of the territory was favorable as
p.000195: to the nature and life resources and at the same time unfavorable as to geopolitical strategic aspect. The country
p.000195: was located in the strategic pass connecting Eastern and Western Europe, being situated between the Carpathians and the
p.000195: Black Sea. The Silk Road, i.e. the longest commercial route connecting the Far East with the western European countries
p.000195: was there in the Middle Age. Since the first centuries AD and until now great states, trying to preserve the influence
p.000195: here had strategic interests in common. Our people have never been involved in wars of aggression but only defensive
p.000195: ones. Such state of affairs left a deep track in the spiritual life of the country. Spirituality of the inhabitants,
p.000195: philosophic thoughts are of the patriotic and the humanist nature. The ideas of the Italian Renaissance were taken here
p.000195: caught on with some works of some local cultural figures.
p.000195: Ştefan cel Mare şi Sfânt (Stephen the Great and Holy) (1457-1504) ruled Moldova during the most
p.000195: difficult times. He provided a long-term unity of the state, its economical growth and prosperity of
p.000195: cultural life. Protecting his land from invasion he stopped the advance of the invaders to the Western Europe. The
p.000195: Patriarch of Rome for that time deemed him verus christianae fidei athleta (true Champion of Christian Faith) for his
p.000195: services. Soon after the king’s death in 1513 Moldova had to resign to regime of the Ottoman suzerainty.
p.000195:
p.000195:
p.000196: 196
p.000196:
p.000197: 197
p.000197:
p.000197: In 1600 Mihai Viteazul (Michael the Brave) (1595-1601) united for the first time and for a short period
p.000197: Moldavia, Wallachia and Transylvania. Several territorial breaking-ups happened after that. During the Russian-
p.000197: Turkish War of 1768–1774 Austria took the north of Moldova including the ancient capital of Suceava. However the
p.000197: painful and drastic re-allotment of Moldova happened in 1812 when as a result of the other Russian-
p.000197: Turkish War the Russian Empire took the territory between the Prut, the Dniester, the Danube and the
...
p.000221: multinationality influenced the foundation of Russian culture. Geographical position of the state at the junction of
p.000221: Europe and Asia resulted in ambivalence of people nature and state organization as European as Asian and gave birth to
p.000221: a philosophical concept of eurasianism, that was founded by one of the most universal Russian thinkers
p.000221: abroad N.S.Trubetskoy (1890-1938). D.L.Lihachev believed that universality and belonging to East and West were
p.000221: the most characteristic features of the Russian culture (14). Junction of East and West civilizations, crossing of
p.000221: two pole streams of culture, which pushed off each other and could not be joined but co-existed, have determined such
p.000221: features of Russian soul, as its polarity, apocalyptic character and nihilism, which “do not admit a middle kingdom of
p.000221: the culture” (1).
p.000221: Habitat, the geographical position, nature and climate where people were settled in the result of
p.000221: historical processes of moving and settling, determined the formation of Russian national character. Famous
p.000221: historian V.O.Kluchevskiy believed that external nature always and everywhere determines the mankind in
p.000221: different way. The different determination specified features of people, first of all everyday and mental, which
p.000221: form the national character; in this case they are the humanitarian foundations characterizing Russians (9).
p.000221: Russian ethnos originated and evaluated on great Russian plains that determined particular life style and view on
p.000221: external world, so-called “Russian soul breadth”. Social surroundings, relationships and labor system
p.000221:
p.000222: 222
p.000222:
p.000223: 223
p.000223:
p.000223: had the great influence on formation of the Russian national character. Humanity, placability and openness
p.000223: of our ancestors soul were formed under the influence of their main activities such as arable farming, cattle
p.000223: breeding and workmanship, and of community social order, which had been lasting longer then at other peoples. Among
p.000223: values of community it should be mentioned justice, power of “world”, thrifty housekeeping, knowing of folk wisdom,
p.000223: bogatyr (a Russian hero) strength, etc. Having given voluntary his destiny over to the community, man condemned himself
p.000223: to be tolerant and obedient. The community, by means of which the Russian people were able to keep their ethnos
p.000223: independent in spite of numerous invasions, had also the high value. For the sake of the community a Russian was ready
p.000223: to suffer, tolerate and sacrifice almost everything. Nevertheless, historical facts demonstrated examples of “Slavic
p.000223: freedom” from Cossacks, drinking- bouts, revelries, disorder, “fantastically fast life” to rebel and revolutions.
p.000223: The Russian culture is well known to exist inasmuch as Russian (and Old Russian) words meaning cultural
p.000223: contents exist. Contemporary analysis of the word “personality” (autonomy of “personality” is one of the
p.000223: principles of bioethics) in Russian and European languages showed that word “personality” is rather young
p.000223: for the Russian language, it was absent in the Old Russian language and in the modern Russian it handed its
p.000223: meaning to word “person” (15). As regards the notion “individuality” it has been adopted slowly and hardly in modern
...
p.000223: of church awareness. First of all everywhere dominance of morality evidences that. We can see it in works of nearly all
p.000223: Russian thinkers even those who had no works devoted to moral problems.
p.000223: Adoption of Christianity determined evaluation of Russian spirituality in subsequent periods. Founding on traditions of
p.000223: eastern orthodoxy, ideas of spirituality, shame and conscience, love to neighbor were brought in Old Russia, a
p.000223: spiritual foundation of charity as everyday piety was formed. Alms as early form of personnel charity was spread among
p.000223: all social classes, it was not only simple execution of commandment of love to a neighbor, but a true need. It was
p.000223: personnel charity that created the foundation necessary for helping the poor at the following times. It was forming
p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
p.000225: people social life organization on the basis of common views (19).
p.000225: Under church influence and with its participation care for people in need for medical and social help
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
p.000225: thousands of disabled, old people and orphans. In the 50’s of XVI century they attempted to place a part of care
...
p.000231: sides in 1917 in an article by B.V. Dmitriev, a physician who worked for a machine factory in Kolomna and whose
p.000231: expertise was based on the consultation that the author obtained from A.F. Kony (12). Considering legal aspect of
p.000231: a doctor’s right for transplanting organs and tissues B.V. Dmitriev asked: “Whether a physician is granted
p.000231: any right to cause even minute and fleeting harm to a healthy person for the sake of another human being? Whether he is
p.000231: competent to decide in every particular situation if the benefit for one patient compensates for the harm done to the
p.000231: other, having the widest sense of the words benefit and harm in mind, that means not only in relation to physical
p.000231: health of these individuals but taking into account a complex of spiritual and physical strength of both?”.
p.000231: In response to these concerns Doctor Dmitriev stated the main provisions of implementing a medical
p.000231: research, the most essential of which are providing information and obtaining a conscious consent (of a donor in this
p.000231: case) which fully complies with the modern requirements. The same article provides a text of the first Russian
p.000231: full-scale minutely formulated patient’s informed consent form which retains its actual continuity up to
p.000231: contemporary time.
p.000231: Achievements of academic medicine did not significantly influence public health factors and demographic
p.000231: processes. Mortality and morbidity rates among population were high, infant mortality was common, there were
p.000231: many physically retarded children. Russia was shaken by epidemics of epidemic typhus, cholera, smallpox, malaria, and
p.000231: diphtheria and other. Medical facilities were scattered between different authorities and were mainly financed
p.000231: through beneficent funds.
p.000231: The number of physicians and hospitals was inadequate to provide citizens with medical service. In late XIX –
p.000231: early XX centuries there were 10 hospital beds and 1.8 physicians for every 10000 people in Russia. Medical service was
p.000231: mainly available in large cities. Out of 257 sanitation physicians 135 worked in Moscow and Saint-Petersburg. According
p.000231: to the data of 1913 allocations in health care accounted for 91 kopeks, for sanitation – 1.25 kopeks per
p.000231: year per capita. The major, rural, part of Russian population was almost completely deprived of medical
p.000231: service. In these conditions the position of F.F Erisman and V.V. Veresaev is a notable one, they called for not
p.000231: staying indifferent to the reasons inducing such situation, not to “powerlessly grumble about the unfair destiny”, but
p.000231: to consider it a moral duty to “take all possible steps to prevent such undue events from happening”
p.000231: Development of country medicine was a great event, the establishing of which was tightly connected with the community
p.000231: mode of life characteristic of Russian people and with the so-called country self-administration introduced in
...
p.000235: Many achievements of ideas in medical ethics were declared left-overs of capitalistic approach to medicine and
p.000235: should have been dumped to a landfill of history. In this respect a bringing under discussion an issue of medical
p.000235: confidentiality is natural and N. A. Semashko claimed “firm course towards eradicating medical secrecy”, although in
p.000235: the years to follow he came back to classical understanding of this problem.
p.000235: Ambiguous attitude of governmental bodies to medical ethics brought to life medical deontology (28). A prominent
p.000235: surgeon in oncology N.N. Petrov in 1944 came to publish his work “Issues of Surgical Deontology” which was reedited
p.000235: several times. It saw into many problems of doctor patient relationship like providing information and
p.000235: obtaining an informed consent form, which are first and foremost principles today. Deontology provided an opportunity
p.000235: to sustain public attention to staple points of humanism in medical practice.
p.000235: In the 60-70’s the interest towards medical deontology grew. Five All- Soviet Union conferences were devoted to the
p.000235: issues of medical deontology, first of which took place in Moscow on January, 28-29 in 1969. One could then observe a
p.000235: singular outburst of publications on aspects of deontology in different fields. A two volume manual “Deontology
p.000235: in Medicine”, published in 1988 and edited by academician B.V. Petrovskiy exercised great influence.
p.000235: Management and funding in medicine and health care in the Soviet years were of centralized character and were
p.000235: characterized by well developed intrabranch links, which were mainly supported by administrative and
p.000235: bureaucratic type of management and planning gaining a narrow corporate nature and becoming almost unavailable to
p.000235: public control. A medical doctor became a civil servant, whose activities were regulated by great number of
p.000235: departmental guidelines and to a large scale were limited to drawing reports.
p.000235: Nevertheless, within relatively short time period based on virtually efficient grounds and principles of
p.000235: public health care system a coherent framework of medical, preventive treatment and epidemiological services was
p.000235: organized. Assessment of health care system developments was done primarily quantitatively, but qualitative data
p.000235: within this field showed impressive success. Many infectious fevers were eradicated, infant mortality drastically
p.000235: dropped, average life expectancy increased. Effectiveness of primary medical was distinguished by the
p.000235: medical community in 1978 during the WHO and UNICEF international conference in Alma-Ata (Kazakhstan).
p.000235: Many achievements in medicine and health care were made due to enthusiasm and responsible attitude of medical
p.000235: professionals, retaining ideas of self-denying and generosity in medical community, pursuit of classical ideas of
p.000235: medical ethics.
p.000235: Gradually in the 70-80’s in the society there started to occur shortcomings underpinned by lack of
...
p.000237:
p.000237: low availability of quality medical service and other. There were indicated adverse trends in public health, in medical
p.000237: and demographic values: drop in birth rate, growth in mortality rate, decrease of mean life expectancy.
p.000237: Retaining an essential principle of free medical care health care system found itself unable to meet the
p.000237: citizens’ needs in provision of high quality of service. Various forms of financing medical service started to be
p.000237: implemented. Apart from that the declared idea of free service brought up consumptive attitude to medicine among
p.000237: citizens, lowered public responsibility for their health issues, deteriorated medical activity of citizens. There was
p.000237: indicated a multilevel approach in medical service provision for different groups of patients. With the growing
p.000237: differentiation and narrow fields of medical activity and no relevant integration processes there occurred
p.000237: “fragmentation” of medical responsibility, weakening of the inner moral control mechanisms, perception of a patient
p.000237: as one whole was lost. In these conditions the controversy between the declared moral principles of medical
p.000237: service and the way they were put into practice became outstanding. Staples of medical ethics alongside with legal
p.000237: standards became increasingly irrelevant to real life social practices. In medicine moral strain became ever
p.000237: increasing; such vital principles as humane and respectful attitude to a patient, medical confidentiality were
p.000237: violated. Increasing intensity of flaws in the field of ethics resulted in decline in medical doctors’ prestige
p.000237: and influence in society, aroused disaffection with their work among doctors, affected the moral climate in the
p.000237: society in general (10).
p.000237: All these issues developed alongside with lack of regulatory framework in the environment of legal and ethical
p.000237: unpreparedness of the citizens to work in new economic situation on the one hand and the growing application of new
p.000237: medical technology on the other.
p.000237: Political, economic and social reforms in the XX century 90’s badly affected all areas of social and spiritual life of
p.000237: people. Unfortunately they were not scientifically proved and never underwent ethical evaluation. The following
p.000237: years demonstrated that immoral economy does not prove effective. But above all – drastic large scale changes
p.000237: in the country significantly influenced the state of mind and mentality of the general public suffering
p.000237: through the pressure of social changes. Because of being psychologically unprepared for the current events, for the
p.000237: suddenly acquired freedom both individuals and certain social groups showed deadaptation
p.000237: which was demonstrated through manifested sense of social destitution and injustice, extraneity to novel social norms,
p.000237: culture and values, awareness of helplessness and alienation (2). The results of the social surveys
p.000237: demonstrated “collapse’ of such traits, traditionally characteristic of the Russians, as friendliness, warm
p.000237: heartedness, sincerity, self-forgetfulness” alongside with the evidently growing manifests of aggressiveness
p.000237: and cynicism (23). All this drastically affected medicine and health care, the medical community and the
...
p.000239: act there was established the Ethical Committee of Federal Agency for Control over Medical Agents (prior to that
p.000239: ethical evaluation of clinical research protocols was carried out by the Special Board of RMA National
p.000239: Committee). In the same 2000 year a spearhead of health care professionals set up the Independent Multidisciplinary
p.000239: Committee on Ethical Evaluation of Clinical Research which was aimed at answering various requests and appeals on
p.000239: voluntary basis. Local and regional ethical committees are set up with lower activity but their number gradually grows
p.000239: (22).
p.000239: The current stage is characterized by booming information and communication technology, rapid
p.000239: development of market economy, drastic changes in demography, persistent urbanization process, and trends towards
p.000239: development of open society. Signs of two controversial tendencies: globalization on the one hand and on
p.000239: the other – increased attention of people to their national and cultural traditions.
p.000239: After seventy years of atheism as state ideology and withdrawal from those ideas and values that the society was
p.000239: governed by, the caused moral vacuum in Russia failed to be compensated with a more or less integral
p.000239: framework of secular ideas and values clear and conventional to people and capable of appealing to people and give them
p.000239: hope. A distinguishing feature of the Russian society is that conventional factors invariably play significant role in
p.000239: many walks of social life, adherence to traditional ideological and social values which saw little influence
p.000239: of the changing social and economic systems, political regimes as well as fresh social and ideological paradigms for
p.000239: development declared in the recent decades of the XX century. Under any state system – monarchical or collective type,
p.000239: totalitarian or liberal – an impact of a number of constants which determine a civilization portrait of Russia is
p.000239: feasibly evident. Among them a crucial role belongs to religion, first and foremost the Orthodox Christian Church which
p.000239: by masses of population is perceived not only as an institution with the main function of not just disseminating the
p.000239: ideas of Christianity but mostly as preserver of the Russian national values and traditions (by different social
p.000239: studies three fourths of believers who are almost half of the population in Russia are Orthodox Christians). The same
p.000239: can be said about the Islam – second confession in Russia in terms of adherents’ number and influence (about 19% among
p.000239: believers) (20).
p.000239: Today religious organizations prove active in most different fields: religion itself, education, health care,
p.000239: culture, charity and mercy, business and economic. Changes occurring in the society and the Church demanded for a
p.000239: comprehensive philosophy that would reflect general attitude of the Church to issues of state and the Church
p.000239: relations and concerns of the modern society on the whole.
p.000239: At the Anniversary Episcopal Assembly in 2000 the Basic Social Conception of Russian Orthodox Church was
p.000239: adopted. The conception falls into 16 sections covering most various issues related to life of a Christian believer in
p.000239: secular world. In section 11 – “Public and Individual Health” – the attitude of Orthodox Church to disease and health
p.000239: is rendered, importance of church activities in health care is stressed, necessity of society and church cooperation in
p.000239: public health care issues is emphasized. It covers such vital from religious viewpoint principles as doctor and patient
p.000239: relationship which should be based with respect to integrity, free choice and “personal dignity”. In particular it
p.000239: stresses: “We should by all means encourage a dialogue between a doctor and a patient that is
p.000239: characteristic of current medical approach. This approach is undoubtedly engrained in the Christian tradition,
p.000239: although there is a temptation to relegate it to a level of merely agreement relationship. At the same time one should
...
p.000269: well as inconveniences and objectively expected risks for both patients/healthy volunteers and a fetus or infants; all
p.000269: study procedures (especially accurately
p.000269:
p.000270: 270
p.000270:
p.000271: 271
p.000271:
p.000271: there shall be highlighted issues on all invasive procedures planned during the study); obligations of the
p.000271: subject-participant; compensation and/or treatment the subject might expect in case the damage is incurred to his/her
p.000271: health during the study. The information note for the patient must contain a declaration that his/her participation
p.000271: in the study is voluntary and that he/she can in any moment of time refuse of participation in the study or to
p.000271: discontinue it without any sanctions or his/her rights infringement; there shall be clearly identified a list
p.000271: of persons that will be granted with direct access to information in the primary medical documentation (investigators,
p.000271: auditors, regulatory authorities, ethical committee members), and provided assurance that data identifying
p.000271: personality of the study subject will be kept secret and its disclosure is possible only within the limits
p.000271: stipulated with corresponding laws and/or by-laws. For instance, in case of public representation and
p.000271: publication of the study results anonymity of its subjects (confidentiality of information about them) is
p.000271: guaranteed. The patient information note must indicate investigator obligations in case of appearance of new data
p.000271: in the given CT that can influence the subject decision on continuing participation in the study to
p.000271: immediately inform the study subject or his/her legal representative about them, define a list of persons that one can
p.000271: address if it is necessary to obtain additional data concerning this CT the subject-participant and the rights of the
p.000271: subject as well as other specialists that the study subject can contact in case his/her health is
p.000271: compromised during the study (these are representative of the study team, local EC). It is obligatory to provide
p.000271: conditions when participation of the patient/healthy volunteer can be discontinued without his/her consent, suggested
p.000271: duration of the study, and approximate number of the subjects in different regions and in the given clinical site. The
p.000271: information provided to the patient shall be logically completed with the informed consent form, which exhibits, if
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
...
p.000285: still considered encyclopaedias of Muslim Neoplatonism. Another work by Ibn Sina “The Justice” that has not survived to
p.000285: our days presented an analysis and comparison of views of Alexandria and Baghdad schools of Neoplatonism. In “The
p.000285: Justice” Abu Ali Ibn Sina is an arbitrator between the two quite famous medieval philosophical schools. His book
p.000285: “Oriental Wisdom”, probably, also offered an analysis of works by oriental philosophers who commented on
p.000285: Neoplatonism considering views of Alexandria scientists. “Book of Directions” that was, by legend, Ibn Sina’s last
p.000285: work shows the author’s Sufi views. A number of works consider the problem of free will. Abu Ibn Sina associated
p.000285: free will with active, practical intellect, which stressed a purely ethical, not psychological, nature of his
p.000285: theory. A.K.Zakuev rightly noted that Ibn Sina’s teaching covers problems of regulating human behaviour, moral
p.000285: judgments, and of ethical compliance of human behaviour with commonly recognized moral principles and with an
p.000285: individual’s own views derived from those principles for regulating his/her behaviour of his/
p.000285: her own volition.
p.000285: Some works by Ibn Sina show us his adherence to certain aspects of Sufism and mystical symbolism. Famous for its
p.000285: encyclopaedic character, his philosophy served for reconciliation of religious views and rationalistic sciences, which
p.000285: alone would suffice to consider him an original philosopher. Avicenna had a noticeable influence on views of
p.000285: Thomas d’Aquin and Albert the Great – the two prominent medieval philosophers. Agiographic texts abound in
p.000285: evidences on remarkable abilities of Hadji Naseeruddin Obaidullah Ahmar from Maverannahr (1404-1490), a religious
p.000285: figure, who worked miracles to protect order, justice and the oppressed. His actions
p.000285:
p.000286: 286
p.000286:
p.000287: 287
p.000287:
p.000287: showed his mercy to the oppressed and sternness towards oppressors and their accomplices who forgot the moral norms of
p.000287: Sharia. His style of behaviour demonstrated norms of righteousness, good deeds and ethical conduct.
p.000287: Abu Ali Ibn Sina was very popular among European scholastics (especially in the XIII c.). In the Middle
p.000287: Ages separate chapters from Avicenna’s “Book of Healing”, such as “Logic”, “On the Soul” and
p.000287: “Metaphysics” were translated into Latin, and Christian philosophers all over Europe considered themselves
p.000287: either followers of admirers of Abu Ali Ibn Sina.
p.000287: Ethical views of another great Tajik scientist, thinker and political figure of the XIII century Naseeruddin
p.000287: Tusi on the essence and norms of morals we find in his work “Ahloki Nosiri” composed of two parts: “On the fundamentals
p.000287: of morals” and “Doctrine of the purpose”. For him ethics as a science of behaviour is an essence of not only innate but
p.000287: also of acquired qualities, and being a product of social relations it may change according to social events. The
p.000287: author describes factors causing ethical changes.
p.000287: Ar-Razi proceeded from the materialistic tradition of Democritus who recognized natural regularities of nature
p.000287: and society and affirmed the cognoscibility of the world. Advanced ideas of Biruni who opposed the
p.000287: natural-science approach to the religious worldview were widespread. During the IX-XIV century, kalam, a scholastic
p.000287: philosophy of Islam that emerged in the VIII century, gained popularity and was opposing progressive views of Ibn Sina
p.000287: and his followers. Kalam defenders (Gazalii Fahruddin Rosi) advocated the idea of the Creation and believed that the
p.000287: world depends on the divine will. In the XI century, the teachings of Ismailism (a philosophical doctrine of Ismailism
p.000287: based on Neoplatonic and Aristotle’s views) became very influential (Nasir Hisrov). In their teaching on the
p.000287: harmony of the universe the Ismailis likened the constitution of the universe (“macrocosm”) to the constitution of
p.000287: human body (“microcosm”).
p.000287: Continuous internal wars in khanates of the Central Asia over XVI-XIX centuries resulted in the decline of productive
p.000287: forces, and living conditions of working masses changed for the worse. During that period, reactionary clergy was
p.000287: extremely influential, and repressed any scientific thought. The main attention was given to Muslim theology and
p.000287: ethics. The influence of the Sufi doctrine and literature with biographies of Sufi sheikhs and moral regulations of
p.000287: various Sufi Orders was particularly strong. Progressive
p.000287: tendencies and anti-feudal views were expressed in works by Tajik poets and thinkers, such as Binoi (1453-1512), Vasifi
p.000287: (1485-1551), Hiloli (executed in 1529), Saiido Nasafi (died in 1707 or in 1711), Bedil (1644-1721) and others. Their
p.000287: works reflected interests of working people and their protest against a feudal exploitation.
p.000287: Starting from the second half of the XIX century, the Russian Empire had a favourable influence on the development of
p.000287: philosophical and socio- political thought of the Tajik and other peoples of the Central Asia. Under the influence of
p.000287: Russian culture, democratic and enlightening views paved the way to Marxist-Leninist ideology. The involvement in the
p.000287: sphere of economic and scientific interests of Russia, despite an imperial policy of tsarism, facilitated the
p.000287: process of the implementation in Tajikistan of new and more developed agricultural and industrial machinery, transport
p.000287: equipment, new methods of farming and new crops. In the period from the end of the XIX to the beginning of the XX
p.000287: century, Russian culture influenced the development of the Tajik philosophical, scientific and engineering thought.
p.000287: Ahmad Donish, Hodji Halif, Hodji Jusup, Yakubi Farang, Hairat, Somi, Sobir, Asiri, Siddiki, Aini and others advocated
p.000287: ideas of national progress and social justice and criticized medieval feudal system. Scientific centres of Moscow,
p.000287: Leningrad and other cities were helpful in rising Tajik philosophers. The study of the history of Tajik philosophy and
p.000287: teachings of ancient peoples of the Central Asia was also very important. S.Aini, A.A.Semenov, A.M.Bogoutdinov,
p.000287: Z.Sh.Radzhabov, M.Boltaev, G.A.Ashurov, M.Dinorshoev, M.Radjabov and others analyzed in their works problems of the
p.000287: unity of the national and the international in the history of Tajik culture and philosophy, revealed special
p.000287: regularities of their development, the character of interaction with other philosophical trends and unmasked
p.000287: reactionary nature of Europocentric and Asiacentric concepts. Tajik scientists carried out studies in the
...
p.000315: it is easy to imagine the heavy load of the shoulders of ethics committees/commissions members. The role and
p.000315: responsibility of ethics committees/commissions at scientific- research institutions in the sphere of medicine and
p.000315: biology grows also due to the requirement to carry out a compulsory ethical review of scientific projects
p.000315: (earlier it concerned mainly international projects). Ethical review of publications in scientific journals is
p.000315: also becoming a routine practice. In 2005 a compulsory ethical review of dissertation works in medicine,
p.000315: biology and veterinary medicine. The continuously growing amount of
p.000315: 47 www.pharma-Centre.kiev.ua/clinic/programm.doc
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p.000316: 316
p.000316:
p.000317: 317
p.000317:
p.000317: work performed by ethics committees/commissions makes us think about the necessity of financing this work.
p.000317: New demands on the quality of ethical review require improving the work of existing local ethics committees. It
p.000317: is necessary to organize a continuing education of ethics committees members and to develop legal regulation of
p.000317: operation and interaction of committees at different levels.
p.000317:
p.000317: 3.10.5. Perspectives and Forms of International Cooperation
p.000317:
p.000317: World tendencies of bioethics development have an essential influence on its development in Ukraine. First local ethics
p.000317: committees in Ukraine were established in 1992. They were approved at the Board Meeting of the Ukrainian Ministry of
p.000317: Health, and thus became legitimate to carry out ethical review of scientific projects. This idea can be
p.000317: illustrated with two large international projects. The Institute of Pediatrics, Obstetrics and Gynecology of the
p.000317: Ukraine Academy of Medical Sciences participated in an international multicentre epidemiological study “Mother
p.000317: and Child”, and the Institute of Occupational Medicine of the Ukrainian Academy of Medical Sciences in cooperation
p.000317: with colleagues from USA conducted an ophthalmologic research in rescuers who had participated in the elimination of
p.000317: the Chernobyl accident. Both projects were carried out in cooperation with the University of Illinois and
p.000317: Columbia University (USA). Within the framework of the projects the teaching staff of universities provided a basic
p.000317: training in bioethics for Ukrainian medical specialists involved in the projects.
p.000317: Since 1998 Ukraine cooperates with different UN organizations including UNESCO that has initiated
p.000317: establishing the National Committee on Bioethics in Ukraine. In 1998 the Committee on Bioethics was established at the
p.000317: Presidium of the Ukraine National Academy of Sciences that had been functioning as a national agency till 2001. After
p.000317: the First National Congress on Bioethics with many participants from abroad (Kiev, 2001) the Commission on Bioethics at
p.000317: the Ukrainian Cabinet of Ministers was established. From the very beginning of its activity, the Commission established
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p.000167: - The use of new methods and means of disease prevention, diagnostics, treatment and medical rehabilitation is possible
p.000167: only after positive results of clinical trials were obtained.
p.000167: According to the article 9 of the same law (“The competence of responsible institution”) the Ministry of Health of
p.000167: Kazakhstan has the right to:
p.000167: - determine the requirements for the use of new methods and means of disease prevention, diagnostics, treatment and
p.000167: medical rehabilitation;
p.000167: - determine the requirements for implementation of preclinical studies and medical and biological experiments as well
p.000167: as to clinical trials;
p.000167: - develop and approve the order and conditions of collection, conservation and transplantation of
p.000167: tissues and (or) organs (fragments of organs) from human to human, from the dead body to human and
p.000167: from animals to humans.
p.000167: According to the article 14 of this law every person has the right to receive the information on possible methods of
p.000167: treatment and consequences of clinical trials from public health institutions.
p.000167: According to the article 15 any person has a right to apply to independent experts for assessment of the quality of
p.000167: medical procedures that were offered to this person.
p.000167: The law “On Medical Drugs” approved on 13th of January 2004 contains articles 18, 19 and 20 that describe the
p.000167: order of development of biologically active substances and their preclinical studies or clinical trials of medical
p.000167: drugs. These articles were developed in the line with international experience (5):
p.000167: - the participation of the patient in clinical trials and (or) in testing of pharmaceutical substance or
p.000167: medical drug should be voluntary and is possible with his/her written informed consent only;
p.000167: - before clinical trials and (or) testing all information on the substance/ drug, on the contents of trials or tests,
p.000167: on safety and risks for patients health, on actions in the case of unforeseen effects of pharmaceutical substance or
p.000167: medical drug for the patient’s health as well as on patient’s health and life insurance should be provided to the
p.000167: patient;
p.000167: - the patient has a right to interrupt his/her participation in trials and (or) tests of pharmaceutical substance or
p.000167: medical drug at any phase of such trials or tests;
p.000167: - it is strictly prohibited to perform clinical trials and (or) tests of pharmaceutical substances or
p.000167: medical drugs with participation of: children and adolescents; pregnant women; military persons; imprisoned
p.000167: or incarcerated persons; non-competent persons.
p.000167: At the web-site www.medik.kz the Association of Physicians and Pharmacists of Kazakhstan has the page, where
p.000167: all legislative and regulatory documents in public health area. At present time specialists began to develop the Code
p.000167: of Republic of Kazakhstan “On Population Health and Public Health System” that will take into consideration all
p.000167: international legislative experience including legislative acts in area of biological and medical studies. For
p.000167: example, on 22nd of January 2007 the Frame Convention on Tobacco Control was officially ratified by the Republic of
p.000167: Kazakhstan; it is planned to bring laws of Kazakhstan in line with international documents that can ensure good
p.000167: clinical practice and improvement of activity of ethical committees [6].
p.000167: In 1995 according to initiative of the Association of Physicians and Pharmacists of Kazakhstan drafts of “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
...
p.000171: The serious progress in the field of protection of human rights of persons participating in clinical trials was the
p.000171: description by this Order of norms that allow the ethical commission to formulate the conclusion on possibility of
p.000171: clinical trials or on refusal. At the same time there is some controversy in this document, namely the delegation
p.000171: of monopolistic/exclusive right for conclusion on approval or disapproval of clinical trial to such institution as
p.000171: National Centre.
p.000171: For protection of rights of persons participating in studies or trials the article 35 clarifies that the person “can be
p.000171: included in the trial only after receiving of information”:
p.000171: 1) on medical drug and on the principles of its clinical trial;
p.000171: 2) on safety and efficacy of medical drug as well as on the potential risks for the health of the participant;
p.000171: 3) on actions to be taken in case of unforeseen effects of medical drug on the health of trials participant;
p.000171: 4) on terms of medical insurance of participant’s health”.
p.000171: The Order contains several annexes, including the standard form of informed consent; using this form the
p.000171: potential participant can refuse to participate or to continue the clinical trials of pharmaceutical
p.000171: substance or medical drug during any phase of the trial. This Order is comparatively big document because it contains
p.000171: detailed descriptions of application form and process, protocol of the study, the form of conclusion, the structure and
p.000171: contents of researcher brochure and so on.
p.000171: In this Order the special attention is given to the “Instructions on activity of ethical commission and on performance
p.000171: of ethical assessment of clinical trials”. This instructions clarifies the basic requirements to assessment of ethical,
p.000171: moral and legislative aspects of materials of clinical trials that can be done in patients. The principal goals and
p.000171: targets of the commission are described as follows:
p.000171: 1) protection of rights and interests of participants involved in clinical trials;
p.000171: 2) protection of rights and interests of researches;
p.000171: 3) assessment of importance and reliability of clinical trials goals;
p.000171: 4) ensuring the ethical, moral and legislative assessment of materials of clinical trials.
p.000171: The main principles of commission activity include independence, competence, pluralism, openness, high
p.000171: professional standards, internal believes “for good only and never to harm people”, interests of participant prevails
p.000171: over interests of any scientific research, positive effects are much greater in comparison with potential risks.
p.000171: It is anticipated that commissions to be organized under the responsible institution will have responsibility of the
...
p.000283: Middle Ages particularly close relations were between East-Iranian (ancestors of the Tajiks) and West-Iranian
p.000283: (ancestors of the Persians) people. The Tajik- Persian philosophical thought had also a connection with Indian and
p.000283: Greek philosophy. However the closest links connected the Tajik culture and spiritual and philosophic outlook
p.000283: with cultures of Turkic peoples of Central Asia and Azerbaijan. There was a mutual enrichment of cultures, spiritual
p.000283: values and scientific achievements.
p.000283: Religious and philosophical ideas of Tajik ancestors roots back to an ancient monument of spiritual
p.000283: culture “Avesta” the holy canon of Zoroastrism (Mazdeism) containing not only religious dogmas but also
p.000283: ideas on cosmogony, philosophy, morals and law. The characteristic feature of Zoroastrianism is dualism, i.e. the view
p.000283: that two fundamental concepts exist, such as good and evil, and the struggle between these is the pivot and content of
p.000283: the universe. Zoroastrianism formulated a ternary ideal of the righteous man (“good thoughts”, “good words” and
p.000283: “good deeds”) opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked words” and “wicked deeds”). The
p.000283: Zoroastrian idea about infinite time as an initial substance gave rise to zervanism – a teaching in the framework of
p.000283: which a materialistic trend developed that denied the creation, and god as the creator of the universe, and
p.000283: affirmed the belief in the eternity of the world. In the end of the slave-owning system and in the beginning of
p.000283: feudalism, Manichaeism (Mani, 215-276) and Mazdakism (Mazdak, the end of the V - the beginning of the VI century)
p.000283: became very influential. Those philosophical trends assimilated the Zoroastrian ideal about the struggle
p.000283: between the good and the evil. The social doctrine of Mazdakism proclaimed ideas of justice and equality.
p.000283: The earliest written evidence that peoples of Central Asia had a good knowledge of mathematics and astronomy is
p.000283: “Avesta” containing data on the movement of celestial bodies, the system of time count and some mathematical rules.
p.000283: In that period, early states in Central Asia achieved a high
p.000283: level of material production and culture: crafts, agriculture, architecture and art. That was the time when many
p.000283: written monuments of religious, political and scientific thought were created, many of which were destroyed during the
p.000283: invasion of the army of the Arab Caliphate (VII-VIII centuries).
p.000283: During the VIII-XV centuries philosophical, social and political ideas were developing in the atmosphere of
...
p.000285: five centuries. He was the author of works on philosophy (e.g. commentaries on Aristotle’s “Poetics”), wrote lyrical
p.000285: poetry, and some poems have survived to out time. Ibn Sina’s “Book of Healing” was the highest achievement of the
p.000285: medieval philosophy, particularly, as it tried to reconcile rationalistic thinking and religion. A great
p.000285: number of his works were translated into Latin in the second half of the XII century.
p.000285: “Book of Healing” in 18 volumes included “Logic”, “Poetics”, “Rhetoric”, “Physics” (in eight
p.000285: chapters; the sixth chapter was entitled “On the Soul”) and “Metaphysics”. Dominique Gundisalvi from
p.000285: Toledo completed the latter in 1180.
p.000285: Following Aristotle, Abu Ali Ibn Sina classified knowledge into theoretical and practical trends, and
p.000285: attributed ethics, economics and politics to the practical area. He considered problems of essence and existence in the
p.000285: light of Neoplatonism.
p.000285: The starting point of Aristotle’s ethical teaching was the theory that social life of human beings is realized
p.000285: in actions and in their interaction. Already in the first paragraph of “Great Ethics” Aristotle wrote that to act in
p.000285: social life, one should have certain ethical qualities and be a worthy man. To be a worthy man means to have virtues.
p.000285: Therefore, the one who intends to act in social and political life should be a virtuous man. Substance and form cannot
p.000285: exist independently, they are interconnected. In the so called “dispute of universalia”– one of the fundamental
p.000285: problems in medieval scholasticism – Abu Ali Ibn Sina followed Aristotle’s theory of interrelation of substance and
p.000285: form and believed that universalia exist both in things and in human mind. The latter elicits universalia from
p.000285: things, and even ante things (ante res) and after things (post res). Ibn Sina did not doubt that the world is
p.000285: intelligible and stressed the importance of logic considering it as an introduction to every science. With regard to
p.000285: psychology, Ibn Sina also
p.000285: followed Aristotle and distinguished the vegetable, animal and rational soul. He gave a special attention to
p.000285: the human soul and did not deny its immortality, not in the direct, but in the philosophical sense, i.e. he
p.000285: did not believe in metempsychosis. Neoplatonic ideas of Aristotle are present also in those philosophical views of Abu
p.000285: Ali Ibn Sina that contain elements of Sufism. Aristotle’s philosophy developed by Abu Ali Ibn Sina and his followers
p.000285: (including Omar Khayyam) was very popular in the orient. The teaching of Ibn Sina contained some materialistic elements
p.000285: (the idea of the eternal material world, sensualist elements in the theory of cognition, etc.). Ibn Sina’s talent shows
p.000285: itself most fully in the analysis of Neoplatonism philosophy. His works “Book of Healing” and “Book of Salvation” are
p.000285: still considered encyclopaedias of Muslim Neoplatonism. Another work by Ibn Sina “The Justice” that has not survived to
p.000285: our days presented an analysis and comparison of views of Alexandria and Baghdad schools of Neoplatonism. In “The
p.000285: Justice” Abu Ali Ibn Sina is an arbitrator between the two quite famous medieval philosophical schools. His book
...
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p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
p.000167: developed. In 2002 the Second Congress of Physicians and Pharmacists approved the text of “The Oath of Physician of the
p.000167: Republic of Kazakhstan” that was reflected in special Decree of the Government of the Republic of Kazakhstan No/ 1189
p.000167: published on 27th of November 2003 and in the article 50 of the Law of the Republic of Kazakhstan “On the
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan”.
p.000167: In 2006 according the law “On changes and additions to some legislative documents on public health of the Republic of
p.000167: Kazakhstan” the article 20 was supplemented with the following paragraphs:
p.000167: «it is prohibited to perform clinical trials and(or) testing of pharmaceutical substances or medical drugs with
p.000167: participation of:
p.000167:
p.000167:
p.000168: 168
p.000168:
p.000169: 169
p.000169:
p.000169: - persons before coming to age with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treatment of children diseases or when the goal of clinical trial is to collect data on the optimal dosage of this
p.000169: medical drug supposed for usage in children and adolescents. In the last case clinical studies of any medical drug in
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
...
p.000223: breeding and workmanship, and of community social order, which had been lasting longer then at other peoples. Among
p.000223: values of community it should be mentioned justice, power of “world”, thrifty housekeeping, knowing of folk wisdom,
p.000223: bogatyr (a Russian hero) strength, etc. Having given voluntary his destiny over to the community, man condemned himself
p.000223: to be tolerant and obedient. The community, by means of which the Russian people were able to keep their ethnos
p.000223: independent in spite of numerous invasions, had also the high value. For the sake of the community a Russian was ready
p.000223: to suffer, tolerate and sacrifice almost everything. Nevertheless, historical facts demonstrated examples of “Slavic
p.000223: freedom” from Cossacks, drinking- bouts, revelries, disorder, “fantastically fast life” to rebel and revolutions.
p.000223: The Russian culture is well known to exist inasmuch as Russian (and Old Russian) words meaning cultural
p.000223: contents exist. Contemporary analysis of the word “personality” (autonomy of “personality” is one of the
p.000223: principles of bioethics) in Russian and European languages showed that word “personality” is rather young
p.000223: for the Russian language, it was absent in the Old Russian language and in the modern Russian it handed its
p.000223: meaning to word “person” (15). As regards the notion “individuality” it has been adopted slowly and hardly in modern
p.000223: word usage. This fact differs Russia from Western Europe where individuality became the main value of the Modern time.
p.000223: The idea of person, personality itself began to form here in XIII century. And today in Western Europe the notion of
p.000223: personality is central, important as daily bread, and it is not high but everyday, though in Russia the word
p.000223: “personality” is in one row with the high notions and its meanings are not everyday.
p.000223: Speaking about language as means of communication one should note one more feature which is important for
p.000223: doctor-patient relations. The Russian language in contrast with the Romance and German languages is synthetic, not
p.000223: analytical, i.e. it may be axiomatizated hardly but is able to express emotions and feelings (22,27).
p.000223: Folk proverbs are very important feature of ethnos awareness and national mentality. They accumulate important
p.000223: conclusions and observations about nature and society laws. Many of them assert group priority over
p.000223: personality, collective things priority over individual, necessity to obey any group law. Man strength is in his group
p.000223: membership, whilst his personnel responsibility is vogue (25).
p.000223: Russians were characterized to have many interethnic contacts with people of different origin, cultural
p.000223: traditions and language that influenced undoubtedly the general Slavic culture foundation. Connections with
p.000223: Byzantine, a godmother and keeper of ancient civilization where Orthodoxy became a state religion, were the most
...
p.000229: efforts of progressive society resulted in foundation of the first Russian Women Medical Institute, which was opened in
p.000229: Saint- Petersburg (now the Saint-Petersburg Medical University named after I.P. Pavlov).
p.000229: Events in medicine and health protection happened in period from 2nd half of the XIX — beginning of the XX century
p.000229: stimulated development of medical ethical ideas. Many old problems became more acute and new ones appeared, relations
p.000229: of doctor and society, doctor and patient, intercolleagueal relations in medicine were changed. Russian physicians were
p.000229: characteristic of not only speeches and declarations, talks about duty and morality but of deeds, behavior, example,
p.000229: and demonstration – quite often during dozens of years or even during their whole life - of what a doctor should be.
p.000229: Open discussion of “complicated” medical issues not only inside of medical society can be considered as
p.000229: a root of such bioethics feature as openness, transparency, necessity in public monitoring of biological
p.000229: researches.
p.000229: Development of a method of chronic experiment in animals is linked to the name of I.P.Pavlov (1849-1936). In 1876 at
p.000229: the Botkin’s clinic of the Medical Military Academy in Saint-Petersburg an experimental laboratory was founded. In
p.000229: 1878-1889 I.P.Pavlov made his researches here. Approval of experiments with animals as a basis of medicine
p.000229: resulted in usage of many animals and their death. It caused reproaches to experimentalists in cruelty, their
p.000229: accusation in misuse of vivisection. In reply to the letter of the Russian association of animal patronage “On
p.000229: vivisection as shocking and useless misused in the sake of science” of January 17, 1904, the commission
p.000229: consisting of professors P.M. Albitskiy, I.P. Pavlov and N.P. Kravkov was founded in the Medical Military
p.000229: Academy. This commission
p.000229: presented its conclusions on this letter. Conclusions showed disagreements with accusations, the statements of the
p.000229: letter were named anti-scientific and sanctimonious. Nevertheless this case forced to think about humanity of
p.000229: experiments in animals and improvements of conditions of their keeping.
p.000229: At the same time legitimacy of trials with human subjects is under discussion in the society. In connection
p.000229: with achievements in microbiology doctors by way of self-experimenting researched contagiousness of infectious diseases
p.000229: even the highly harmful ones. Self-experimentations carried out by physicians have never been disapproved of; they were
p.000229: rather perceived as acts of heroism and admired. There were a great number of such examples. In 70-s of the XIX century
p.000229: O.O. Motchutkovskiy, a physician from Odessa, several times made self injections with blood samples from patients
p.000229: infected with epidemic typhus and got severely diseased. After injecting themselves with blood samples from patients
p.000229: infected with relapsing fever, G. N. Mikh and N.I. Mechnikov also suffered through severe illnesses. N.F. Gamaleja,
p.000229: N.I. Metchnikov, D.K. Zabolotnyi, M. Pettnkofer took pure culture of cholera vibrio. Such examples can be
p.000229: continued.
...
Health / HIV/AIDS
Searching for indicator HIV:
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p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
p.000023: addicts. Every five years the amount of drug addicts in the “youngest” group is increasing by 100%. The children
p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
p.000023: population, and where in the case of an essential improvement of the economic situation the extended reproduction may
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
...
p.000033: 11 Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of Moldova,
p.000033: respectively.
p.000033:
p.000034: 34
p.000034:
p.000035: 35
p.000035:
p.000035: the Law of the Republic of Belarus On Health Care (1999), the Law of Georgia On Health Care (1997), the
p.000035: Law of the Republic of Kazakhstan On Protection of Population Health of the Republic of Kazakhstan (1991), the Law of
p.000035: the Kyrgyz Republic On Protection of Population Health of the Kyrgyz Republic (09.01.2005), the Law of the
p.000035: Republic of Moldova On Rights and Responsibility of Patient (27.10.2005), Basics of the Law of the Russian Federation
p.000035: On Protection of Citizen Health (22.07.1993), the Law of the Republic of Tajikistan On Protection of Population Health
p.000035: (15.05.1997), Basics of the Law of the Ukraine On Health Care (1992), the Law of the Republic of Uzbekistan On
p.000035: Protection of Citizen Health (29.08.1996). Legislation specifically related to protection of especially vulnerable
p.000035: groups of patients and subjects is of particular importance for regulation of biomedical activities including valuation
p.000035: of biomedical research. Virtually all countries adopted separate laws on psychiatric assistance to population,
p.000035: counteraction to HIV infection, donorship, transplantation, protection of children rights. These enactments reflect
p.000035: specificity of institutions of informed consent and patient confidentiality in some situations of biomedical int
p.000035: rventions as well as stipulate additional guarantees of rights of dependent groups of patients/ subjects. In many CIS
p.000035: countries laws and by-laws regulate various issues in the area of auxiliary methods of reproduction and genetic
p.000035: assistance to the population12. Two countries (the Russian Federation and the Ukraine)
p.000035: 12 For instance, in the Republic of Armenia – the Law of the Republic of Armenia On Reproductive Health
p.000035: and Reproductive Rights of Person, 12 of September 2002, in the Republic of Belarus – the Law of the
p.000035: Republic of Belarus On Safety of Gene Engineering Activities, 9 of January 2006, in the Republic of Kazakhstan – the
p.000035: Law of the Republic of Kazakhstan, 16 of July , 2004, N 565-2 On Reproductive Rights of Citizens and Guarantees of
p.000035: Implementation Thereof, in the Kyrgyz Republic – the Law of the Kyrgyz Republic, 20 of December 1999, On Reproductive
p.000035: Rights of Citizens, in the Russian Federation – the Order of the Ministry of Health of the Russian Federation. 26 of
p.000035: February 2003, N 67 On Utilization of Assisting Reproductive Technologies (ART) for Treatment of Female and Male
p.000035: Infertility, the Federal Law, 5 of July 1996, N 86-FZ On State Regulation in the Field of Gene-Engineering Activities,
p.000035: the Order of the Ministry of Health of the Russian Federation, 30 of December 1993, N 316 On Further Development of the
...
p.000039: In accordance with basic statements on protection of human rights and freedoms there are being prepared model
p.000039: laws related to both forming of domestic policy in the Commonwealth countries in the field of health care and
p.000039: developing of common approaches to international cooperation of the states in this field. An important role for
p.000039: legislative regulation of special situations in the area of medical practice and their potential application
p.000039: to cases of
p.000039: biomedical studies and ethical review is assigned to the following model laws: On Sanitary and Epidemic
p.000039: Well-being of the Population, On Prevention of Spread of Diseases with Social Significance, the Concept on Formation of
p.000039: Legal Basics and Mechanisms for Implementation of Social State in the CIS Countries, the Charter of Social Rights and
p.000039: Guarantees for Citizens of Independent States (adopted by IPA CIS, 29.10.1994). Also many projects of model acts
p.000039: included into perspective plan of model law development are also important for formation of state policies of the CIS
p.000039: countries in the field of health care and biomedicine such as the following: On Social Protection of Handicapped, On
p.000039: Folk Medicine, Recommendations on National Legislations Adjustment of the CIS Member States in the Sphere of Social
p.000039: Protection and Medical Service for Liquidation Participants of the Disaster Consequences at the Chernobyl NPS, On
p.000039: Counteracting HIV/AIDS in the CIS Member States, Medical Code of the CIS Member States, On Preventing
p.000039: Distribution of Forged and Low-quality Drugs, On Natural Medical Resources, Medicinal- sanitary Areas and Resorts, and
p.000039: many others.
p.000039: Activity of IPA CIS also facilitates development of regional legal cooperation in the field of health care and
p.000039: social protection of the population at the level of heads of states and governments. As per initiatives of this
p.000039: authority the member states executed the following basic agreements:
p.000039: - Agreement on Cooperation in the Field of Protection of Population Health (Minsk, 26 of June 1992),
p.000039: - Agreement on Medical Services for Military Personnel and Their Family Members, Workers and Servants of
p.000039: Frontier Troops (Minsk, 26 of June, 1992),
p.000039: - Agreement on Provision for Population of Medicinal Drugs, Vaccines and Other Immunobiological Agents, Goods for
p.000039: Medicinal Use and Medical Equipment Manufactured at the Territory of the CIS Member States (Ashkhabat, 24 of
p.000039: December 1993),
p.000039: - Agreement on Social Security and Health Protection of Citizens Exposed to Ionizing Radiation as a Result of
p.000039: Chernobyl and Other Radiation Catastrophes and Accidents as well as Nuclear Testing (Moscow, 9 of September
p.000039: 1994),
p.000039: - Agreement on Cooperation for Resolution of Issues of Disability and Disabled (Moscow, 12 of April 1996),
p.000039:
p.000040: 40
p.000040:
p.000041: 41
p.000041:
p.000041: - Agreement on Provision of Medical Care to Citizens of the CIS Member States (Moscow, 27 of March 1997),
p.000041: - Convention on Transfer of Persons with Mental Disorders for Compulsory Treatment (Moscow, 28 of March 1997),
p.000041: - Agreement on Cooperation for Resolution of Issues of HIV Infection (Moscow, 25 of November 1998),
p.000041: - Agreement on Prevention of Iodine-deficient Disorders among Citizens of the CIS Member States (Minsk, 31
p.000041: of May, 2001),
p.000041: - Agreement on Cooperation of the CIS Member States in the Field of Protection of Population Health (Yalta, 18 of
p.000041: September 2003),
p.000041: - Decision on the Order of Medical Examination of a Donor of Blood and Components Thereof (Cholpon-Ata, 2 of April
p.000041: 2004),
p.000041: - Agreement on Order of Interaction for Hygienic Assessment of Potentially Hazardous Products Imported to the
p.000041: CIS Countries (Cholpon- Ata, 16 of April, 2004),
p.000041: - Agreement on Cooperation of the CIS Member States against Trafficking of human beings, Human Organs and
p.000041: Tissues (Moscow, 25 of November 2005)
p.000041: - Concept for Development of Social and Medical Basics for Improvement of Quality of Life and Prevention of Disability
p.000041: of War Veterans, Participants of Local Conflicts, Peace-making Operations and Terrorism Victims in the VIS Member
p.000041: States for 2006-2010 (Dushanbe, 25 of May 2006), etc.
p.000041: From the point of view of international legislative practice adoption of the Model Law on Protection of Human Rights
p.000041: and Dignity in Biomedical Researches in the CIS by the General Assembly of IPA CIS at 18 November 2005, is fairly
p.000041: unique. Development of this document illustrates fruitful cooperation of the CIS Forum for Ethics Committees in
p.000041: the CIS and the Permanent Commission on social policy and human rights of IPA CIS. Adoption of the given
...
p.000043: countries and international community for the fastest inclusion of the model law statements into professional,
p.000043: regulatory and general humanitarian spheres of life in the region countries. Certainly, this process, beside
p.000043: knowledge and confidence, will require signs of respect, acknowledgement, tolerance and mutual understanding in order
p.000043: to bring forth comprehensive dialogue with various social layers having final goal of reaching social and individual
p.000043: ethical legal sense in the space of the CIS member states and their full-grown inclusion in the global
p.000043: international regulatory framework on adherence and preservation of human rights and freedoms. It is gratifying to
p.000043: claim that value of the given model law for the international community was time and again demonstrated at its
p.000043: development by representatives of such international organizations as WHO, the Council of Europe, the European
p.000043: Commission, the European Forum for Good Clinical Practice, UNESCO, the World Medical Association, etc. Need for the
p.000043: model law implementation into national legislation of the CIS countries and readiness of corresponding structures for
p.000043: provision of enforcement of these statements was exhibited with universal response of leading specialists in the field
p.000043: of medicine, biology, ethics, legislation and sociology desiring to participate in promotion of the given regulatory
p.000043: document in their countries and to facilitate to parliaments and governments of their countries in reaching the said
p.000043: goal.
p.000043: In regard to continuation of regulatory initiatives of the FECCIS with IPA CIS there is work on-going on forming
p.000043: regulatory and ethical standards for counteraction against HIV/AIDS at the CIS space as well as development of the
p.000043: model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS within the
p.000043: framework of cooperation with the Permanent Commission of IPA CIS on Science and Education.
p.000043: Summarizing statements in common trends in ethical and legal regulation of public relationships on the
p.000043: field of medicine and biology in the CIS countries one should note that the policy of the Commonwealth countries
p.000043: including rational features of previous rich and versatile historical and cultural experience is open to
p.000043: interaction with world bioethical community and ready for rational collaboration in the region directed to development
p.000043: of optimal conditions for reaching ethical comfort in medicine and in research
p.000043: via building up of the society’s ethical self-consciousness, legal sense and attaining of a new type of relationships
p.000043: among individuals, social groups and states based on social partnership and dialogue in regard to the most crucial
p.000043: issues of ethical content.
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: References to international documents mentioned in the text are provided in the chapter for the member states.
p.000043: Texts of the model laws of IPA CIS are available at the web site: www.iacis.ru/html, the text of the model
p.000043: law of IPA CIS On Protection of Human Rights and Dignity in Biomedical Researches in the CIS and the text of
...
p.000093: evaluation of risks for patients and protection of their rights.
p.000093: As we know from the history of clinical trials, initially the organization and performance of those was lacking
p.000093: for an ordered and systematic approach, and there were problems regarding implementation of GCP guidelines
p.000093: in different countries. At the same time, it is clear that safe and reliable research outcomes may be obtained only if
p.000093: the rules are observed.
p.000093: To protect rights and health of human subjects involved into clinical trials of new drugs, treatment methods
p.000093: and medical technologies,
p.000093: Ethics Committee at the Ministry of Health of Republic of Armenia was established in 1996 on the initiative of the
p.000093: Agency for Drugs and Medical Technologies.
p.000093: With regard to legal regulation in the sphere of human rights protection, members of Ethics Committee are guided in
p.000093: their ethical review practice by the following documents:
p.000093: • Constitution of Republic of Armenia (Article 34)
p.000093: • Law on Healthcare in Armenia
p.000093: • Law on Drugs
p.000093: • Law on Social Protection of the Disabled
p.000093: • Law on the Rights of the Child
p.000093: • Law on the Prevention of HIV Infection
p.000093: • Law on Transplantation of Human Organs and/or Tissues
p.000093: • Law on Reproductive Health
p.000093: • Law on Providing Psychiatric Care
p.000093:
p.000093: As to international legal documents, Republic of Armenia ratified Convention on the Rights of the Child.
p.000093: The practice of ethical review is regulated by principles set in the relevant WHO and WMA documents as well as in
p.000093: other international legal and ethical documents.
p.000093:
p.000093: 3.1.3. Education in Bioethics
p.000093:
p.000093: At Yerevan State University named after M.Heratsi ethics and aesthetics have been traditionally taught over many
p.000093: decades. In 2000 bioethics was introduced into the programme of the Department of Social Sciences as a compulsory
p.000093: discipline.
p.000093: In the post-Soviet space, including Armenia, a different – “home” – model of bioethics has been developed, in which
p.000093: bioethics is an interdisciplinary, orientated on biology, modern field of knowledge analyzing moral problems of human
p.000093: existence and human attitude to life and to individual living organisms. This model covers the range from the
p.000093: development of ethical norms and principles regulating human practical activity in the process of studying nature and
p.000093: human beings to the study of the role and place of the human being in the context of biological reality and the
p.000093: estimate of the status of life and death categories.
p.000093:
p.000094: 94
p.000094:
p.000095: 95
p.000095:
p.000095: In the beginning bioethics was taught only to students who were citizens of Armenia, but since 2003
...
p.000105: society) underwent a strong correction. Academicians Z.A.Alieva, A.T.Amiraslanov, A.A.Namazova et al. made a great
p.000105: contribution into the development of bioethics.
p.000105: An important milestone in the history of Azerbaijan was the year of 1999, when, on the initiative of UNESCO, the
p.000105: Presidium of National Academy of Sciences established the Committee on Bioethics and Technology Ethics (Decree
p.000105: 9/1).
p.000105: 3.2.2. Legal Regulations
p.000105:
p.000105: Health is one of a few subjective human values without which many other comforts and values lose their significance.
p.000105: Today every democratic country acknowledges the importance of human rights protection in all spheres of social
p.000105: life. Within last years, the National Assembly of Azerbaijan adopted legislative acts setting forth political,
p.000105: economic, social, cultural, scientific and medical measures for maintaining and strengthening physical and mental
p.000105: health of every person and providing medical care in case of loss of health. When drawing up the documents the
p.000105: experience of other countries was used, and the following legal norms based on international legal norms were adopted:
p.000105: - UN Convention on Children’s Rights (Decree of the National Assembly of Azerbaijan Republic. No 236; 21 of July 1992)
p.000105: - Law on Sanitary-and-epidemiologic Well-being of Population (10.11.1992)
p.000105: - Law on Preventing the Spread of the Disease Caused by HIV in Azerbaijan (16.04.1996)
p.000105: - Law on Pharmaceutical Activity (05.11.1996)
p.000105: - Law on Health Protection (26.07.1997)
p.000105: - Law on Medical Insurance (1997)
p.000105: - Law on Radiation Safety (30.12.1997)
p.000105: - Law on Children’s Rights (19.05.1998)
p.000105: - Law on Transplantation of Human Organs and Tissues (28.10.1999)
p.000105: - Law on Immunoprophylaxis of Infectious Diseases (14.04.2000)
p.000105: - Law on Tuberculosis Control in Azerbaijan (05.02.2000)
p.000105: - Law on Psychiatric Care (12.06.2001)
p.000105: - Law on Narcological Service and Control (29.06.2001)
p.000105: - Law on Nutrition of Newborns and Infants (17.06.2003)
p.000105: - Law on the State Care for Patients with Diabetes (23.12.2003)
p.000105: - Law on Iodination of Sodium Chloride for the Mass Prevention of Iodine Deficiency.
p.000105: - Law on Donorship of Blood, Blood Components and Blood Donor Service (03.05.2005)
p.000105: - Law on State Care for Patients with Hereditary Diseases Such as Hemophilia and Thalassemia (03.05.2005).
p.000105:
p.000106: 106
p.000106:
p.000107: 107
p.000107:
p.000107: 3.2.3. Education in Bioethics
p.000107:
p.000107: When considering problems of education we precede from the fact that bioethics, in relation to medicine, is
p.000107: nowadays a developing academic discipline with its inherent strict standards. We should start teaching
p.000107: bioethics in the period when students pass on from theoretical subjects to practical activity.
...
p.000149: its own legislation independently.
p.000149: During aforementioned 70 years legislative activity in Georgia was restricted to the slight alteration or, at
p.000149: best, adaptation of the frame laws, provided by the central authorities (Moscow). As well as in other republics of the
p.000149: Soviet Union there was no tradition of training the legal professionals for the health care system in Georgia. Before
p.000149: re-establishment of Georgia’s sovereignty, the Law on Health Care, adopted in 1972 by Soviet Government, was in force.
p.000149: This document showed significant negligence of individual rights of patients. Almost none of the basic principles of
p.000149: ensuring patients’
p.000149: autonomy and self-determination (except the right to keep personal data confidentially) were even declared.
p.000149: The creation of national legislation is an essential condition for building the national and democratic state and a
p.000149: civil society. Adoption of Georgian Constitution (24 of August 1995) and Georgian Civil Code (26 of June 1997) is
p.000149: definitely significant step toward establishment of national state.
p.000149:
p.000149: 3.4.2 Legal Regulations
p.000149:
p.000149: Legislation of Georgia related to health, biomedicine and human rights comprise laws which regulate
p.000149: various aspects of medicine/health care: rights of patients and research subjects (including vulnerable groups; such
p.000149: as minors, persons with mental disorders, patients with HIV/AIDS etc.), duties and responsibilities of health
p.000149: care professionals, human organ transplantation, assisted reproductive technologies etc.
p.000149: From the above-mentioned laws the Law of Georgia on Health Care (adopted by the Parliament of Georgia in 1997)
p.000149: is considered to be the framework law, which determines the priorities and sets out fundamental principles of the
p.000149: health care legislation of Georgia. It covers full range of problems related to health, including issues related to
p.000149: protection of research subjects.
p.000149: In general, there are three major documents serving the legal basis for biomedical research involving human subjects.
p.000149: These legal texts are:
p.000149: • Convention on Human Rights and Biomedicine (Signed by Georgia in May 2000; Ratified by the Parliament in September
p.000149: 2002; Entered into force on 1 of March 2001);
p.000149: • Law of Georgia on Health Care (Adopted by the Parliament of Georgia in December, 1997);
p.000149: • Law of Georgia on Drug and Pharmaceutical Activity (Adopted by the Parliament of Georgia in 1995; Updated in
p.000149: 2001).
p.000149: The draft of specific law on biomedical research –“Law on Biomedical Research Involving Human Subjects” will be
p.000149: the fourth and the most comprehensive document regulating research on human subject. Draft “Law on
p.000149: Biomedical Research Involving Human Subjects” (originally drafted in 1999) has been reviewed by the expert
p.000149: appointed by the Council of Europe in 2000 and updated according to the comments provided.
p.000149:
p.000150: 150
p.000150:
p.000151: 151
p.000151:
...
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
p.000191: trials of pharmaceutical products involving subjects with mental disorders may only be carried out after
p.000191: obtaining a written informed consent from a legally authorized representative in accordance with applicable law.
p.000191: Protection of patients’ rights in biomedical research and other interventions in Kyrgyz Republic are
p.000191: also regulated by the following laws:
p.000191: - “On Narcotic and Psychoactive Drugs and Precursors” (No 66, 22 May 1998);
p.000191: - “On Donorship of Blood and Blood Components in Kyrgyz Republic” (No 951-XII, 3 July 1992);
p.000191: - “On Tuberculosis Prevention in Kyrgyz Republic” (No 56, 18 May 1998);
p.000191: - “On Prevention of Diseases Caused by Iodine Deficit” (No 40, 8 February 2000);
p.000191: - “On Citizens’ Medical Insurance in Kyrgyz Republic” (No 208, 28 December 2006);
p.000191: - “On HIV/AIDS Prevention in Kyrgyz Republic” (No 149, 13 August 2005);
p.000191: - “On Citizens’ Reproductive Rights” (No 5, 13 January 2000).
p.000191: Statements of civil, administrative and criminal codes set the responsibility in case of violating
p.000191: patients’ rights in medical interventions and in case of violating the legally established order of practice in
p.000191: healthcare and biomedicine.
p.000191: 3.6.3. Education in Bioethics
p.000191:
p.000191: Today Kyrgyz Republic has several institutions for a higher medical education: the Kyrgyz State Medical Academy,
p.000191: Medical Faculty of the Kyrgyz-Russian (Slavic) University, Medical Faculty at the International University of
p.000191: Kyrgyzstan and Medical Faculty at the Osh State University.
p.000191: The State Standard of Education in Kyrgyz Republic does not include bioethics as a separate subject. Nevertheless,
p.000191: bioethics has been introduced into the syllabus of the Kyrgyz State Medical Academy and is taught to
p.000191: undergraduate students. The course in bioethics consists of lectures (36
p.000191: h) and practical seminars (18 h). One of the course topics is “Ethical and Legal Control of Biomedical Research”.
p.000191: Bioethics is also taught at Chairs of Clinical Medicine and Pediatrics of the Medical Faculty at the Kyrgyz- Russian
p.000191: (Slavic) University (lectures – 19 h and seminars – 19 h). Bioethics is not taught at the postgraduate level.
p.000191: Presently, there is no state system of teaching GCP to members of ethics committees. However courses on basic and
...
p.000249: account the general norms guarantying the protection of personal data which are fixed by the Federal Law
p.000249: of the Russian Federation “On information, information technologies and protection of information” of 27 July
p.000249: 2006 and by the Federal Law of the Russian Federation “On personal data” of 27 July 200633.
p.000249: 32 Federal Law of Russian Federation “On psychiatric assistance and related guarantees of citizens” N 3185-1 of July
p.000249: 2, 1992 // Vedomosty of CND and VS RF, 20 of August 1992.
p.000249: № 33, article 1913.
p.000249: 33 Federal Law of Russian Federation “On information, information technologies and protection of
p.000249: information” of July, 27 2006, Federal Law of Russian Federation “On personal data” on 27 of July 2006// Rossiyskaya
p.000249: Gaseta, N 165, 29.07.2006
p.000249:
p.000250: 250
p.000250:
p.000251: 251
p.000251:
p.000251: The legal rules on specifics of the institutes of informed consent and medical secrecy in some particular situations as
p.000251: well as norms concerning guaranties of the other rights of patients/subjects were also reflected in the following acts:
p.000251: the Federal Law of the Russian Federation “On transplantation of human organ and tissues” on 22 of December 1992, N
p.000251: 4180-1, the Federal Law of the Russian Federation “On blood donation” on 9 of June 1993, N 5142-1, the
p.000251: Federal Law of the Russian Federation “On prevention of dissemination of the disease caused by HIV” on 30 of March
p.000251: 1995, N 38- FZ, the Federal Law of the Russian Federation “On immune prophylactics of infection diseases” on 17 of
p.000251: September 1998, N 157- FZ34.
p.000251: The norms related to some organizational, administrative and financial aspects of biomedical research have also
p.000251: the crucial importance for the effectiveness of ethical evaluation.
p.000251: In particular, the issues of planning and conducting studies involving human, standards of the recording and presenting
p.000251: of findings, are ruled by the mentioned Federal law of the Russian Federation “ On Pharmaceutical Products”, as well
p.000251: as by-laws: The Rules of Clinical Practice in the Russian Federation”, adopted by the order of Ministry of
p.000251: Public Health of the Russian Federation on 19 of June 2003, N 266, the national standard “Good Clinical Practice.
p.000251: GOST- R 52379-2005 “ on 27 of September 2005, N 232- st., adopted by the order of the Federal agency for
p.000251: technical regulation and metrology, The Instruction “On the Organization and Conducting of Expertise,
p.000251: Clinical Trials and Registering of Foreign Medicines and Substances” on 15 of May 1996, adopted by the
p.000251: order of the Ministry of Public Health and medical industries of the Russian Federation, the Operating
p.000251: Instruction “Conducting qualitative studies of bioequivalence “ on 10 August 2004, adopted by Ministry of
p.000251: Public Health of the Russian Federation, the Instruction “On Expertise and Trials of Medical Immunobiological Products
p.000251: with the Purpose of Registration “
p.000251:
p.000251: 34 Federal Law of Russian Federation “On transplantation of human organ and tissues” on 22 of December
p.000251: 1992, N 4180-1// Vedomosty of CND and VS RF, 1993. № 2, article 62, Federal Law of Russian Federation “On blood
p.000251: donation”, 9 of June 1993, N 5142-1// Vedomosty of CND and VS RF, 1993. № 28, article 1064, Federal Law of Russian
p.000251: Federation “On prevention of dissemination of the disease caused by HIV” on 30 of March 1995, N 38-FZ//Sobranie
p.000251: zakonodatelstva, 03/04/1995, N 14, article 1212, Federal Law of Russian Federation “On immune prophylactics of
p.000251: infection diseases” on 17 of September 1998, N 157- FZ// Sobranie zakonodatelstva, 21.09.1998, N 38, article 4736.
p.000251: on 15 April 1999, N 129, adopted by the order of Ministry of Public Health of the Russian Federation, the Branch
p.000251: Standard “ Clinical and economic research. General provisions” (OST 91500.14.0001-2002) on 27 of May 2002, N 163,
p.000251: adopted by the order of Ministry of Public Health of the Russian Federation and other documents35.
p.000251: The provisions of these legal acts set out requirements to the scientific validity of biomedical research, the
p.000251: risk and benefit ratio, safety of the investigational products or medical methods, the follow-up procedure to
p.000251: monitor the reliability of the research findings, and a number of other requirements that should be met when
p.000251: conducting biomedical research in Russia.
p.000251: With regard to regulation of ethical review of biomedical research it should be marked the importance of the positions
p.000251: of chapter IX of the Federal Law of the Russian Federation “On Pharmaceutical Products”, namely item 2 of the article
p.000251: 37 and item 1 of the article 39. These norms mention two forms of ethics committees, which participate in taking the
p.000251: decision on the forthcoming research.
p.000251: First, this is ethics committee at an institution that conducts the clinical trials. In particular, it is stipulated
p.000251: that this committee takes part in working out the program of the clinical research.
p.000251:
p.000251:
...
p.000261: Currently training of medical doctors and pharmacists is conducted in 47 universities and academies subjected to the
p.000261: Federal Agency on health care and social development as well as 25 departments and institutions of the Russian
p.000261: education ministry, 5 military medical educational facilities, 10 private higher educational facilities as well as in
p.000261: the Kyrgyz-Russian Slavic University accredited in Russia.
p.000261: Typical unified program of education in higher medical educational facilities in Russia was developed in 2001 by the
p.000261: group of Moscow scientists, and in 2003 the reference curriculum on bioethics for Pharmacy trade was published (authors
p.000261: – workers of the Moscow Medical Academy named after Sechenov I.M.), which are planned for 36 academic hours of class
p.000261: work (18 hours of lectures and 18 hours of seminars) and 18 hours of independent work in the 2nd semester. The
p.000261: curriculum stipulates learning of history and traditions of Russian ethics, theoretical basics of biomedical ethics,
p.000261: models and rules of relationships between doctor and patient, patient rights, analysis of bioethical issues of
p.000261: experimental medicine, reproductive technologies, euthanasia, transplantology and medical genetics, HIV infection,
p.000261: ethics in psychiatry, moral issues of distribution of health care resources. Working educational programs that the
p.000261: education is based upon are developed by departments implementing them.
p.000261: Currently training in bioethics at the specialized department is conducted only in one higher educational facility, the
p.000261: Russian State Medical University. Three cities (Ivanovo, Kazan, Samara) have departments on bioethics and law
p.000261: associated with other subjects (forensics medicine, history of medicine) or without it. Five educational
p.000261: facilities provide such education at the departments of philosophy, another five changed department titles to
p.000261: mention “philosophy and bioethics”. Three cities delegated this coaching to health care management department. In every
p.000261: third of medical educational facilities
p.000261:
p.000262: 262
p.000262:
p.000263: 263
p.000263:
p.000263: bioethics is learned at departments of humanitarian and social and economic type. Finally, another three higher
p.000263: educational facilities (Astrakhan Medical Academy, St-Petersburg Medical University named after Pavlov I.P. and
p.000263: Stavropol Medical Academy) formed interdepartmental teams for teaching the subject involving clinicians (clinical
p.000263: pharmacologists, psychiatrists).
...
p.000293: - Constitution of Republic of Tajikistan (RT) (1994)
p.000293: - RT law “On AIDS Prevention” (No 904; 23 of December 1993)
p.000293: - RT law “On Donorship of Blood and its Components” (No 901; 23 December 1993)
p.000293: - RT law “On the State Sanitary Inspection” (No 987; 20 of July 1994)
p.000293: - RT law “On the Protection of Population Health” (No 419; 15 of May 1997)
p.000293: - RT Labour Code (1997).
p.000293: - Family Code (1997).
p.000293: - RT law “On Narcotic Drugs, Psychotropic and Precursors” (No 874, 10 of December 1999)
p.000293: - RT law “On Pharmaceutical Products and Pharmaceutical Activity” (No 39; 6 of August 2001)
p.000293: - RT law “On Psychiatric Care” (No 90, 2 of December 2000)
p.000293: - RT law “On Reproductive Health and Reproductive Rights” (No 72; 2 of December 2002)
p.000293: - RT law “On Private Medical Practice” (No 60; 3 of December 2000)
p.000293: - RT law “On Salt Iodination” (No 85; 2 of December 2002)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Tropical
p.000293: Diseases (Malaria) in Republic of Tajikistan in 1997-2005” (No 342, 4 of December 1997)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Viral
p.000293: Hepatitis “B” in Tajikistan in 2000- 2007” (No 100; 11 of March 2000)
p.000293:
p.000294: 294
p.000294:
p.000295: 295
p.000295:
p.000295: - Decree of the RT Government “On the Approval of the Concept of Healthcare Reformation in Republic of Tajikistan”
p.000295: (No 94; 4 of March 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Prevention and Control of
p.000295: HIV/AIDS/STD in Republic of Tajikistan in the Period to 2007” (No 475; 27 of November 2002)
p.000295: - Decree of the RT Government “On the RT Strategy for Preventing the Menace of AIDS Spreading for the Period of
p.000295: 2002-2005” (No 389; 1 of October 2002)
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
p.000295: access to the service of reproductive health, at preventing HIV/ AIDS spreading and at eliminating sex discrimination
p.000295: in the field of primary and secondary education. To ensure the national demographic policy, the Government approved
p.000295: and adopted the programme “The Concept of RT State Demographic Policy for the Period 2003-2015” (2002).
p.000295: The independent Tajikistan with its scientific potential in healthcare has reached a new, international level of
p.000295: science development, and therefore it is necessary to carry out ethical review of biomedical research in compliance
p.000295: with international regulations. The controlling body is the Committee on Medical Ethics (CME) at the RT Health
p.000295: Ministry. In its activity, the CME is guided by the Constitution of Republic Tajikistan. Documents regulating the
p.000295: CME practice comply with international legal standards and RT laws. The CME forms a part of the Forum for Ethics
p.000295: Committees in the Commonwealth of Independent States. The CME is to review and monitor scientific research in medicine
p.000295: and the compliance with ethical regulations to protect right and dignity of a research subject. Presently, the RT
p.000295: Government is considering the law “On the Protection of Human Rights and Dignity in Biomedical Research”
p.000295: based on the IPA CIS model Law “On the Protection of Human Rights and Dignity in Biomedical Research in CIS”.
p.000295:
p.000295: 3.9.3 Education in Bioethics
p.000295:
...
p.000327: the State social policy should be directed at maintaining social health, which is described by three groups of
p.000327: characteristics: 1) population health (physical, mental and social); 2) intellectual potential and the level of
p.000327: professional knowledge; 3) spiritual and moral values.
p.000327: To maintain and improve population health and to raise a healthy generation, the Ministry of Public
p.000327: Health of the Republic of Uzbekistan undertakes a considerable work on reforming healthcare based on a number of
p.000327: principles and with a special attention to:
p.000327: • the observance of constitutional rights to receive a qualified medical care and
p.000327: • the principle of an equitable access to medical service.
p.000327: Issues relating to social relations in medicine are regulated by the Constitution of the Republic of
p.000327: Uzbekistan (Art. 24, 26, 40, 43; 1922) and by laws directed to the protection of citizens’ rights in medicine.
p.000327: 1. “On the State Control” (3 of July 1992; revised editions: 6 of May 1995; 15 of April 1999; 31 of August 2000);
p.000327: 2. “On the Protection of Consumers’ Rights” (26 of April 1996; revised edition: 5 of April 2002);
p.000327: 3. “On the Protection of Citizens’ Health” (29 of August 1997);
p.000327: 4. “On Drugs and Pharmaceutical Activity” (25 of April 1997);
p.000327: 5. “On Narcotic and Psychoactive Drugs (19 of August 1999; revised edition: 15 of December 2000);
p.000327: 6. “On the Prevention of Diseases Caused by HIV” (19 of August 1999);
p.000327: 7. “On Providing Psychiatric Care” (31 of August 2000);
p.000327: 8. “Radiation Safety” (2001);
p.000327: 9. “On the Protection of Population from Tuberculosis” (11 of May 2001);
p.000327: 10. “On Donor Blood and Its Components” (12 of August 2002).
p.000327: Constitution of the Republic of Uzbekistan states that every citizen has the right to a qualified medical care (Art.
p.000327: 40).
p.000327:
p.000328: 328
p.000328:
p.000329: 329
p.000329:
p.000329: The law “On Protection of Citizens’ Health” adopted in 1996 sets out relevant principles of health protection and
p.000329: guarantees medical care for the citizens. In other words, the State safeguards citizens’ rights to the protection of
p.000329: health, stimulates the development of a healthy mode of life and regulates
p.000329:
p.000329: aid;
p.000329: - confidentiality with regard to information about applying for medical
p.000329:
p.000329: - voluntary consent to a medical intervention or refusal of it;
p.000329: - receiving information about his/her rights and responsibilities and his/
p.000329:
p.000329: the activity of state structures, national enterprises, institutions and public unions in the field of healthcare
p.000329: (Kolesnikova L. Some Legal Aspects of Regulating Physician--Patient Relationship. Materials of the First National
p.000329: Congress on Bioethics with International Participation. Tashkent, 2005, pp. 58-59; Kolesnikova L. Relations of Doctor
p.000329: and Patient in the Light of Laws in Force in Uzbekistan: Clinical, Philosophical and Legal Aspects. Tashkent, 2006, pp.
p.000329: 129-135).
...
p.000349: The idea to combine scientific progress and ethics brought together about 200 medical scientists and members
p.000349: of teaching staff, investigators, physicians, biologists, experts in law, philosophers, theologists, journalists,
p.000349: deputies of the Legislative Chamber of Uzbekistan Parliament, representatives of various public organizations,
p.000349: delegates from different Uzbekistan cities, as well as from Kazakhstan, Kyrgyzstan, Tajikistan, Ukraine, Russia,
p.000349: Belgium, South Africa, Philippines, Singapore and other countries.
p.000349: The Congress participants discussed key issues of bioethics relating to the protection of human rights and dignity of
p.000349: biomedical research subjects in connection with the use of achievements in biology and medicine.
p.000349: The Congress participants made many interesting presentations. The Minister of Healthcare of Uzbekistan, prof.
p.000349: F.G.Nazirov spoke about ethical aspects of using new technologies in medicine; Doctor of Philosophy, professor Moshin
p.000349: Ebrahim from the Islamic University of South African Republic shared his opinion on the rights of a fetus; scientists
p.000349: from Philippines, Ukraine and Russia touched upon ethical problems concerning the use of embryonic and stromal human
p.000349: stem cells in treating various diseases. The Chairperson of the FECCIS, prof. O.I.Kubar from St.-Petersburg and Dr.U.
p.000349: Sharapov gave a talk
p.000349: on ethical aspects of clinical trials concerning HIV/AIDS; physicians from the Republican Specialized Surgery Centre at
p.000349: the Ministry of Public Health of Uzbekistan spoke about bioethical aspects of organ and tissue transplantation, and
p.000349: specialists from the Scientific Centre for Emergency Medical Care presented talks on similar problems in
p.000349: emergency medicine.
p.000349: J.N.Franco from Singapore and a group of physicians from Belgium spoke about problems of patient—physician relationship
p.000349: in the conditions of a rapid development of new biotechnologies and about truth-telling with regard to
p.000349: patients with terminal diseases. M.Baimukhamedov gave a talk on ethical aspects of the protection of patients’ rights
p.000349: in TV-medical consultations. The Congress participants discussed problems of ecological ethics and the use of
p.000349: genetically modified products and their effect on integral health (presentations by academician T.I.Iskanderov
p.000349: from Uzbekistan, Z.Nasyrova and Z.Akhrorova - scientists from Kazakhstan and Tajikistan). The Head of the WHO
p.000349: Office in Uzbekistan Dr. Arun Nanda, prof.
p.000349: E.I.Musabaev (Uzbekistan), physicians from Russia, The Tashkent Medical Academy and Samarkand Scientific Center
p.000349: presented talks on legal aspects of bioethics.
p.000349: The Chairperson of the NEC and of the Medical Council of the Ministry of Public Health, academician
p.000349: M.S.Abdullakhodjaeva spoke about ethics in science, and professors from the Tashkent Medical Academy
...
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p.000069: course of science development and in medical practice.
p.000069: Thus, it is obvious that ethics is the measure and criterion of resolving conflicts of interests resulting from the
p.000069: advance of biomedical science, and ethical review, alongside with the scientific consistency, becomes an integral part
p.000069: of the research. In this context, the universal significance of the ethical component of the scientific research and
p.000069: its global effect on the development of ethical ideas and on the ways of their implementation at the
p.000069: general level of civilization in the history of humankind is quite obvious. From the theoretical viewpoint, it is
p.000069: impossible to speak about the history of medical ethics without considering interdependent processes of the
p.000069: development of various ethical concepts and an essential role of main landmarks in the history of world ethical
p.000069: practice that have determined a harmonious and comprehensive understanding of general ethical principles of the
p.000069: research.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000071: 71
p.000071:
p.000071: From the practical point of view, the history of biomedical research ethics is inseparable from
p.000071: understanding the essence and process of the biomedical research as such.
p.000071: According to the main research subject, the biomedical research may be divided into the following categories:
p.000071: • Research that physicians carry out on themselves (autoexperiments);
p.000071: • Research involving healthy people;
p.000071: • Research involving patients.
p.000071: In historical context, the concept of informed and voluntary consent of a research subject requires subdividing
p.000071: into separate groups within these categories
p.000071: Besides, both in healthy (e.g. prisoners and military men) and ill (e.g. persons with mental disorders or ill
p.000071: minors) research subjects, groups of vulnerable contingents should be distinguished, i.e. groups of persons who for
p.000071: social, legal, age-specific, intellectual, mental or other reasons have a limited capacity or do not
p.000071: have the capacity to make an independent, informed and voluntary decision to participate in a clinical research.
p.000071: It is also essential to distinguish different types of biomedical research depending on the character of the connection
p.000071: between the research goal and its actual clinical motivation.
p.000071: Research of the first type, defined in international documents as “therapeutic” (or clinical) biomedical
p.000071: research, implies the application of new diagnostic, therapeutic or preventive pharmaceuticals or methods, i.e.
p.000071: research conducted in the interests of a particular research subject.
p.000071: Research of the second type, defined as “non-therapeutic” (or non- clinical) biomedical research, does not
...
p.000201: authorized body.
p.000201:
p.000202: 202
p.000202:
p.000203: 203
p.000203:
p.000203: 5) Clinical research must be performed by skilled specialists in the relevant sphere.
p.000203: 6) Clinical research of the medicinal agent may be permitted only after receipt of positive conclusion on
p.000203: ethical and moral and legal issues of research program issued by ethics commissions created and operating at patient
p.000203: treatment and prevention facilities having held clinical researches.
p.000203: 7) Ethics Commissions shall be formed in each medical institution empowered by the Ministry of Health Care to
p.000203: perform clinical researches. Ethics Commission includes therapists, pharmacists, pharmacologists, layers, and
p.000203: representatives of professional and public organizations.
p.000203: 8) A sponsor of clinical research shall have the right to obtain information on pharmaceuticals research
p.000203: process, results of review and demand substitution of medical institution carrying out the research;
p.000203: 9) Inspection of clinical research shall be carried out by the Ministry of Health Care or by the authorized body.
p.000203: Article 12 of the Law “On Pharmaceutical Products” is fully devoted to protection of patient (volunteer) rights:
p.000203: 1) Clinical researches shall be performed on volunteers (healthy people) and on patients during their disease
p.000203: treatment;
p.000203: 2) Clinical research shall be performed only with written consent of the patient or volunteer, and in case of
p.000203: non-adult or disabled person – with written consent of their legal representative;
p.000203: 3) Patient, volunteer or their legal representatives shall be entitled to obtain information on research content,
p.000203: medical agent properties, expected effect of application and possible adverse events, risk level affecting
p.000203: the person in the research;
p.000203: 4) The sponsor of a clinical study shall be obliged before the research to execute life and health insurance contract
p.000203: with respect to the patient or volunteer as provided in the applicable laws;
p.000203: 5) In case of danger to health or life of the patient or the volunteer, as well as its own desire, the head of the
p.000203: clinical research shall have the right to interrupt the research;
p.000203: 6) The Ministry of Health Care or authorized body shall cancel the clinical research in case of:
p.000203: a) danger to health and life of the patient or the volunteer;
p.000203: b) violation of ethical regulations at conduct of clinical research;
p.000203: c) absence or insufficient expected effect.
p.000203: So, the Law “On Pharmaceutical Products” from one side details above requirements and principles for biomedical
...
p.000323: death means “the return” to an origin. This idea was developed in many works, particularly in works by Ilya Mechnikov
p.000323: (1845- 1916) who attempted to explain the concept of “the instinct of natural death” from the viewpoint of biology and
p.000323: psychophysiology.
p.000323: With regard to ethical principles, “Canon of medical Science” is a literary source containing elements of
p.000323: bioethics. It differs from its antiquity analogues in the attempt to characterize medicine not only as a system of
p.000323: medical and biological knowledge, but also as a canon of spiritual and ethical basis of the entire medical science
p.000323: (“Avicenna and the ethics of science and technology today”. Division of Science and Technology Ethics, UNESCO, France,
p.000323: 2006, p. 1-16). There were many reasons why “Canon” excited much interest in different historical periods including the
p.000323: European Renaissance. However, there are no doubts that in “Canon of Medical Science” a human being for the first time
p.000323: becomes not merely a subject of an anatomical or physiological research but a person. It is noteworthy that the “Canon”
p.000323: is really permeated with humanistic ideas. It has a powerful spiritual and moral potential for the development of
p.000323: medical science the subject of which is not just a human being but also his/her life style with all the variety of
p.000323: cultural,
p.000323:
p.000324: 324
p.000324:
p.000325: 325
p.000325:
p.000325: legal, religious and other features. According to Ibn Sina, it is essential to humanize the process of bringing up
p.000325: healthy people and to find the ways for maintaining and developing spiritual harmony throughout a person’s life.
p.000325: Ethical views of Ibn Sina are still topical nowadays. He saw a physician as a patient’s friend, tutor and helper.
p.000325: To fulfill this noble mission, the physician, apart from professional knowledge and experience, should have many
p.000325: positive qualities – mercy, respect for human dignity, readiness to self-sacrifice in a patient’s interests,
p.000325: etc.
p.000325: When analyzing Ibn Sina’s ethical precepts we should note that those were in line with Hippocrates’s teaching. Ibn Sina
p.000325: wrote: “The physician should read Hippocrates’s precepts so as to be able to show honesty and frankness when treating
p.000325: patients. He should keep his clothes clean, be neat and perfumed. When he visits a patient he should be amiable, and
p.000325: cheerful, and witty so that he could cheer the ill person, because support offered by the physician multiplies the
p.000325: strength of natural warmth”. He was tireless in calling upon physicians to develop their general and special knowledge,
p.000325: to exchange professional experience and travel. In those times, travels served to extend scientific contacts. In the
p.000325: Middle Ages, there were many charlatan “healers” and even physicians deceiving their patients. Reasons for that Ibn
p.000325: Sina saw in a poor medical training, as physicians were not taught to see in each person his/her unique world of
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
...
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p.000133: the approval of the dissertation theme by the Scientific Council.
p.000133: While one of the main NCBE tasks is to facilitate public control ensuring the observance of ethical norms and
p.000133: regulations in pre-clinical and clinical trials, local ECs at healthcare institutions are implementing in practice the
p.000133: system of administrative and State control ensuring the protection trial subjects’ rights and interests.
p.000133: Presently, local ECs carry out ethical review, which includes the review of documents (research protocols,
p.000133: forms of individual registration cards, informed consent forms, etc.) relating to pre-registration (Phase I, II and III
p.000133: trials, generic bioequivalence studies) and post-registration (Phase
p.000133: IV) clinical trials in various fields of medicine (cardiology, oncology, gastroenterology, allergology,
p.000133: endocrinology, traumatology) including international multicentre trials.
p.000012: 12
p.000011: 11
p.000010: 10
p.000010: 10
p.000010:
p.000010:
p.000008: 8
p.000008:
p.000008:
p.000006: 6
p.000005: 5
p.000004: 4
p.000004: 4
p.000002: 2
p.000002: 2 1 1 1
p.000002:
p.000000: 0
p.000000: 1998 1999 2000 2001 2002 2003 2004
p.002005: 2005
p.002005:
p.002005:
p.002005: Multicentre clinical trials of pharmaceutical products in Belarus
p.002005: (1998-2005)
p.002005:
p.002005: When conducting ethical review ECs give a special attention to the protection of rights and interests of
p.002005: healthy volunteers involved in the Phase I clinical trials and in the clinical stage of bioequivalence studies. A
p.002005: special consideration is also given to research involving vulnerable groups (children, aged people, armed forces
p.002005: personnel, etc.).
p.002005:
p.000134: 134
p.000134:
p.000135: 135
p.000135:
p.000135: 9 8
p.000008: 8
p.000007: 7
p.000007: 7 6 6
p.000006: 6
p.000005: 5
p.000005: 5
p.000005: 5
p.000005:
p.000004: 4
p.000004:
p.000003: 3
p.000002: 2
p.000002: 2
p.000002:
p.000001: 1
p.000001:
p.000000: 0
p.000000: 1999 2000 2001 2002 2003 2004 2005
p.000000:
p.000000: Bioequivalence Studies of Pharmaceutical Products
p.000000: The review of documents referring to clinical trials, including the trial protocol, is performed by local ECs within
p.000000: 5-7 days. Without the approval from local ECs the Chairman of the Pharmacological Committee of the Health
p.000000: Ministry of Belarus may not approve the documents, and the trial may not be started. In the case of disagreement with
p.000000: the EC decision, the applicant (sponsor) may appeal against the decision to the NCBE.
p.000000: The activity of local ECs is regulated by respective normative and legal acts, the EC Statute and Standard Operational
p.000000: Procedures. These documents define the following:
p.000000: 1. Composition of the EC and membership requirements (qualification, etc.);
p.000000: 2. Operating schedule, contact telephones of the EC members, notification procedure;
...
p.000269: When examining the clinical study protocol, specialists consider possibility of reaching study objectives with
p.000269: involvement of less amount of subjects, assess inclusion and exclusion criteria, early exclusion criteria from
p.000269: participating in the clinical study, conditions of the study termination, objective control methods, expected
p.000269: adverse events and inconveniences for patients.
p.000269: Reviewing the Investigator Brochure there are examined data on efficacy and safety, pharmacological, pharmaceutical and
p.000269: toxicological properties of the tested medical agent as well as data on results of previously conducted preclinical and
p.000269: clinical studies.
p.000269: Requirements for information on the study provided to a candidate subject are very strict. It must
p.000269: correspond to a level of understanding of those to be involved in the study, to be easy to read and not to
p.000269: contain many medical terms. This document must describe the following: study purpose and objectives; description of the
p.000269: tested medicinal article; concomitant treatment permitted or prohibited in the given the trial’s subjects. probability
p.000269: of random assignment in one of the study groups (including the control that might be treated with placebo. Explanations
p.000269: for all terms and concepts, for instance, placebo, is obligatory!); objectively expected benefit for the patient as
p.000269: well as inconveniences and objectively expected risks for both patients/healthy volunteers and a fetus or infants; all
p.000269: study procedures (especially accurately
p.000269:
p.000270: 270
p.000270:
p.000271: 271
p.000271:
p.000271: there shall be highlighted issues on all invasive procedures planned during the study); obligations of the
p.000271: subject-participant; compensation and/or treatment the subject might expect in case the damage is incurred to his/her
p.000271: health during the study. The information note for the patient must contain a declaration that his/her participation
p.000271: in the study is voluntary and that he/she can in any moment of time refuse of participation in the study or to
p.000271: discontinue it without any sanctions or his/her rights infringement; there shall be clearly identified a list
p.000271: of persons that will be granted with direct access to information in the primary medical documentation (investigators,
p.000271: auditors, regulatory authorities, ethical committee members), and provided assurance that data identifying
p.000271: personality of the study subject will be kept secret and its disclosure is possible only within the limits
p.000271: stipulated with corresponding laws and/or by-laws. For instance, in case of public representation and
p.000271: publication of the study results anonymity of its subjects (confidentiality of information about them) is
p.000271: guaranteed. The patient information note must indicate investigator obligations in case of appearance of new data
p.000271: in the given CT that can influence the subject decision on continuing participation in the study to
p.000271: immediately inform the study subject or his/her legal representative about them, define a list of persons that one can
...
p.000313: institutions in line with modern international requirements. During these years a number of public organizations
p.000313: having a concern in bioethics have emerged, and the implementation of the system of ethical review for biomedical
p.000313: research has begun on a large scale.
p.000313: Today we have the following system of ethical review. Firstly, there are different laws and by-laws regulating
p.000313: biomedical research. The order of conducting clinical trials of pharmaceutical products and reviewing materials of
p.000313: clinical trials has been developed in compliance with the Articles 7 and 8 of the Ukrainian Law “On Pharmaceutical
p.000313: Products”43 and in line with requirements of the Directive 2001/20/EC of the European Parliament and of the
p.000313: Council EC ICH GCP44 and Declaration of Helsinki45. It was approved by the Order of the Ministry of health
p.000313: of Ukraine No 6646. The responsibility for reviewing documentation on clinical drug trials rests with the State
p.000313: Pharmacological Centre of the Ukrainian Ministry of Health.
p.000313: General principles of conducting clinical trials:
p.000313: • According to the sponsor’s choice, clinical trials are mostly conducted at specialized medical
p.000313: institutions the list of which is submitted by the Centre in accordance with established procedure and approved by the
p.000313: Ministry of Health.
p.000313: • All clinical trials are conducted in compliance with ethical principles set by Helsinki Declaration, and on the
p.000313: condition that the basic requirements relating to the protection of research subjects (patients or healthy volunteers)
p.000313: are observed. Clinical trials may only be conducted if the expected benefit justifies the risk.
p.000313: • All clinical trials are conducted only after a compulsory review of trial protocol by ethics committees
p.000313: established to protect trial subjects’ rights, safety and well-being, and to guarantee the protection for the society.
p.000313: • Planning, conducting and reporting at all phases of clinical trials, including studies of bioavailability and
p.000313: bioequivalence, should meet GCP requirements adopted by the Ukrainian Ministry of Health.
p.000313: • Trial management, data handling, documentation and an assessment of results obtained in a trial should comply with
p.000313: requirements set in standard operational procedures.
p.000313: • Registration, processing and archiving of information obtained in a trial should ensure an accurate presentation,
p.000313: interpretation and verification
p.000313:
p.000313: 43 http://www.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=123/96-вр
p.000313: 44 europa.eu/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf
p.000313: 45 http://www.wma.net/e/policy/b3.htm
p.000313: 46 http://www.pharma-Centre.kiev.ua/files/2006/Nakaz_66_d.doc
p.000313:
p.000314: 314
p.000314:
p.000315: 315
p.000315:
p.000315: of the data. Main trial related documents are archived and retained at the site of the trial and at the sponsor’s for
p.000315: no less than 15 years after the trial.
p.000315: • Manufacturing, storage and use of pharmaceutical products should be in accordance with established procedure
...
Searching for indicator volunteers:
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p.000063: approval of documents was strictly followed.
p.000063: Such specialization could be tracked at all stages of biomedical research from examination of application
p.000063: documents at the level of specialized commissions to study conduct in specialized sites only. Even the list of
p.000063: clinical sites mentioned above did not assume participation of each of those facilities included in this list
p.000063: in biomedical research of any specialization but it was clearly structured in regard to capabilities for
p.000063: conduct of various studies. For instance, this list contained a system of headings that included lists of
p.000063: facilities where it was permitted to perform studies of immunobiological, antiviral, oncology, cardiovascular agents,
p.000063: etc. Practically it meant that a particular facility had a technical complex able of providing proper diagnostic degree
p.000063: and dynamic observation taking into account registration of parameters significant for this pathology that was
p.000063: stipulated with corresponding instructions as well as had specialists in this particular field. The given specification
p.000063: was not limited with only medicinal agents but also included medical devices and cosmetics. There was a system of
p.000063: specialized, central expert institutions.
p.000063: From the financial and economical point of view all studies (for institutions and research personnel) did not
p.000063: assume any additional financial investments and were based on the general budget of the institution. For some cases
p.000063: there was a system of bonuses for participation in international studies that was centrally defined.
p.000063: Structure of the conducted biomedical research included also studies involving volunteers in specifically established
p.000063: sites. There was an instruction on the order for conduct of studies involving volunteers approved by the Ministry of
p.000063: Health of the USSR with a list of facilities where such studies could be conducted. And in the 60’s of the last century
p.000063: there were established hospitals for testing vaccine strain candidates and for space-related studies. The order of
p.000063: participation of volunteers in these studies assumed their informed written consent and reimbursement for their
p.000063: participation.
p.000063: From the point of view of international status the USSR participated in all significant international conventions in
p.000063: this field, was a partner with WHO and some other international organizations, conventions of narcotics (1961),
p.000063: psychotropic agents (1971) were signed. In regard to patent protection the
p.000063:
p.000064: 64
p.000064:
p.000065: 65
p.000065:
p.000065: country was a member of the Paris Convention (1965), protection of patent rights covered invention, utility models and
p.000065: industrial designs and it lasted for 20 years for the whole world. At the beginning of the 90’s first (approved by
p.000065: authorized agencies) contract research organizations appeared.
p.000065: The entire set of these elements in combination with peculiarities of the system of health care and medical education
p.000065: determined unique features inherited from the former USSR providing motivation for pharmaceutical companies to conduct
p.000065: biomedical research in the CIS countries. All analytical reviews from all representatives of world pharmaceutical
p.000065: industry interested in conduct of studies made in the beginning of the 90’s of the XX century noted their interest for
p.000065: conduct of biomedical research in this region, first of all, due to the following reasons:
p.000065: - existence of centralized specialized Centres capable of inclusion large number of patients into a study within short
p.000065: term;
p.000065: - epidemiology of infectious and non-infectious diseases in conditions of absence of treatment standards approved
...
p.000127: ethics-orientated and provide ethical and humanitarian comments by ethicists.
p.000127: At the same time, we are searching for interdisciplinary approaches to bring moral and ethical norms in conformity with
p.000127: the current medical and biological reality.
p.000127: An important achievement of the BSMU is that already at the stage of pre- clinical training medical students
p.000127: participate in resolving ethical problems relating to using dead human bodies in the teaching process and experiments
p.000127: on animals [14, 20]. In the course on human anatomy students are informed about legal, ethical and religious aspects of
p.000127: using a dead body of separate organs for an educational or scientific purpose. Learning ethical norms of handling
p.000127: anatomic preparations facilitates the development of the most essential humanistic quality – respect for a human
p.000127: being. Humane attitude to animals involved in experiments is very important for the development of compassion and
p.000127: empathy. Implementation of teaching aids alternative to experiments (computer programmes of experiments on virtual
p.000127: animals, video-films, CDs, three-dimensional models, etc.) allowed to exclude or minimize experiments on
p.000127: animals. As the result, students see that ethical principles are not merely postulated but implemented in practice.
p.000127: Medical students acquire bioethical knowledge out of class as well. Students of BSMU participate actively in
p.000127: the hospice movement. During several years they have been taking part in the BACCUP Programme at the Cardiff
p.000127: Medical University working as volunteers together with British medical students in summer holidays.
p.000127: Problems of bioethics, medical deontology and clinical ethics in medical practice can be successfully resolved only if
p.000127: medical professionals know the
p.000127: current legislation referring to healthcare. Therefore it is necessary, firstly, to regulate norms of medical activity
p.000127: according to new conditions in practical healthcare, and, secondly, to provide legal knowledge to medical specialists.
p.000127: Sociological surveys carried out in Belarus showed that, unfortunately, medical students, as a rule, do
p.000127: not have systematic knowledge in either deontology or medical ethics, or in medical and common law.
p.000127: A low level of education in ethics is typical of other categories: medical specialists and investigators, members of
p.000127: ECs, representatives of governing and legal institutions adopting laws and making decisions in healthcare and
p.000127: biomedicine, general public. This is a problem not only in Belarus or all regions of the post-Soviet space but in many
p.000127: other countries. Even when the level of education in bioethics may seem quite satisfactory, there is much of
p.000127: traditional paternalism. Thus, we still cannot get used to the idea that an individual’s right to life and
p.000127: death is his/her right and not the right of a physician, investigator or a legislator. Paternalism, in its turn, roots
p.000127: back to the authoritarian ethics in which interests of the society, State, science prevail over interests of an
...
p.000193: Committee at the Health Ministry of Kyrgyz Republic. Chapter 7 of the Law “On Pharmaceutical Products” entitled
p.000193: “Design, Pre-Clinical and Clinical Trials of Pharmaceutical Products” includes 5 Articles, 3 of which directly
p.000193: concern clinical trials. Article 28 emphasizes rights of the patients involved into clinical trials of pharmaceutical
p.000193: products stating that boards at authorized healthcare state institutions of Kyrgyz Republic “are guarantees for
p.000193: the patients’ rights”. Besides a set of documents has been designed in compliance with GCP international
p.000193: standards.
p.000193: All documents relating to pharmaceutical products submitted to the Pharmacological Committee (the
p.000193: institution responsible for ethical review of research protocols) are simultaneously submitted to the
p.000193: Ethics Committee for ethical review. There is a certain algorithm of conducting ethical review using standard
p.000193: operational procedures; however we lack a complete and comprehensive SOP system. According to the Statute of the
p.000193: Ethics Committee, a decision is made within 30 days after submitting the complete set of documents.
p.000193: Currently Kyrgyz Republic does not have systems of certifying ethics committees and surveying ethical review practices;
p.000193: neither has it a procedure for appealing against decisions. During last eight years The Ethics Committee has carried
p.000193: out ethical review of 23 clinical trial protocols, mostly phase 3 and 4 trials. Phase 1 clinical trials do not involve
p.000193: volunteers.
p.000193: Education and training for members of ethics committees is essential for their efficient work. Meanwhile there is no
p.000193: regular system of education for members of ethics committees; however, in the framework of cooperation in FECCIS
p.000193: members of the Ethics Committee of Kyrgyz Republic participated in WHO training programmes on the protection of
p.000193: patients’ rights and the meaning of SOPs in EC practice.
p.000193: Thus, at the present stage of sovereign Kyrgyzstan development basic legislation has been developed and the order of
p.000193: the Ethics Committee practice in compliance with international standards has been established. Now there is a
p.000193: theoretical and practical basis for a successful integration of Kyrgyz republic into the international process of
p.000193: ethical review development.
p.000193:
p.000193: 3.6.5. Perspectives and Forms of International Cooperation
p.000193:
p.000193: The independent Ethics Committee of the Kyrgyz Republic is a member of FECCIS, which gives an opportunity for
p.000193: cooperation in research ethics. The activity of EC of the Kyrgyz Republic has been presented at international
p.000193: conferences, which facilitates the exchange of information and working experience.
p.000193: In addition to participation of EC members in training courses organized by FECCIS, there is an opportunity to
...
p.000201: be less than expected benefit.
p.000201: 4) Procedure for clinical research materials review shall be established by the Ministry of Health Care or by the
p.000201: authorized body.
p.000201:
p.000202: 202
p.000202:
p.000203: 203
p.000203:
p.000203: 5) Clinical research must be performed by skilled specialists in the relevant sphere.
p.000203: 6) Clinical research of the medicinal agent may be permitted only after receipt of positive conclusion on
p.000203: ethical and moral and legal issues of research program issued by ethics commissions created and operating at patient
p.000203: treatment and prevention facilities having held clinical researches.
p.000203: 7) Ethics Commissions shall be formed in each medical institution empowered by the Ministry of Health Care to
p.000203: perform clinical researches. Ethics Commission includes therapists, pharmacists, pharmacologists, layers, and
p.000203: representatives of professional and public organizations.
p.000203: 8) A sponsor of clinical research shall have the right to obtain information on pharmaceuticals research
p.000203: process, results of review and demand substitution of medical institution carrying out the research;
p.000203: 9) Inspection of clinical research shall be carried out by the Ministry of Health Care or by the authorized body.
p.000203: Article 12 of the Law “On Pharmaceutical Products” is fully devoted to protection of patient (volunteer) rights:
p.000203: 1) Clinical researches shall be performed on volunteers (healthy people) and on patients during their disease
p.000203: treatment;
p.000203: 2) Clinical research shall be performed only with written consent of the patient or volunteer, and in case of
p.000203: non-adult or disabled person – with written consent of their legal representative;
p.000203: 3) Patient, volunteer or their legal representatives shall be entitled to obtain information on research content,
p.000203: medical agent properties, expected effect of application and possible adverse events, risk level affecting
p.000203: the person in the research;
p.000203: 4) The sponsor of a clinical study shall be obliged before the research to execute life and health insurance contract
p.000203: with respect to the patient or volunteer as provided in the applicable laws;
p.000203: 5) In case of danger to health or life of the patient or the volunteer, as well as its own desire, the head of the
p.000203: clinical research shall have the right to interrupt the research;
p.000203: 6) The Ministry of Health Care or authorized body shall cancel the clinical research in case of:
p.000203: a) danger to health and life of the patient or the volunteer;
p.000203: b) violation of ethical regulations at conduct of clinical research;
p.000203: c) absence or insufficient expected effect.
...
p.000346:
p.000347: 347
p.000347:
p.000347: Preclinical Trials of Pharmaceutical Products Safety” stating that placebo is used only to study pharmaceutical
p.000347: products for adjuvant therapy in patients with a mild or medium degree of a disease. Besides, there are
p.000347: special conditions for research participants from vulnerable groups.
p.000347: In 2001 paragraphs referring to CT ethics were included into the “Guidelines for Conducting Clinical Trials
p.000347: of Pharmaceutical Products and Expertise of Trial Materials”. Now, apart from the research Protocol and individual
p.000347: registration form, documentation submitted by the applicant to the NEC should include written informed consent forms
p.000347: signed by potential trial participants.
p.000347: The NEC activity in the sphere of implementing ethical principles into medical science and healthcare enhanced the
p.000347: quality of patient—physician relationship and of medical services provided by healthcare institutions. This
p.000347: also served to reduce the number of complaints from patients.
p.000347: The NEC coordinates its activity with the Centre of Science and Technology. The latter considers applied,
p.000347: fundamental and innovation grant projects relating to biomedical research after they were approved by the NEC.
p.000347: The NEC collaborates with the Higher Certifying Commission at the Cabinet of the Republic of Uzbekistan. According
p.000347: to the petition of the NEC Medical Council “On the Necessity to Conduct Ethical Review of Dissertation
p.000347: Works Involving Patients or Volunteers as Research Subjects” (Protocol No 25, 2002) the Commission considers
p.000347: dissertation works only after the NEC permission to carry out the research (including biomedical research with animals)
p.000347: was obtained.
p.000347: The NEC participated in the organization of the First National Congress on Bioethics with international participation
p.000347: (2005) and a scientific conference “Ethical Aspects of New Biotechnologies in Biology and Medicine” (2006). It
p.000347: facilitated the publication of the Conference papers and of a book “Bioethics in Uzbekistan. Clinical, Philosophical
p.000347: and Legal Aspects” (2006).
p.000347: At the First National Congress four trends in bioethics were discussed:
p.000347: - ethical problems in science;
p.000347: - legal aspects of bioethics;
p.000347: - bioethics and education;
p.000347: - bioethics and the environment.
p.000347: A special attention was given to ethical aspects of new biotechnologies, patient-physician relationships in various
p.000347: fields of healthcare (pediatrics, neonatology, surgery, neurosurgery, emergency care, neurology, psychiatry) and
p.000347: bioethical education.
p.000347: The Congress adopted a Resolution that will facilitate the development of bioethics in Uzbekistan.
p.000347: The main tasks of the Congress were to promote legislation with regard to the protection of human rights and
p.000347: dignity in biomedical research involving human subjects; to outline the strategy for developing the activity of the NEC
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.000023: which, as shown above, alongside with the decrease of fertility and, consequently, the decrease of the population under
p.000023: the working age, can lead to the population ageing and the decrease of the population initiative and economic activity.
p.000023: The number of children under 16 in the CIS countries is nearly 80 millions. Compared with 1989, the
p.000023: part of children under 16 in the total population size of the CIS countries decreased by 11%. The youngest is
p.000023: the population of Azerbaijan and Armenia where children make 35 and 29% of the population. In the countries of
p.000023: Central Asia, due to a relatively high fertility, children make on the average 39-45% of the total population. If we
p.000023: consider the demographic situation in the Russian Federation, particularly with regard to children, it should be noted
p.000023: that during the 90-s the number of births was by 60 millions less than in the 80-s. In recent decade, the children’s
p.000023: morbidity has increased dramatically. The most disturbing is the fact of the mental health worsening, since in recent
p.000023: ten years the rate of mental diseases in children doubled, that of moronity increased in 1.5 times and imbecility in
p.000023: 1.6 times. We have to recognize the growing number of disabled children; in the CIS countries there are about 1.5
p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
...
p.000039: Distribution of Forged and Low-quality Drugs, On Natural Medical Resources, Medicinal- sanitary Areas and Resorts, and
p.000039: many others.
p.000039: Activity of IPA CIS also facilitates development of regional legal cooperation in the field of health care and
p.000039: social protection of the population at the level of heads of states and governments. As per initiatives of this
p.000039: authority the member states executed the following basic agreements:
p.000039: - Agreement on Cooperation in the Field of Protection of Population Health (Minsk, 26 of June 1992),
p.000039: - Agreement on Medical Services for Military Personnel and Their Family Members, Workers and Servants of
p.000039: Frontier Troops (Minsk, 26 of June, 1992),
p.000039: - Agreement on Provision for Population of Medicinal Drugs, Vaccines and Other Immunobiological Agents, Goods for
p.000039: Medicinal Use and Medical Equipment Manufactured at the Territory of the CIS Member States (Ashkhabat, 24 of
p.000039: December 1993),
p.000039: - Agreement on Social Security and Health Protection of Citizens Exposed to Ionizing Radiation as a Result of
p.000039: Chernobyl and Other Radiation Catastrophes and Accidents as well as Nuclear Testing (Moscow, 9 of September
p.000039: 1994),
p.000039: - Agreement on Cooperation for Resolution of Issues of Disability and Disabled (Moscow, 12 of April 1996),
p.000039:
p.000040: 40
p.000040:
p.000041: 41
p.000041:
p.000041: - Agreement on Provision of Medical Care to Citizens of the CIS Member States (Moscow, 27 of March 1997),
p.000041: - Convention on Transfer of Persons with Mental Disorders for Compulsory Treatment (Moscow, 28 of March 1997),
p.000041: - Agreement on Cooperation for Resolution of Issues of HIV Infection (Moscow, 25 of November 1998),
p.000041: - Agreement on Prevention of Iodine-deficient Disorders among Citizens of the CIS Member States (Minsk, 31
p.000041: of May, 2001),
p.000041: - Agreement on Cooperation of the CIS Member States in the Field of Protection of Population Health (Yalta, 18 of
p.000041: September 2003),
p.000041: - Decision on the Order of Medical Examination of a Donor of Blood and Components Thereof (Cholpon-Ata, 2 of April
p.000041: 2004),
p.000041: - Agreement on Order of Interaction for Hygienic Assessment of Potentially Hazardous Products Imported to the
p.000041: CIS Countries (Cholpon- Ata, 16 of April, 2004),
p.000041: - Agreement on Cooperation of the CIS Member States against Trafficking of human beings, Human Organs and
p.000041: Tissues (Moscow, 25 of November 2005)
p.000041: - Concept for Development of Social and Medical Basics for Improvement of Quality of Life and Prevention of Disability
p.000041: of War Veterans, Participants of Local Conflicts, Peace-making Operations and Terrorism Victims in the VIS Member
p.000041: States for 2006-2010 (Dushanbe, 25 of May 2006), etc.
...
p.000057: systems can forecast future course of events.
p.000057:
p.000057: Industry of Biomedical Research
p.000057: Thus, scientific research to larger and larger scale is focused on cognition, on one hand, of various ways of
p.000057: influencing a man and, on the other, capacities of a man. Multiple experiments, where a man participates as a subject
p.000057: can be considered as the most characteristic expression of both. Each such experiment, generally speaking, is
p.000057: designed to extend our knowledge of properties of various agents, devices, methods of influencing a man, etc. At that,
p.000057: necessity for its conduct can be determined with needs of development of some particular section of biology, or
p.000057: medicine, or another field of knowledge. If, however, one attempts to imagine integral totality of such experiments
p.000057: (taken irrespective of subject specificity of each of them), than it turns out that it provides us with some knowledge
p.000057: about a man. We can claim: the more science pretends to serve interests and benefit of man, the more significant role
p.000057: there should be played with experiments involving human subjects.
p.000057: Several decades ago H.Jonas discussing issues of experiments involving a man, said perspicuously about a need to
p.000057: limit somehow “exorbitant appetite of the industry of scientific research”. Also he turned attention to the
p.000057: following - “now the scientific society will have to struggle with the strongest temptation – to switch to
p.000057: regular, daily experimenting with the most available human material: dependent ones due to various
p.000057: reasons, ignorant and suggestible disabled” (H.Jonas. Philosophical reflections on experiments with human
p.000057: subjects. In: Experimentation with human subjects, ed. by P.Freund, George Braziller Inc., 1970, p. 529).
p.000057: At the same time Jonas – and this was, generally, the commonly accepted point of view – could claim that
p.000057: experiments with human subjects
p.000057:
p.000058: 58
p.000058:
p.000059: 59
p.000059:
p.000059: “we consider as extraordinary but not normal ways to serve to public good” (the same, p. 526). But
p.000059: those days no one disputed of the crucial principles of the Nuremberg Code: each of such experiments due to
p.000059: risks it is associated with can be justified only with paramount necessity. In other words, it is acceptable only when
p.000059: there is not other way to gain knowledge being extremely important for the society and science.
p.000059: During the past decades an industry of scientific research or, being more specific, biomedical research
p.000059: involving human subjects became full- scaled reality. At that, biomedical researches by themselves are more and more
p.000059: often considered not only from the point of view of risks, but also from the point of view of benefits that they can
p.000059: bring to a subject. Usually, a therapeutic effect of a developed novel medicinal agent or a new method of treatment is
p.000059: considered as such benefit.
p.000059: And the issue on which of these two interpretations of biomedical research is more acceptable is worth
p.000059: of specific discussion that we have no possibility to talk over herein. It is important for us to stress that
p.000059: ethical tracking for such researches became a commonly accepted principle. In other words, in the modern scientific
p.000059: practice fairly well developed mechanisms for ethical control over studies function.
p.000059:
...
p.000077: only ethical issue that might arise concerned the permissibility of such a deal in a situation where the
p.000077: “seller” was a minor, imbecile, or a person in a state of artificial excitation, and where the “buyer” was a
p.000077: person who acted through psychological compulsion, deception, seduction, promise of profit or suggestion by authority.
p.000077: On the whole, the analysis of legal and ethical principles referring to biomedical research existing in the tsarist
p.000077: Russia in the beginning of the XX century shows that humanistic concepts of a voluntary and conscious choice made by
p.000077: the research subject and confidentiality have been combined with a responsible and merciful attitude on the part of a
p.000077: physician-investigator, and reinforced with accepted moral and ethical norms and legislative acts in force.
p.000077: Turning to a more recent period in national history, the following stages of Soviet law development illustrate how the
p.000077: issues in ethical and legal regulation of medical and biological research were interpreted in the USSR.
p.000077: In the law of the Russian Soviet Federal Socialistic Republic (RSFSR) on 1 of December 1924 “On the Professional
p.000077: Activity and Rights of Health Professionals” the need to obtain the patient’s consent, in particular when surgery is
p.000077: being planned, was declared. It was also stated that “with respect to those under 16 years of age or mentally disabled,
p.000077: the consent of their parents or care-givers”, i.e., their legal representatives, was necessary. Similar laws were
p.000077: adopted in the other Republics of the USSR. One should specifically underline that neither the law on 1 of December
p.000077: 1924, nor the decrees of the Soviet Ministries of Health until 1936, clarified how the patient’s consent was to be
p.000077: documented, and how it was necessary to regulate the conditions of medical research involving human subjects.
p.000077: In 1936 the legal regulation of the scientific and ethical aspects of the medical experiment was addressed in the
p.000077: Statutes “On the conduct of study of new medicines and medical methods associated with the risk for life and health of
p.000077: patients” adopted by the Scientific Medical Council of the People’s Commissariat of Health Care of the RSFSR
p.000077: (Resolution of the Bureau of the Scientific Medical Council, 23 of April 1936. In: Book of Resolutions
p.000077: - Peoples Commissariat of Health Care of the RSFSR. Scientific Medical Council. No 1-4, pp. 37-38).
p.000077: The events that encouraged the authorities to develop this document were described in detail in an article by
p.000077: professor I.Ya. Bychkov, where the author emphasized that in medicine “in order to assess the value of
p.000077: invention it is always necessary to study it in humans; and considering the fact that the medicine or device is new, it
p.000077: is always associated with some risk, can cause health problems or even endanger the life of the person who is the
...
p.000093: rights is guaranteed by independent ethics committees that review documents relating to the clinical trial in view of
p.000093: evaluation of risks for patients and protection of their rights.
p.000093: As we know from the history of clinical trials, initially the organization and performance of those was lacking
p.000093: for an ordered and systematic approach, and there were problems regarding implementation of GCP guidelines
p.000093: in different countries. At the same time, it is clear that safe and reliable research outcomes may be obtained only if
p.000093: the rules are observed.
p.000093: To protect rights and health of human subjects involved into clinical trials of new drugs, treatment methods
p.000093: and medical technologies,
p.000093: Ethics Committee at the Ministry of Health of Republic of Armenia was established in 1996 on the initiative of the
p.000093: Agency for Drugs and Medical Technologies.
p.000093: With regard to legal regulation in the sphere of human rights protection, members of Ethics Committee are guided in
p.000093: their ethical review practice by the following documents:
p.000093: • Constitution of Republic of Armenia (Article 34)
p.000093: • Law on Healthcare in Armenia
p.000093: • Law on Drugs
p.000093: • Law on Social Protection of the Disabled
p.000093: • Law on the Rights of the Child
p.000093: • Law on the Prevention of HIV Infection
p.000093: • Law on Transplantation of Human Organs and/or Tissues
p.000093: • Law on Reproductive Health
p.000093: • Law on Providing Psychiatric Care
p.000093:
p.000093: As to international legal documents, Republic of Armenia ratified Convention on the Rights of the Child.
p.000093: The practice of ethical review is regulated by principles set in the relevant WHO and WMA documents as well as in
p.000093: other international legal and ethical documents.
p.000093:
p.000093: 3.1.3. Education in Bioethics
p.000093:
p.000093: At Yerevan State University named after M.Heratsi ethics and aesthetics have been traditionally taught over many
p.000093: decades. In 2000 bioethics was introduced into the programme of the Department of Social Sciences as a compulsory
p.000093: discipline.
p.000093: In the post-Soviet space, including Armenia, a different – “home” – model of bioethics has been developed, in which
p.000093: bioethics is an interdisciplinary, orientated on biology, modern field of knowledge analyzing moral problems of human
p.000093: existence and human attitude to life and to individual living organisms. This model covers the range from the
p.000093: development of ethical norms and principles regulating human practical activity in the process of studying nature and
p.000093: human beings to the study of the role and place of the human being in the context of biological reality and the
...
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
p.000189: elderly persons, disabled persons, persons who had suffered from an emergency situation and residents of ecologically
p.000189: unfavorable regions (Art. 67, 68, 69, 70, 71).
p.000189: The Law on Pharmaceutical Products (March 2003) regulates clinical trials of pharmaceutical products.
p.000189: According to this Law, no clinical trials of pharmaceutical products in Kyrgyz Republic may be carried out
p.000189: without the permission granted by the authorized healthcare state institution of Kyrgyz Republic. Those guilty of
p.000189: violating rules of clinical trials, falsifying clinical results obtained in clinical trials of pharmaceutical
p.000189: products or conducting the trials without the permission granted by an authorized healthcare state institutions of
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
p.000189: necessary for an authorized healthcare state institutions of Kyrgyz Republic to make a decision about a clinical trial
p.000189: of a pharmaceutical product. The list includes an approval by the ethics committee of an authorized
p.000189: healthcare state institution of Kyrgyz Republic. Article 27 states that the ethics committee of an authorized
p.000189: healthcare state
p.000189: institution of Kyrgyz Republic participates in the design of a clinical trial programme.
p.000189: According to this Article, clinical trial results are referred only to the authorized healthcare state institution of
p.000189: Kyrgyz Republic. It is forbidden to provide any information about the process and results of a clinical trial of a
...
p.000203: ethical and moral and legal issues of research program issued by ethics commissions created and operating at patient
p.000203: treatment and prevention facilities having held clinical researches.
p.000203: 7) Ethics Commissions shall be formed in each medical institution empowered by the Ministry of Health Care to
p.000203: perform clinical researches. Ethics Commission includes therapists, pharmacists, pharmacologists, layers, and
p.000203: representatives of professional and public organizations.
p.000203: 8) A sponsor of clinical research shall have the right to obtain information on pharmaceuticals research
p.000203: process, results of review and demand substitution of medical institution carrying out the research;
p.000203: 9) Inspection of clinical research shall be carried out by the Ministry of Health Care or by the authorized body.
p.000203: Article 12 of the Law “On Pharmaceutical Products” is fully devoted to protection of patient (volunteer) rights:
p.000203: 1) Clinical researches shall be performed on volunteers (healthy people) and on patients during their disease
p.000203: treatment;
p.000203: 2) Clinical research shall be performed only with written consent of the patient or volunteer, and in case of
p.000203: non-adult or disabled person – with written consent of their legal representative;
p.000203: 3) Patient, volunteer or their legal representatives shall be entitled to obtain information on research content,
p.000203: medical agent properties, expected effect of application and possible adverse events, risk level affecting
p.000203: the person in the research;
p.000203: 4) The sponsor of a clinical study shall be obliged before the research to execute life and health insurance contract
p.000203: with respect to the patient or volunteer as provided in the applicable laws;
p.000203: 5) In case of danger to health or life of the patient or the volunteer, as well as its own desire, the head of the
p.000203: clinical research shall have the right to interrupt the research;
p.000203: 6) The Ministry of Health Care or authorized body shall cancel the clinical research in case of:
p.000203: a) danger to health and life of the patient or the volunteer;
p.000203: b) violation of ethical regulations at conduct of clinical research;
p.000203: c) absence or insufficient expected effect.
p.000203: So, the Law “On Pharmaceutical Products” from one side details above requirements and principles for biomedical
p.000203: researches, and from the other side established some regulations for pharmaceuticals research and patient care methods.
p.000203: The Law states that the pre-clinical researches of medicaments must be performed prior to clinical researches pursuant
p.000203: to the Regulations on Good Laboratory Practice approved by the Ministry of Health Care and Social Security.
...
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
p.000225: thousands of disabled, old people and orphans. In the 50’s of XVI century they attempted to place a part of care
p.000225: for people health, social support for sick and weak people on the state. Stoglav, a great council of Russian
p.000225: bishops held in 1551, together with tsar and boyar Duma ordered to found everywhere hospices for “leprous, aged,
p.000225: lying in boxes on the streets, carrying carts and sledges and having no place to sleep”. “Desyatina”, the tenth
p.000225: part of funds from sale of bread, cattle and from rent, was brought in to keep churches, monasteries, hospitals,
p.000225: hospices and receive odd and poor people. At the same time representatives of different social classes donated money
p.000225: for church and charity needs.
p.000225: Breakup between secular and church ideologies that began in the second half of the XVII century became wider in the
p.000225: XVIII century. Peter I activity is characterized with two mutually exclusive tendencies: strengthening
p.000225: of absolutism and europeisation of Russia. Implementing reforms for strengthening of role of the state in all
p.000225: spheres Peter I included the Orthodox church in government structure and strengthen state control on it and
p.000225: consequently on church charity. On Peter’s initiative social charity became state one. At Peter I times they took
p.000225: measures against beggary, parish as self- organized church and social unit was abolished.
p.000225: At the same time in the XVIII century higher medical education was formed in Russia. Hospital schools, medical
p.000225: department of the Moscow University, surgery academies were founded. In these circumstances the following
...
p.000321: and values of Zoroastrism and Islam and achievements in medicine and philosophy of the Moslem (Arabic)
p.000321: Renaissance, creative heritage of Central Asian thinkers and physicians Abu Ali Ibn Sina, Abu Abdullah
p.000321: Khorezmi, Abu Nasr Mohammed al-Farabi, Abu Raihan Beruni and other prominent figures representing Islamic
p.000321: philosophical and religious thought (Al Kindi, Abu Hamida Gazali, Ibn Rushda, Abu Bakra Ar-Razi). However,
p.000321: nowadays syncretism of oriental philosophy reveals itself in the fact that modern Uzbek philosophers and physicians do
p.000321: not make a clear distinction between secular and religious argumentation. Sacred texts have traditionally been a source
p.000321: of philosophical thought for Uzbek investigators. Western scientists usually state their positions. The Western
p.000321: bio[medical] ethics distinguishes between biomedical ethics based on religious teachings and secular biomedical ethics
p.000321:
p.000322: 322
p.000322:
p.000323: 323
p.000323:
p.000323: that uses ethical argumentation as such. Sacred texts offer a comprehensive collection of thoughts, and one may find in
p.000323: them confirmation from “above” of nearly any statement.
p.000323: Moslem teaching has developed special canons of the attitude to patients and disabled persons that, to a large
p.000323: extent, formed the basis for patient-physician relationship. First of all, Al Bukhari’s khadises remind Moslems
p.000323: that the Prophet suffered severely, and therefore, who, if not Him, knows better what it means to be ill and suffer
p.000323: (Abu Abdullah Muhammad ibn Ismoil al-Bukhoriy. Khadis. Al-jomi’ ac-cokhikh 4. Ishornali tiuplam. Tashkent, Komuslar
p.000323: bosh takhririiati, 1992. B. 3 – in Uzbek). Everything that befalls human beings is of God’s will. To visit the sick,
p.000323: even infants, is a duty of each Moslem. It is a tradition not to ask about the disease or name the disease aloud; one
p.000323: should ask about the general state of health and use euphemisms in telling the diagnosis: “that very illness”, “caught
p.000323: some cold”, “a bad illness”, etc. There are many variants. This is a kind of medical secrecy observed by persons in the
p.000323: patient’s environment. In the end of the visit the physician should say some words of support, to express his firm
p.000323: belief that the patient will recover, even if the physician knows that it is hardly possible. Moslems should support
p.000323: all disabled people and have mercy to ugly persons, because they are what they are of God’s will. To care for the
p.000323: disabled is the duty of all relatives and people from the community.
p.000323: Patients too have their duties. They have to bear their suffering as much as they can, not to grumble or fall into
p.000323: despair, to suppress one’s moans, not to ask for death. If a Moslem anticipates his death he should pay his debts,
p.000323: make his will and directions concerning funerals, beg everyone’s forgiveness and to repent of his sins
p.000323: (Sadyk-i-Kashgari M. Oriental Code of Decencies. Adab-ul-Salikhyn. Tashkent, 1992, pp. 35-37; in Uzbek). The precept
p.000323: “Thou should not ask for your death” suggests a direct answer to the question what Islamic teaching says about
p.000323: euthanasia. The person’s right to euthanasia, both active and passive still remains a topic of heated debates. Islam
p.000323: may not approve of either kind of euthanasia, as it is nothing but a conscious murder of a human being (even if he/she
p.000323: has a terminal illness) committed by another person, particularly by a physician. If the patient has a terminal
p.000323: illness, the physician’s duty is to relieve his/her suffering with various analgesics and to render moral support
p.000323: in the face of impending death, so that the patient would leave this world as a sensible person who
p.000323: completed all his/her earthy tasks, bid farewell to his/her relatives and repented before the Almighty Allah.
p.000323: Abu Ali Ibn Sina (980-1037) expressed his attitude to euthanasia in his “Biography” wrote that a
...
Searching for indicator mentally:
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p.000075: performed, and that in the books where it is described it is not stated how the people from whom pieces of thyroid
p.000075: gland were taken felt themselves, but experiments on animals prove that one can remove up to two-thirds of the thyroid
p.000075: gland without doing any harm to the animal, and that because with respect to the thyroid animals and human beings are
p.000075: similar, these conclusions are probably applicable to humans as well; and indeed, when the tumors of thyroids are
p.000075: removed, it can be enough to preserve a very small portion of it so that the person can continue living without
p.000075: experiencing troubles related to the absence of the thyroid gland. I am also aware how a shortage of thyroid gland
p.000075: affects the human.
p.000075:
p.000076: 76
p.000076:
p.000077: 77
p.000077:
p.000077: Then I was told that although I will have analgesic medicine injected under the skin for pain relief, I will
p.000077: possibly feel some pain during the surgery and afterwards. And finally, it was explained to me, that in the case
p.000077: of successful operation or especially if the wound suppurates I will have a scar for life on my neck about 7.5-10 cm
p.000077: long. And, despite all the facts mentioned above, I agree to the surgery, and whatever happens, I will never have any
p.000077: claims either against the doctors who will perform the surgery, or the patient who will receive my thyroid gland. I am
p.000077: signing this paper in the presence of doctors B.V.Dmitriev, E.K.Vinakurova, M.P.Alexeev and the nurse
p.000077: E.V.Shevchenko (signature); we witnessed the reading and signing of this paper and hereby certify that E.P. is an adult
p.000077: and mentally capacitated person (signatures of doctors and nurse)”.
p.000077: This document dated 1917, contains all elements of current ethical concept relating to biomedical
p.000077: research: confidentiality, respect for a person’s autonomy, information about all risks associated with the
p.000077: research, freedom of a voluntary choice, verification of the research subject’s social and mental maturity.
p.000077: All statements in Dmitriev’s article base on a legal concept of a famous lawyer A.F.Kony who testified to the
p.000077: absence of criminal deed in the case of the sale of organs for treatment purposes in accordance with the contract
p.000077: between the donor (seller) and recipient (buyer). At the same time he noted that “under these circumstances the
p.000077: only ethical issue that might arise concerned the permissibility of such a deal in a situation where the
p.000077: “seller” was a minor, imbecile, or a person in a state of artificial excitation, and where the “buyer” was a
p.000077: person who acted through psychological compulsion, deception, seduction, promise of profit or suggestion by authority.
p.000077: On the whole, the analysis of legal and ethical principles referring to biomedical research existing in the tsarist
p.000077: Russia in the beginning of the XX century shows that humanistic concepts of a voluntary and conscious choice made by
p.000077: the research subject and confidentiality have been combined with a responsible and merciful attitude on the part of a
p.000077: physician-investigator, and reinforced with accepted moral and ethical norms and legislative acts in force.
p.000077: Turning to a more recent period in national history, the following stages of Soviet law development illustrate how the
p.000077: issues in ethical and legal regulation of medical and biological research were interpreted in the USSR.
p.000077: In the law of the Russian Soviet Federal Socialistic Republic (RSFSR) on 1 of December 1924 “On the Professional
p.000077: Activity and Rights of Health Professionals” the need to obtain the patient’s consent, in particular when surgery is
p.000077: being planned, was declared. It was also stated that “with respect to those under 16 years of age or mentally disabled,
p.000077: the consent of their parents or care-givers”, i.e., their legal representatives, was necessary. Similar laws were
p.000077: adopted in the other Republics of the USSR. One should specifically underline that neither the law on 1 of December
p.000077: 1924, nor the decrees of the Soviet Ministries of Health until 1936, clarified how the patient’s consent was to be
p.000077: documented, and how it was necessary to regulate the conditions of medical research involving human subjects.
p.000077: In 1936 the legal regulation of the scientific and ethical aspects of the medical experiment was addressed in the
p.000077: Statutes “On the conduct of study of new medicines and medical methods associated with the risk for life and health of
p.000077: patients” adopted by the Scientific Medical Council of the People’s Commissariat of Health Care of the RSFSR
p.000077: (Resolution of the Bureau of the Scientific Medical Council, 23 of April 1936. In: Book of Resolutions
p.000077: - Peoples Commissariat of Health Care of the RSFSR. Scientific Medical Council. No 1-4, pp. 37-38).
p.000077: The events that encouraged the authorities to develop this document were described in detail in an article by
p.000077: professor I.Ya. Bychkov, where the author emphasized that in medicine “in order to assess the value of
p.000077: invention it is always necessary to study it in humans; and considering the fact that the medicine or device is new, it
...
p.000223: personnel charity that created the foundation necessary for helping the poor at the following times. It was forming
p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
p.000225: people social life organization on the basis of common views (19).
p.000225: Under church influence and with its participation care for people in need for medical and social help
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
p.000225: thousands of disabled, old people and orphans. In the 50’s of XVI century they attempted to place a part of care
p.000225: for people health, social support for sick and weak people on the state. Stoglav, a great council of Russian
p.000225: bishops held in 1551, together with tsar and boyar Duma ordered to found everywhere hospices for “leprous, aged,
p.000225: lying in boxes on the streets, carrying carts and sledges and having no place to sleep”. “Desyatina”, the tenth
p.000225: part of funds from sale of bread, cattle and from rent, was brought in to keep churches, monasteries, hospitals,
p.000225: hospices and receive odd and poor people. At the same time representatives of different social classes donated money
p.000225: for church and charity needs.
...
Searching for indicator disability:
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p.000039: Distribution of Forged and Low-quality Drugs, On Natural Medical Resources, Medicinal- sanitary Areas and Resorts, and
p.000039: many others.
p.000039: Activity of IPA CIS also facilitates development of regional legal cooperation in the field of health care and
p.000039: social protection of the population at the level of heads of states and governments. As per initiatives of this
p.000039: authority the member states executed the following basic agreements:
p.000039: - Agreement on Cooperation in the Field of Protection of Population Health (Minsk, 26 of June 1992),
p.000039: - Agreement on Medical Services for Military Personnel and Their Family Members, Workers and Servants of
p.000039: Frontier Troops (Minsk, 26 of June, 1992),
p.000039: - Agreement on Provision for Population of Medicinal Drugs, Vaccines and Other Immunobiological Agents, Goods for
p.000039: Medicinal Use and Medical Equipment Manufactured at the Territory of the CIS Member States (Ashkhabat, 24 of
p.000039: December 1993),
p.000039: - Agreement on Social Security and Health Protection of Citizens Exposed to Ionizing Radiation as a Result of
p.000039: Chernobyl and Other Radiation Catastrophes and Accidents as well as Nuclear Testing (Moscow, 9 of September
p.000039: 1994),
p.000039: - Agreement on Cooperation for Resolution of Issues of Disability and Disabled (Moscow, 12 of April 1996),
p.000039:
p.000040: 40
p.000040:
p.000041: 41
p.000041:
p.000041: - Agreement on Provision of Medical Care to Citizens of the CIS Member States (Moscow, 27 of March 1997),
p.000041: - Convention on Transfer of Persons with Mental Disorders for Compulsory Treatment (Moscow, 28 of March 1997),
p.000041: - Agreement on Cooperation for Resolution of Issues of HIV Infection (Moscow, 25 of November 1998),
p.000041: - Agreement on Prevention of Iodine-deficient Disorders among Citizens of the CIS Member States (Minsk, 31
p.000041: of May, 2001),
p.000041: - Agreement on Cooperation of the CIS Member States in the Field of Protection of Population Health (Yalta, 18 of
p.000041: September 2003),
p.000041: - Decision on the Order of Medical Examination of a Donor of Blood and Components Thereof (Cholpon-Ata, 2 of April
p.000041: 2004),
p.000041: - Agreement on Order of Interaction for Hygienic Assessment of Potentially Hazardous Products Imported to the
p.000041: CIS Countries (Cholpon- Ata, 16 of April, 2004),
p.000041: - Agreement on Cooperation of the CIS Member States against Trafficking of human beings, Human Organs and
p.000041: Tissues (Moscow, 25 of November 2005)
p.000041: - Concept for Development of Social and Medical Basics for Improvement of Quality of Life and Prevention of Disability
p.000041: of War Veterans, Participants of Local Conflicts, Peace-making Operations and Terrorism Victims in the VIS Member
p.000041: States for 2006-2010 (Dushanbe, 25 of May 2006), etc.
p.000041: From the point of view of international legislative practice adoption of the Model Law on Protection of Human Rights
p.000041: and Dignity in Biomedical Researches in the CIS by the General Assembly of IPA CIS at 18 November 2005, is fairly
p.000041: unique. Development of this document illustrates fruitful cooperation of the CIS Forum for Ethics Committees in
p.000041: the CIS and the Permanent Commission on social policy and human rights of IPA CIS. Adoption of the given
p.000041: model law facilitates provision of protection of dignity and respect, rights, security, health and interests of
p.000041: participants of biomedical researches; reliability of the study results and development of united legal space
p.000041: conducting biomedical research involving human subjects in the region of the Commonwealth countries and within
p.000041: the framework of international studies. The model law stipulates a conduct of ethical and scientific review of
p.000041: biomedical studies as a basic instrument for protection of each individual subject and community of people
p.000041: participating in the
p.000041: study. Currently the member states work on implementation of the Model Law into national legislation. In particular,
p.000041: the project of the Federal Law on Biomedical Studies (Analytical Materials on the project Analysis of
p.000041: Regulatory and Legal Framework in the Field of Human Rights in the Context of Biomedical Research and Development of
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.000151: research projects being carried within jurisdiction of Georgia. However, more specific impact on biomedical
p.000151: research and its ethical evaluation will have its Additional Protocol on Biomedical Research, which has been signed by
p.000151: Georgia but is not yet ratified.
p.000151: The law of Georgia on Health Care includes separate chapter – Chapter XIX “Biomedical Research”, in which basic
p.000151: principles regulating biomedical research are set out. Particularly according to the above-mentioned law:
p.000151: • aims, objectives, methods and possible outcomes of the research should be specified in the research
p.000151: protocol; research should be carried out only within the frames of the research protocol;
p.000151: • research protocol should be reviewed by independent body and ethics committee;
p.000151: • risks and benefits of the research should be assessed; risk associated with the research should not be
p.000151: disproportional to the expected benefits;
p.000151: • research subject should be fully informed about the details of the research (objectives, methods, potential
p.000151: benefits, risks, alternatives etc.);
p.000151: • research should not be started without informed consent of the research subject;
p.000151: • research subject has the right to refuse to participate in the research or withdraw from the research at any
p.000151: time despite already given written informed consent.
p.000151: The law also outlines general principles for the protection of incapable persons and minorities in the context of
p.000151: biomedical research.
p.000151: The law on Drug and Pharmaceutical Activity sets out the rules for organizing drug trials including trials in
p.000151: clinical phase when human beings are involved in the research programme. It requires that ethics committee to be
p.000151: created at the institution where the trial is to be carried out. Interestingly, this law specifically mentions
p.000151: recommendations set out in WMA Declaration of Helsinki to be the basis for conducting clinical trials on human beings.
p.000151: As already mentioned the most specific law on the protection of the research subjects will be the Law on
p.000151: Biomedical Research involving Human Subjects, which is being submitted to the Government this year. The aim of the
p.000151: draft law is protection of the rights, health and life of a research subject of biomedical research and provision of
p.000151: safety and respect for dignity during the research. The draft law concerns any type of research aiming at obtaining
p.000151: information and broadening knowledge in the sphere of biomedicine, which serves the interests of human health
p.000151: protection and implies:
p.000151: • Physical intervention on human being;
p.000151: • Research on biological materials which initially were taken and stored with other purpose;
p.000151: • Intervention which doesn’t imply physical intervention on human being but can pose danger to mental health or
...
p.000203: also contains regulations devoted to operation of the ethical committees. It is specifically prescribed that such
p.000203: committees must operate under institutions of public health (local and territorial) in accordance with model
p.000203: regulations approved by the Ministry of Health Care and duties and responsibilities of the committees must
p.000203: include participation in development of clinical research protocol. Local commissions and ethics committees set under
p.000203: Academy of Science of Moldova and public health institutions (republic’s, municipal and district ones) being a
p.000203: structure with extended functions are set by relevant enactments and operate.
p.000203: The Law On the Rights and Responsibility of a Patient sets general requirements to performance of biomedical
p.000203: research.
p.000203: First it is necessary to stress that pursuant to said law the patient is a person in need for medical service, using
p.000203: such services or applied for the latter notwithstanding the state of his health, or voluntary participating as a
p.000203: subject in biomedical researches. That means all set rights of the patient relate to subjects of the medical research
p.000203: as well.
p.000203: To ensure the rights of the patient during biomedical research connected with use of new diagnostic, treatment,
p.000203: prevention, rehabilitation methods, medicaments and other similar means the said law sets the following
p.000203: provisions:
p.000203: Any biomedical research may be performed only after obtaining of written consent from the patient;
p.000203:
p.000204: 204
p.000204:
p.000205: 205
p.000205:
p.000205: a) persons incapable to express their will except for researches in the interest of patient and consent of
p.000205: the legal representative shall not be involved in the clinical research;
p.000205: b) At receipt of patient’s consent on participation in the biomedical research, the latter should be provided
p.000205: with comprehensive information on objectives, methods, adverse events, possible risk, benefits and expected
p.000205: results of the study;
p.000205: c) the patient may refuse from participation in the biomedical research at any stage of such research;
p.000205: d) during biomedical research life and health of the person participating in the trial shall be insured at the
p.000205: expense of an institution performing this research in one of insurance agencies operating in the Republic of Moldova in
p.000205: accordance with the laws;
p.000205: e) to perform biomedical research the permit of the body on ethics for biomedical researches must be obtained;
p.000205: f) Performance of the biomedical research shall be permitted only in organizations of the state system
p.000205: of public health and shall be based on preliminary laboratory research. Performance of the research must
p.000205: be recorded in the research protocol in accordance with a sample elaborated and approved by the Ministry of Health Care
p.000205: and Social Security;
p.000205: g) new diagnostics, prevention and rehabilitation methods may be used for patient care only after written consent of
p.000205: the patient, and for treatment of a person with limited capability at direct danger to his life and with written
...
p.000231: denoted lawyer A.F. Kony (1844-1927), who considered that in situations of grave threat needs of the society should
p.000231: prevail over the ban to disclose patients’ secrets. At the same time he advocated the idea of sticking to medical
p.000231: confidentiality after a patient’s death. A.F. Kony also stipulated the conditions which allowed active euthanasia both
p.000231: legally and ethically.
p.000231: In he beginning of the XX century it was acknowledged that relationship of physicians with the community require
p.000231: dramatic revision especially when it comes to correlation of a doctor’s right to perform medical assistance essential
p.000231: for a patient and consent of the latter to have it in terms of observing or violating the principle of physical
p.000231: integrity (“Court newspaper”, 1901, №№ 51, 52) and also about the legal grounds and limits of criminal responsibility
p.000231: for the harm caused to patients health (‘Law”, 1902, №51). The issue to what extent the patient’s consent for medical
p.000231: treatment should be based upon his conscious understanding of the nature of this treatment especially if it is
p.000231: performed not only for the benefit of a patient but out of experimental needs. Prominent law experts A.F. Kony, N.G.
p.000231: Tagantsev, I.G. Sceglovitov, S.N. Tregubov and others come to join this discussion. According to Professor of Criminal
p.000231: Law N.G. Tagantsev “patients consent is incapable of setting impunity to all medical cases”. The fundamental principles
p.000231: of biomedical research in connection with thyroid gland transplantation were described from both legal and ethical
p.000231: sides in 1917 in an article by B.V. Dmitriev, a physician who worked for a machine factory in Kolomna and whose
p.000231: expertise was based on the consultation that the author obtained from A.F. Kony (12). Considering legal aspect of
p.000231: a doctor’s right for transplanting organs and tissues B.V. Dmitriev asked: “Whether a physician is granted
p.000231: any right to cause even minute and fleeting harm to a healthy person for the sake of another human being? Whether he is
p.000231: competent to decide in every particular situation if the benefit for one patient compensates for the harm done to the
p.000231: other, having the widest sense of the words benefit and harm in mind, that means not only in relation to physical
p.000231: health of these individuals but taking into account a complex of spiritual and physical strength of both?”.
p.000231: In response to these concerns Doctor Dmitriev stated the main provisions of implementing a medical
p.000231: research, the most essential of which are providing information and obtaining a conscious consent (of a donor in this
p.000231: case) which fully complies with the modern requirements. The same article provides a text of the first Russian
p.000231: full-scale minutely formulated patient’s informed consent form which retains its actual continuity up to
p.000231: contemporary time.
...
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
p.000249: carried out only after obtaining the written consent of legal guardians of these persons32.
p.000249: The latter Law states that all persons with mental disorders have to right for the preliminary consent or to refusal at
p.000249: any time to be used as a subject of trials of drugs and medical methods, scientific investigations or study
p.000249: process, video or photo or film shooting (item 2 of the article 2).
p.000249: Besides the Article 11 of this Law clarifies that the clinical trials involving persons under compulsory
p.000249: medical treatment or involuntarily hospitalized persons are absolutely prohibited.
p.000249: Such a key element of the ethical review as confidentiality of the information about patient and
p.000249: received from the patient throughout biomedical research is guarantied by means of the institute of medical
p.000249: secrecy stipulated by the Fundamental principles of Legislation and by the institute of personal and family secrecy
p.000249: (privacy) provided by the Constitution of the Russian Federation (the Article 23). It is also necessary to take into
p.000249: account the general norms guarantying the protection of personal data which are fixed by the Federal Law
...
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
p.000271: alterations of the drug introduction routes, its doses, and significant changes in number of the CT subjects. An ethics
p.000271: committee can approve amendments to the clinical study conduct only if presented changes do not lead to worsening of
p.000271: conditions for subjects.
p.000271: After the application review an ethics committee can make one of the following decisions: to approve study
...
p.000329:
p.000330: 330
p.000330:
p.000331: 331
p.000331:
p.000331: resulting from an intervention is entitled to fair financial compensation estimated according to the
p.000331: conditions and procedures prescribed by law.
p.000331: Currently, there are but single instances of suits brought by patients or their relatives against medical institutions.
p.000331: Uzbekistan has little experience in considering such complaints at court, because citizens are not properly informed
p.000331: about their rights. The lack of knowledge in this field negatively affects physician-patient relationships and the
p.000331: treatment efficiency. It is physicians’ professional duty to know patients’ and physicians’ rights and
p.000331: responsibilities. Incidentally, while the patient may be ignorant of his rights and responsibilities relating to
p.000331: medical care, the physician usually has this knowledge but intentionally conceals it from the patient,
p.000331: which is a disadvantage to both the patient and the physician.
p.000331: To involve medical professionals in educational activity aiming at informing patients about their rights, as
p.000331: well as physicians’ rights is one of urgent tasks for the healthcare system of Uzbekistan. .
p.000331: Ethical norms considering special features in relationship with patients from various age and social groups should have
p.000331: a significant place in the system regulating medical activity, particularly the rule of confidentiality relating to
p.000331: information obtained from the patient. This rule applies to adults (capable), minors (incapable or partially
p.000331: capable) and to persons with restricted capabilities who need a constant care.
p.000331: Ethical principles are essential in providing medical care to patients with sexually transmitted diseases. A
p.000331: more tolerant attitude of the society and law-enforcement bodies to patients from risk groups (sex workers,
p.000331: truckers, etc.) requires the development of legislation and social tolerance via public institutions (mahalline
p.000331: committees).
p.000331: The law of the Republic of Uzbekistan “On the Protection of Citizen’s Health” contains a number of articles concerning
p.000331: ethical issues. Thus, Article 46 sets out main principles safeguarding patents’ rights. The law of the
p.000331: Republic of Uzbekistan “On Pharmaceutical Products and Pharmaceutical Activity” (1997) also protects patients’
p.000331: rights in biomedical research. It defines the State authorities and competence of the Ministry of Public Health of
p.000331: the Republic of Uzbekistan in the sphere of clinical trials.
p.000331: Article 10 states that the decision about a clinical trial (CT) is based on
p.000331: - consent obtained from a patient or volunteer to participate in CT;
p.000331: - findings of a pre-clinical study of safety and efficiency of pharmaceutical products;
p.000331: - available data testifying that a potential risk is essentially lower than an expected benefit.
...
Health / Motherhood/Family
Searching for indicator family:
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p.000007: social policy, a dramatic decline in living standards at various social levels, and aggravation of ecological
p.000007: conditions. Specific features in each State are determined by different styles of life in the CIS countries due to
p.000007: their historical, religious, cultural and ethnic development. All these factors resulted in a general fertility rate
p.000007: decrease, mortality growth and a fall of the health quality index. These processes affect negatively the demographic,
p.000007: labour and migration potential of the CIS countries.
p.000007: The last decade of the XX century was characterized by an essential aggravation of the demographic situation that could
p.000007: be defined as a crisis. High mortality rates had practically no precedents in the Eurasian peacetime history. The
p.000007: “excess mortality” in the period since 1989 was much higher than the mortality rate in the period of Great Depression
p.000007: in the North America (1929-1933). Besides, recent changes of mortality rate, marriage ability and fertility shifts have
p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
p.000009: stability and to the whole process of reformation; however, there is a certain stabilization of the situation.
p.000009: Let us consider changes in resident population of the CIS countries and Turkmenistan in the period from 1991 to 2006.
p.000009: (Table 1).
...
p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
p.000021: into the international system of biomedical research both from a viewpoint of interested researchers and potential
p.000021: participants.
p.000021: In the period of transition to the market economics all the CIS countries had to face such problems as considerable
p.000021: inequity in the income distribution, stratification of the society by income and increasing poverty. In 2004, the ratio
p.000021: of the total income of 10% of the most and 10% of the least well-to- do population was 3-5 times in Azerbaijan, Belarus
p.000021: and Ukraine; 11 times in Kazakhstan, Kyrgyzstan, Moldova, Russia and Tajikistan; 21 times in Armenia.
p.000021: In recent years (2005-2007), in the majority of the CIS countries some smoothing of the society stratification by
p.000021: income and the decrease of the population quota with the income beyond the cost of living (poverty line) was observed.
p.000021: Some processes were observed in the CIS countries that were not typical before. Thus, the number of the “poor” children
p.000021: usually was growing much faster than the number of poor persons in every other age group because of the rapid spread of
p.000021: the unemployment and increasing number of persons in a low-paid job, alongside with a disproportional indexation of the
p.000021: family allowances. The level of food consumption by children has considerably decreased. Presently, the change
p.000021: in the nutrition structure is expressed by transition to food products that are less expensive and richer in
p.000021: calories. There is a lack of food products that are necessary for the normal growth and development of the organism.
p.000021: Besides, a decrease in food consumption and the worsening of the sanitary situation, hygiene and living conditions have
p.000021: caused the increase of the number of diseases (tuberculosis, rachitis) traditionally associated with poverty.
p.000021: Specific features of the demographic situation and, indirectly, the amount of labor resources depend also on
p.000021: the age groups prevailing in the total population size, which, in its turn, implies special approaches to the
p.000021: healthcare structure development in the CIS countries. The increase of
p.000021:
p.000022: 22
p.000022:
p.000023: 23
p.000023:
p.000023: the elder population and the decrease of the share of children in the total population are typical for the majority of
p.000023: the CIS countries.
p.000023: In fact, during the period from 1989 to 2004 in all the CIS countries the part of population under working age
p.000023: decreased. This especially concerns the age group under four. The part of working population did not decrease due to
p.000023: the generation born in the period from the late 70s to the mid-80s (time interval characterized as a period of the
...
p.000031: of ethical and legal unity in medical care is trends and mechanisms based on
p.000031: realia of regional cooperation of the CIS member states.
p.000031: Due to international and regional legal collaboration the constitutional regulation of a legal status of a
p.000031: person in the Commonwealth countries is adjusted to international standards creating legal opportunities
p.000031: for implementing such important ethical principles of biomedical research as
p.000031:
p.000032: 32
p.000032:
p.000033: 33
p.000033:
p.000033: respect to autonomy and individual dignity of a patient/subject as well as a principle of justice.
p.000033: Majority of constitutions of the CIS countries proclaim a person as a basic value (Art. 4, Constitution of Armenia;
p.000033: Art. 13, Constitution of Azerbaijan; Art. 2, Constitution of Belarus, Art. 3, Constitution of the Ukraine, Art. 2,
p.000033: Constitution of Russia; P.1, Art. 36, Constitution of Moldova, etc.). Free development of a person is
p.000033: protected by law and independent court. Person dignity is acknowledged as a special value to be protected by the state
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
p.000033: state becomes a guarantor for protection of personal rights and freedoms. Other directions of the state
p.000033: policy in social sphere are also extremely important for provision of human rights in the area of health care and
p.000033: biomedical research.
...
p.000039: Guarantees for Citizens of Independent States (adopted by IPA CIS, 29.10.1994). Also many projects of model acts
p.000039: included into perspective plan of model law development are also important for formation of state policies of the CIS
p.000039: countries in the field of health care and biomedicine such as the following: On Social Protection of Handicapped, On
p.000039: Folk Medicine, Recommendations on National Legislations Adjustment of the CIS Member States in the Sphere of Social
p.000039: Protection and Medical Service for Liquidation Participants of the Disaster Consequences at the Chernobyl NPS, On
p.000039: Counteracting HIV/AIDS in the CIS Member States, Medical Code of the CIS Member States, On Preventing
p.000039: Distribution of Forged and Low-quality Drugs, On Natural Medical Resources, Medicinal- sanitary Areas and Resorts, and
p.000039: many others.
p.000039: Activity of IPA CIS also facilitates development of regional legal cooperation in the field of health care and
p.000039: social protection of the population at the level of heads of states and governments. As per initiatives of this
p.000039: authority the member states executed the following basic agreements:
p.000039: - Agreement on Cooperation in the Field of Protection of Population Health (Minsk, 26 of June 1992),
p.000039: - Agreement on Medical Services for Military Personnel and Their Family Members, Workers and Servants of
p.000039: Frontier Troops (Minsk, 26 of June, 1992),
p.000039: - Agreement on Provision for Population of Medicinal Drugs, Vaccines and Other Immunobiological Agents, Goods for
p.000039: Medicinal Use and Medical Equipment Manufactured at the Territory of the CIS Member States (Ashkhabat, 24 of
p.000039: December 1993),
p.000039: - Agreement on Social Security and Health Protection of Citizens Exposed to Ionizing Radiation as a Result of
p.000039: Chernobyl and Other Radiation Catastrophes and Accidents as well as Nuclear Testing (Moscow, 9 of September
p.000039: 1994),
p.000039: - Agreement on Cooperation for Resolution of Issues of Disability and Disabled (Moscow, 12 of April 1996),
p.000039:
p.000040: 40
p.000040:
p.000041: 41
p.000041:
p.000041: - Agreement on Provision of Medical Care to Citizens of the CIS Member States (Moscow, 27 of March 1997),
p.000041: - Convention on Transfer of Persons with Mental Disorders for Compulsory Treatment (Moscow, 28 of March 1997),
p.000041: - Agreement on Cooperation for Resolution of Issues of HIV Infection (Moscow, 25 of November 1998),
p.000041: - Agreement on Prevention of Iodine-deficient Disorders among Citizens of the CIS Member States (Minsk, 31
p.000041: of May, 2001),
p.000041: - Agreement on Cooperation of the CIS Member States in the Field of Protection of Population Health (Yalta, 18 of
p.000041: September 2003),
p.000041: - Decision on the Order of Medical Examination of a Donor of Blood and Components Thereof (Cholpon-Ata, 2 of April
p.000041: 2004),
...
p.000095: 3. The Supplement includes main legislative acts adopted not only by the international community but also by the
p.000095: National Assembly of Republic of Armenia.
p.000095: 4. The Supplement also contains different tests and questionnaires for the self-analysis, so that students could test
p.000095: to what extent they are morally and physiologically ready to follow rules and requirements of modern
p.000095: bioethics. Besides, there are Case Studies arousing lively discussions. Prof.
p.000095: A. Karmy from Israel kindly sent these Case Studies to us.
p.000095: In spite of all difficulties in teaching bioethics, we have a noteworthy experience of student’s work. Within the
p.000095: framework of international student conferences, the Medical University organized round table
p.000095: discussions. In 2001 and 2003 two international student conferences on the fundamental principles and norms of
p.000095: bioethics were held. The majority of both foreign and Armenian students for the first time began to learn
p.000095: elements of bioethics. For a more comprehensive study of such topics as patient—physician relationship, the
p.000095: culture of physician’s speech and professional communication, compulsory hospitalization, etc., we give several
p.000095: lectures in Yerevan theatres instead of University lecture halls. These theatres show specially and only
p.000095: for our students, such plays as “Psychosis” and “The Street-Car Named Desire” (Sandukian Academic Theatre),
p.000095: “The Dentist from the East” (Akop Paronian Theatre of Musical Comedy) and “Physiology of Family” (Malian Theatre). Each
p.000095: performance is followed by a vivid discussion with actors and directors, and after that students write their essays
p.000095: on a suggested topic. In addition to theatre performances, students are invited to watch relevant films
p.000095: (documentaries and feature films).
p.000095: Together with the Institute of Philosophy, Sociology and Law of the Academy of Science of Republic of Armenia
p.000095: our Chair is writing a brochure “Albert Schweizer: A Great Humanist”. We also prepare for publication the glossary on
p.000095: bioethics in Armenian language. We give a special attention to practical aspects of teaching bioethics. Thus we began
p.000095: to design special training programmes on bioethics for students of medical institutes in Armenia.
p.000095:
p.000096: 96
p.000096:
p.000097: 97
p.000097:
p.000097: TV programmes on cloning, euthanasia and other problems with participation of associate professor S.Davtyan
p.000097: evoked a wide public response. If we manage to resolve the problem of sponsorship in the nearest future, we shall
p.000097: be able to give a series of TV programmes on topical issues of bioethics. This would facilitate a more active
p.000097: propagation of bioethical knowledge in various strata of Armenian society. UNESCO Office in Yerevan may
p.000097: participate in financing of the projects.
p.000097: Despite all this work a considerable part of Armenian medical community are skeptical about bioethics.
p.000097: Some physicians and University professors believe that teaching bioethics is something needless, to put it mildly.
p.000097: Apart from implicit forms of discrediting teaching of bioethics, there are cases when lecturers openly tell students
...
p.000181: Kyrgyz civilization. In fact, “Manas” is a moral code of the nomads and still a source of morals and humanism,
p.000181: as it describes customs and moral traditions, philosophical and aesthetic views, moral principles and norms
p.000181: of behaviour. With regard to its moral significance, “Manas” may be compared to Confucian Pentateuch. Like
p.000181: Confucian ethics, “Manas” depicts a model of putting the world into good order. Much attention is given
p.000181: to the struggle against chaos, which is expressed through regulation of human relationships, i.e. by establishing norms
p.000181: of behaviour, the system of prohibitions and social stratification.
p.000181: “Manas” is called a “cultural encyclopedia” of Kyrgyz people. It ranks among outstanding monuments of world
p.000181: culture, such as “Iliad” and “Odissey”, “Mahabharata”, “Epic of Gilgamesh”, “Kalevala”, “Rigveda” and many
p.000181: others. The Turkic epic poem “Manas” differs from west European, Slavonic and other epic poems not just in its
p.000181: volume. It covers a long historical period and gives a detailed genealogy and a distinct biographical line of
p.000181: athlete Manas – the central hero of the epic poem – from the moment of his birth to his death including the description
p.000181: of main events of his life. Poems, songs and legends passed across the generations served as a teaching
p.000181: material in folk pedagogics. The unique nature of oral folklore allows people to pass their moral knowledge to
p.000181: future generations within a family and within a clan thus ensuring continuity of spiritual life and
p.000181: connection between epochs. Another equally efficient method of education was joining to folk customs and traditions.
p.000181: Epic poems embraced all sides
p.000181: Ethical views of the early Kyrgyz make up a system of values, norms and rules based on aspiration for happiness.
p.000181: Therefore, ethics of the ancient Kyrgyz may be defined as the ethics of positive eudemonism19, and their overall
p.000181: worldview as world- and life-asserting.
p.000181: Although the epic poem does not contain distinctly formulated precepts, moral lessons learned from centuries-long
p.000181: history formed a traditional system of moral values that has survived to our days:
p.000181: 1. unity and solidarity of the nation,
p.000181: 2. international accord,
p.000181: 3. national honour,
p.000181: 4. movement towards prosperity and well-being through a continuous labour and knowledge,
p.000181: 5. humanism, generosity, tolerance,
p.000181: 6. harmony with nature,
p.000181: 7. strengthening and protection of Kyrgyzstan state system.
p.000181: Ethical norms in “Manas” are based on four cardinal virtues (wisdom, patience, conscience and generosity) that are
p.000181: personified in images. They are opposed by four vices: laziness, wickedness, greed and arrogance. It is said that a
p.000181: clever person is always able by using one’s mind which is “the best of all treasures” to oppose positive qualities to
p.000181: negative ones and defeat the evil by kindness, wickedness by patience, greed by generosity. Hence, the person has to
...
p.000187: 12. Tolubai-Synchi. Ibid.
p.000187: 13. http://www.peoples.ru/art/literatur...age/balasaguny.
p.000187:
p.000187: 3.6.2. Legal Regulations
p.000187:
p.000187: In Kyrgyz Republic biomedical research and protection of human rights in this sphere is regulated by a number of
p.000187: national legal acts, and first of all by Constitution.
p.000187: According to the principal Law, residents of the Kyrgyz republic have the right to health protection, free health
p.000187: care provision by a network of state healthcare institutions. The Constitution guarantees rights to healthy
p.000187: environment and to indemnification for harm caused to health or property due to actions in the sphere of nature
p.000187: management.
p.000187: Article 18 of the Constitution states that no medical, biological, and psychological experiments on human subjects
p.000187: shall be permitted unless there is a voluntary consent of the potential research subject, properly expressed and duly
p.000187: authenticated.
p.000187: The legal basis for the protection of human subjects in biomedical research are the Constitution provisions
p.000187: ensuring every individual’s right
p.000187:
p.000188: 188
p.000188:
p.000189: 189
p.000189:
p.000189: to life, physical and moral inviolability; the right to freedom and safety, the right to a free development of one’s
p.000189: personality; right to dignity and freedom of private life, confidentiality of personal and family information et al.
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
...
p.000239: depend on doctor’s morality. Not giving preference to any of the health care organization models the Church
p.000239: considers that this service should work efficiently at its maximum and must be available to all members of society
p.000239: disregarding their financial and social status even with limited medical resources distributed. For such distribution
p.000239: to be fair the aspect of “vital requirements” should prevail over the aspect of “market relations”. The doctor should
p.000239: not see the degree of their responsibility for medical service in relation with financial reward and its amount only by
p.000239: this turning his profession into pure profit making. At the same time decent payment for medical professionals is seen
p.000239: as an essential task for the society and the state (26).
p.000239: Section 12 “Bioethical Issues” shows the official position of RCOC
p.000239: on a range of aspects which currently are concerning in the society and are brought about by blooming development of
p.000239: biomedical technology in late the
p.000239:
p.000240: 240
p.000240:
p.000241: 241
p.000241:
p.000241: XX century. These completely new challenges are once again comprehended and reinterpreted in the context of ideas of
p.000241: human life and personal dignity which are entrenched in the “Divine afflation”. It shows attitude of the
p.000241: Church to abortion, new reproductive methods, medical genetic methods of diagnostics, tissue and organ
p.000241: transplantation, reanimation and help to the parting, sexual issues. Moreover some sections of the social
p.000241: conception are devoted to the questions of marriage and family, psychological health, problems of drug and alcohol
p.000241: addiction, health care and the ecological environment (7).
p.000241: The current trend is towards younger age among religious groups of society. A study by VCIOM showed that 58% of young
p.000241: Russian citizens under the age of 25 refer to themselves as Orthodox Christians, a similar trend can be observed among
p.000241: adherents of the Islam.
p.000241: It should be particularly stressed that among young believers patriotic, pro-governmental ideas, believe that there is
p.000241: a necessity to restore the decent position of Russia in the world community, strive for order, strong power, collective
p.000241: like, collegial philosophies, support of the current government and antagonism to liberal western ideas
p.000241: prevail. A common trend among all young interviewees, disregarding distinctions in their philosophic and
p.000241: religious ideas, towards moral and spiritual values is demonstrated, for instance, the way they reacted to the
p.000241: concept of ‘morality’ (positive 87.9% among believers and 81.8% among non-believers, negative 12.1% and 18.2%
p.000241: respectively), ‘justice’(positive 96.6% and 94.3%, negative 3.4%
p.000241: and 5.7%), ‘faith’ (positive 97.1% and 85.9%, negative 2.9% and 14.1%),
p.000241: ‘prayer’ (positive 92.3% and 56.3%, negative 7.7% and 43.8%). A particular part of young believers and
p.000241: non-believers advocates the idea of paternal mode of relations, sticks to the idea of conventional patriarchal
p.000241: views in family pattern, supporting filial piety within the family, male dominance in family relations (believers 28%,
p.000241: non-believers 21.9%).
p.000241: For the Russian medicine and health care a paternal model of doctor and patient relations is a typical one. Genesis of
p.000241: these relations can not be seen apart either from economic and cultural development of Russia on the whole or from the
p.000241: ethical staples of medical activity in Russia. Orthodox theological ideas and Russian religious philosophy to a
p.000241: significant extent reinforced the paternal model of doctor and patient relations, promoting ideas of humbling,
p.000241: non-resistance, and respect to universal hierarchy.
p.000241: Developments in medical science and biotechnology increased the power and responsibility of a medical doctor in
p.000241: terms of understanding what life and death and use harm mean. A simultaneous turn of mind in social ideas and mentality
p.000241: of people brought about by a wide spread liberal ideas gave a great impetus to new attitudes based on ideas of personal
p.000241: rights and freedom. All this entailed a necessity to seek for such grounds in doctor and patient
p.000241: communication as recognizing patients’ autonomy, their right for identity and decision making. Process of shifting
p.000241: towards non-paternal model in our country is not a smooth one.
p.000241: One can judge about the steadiness of paternal model by numerous interviews among doctors and patients
p.000241: carried out in recent years. The results of medical and social study in the St-Petersburg Pediatric Academy in 2002-
...
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
p.000249: carried out only after obtaining the written consent of legal guardians of these persons32.
p.000249: The latter Law states that all persons with mental disorders have to right for the preliminary consent or to refusal at
p.000249: any time to be used as a subject of trials of drugs and medical methods, scientific investigations or study
p.000249: process, video or photo or film shooting (item 2 of the article 2).
p.000249: Besides the Article 11 of this Law clarifies that the clinical trials involving persons under compulsory
p.000249: medical treatment or involuntarily hospitalized persons are absolutely prohibited.
p.000249: Such a key element of the ethical review as confidentiality of the information about patient and
p.000249: received from the patient throughout biomedical research is guarantied by means of the institute of medical
p.000249: secrecy stipulated by the Fundamental principles of Legislation and by the institute of personal and family secrecy
p.000249: (privacy) provided by the Constitution of the Russian Federation (the Article 23). It is also necessary to take into
p.000249: account the general norms guarantying the protection of personal data which are fixed by the Federal Law
p.000249: of the Russian Federation “On information, information technologies and protection of information” of 27 July
p.000249: 2006 and by the Federal Law of the Russian Federation “On personal data” of 27 July 200633.
p.000249: 32 Federal Law of Russian Federation “On psychiatric assistance and related guarantees of citizens” N 3185-1 of July
p.000249: 2, 1992 // Vedomosty of CND and VS RF, 20 of August 1992.
p.000249: № 33, article 1913.
p.000249: 33 Federal Law of Russian Federation “On information, information technologies and protection of
p.000249: information” of July, 27 2006, Federal Law of Russian Federation “On personal data” on 27 of July 2006// Rossiyskaya
p.000249: Gaseta, N 165, 29.07.2006
p.000249:
p.000250: 250
p.000250:
p.000251: 251
p.000251:
p.000251: The legal rules on specifics of the institutes of informed consent and medical secrecy in some particular situations as
p.000251: well as norms concerning guaranties of the other rights of patients/subjects were also reflected in the following acts:
p.000251: the Federal Law of the Russian Federation “On transplantation of human organ and tissues” on 22 of December 1992, N
p.000251: 4180-1, the Federal Law of the Russian Federation “On blood donation” on 9 of June 1993, N 5142-1, the
...
p.000293: Economic, political and social recession affected indices of the population health. Most urgent were problems
p.000293: concerning food, water supply, sanitary situation, the growth of
p.000293: infectious diseases (typhoid, malaria, tuberculosis, diphtheria, acute viral hepatitis) acute respiratory
p.000293: diseases, anemia, diseases caused by iodine deficit and reproductive health. Despite instability in
p.000293: political and socio- economic life during the first years of independence, Tajikistan Government took comprehensive
p.000293: measures on the protection of the population health. During that period, Tajikistan ratified important
p.000293: international documents referring to the protection of human rights such as the Convention on the Elimination of All
p.000293: Forms of Discrimination against Women (ratified in 1993), Convention on Children’s Rights (ratified in
p.000293: 1993). Presently, the following documents form the legislative basis in healthcare:
p.000293: - Constitution of Republic of Tajikistan (RT) (1994)
p.000293: - RT law “On AIDS Prevention” (No 904; 23 of December 1993)
p.000293: - RT law “On Donorship of Blood and its Components” (No 901; 23 December 1993)
p.000293: - RT law “On the State Sanitary Inspection” (No 987; 20 of July 1994)
p.000293: - RT law “On the Protection of Population Health” (No 419; 15 of May 1997)
p.000293: - RT Labour Code (1997).
p.000293: - Family Code (1997).
p.000293: - RT law “On Narcotic Drugs, Psychotropic and Precursors” (No 874, 10 of December 1999)
p.000293: - RT law “On Pharmaceutical Products and Pharmaceutical Activity” (No 39; 6 of August 2001)
p.000293: - RT law “On Psychiatric Care” (No 90, 2 of December 2000)
p.000293: - RT law “On Reproductive Health and Reproductive Rights” (No 72; 2 of December 2002)
p.000293: - RT law “On Private Medical Practice” (No 60; 3 of December 2000)
p.000293: - RT law “On Salt Iodination” (No 85; 2 of December 2002)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Tropical
p.000293: Diseases (Malaria) in Republic of Tajikistan in 1997-2005” (No 342, 4 of December 1997)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Viral
p.000293: Hepatitis “B” in Tajikistan in 2000- 2007” (No 100; 11 of March 2000)
p.000293:
p.000294: 294
p.000294:
p.000295: 295
p.000295:
p.000295: - Decree of the RT Government “On the Approval of the Concept of Healthcare Reformation in Republic of Tajikistan”
p.000295: (No 94; 4 of March 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Prevention and Control of
p.000295: HIV/AIDS/STD in Republic of Tajikistan in the Period to 2007” (No 475; 27 of November 2002)
p.000295: - Decree of the RT Government “On the RT Strategy for Preventing the Menace of AIDS Spreading for the Period of
p.000295: 2002-2005” (No 389; 1 of October 2002)
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
p.000295: access to the service of reproductive health, at preventing HIV/ AIDS spreading and at eliminating sex discrimination
p.000295: in the field of primary and secondary education. To ensure the national demographic policy, the Government approved
p.000295: and adopted the programme “The Concept of RT State Demographic Policy for the Period 2003-2015” (2002).
p.000295: The independent Tajikistan with its scientific potential in healthcare has reached a new, international level of
p.000295: science development, and therefore it is necessary to carry out ethical review of biomedical research in compliance
...
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
p.000325: Ibn Sina’s views on childhood are noteworthy. “Canon of Medical Science” states that child’s life and health
p.000325: should be objects of care, protection and a special regimen from the moment of conception, not just from the moment of
p.000325: birth. A newborn baby needs a wet nurse with a stable nervous system. Games are essential, as all educational
p.000325: and formative processes, starting from very early years, should proceed from games. One may not punish a child, as
p.000325: the task of a tutor and physician if to protect the child’s soul, to facilitate the development of the feeling of
p.000325: self-respect. It is particularly important to prohibit any punishment for children under age of five, i.e. at the age
p.000325: when a child does not realize the meaning of his/her actions. Abu Ali Ibn Sina believed that, irrespective of state and
p.000325: public benefits, a child should receive a good intellectual, moral and ethical education in the family and at school.
p.000325: In his works, Ali Abu Ibn Sina gave much attention to school education. Kind and well-educated teachers may only
p.000325: teach at school,
p.000325: where children are brought up and educated until the age of fourteen. A teacher should know well the subject
p.000325: he teaches; he should follow the moral principles and be an honest, loving and courageous person.
p.000325: In the system of Ibn Sina’s ethical views, a concept of mizaj implying the necessity of an entirely individual approach
p.000325: to each individual, irrespective of the person’s age of health condition and considering a unique combination of
p.000325: qualities on the individual and his/her living and working conditions.
p.000325: The knowledge of human nature and temperament is the basis of a physician’s strategy when maintaining a
p.000325: proper level of health, and, if need be, planning the therapy. A comprehensive study of the “Canon” helps us to tell a
p.000325: sanguine person from a phlegmatic one or a choleric person from a melancholy one, and to mark out characteristic
p.000325: biotypes. If we translate it into the language of modern bioethics, we can see clearly the logical construct of
p.000325: Hippocrates, Galen and Avicenna; treat not a disease but a person, and not just a person but also a biotype
p.000325: whose psychological responses are subordinate to its biological nature (mizaj), or temperament. Ages later Ivan
p.000325: Pavlov mentioned the biotypological approach used widely by Ibn Sina as a fruitful one, revealing “fundamental
p.000325: features” of human nature.
...
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p.000089: translated into Armenian. Those texts inspired medieval Armenian physicians and naturalists, e.g. Grigor
p.000089: Magistros (X-XI c.), Mekhitar Heratsi (XII c.), Amirdovlat Amasiatsi (XV c.) et al.
p.000089: It is noteworthy that great Armenian philosophers (David the Invincible, Anania Shirakatsi et al.) placed high
p.000089: emphasis on the problems of good and evil, suffering and compassion, life and death. They considered those issues
p.000089: in light of Christian morals. Today Armenian Apostolic Church is continuing this tradition. Suffice it to say,
p.000089: that the Ararat Eparchy with its rich experience in propagating ideas of bioethics is planning to establish a Church
p.000089: Public Council for Medical Ethics. Armenian Apostolic Church takes a rather strict position on some problems of
p.000089: bioethics: it prohibits human cloning and cloning of human organs, euthanasia, artificial fertilization and abortion,
p.000089: which is considered as infringement of human life.
p.000089: In this context the views of David Anhaght (the Invincible) formulated in his works (“Definition of Philosophy”,
p.000089: “Commentary on Aristotle’s Analytics” and “Commentary on Porphyry’s Introduction”) are of much interest.
p.000089: David Anhaght took problems of medical ethics very much to heart. His ideas on the value of human life are of
p.000089: particular importance. In his book “Definition of Medicine” he mentioned views of the Stoics who tended to justify
p.000089: suicide under certain conditions: starvation, loss of close relatives, natural cataclysms, violation of human dignity,
p.000089: terminal illness and senile marasmus. Two last cases are directly related to medicine. The Stoics wrote: “A man who
p.000089: kills himself to rid himself of pain in his ill and wretched body, commits the righteous act. Thus, a philosopher
p.000089: who was half-paralyzed appealed to the emperor Julian: Half of my body is dead; the other half is still alive. Have
p.000089: pity on the half-alive philosopher and order either to heal or to kill me. Likewise, it would be right for a man who
p.000089: had reached old age to kill himself when he is delirious, confused and utters meaningless phrases”.
p.000089: David Anhaght did not share Stoic views on permissibility of suicides under conditions mentioned: “In this regard
p.000089: we say that no one should kill oneself – neither those who have the right to do this, nor those who don’t… Trials,
p.000089: whenever or wherever they happen, come to us not in order that we should kill ourselves, but so that we tried our soul.
p.000089: Like a good helmsman is tested not in still water, but in the stormy sea, the lofty soul goes to meet a trial”.
p.000089: Thus David Anhaght (the Invincible), in line with Nerses the Great, a prominent philosopher (V c.), gave a negative
p.000089: answer to the question “Does the physician have a moral right to hasten his patient’s death?”.
p.000089:
p.000090: 90
p.000090:
p.000091: 91
p.000091:
p.000091: Similar views we find in works of Armenian thinkers Mkhitar Hosha and Smbat Hundstabl (XIII c.). In “The Book
p.000091: of Laws” we read: “The physician who deliberately or through ignorance does harm to the patient’s health or, what
p.000091: is more, hastens the patient’s death, as well as the physician who educates a disciple, but does not give him proper
...
p.000321: of philosophical thought for Uzbek investigators. Western scientists usually state their positions. The Western
p.000321: bio[medical] ethics distinguishes between biomedical ethics based on religious teachings and secular biomedical ethics
p.000321:
p.000322: 322
p.000322:
p.000323: 323
p.000323:
p.000323: that uses ethical argumentation as such. Sacred texts offer a comprehensive collection of thoughts, and one may find in
p.000323: them confirmation from “above” of nearly any statement.
p.000323: Moslem teaching has developed special canons of the attitude to patients and disabled persons that, to a large
p.000323: extent, formed the basis for patient-physician relationship. First of all, Al Bukhari’s khadises remind Moslems
p.000323: that the Prophet suffered severely, and therefore, who, if not Him, knows better what it means to be ill and suffer
p.000323: (Abu Abdullah Muhammad ibn Ismoil al-Bukhoriy. Khadis. Al-jomi’ ac-cokhikh 4. Ishornali tiuplam. Tashkent, Komuslar
p.000323: bosh takhririiati, 1992. B. 3 – in Uzbek). Everything that befalls human beings is of God’s will. To visit the sick,
p.000323: even infants, is a duty of each Moslem. It is a tradition not to ask about the disease or name the disease aloud; one
p.000323: should ask about the general state of health and use euphemisms in telling the diagnosis: “that very illness”, “caught
p.000323: some cold”, “a bad illness”, etc. There are many variants. This is a kind of medical secrecy observed by persons in the
p.000323: patient’s environment. In the end of the visit the physician should say some words of support, to express his firm
p.000323: belief that the patient will recover, even if the physician knows that it is hardly possible. Moslems should support
p.000323: all disabled people and have mercy to ugly persons, because they are what they are of God’s will. To care for the
p.000323: disabled is the duty of all relatives and people from the community.
p.000323: Patients too have their duties. They have to bear their suffering as much as they can, not to grumble or fall into
p.000323: despair, to suppress one’s moans, not to ask for death. If a Moslem anticipates his death he should pay his debts,
p.000323: make his will and directions concerning funerals, beg everyone’s forgiveness and to repent of his sins
p.000323: (Sadyk-i-Kashgari M. Oriental Code of Decencies. Adab-ul-Salikhyn. Tashkent, 1992, pp. 35-37; in Uzbek). The precept
p.000323: “Thou should not ask for your death” suggests a direct answer to the question what Islamic teaching says about
p.000323: euthanasia. The person’s right to euthanasia, both active and passive still remains a topic of heated debates. Islam
p.000323: may not approve of either kind of euthanasia, as it is nothing but a conscious murder of a human being (even if he/she
p.000323: has a terminal illness) committed by another person, particularly by a physician. If the patient has a terminal
p.000323: illness, the physician’s duty is to relieve his/her suffering with various analgesics and to render moral support
p.000323: in the face of impending death, so that the patient would leave this world as a sensible person who
p.000323: completed all his/her earthy tasks, bid farewell to his/her relatives and repented before the Almighty Allah.
p.000323: Abu Ali Ibn Sina (980-1037) expressed his attitude to euthanasia in his “Biography” wrote that a
p.000323: seriously ill person consciously “broke the regimen for the last time”, which hastened his death. Here
p.000323: we have to mention his views on medical and ethical problems of dying and natural death. These views expand the scope
p.000323: of modern bioethics, which allows us to retransmit from the past entire strata of knowledge about the physician’s duty
p.000323: and search of new ways for applying ethics when it is necessary to care for a dying patient, to form behaviour
p.000323: standards in seriously ill patients, to safeguard their rights for a good death and to maintain their faith in
p.000323: spiritual and moral immortality of human soul.
p.000323: In the light of the aforesaid, Ibn Sina’s treatise “Illumination” that is not widely known among researches is of a
p.000323: particular interest. The treatise adds to concepts of natural death presented in “Canon”. In modern terms, the treatise
p.000323: suggests that the philosophy of death ensues logically from a moral comprehension of life. Ibn Sina offers a systemic
...
Searching for indicator physically:
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p.000231: a doctor’s right for transplanting organs and tissues B.V. Dmitriev asked: “Whether a physician is granted
p.000231: any right to cause even minute and fleeting harm to a healthy person for the sake of another human being? Whether he is
p.000231: competent to decide in every particular situation if the benefit for one patient compensates for the harm done to the
p.000231: other, having the widest sense of the words benefit and harm in mind, that means not only in relation to physical
p.000231: health of these individuals but taking into account a complex of spiritual and physical strength of both?”.
p.000231: In response to these concerns Doctor Dmitriev stated the main provisions of implementing a medical
p.000231: research, the most essential of which are providing information and obtaining a conscious consent (of a donor in this
p.000231: case) which fully complies with the modern requirements. The same article provides a text of the first Russian
p.000231: full-scale minutely formulated patient’s informed consent form which retains its actual continuity up to
p.000231: contemporary time.
p.000231: Achievements of academic medicine did not significantly influence public health factors and demographic
p.000231: processes. Mortality and morbidity rates among population were high, infant mortality was common, there were
p.000231: many physically retarded children. Russia was shaken by epidemics of epidemic typhus, cholera, smallpox, malaria, and
p.000231: diphtheria and other. Medical facilities were scattered between different authorities and were mainly financed
p.000231: through beneficent funds.
p.000231: The number of physicians and hospitals was inadequate to provide citizens with medical service. In late XIX –
p.000231: early XX centuries there were 10 hospital beds and 1.8 physicians for every 10000 people in Russia. Medical service was
p.000231: mainly available in large cities. Out of 257 sanitation physicians 135 worked in Moscow and Saint-Petersburg. According
p.000231: to the data of 1913 allocations in health care accounted for 91 kopeks, for sanitation – 1.25 kopeks per
p.000231: year per capita. The major, rural, part of Russian population was almost completely deprived of medical
p.000231: service. In these conditions the position of F.F Erisman and V.V. Veresaev is a notable one, they called for not
p.000231: staying indifferent to the reasons inducing such situation, not to “powerlessly grumble about the unfair destiny”, but
p.000231: to consider it a moral duty to “take all possible steps to prevent such undue events from happening”
p.000231: Development of country medicine was a great event, the establishing of which was tightly connected with the community
p.000231: mode of life characteristic of Russian people and with the so-called country self-administration introduced in
p.000231: the 60-s of the XIX century. Subsequently, country medicine widely implemented in 34 provinces in European part of
p.000231: Russia (in 1911 6 more were added) appeared at that time most reasonable form of medical service for rural population
p.000231: and was unique to our country.
...
Health / Physically Ill
Searching for indicator sick:
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p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
p.000009: stability and to the whole process of reformation; however, there is a certain stabilization of the situation.
p.000009: Let us consider changes in resident population of the CIS countries and Turkmenistan in the period from 1991 to 2006.
p.000009: (Table 1).
p.000009: The presented data show the increase of population in Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan,
p.000009: Turkmenistan and Uzbekistan considering the change in the tendencies of population reproduction.
p.000009: The population in the CIS member-countries is about 5% of world population. The population density in
p.000009: the CIS countries varies from 6- 9 persons per sq. km in Kazakhstan, Russia and Turkmenistan to 126-129 persons in
p.000009: Armenia and Moldova. Thus, the average population density in the CIS countries is 13 persons per sq. km. For
p.000009: comparison: the population in the European Union (EU) makes 7% of world population, while the average density of
p.000009: population in the EU is 114 persons per sq. km. Over 66% of Belarus, Armenia, Ukraine, and 73% of Russia population are
p.000009: city residents. In the territory of the CIS there are 24 cities with the population over 1 million.
...
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
p.000225: people social life organization on the basis of common views (19).
p.000225: Under church influence and with its participation care for people in need for medical and social help
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
p.000225: thousands of disabled, old people and orphans. In the 50’s of XVI century they attempted to place a part of care
p.000225: for people health, social support for sick and weak people on the state. Stoglav, a great council of Russian
p.000225: bishops held in 1551, together with tsar and boyar Duma ordered to found everywhere hospices for “leprous, aged,
p.000225: lying in boxes on the streets, carrying carts and sledges and having no place to sleep”. “Desyatina”, the tenth
p.000225: part of funds from sale of bread, cattle and from rent, was brought in to keep churches, monasteries, hospitals,
p.000225: hospices and receive odd and poor people. At the same time representatives of different social classes donated money
p.000225: for church and charity needs.
p.000225: Breakup between secular and church ideologies that began in the second half of the XVII century became wider in the
p.000225: XVIII century. Peter I activity is characterized with two mutually exclusive tendencies: strengthening
p.000225: of absolutism and europeisation of Russia. Implementing reforms for strengthening of role of the state in all
p.000225: spheres Peter I included the Orthodox church in government structure and strengthen state control on it and
p.000225: consequently on church charity. On Peter’s initiative social charity became state one. At Peter I times they took
p.000225: measures against beggary, parish as self- organized church and social unit was abolished.
p.000225: At the same time in the XVIII century higher medical education was formed in Russia. Hospital schools, medical
p.000225: department of the Moscow University, surgery academies were founded. In these circumstances the following
p.000225: feature of Russian nature revealed: to study and to alter forms and methods of organization appeared in other
...
p.000321: nowadays syncretism of oriental philosophy reveals itself in the fact that modern Uzbek philosophers and physicians do
p.000321: not make a clear distinction between secular and religious argumentation. Sacred texts have traditionally been a source
p.000321: of philosophical thought for Uzbek investigators. Western scientists usually state their positions. The Western
p.000321: bio[medical] ethics distinguishes between biomedical ethics based on religious teachings and secular biomedical ethics
p.000321:
p.000322: 322
p.000322:
p.000323: 323
p.000323:
p.000323: that uses ethical argumentation as such. Sacred texts offer a comprehensive collection of thoughts, and one may find in
p.000323: them confirmation from “above” of nearly any statement.
p.000323: Moslem teaching has developed special canons of the attitude to patients and disabled persons that, to a large
p.000323: extent, formed the basis for patient-physician relationship. First of all, Al Bukhari’s khadises remind Moslems
p.000323: that the Prophet suffered severely, and therefore, who, if not Him, knows better what it means to be ill and suffer
p.000323: (Abu Abdullah Muhammad ibn Ismoil al-Bukhoriy. Khadis. Al-jomi’ ac-cokhikh 4. Ishornali tiuplam. Tashkent, Komuslar
p.000323: bosh takhririiati, 1992. B. 3 – in Uzbek). Everything that befalls human beings is of God’s will. To visit the sick,
p.000323: even infants, is a duty of each Moslem. It is a tradition not to ask about the disease or name the disease aloud; one
p.000323: should ask about the general state of health and use euphemisms in telling the diagnosis: “that very illness”, “caught
p.000323: some cold”, “a bad illness”, etc. There are many variants. This is a kind of medical secrecy observed by persons in the
p.000323: patient’s environment. In the end of the visit the physician should say some words of support, to express his firm
p.000323: belief that the patient will recover, even if the physician knows that it is hardly possible. Moslems should support
p.000323: all disabled people and have mercy to ugly persons, because they are what they are of God’s will. To care for the
p.000323: disabled is the duty of all relatives and people from the community.
p.000323: Patients too have their duties. They have to bear their suffering as much as they can, not to grumble or fall into
p.000323: despair, to suppress one’s moans, not to ask for death. If a Moslem anticipates his death he should pay his debts,
p.000323: make his will and directions concerning funerals, beg everyone’s forgiveness and to repent of his sins
p.000323: (Sadyk-i-Kashgari M. Oriental Code of Decencies. Adab-ul-Salikhyn. Tashkent, 1992, pp. 35-37; in Uzbek). The precept
p.000323: “Thou should not ask for your death” suggests a direct answer to the question what Islamic teaching says about
p.000323: euthanasia. The person’s right to euthanasia, both active and passive still remains a topic of heated debates. Islam
...
Health / Pregnant
Searching for indicator pregnant:
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p.000033: Constitution of the Republic of Belarus, Art. 37 of the Constitution of Georgia, Art. 29 of the Constitution of the
p.000033: Republic of Kazakhstan, Art. 34 of the Constitution of the Kyrgyz Republic, Art. 36 of the Constitution of the
p.000033: Republic of Moldova, Art. 41 of the Constitution of the Russian Federation, Art. 38 of the Constitution of the
p.000033: Republic of Tajikistan, Art. 49 of the Constitution of the Republic of the Ukraine, Art. 40 of the Constitution of the
p.000033: Republic of Uzbekistan).
p.000033: Majority of the CIS countries also declared in their constitutions the right for medical care in different forms
p.000033: (excluding three republics – Armenia, Azerbaijan and Uzbekistan: in these states guarantees of availability of
p.000033: health care for people are set at the level of branch laws regulating public relationships in the health care system).
p.000033: At the same time one should note that the issue of underfunding in regard to required amount of medical care today is
p.000033: still one of the most acute problems almost in all countries of the Commonwealth.
p.000033: States implement programs on population health protection, measures for environmental protection and provision of
p.000033: free access to reliable information on its status, living and working conditions, quality of food products
p.000033: and household goods, facilitate development of physical culture and sports, create opportunities for various
p.000033: forms of health insurance. Financial support is guaranteed to pregnant women11, mothers with small children and in
p.000033: case of children with disabilities – until they become older
p.000033: – to families with many children, persons with various diseases and drug abuse. The state provides special care
p.000033: for those who broke their health protecting state and common interests. An important issue is inclusion into the
p.000033: sphere of state policy and legal regulation of an issue of preservation of national gene pool.
p.000033: It is truly important that virtually all CIS countries adopted branch laws related to issues of health care and patient
p.000033: rights – the Law of the Republic of Armenia On Medical Care and on Services for Population (1996), the Law of the
p.000033: Republic of Azerbaijan On Protection of Population Health (26.07.1997),
p.000033: 11 Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of Moldova,
p.000033: respectively.
p.000033:
p.000034: 34
p.000034:
p.000035: 35
p.000035:
p.000035: the Law of the Republic of Belarus On Health Care (1999), the Law of Georgia On Health Care (1997), the
p.000035: Law of the Republic of Kazakhstan On Protection of Population Health of the Republic of Kazakhstan (1991), the Law of
p.000035: the Kyrgyz Republic On Protection of Population Health of the Kyrgyz Republic (09.01.2005), the Law of the
...
p.000117: Bioethics Committees” (2005); UNESCO Guide No 2 “Bioethics Committees at Work: Procedures and Policies” (2005).
p.000117: The National Strategy of Steady Development and the Concept of Healthcare Development in Belarus (1995) are
p.000117: the basis for adopting legal acts and national programmes and determine particular measures and resources for ethical
p.000117: and legal control of biomedical research. Laws of Belarus “On Healthcare” (1999 with subsequent amendments), “On the
p.000117: Safety of Genetic Engineering” (2005), the Draft Law “On transplantation of Human Organs and Tissues”, orders and
p.000117: instructions of the Belarus Health Ministry of are in compliance with the main principles of bioethics set out by WHO.
p.000117: The central law determining the State policy in the sphere of citizens’ health protection, legal, economical and
p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armed forces, prisoners and persons under arrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
...
p.000167: order of development of biologically active substances and their preclinical studies or clinical trials of medical
p.000167: drugs. These articles were developed in the line with international experience (5):
p.000167: - the participation of the patient in clinical trials and (or) in testing of pharmaceutical substance or
p.000167: medical drug should be voluntary and is possible with his/her written informed consent only;
p.000167: - before clinical trials and (or) testing all information on the substance/ drug, on the contents of trials or tests,
p.000167: on safety and risks for patients health, on actions in the case of unforeseen effects of pharmaceutical substance or
p.000167: medical drug for the patient’s health as well as on patient’s health and life insurance should be provided to the
p.000167: patient;
p.000167: - the patient has a right to interrupt his/her participation in trials and (or) tests of pharmaceutical substance or
p.000167: medical drug at any phase of such trials or tests;
p.000167: - it is strictly prohibited to perform clinical trials and (or) tests of pharmaceutical substances or
p.000167: medical drugs with participation of: children and adolescents; pregnant women; military persons; imprisoned
p.000167: or incarcerated persons; non-competent persons.
p.000167: At the web-site www.medik.kz the Association of Physicians and Pharmacists of Kazakhstan has the page, where
p.000167: all legislative and regulatory documents in public health area. At present time specialists began to develop the Code
p.000167: of Republic of Kazakhstan “On Population Health and Public Health System” that will take into consideration all
p.000167: international legislative experience including legislative acts in area of biological and medical studies. For
p.000167: example, on 22nd of January 2007 the Frame Convention on Tobacco Control was officially ratified by the Republic of
p.000167: Kazakhstan; it is planned to bring laws of Kazakhstan in line with international documents that can ensure good
p.000167: clinical practice and improvement of activity of ethical committees [6].
p.000167: In 1995 according to initiative of the Association of Physicians and Pharmacists of Kazakhstan drafts of “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
p.000167: developed. In 2002 the Second Congress of Physicians and Pharmacists approved the text of “The Oath of Physician of the
p.000167: Republic of Kazakhstan” that was reflected in special Decree of the Government of the Republic of Kazakhstan No/ 1189
p.000167: published on 27th of November 2003 and in the article 50 of the Law of the Republic of Kazakhstan “On the
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
...
p.000167: In 2006 according the law “On changes and additions to some legislative documents on public health of the Republic of
p.000167: Kazakhstan” the article 20 was supplemented with the following paragraphs:
p.000167: «it is prohibited to perform clinical trials and(or) testing of pharmaceutical substances or medical drugs with
p.000167: participation of:
p.000167:
p.000167:
p.000168: 168
p.000168:
p.000169: 169
p.000169:
p.000169: - persons before coming to age with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treatment of children diseases or when the goal of clinical trial is to collect data on the optimal dosage of this
p.000169: medical drug supposed for usage in children and adolescents. In the last case clinical studies of any medical drug in
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
p.000169: The article 43 of the Law of the Republic of Kazakhstan “On the System of Public Health” published on 4th
p.000169: June 2003 contains the juridical definition of scientific medical expertise; in this article it is indicated that
p.000169: objects of scientific medical expertise are as follows:
p.000169: - drafts of programmes of basic and applied scientific research;
p.000169: - republican targeted scientific medical programmes;
p.000169: - results of completed scientific medical programmes and projects;
p.000169: - scientific research that were nominated for the state awards of the Republic of Kazakhstan;
p.000169: - results of scientific medical programmes that are supposed to be implemented into public health practice.
p.000169: The order of scientific medical expertise is determined by the national authority in public health area.
p.000169: The article 42 “Expertise of medical drug” of the same Law says that the expertise of medical drug represents a study
p.000169: or a trial of medical drug
...
p.000187:
p.000188: 188
p.000188:
p.000189: 189
p.000189:
p.000189: to life, physical and moral inviolability; the right to freedom and safety, the right to a free development of one’s
p.000189: personality; right to dignity and freedom of private life, confidentiality of personal and family information et al.
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
p.000189: elderly persons, disabled persons, persons who had suffered from an emergency situation and residents of ecologically
p.000189: unfavorable regions (Art. 67, 68, 69, 70, 71).
p.000189: The Law on Pharmaceutical Products (March 2003) regulates clinical trials of pharmaceutical products.
p.000189: According to this Law, no clinical trials of pharmaceutical products in Kyrgyz Republic may be carried out
p.000189: without the permission granted by the authorized healthcare state institution of Kyrgyz Republic. Those guilty of
p.000189: violating rules of clinical trials, falsifying clinical results obtained in clinical trials of pharmaceutical
p.000189: products or conducting the trials without the permission granted by an authorized healthcare state institutions of
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
p.000189: necessary for an authorized healthcare state institutions of Kyrgyz Republic to make a decision about a clinical trial
p.000189: of a pharmaceutical product. The list includes an approval by the ethics committee of an authorized
p.000189: healthcare state institution of Kyrgyz Republic. Article 27 states that the ethics committee of an authorized
p.000189: healthcare state
p.000189: institution of Kyrgyz Republic participates in the design of a clinical trial programme.
...
p.000189: pharmaceutical products and ensure the protection of patient’s rights.
p.000189: This Law contains important provisions concerning human rights in clinical trials of pharmaceutical
p.000189: products. In particular, it says that a patient gives his or her written consent to participate in a clinical
p.000189: trial of a pharmaceutical product and has the right to withdraw his or her consent at any stage of the research. Before
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
p.000189: out in such vulnerable patients as children without parents; military personnel; prisoners and persons under
p.000189: investigation in detention Centres; pregnant women (except for cases when clinical trials are designed specially
p.000189: for pregnant women and when the
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000191: 191
p.000191:
p.000191: necessary information can only be obtained in a clinical trial provided that the trail is not hazardous to a woman or
p.000191: to a fetus).
p.000191: Besides, the Law sets certain restrictions relating to clinical trials involving children. Thus the trials are
p.000191: only permitted if the investigational pharmaceutical product is specially indicated for use in children or to obtain
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
p.000191: trials of pharmaceutical products involving subjects with mental disorders may only be carried out after
p.000191: obtaining a written informed consent from a legally authorized representative in accordance with applicable law.
...
p.000249: The provision of the Law concerning the necessity of health insurance as well as insurance of civil liability of
p.000249: persons who carry out the study (items 3, 9 of the article 40, items 2 of the article 38) ensures an important
p.000249: additional guarantee of protection of subjects’ interests.
p.000249: At the same time, we cannot but mention an excessively “soft” approach to the question of terminating a clinical trial
p.000249: in the case of events that may be hazardous to the patient’s health. The Law states only that clinical trials may be
p.000249: terminated, while it should state that clinical trials must be terminated.
p.000249: Aiming at safeguarding the rights and interests of vulnerable contingents the Law forbids or
p.000249: limits their participation in clinical trials of medicines. Particularly clinical trials involving minors who
p.000249: don’t have parents, soldiers, persons under any form of detention or imprisonment is absolutely forbidden. The Law also
p.000249: sets up the limitation for the cases of clinical studies involving minors who have parents – such studies may be
p.000249: conducted only if pharmaceutical product is proposed for treatment of child diseases or if the aim of clinical trial is
p.000249: the getting the information about the best dosing of drug for therapy of minors. In latter situation the clinical trial
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
p.000249: carried out only after obtaining the written consent of legal guardians of these persons32.
p.000249: The latter Law states that all persons with mental disorders have to right for the preliminary consent or to refusal at
p.000249: any time to be used as a subject of trials of drugs and medical methods, scientific investigations or study
p.000249: process, video or photo or film shooting (item 2 of the article 2).
p.000249: Besides the Article 11 of this Law clarifies that the clinical trials involving persons under compulsory
p.000249: medical treatment or involuntarily hospitalized persons are absolutely prohibited.
p.000249: Such a key element of the ethical review as confidentiality of the information about patient and
p.000249: received from the patient throughout biomedical research is guarantied by means of the institute of medical
...
p.000271: duration of the study, and approximate number of the subjects in different regions and in the given clinical site. The
p.000271: information provided to the patient shall be logically completed with the informed consent form, which exhibits, if
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
...
Health / Terminally Ill
Searching for indicator terminally:
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p.000115: self-perception and impersonal collectivism; the feeling of belonging to the humankind and national
p.000115: self-boasting; humility and inclination to a revolt; love of freedom and a need for the authoritarian State system.
p.000115: These features show themselves distinctly in social life, business relations and scientific activity. Besides,
p.000115: Orthodoxy has always supported orientation towards a strong power, as the Orthodox Church believed that only
p.000115: a strong State system could struggle against evil. At the same time, Lossky noted that in their character the
p.000115: Slavs are more disposed to democracy, which shows itself, for example, in the protest against all sorts of
p.000115: conventionalities.
p.000115: Currently the Orthodox Church still has a strong effect on the development of bioethics in Belarus,
p.000115: which has both positive and negative aspects. The programme of interaction between the Orthodox Church of the country
p.000115: and the Belarus Health Ministry of is being realized. The programme helps to introduce moral constants into the medical
p.000115: community, facilitates moral and spiritual growth of the worldview of students (future specialists in medicine, biology
p.000115: and biotechnology) and the general growth of bioethical competence in the society. A rich experience in promoting ideas
p.000115: of bioethics has the Orthodox Medical Brotherhood at the Minsk Eparchy of the Belarus Exarchate. Charity Centre has
p.000115: been organized at the Parish of the Church of All Saints in Minsk. Belarus Children’s Hospice within Children’s Cancer
p.000115: Centre provides spiritual and medico-psychological care for terminally ill children. However we should not ignore the
p.000115: conservatism of the Orthodox Church and, in particular, with regard to topical bioethical problems. In
p.000115: relation to a number of bioethical problems, the Orthodox Church adheres to a very strict position: it prohibits human
p.000115: cloning and cloning of human organs (especially heart cloning) and euthanasia; expresses censure on artificial
p.000115: fertilization, abortion, sexual education of young people. They also hold to uncompromising position regarding some
p.000115: issues of transplantation of certain organs, which showed itself in the discussion of amendments to the “Law on
p.000115: Transplantation of the Republic of Belarus”.
p.000115: Since 1995 bioethics in Republic Belarus has been developing in parallel, along two main lines — theoretical
p.000115: and practice-organizing ones, and initially the connection between these lines was rather weak.
p.000115: Theoretical trend implied the analysis of bioethics as an interdisciplinary scientific knowledge showing, most
p.000115: fully, the tendencies of science development in the XX century. On the other hand, bioethics was analyzed as a
p.000115: special field of applied ethics with its distinctive features and modifications, and, at the same time, allegiant to
p.000115: fundamental ethical principles and general human values [8, part II, 9,10,13]. In choosing priorities we are guided,
p.000115: first of all, by general tendencies in the evolution of scientific knowledge as a whole, and ethics in particular, as
...
Searching for indicator terminal:
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p.000089: translated into Armenian. Those texts inspired medieval Armenian physicians and naturalists, e.g. Grigor
p.000089: Magistros (X-XI c.), Mekhitar Heratsi (XII c.), Amirdovlat Amasiatsi (XV c.) et al.
p.000089: It is noteworthy that great Armenian philosophers (David the Invincible, Anania Shirakatsi et al.) placed high
p.000089: emphasis on the problems of good and evil, suffering and compassion, life and death. They considered those issues
p.000089: in light of Christian morals. Today Armenian Apostolic Church is continuing this tradition. Suffice it to say,
p.000089: that the Ararat Eparchy with its rich experience in propagating ideas of bioethics is planning to establish a Church
p.000089: Public Council for Medical Ethics. Armenian Apostolic Church takes a rather strict position on some problems of
p.000089: bioethics: it prohibits human cloning and cloning of human organs, euthanasia, artificial fertilization and abortion,
p.000089: which is considered as infringement of human life.
p.000089: In this context the views of David Anhaght (the Invincible) formulated in his works (“Definition of Philosophy”,
p.000089: “Commentary on Aristotle’s Analytics” and “Commentary on Porphyry’s Introduction”) are of much interest.
p.000089: David Anhaght took problems of medical ethics very much to heart. His ideas on the value of human life are of
p.000089: particular importance. In his book “Definition of Medicine” he mentioned views of the Stoics who tended to justify
p.000089: suicide under certain conditions: starvation, loss of close relatives, natural cataclysms, violation of human dignity,
p.000089: terminal illness and senile marasmus. Two last cases are directly related to medicine. The Stoics wrote: “A man who
p.000089: kills himself to rid himself of pain in his ill and wretched body, commits the righteous act. Thus, a philosopher
p.000089: who was half-paralyzed appealed to the emperor Julian: Half of my body is dead; the other half is still alive. Have
p.000089: pity on the half-alive philosopher and order either to heal or to kill me. Likewise, it would be right for a man who
p.000089: had reached old age to kill himself when he is delirious, confused and utters meaningless phrases”.
p.000089: David Anhaght did not share Stoic views on permissibility of suicides under conditions mentioned: “In this regard
p.000089: we say that no one should kill oneself – neither those who have the right to do this, nor those who don’t… Trials,
p.000089: whenever or wherever they happen, come to us not in order that we should kill ourselves, but so that we tried our soul.
p.000089: Like a good helmsman is tested not in still water, but in the stormy sea, the lofty soul goes to meet a trial”.
p.000089: Thus David Anhaght (the Invincible), in line with Nerses the Great, a prominent philosopher (V c.), gave a negative
p.000089: answer to the question “Does the physician have a moral right to hasten his patient’s death?”.
p.000089:
p.000090: 90
p.000090:
p.000091: 91
p.000091:
p.000091: Similar views we find in works of Armenian thinkers Mkhitar Hosha and Smbat Hundstabl (XIII c.). In “The Book
p.000091: of Laws” we read: “The physician who deliberately or through ignorance does harm to the patient’s health or, what
...
p.000323: should ask about the general state of health and use euphemisms in telling the diagnosis: “that very illness”, “caught
p.000323: some cold”, “a bad illness”, etc. There are many variants. This is a kind of medical secrecy observed by persons in the
p.000323: patient’s environment. In the end of the visit the physician should say some words of support, to express his firm
p.000323: belief that the patient will recover, even if the physician knows that it is hardly possible. Moslems should support
p.000323: all disabled people and have mercy to ugly persons, because they are what they are of God’s will. To care for the
p.000323: disabled is the duty of all relatives and people from the community.
p.000323: Patients too have their duties. They have to bear their suffering as much as they can, not to grumble or fall into
p.000323: despair, to suppress one’s moans, not to ask for death. If a Moslem anticipates his death he should pay his debts,
p.000323: make his will and directions concerning funerals, beg everyone’s forgiveness and to repent of his sins
p.000323: (Sadyk-i-Kashgari M. Oriental Code of Decencies. Adab-ul-Salikhyn. Tashkent, 1992, pp. 35-37; in Uzbek). The precept
p.000323: “Thou should not ask for your death” suggests a direct answer to the question what Islamic teaching says about
p.000323: euthanasia. The person’s right to euthanasia, both active and passive still remains a topic of heated debates. Islam
p.000323: may not approve of either kind of euthanasia, as it is nothing but a conscious murder of a human being (even if he/she
p.000323: has a terminal illness) committed by another person, particularly by a physician. If the patient has a terminal
p.000323: illness, the physician’s duty is to relieve his/her suffering with various analgesics and to render moral support
p.000323: in the face of impending death, so that the patient would leave this world as a sensible person who
p.000323: completed all his/her earthy tasks, bid farewell to his/her relatives and repented before the Almighty Allah.
p.000323: Abu Ali Ibn Sina (980-1037) expressed his attitude to euthanasia in his “Biography” wrote that a
p.000323: seriously ill person consciously “broke the regimen for the last time”, which hastened his death. Here
p.000323: we have to mention his views on medical and ethical problems of dying and natural death. These views expand the scope
p.000323: of modern bioethics, which allows us to retransmit from the past entire strata of knowledge about the physician’s duty
p.000323: and search of new ways for applying ethics when it is necessary to care for a dying patient, to form behaviour
p.000323: standards in seriously ill patients, to safeguard their rights for a good death and to maintain their faith in
p.000323: spiritual and moral immortality of human soul.
p.000323: In the light of the aforesaid, Ibn Sina’s treatise “Illumination” that is not widely known among researches is of a
p.000323: particular interest. The treatise adds to concepts of natural death presented in “Canon”. In modern terms, the treatise
p.000323: suggests that the philosophy of death ensues logically from a moral comprehension of life. Ibn Sina offers a systemic
...
p.000349: biomedical research subjects in connection with the use of achievements in biology and medicine.
p.000349: The Congress participants made many interesting presentations. The Minister of Healthcare of Uzbekistan, prof.
p.000349: F.G.Nazirov spoke about ethical aspects of using new technologies in medicine; Doctor of Philosophy, professor Moshin
p.000349: Ebrahim from the Islamic University of South African Republic shared his opinion on the rights of a fetus; scientists
p.000349: from Philippines, Ukraine and Russia touched upon ethical problems concerning the use of embryonic and stromal human
p.000349: stem cells in treating various diseases. The Chairperson of the FECCIS, prof. O.I.Kubar from St.-Petersburg and Dr.U.
p.000349: Sharapov gave a talk
p.000349: on ethical aspects of clinical trials concerning HIV/AIDS; physicians from the Republican Specialized Surgery Centre at
p.000349: the Ministry of Public Health of Uzbekistan spoke about bioethical aspects of organ and tissue transplantation, and
p.000349: specialists from the Scientific Centre for Emergency Medical Care presented talks on similar problems in
p.000349: emergency medicine.
p.000349: J.N.Franco from Singapore and a group of physicians from Belgium spoke about problems of patient—physician relationship
p.000349: in the conditions of a rapid development of new biotechnologies and about truth-telling with regard to
p.000349: patients with terminal diseases. M.Baimukhamedov gave a talk on ethical aspects of the protection of patients’ rights
p.000349: in TV-medical consultations. The Congress participants discussed problems of ecological ethics and the use of
p.000349: genetically modified products and their effect on integral health (presentations by academician T.I.Iskanderov
p.000349: from Uzbekistan, Z.Nasyrova and Z.Akhrorova - scientists from Kazakhstan and Tajikistan). The Head of the WHO
p.000349: Office in Uzbekistan Dr. Arun Nanda, prof.
p.000349: E.I.Musabaev (Uzbekistan), physicians from Russia, The Tashkent Medical Academy and Samarkand Scientific Center
p.000349: presented talks on legal aspects of bioethics.
p.000349: The Chairperson of the NEC and of the Medical Council of the Ministry of Public Health, academician
p.000349: M.S.Abdullakhodjaeva spoke about ethics in science, and professors from the Tashkent Medical Academy
p.000349: Sh.E.Atakhanov, M.T.Rustamova and others discussed issues on teaching ethics to medical students.
p.000349: In the framework of the Congress a training seminar was held for considering fundamental problems of
p.000349: bioethics. Members of ECs from Uzbekistan, Kyrgyzstan and Tajikistan took part in the seminar.
p.000349: The First National Congress on Bioethics adopted a Resolution that reflected basic priorities of biomedical
p.000349: ethics in Uzbekistan and set out a programme for the NEC activity relating to the development of bioethics in
p.000349: Uzbekistan. The Ethical Code of Uzbekistan Physician-Investigator regulates moral aspects of physicians’
...
Health / addiction
Searching for indicator addicts:
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p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
p.000023: addicts. Every five years the amount of drug addicts in the “youngest” group is increasing by 100%. The children
p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
p.000023: population, and where in the case of an essential improvement of the economic situation the extended reproduction may
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
p.000023: To summarize the analysis of the demographic situation, it is necessary to note that with regard to self-preservation
p.000023: the following public processes are crucial:
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
...
p.000247: disinfectants, and conducting biomedical research29. The Article states that biomedical research may only be
p.000247: conducted at the institutions of public or municipal system of healthcare and should be preceded by preliminary
p.000247: laboratory studies. Besides, it is indicated that methods of disease prevention, diagnostics and
p.000247: treatment, as well as pharmaceutical products are not officially permitted but are under consideration
p.000247: according to the established procedure can be applied in the interests of a patient. Hence, we may conclude that
p.000247: Fundamentals of Legislation relate only to clinical (therapeutic) research. The mentioned Act also demands as an
p.000247: obligatory condition for biomedical research the written voluntary consent of a subject for participating in the study
p.000247: and guaranties his right to withdraw the consent at any moment of the study. Before the obtaining of consent for
p.000247: biomedical research the patient should be informed about goals, methods, side effects, possible risk, duration and
p.000247: expected results of the investigation.
p.000247:
p.000247: 28 Constitution of the Russian Federation, St-Pb, 1995.
p.000247: 29 Fundamental principals of Legislation of Russian Federation Concerning Public Healthcare?
p.000247: on 22 of July 1993// Rossiyskaya Gaseta, August 18, 1993. № 158.
p.000247: The given Article sets rather strict limitations on research involving minors (under 15 – in general
p.000247: cases, and under 16 in the case of drug addicts). In this case, the methods of disease prevention, diagnostics
p.000247: and treatment, as well as pharmaceuticals that are not officially permitted but are under consideration may only be
p.000247: applied for the treatment of minors if there is a direct threat to their life and with a written consent
p.000247: of their legal representatives. Here we should mention the Act “On Applying Pharmaceutical Products according
p.000247: to the Necessities of life” adopted by the Order of Ministry of Health and Social Development (09.08.2005, No. 494).30
p.000247: This Act regulates issues relating to the individual case of application, according to the necessities of life, of a
p.000247: pharmaceutical product that is not registered in Russian Federation. This is a matter of non-interventional
p.000247: research. The decision about the use of a pharmaceutical product in this case is made via the Federal
p.000247: specialized medical commission; the protocol is documented and signed by the medical director of the director of the
p.000247: Federal specialized medical commission. This document emphasizes again the need to seek the patient’s voluntary written
p.000247: consent (in cases provided by law the consent from the patient’s legal representatives) to apply an
p.000247: unregistered pharmaceutical product. The physician should inform the patient about the pharmaceutical product, its
...
p.000289: findings for economic reasons. To eliminate this injustice, the medical community took certain measures. The WMA
p.000289: Declaration of Helsinki and the additional Protocol to the CE Convention on Human Rights and Biomedicine require
p.000289: that in the countries where a biomedical research is planned the permission should be sought from state structures, and
p.000289: interests of people who live there and who are potential research subjects should be considered.
p.000289: The involvement of Republic of Tajikistan, as an independent state, in international research projects
p.000289: requiring ethical review to ensure the compliance with international regulations triggered the process of
p.000289: establishing in Tajikistan the Committee on Medical Ethics and developing the system
p.000289: of State registration of pharmaceutical products, medical facilities and other medical goods.
p.000289: For a further development of medical ethical review of scientific-research projects, the Ministry of Health established
p.000289: the Republican Committee on Medical Ethics at the Department of the Management of Medical Personnel and Science (Order
p.000289: No 250; 4 of June 2004). The first research project that had to undergo ethical review to ensure the compliance
p.000289: with documents setting international rules in ethics was a joint Tajik-American research on AIDS and hepatitis C in
p.000289: drug addicts.
p.000289:
p.000289: 3.9.2. Legal Regulations
p.000289:
p.000289: One of fundamental human rights is the right for life and health protection. Health is a natural, absolute
p.000289: and vitally important value taking the top position in the hierarchy of human values and in the system of such
p.000289: categories of human existence as interests and ideals, harmony and beauty, the meaning of life, happiness, creative
p.000289: labour and rhythm of life.
p.000289: The execution and efficiency of legal regulations depends on how much they correspond with moral requirements. Quite
p.000289: often legal regulations fix moral norms directly and reinforce them with legal sanctions. Thus, many legal norms
p.000289: prohibit actions that are hazardous to the society and human health.
p.000289: In healthcare, the integration of moral and ethical norms into the legal system should be a priority. Therefore, the
p.000289: moral and ethical components in the work of medical professionals should correspond to legislative principles
p.000289: referring to the protection of the patient’s rights and dignity. By now, the Committee on Medical Ethics at the Health
p.000289: Ministry of Republic of Tajikistan (HM RT) has worked out a number of important documents adapted to the needs of
p.000289: Tajikistan:
p.000289: • the Statement “On the Committee on Medical Ethics” (HM RT Order of No 118, 10 of March 2005);
p.000289: • “Ethical Aspects of Regulations for Clinical Practice in Republic of Tajikistan” (Supplement to the HM RT Order No
p.000289: 118, 10 of March 2005) and
...
p.000329:
p.000329: the activity of state structures, national enterprises, institutions and public unions in the field of healthcare
p.000329: (Kolesnikova L. Some Legal Aspects of Regulating Physician--Patient Relationship. Materials of the First National
p.000329: Congress on Bioethics with International Participation. Tashkent, 2005, pp. 58-59; Kolesnikova L. Relations of Doctor
p.000329: and Patient in the Light of Laws in Force in Uzbekistan: Clinical, Philosophical and Legal Aspects. Tashkent, 2006, pp.
p.000329: 129-135).
p.000329: Article 3 of the Law defines main principles of citizens’ health protection:
p.000329: - observance of human rights in the field of health protection;
p.000329: - availability of medical care for all social strata;
p.000329: - the priority of preventive measures;
p.000329: - social protection of citizens in cases of health loss;
p.000329: - the unity of medical science and practice.
p.000329: According to Article 13 of the Law, “…the State ensures the protection against discrimination irrespective of a disease
p.000329: the citizen has. Appropriate sanctions should be applied in the event of infringement of the provisions contained in
p.000329: this Article”.
p.000329: Nevertheless, in current practice of physician—patient relationship there are cases of marginalization and
p.000329: stigmatization, which shows itself in relation to most vulnerable social groups – drug and alcohol addicts, sex
p.000329: workers, etc. In the event of diagnosing an “improper disease” (venereal diseases, AIDS) a patient is labeled as
p.000329: “shameful”. A suspicious attitude of medical staff to patients with such a diagnosis infringes patients’ rights, which
p.000329: affects their moral and psychological state and, consequently, has a negative impact on the treatment efficiency.
p.000329: According to Article 24 of the Law, the patient has the right to:
p.000329: - respectful and humane attitude of medical staff;
p.000329: - choice of a physician;
p.000329: - medical aid (examination, treatment, etc.) provided in compliance with relevant sanitary requirements;
p.000329: - consultation by a medical specialist on the patient’s request;
p.000329: her health condition;
p.000329: - compensation in the event of a damage to his/her health;
p.000329: - access to a lawyer or another representative for the protection of his/ her rights.
p.000329: In case of infringement of a patient’s rights, his/her legal representative may make a complaint to any instance.
p.000329: Article 34 of the law “On the Protection of Citizens’ Health” permits to conduct biomedical research involving human
p.000329: subjects at state institutions after laboratory experiments and with informed consent from a research
p.000329: participant.
p.000329: To protect patients’rights and dignity,Article 25 prohibits propagandizing, including information in mass media,
p.000329: methods of prevention, diagnostics and treatment, as well as pharmaceutical products unless they undergo trials.
...
Health / alcoholism
Searching for indicator alcoholism:
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p.000007: of a living standard for its residents if it does not participate in regulation of the current demographic situation
p.000007: and labour market.
p.000007: The demographic situation in the CIS countries has both common and specific features. Common features
p.000007: result from a long-term socio- economic crisis of the 1990s, discrepancy between introduced reforms and
p.000007: social policy, a dramatic decline in living standards at various social levels, and aggravation of ecological
p.000007: conditions. Specific features in each State are determined by different styles of life in the CIS countries due to
p.000007: their historical, religious, cultural and ethnic development. All these factors resulted in a general fertility rate
p.000007: decrease, mortality growth and a fall of the health quality index. These processes affect negatively the demographic,
p.000007: labour and migration potential of the CIS countries.
p.000007: The last decade of the XX century was characterized by an essential aggravation of the demographic situation that could
p.000007: be defined as a crisis. High mortality rates had practically no precedents in the Eurasian peacetime history. The
p.000007: “excess mortality” in the period since 1989 was much higher than the mortality rate in the period of Great Depression
p.000007: in the North America (1929-1933). Besides, recent changes of mortality rate, marriage ability and fertility shifts have
p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
...
p.000023: ten years the rate of mental diseases in children doubled, that of moronity increased in 1.5 times and imbecility in
p.000023: 1.6 times. We have to recognize the growing number of disabled children; in the CIS countries there are about 1.5
p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
p.000023: addicts. Every five years the amount of drug addicts in the “youngest” group is increasing by 100%. The children
p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
p.000023: population, and where in the case of an essential improvement of the economic situation the extended reproduction may
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
p.000023: To summarize the analysis of the demographic situation, it is necessary to note that with regard to self-preservation
p.000023: the following public processes are crucial:
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
p.000023: mortality in able-bodied population, “rejuvenation” of some diseases, spread of alcoholism and drug addiction;
p.000023: - the change in consumption of genetically habitual food products, decrease in food calorie content for the
p.000023: considerable part of the society;
p.000023: - reduced access to social services in conditions of a large-scale commercialization, which negatively
p.000023: affects the quality of human resources, intellectual, scientific and physical potential of the country;
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000025: 25
p.000025:
p.000025: - the decreasing number of medical institutions; a level of the population morbidity and mortality still remains
p.000025: high; the number of handicapped people is increasing;
p.000025: - stratification of the society by income, when 10% of the most well- to-do population have incomes more than 10 times
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
...
Health / degenerative conditions
Searching for indicator degenerate:
(return to top)
p.000043: law of IPA CIS On Protection of Human Rights and Dignity in Biomedical Researches in the CIS and the text of
p.000043: the model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS can be also
p.000043: found at the following web sites: www. feccis.net and www.pasteur-nii.spb.ru
p.000043:
p.000044: 44
p.000044:
p.000045: 45
p.000045:
p.000045: Chapter 2. CURREnt StAtUS AnD PERSPECtIVE oF tHE CIS’ REGIon PARtICIPAtIon
p.000045: In tHE IntERnAtIonAL BIoMEDICAL RESEARCH
p.000045:
p.000045: 2.1 Philosophical Aspects of the Biomedical Research (P.D.tishchenko, B.G.Yudin)
p.000045:
p.000045:
p.000045: Philosophy of modern biomedical research (BMR) is a limitless topic with multiplicity of versatile aspects. Here we
p.000045: would like to dwell on those of them that are to some extent are related to issues of ethical examination
p.000045:
p.000045: Specific Position of Science in the Modern Culture
p.000045: Understanding of trends of development of the modern biomedical research is impossible without taking
p.000045: into account on-going general civilization transformations of our days. First of all, let’s take a look at the
p.000045: most general context of the issue.
p.000045: In this respect it is necessary to remind about a central role that science have played and still plays in the modern
p.000045: culture. As to exact expression by E. Husserl: “When at the beginning of the New Age religious belief began
p.000045: to degenerate more and more into lifeless convention, intellectual humanity stood in a new great faith –
p.000045: faith into autonomous philosophy and science. Scientific judgments were to highlight and guide entire human culture
p.000045: providing it with new autonomous form.” (Husserl E. Cartesian Meditations, p.14). If to take into account that
p.000045: ideology of new European education to a large extent is a gradual process of mastering the system of scientific
p.000045: knowledge, then without exaggeration one can say that the modern man (unlike a person in the Christian culture) is
p.000045: created “in the image and likeness of a scientist”.
p.000045: The leading position of science is retained and considerably strengthened gaining qualitatively new forms. Along
p.000045: with that, in the modern cultural situation science becomes more tolerant to other forms of cognition
p.000045: and comprehending of the reality. Ideas, concepts and practices that several decades ago were considered
p.000045: as superstitions are rehabilitated and gain status of fully-developed modern doctrines. In the whole world
p.000045: one can
p.000045: observe revival of archaic (shamanism, cabala and other esoteric practices) and creation of new non-scientific
p.000045: (and often anti-scientific) ideologies. Appear new bridges for cooperation between science and traditional religions
p.000045: appear.
p.000045: Another process is ongoing along with this paradoxical one. Science is still a mainstream for resolution of human
...
Health / hospitalized patients
Searching for indicator hospitalized:
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p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
p.000249: carried out only after obtaining the written consent of legal guardians of these persons32.
p.000249: The latter Law states that all persons with mental disorders have to right for the preliminary consent or to refusal at
p.000249: any time to be used as a subject of trials of drugs and medical methods, scientific investigations or study
p.000249: process, video or photo or film shooting (item 2 of the article 2).
p.000249: Besides the Article 11 of this Law clarifies that the clinical trials involving persons under compulsory
p.000249: medical treatment or involuntarily hospitalized persons are absolutely prohibited.
p.000249: Such a key element of the ethical review as confidentiality of the information about patient and
p.000249: received from the patient throughout biomedical research is guarantied by means of the institute of medical
p.000249: secrecy stipulated by the Fundamental principles of Legislation and by the institute of personal and family secrecy
p.000249: (privacy) provided by the Constitution of the Russian Federation (the Article 23). It is also necessary to take into
p.000249: account the general norms guarantying the protection of personal data which are fixed by the Federal Law
p.000249: of the Russian Federation “On information, information technologies and protection of information” of 27 July
p.000249: 2006 and by the Federal Law of the Russian Federation “On personal data” of 27 July 200633.
p.000249: 32 Federal Law of Russian Federation “On psychiatric assistance and related guarantees of citizens” N 3185-1 of July
p.000249: 2, 1992 // Vedomosty of CND and VS RF, 20 of August 1992.
p.000249: № 33, article 1913.
p.000249: 33 Federal Law of Russian Federation “On information, information technologies and protection of
p.000249: information” of July, 27 2006, Federal Law of Russian Federation “On personal data” on 27 of July 2006// Rossiyskaya
p.000249: Gaseta, N 165, 29.07.2006
p.000249:
p.000250: 250
p.000250:
p.000251: 251
p.000251:
p.000251: The legal rules on specifics of the institutes of informed consent and medical secrecy in some particular situations as
...
Health / ill
Searching for indicator ill:
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p.000069: its global effect on the development of ethical ideas and on the ways of their implementation at the
p.000069: general level of civilization in the history of humankind is quite obvious. From the theoretical viewpoint, it is
p.000069: impossible to speak about the history of medical ethics without considering interdependent processes of the
p.000069: development of various ethical concepts and an essential role of main landmarks in the history of world ethical
p.000069: practice that have determined a harmonious and comprehensive understanding of general ethical principles of the
p.000069: research.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000071: 71
p.000071:
p.000071: From the practical point of view, the history of biomedical research ethics is inseparable from
p.000071: understanding the essence and process of the biomedical research as such.
p.000071: According to the main research subject, the biomedical research may be divided into the following categories:
p.000071: • Research that physicians carry out on themselves (autoexperiments);
p.000071: • Research involving healthy people;
p.000071: • Research involving patients.
p.000071: In historical context, the concept of informed and voluntary consent of a research subject requires subdividing
p.000071: into separate groups within these categories
p.000071: Besides, both in healthy (e.g. prisoners and military men) and ill (e.g. persons with mental disorders or ill
p.000071: minors) research subjects, groups of vulnerable contingents should be distinguished, i.e. groups of persons who for
p.000071: social, legal, age-specific, intellectual, mental or other reasons have a limited capacity or do not
p.000071: have the capacity to make an independent, informed and voluntary decision to participate in a clinical research.
p.000071: It is also essential to distinguish different types of biomedical research depending on the character of the connection
p.000071: between the research goal and its actual clinical motivation.
p.000071: Research of the first type, defined in international documents as “therapeutic” (or clinical) biomedical
p.000071: research, implies the application of new diagnostic, therapeutic or preventive pharmaceuticals or methods, i.e.
p.000071: research conducted in the interests of a particular research subject.
p.000071: Research of the second type, defined as “non-therapeutic” (or non- clinical) biomedical research, does not
p.000071: imply actions in the interests of ill or healthy subjects. Biomedical research is carried out with the purpose of
p.000071: obtaining some scientific knowledge or studying how the human organism would respond to one or another condition or
p.000071: factor (pharmokinetic studies, studies in the field of normal physiology, in cosmonautics and sport, etc.).
p.000071: Each of the mentioned types of biomedical research forms and determines special ethical and legal
p.000071: relations. In historical context, the influence of ethical dialectics of each type of biomedical research on the
p.000071: current concept of bioethics is most essential.
p.000071: Thus, high moral principles of physicians (investigators) who conducted experiments on themselves gave rise to a symbol
p.000071: of heroic dedication - a “burning candle”, which personified the motto of medical profession “Aliis lucens uror”. The
p.000071: history of medicine knows many examples of heroic dedication to science, self-sacrifice and modesty. Often
p.000071: those experiments ended tragically and entered the chronicle of “tragic medicine” in the world history. Among
p.000071: devotees there are many physicians (investigators) representing peoples of the CIS countries, which is
p.000071: reflected in chapters describing the cultural and historical background of ethics development in each
p.000071: country. On the whole, the scientific feat of those people is of a supranational character, and arouses feelings of a
p.000071: deep respect and admiration. Their work served the purpose of scientific knowledge, saving people’s life and making
p.000071: achievements for the welfare of the humankind.
...
p.000089: It is noteworthy that great Armenian philosophers (David the Invincible, Anania Shirakatsi et al.) placed high
p.000089: emphasis on the problems of good and evil, suffering and compassion, life and death. They considered those issues
p.000089: in light of Christian morals. Today Armenian Apostolic Church is continuing this tradition. Suffice it to say,
p.000089: that the Ararat Eparchy with its rich experience in propagating ideas of bioethics is planning to establish a Church
p.000089: Public Council for Medical Ethics. Armenian Apostolic Church takes a rather strict position on some problems of
p.000089: bioethics: it prohibits human cloning and cloning of human organs, euthanasia, artificial fertilization and abortion,
p.000089: which is considered as infringement of human life.
p.000089: In this context the views of David Anhaght (the Invincible) formulated in his works (“Definition of Philosophy”,
p.000089: “Commentary on Aristotle’s Analytics” and “Commentary on Porphyry’s Introduction”) are of much interest.
p.000089: David Anhaght took problems of medical ethics very much to heart. His ideas on the value of human life are of
p.000089: particular importance. In his book “Definition of Medicine” he mentioned views of the Stoics who tended to justify
p.000089: suicide under certain conditions: starvation, loss of close relatives, natural cataclysms, violation of human dignity,
p.000089: terminal illness and senile marasmus. Two last cases are directly related to medicine. The Stoics wrote: “A man who
p.000089: kills himself to rid himself of pain in his ill and wretched body, commits the righteous act. Thus, a philosopher
p.000089: who was half-paralyzed appealed to the emperor Julian: Half of my body is dead; the other half is still alive. Have
p.000089: pity on the half-alive philosopher and order either to heal or to kill me. Likewise, it would be right for a man who
p.000089: had reached old age to kill himself when he is delirious, confused and utters meaningless phrases”.
p.000089: David Anhaght did not share Stoic views on permissibility of suicides under conditions mentioned: “In this regard
p.000089: we say that no one should kill oneself – neither those who have the right to do this, nor those who don’t… Trials,
p.000089: whenever or wherever they happen, come to us not in order that we should kill ourselves, but so that we tried our soul.
p.000089: Like a good helmsman is tested not in still water, but in the stormy sea, the lofty soul goes to meet a trial”.
p.000089: Thus David Anhaght (the Invincible), in line with Nerses the Great, a prominent philosopher (V c.), gave a negative
p.000089: answer to the question “Does the physician have a moral right to hasten his patient’s death?”.
p.000089:
p.000090: 90
p.000090:
p.000091: 91
p.000091:
p.000091: Similar views we find in works of Armenian thinkers Mkhitar Hosha and Smbat Hundstabl (XIII c.). In “The Book
p.000091: of Laws” we read: “The physician who deliberately or through ignorance does harm to the patient’s health or, what
p.000091: is more, hastens the patient’s death, as well as the physician who educates a disciple, but does not give him proper
p.000091: knowledge deserves a severe punishment, up to death penalty”.
p.000091: This discussion started many ages ago is still topical nowadays. Neither lawsuits against physicians who
...
p.000115: self-boasting; humility and inclination to a revolt; love of freedom and a need for the authoritarian State system.
p.000115: These features show themselves distinctly in social life, business relations and scientific activity. Besides,
p.000115: Orthodoxy has always supported orientation towards a strong power, as the Orthodox Church believed that only
p.000115: a strong State system could struggle against evil. At the same time, Lossky noted that in their character the
p.000115: Slavs are more disposed to democracy, which shows itself, for example, in the protest against all sorts of
p.000115: conventionalities.
p.000115: Currently the Orthodox Church still has a strong effect on the development of bioethics in Belarus,
p.000115: which has both positive and negative aspects. The programme of interaction between the Orthodox Church of the country
p.000115: and the Belarus Health Ministry of is being realized. The programme helps to introduce moral constants into the medical
p.000115: community, facilitates moral and spiritual growth of the worldview of students (future specialists in medicine, biology
p.000115: and biotechnology) and the general growth of bioethical competence in the society. A rich experience in promoting ideas
p.000115: of bioethics has the Orthodox Medical Brotherhood at the Minsk Eparchy of the Belarus Exarchate. Charity Centre has
p.000115: been organized at the Parish of the Church of All Saints in Minsk. Belarus Children’s Hospice within Children’s Cancer
p.000115: Centre provides spiritual and medico-psychological care for terminally ill children. However we should not ignore the
p.000115: conservatism of the Orthodox Church and, in particular, with regard to topical bioethical problems. In
p.000115: relation to a number of bioethical problems, the Orthodox Church adheres to a very strict position: it prohibits human
p.000115: cloning and cloning of human organs (especially heart cloning) and euthanasia; expresses censure on artificial
p.000115: fertilization, abortion, sexual education of young people. They also hold to uncompromising position regarding some
p.000115: issues of transplantation of certain organs, which showed itself in the discussion of amendments to the “Law on
p.000115: Transplantation of the Republic of Belarus”.
p.000115: Since 1995 bioethics in Republic Belarus has been developing in parallel, along two main lines — theoretical
p.000115: and practice-organizing ones, and initially the connection between these lines was rather weak.
p.000115: Theoretical trend implied the analysis of bioethics as an interdisciplinary scientific knowledge showing, most
p.000115: fully, the tendencies of science development in the XX century. On the other hand, bioethics was analyzed as a
p.000115: special field of applied ethics with its distinctive features and modifications, and, at the same time, allegiant to
p.000115: fundamental ethical principles and general human values [8, part II, 9,10,13]. In choosing priorities we are guided,
p.000115: first of all, by general tendencies in the evolution of scientific knowledge as a whole, and ethics in particular, as
...
p.000225: A.S.Shumlyanskiy exemplify it. Physicians of the XIX century such as M.Y.Muromov, E.O.Mukhin. N.I.Pirogov,
p.000225: A.M.Filomafitskiy, S.F.Hotovitskiy, F.I.Inozemtsev and others maintained this tradition. Their professional activity
p.000225: and civil position were based on moral ideals. They wrote works where they discuss qualities characterizing a
p.000225: doctor, ethical aspects of relations with society, patients and colleagues. In everyday activity they pointed and
p.000225: solved problems, which were beginnings of bioethics principles and rules. They used method of experiment,
p.000225: observing disease activity and experimented on animals. At that time ethical approaches to experiments were formed.
p.000225: So, A.M.Filomafitckiy (11807-1849), the first Russian scientist, who made vivisection and surgery method as the base
p.000225: of physiology, said: “... Experiment made by inexperienced hand and aimlessly should be severely punished,
p.000225: especially if sufferings of an animal after blood operation are lengthened without any need, but experiments made
p.000225: by hands of a skillful and loyal observer are necessary for science and saving
p.000225:
p.000226: 226
p.000226:
p.000227: 227
p.000227:
p.000227: of mankind...” (11). D.S.Samoylovich (1744-1805), founder of the Russian epidemiology, self-tested plague infection
p.000227: and its course. There were negative examples. In the middle of the XIX century in Moscow foundling hospital they
p.000227: were searching for substitute of breast milk for children, and among others Libihovskiy beef broth was studied. As a
p.000227: result many children fell ill and so it was concluded to be harmful (8).
p.000227: One of the first who began to defend rights of prisoners on health and medical help was F.P.Gaaz (1780-1853). In his
p.000227: everyday practice he defended and implemented the slogan “hurry up to make good”, displaying humane attitude to most
p.000227: miserable people such as exiles, convicts, he supported them morally and gave medical and social help, took care about
p.000227: their children. He both worked with selfless devotion and attracted unselfish assistants being of different classes and
p.000227: generations.
p.000227: Moral position of N.I.Pirogov (1810-1881) displays principle of honesty in Russia. He paid special attention to medical
p.000227: mistakes. In contrast with existing in medical society opinion he believed that every honest man should be able to
p.000227: admit and proclaim his mistakes to warn against them not well- informed people (24). Many Russian physicians became his
p.000227: followers and were able to admit and analyze their mistakes. They were A.Y.Krasovskiy, C.P.Kolomina, F.I.Sinitsin and
p.000227: others.
p.000227: An issue of patient consent for surgery was discussed by physicians in the past. N.I.Pirogov remembered in the Old
p.000227: Doctor Dairy, that an inspector of medical institutions I.Rule required from doctors in the hospital not to do any
p.000227: surgery without patient agreement.
p.000227: The time since the end of the XVIII century till beginning of the XIX century one can state as a
p.000227: birth of public medicine. First medical papers, medical societies, public hospitals and chemist’s shops,
...
p.000321: Khorezmi, Abu Nasr Mohammed al-Farabi, Abu Raihan Beruni and other prominent figures representing Islamic
p.000321: philosophical and religious thought (Al Kindi, Abu Hamida Gazali, Ibn Rushda, Abu Bakra Ar-Razi). However,
p.000321: nowadays syncretism of oriental philosophy reveals itself in the fact that modern Uzbek philosophers and physicians do
p.000321: not make a clear distinction between secular and religious argumentation. Sacred texts have traditionally been a source
p.000321: of philosophical thought for Uzbek investigators. Western scientists usually state their positions. The Western
p.000321: bio[medical] ethics distinguishes between biomedical ethics based on religious teachings and secular biomedical ethics
p.000321:
p.000322: 322
p.000322:
p.000323: 323
p.000323:
p.000323: that uses ethical argumentation as such. Sacred texts offer a comprehensive collection of thoughts, and one may find in
p.000323: them confirmation from “above” of nearly any statement.
p.000323: Moslem teaching has developed special canons of the attitude to patients and disabled persons that, to a large
p.000323: extent, formed the basis for patient-physician relationship. First of all, Al Bukhari’s khadises remind Moslems
p.000323: that the Prophet suffered severely, and therefore, who, if not Him, knows better what it means to be ill and suffer
p.000323: (Abu Abdullah Muhammad ibn Ismoil al-Bukhoriy. Khadis. Al-jomi’ ac-cokhikh 4. Ishornali tiuplam. Tashkent, Komuslar
p.000323: bosh takhririiati, 1992. B. 3 – in Uzbek). Everything that befalls human beings is of God’s will. To visit the sick,
p.000323: even infants, is a duty of each Moslem. It is a tradition not to ask about the disease or name the disease aloud; one
p.000323: should ask about the general state of health and use euphemisms in telling the diagnosis: “that very illness”, “caught
p.000323: some cold”, “a bad illness”, etc. There are many variants. This is a kind of medical secrecy observed by persons in the
p.000323: patient’s environment. In the end of the visit the physician should say some words of support, to express his firm
p.000323: belief that the patient will recover, even if the physician knows that it is hardly possible. Moslems should support
p.000323: all disabled people and have mercy to ugly persons, because they are what they are of God’s will. To care for the
p.000323: disabled is the duty of all relatives and people from the community.
p.000323: Patients too have their duties. They have to bear their suffering as much as they can, not to grumble or fall into
p.000323: despair, to suppress one’s moans, not to ask for death. If a Moslem anticipates his death he should pay his debts,
p.000323: make his will and directions concerning funerals, beg everyone’s forgiveness and to repent of his sins
p.000323: (Sadyk-i-Kashgari M. Oriental Code of Decencies. Adab-ul-Salikhyn. Tashkent, 1992, pp. 35-37; in Uzbek). The precept
p.000323: “Thou should not ask for your death” suggests a direct answer to the question what Islamic teaching says about
p.000323: euthanasia. The person’s right to euthanasia, both active and passive still remains a topic of heated debates. Islam
p.000323: may not approve of either kind of euthanasia, as it is nothing but a conscious murder of a human being (even if he/she
p.000323: has a terminal illness) committed by another person, particularly by a physician. If the patient has a terminal
p.000323: illness, the physician’s duty is to relieve his/her suffering with various analgesics and to render moral support
p.000323: in the face of impending death, so that the patient would leave this world as a sensible person who
p.000323: completed all his/her earthy tasks, bid farewell to his/her relatives and repented before the Almighty Allah.
p.000323: Abu Ali Ibn Sina (980-1037) expressed his attitude to euthanasia in his “Biography” wrote that a
p.000323: seriously ill person consciously “broke the regimen for the last time”, which hastened his death. Here
p.000323: we have to mention his views on medical and ethical problems of dying and natural death. These views expand the scope
p.000323: of modern bioethics, which allows us to retransmit from the past entire strata of knowledge about the physician’s duty
p.000323: and search of new ways for applying ethics when it is necessary to care for a dying patient, to form behaviour
p.000323: standards in seriously ill patients, to safeguard their rights for a good death and to maintain their faith in
p.000323: spiritual and moral immortality of human soul.
p.000323: In the light of the aforesaid, Ibn Sina’s treatise “Illumination” that is not widely known among researches is of a
p.000323: particular interest. The treatise adds to concepts of natural death presented in “Canon”. In modern terms, the treatise
p.000323: suggests that the philosophy of death ensues logically from a moral comprehension of life. Ibn Sina offers a systemic
p.000323: substantiation of the natural death from the viewpoint of the right to a good death and in the light of the theory that
p.000323: death means “the return” to an origin. This idea was developed in many works, particularly in works by Ilya Mechnikov
p.000323: (1845- 1916) who attempted to explain the concept of “the instinct of natural death” from the viewpoint of biology and
p.000323: psychophysiology.
p.000323: With regard to ethical principles, “Canon of medical Science” is a literary source containing elements of
p.000323: bioethics. It differs from its antiquity analogues in the attempt to characterize medicine not only as a system of
p.000323: medical and biological knowledge, but also as a canon of spiritual and ethical basis of the entire medical science
p.000323: (“Avicenna and the ethics of science and technology today”. Division of Science and Technology Ethics, UNESCO, France,
p.000323: 2006, p. 1-16). There were many reasons why “Canon” excited much interest in different historical periods including the
p.000323: European Renaissance. However, there are no doubts that in “Canon of Medical Science” a human being for the first time
p.000323: becomes not merely a subject of an anatomical or physiological research but a person. It is noteworthy that the “Canon”
p.000323: is really permeated with humanistic ideas. It has a powerful spiritual and moral potential for the development of
p.000323: medical science the subject of which is not just a human being but also his/her life style with all the variety of
p.000323: cultural,
p.000323:
p.000324: 324
p.000324:
p.000325: 325
p.000325:
p.000325: legal, religious and other features. According to Ibn Sina, it is essential to humanize the process of bringing up
p.000325: healthy people and to find the ways for maintaining and developing spiritual harmony throughout a person’s life.
p.000325: Ethical views of Ibn Sina are still topical nowadays. He saw a physician as a patient’s friend, tutor and helper.
p.000325: To fulfill this noble mission, the physician, apart from professional knowledge and experience, should have many
p.000325: positive qualities – mercy, respect for human dignity, readiness to self-sacrifice in a patient’s interests,
p.000325: etc.
p.000325: When analyzing Ibn Sina’s ethical precepts we should note that those were in line with Hippocrates’s teaching. Ibn Sina
p.000325: wrote: “The physician should read Hippocrates’s precepts so as to be able to show honesty and frankness when treating
p.000325: patients. He should keep his clothes clean, be neat and perfumed. When he visits a patient he should be amiable, and
p.000325: cheerful, and witty so that he could cheer the ill person, because support offered by the physician multiplies the
p.000325: strength of natural warmth”. He was tireless in calling upon physicians to develop their general and special knowledge,
p.000325: to exchange professional experience and travel. In those times, travels served to extend scientific contacts. In the
p.000325: Middle Ages, there were many charlatan “healers” and even physicians deceiving their patients. Reasons for that Ibn
p.000325: Sina saw in a poor medical training, as physicians were not taught to see in each person his/her unique world of
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
p.000325: Ibn Sina’s views on childhood are noteworthy. “Canon of Medical Science” states that child’s life and health
p.000325: should be objects of care, protection and a special regimen from the moment of conception, not just from the moment of
p.000325: birth. A newborn baby needs a wet nurse with a stable nervous system. Games are essential, as all educational
p.000325: and formative processes, starting from very early years, should proceed from games. One may not punish a child, as
p.000325: the task of a tutor and physician if to protect the child’s soul, to facilitate the development of the feeling of
...
Health / of childbearing age/fertile
Searching for indicator fertile:
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p.000011: Committee). In comparison with the beginning of 1991, the population has reduced by 2.7 million people or
p.000011: 1.0%.4
p.000011: By the type of demographic processes in the 90-s the CIS countries were divided into two groups. In the
p.000011: first group including Ukraine, Belarus, Russia, Kazakhstan, Moldova, Georgia and Armenia the population has
p.000011: been decreasing from year to year. The second group includes Azerbaijan and Republics of Central Asia where the
p.000011: population and the demographic potential kept on increasing. At the same time, as it was mentioned above, depopulation
p.000011: processes in Belarus, Russia and Ukraine are increasing, which means that the death rate exceeds the birth rate. This
p.000011: results in the increasing polarization of the two groups of CIS countries by the demographic potential, and hence
p.000011: creates, in prospect, additional preconditions for its redistribution between countries through migration processes.
p.000011: (Table 2).
p.000011: During last years in the majority of the CIS countries, the reduction of the fertility rate was not registered. On the
p.000011: contrary, in 2003-2004 it has somewhat increased. In Azerbaijan and Kazakhstan the increase is noticed in all age
p.000011: groups, in Belarus and Ukraine – at the age of 30 and older. At the same time, the highest fertility rate is still
p.000011: registered in women at the age of 20-24 (89-95 newborns per 1000 women of fertile age in Belarus, Georgia, Moldova,
p.000011: Russia and Ukraine, over 120 newborns – in Armenia, Azerbaijan and Kyrgyzstan, 143 – in Kazakhstan).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 3 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 26.
p.000011: 4 In the previous decade – in the 1980s – the population in former Soviet Republics, except for Baltic States,
p.000011: increased by 22.6 mln of people (8.7%).
p.000011:
p.000012: 12
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: The increase of the age-specific rates results in the increase of the total birth rate (the total birth rate is the sum
p.000013: of the age-specific fertility rates in the age range of 15-49 years; it shows the average number of children born by
p.000013: one women in her life if for every age the fertility rate remained the same as it was in the year for which the
p.000013: age-specific rates were calculated). The most significant increase of the fertility rate was in Kazakhstan where the
p.000013: total fertility rate in 2004 was 2,21 versus 2,03 in 2003. According to the recent data, the average value of this
...
p.000021: than females. This growing disparity resulted in the increase of the number of incomplete families and widows,
p.000021: aggravation of the existing disbalance (as will be shown below) in the sex structure, reduction of
p.000021: nuptiality and population reproduction potential, and in a growing difference of the lifespan between the sexes. In
p.000021: spite of substantiated expectations, the high mortality rate in the period of transition at the early nineteenth did
p.000021: not affect seriously those population groups that usually are considered as particularly vulnerable due to biological
p.000021: or social causes, namely children and elder people. Perhaps the most remarkable feature of this recent population
p.000021: health crisis became a significant increase of the mortality rate for age groups of gainfully employed population. The
p.000021: most drastic relative growth of the mortality rate for adult males was registered in the group of “blooming age” i.e.
p.000021: at the age of 35-49, which is most typical for Russia. As to females, the mortality changes had unequal intensity, and
p.000021: the increase of mortality here was less marked, but it affected exactly the “blooming” age group from 35 to 49 years.
p.000021: As we know, the population reproduction depends mostly on two factors: firstly – on the ratio of marriages and
p.000021: divorces; secondly – on the ratio between males and females at the fertile age. As to the first factor, in
p.000021: the conditions of the increasing youth unemployment, rapidly growing prices housing costs and uncertain prospects, the
p.000021: nuptial ratio has decreased in all nine countries from 4% (Azerbaijan) to 34% (Russian Federation). The decrease of the
p.000021: nuptial ratio for persons in the second marriage in all countries was even sharper. An average decrease of this index
p.000021: was 28%; only in Ukraine the increase of the nuptial ratio was registered, but in 1993 the fertility in this country
p.000021: has decreased dramatically (by 20%), and hence the hopes associated with the nuptial ratio were not justified. In
p.000021: contrast to the number of marriages the number of the divorces was growing. The second factor is also unfavorable. The
p.000021: female population exceeds male population, and this ratio becomes worse with every new age group.
p.000021: Thus, the marriage/divorce ratio, as well as male/female ratio determines negative tendencies in demographic
p.000021: situation in the CIS countries. The mentioned ratios have a negative impact on the generation renewal,
p.000021: and retain conditions for a narrow reproduction.
p.000021: When considering the situation we should note that the most dramatic aggravation was observed in the areas of the
p.000021: income per person, poverty, demography and social unity, which is essential for understanding social- economic
p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
...
Health / patients in emergency situations
Searching for indicator emergency situation:
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p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
p.000189: elderly persons, disabled persons, persons who had suffered from an emergency situation and residents of ecologically
p.000189: unfavorable regions (Art. 67, 68, 69, 70, 71).
p.000189: The Law on Pharmaceutical Products (March 2003) regulates clinical trials of pharmaceutical products.
p.000189: According to this Law, no clinical trials of pharmaceutical products in Kyrgyz Republic may be carried out
p.000189: without the permission granted by the authorized healthcare state institution of Kyrgyz Republic. Those guilty of
p.000189: violating rules of clinical trials, falsifying clinical results obtained in clinical trials of pharmaceutical
p.000189: products or conducting the trials without the permission granted by an authorized healthcare state institutions of
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
p.000189: necessary for an authorized healthcare state institutions of Kyrgyz Republic to make a decision about a clinical trial
p.000189: of a pharmaceutical product. The list includes an approval by the ethics committee of an authorized
p.000189: healthcare state institution of Kyrgyz Republic. Article 27 states that the ethics committee of an authorized
p.000189: healthcare state
p.000189: institution of Kyrgyz Republic participates in the design of a clinical trial programme.
p.000189: According to this Article, clinical trial results are referred only to the authorized healthcare state institution of
p.000189: Kyrgyz Republic. It is forbidden to provide any information about the process and results of a clinical trial of a
p.000189: pharmaceutical to a research sponsor without the permission from an authorized healthcare state institution of Kyrgyz
p.000189: Republic.
...
Health / sexually transmitted disases
Searching for indicator sexually transmitted:
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p.000331: Uzbekistan has little experience in considering such complaints at court, because citizens are not properly informed
p.000331: about their rights. The lack of knowledge in this field negatively affects physician-patient relationships and the
p.000331: treatment efficiency. It is physicians’ professional duty to know patients’ and physicians’ rights and
p.000331: responsibilities. Incidentally, while the patient may be ignorant of his rights and responsibilities relating to
p.000331: medical care, the physician usually has this knowledge but intentionally conceals it from the patient,
p.000331: which is a disadvantage to both the patient and the physician.
p.000331: To involve medical professionals in educational activity aiming at informing patients about their rights, as
p.000331: well as physicians’ rights is one of urgent tasks for the healthcare system of Uzbekistan. .
p.000331: Ethical norms considering special features in relationship with patients from various age and social groups should have
p.000331: a significant place in the system regulating medical activity, particularly the rule of confidentiality relating to
p.000331: information obtained from the patient. This rule applies to adults (capable), minors (incapable or partially
p.000331: capable) and to persons with restricted capabilities who need a constant care.
p.000331: Ethical principles are essential in providing medical care to patients with sexually transmitted diseases. A
p.000331: more tolerant attitude of the society and law-enforcement bodies to patients from risk groups (sex workers,
p.000331: truckers, etc.) requires the development of legislation and social tolerance via public institutions (mahalline
p.000331: committees).
p.000331: The law of the Republic of Uzbekistan “On the Protection of Citizen’s Health” contains a number of articles concerning
p.000331: ethical issues. Thus, Article 46 sets out main principles safeguarding patents’ rights. The law of the
p.000331: Republic of Uzbekistan “On Pharmaceutical Products and Pharmaceutical Activity” (1997) also protects patients’
p.000331: rights in biomedical research. It defines the State authorities and competence of the Ministry of Public Health of
p.000331: the Republic of Uzbekistan in the sphere of clinical trials.
p.000331: Article 10 states that the decision about a clinical trial (CT) is based on
p.000331: - consent obtained from a patient or volunteer to participate in CT;
p.000331: - findings of a pre-clinical study of safety and efficiency of pharmaceutical products;
p.000331: - available data testifying that a potential risk is essentially lower than an expected benefit.
p.000331: Article 11 sets out provisions with regard to the patient’s or a volunteer’s rights in a clinical trial. Before the
p.000331: patient/volunteer signs written consents to participate in a clinical trial of a pharmaceutical, the physician
...
Searching for indicator std:
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p.000293: - RT law “On AIDS Prevention” (No 904; 23 of December 1993)
p.000293: - RT law “On Donorship of Blood and its Components” (No 901; 23 December 1993)
p.000293: - RT law “On the State Sanitary Inspection” (No 987; 20 of July 1994)
p.000293: - RT law “On the Protection of Population Health” (No 419; 15 of May 1997)
p.000293: - RT Labour Code (1997).
p.000293: - Family Code (1997).
p.000293: - RT law “On Narcotic Drugs, Psychotropic and Precursors” (No 874, 10 of December 1999)
p.000293: - RT law “On Pharmaceutical Products and Pharmaceutical Activity” (No 39; 6 of August 2001)
p.000293: - RT law “On Psychiatric Care” (No 90, 2 of December 2000)
p.000293: - RT law “On Reproductive Health and Reproductive Rights” (No 72; 2 of December 2002)
p.000293: - RT law “On Private Medical Practice” (No 60; 3 of December 2000)
p.000293: - RT law “On Salt Iodination” (No 85; 2 of December 2002)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Tropical
p.000293: Diseases (Malaria) in Republic of Tajikistan in 1997-2005” (No 342, 4 of December 1997)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Viral
p.000293: Hepatitis “B” in Tajikistan in 2000- 2007” (No 100; 11 of March 2000)
p.000293:
p.000294: 294
p.000294:
p.000295: 295
p.000295:
p.000295: - Decree of the RT Government “On the Approval of the Concept of Healthcare Reformation in Republic of Tajikistan”
p.000295: (No 94; 4 of March 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Prevention and Control of
p.000295: HIV/AIDS/STD in Republic of Tajikistan in the Period to 2007” (No 475; 27 of November 2002)
p.000295: - Decree of the RT Government “On the RT Strategy for Preventing the Menace of AIDS Spreading for the Period of
p.000295: 2002-2005” (No 389; 1 of October 2002)
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000303: Today commissions and committees on bioethics are actively working at the National Academy of Sciences, Ukrainian
p.000303: Academy of Medical Sciences and all medical universities, at research institutes and other biomedical
p.000303: institutions. Presently there are about 100 bioethics committe es and commissions functioning on
p.000303: different levels. Their work is particularly active in the Crimea, Lvov, Odessa and Kharkov. The main task of
p.000303: commissions and committees on bioethics is to promote ethical principles in all spheres of their institutions’ activity
p.000303: and perform ethical review of research projects. In the institutes of higher education they have to participate in
p.000303: teaching bioethics.
p.000303: Now we are facing a new stage: each committee or commission functioning at the local level should be
p.000303: accredited by the central institution and continuously provided with all relevant information. For this purpose we need
p.000303: to develop the system of accreditation and to establish the information centre. These are the principal directions of
p.000303: our current active work.
p.000303: Over the last two years the Supreme Certifying Commission of Ukraine have been carrying out ethical review of all
p.000303: dissertations in medicine and biology.
p.000303: We have established an effective cooperation with the Division on Bioethics at the Council of Europe. Within
p.000303: this period two bilateral meetings in Strasbourg and Kiev were held with the participation of authoritative
p.000303: experts Anna Maclaren (United Kingdom) and Maria Louisa Labat (France). Preparation for the Convention ratification
p.000303: and problems relating to the use of stem cells were on the agenda. That was not only mutual exchange of
p.000303: information but also the search of adequate decisions. All participants agreed that fundamental research should go on
p.000303: the use of stem cells should go on and that too much of advertising and commercialization discredits the whole thing.
p.000303: The third bilateral meeting is to be held in the end of 2007.
p.000303: The greatest achievement, however, is that bioethics gradually enters into the life of scientific laboratories and
p.000303: institutes as well as into syllabi of medical universities. Ethical review of new research projects has become a
p.000303: routine practice.
p.000303: 3.10.2. Legal Regulations
p.000303:
p.000303: The protection of human rights in biomedical research is a particularly important field requiring a special
p.000303: legislative approach. In Ukraine legislation there is a number of general and special acts setting both general
p.000303: principles concerning the protection of human rights in biomedical research and detailed statements regulating the
p.000303: order of conducting those.
p.000303: The Constitution of Ukraine (1966) is the main law proclaiming the priority of the individual, his/her life and health,
p.000303: dignity, honour, personal inviolability and safety, protection of human rights and freedoms (Art. 3). The Constitution
p.000303: states the principle of freedom and equality with regard to human rights and dignity (Art. 21); non-admission of
p.000303: discrimination (Art. 24); person’s inalienable right to life (Art. 27); everyone’s right to respect of his/her dignity,
p.000303: (Art. 28). Article 28 states in particular: “No person shall be subjected to medical, scientific or other experiments
p.000303: without his or her free consent”. Article 32 states that the collection, storage, use and dissemination of confidential
...
p.000349: newspapers and scientific journals broadly covered issues of biomedical ethics discussed at the Congress.
p.000349: The idea to combine scientific progress and ethics brought together about 200 medical scientists and members
p.000349: of teaching staff, investigators, physicians, biologists, experts in law, philosophers, theologists, journalists,
p.000349: deputies of the Legislative Chamber of Uzbekistan Parliament, representatives of various public organizations,
p.000349: delegates from different Uzbekistan cities, as well as from Kazakhstan, Kyrgyzstan, Tajikistan, Ukraine, Russia,
p.000349: Belgium, South Africa, Philippines, Singapore and other countries.
p.000349: The Congress participants discussed key issues of bioethics relating to the protection of human rights and dignity of
p.000349: biomedical research subjects in connection with the use of achievements in biology and medicine.
p.000349: The Congress participants made many interesting presentations. The Minister of Healthcare of Uzbekistan, prof.
p.000349: F.G.Nazirov spoke about ethical aspects of using new technologies in medicine; Doctor of Philosophy, professor Moshin
p.000349: Ebrahim from the Islamic University of South African Republic shared his opinion on the rights of a fetus; scientists
p.000349: from Philippines, Ukraine and Russia touched upon ethical problems concerning the use of embryonic and stromal human
p.000349: stem cells in treating various diseases. The Chairperson of the FECCIS, prof. O.I.Kubar from St.-Petersburg and Dr.U.
p.000349: Sharapov gave a talk
p.000349: on ethical aspects of clinical trials concerning HIV/AIDS; physicians from the Republican Specialized Surgery Centre at
p.000349: the Ministry of Public Health of Uzbekistan spoke about bioethical aspects of organ and tissue transplantation, and
p.000349: specialists from the Scientific Centre for Emergency Medical Care presented talks on similar problems in
p.000349: emergency medicine.
p.000349: J.N.Franco from Singapore and a group of physicians from Belgium spoke about problems of patient—physician relationship
p.000349: in the conditions of a rapid development of new biotechnologies and about truth-telling with regard to
p.000349: patients with terminal diseases. M.Baimukhamedov gave a talk on ethical aspects of the protection of patients’ rights
p.000349: in TV-medical consultations. The Congress participants discussed problems of ecological ethics and the use of
p.000349: genetically modified products and their effect on integral health (presentations by academician T.I.Iskanderov
p.000349: from Uzbekistan, Z.Nasyrova and Z.Akhrorova - scientists from Kazakhstan and Tajikistan). The Head of the WHO
p.000349: Office in Uzbekistan Dr. Arun Nanda, prof.
p.000349: E.I.Musabaev (Uzbekistan), physicians from Russia, The Tashkent Medical Academy and Samarkand Scientific Center
p.000349: presented talks on legal aspects of bioethics.
...
p.000357: SIDCER – Strategic Initiative for Developing Capacity in Ethical Review
p.000357: SoP – Standard Operating Procedures
p.000357: tDR – Special Programme for Research and Training in Tropical Diseases)
p.000357: UnESCo – United National Educational, Scientific and Cultural Organization
p.000357: WHo – World Health Organization
p.000357: WMA – World Medical Association
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357: The authors of the Book wish to express their gratitude to their colleagues from the Forum for Ethics
p.000357: Committee in Commonwealth of Independent States; experts and specialists from all other national, regional
p.000357: and international organizations who contributed in the process of establishment and development ethical review system
p.000357: in the Commonwealth of Independent States, which became the background of this Book.
p.000357:
p.000357: It is the special pleasure to thank the UNESCO Office in Moscow, Saint-Petersburg Pasteur Institute and the
p.000357: Inter-Parliamentary Assembly of the Commonwealth of Independent States for their constant support and fruitful
p.000357: cooperation during the process of the preparation of this BookWe also thank the following organizations for their
p.000357: financial support that enabled us to have this Book printed and presented.
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000358: 358
p.000358:
p.000359: 359
p.000359:
p.000359: StemXCells Bank of Kazan State Medical University, Republic of Tatarstan, Russia
p.000359:
p.000359:
p.000359:
p.000359:
p.000359:
p.000359:
p.000359: Ethics Committee of Health Care Ministry, Republic of Tatarstan, Russia
p.000359:
p.000359:
p.000359: Republican Centre of Expertise and Trials in Healthcare, Republic of Belarus
p.000359:
p.000359:
p.000359:
p.000359:
p.000359:
p.000359: Foundation Internationale A.S.Pouchkine International A.S.Pushkin Foundation, Kingdom of Belgium
p.000359:
p.000359:
p.000359:
p.000359:
p.000359:
p.000359:
p.000359:
p.000359: Accel Clinical Research, llc
p.000359:
p.000359:
p.000359:
p.000359:
p.000359:
p.000359: Printed by Phoenix, Ltd.
p.000359: 27, Engelsa pr., Saint-Petersburg, 194156.
p.000359: Order № , Circulation 500.
p.000359:
...
Social / Access to Social Goods
Searching for indicator necessities:
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p.000247: obligatory condition for biomedical research the written voluntary consent of a subject for participating in the study
p.000247: and guaranties his right to withdraw the consent at any moment of the study. Before the obtaining of consent for
p.000247: biomedical research the patient should be informed about goals, methods, side effects, possible risk, duration and
p.000247: expected results of the investigation.
p.000247:
p.000247: 28 Constitution of the Russian Federation, St-Pb, 1995.
p.000247: 29 Fundamental principals of Legislation of Russian Federation Concerning Public Healthcare?
p.000247: on 22 of July 1993// Rossiyskaya Gaseta, August 18, 1993. № 158.
p.000247: The given Article sets rather strict limitations on research involving minors (under 15 – in general
p.000247: cases, and under 16 in the case of drug addicts). In this case, the methods of disease prevention, diagnostics
p.000247: and treatment, as well as pharmaceuticals that are not officially permitted but are under consideration may only be
p.000247: applied for the treatment of minors if there is a direct threat to their life and with a written consent
p.000247: of their legal representatives. Here we should mention the Act “On Applying Pharmaceutical Products according
p.000247: to the Necessities of life” adopted by the Order of Ministry of Health and Social Development (09.08.2005, No. 494).30
p.000247: This Act regulates issues relating to the individual case of application, according to the necessities of life, of a
p.000247: pharmaceutical product that is not registered in Russian Federation. This is a matter of non-interventional
p.000247: research. The decision about the use of a pharmaceutical product in this case is made via the Federal
p.000247: specialized medical commission; the protocol is documented and signed by the medical director of the director of the
p.000247: Federal specialized medical commission. This document emphasizes again the need to seek the patient’s voluntary written
p.000247: consent (in cases provided by law the consent from the patient’s legal representatives) to apply an
p.000247: unregistered pharmaceutical product. The physician should inform the patient about the pharmaceutical product, its
p.000247: expected benefit, safety and the degree of risk. The physician should also explain measures that will be taken in the
p.000247: case of unexpected effect of the pharmaceutical product on the patient’s health.
p.000247: The Article 29 of the Fundamental principles of Legislation also imposes the ban on biomedical trials involving persons
p.000247: under any form of detention or imprisonment.
p.000247: The strict character of legal norms relating to biomedical trials involving two categories of vulnerable subjects –
p.000247: minors and persons under detention or imprisonment – from the one hand is the sign of the law-maker’s intention to
p.000247: prevent the possibility of abuse of depending persons, from the other hand
p.000247: - it actually means the limitation of rights of mentioned persons to access to new medicines, diagnostic and
p.000247: prophylactic methods.
p.000247: At the same time it is to be taken into account that the Federal aw of the Russian Federation ”On Pharmaceutical
p.000247: Products” on 22 of June 1998
p.000247: 30 Order “On Applying Pharmaceutical Products according to the Necessities of life” adopted by the Order of Ministry
p.000247: of Health and Social Development (09.08.2005, No. 494) //Bulletin of normative acts of Federal Executive Authorities.
p.000247: No 36, 05.09.2005.
p.000247:
p.000248: 248
p.000248:
p.000249: 249
p.000249:
p.000249: N86-FZ fixes another approach towards some vulnerable contingents31. This document takes the central place in
p.000249: legal regulation of preclinical and clinical study of pharmaceutical products.
p.000249: The issues concerning rights of patients participating in clinical trials are touched on by the Article 40 of the
p.000249: mentioned law. The general rules of obtaining the informed consent for participating in research constituted by this
p.000249: article correspond in a whole with the discussed provisions of the Fundamental principles of Legislation. The
p.000249: noteworthy point is the more detailed description of information which should be given to subject, namely: 1)
p.000249: information on pharmaceutical products and nature of clinical trials of this drugs; 2) information on anticipated
p.000249: efficiency, the drug safety, and the degree of risks for the patient; 3) information on measures in the case of
p.000249: unforeseeable effects of pharmaceutical product on his health;
p.000249: 4) information on the terms of patient’s health insurance.
p.000249: The provision of the Law concerning the necessity of health insurance as well as insurance of civil liability of
p.000249: persons who carry out the study (items 3, 9 of the article 40, items 2 of the article 38) ensures an important
p.000249: additional guarantee of protection of subjects’ interests.
...
Searching for indicator access:
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p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
p.000023: population, and where in the case of an essential improvement of the economic situation the extended reproduction may
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
p.000023: To summarize the analysis of the demographic situation, it is necessary to note that with regard to self-preservation
p.000023: the following public processes are crucial:
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
p.000023: mortality in able-bodied population, “rejuvenation” of some diseases, spread of alcoholism and drug addiction;
p.000023: - the change in consumption of genetically habitual food products, decrease in food calorie content for the
p.000023: considerable part of the society;
p.000023: - reduced access to social services in conditions of a large-scale commercialization, which negatively
p.000023: affects the quality of human resources, intellectual, scientific and physical potential of the country;
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000025: 25
p.000025:
p.000025: - the decreasing number of medical institutions; a level of the population morbidity and mortality still remains
p.000025: high; the number of handicapped people is increasing;
p.000025: - stratification of the society by income, when 10% of the most well- to-do population have incomes more than 10 times
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
p.000025: efficiency of social assistance programs by weight of amounts received by families beyond the poverty line in total
p.000025: amounts of social support).
p.000025: 1.2 Ethical and Legal Issues
p.000025: in the Field of Biology and Medicine (o.I.Kubar, B.G.Yudin, A.E.nikitina, E.Yu.Vladimirova)
p.000025:
...
p.000033: 10 Art. 16 and Art. 24 of the Constitutions of Kyrgyz Republic and the Republic of Moldova, respectively.
p.000033: The right for protection of health and its state support are legally fixed in all Commonwealth countries (Art. 34 of
p.000033: the Constitution of the Republic of Armenia, Art. 41 of the Constitution of the Republic of Azerbaijan, Art. 45 of the
p.000033: Constitution of the Republic of Belarus, Art. 37 of the Constitution of Georgia, Art. 29 of the Constitution of the
p.000033: Republic of Kazakhstan, Art. 34 of the Constitution of the Kyrgyz Republic, Art. 36 of the Constitution of the
p.000033: Republic of Moldova, Art. 41 of the Constitution of the Russian Federation, Art. 38 of the Constitution of the
p.000033: Republic of Tajikistan, Art. 49 of the Constitution of the Republic of the Ukraine, Art. 40 of the Constitution of the
p.000033: Republic of Uzbekistan).
p.000033: Majority of the CIS countries also declared in their constitutions the right for medical care in different forms
p.000033: (excluding three republics – Armenia, Azerbaijan and Uzbekistan: in these states guarantees of availability of
p.000033: health care for people are set at the level of branch laws regulating public relationships in the health care system).
p.000033: At the same time one should note that the issue of underfunding in regard to required amount of medical care today is
p.000033: still one of the most acute problems almost in all countries of the Commonwealth.
p.000033: States implement programs on population health protection, measures for environmental protection and provision of
p.000033: free access to reliable information on its status, living and working conditions, quality of food products
p.000033: and household goods, facilitate development of physical culture and sports, create opportunities for various
p.000033: forms of health insurance. Financial support is guaranteed to pregnant women11, mothers with small children and in
p.000033: case of children with disabilities – until they become older
p.000033: – to families with many children, persons with various diseases and drug abuse. The state provides special care
p.000033: for those who broke their health protecting state and common interests. An important issue is inclusion into the
p.000033: sphere of state policy and legal regulation of an issue of preservation of national gene pool.
p.000033: It is truly important that virtually all CIS countries adopted branch laws related to issues of health care and patient
p.000033: rights – the Law of the Republic of Armenia On Medical Care and on Services for Population (1996), the Law of the
p.000033: Republic of Azerbaijan On Protection of Population Health (26.07.1997),
p.000033: 11 Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of Moldova,
p.000033: respectively.
p.000033:
p.000034: 34
p.000034:
p.000035: 35
p.000035:
p.000035: the Law of the Republic of Belarus On Health Care (1999), the Law of Georgia On Health Care (1997), the
...
p.000081: associated with the research;
p.000081:
p.000082: 82
p.000082:
p.000083: 83
p.000083:
p.000083: • to develop a special system for training EC members;
p.000083: • to introduce the practice of the state inspection and independent audit of EC performance;
p.000083: • to develop legal regulations for the EC economic activity.
p.000083: The analysis of the current state from the viewpoint of the principle of obtaining research subjects’ informed
p.000083: consent shows that a principal achievement of the CIS countries is a legal regulation of this procedure.
p.000083: Among issues requiring a further development we should mention first the need to work out guidelines and norms for
p.000083: interpreting separate statements in legislative acts, terms of their application and their harmonization with norms of
p.000083: international law in the field of bioethics. There is a particularly urgent need to create bioethics information
p.000083: field with potentials for a differential education of various population groups aiming at raising the
p.000083: level of public knowledge about human rights and moral responsibility in biomedical research.
p.000083: In the history of establishing a system of ethical review and ethics committees in the region the
p.000083: performance of the mentioned Forum for Ethics Committees in the Commonwealth of Independent States takes a
p.000083: special place as a public movement aiming at fulfilling this task in the region via creating a possibility for the
p.000083: access to the world experience in the development of ethical concept of biomedical research considering national
p.000083: cultural and moral values.
p.000083: The FECCIS was established on 21 of March 2001 according to the Resolution of the Conference for representatives of
p.000083: ethics committees and others authorized bodies from the CIS countries held in Saint-Petersburg, Russia. The FECCIS is
p.000083: one of the five regional forums, established in the framework of the WHO/SIDCER project.
p.000083: Sharing the basic priorities of the SIDCER project referring to the protection of human rights and dignity in
p.000083: biomedical research all over the world with respect to cultural, historical, religious and social differences, the
p.000083: FECCIS has defined as its the main objective to support the development of bioethics in the region with an emphasis on
p.000083: ethics of biomedical research involving human subjects.
p.000083: Over the period 2001-2006, the FECCIS activity has been directed to developing legislative and normative
p.000083: system in the field of research ethics, working out and implementing educational programmes for the EC
p.000083: members, developing informational space and a dialogue with all interested parties participating in the review of
p.000083: biomedical research.
...
p.000085: Protection”, “Standard Operational Procedures” and “Inspection and Survey of the Ethics Committee”. This
p.000085: Project is actually the first stage of implementing the system of the EC accreditation, certification and survey in
p.000085: the CIS countries.
p.000085: Organization of 17 international seminars and conferences in 8 of 11 CIS countries has been very important with regard
p.000085: to the formation of the common informational field. Conference and seminars have been held in cooperation with
p.000085: different national and international structures. Conference materials have been published in Russian, English and
p.000085: national languages of the CIS countries.
p.000085: The conferences and seminars aimed at exchanging information and discussing topical issues of the development
p.000085: of regulation and educational standards relating to the protection of research participants’ rights, to the development
p.000085: of national systems of ethical review and to the creation of a harmonized legislation and methodology referring to
p.000085: biomedical research ethics both in the CIS region and in the global international space.
p.000085: Due to the development of these main initiatives, the following has been achieved and accomplished:
p.000085: • information exchange in the field of bioethics in the CIS region;
p.000085: • the analysis of issues relating to bioethical education in the region;
p.000085: • an open access to and discussion of international documents and guidelines on bioethics and research
p.000085: ethics (translation into national languages);
p.000085: • implementation of SOPs into the process of ethical review;
p.000085: • stimulation of efforts directed towards the development of national systems of ethical review in compliance
p.000085: with the GCP standards and international guidelines;
p.000085: • assistance in the organization of the EC members education and training in the region;
p.000085: • the EC preparation for the survey and evaluation of their performance;
p.000085: • raising the EC authority and their role in the development of international standards concerning the
p.000085: protection of research subjects’ rights;
p.000085: • assistance in the development of national Forums for Ethics Committees in the CIS countries;
p.000085: • the evaluation of the current legislation referring to the protection of human rights in biomedical research and
p.000085: medical practice in the region;
p.000085: • the performance as a regional centre for cooperation in the field of ethical review development;
p.000085:
p.000086: 86
p.000086:
p.000087: 87
p.000087:
p.000087: • assistance in the practical application of the SOPs for ethical review in the region in compliance with
p.000087: Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO, 2002);
...
p.000111: particularly, the Committee for Bioethics at the Medical University and Ethics Committee at the Azerbaijan Medical
p.000111: Association, make mutual efforts for establishing different forms and methods of international relations and
p.000111: extending cooperation with leading organizations, committees and associations in different countries having
p.000111: experience in the study of biomedical ethics.
p.000111: In 2001 the Republic of Azerbaijan entered the Forum for Ethics Committees in the Commonwealth of Independent
p.000111: States, and thus got a wider opportunity to exchange achievements in the field of bioethics and law with leading world
p.000111: specialists. This continuous interaction is fulfilled through:
p.000111: - corresponding by means of electronic technologies;
p.000111: - studying and implementing international legal documents and acts on biomedical ethics;
p.000111: - visiting meetings and conferences on topical issues of bioethics;
p.000111: - consultations and exchange of experience with leading international specialists;
p.000111: - seminars and training courses on principles of organizing good ethical review;
p.000111: - providing FECCIS members with necessary literature.
p.000111: The “working group” at Azerbaijan Medical University and Azerbaijan Medical Association was rendered a special support
p.000111: and assistance.
p.000111: In October 2004 the international conference “Health Legislation in Human Rights Protection and Access to
p.000111: Medicines in Health Research in the CIS” was held in Baku. It was organized with the assistance of
p.000111: FECCIS, Permanent Commission on Social Policy and Human Rights of the Inter-Parliamentary Assembly of CIS, and a
p.000111: number of international organizations (WHO, European Forum for Good Clinical Practice, World Medical Association, and
p.000111: DHHS, USA).
p.000111: In the framework of this conference, the open session of Permanent Commission on Social Policy and Human
p.000111: Rights of the Inter-Parliamentary Assembly of CIS together with scientists and specialists in bioethics from Baltic
p.000111: States and international organizations was held. At the Session, the draft project of the model law “On the
p.000111: Protection of Human Rights and Dignity in Biomedical Research in the CIS” was discussed in detail.
p.000111: Due to acquired experience, the initiative group succeeded in working out teaching and methodical materials.
p.000111: Perspective plans imply an extension of the network of bioethics committees and further broadening of relations and
p.000111: cooperation with FECCIS and other international organizations keeping to the strategy of World Health Organization.
p.000111:
p.000112: 112
p.000112:
p.000113: 113
p.000113:
p.000113: 3.3 REPUBLIC oF BELARUS (t.V. Mishatkina, Ya.S. Yaskevich)
p.000113:
p.000113: 3.3.1 Historical and Cultural Background
p.000113:
p.000113: A specific social and cultural development of Belarus had been predetermined by its geographical position and
p.000113: geopolitical features. Belarus Republic stands at the juncture of the Western and Eastern civilizations, and therefore
...
p.000141: Russia, Belarus and other countries of East Europe, Asia and Africa) attended the Conference. Forty- five presentations
p.000141: made at the Conference reflected the current situation with regard to the environment pollution with radiation and
p.000141: chemical products. The speakers suggested possible ways of preventing negative consequences caused by anthropogenic
p.000141: factors. Reported data are of a great interest for the Belarusian science. They also are helpful in outlining ways for
p.000141: the use of achievements of modern science taking into account bioethical problems. Joint scientific projects aiming at
p.000141: the elimination of consequences from a combined effect of anthropogenic factors were designed in the framework of
p.000141: international scientific-and-technical programmes. Full texts of the Conference reports (about 1000 pages) will
p.000141: be published in a monograph. The co-editor of the monograph from Belarus is prof. I.B. Mosse.
p.000141: Cooperation in the field of bioethical education is focused on the development of teaching programmes and
p.000141: on the exchange of methods, materials and experience in bioethical education with countries which are most
p.000141: developed in this respect. In the post-Soviet space, our partners are Russia, Lithuania (Lithuanian Bioethical
p.000141: Committee, Medical Faculty of the Vilnius University, Kaunas Medical University), Ukraine (Ukrainian
p.000141: Association on Bioethics, the Medical Academy of Post-Graduate Education of Ukraine); Moldova and Armenia are our
p.000141: prospective partners.
p.000141: Cooperation in this field aims at enhancing the access to existing information resources and widening
p.000141: contacts between experts in bioethics.
p.000141:
p.000142: 142
p.000142:
p.000143: 143
p.000143:
p.000143: Another objective is to develop and introduce into practice teaching programmes, methods and approaches
p.000143: ensuring the acknowledgement and understanding of principal bioethical problems in medical community and in public at
p.000143: large.
p.000143: Main ways of cooperation here are the design and subsequent use of modules of teaching programmes on biomedical ethics
p.000143: for a differentiated ethical education in different social communities.
p.000143: One of the last events demonstrating the cooperation in bioethical education was a Scientific-and-Practical
p.000143: Seminar “Humanization in the Education of Specialists in Medicine and Biology” held by young scientists of the
p.000143: Belarus Academy of Post-Graduate Education. The Seminar was supported by the Health Ministry of Republic
p.000143: Belarus, the National Committee on Bioethics and the Belarusian Republican Fund of Fundamental Research at the National
p.000143: Academy of Science of Belarus. Experts from UNESCO, InterNICHE (United Kingdom) and Centre for Protection Animals’
p.000143: Rights “Vita” (Russia) participated in the Seminar. The main objectives of the seminar were the
p.000143: discussions relating to the observance of principles of bioethics in scientific and educational activity,
...
p.000183: the most essential concepts. Every Kyrgyz had his ancestors, his land and his clan. Each clan had its hierarchy
p.000183: at the head of which was the most respected clan member. Collectivism, mutual aid, empathy, respect for other
p.000183: people – those were the qualities inherent in Kyrgyz mentality.
p.000183: Cultural and historical sources reveal respect to women in nomadic tribes, however there were conflicting
p.000183: traditions with regard to this issue. It is noteworthy that women had a high social status in Kyrgyz society [6].
p.000183: Ethical ideas in works by Kyrgyz thinkers. Spiritual culture of Kyrgyz people reflected in philosophical and poetic art
p.000183: of akyns20 is characterized by the search for perfection. Problems of upbringing and education, of humanism
p.000183: and love for people have a significant place in philosophical poetry of Kyrgyz thinkers, and therefore there
p.000183: is every reason to consider
p.000183: 20 Akyn is an improvising poet and singer in the Kazakh and Kyrgyz cultures. Akyns played and important role in terms
p.000183: of expressing people’s thoughts and feelings, exposing social vices, and glorifying heroes.
p.000183:
p.000184: 184
p.000184:
p.000185: 185
p.000185:
p.000185: it as a code of moral and ethical norms on human behaviour in Kyrgyz culture. Some scientists associate
p.000185: this special attention to moral issues with an access to Chinese sources known for their interest in ethics. The
p.000185: history of development of ethical and philosophical ideas in Kyrgyz culture may be divided into three stages. The first
p.000185: stage is associated with names of late medieval Kyrgyz thinkers: Asan-Kaigy (XV c), Tolubai Synchi and Sanch- Synchi
p.000185: (XIII c) [3]. Kyrgyz people justly call them legendary thinkers, folk sages (akylmanam). We know about these
p.000185: Kyrgyz thinkers from folk legends. Only fragments of their sayings survived to our time.
p.000185: The epoch of late Middle Ages with its patriarchal and feudal system sets a number of moral tasks. Undoubtedly, moral
p.000185: in a class society was at all times an instrument for ruling people, however, in akyns’ philosophical poetry one may
p.000185: find an unbiased opinion on moral and ethical issues. They reflected on the eternal question about struggle with
p.000185: the evil and dreamt about “universal well-being”. Due to reconstruction of Asan Kaigy’s ethical ideas, we may see
p.000185: that empathy, compassion, sympathy for others are the main principles of his moral.
p.000185: Considering the time when the sage lived and worked, it would be appropriate to note that the call for
p.000185: compassion and love for all living beings related mostly to the oppressed people, disunited by internecine
p.000185: feud, and the compassion might be interpreted as a protest against the existing system of inequality. Therefore Asan
p.000185: Kaigy saw his task in cultivating love and compassion not only for human beings but also for everything alive.
p.000185: Actually, Asan Kaigy proclaimed a categorical imperative “treat others as you would like to be treated, if you were
...
p.000247: pharmaceutical product that is not registered in Russian Federation. This is a matter of non-interventional
p.000247: research. The decision about the use of a pharmaceutical product in this case is made via the Federal
p.000247: specialized medical commission; the protocol is documented and signed by the medical director of the director of the
p.000247: Federal specialized medical commission. This document emphasizes again the need to seek the patient’s voluntary written
p.000247: consent (in cases provided by law the consent from the patient’s legal representatives) to apply an
p.000247: unregistered pharmaceutical product. The physician should inform the patient about the pharmaceutical product, its
p.000247: expected benefit, safety and the degree of risk. The physician should also explain measures that will be taken in the
p.000247: case of unexpected effect of the pharmaceutical product on the patient’s health.
p.000247: The Article 29 of the Fundamental principles of Legislation also imposes the ban on biomedical trials involving persons
p.000247: under any form of detention or imprisonment.
p.000247: The strict character of legal norms relating to biomedical trials involving two categories of vulnerable subjects –
p.000247: minors and persons under detention or imprisonment – from the one hand is the sign of the law-maker’s intention to
p.000247: prevent the possibility of abuse of depending persons, from the other hand
p.000247: - it actually means the limitation of rights of mentioned persons to access to new medicines, diagnostic and
p.000247: prophylactic methods.
p.000247: At the same time it is to be taken into account that the Federal aw of the Russian Federation ”On Pharmaceutical
p.000247: Products” on 22 of June 1998
p.000247: 30 Order “On Applying Pharmaceutical Products according to the Necessities of life” adopted by the Order of Ministry
p.000247: of Health and Social Development (09.08.2005, No. 494) //Bulletin of normative acts of Federal Executive Authorities.
p.000247: No 36, 05.09.2005.
p.000247:
p.000248: 248
p.000248:
p.000249: 249
p.000249:
p.000249: N86-FZ fixes another approach towards some vulnerable contingents31. This document takes the central place in
p.000249: legal regulation of preclinical and clinical study of pharmaceutical products.
p.000249: The issues concerning rights of patients participating in clinical trials are touched on by the Article 40 of the
p.000249: mentioned law. The general rules of obtaining the informed consent for participating in research constituted by this
p.000249: article correspond in a whole with the discussed provisions of the Fundamental principles of Legislation. The
p.000249: noteworthy point is the more detailed description of information which should be given to subject, namely: 1)
p.000249: information on pharmaceutical products and nature of clinical trials of this drugs; 2) information on anticipated
p.000249: efficiency, the drug safety, and the degree of risks for the patient; 3) information on measures in the case of
p.000249: unforeseeable effects of pharmaceutical product on his health;
...
p.000271: personality of the study subject will be kept secret and its disclosure is possible only within the limits
p.000271: stipulated with corresponding laws and/or by-laws. For instance, in case of public representation and
p.000271: publication of the study results anonymity of its subjects (confidentiality of information about them) is
p.000271: guaranteed. The patient information note must indicate investigator obligations in case of appearance of new data
p.000271: in the given CT that can influence the subject decision on continuing participation in the study to
p.000271: immediately inform the study subject or his/her legal representative about them, define a list of persons that one can
p.000271: address if it is necessary to obtain additional data concerning this CT the subject-participant and the rights of the
p.000271: subject as well as other specialists that the study subject can contact in case his/her health is
p.000271: compromised during the study (these are representative of the study team, local EC). It is obligatory to provide
p.000271: conditions when participation of the patient/healthy volunteer can be discontinued without his/her consent, suggested
p.000271: duration of the study, and approximate number of the subjects in different regions and in the given clinical site. The
p.000271: information provided to the patient shall be logically completed with the informed consent form, which exhibits, if
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
...
p.000295: - Decree of the RT Government “On the RT Strategy for Preventing the Menace of AIDS Spreading for the Period of
p.000295: 2002-2005” (No 389; 1 of October 2002)
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
p.000295: access to the service of reproductive health, at preventing HIV/ AIDS spreading and at eliminating sex discrimination
p.000295: in the field of primary and secondary education. To ensure the national demographic policy, the Government approved
p.000295: and adopted the programme “The Concept of RT State Demographic Policy for the Period 2003-2015” (2002).
p.000295: The independent Tajikistan with its scientific potential in healthcare has reached a new, international level of
p.000295: science development, and therefore it is necessary to carry out ethical review of biomedical research in compliance
p.000295: with international regulations. The controlling body is the Committee on Medical Ethics (CME) at the RT Health
p.000295: Ministry. In its activity, the CME is guided by the Constitution of Republic Tajikistan. Documents regulating the
p.000295: CME practice comply with international legal standards and RT laws. The CME forms a part of the Forum for Ethics
p.000295: Committees in the Commonwealth of Independent States. The CME is to review and monitor scientific research in medicine
p.000295: and the compliance with ethical regulations to protect right and dignity of a research subject. Presently, the RT
p.000295: Government is considering the law “On the Protection of Human Rights and Dignity in Biomedical Research”
p.000295: based on the IPA CIS model Law “On the Protection of Human Rights and Dignity in Biomedical Research in CIS”.
p.000295:
...
p.000327: a key issue of the contemporary medical ethics in Uzbekistan.
p.000327: Thus, the Uzbekistan model of biomedical ethics is at the stage of intensive development. The intensity
p.000327: of research development in this field is predetermined by ethical tendencies in Uzbekistan education and
p.000327: philosophy existing throughout the history of Uzbekistan (Zagyrtdinove
p.000327: F.B. Peculiarities of Biomedical Ethics in Uzbekistan. In: “”Bioethics in Uzbekistan – Clinical, Philosophical
p.000327: and Legal Aspects.” Tashkent, 2006, pp. pp. 122-128).
p.000327: 3.11.2. Legal Regulations
p.000327:
p.000327: The State plays a key role in safeguarding social and economic rights of its citizens, and therefore
p.000327: the State social policy should be directed at maintaining social health, which is described by three groups of
p.000327: characteristics: 1) population health (physical, mental and social); 2) intellectual potential and the level of
p.000327: professional knowledge; 3) spiritual and moral values.
p.000327: To maintain and improve population health and to raise a healthy generation, the Ministry of Public
p.000327: Health of the Republic of Uzbekistan undertakes a considerable work on reforming healthcare based on a number of
p.000327: principles and with a special attention to:
p.000327: • the observance of constitutional rights to receive a qualified medical care and
p.000327: • the principle of an equitable access to medical service.
p.000327: Issues relating to social relations in medicine are regulated by the Constitution of the Republic of
p.000327: Uzbekistan (Art. 24, 26, 40, 43; 1922) and by laws directed to the protection of citizens’ rights in medicine.
p.000327: 1. “On the State Control” (3 of July 1992; revised editions: 6 of May 1995; 15 of April 1999; 31 of August 2000);
p.000327: 2. “On the Protection of Consumers’ Rights” (26 of April 1996; revised edition: 5 of April 2002);
p.000327: 3. “On the Protection of Citizens’ Health” (29 of August 1997);
p.000327: 4. “On Drugs and Pharmaceutical Activity” (25 of April 1997);
p.000327: 5. “On Narcotic and Psychoactive Drugs (19 of August 1999; revised edition: 15 of December 2000);
p.000327: 6. “On the Prevention of Diseases Caused by HIV” (19 of August 1999);
p.000327: 7. “On Providing Psychiatric Care” (31 of August 2000);
p.000327: 8. “Radiation Safety” (2001);
p.000327: 9. “On the Protection of Population from Tuberculosis” (11 of May 2001);
p.000327: 10. “On Donor Blood and Its Components” (12 of August 2002).
p.000327: Constitution of the Republic of Uzbekistan states that every citizen has the right to a qualified medical care (Art.
p.000327: 40).
p.000327:
p.000328: 328
p.000328:
p.000329: 329
p.000329:
p.000329: The law “On Protection of Citizens’ Health” adopted in 1996 sets out relevant principles of health protection and
...
p.000329: - social protection of citizens in cases of health loss;
p.000329: - the unity of medical science and practice.
p.000329: According to Article 13 of the Law, “…the State ensures the protection against discrimination irrespective of a disease
p.000329: the citizen has. Appropriate sanctions should be applied in the event of infringement of the provisions contained in
p.000329: this Article”.
p.000329: Nevertheless, in current practice of physician—patient relationship there are cases of marginalization and
p.000329: stigmatization, which shows itself in relation to most vulnerable social groups – drug and alcohol addicts, sex
p.000329: workers, etc. In the event of diagnosing an “improper disease” (venereal diseases, AIDS) a patient is labeled as
p.000329: “shameful”. A suspicious attitude of medical staff to patients with such a diagnosis infringes patients’ rights, which
p.000329: affects their moral and psychological state and, consequently, has a negative impact on the treatment efficiency.
p.000329: According to Article 24 of the Law, the patient has the right to:
p.000329: - respectful and humane attitude of medical staff;
p.000329: - choice of a physician;
p.000329: - medical aid (examination, treatment, etc.) provided in compliance with relevant sanitary requirements;
p.000329: - consultation by a medical specialist on the patient’s request;
p.000329: her health condition;
p.000329: - compensation in the event of a damage to his/her health;
p.000329: - access to a lawyer or another representative for the protection of his/ her rights.
p.000329: In case of infringement of a patient’s rights, his/her legal representative may make a complaint to any instance.
p.000329: Article 34 of the law “On the Protection of Citizens’ Health” permits to conduct biomedical research involving human
p.000329: subjects at state institutions after laboratory experiments and with informed consent from a research
p.000329: participant.
p.000329: To protect patients’rights and dignity,Article 25 prohibits propagandizing, including information in mass media,
p.000329: methods of prevention, diagnostics and treatment, as well as pharmaceutical products unless they undergo trials.
p.000329: The law “On Protection of Citizens’ Health” is closely linked with the law of the Republic of Uzbekistan “On Protection
p.000329: of Consumers’ Rights”. The title reflects the essence of the law – to protect consumers of any services (general,
p.000329: community, trade services, etc.) including medical ones. According to the Law, “a consumer is a citizen (natural
p.000329: person) who purchases, orders or has an intention to purchase or order goods or a service for personal use or a private
p.000329: non-profit household”.
p.000329: A consumer of medical services is a patient having certain rights defined by the Law. It is difficult
p.000329: enough to put a patient on the same level as the consumer of general, community or trade services. To provide a
...
p.000353: in this sphere is preservation of communication on one language and traditional mutual penetration of
p.000353: cultures and standards becoming a root system of information bases, educational materials and educational
p.000353: testing.
p.000353: Especially advantageous situation for cooperation is created in the sphere of development and
p.000353: establishment of the system of ethical examination. Simultaneous start of development of this field and
p.000353: unique support of the global community through establishment of the Forum for Ethics Committees in the CIS and
p.000353: inclusion of this region as a single constituent of the global WHO Project SIDCER provided permanent
p.000353: international dialogue on key issues of research ethics with international agencies leading in this sphere –
p.000353: such as WHO, the European Commission, the Council of Europe, UNESCO, the European Forum for Good Clinical Practice,
p.000353: the World Medical Association as well as authoritative national agencies: DHHS, USA and Ethics Committees of
p.000353: countries of all Continents. Such dialogue became a basis for experience exchange and real integration of ethical
p.000353: examination systems of the CIS countries into global discussion and research process.
p.000353: Integrity and value of cooperation with international organization is also presented with equal access for
p.000353: the CIS countries to discussion and development of international documents and guidelines on ethics of
p.000353: biomedical studies such as the Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000,
p.000353: 2002); work on new edition of the Declaration of Helsinki, documents of the Council of Europe, new version of the
p.000353: International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS), the Universal
p.000353: Declaration on the Human Genome and Human Rights, the International Declaration on Human Genetic Data, the
p.000353: Declaration on Common Bioethics Standards (UNESCO), guidelines on bioethics, legal and social consequences of genetic
p.000353: testing (the European Commission) and other universal documents and guidelines in which development members of
p.000353: the FECCIS participated.
p.000353: In general, cooperation within the framework of the FECCIS is developed with the purpose to facilitate
p.000353: creation of systems of good ethical
p.000353:
p.000354: 354
p.000354:
p.000355: 355
p.000355:
p.000355: practice and development of ethical responsibility in researchers, sponsors, authorized regulatory agencies and the
p.000355: society as a whole. This process in combination with advancements of science and social and legal trends
p.000355: facilitates appearance of constitutional society and state regulation in the CIS region. Inclusion of the CIS countries
p.000355: in the process of establishment of good practices of ethical review at international scale is focused on
p.000355: understanding of necessity of reaching independence, competence, openness and responsibility in the field of human
p.000355: rights protection when conducting biomedical studies. Development of cooperation facilitates free discussion among
p.000355: colleagues, exchange with experience, problems and successes, formation of collective recognition of ethics role
p.000355: in research and individual ethical thought of all participants of biomedical process.
p.000355: In conclusion of this chapter we consider as our priority tight to express our assurance that the given work will
p.000355: become a token and impulse of the new age of international cooperation among the region countries in the
p.000355: sphere of ethical regulation of biomedical studies. Publication of this book will provide informational access to the
p.000355: following data:
p.000355: • conditions and perspectives for development of ethical review of biomedical research in the CIS
p.000355: countries (historical and culture roots, economic and social prerequisites, regulatory legislation, staff
p.000355: training system, management);
p.000355: • description of model legislation of IPA CIS in issues of regulation of research in the field of biology and medicine
p.000355: and protection of human rights and dignity;
p.000355: • methodology and structure of national programs and their interaction in the region and beyond for implementation of a
p.000355: strategy for compliance with international ethical standards;
p.000355: • general trends and specificity of development of ethical review to form priority directions for cooperation
p.000355: at the regional and global scale;
p.000355: • information concerning experience of regional cooperation within the framework of the FECCIS;
p.000355: • approach to harmonization of norms and standards of ethical review of biomedical research in the region and at the
p.000355: global scale.
p.000355: Objective and open knowledge of wide-scaled layer of national and regional realia of ethics of biomedical
p.000355: studies in the Commonwealth countries unveils a whole range of opportunities for all stakeholders in
p.000355: regard to search for ways to further collaboration in this sphere basing on adherence to universal values and ethical
p.000355: principles.
p.000355: In general, contribution to the world society harmonizing standards is based upon respect to human
p.000355: dignity, right and freedoms; recognition of achievements of scientific and technical progress; facilitation of
p.000355: equal access to scientific achievements through support of maximal, as much as possible free flow and
p.000355: exchange of knowledge and mutual benefiting from such exchange; protection of interests of existing and future
p.000355: human generations that the current publication is dedicated to.
p.000355:
p.000356: 356
p.000356:
p.000357: 357
p.000357:
p.000357: ABBREVIAtIon
p.000357:
p.000357:
p.000357: BMR – Biomedical Research
p.000357: CIoMS – Council for International Organizations of Medical Science
p.000357: CIS – Commonwealth of Independent States
p.000357: Ct – Clinical Trials
p.000357: EC/ECs – Ethics Committee/Ethics Committees EFGCP – European Forum for Good Clinical Practice FECCIS – Forum for Ethics
p.000357: Committees in the CIS GCP – Good Clinical Practice
p.000357: GLP Good Laboratory Practice
p.000357: GMP – Good Manufacture Practice
p.000357: ICH – International Conference on Harmonization of Technical Requirements for the Registration of
p.000357: Pharmaceuticals for Human Use IPA CIS – Inter-Parliamentary Assembly of the Commonwealth of Independent States
p.000357: SIDCER – Strategic Initiative for Developing Capacity in Ethical Review
p.000357: SoP – Standard Operating Procedures
p.000357: tDR – Special Programme for Research and Training in Tropical Diseases)
...
Searching for indicator access to information:
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p.000097: absence of a system for training specialists on bioethics.
p.000097: In the period from September 2004 until February 2005 the Society for Bioethics Development of Republic of Armenia
p.000097: implemented the project aiming at acquainting medical community of Armenia with the principles and norms of
p.000097: bioethics. The Democracy Committee of the USA Embassy in Armenia sponsored the project. Within the framework of the
p.000097: project, the Committee published brochures in Armenian language distributed in the medical community and made
p.000097: a 30-minute publicistic film demonstrated on two national TV channels. At the same time specialists from
p.000097: Society for Bioethics Development held seminars where explained norms and principles of bioethics, discussed
p.000097: specific bioethical problems and focused the attention of the medical community on different bioethical issues. It is
p.000097: necessary to underline that this programme was developed according to recommendations of this fund. The main
p.000097: idea of the project was to develop foundations of democratic society and to raise the level of legal competence in the
p.000097: medical community and in public at large.
p.000097: Results of the research in the medical community (1600 participants from all regional municipal clinics in Armenia and
p.000097: Yerevan) revealed the scarcity of information on bioethics and the fact that the interest to bioethical
p.000097: problems rose sharply after the seminars. However, it is necessary to mention that literature on bioethics is
p.000097: available, if any, only in Russian and in English, which essentially hampers the access to information on bioethics for
p.000097: the medical community.
p.000097: Unfortunately, our experience shows that with regard to financing of different programs (international grants) Armenia
p.000097: is currently outside the zone of interests of donor organizations, while funds functioning in Armenia have mandates
p.000097: that do not correspond to our goals and tasks. Personal initiatives are also unrealizable for technical
p.000097: or financial reasons (e.g. implementation of a programme, attending international training seminars and conferences,
p.000097: etc.).
p.000097: It would be reasonable that The Division of Science and Technology Ethics within the Social and Human Sciences Sector
p.000097: at UNESCO did not confine its activity to providing information for national ethics and bioethics committees, but also
p.000097: furnished a financial support for our organization and for implementation of training courses as well as for
p.000097: publication of teaching materials on bioethics in Armenian language.
p.000097: It is clear that the development of teaching programmes on bioethics and research ethics in Armenia should be adapted
p.000097: to its national, social and spiritual traditions and its healthcare system. At the same time, it should correlate with
p.000097: actual models of modern bioethics, and therefore we make steps towards integrating Yerevan Medical University
p.000097: named after M. Heratsi into the system of UNESCO International Committee for Medical Schools.
p.000097: Universityadministrationdoesitsbestforinternationalacknowledgement of our University as a member of UNESCO
...
p.000269: correspond to a level of understanding of those to be involved in the study, to be easy to read and not to
p.000269: contain many medical terms. This document must describe the following: study purpose and objectives; description of the
p.000269: tested medicinal article; concomitant treatment permitted or prohibited in the given the trial’s subjects. probability
p.000269: of random assignment in one of the study groups (including the control that might be treated with placebo. Explanations
p.000269: for all terms and concepts, for instance, placebo, is obligatory!); objectively expected benefit for the patient as
p.000269: well as inconveniences and objectively expected risks for both patients/healthy volunteers and a fetus or infants; all
p.000269: study procedures (especially accurately
p.000269:
p.000270: 270
p.000270:
p.000271: 271
p.000271:
p.000271: there shall be highlighted issues on all invasive procedures planned during the study); obligations of the
p.000271: subject-participant; compensation and/or treatment the subject might expect in case the damage is incurred to his/her
p.000271: health during the study. The information note for the patient must contain a declaration that his/her participation
p.000271: in the study is voluntary and that he/she can in any moment of time refuse of participation in the study or to
p.000271: discontinue it without any sanctions or his/her rights infringement; there shall be clearly identified a list
p.000271: of persons that will be granted with direct access to information in the primary medical documentation (investigators,
p.000271: auditors, regulatory authorities, ethical committee members), and provided assurance that data identifying
p.000271: personality of the study subject will be kept secret and its disclosure is possible only within the limits
p.000271: stipulated with corresponding laws and/or by-laws. For instance, in case of public representation and
p.000271: publication of the study results anonymity of its subjects (confidentiality of information about them) is
p.000271: guaranteed. The patient information note must indicate investigator obligations in case of appearance of new data
p.000271: in the given CT that can influence the subject decision on continuing participation in the study to
p.000271: immediately inform the study subject or his/her legal representative about them, define a list of persons that one can
p.000271: address if it is necessary to obtain additional data concerning this CT the subject-participant and the rights of the
p.000271: subject as well as other specialists that the study subject can contact in case his/her health is
p.000271: compromised during the study (these are representative of the study team, local EC). It is obligatory to provide
p.000271: conditions when participation of the patient/healthy volunteer can be discontinued without his/her consent, suggested
p.000271: duration of the study, and approximate number of the subjects in different regions and in the given clinical site. The
p.000271: information provided to the patient shall be logically completed with the informed consent form, which exhibits, if
...
p.000299: mechanisms for safeguarding patients’ rights for physicians of healthcare institutions in Dushanbe and five other
p.000299: regions (Rudaki, Gissar, Tursun- Zade, Varzob and Vahdat). Unfortunately, medical professionals showed a low level
p.000299: of knowledge referring to patients’ rights. Thus, 50% of responding physicians in Dushanbe and about 100% of physicians
p.000299: in the regions did not have a proper knowledge on the relevant legislation. A survey revealed frequent cases of the
p.000299: violation of patients’ rights on different levels of medical and social services (50% of physicians
p.000299: mentioned healthcare institutions, 20% - institutions of social service, 30% - public authorities).
p.000299: Only 2% of respondents mentioned that patients might defend their rights via public institutions. According to the
p.000299: survey data, all physicians (100%) believe that medical secrecy implies non-disclosure of a diagnosis and that
p.000299: information on a patient’s health should be concealed from him/her, which conflicts with the Declaration of
p.000299: Patients’ Rights. However the majority of respondents gave correct answers to questions about the
p.000299: physician’s responsibility for a patient’s health if the patient refuses to follow medical prescriptions or regimen. As
p.000299: to legitimization of euthanasia in Tajikistan, 95% of respondents gave negative answers. The survey results show that
p.000299: the development of a mechanism for safeguarding patient’ rights should be in the centre of all healthcare reforms in
p.000299: Tajikistan. To develop the ethical review system, it is necessary to raise the level of professional ethical knowledge
p.000299: and to provide an access to information on human rights and their protection in biomedicine for public at large.
p.000299:
p.000299: 3.9.5. Perspectives and Forms of International Cooperation
p.000299:
p.000299: The process of harmonization on a global scale is a characteristic feature of the development of standards for ethical
p.000299: review. This situation implies the development of national systems for ethical review. A necessary condition for the
p.000299: functioning of the CME at the Health Ministry of Tajikistan is to develop its activity and to widen its contacts with
p.000299: ECs in other countries. It is necessary to raise the level of ethical knowledge in the CME members and investigators,
p.000299: and to participate in training seminars on ethical review held outside Tajikistan. Professional discussions of ethical
p.000299: issues are also of great importance. Cooperation with the FECCIS and other leading international institutions has great
p.000299: potential with regard to harmonization of international relations in this sphere within the CIS region and in
p.000299: all countries of the world community.
p.000299:
p.000300: 300
p.000300:
p.000301: 301
p.000301:
p.000301: 3.10 UKRAInE (Yu.I.Kundiev, n.A.Chaschin, A.n. Chaschin,
p.000301: S.V.Pustovit, P.n.Vitte)
p.000301:
p.000301: 3.10.1. Historical and Cultural Background
p.000301:
p.000301: Bioethics in Ukraine, as in many other countries, has been developing in the context of preceding millennial experience
p.000301: of medical ethics and deontology. Many legends about humanism and high moral qualities of leading physicians survived
...
p.000303:
p.000303: The protection of human rights in biomedical research is a particularly important field requiring a special
p.000303: legislative approach. In Ukraine legislation there is a number of general and special acts setting both general
p.000303: principles concerning the protection of human rights in biomedical research and detailed statements regulating the
p.000303: order of conducting those.
p.000303: The Constitution of Ukraine (1966) is the main law proclaiming the priority of the individual, his/her life and health,
p.000303: dignity, honour, personal inviolability and safety, protection of human rights and freedoms (Art. 3). The Constitution
p.000303: states the principle of freedom and equality with regard to human rights and dignity (Art. 21); non-admission of
p.000303: discrimination (Art. 24); person’s inalienable right to life (Art. 27); everyone’s right to respect of his/her dignity,
p.000303: (Art. 28). Article 28 states in particular: “No person shall be subjected to medical, scientific or other experiments
p.000303: without his or her free consent”. Article 32 states that the collection, storage, use and dissemination of confidential
p.000303: information about a person without his or her consent shall not be permitted. The Constitution declares that everyone
p.000303: has the right to health protection, medical care and medical insurance (Art. 49); and that everyone has the right to an
p.000303: environment that is safe for life and health is guaranteed the right of free access to information about the
p.000303: environmental situation, the quality of food and consumer goods (Art. 50). Thus, The Constitution secures the
p.000303: fundamental human rights with regard to biomedical research.
p.000303: Another important document is “Basic Legislation on Public Health Service in Ukraine “. This law adopted in
p.000303: 1992 is continuously revised and amended. It sets general healthcare principles and those concerning
p.000303: biomedical research, defines state and public responsibility for the health level and preservation of the Ukraine gene
p.000303: pool.
p.000303: The “Basic Legislation” contains statements on professional standards. It stipulates that only those
p.000303: who have an appropriate education and qualification meeting uniform qualification requirements may take up medical and
p.000303: pharmacological practice (Art. 74.1). All methods used for diagnostics, treatment and prevention of diseases, as
p.000303: well as pharmaceutical products should be authorized by the Ministry of Health (Art. 44.1). The Law establishes the
p.000303: mechanism of state regulation ensuring adherence to medical legislation, state standards, criteria and requirements
p.000303: relating to providing
p.000303:
p.000304: 304
p.000304:
p.000305: 305
p.000305:
p.000305: a healthy environment and conditions for sanitary-and-epidemiologic well- being (Art. 22). The regulatory mechanism set
p.000305: out in this Article concerns also norms of professional activity in healthcare, standards of medical service, medicinal
p.000305: products and technologies and rules of the State Pharmacopoeia. The Law stipulates for a possibility that the Ukrainian
p.000305: Cabinet of Ministers and other authorized institutions, including local governing bodies, may terminate the
...
p.000353: in the sphere of social and humanitarian development of society, and by themselves they form a wonderful example
p.000353: of collective law development in the form of model laws providing reference points for national law and
p.000353: order. Determining value of model law development in health care, science and education aimed for improvement of the
p.000353: bioethical component is demonstrated during presentation of both general trends of construction of an
p.000353: ethical examination system in the region and when national specific features are described. Attractiveness of the
p.000353: region countries for biomedical research and mutual responsibility of both international organizations and
p.000353: parliaments and governments of the Commonwealth countries for provision of adequate, complying to universal
p.000353: standards, regulatory framework for human rights protection are also a serious incentive. This sphere has
p.000353: multiple in their forms components of collaboration: counseling, joint law development, adaptation and
p.000353: ratification, international system of legal responsibility for their breaching and interstate appeal options.
p.000353: In the field of development of bioethical education and training for members of ethical committees there
p.000353: is well established system of interregional cooperation. Significant contribution is made by creation of national
p.000353: UNESCO commissions in the region countries with common policy aimed on the following priorities:
p.000353: - access to information and intellectual exchange;
p.000353: - development of educational programs and approaches;
p.000353: - strengthening capacities of national agencies working on ethical issues;
p.000353: - implementation of ethical norms aimed on protection of human rights in the sphere of biomedicine;
p.000353: - improvement of information awareness and training in the sphere of bioethics;
p.000353: - distribution of knowledge on bioethics among professional and public groups including via mass media;
p.000353: - counseling and education to bioethics issues among social sphere facilities;
p.000353: - extension of availability of information about regulatory documents, human rights and procedures of their protection;
p.000353: - development of training programs on ethics and their integration into educational process.
p.000353: It is noteworthy that cooperation in this sphere becomes both bilateral and multilateral. Advantage of the region
p.000353: in this sphere is preservation of communication on one language and traditional mutual penetration of
p.000353: cultures and standards becoming a root system of information bases, educational materials and educational
p.000353: testing.
p.000353: Especially advantageous situation for cooperation is created in the sphere of development and
...
Social / Age
Searching for indicator age:
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p.000009: number of deaths in 1993 exceeded the number of births by 800,000. That was the lowest fertility rate (9.4 of
p.000009: births per 1000 of population) among all the CIS countries.
p.000009:
p.000010: 10
p.000010:
p.000011: 11
p.000011:
p.000011: We should note that 1993 was one of the most hard years in the demography in the CIS countries, as the
p.000011: fertility rate decreased in all CIS countries (except Tajikistan). In comparison with 1986, when the highest fertility
p.000011: rate in the USSR for the last 50 years was registered, the fertility rate in 1993 in the CIS countries decreased by 33%
p.000011: (and by 8% in comparison with 1992, which is much enough in terms of annual oscillations) and was 13.5
p.000011: births per 1000 of population. The number of deaths in 1993 in the CIS countries was 3.6 million, and increased, in
p.000011: comparison with 1992, by 429,000. The general mortality rate increased by 14% and was 12.6 deaths per 1000 of
p.000011: population2.
p.000011: The growing share of elder people and a decreasing weight of children in the total population are typical for the
p.000011: majority of the CIS countries. This is connected with worldwide tendencies to population ageing and a drop in birth
p.000011: rate, as well as with the crisis at the end of the 20th century. In six of the CIS countries even the simple
p.000011: reproduction of population is not achieved,
p.000011: i.e. the total fertility rate (see below) is equal to or less than 2.1. These countries are Armenia,
p.000011: Belarus, Georgia, Moldova, Russia and Ukraine
p.000011: Belarus, Georgia, Russia and Ukraine are noted for the ratio of persons over 65 to the so called economically
p.000011: productive persons (at the age of 15-64), and Kyrgyz Republic, Tajikistan, Turkmenistan and Uzbekistan,
p.000011: where the age-dependency ratio is 2-3 times higher than in Belarus, Russia and Ukraine, stand out for that of children
p.000011: under 15.
p.000011: The greatest reduction of the able-bodied population in comparison with 1989 is observed in Georgia (by 20% for males
p.000011: and by 18% for females) and Ukraine (by 3,8% for males and by 4,9% for females). A significant increase of the
p.000011: able-bodied citizens (by 26-47%) is registered in Azerbaijan, Kyrgyzstan, Uzbekistan, Tajikistan and Turkmenistan
p.000011: The increase in the number of young people has a favorable effect on the increase of the total population, and the
p.000011: growing number of early marriages implies a perspective of a sooner birth of the first children and the increase of the
p.000011: total fertility rate.
p.000011: During last four years in the majority of the CIS countries no decrease of the fertility rate was registered. On
p.000011: the contrary, in 2003-2004 it has slightly increased. This process can be related to some stabilization
p.000011: in
p.000011:
p.000011: 2 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 23.
p.000011: social and economic situation in the CIS countries, as well as to the fact that people, born in the middle of 1980-s
p.000011: when the birth rate in Soviet Union was relatively high reached the fertility age.3
p.000011: At the beginning of 2005, the population size in the CIS countries was 279 million people (according to the Statistic
p.000011: Committee). In comparison with the beginning of 1991, the population has reduced by 2.7 million people or
p.000011: 1.0%.4
p.000011: By the type of demographic processes in the 90-s the CIS countries were divided into two groups. In the
p.000011: first group including Ukraine, Belarus, Russia, Kazakhstan, Moldova, Georgia and Armenia the population has
p.000011: been decreasing from year to year. The second group includes Azerbaijan and Republics of Central Asia where the
p.000011: population and the demographic potential kept on increasing. At the same time, as it was mentioned above, depopulation
p.000011: processes in Belarus, Russia and Ukraine are increasing, which means that the death rate exceeds the birth rate. This
p.000011: results in the increasing polarization of the two groups of CIS countries by the demographic potential, and hence
p.000011: creates, in prospect, additional preconditions for its redistribution between countries through migration processes.
p.000011: (Table 2).
p.000011: During last years in the majority of the CIS countries, the reduction of the fertility rate was not registered. On the
p.000011: contrary, in 2003-2004 it has somewhat increased. In Azerbaijan and Kazakhstan the increase is noticed in all age
p.000011: groups, in Belarus and Ukraine – at the age of 30 and older. At the same time, the highest fertility rate is still
p.000011: registered in women at the age of 20-24 (89-95 newborns per 1000 women of fertile age in Belarus, Georgia, Moldova,
p.000011: Russia and Ukraine, over 120 newborns – in Armenia, Azerbaijan and Kyrgyzstan, 143 – in Kazakhstan).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 3 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 26.
p.000011: 4 In the previous decade – in the 1980s – the population in former Soviet Republics, except for Baltic States,
p.000011: increased by 22.6 mln of people (8.7%).
p.000011:
p.000012: 12
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: The increase of the age-specific rates results in the increase of the total birth rate (the total birth rate is the sum
p.000013: of the age-specific fertility rates in the age range of 15-49 years; it shows the average number of children born by
p.000013: one women in her life if for every age the fertility rate remained the same as it was in the year for which the
p.000013: age-specific rates were calculated). The most significant increase of the fertility rate was in Kazakhstan where the
p.000013: total fertility rate in 2004 was 2,21 versus 2,03 in 2003. According to the recent data, the average value of this
p.000013: index in the CIS countries is 1,9 of births per one woman. The half of the population of the CIS lives in the countries
p.000013: where the simple reproduction of the population is not reached, i.e. this rate is below 2,1 (1,38 in Armenia (2004),
p.000013: 1,20 in Belarus (2004), 1,40 in Georgia (2003),
p.000013: 1,22 in Moldova (2003), 1,34 in Russia (2004), 1,20 in Ukraine (2003)).6 The problem of saving life and health
p.000013: of newborns is particularly
p.000013: important especially considering the long period of fertility decrease. In spite of a marked reduction of the
p.000013: infant mortality in all CIS countries in recent years, its level remains very high. The infant mortality rate in the
p.000013: CIS countries is much higher than that in the developed countries where its value is 3-5 deaths during the first year
p.000013: per 1000 newborns. (Table 3).
p.000013: About a half of dying infants falls to the share of the babies of the first year of life, nearly 70% of which die in
p.000013: the first week. The prenatal mortality rate in the CIS countries is fluctuating from 6 to 16 deaths at the age of 0-6
p.000013: days and still-borns per every 1000 of births. The causes of these deaths are respiratory states typical for the
p.000013: prenatal period, cases of the fetal asphyxia and asphyxia at birth.
p.000013: In many respects, a high death rate registered in the majority of the CIS countries over a long period can be
p.000013: explained, by the population ageing and by the decrease of the quality of life and health. At the same time, the number
p.000013: of births per 1000 population in the countries of the European Union is less (at the average 11,1) than in Azerbaijan
p.000013: (24,2), Kyrgyzstan (26,1), Tajikistan and Turkmenistan (33,1). However, in spite of the high population ageing rate,
p.000013: the number of deaths in the EU countries is lower (10,1) than in the CIS countries (12,6), which in it’s turn, may be
p.000013: explained by the level of preventive measures and healthcare in general, and by the social-economic situation in the
p.000013: CIS countries.
p.000013:
p.000013: 6 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000013: 2005, p. 62“.
p.000013:
p.000014: 14
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: The natural increase of the population is the main source for advanced reproduction of labor resources at a certain
p.000015: territory. According to the data shown above, in the CIS countries two types of reproduction prevail that may by
p.000015: characterized as simple and reductive. If the simple population reproduction requires the numeral equality
p.000015: of the parent and children generation, the current level of survival rate (including the average life
p.000015: expectancy) requires 250-260 births per each 100 families. The birth rate corresponding to such a level is
p.000015: registered only in some CIS countries, such as Azerbaijan, Kyrgyzstan and Tajikistan. The functions of fertility
p.000015: and survival, as exogenous characteristics of the population reproduction, form its endogenous characteristics, i.e.
p.000015: age structure of population and also the measure of the population growth (net coefficient of population reproduction)
p.000015: and, hence, the actual level of the natality. The Russian Federation shows a tendency to a reductive
p.000015: reproduction of the population; however, in some years the increase due to the migration has compensated the natural
p.000015: decrease of the population, which is not so typical for Moldova, Belarus and Ukraine. Therefore, the total population
p.000015: size has not reduced. During the last five years the natural decrease of the population in the Russian
p.000015: Federation has prevailed over the increase due to the migration, which has decreased after 1994, and the total number
p.000015: of citizens began to decrease steadily.
p.000015: The population structure and the morbidity level characterize the general social-demographic situation in the
p.000015: CIS countries.
p.000015: Diseases of blood circulation system that are typical causes of death in elder people, take the leading role
p.000015: among the main causes of death. In 2003, the male mortality by this cause was 41% of deaths in Kyrgyzstan, 45% in
p.000015: Kazakhstan, 48-49% in Russia and Moldova, 50% and more in Azerbaijan, Armenia, Belarus and Ukraine. Female
p.000015: mortality from these diseases is somewhat higher – 55-61% of female deaths (in Ukraine – 72%). (pic. 1 and 2).
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000017: 17
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.006000: 6000
p.006000:
p.005000: 5000
p.005000:
p.004000: 4000
p.004000:
p.003000: 3000
p.003000:
p.002000: 2000
p.002000:
p.001000: 1000
p.001000:
p.000000: 0
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.001000: 1000
p.001000:
p.000800: 800
p.000800:
p.000600: 600
p.000600:
p.000400: 400
p.000400:
p.000200: 200
p.000200:
p.000000: 0
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000: Picture 1. Diseases of blood circulation system (per 100 000 of
p.000000: population)
p.000000: Malignant tumors (respiratory organs diseases – in Kyrgyzstan) are in the second place among female death causes.
p.000000: Malignant tumors as a death cause in men are in the second place in Azerbaijan (88 deaths per 100000 of
p.000000: population in 2003) and Armenia (160). The male mortality rate from suicides and other external causes in
p.000000: other countries is higher than the mortality rate from cancer. In 2004 this index in Belarus was 281 deaths from
p.000000: external causes10 per 100000 of population, which is slightly higher than the mortality rate from the
p.000000: malignant tumors (240); in Kazakhstan – 232 (142), in Kyrgyzstan – 110
p.000000: (64), in Moldova – 162 (158), in Russia – 390 (236), in Ukraine – 258
p.000000: (236). (Table 4).
p.000000: In Belarus, Kazakhstan and Russia the mortality rate for males from external causes is 4-5 times higher than that from
p.000000: diseases of respiratory and digestion organs. Nearly 40% of deaths by these causes falls to the share of working
p.000000: citizens.
p.000000: On the average, in recent 15 years (in comparison to 1989) the male mortality rate at the age of 15-64 has
p.000000: increased: in Belarus – by 41%, in Kazakhstan – by 46%, in Russia – by 70%, in Ukraine – by 46%. In Kyrgyzstan and
p.000000: Moldova the mortality rate of males at the age of 35-64 has been increased by 20% and 25% respectively.
p.000000: The female mortality rate in women of working age is somewhat lower than that for men, but the scale
p.000000: of its increase is the same. Thus in the indicated period the mortality rate for females in the age
p.000000: 15-64 has increased in Kazakhstan by 32%, in Russia – by 62%, in Belarus and Kyrgyzstan (for the age of 30-64) – by 30%
p.000000: and 14% respectively, and in Ukraine (for the age of 20-64) – by 42%.
p.000000:
p.000000:
p.000000: 2000. 2004 (Georgia – 2003).
p.000000:
p.000000:
p.000000:
p.000000:
p.000000: Picture 2. Mortality from diseases of blood circulation system (per 100 000 of population)
p.000000: The most comprehensive index of the population health and of the labor resources is the life expectancy.
p.000000: Since the beginning of the transition period, it has decreased in the majority of the countries. (Table 5).
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000018: 18
p.000018:
p.000019: 19
p.000019:
p.000019:
p.000019: Mortality by main groups of death causes in 2004
p.000019: Table 4
p.000019: Table 5
p.000019: Life expectancy in people of certain age1) in several CIS countries
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: 1) 2003.
p.000019: 2) 2000.
p.000019: 3) From neoplasm. 4) 1995.
p.000019: 5) 2001.
p.000019:
p.000019:
p.000019:
p.000019: 1) Life expectancy is the average number of additional years a person could expect to live if current mortality trends
p.000019: were to continue for the rest of that person’s life.
p.000019:
p.000020: 20
p.000020:
p.000021: 21
p.000021:
p.000021: The significant increase of the total mortality rate and the decrease of the life expectancy at birth, as shown above,
p.000021: affected different age and sex groups with different intensity. First, the increase of mortality concerned males more
p.000021: than females. This growing disparity resulted in the increase of the number of incomplete families and widows,
p.000021: aggravation of the existing disbalance (as will be shown below) in the sex structure, reduction of
p.000021: nuptiality and population reproduction potential, and in a growing difference of the lifespan between the sexes. In
p.000021: spite of substantiated expectations, the high mortality rate in the period of transition at the early nineteenth did
p.000021: not affect seriously those population groups that usually are considered as particularly vulnerable due to biological
p.000021: or social causes, namely children and elder people. Perhaps the most remarkable feature of this recent population
p.000021: health crisis became a significant increase of the mortality rate for age groups of gainfully employed population. The
p.000021: most drastic relative growth of the mortality rate for adult males was registered in the group of “blooming age” i.e.
p.000021: at the age of 35-49, which is most typical for Russia. As to females, the mortality changes had unequal intensity, and
p.000021: the increase of mortality here was less marked, but it affected exactly the “blooming” age group from 35 to 49 years.
p.000021: As we know, the population reproduction depends mostly on two factors: firstly – on the ratio of marriages and
p.000021: divorces; secondly – on the ratio between males and females at the fertile age. As to the first factor, in
p.000021: the conditions of the increasing youth unemployment, rapidly growing prices housing costs and uncertain prospects, the
p.000021: nuptial ratio has decreased in all nine countries from 4% (Azerbaijan) to 34% (Russian Federation). The decrease of the
p.000021: nuptial ratio for persons in the second marriage in all countries was even sharper. An average decrease of this index
p.000021: was 28%; only in Ukraine the increase of the nuptial ratio was registered, but in 1993 the fertility in this country
p.000021: has decreased dramatically (by 20%), and hence the hopes associated with the nuptial ratio were not justified. In
p.000021: contrast to the number of marriages the number of the divorces was growing. The second factor is also unfavorable. The
p.000021: female population exceeds male population, and this ratio becomes worse with every new age group.
p.000021: Thus, the marriage/divorce ratio, as well as male/female ratio determines negative tendencies in demographic
p.000021: situation in the CIS countries. The mentioned ratios have a negative impact on the generation renewal,
p.000021: and retain conditions for a narrow reproduction.
p.000021: When considering the situation we should note that the most dramatic aggravation was observed in the areas of the
p.000021: income per person, poverty, demography and social unity, which is essential for understanding social- economic
p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
p.000021: into the international system of biomedical research both from a viewpoint of interested researchers and potential
p.000021: participants.
p.000021: In the period of transition to the market economics all the CIS countries had to face such problems as considerable
p.000021: inequity in the income distribution, stratification of the society by income and increasing poverty. In 2004, the ratio
p.000021: of the total income of 10% of the most and 10% of the least well-to- do population was 3-5 times in Azerbaijan, Belarus
p.000021: and Ukraine; 11 times in Kazakhstan, Kyrgyzstan, Moldova, Russia and Tajikistan; 21 times in Armenia.
p.000021: In recent years (2005-2007), in the majority of the CIS countries some smoothing of the society stratification by
p.000021: income and the decrease of the population quota with the income beyond the cost of living (poverty line) was observed.
p.000021: Some processes were observed in the CIS countries that were not typical before. Thus, the number of the “poor” children
p.000021: usually was growing much faster than the number of poor persons in every other age group because of the rapid spread of
p.000021: the unemployment and increasing number of persons in a low-paid job, alongside with a disproportional indexation of the
p.000021: family allowances. The level of food consumption by children has considerably decreased. Presently, the change
p.000021: in the nutrition structure is expressed by transition to food products that are less expensive and richer in
p.000021: calories. There is a lack of food products that are necessary for the normal growth and development of the organism.
p.000021: Besides, a decrease in food consumption and the worsening of the sanitary situation, hygiene and living conditions have
p.000021: caused the increase of the number of diseases (tuberculosis, rachitis) traditionally associated with poverty.
p.000021: Specific features of the demographic situation and, indirectly, the amount of labor resources depend also on
p.000021: the age groups prevailing in the total population size, which, in its turn, implies special approaches to the
p.000021: healthcare structure development in the CIS countries. The increase of
p.000021:
p.000022: 22
p.000022:
p.000023: 23
p.000023:
p.000023: the elder population and the decrease of the share of children in the total population are typical for the majority of
p.000023: the CIS countries.
p.000023: In fact, during the period from 1989 to 2004 in all the CIS countries the part of population under working age
p.000023: decreased. This especially concerns the age group under four. The part of working population did not decrease due to
p.000023: the generation born in the period from the late 70s to the mid-80s (time interval characterized as a period of the
p.000023: highest fertility rate). At the same time, on the average, the part of the population over working age has increased,
p.000023: which, as shown above, alongside with the decrease of fertility and, consequently, the decrease of the population under
p.000023: the working age, can lead to the population ageing and the decrease of the population initiative and economic activity.
p.000023: The number of children under 16 in the CIS countries is nearly 80 millions. Compared with 1989, the
p.000023: part of children under 16 in the total population size of the CIS countries decreased by 11%. The youngest is
p.000023: the population of Azerbaijan and Armenia where children make 35 and 29% of the population. In the countries of
p.000023: Central Asia, due to a relatively high fertility, children make on the average 39-45% of the total population. If we
p.000023: consider the demographic situation in the Russian Federation, particularly with regard to children, it should be noted
p.000023: that during the 90-s the number of births was by 60 millions less than in the 80-s. In recent decade, the children’s
p.000023: morbidity has increased dramatically. The most disturbing is the fact of the mental health worsening, since in recent
p.000023: ten years the rate of mental diseases in children doubled, that of moronity increased in 1.5 times and imbecility in
p.000023: 1.6 times. We have to recognize the growing number of disabled children; in the CIS countries there are about 1.5
...
p.000043:
p.000043: References to international documents mentioned in the text are provided in the chapter for the member states.
p.000043: Texts of the model laws of IPA CIS are available at the web site: www.iacis.ru/html, the text of the model
p.000043: law of IPA CIS On Protection of Human Rights and Dignity in Biomedical Researches in the CIS and the text of
p.000043: the model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS can be also
p.000043: found at the following web sites: www. feccis.net and www.pasteur-nii.spb.ru
p.000043:
p.000044: 44
p.000044:
p.000045: 45
p.000045:
p.000045: Chapter 2. CURREnt StAtUS AnD PERSPECtIVE oF tHE CIS’ REGIon PARtICIPAtIon
p.000045: In tHE IntERnAtIonAL BIoMEDICAL RESEARCH
p.000045:
p.000045: 2.1 Philosophical Aspects of the Biomedical Research (P.D.tishchenko, B.G.Yudin)
p.000045:
p.000045:
p.000045: Philosophy of modern biomedical research (BMR) is a limitless topic with multiplicity of versatile aspects. Here we
p.000045: would like to dwell on those of them that are to some extent are related to issues of ethical examination
p.000045:
p.000045: Specific Position of Science in the Modern Culture
p.000045: Understanding of trends of development of the modern biomedical research is impossible without taking
p.000045: into account on-going general civilization transformations of our days. First of all, let’s take a look at the
p.000045: most general context of the issue.
p.000045: In this respect it is necessary to remind about a central role that science have played and still plays in the modern
p.000045: culture. As to exact expression by E. Husserl: “When at the beginning of the New Age religious belief began
p.000045: to degenerate more and more into lifeless convention, intellectual humanity stood in a new great faith –
p.000045: faith into autonomous philosophy and science. Scientific judgments were to highlight and guide entire human culture
p.000045: providing it with new autonomous form.” (Husserl E. Cartesian Meditations, p.14). If to take into account that
p.000045: ideology of new European education to a large extent is a gradual process of mastering the system of scientific
p.000045: knowledge, then without exaggeration one can say that the modern man (unlike a person in the Christian culture) is
p.000045: created “in the image and likeness of a scientist”.
p.000045: The leading position of science is retained and considerably strengthened gaining qualitatively new forms. Along
p.000045: with that, in the modern cultural situation science becomes more tolerant to other forms of cognition
p.000045: and comprehending of the reality. Ideas, concepts and practices that several decades ago were considered
p.000045: as superstitions are rehabilitated and gain status of fully-developed modern doctrines. In the whole world
p.000045: one can
p.000045: observe revival of archaic (shamanism, cabala and other esoteric practices) and creation of new non-scientific
...
p.000047: far from vital interests of common people and, moreover, even hostile to them, facilitating not democratic but
p.000047: totalitarian trends, dehumanizing the world, begetting and strengthening human alienation and enslavement.
p.000047: In this case we are not interested in one or another point of view for these counter-cultural and counter-scientific
p.000047: movements. But among many consequences they caused it is worth to note rather basic and distressful
p.000047: reappraisal of many values. It is characteristic that the criticism of science by these new lefts was quite effective
p.000047: although as it often happens in the history its further development took not the pace they dreamt of.
p.000047: As a result initially in the USA and then in the countries of Western Europe the range of expectations from the society
p.000047: considerably transformed along with scientific and technical policies of a state. Now scientific researches
p.000047: are required more and more that their results are to satisfy social needs and personal requirements.
p.000047:
p.000047: Science in the “Society of Knowledge”
p.000047: One of the developers of the term “society of knowledge” is the American sociologist, Piter Drucker, who in 1994
p.000047: set a question on developing in modern culture deep social transformations he determined as establishing of new
p.000047: institutions of the “society of knowledge”. The society of knowledge has altered nature of labor, higher education and
p.000047: ways of functioning for the entire society as a complicated interrelated system (P. Drucker. The Age of Social
p.000047: Transformation. The Atlantic Monthly, 274 – November 1994, 53-80). In our analysis we are going to use
p.000047: the Drucker’s ideas to some extent adding them with useful, from our point of view, results from other researchers.
p.000047: P.Drucker proceeded from that transformation of scientific knowledge into a main source of new technologies started as
p.000047: per historical measurements quite recently. He stated that yet in the XVIII century “no one even tried to talk over
p.000047: application of science for development of instruments of production, technologies and goods, i.e. about use of
p.000047: scientific knowledge in the field of techniques and technology. This idea matured only … in 1830 when the German
p.000047: chemist, Justus von Libikh (1803-1873), first invented
p.000047: artificial manure and then a method for storing animal proteins (P. Drucker. From Capitalism to Society of Knowledge.
p.000047: In: New Post-Industrial Wave in the West, edited by Inozemtsev V.L., M., 1999). According to Drucker that time the
p.000047: industrial revolution as a process of global transformation of the society and civilization on the basis of technical
p.000047: development began. At that, scientific knowledge took new, previously not characteristic role – as a factor actively
p.000047: influencing life of a man and society and dynamicizing it.
p.000047: In the context of technological application of science a research is not only an investigation of the
p.000047: world as it is, the natural world, but as transformation of this world, that is, as development of an
p.000047: artificial world (being more precise, worlds). And in such respect the research is a prototype of a technological
p.000047: method for learning and, moreover, vision of the world.
...
p.000069: development of various ethical concepts and an essential role of main landmarks in the history of world ethical
p.000069: practice that have determined a harmonious and comprehensive understanding of general ethical principles of the
p.000069: research.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000071: 71
p.000071:
p.000071: From the practical point of view, the history of biomedical research ethics is inseparable from
p.000071: understanding the essence and process of the biomedical research as such.
p.000071: According to the main research subject, the biomedical research may be divided into the following categories:
p.000071: • Research that physicians carry out on themselves (autoexperiments);
p.000071: • Research involving healthy people;
p.000071: • Research involving patients.
p.000071: In historical context, the concept of informed and voluntary consent of a research subject requires subdividing
p.000071: into separate groups within these categories
p.000071: Besides, both in healthy (e.g. prisoners and military men) and ill (e.g. persons with mental disorders or ill
p.000071: minors) research subjects, groups of vulnerable contingents should be distinguished, i.e. groups of persons who for
p.000071: social, legal, age-specific, intellectual, mental or other reasons have a limited capacity or do not
p.000071: have the capacity to make an independent, informed and voluntary decision to participate in a clinical research.
p.000071: It is also essential to distinguish different types of biomedical research depending on the character of the connection
p.000071: between the research goal and its actual clinical motivation.
p.000071: Research of the first type, defined in international documents as “therapeutic” (or clinical) biomedical
p.000071: research, implies the application of new diagnostic, therapeutic or preventive pharmaceuticals or methods, i.e.
p.000071: research conducted in the interests of a particular research subject.
p.000071: Research of the second type, defined as “non-therapeutic” (or non- clinical) biomedical research, does not
p.000071: imply actions in the interests of ill or healthy subjects. Biomedical research is carried out with the purpose of
p.000071: obtaining some scientific knowledge or studying how the human organism would respond to one or another condition or
p.000071: factor (pharmokinetic studies, studies in the field of normal physiology, in cosmonautics and sport, etc.).
p.000071: Each of the mentioned types of biomedical research forms and determines special ethical and legal
p.000071: relations. In historical context, the influence of ethical dialectics of each type of biomedical research on the
p.000071: current concept of bioethics is most essential.
p.000071: Thus, high moral principles of physicians (investigators) who conducted experiments on themselves gave rise to a symbol
...
p.000077: between the donor (seller) and recipient (buyer). At the same time he noted that “under these circumstances the
p.000077: only ethical issue that might arise concerned the permissibility of such a deal in a situation where the
p.000077: “seller” was a minor, imbecile, or a person in a state of artificial excitation, and where the “buyer” was a
p.000077: person who acted through psychological compulsion, deception, seduction, promise of profit or suggestion by authority.
p.000077: On the whole, the analysis of legal and ethical principles referring to biomedical research existing in the tsarist
p.000077: Russia in the beginning of the XX century shows that humanistic concepts of a voluntary and conscious choice made by
p.000077: the research subject and confidentiality have been combined with a responsible and merciful attitude on the part of a
p.000077: physician-investigator, and reinforced with accepted moral and ethical norms and legislative acts in force.
p.000077: Turning to a more recent period in national history, the following stages of Soviet law development illustrate how the
p.000077: issues in ethical and legal regulation of medical and biological research were interpreted in the USSR.
p.000077: In the law of the Russian Soviet Federal Socialistic Republic (RSFSR) on 1 of December 1924 “On the Professional
p.000077: Activity and Rights of Health Professionals” the need to obtain the patient’s consent, in particular when surgery is
p.000077: being planned, was declared. It was also stated that “with respect to those under 16 years of age or mentally disabled,
p.000077: the consent of their parents or care-givers”, i.e., their legal representatives, was necessary. Similar laws were
p.000077: adopted in the other Republics of the USSR. One should specifically underline that neither the law on 1 of December
p.000077: 1924, nor the decrees of the Soviet Ministries of Health until 1936, clarified how the patient’s consent was to be
p.000077: documented, and how it was necessary to regulate the conditions of medical research involving human subjects.
p.000077: In 1936 the legal regulation of the scientific and ethical aspects of the medical experiment was addressed in the
p.000077: Statutes “On the conduct of study of new medicines and medical methods associated with the risk for life and health of
p.000077: patients” adopted by the Scientific Medical Council of the People’s Commissariat of Health Care of the RSFSR
p.000077: (Resolution of the Bureau of the Scientific Medical Council, 23 of April 1936. In: Book of Resolutions
p.000077: - Peoples Commissariat of Health Care of the RSFSR. Scientific Medical Council. No 1-4, pp. 37-38).
p.000077: The events that encouraged the authorities to develop this document were described in detail in an article by
p.000077: professor I.Ya. Bychkov, where the author emphasized that in medicine “in order to assess the value of
p.000077: invention it is always necessary to study it in humans; and considering the fact that the medicine or device is new, it
...
p.000089: Public Council for Medical Ethics. Armenian Apostolic Church takes a rather strict position on some problems of
p.000089: bioethics: it prohibits human cloning and cloning of human organs, euthanasia, artificial fertilization and abortion,
p.000089: which is considered as infringement of human life.
p.000089: In this context the views of David Anhaght (the Invincible) formulated in his works (“Definition of Philosophy”,
p.000089: “Commentary on Aristotle’s Analytics” and “Commentary on Porphyry’s Introduction”) are of much interest.
p.000089: David Anhaght took problems of medical ethics very much to heart. His ideas on the value of human life are of
p.000089: particular importance. In his book “Definition of Medicine” he mentioned views of the Stoics who tended to justify
p.000089: suicide under certain conditions: starvation, loss of close relatives, natural cataclysms, violation of human dignity,
p.000089: terminal illness and senile marasmus. Two last cases are directly related to medicine. The Stoics wrote: “A man who
p.000089: kills himself to rid himself of pain in his ill and wretched body, commits the righteous act. Thus, a philosopher
p.000089: who was half-paralyzed appealed to the emperor Julian: Half of my body is dead; the other half is still alive. Have
p.000089: pity on the half-alive philosopher and order either to heal or to kill me. Likewise, it would be right for a man who
p.000089: had reached old age to kill himself when he is delirious, confused and utters meaningless phrases”.
p.000089: David Anhaght did not share Stoic views on permissibility of suicides under conditions mentioned: “In this regard
p.000089: we say that no one should kill oneself – neither those who have the right to do this, nor those who don’t… Trials,
p.000089: whenever or wherever they happen, come to us not in order that we should kill ourselves, but so that we tried our soul.
p.000089: Like a good helmsman is tested not in still water, but in the stormy sea, the lofty soul goes to meet a trial”.
p.000089: Thus David Anhaght (the Invincible), in line with Nerses the Great, a prominent philosopher (V c.), gave a negative
p.000089: answer to the question “Does the physician have a moral right to hasten his patient’s death?”.
p.000089:
p.000090: 90
p.000090:
p.000091: 91
p.000091:
p.000091: Similar views we find in works of Armenian thinkers Mkhitar Hosha and Smbat Hundstabl (XIII c.). In “The Book
p.000091: of Laws” we read: “The physician who deliberately or through ignorance does harm to the patient’s health or, what
p.000091: is more, hastens the patient’s death, as well as the physician who educates a disciple, but does not give him proper
p.000091: knowledge deserves a severe punishment, up to death penalty”.
p.000091: This discussion started many ages ago is still topical nowadays. Neither lawsuits against physicians who
p.000091: support euthanasia thus violating one of the fundamental principles in The Hippocratic Oath (“To please no one will I
p.000091: prescribe a deadly drug nor give advice which may cause his death”), nor protests of public at large advocating
p.000091: traditional views do not guarantee that those who stick to more radical opinions will not triumph in the near future
...
p.000119: human life sanctity (value) directs the physician’s activity towards all possible care for patients and implies
p.000119: that euthanasia is
p.000119: unacceptable:
p.000119: - “The physician should relieve sufferings of a dying patient by every available and legal means. Euthanasia as an
p.000119: act of an intentional taking of one’s life is not permissible at the patient’s or his/her relative’s
p.000119: request” (Art. 25 CME).
p.000119: - “Medical or pharmaceutical professionals are not permitted to perform euthanasia. A person who
p.000119: consciously induces the patient to euthanasia and/or performs euthanasia shall bear criminal responsibility
p.000119: according to legislation of Republic of Belarus” (Art. 38 of the Law on Healthcare).
p.000119: Priority of a person’s interests implies that interests and well-being of an individual should prevail over scientific
p.000119: and public interests:
p.000119: - “In his/her scientific and research activity the physician should be guided by the priority of the
p.000119: patient’s benefit over scientific interests; clinical trials and research may only be carried out in compliance with
p.000119: the rules established by law and with the patient’s consent” (Art. 36 CME).
p.000119: Principle of tolerance implies that all citizens, with no exception, are guaranteed that the individual’s integrity,
p.000119: principal rights and freedoms shall be respected:
p.000119: - “The main goal of physician’s professional activity is to save an individual’s life and health…
p.000119: regardless of the patient’s sex, age, nationality, social and financial status, political convictions and religion”
p.000119: (Art. 2, CME);
p.000119: - “Physician shall in every possible way contribute into protection of population health and to
p.000119: struggle against any forms of cruelty and disparagement” (Art. 5 CME).
p.000119: Equal rights and cooperation in physician-patient relationship as a cardinal principle of modern deontology
p.000119: implies the following:
p.000119: - “Physician and patient have equal rights to respect for their human dignity and may protect it according to
p.000119: current legislation” (Art. 14 CME).
p.000119: Principle of physician’s and patient’s autonomy following from the above statement reveals itself in recognizing the
p.000119: autonomy of the physician:
p.000119:
p.000120: 120
p.000120:
p.000121: 121
p.000121:
p.000121: - “Physician shall bear responsibility for all his/her professional decisions and has the right to reject
p.000121: any attempts of pressure from colleagues, patients and other persons if their requests contradict ethical
p.000121: principles, professional duty and law.” (Art. 11 CME).
p.000121: Secondly, the principle of autonomy implies the patient’s autonomy:
p.000121: - “Patient is an active participant of the treatment process” (Art. 16 CME).
p.000121: - “Patient has the right to choose the physician. In case of a disagreement with the physician the
...
p.000123: • In October 1997, on the initiative of the Minsk State Medical Institute and with the support from
p.000123: the Health Ministry of Belarus, the European Parliament, The Embassy of United Kingdom in Belarus,
p.000123: and World Association for the Protection of Animals, the international symposium “Ethical Problems of Using
p.000123: Animals in Teaching and Scientific Research” was held in Belarus. The Symposium stimulated the study of the problems of
p.000123: humanizing medical education. Members of the teaching staff and students from Belarus, Russia, United Kingdom and
p.000123: Sweden took part in the Symposium [14,16,18,19].
p.000123: • In 1999 recommendations “Teaching Basics of Medical Ethics and Deontology in the Course on Human Anatomy” (Denisov
p.000123: S.D., Yaroshevich S.P.) were published, as well as other works relating to ethical norms of handling
p.000123: anatomic preparations [3,15,17].
p.000123: • In 2000 Minsk hosted the international scientific-and-practical conference “Biomedical Ethics: Problems and
p.000123: Perspectives”; a volume of conference proceedings was published [9].
p.000123: • In 2000 one of the first text-books in CIS countries “Biomedical Ethics” (220 p.) for students studying
p.000123: medicine and biology approved by the Ministry of Education of Belarus was published [12]. The text-book includes a
p.000123: supplement in which leading scientists and physicians of Belarus of different age and specialties give their
p.000123: professional opinion on ethical problems.
p.000123: • In 2001 the International State Ecological University named after A.D.Sakharov introduced a course “Basics of
p.000123: Biomedical Ethics” (20 h) into the syllabus for students studying medicine and biology. Since 2003
p.000123:
p.000123: * Data by N.E. Luigas and C.D. Denisov
p.000123:
p.000124: 124
p.000124:
p.000125: 125
p.000125:
p.000125: the course in biomedical ethics (36 h) is taught at the Belarus State Medical University (BSMU) and other
p.000125: institutes of higher medical education. Teaching programmes “Basics of Biomedical Ethics” for undergraduate
p.000125: students and “Topical Problems of Biomedical Ethics” for medical post- graduates have been designed.
p.000125: • A programme in biomedical ethics has been developed for the system of raising the professional level of medical
p.000125: practitioners and teaching staff of medical institutes (18—36 h). Academy for Post-Graduate Education of Republic
p.000125: Belarus offers a course “Biomedical Ethics in Psychiatry” (for teaching professionals, clinical psychiatrists
p.000125: and investigators – 24 h).
p.000125: • In the framework of Russia—Belarus scientific-and-practical conferences on the problem of
...
p.000167: international legislative experience including legislative acts in area of biological and medical studies. For
p.000167: example, on 22nd of January 2007 the Frame Convention on Tobacco Control was officially ratified by the Republic of
p.000167: Kazakhstan; it is planned to bring laws of Kazakhstan in line with international documents that can ensure good
p.000167: clinical practice and improvement of activity of ethical committees [6].
p.000167: In 1995 according to initiative of the Association of Physicians and Pharmacists of Kazakhstan drafts of “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
p.000167: developed. In 2002 the Second Congress of Physicians and Pharmacists approved the text of “The Oath of Physician of the
p.000167: Republic of Kazakhstan” that was reflected in special Decree of the Government of the Republic of Kazakhstan No/ 1189
p.000167: published on 27th of November 2003 and in the article 50 of the Law of the Republic of Kazakhstan “On the
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan”.
p.000167: In 2006 according the law “On changes and additions to some legislative documents on public health of the Republic of
p.000167: Kazakhstan” the article 20 was supplemented with the following paragraphs:
p.000167: «it is prohibited to perform clinical trials and(or) testing of pharmaceutical substances or medical drugs with
p.000167: participation of:
p.000167:
p.000167:
p.000168: 168
p.000168:
p.000169: 169
p.000169:
p.000169: - persons before coming to age with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treatment of children diseases or when the goal of clinical trial is to collect data on the optimal dosage of this
p.000169: medical drug supposed for usage in children and adolescents. In the last case clinical studies of any medical drug in
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
...
p.000171: 1) assessment and coordination of the activity of local commissions responsible for ethical reviews of
p.000171: clinical trials;
p.000171: 2) arbitration of complex aspects on ethical assessment performed by local commissions;
p.000171: 3) registration of clinical trials that are performed in the province or in the city;
p.000171: 4) counseling of members of local commissions.
p.000171: The main functions of local commissions responsible for ethical reviews are as follows:
p.000171: 1) performance of ethical assessment of all documentation on clinical trials;
p.000171:
p.000171:
p.000172: 172
p.000172:
p.000173: 173
p.000173:
p.000173: 2) performance of ethical assessment of all changes and additions to documentation on clinical trials;
p.000173: 3) conclusions on agreement or refusal for the beginning or continuation of clinical trials;
p.000173: 4) assessment of following ethical, moral and juridical norms in the process of clinical trials and after
p.000173: their end.
p.000173: The commission should include sufficient number of members that would have the necessary experience and
p.000173: qualification to be able to assess all ethical, moral and juridical aspects of planned research; besides commission
p.000173: members should be independent of researches and sponsors and should not participate in the planned
p.000173: clinical research. The commission should include at least 5 members, namely specialists that are competent
p.000173: in the area of clinical trials as well as persons who are not researches themselves, specialist in legislation,
p.000173: representatives of religious community and of non- governmental organizations; the commission should include
p.000173: males and females of different age groups.
p.000173:
p.000173: 3.5.3. Education in Bioethics
p.000173:
p.000173: During the last decades due to new approaches to moral and ethical problems in medicine and science,
p.000173: development of bioethics as a interdisciplinary field, it was necessary to revise the respective educational
p.000173: programmes at all levels.
p.000173: The science “Bioethics” as a separate science was not included in the State standard of university medical education in
p.000173: the Republic of Kazakhstan, but many aspects related to bioethics were included in other programmes (specialties). For
p.000173: example, at the Semipalatinsk State Medical Academy problems of biomedical ethics were included in the programme
p.000173: of discipline “Communicative skills” at the department of internal diseases. At the moment special training
p.000173: programme is under the process of development. At the Kazakhstan State Medical Academy (in Astana) problems of
p.000173: biomedical ethics were included in the training programme at the department of public health. Similar situation took
p.000173: place in other medical universities of the country. In December 2006 the Scientific Council of the Almaty
p.000173: Institute for Postgraduate Training has decided to organize the Department of health legislation and bioethics in
p.000173: 2007. It will allow to introduce widely into
p.000173: the practice main principles of human rights protection of persons who participate in studies or experiments.
...
p.000177: Kazakhstan №1189 of 27.11.2003.
p.000177: 8. «On the System of Public Health». The Law of the Republic of Kazakhstan N430 of 4 June 2003, the
p.000177: last revision date: 29.12.2006, № 15742 in the State List (Inventory).
p.000177: 9. «On Changes and Additions to Several Laws of the Republic of Kazakhstan on Public Health». The Law
p.000177: of the Republic of Kazakhstan N171 of 7 July 2006, the last revision date: 07.07.2006, № 28850 in the State List
p.000177: (Inventory).
p.000177:
p.000177:
p.000178: 178
p.000178:
p.000179: 179
p.000179:
p.000179: 3.6. KYRGYz REPUBLIC (A.z.zurdinov, U.M.tilekeeva, B.A.Alisherov)
p.000179:
p.000179: 3.6.1. Historical and Cultural Background
p.000179:
p.000179: Kyrgyz Republic is a country in the middle part of Central Asia; most of it is located in the Tenir-Too
p.000179: mountainous region. The territory of Kyrgyzstan is equal to 198.5 thousands sq. km; nearly 90% of the territory is 1500
p.000179: m above the sea level. According to 1999 census, the population is 4.8 million people including 3.1 million of
p.000179: ethnic Kyrgyz. About one third of Kyrgyzstan population (35%) lives in urban areas and 65% are rural population
p.000179: (1999).
p.000179: Kyrgyzstan is a multinational unitary state. The country is divided into seven administrative regions: Batken,
p.000179: Zhalal-Abad, Naryn, Osh, Talass, Chuisk, Issyk-Kul. The capital of Kyrgyz Republic is Bishkek, the form of
p.000179: government – republic.
p.000179: The land of Kyrgyzstan, like all Central Asia, is one of the most ancient places of human civilization. Archeological
p.000179: studies show that primitive men settled there in the time of the Stone Age. Kyrgyz ethnos that was known in Central
p.000179: Asia since the first millennium BC retained its self-name to our time. First politically organized communities in the
p.000179: territory of the present-
p.000179: day Kyrgyzstan appeared in the II century BC when southern agricultural regions joined the State of Parkan.
p.000179: During the IV and III centuries BC early Kyrgyz formed part of powerful unions of nomadic tribes that were a
p.000179: serious problem for China. It was the time when the Great Wall of China began to be built. During the II and I
p.000179: centuries BC a part of Kyrgyz tribes got away from the power of Hunnu State and moved to Enisei (the Kyrzys meaning of
p.000179: “Ene-sai” is the Mother-River) and Baikal (Rich Lake) regions. There they founded their first state Kyrgyz Kaganat that
p.000179: became the centre of the Kyrgyz consolidation and the centre of their culture where their written language
p.000179: developed. Runic inscriptions still can be seen on stone monuments. Invaders destroyed the state but they could not
p.000179: destroy people’s memory, although the written language was lost.
p.000179: During the V century the transition from nomadic to settled lifestyle began in the North of Kyrgyzstan. First written
p.000179: sources mentioning Kyrgyz tribes inhabiting Tian Shan date back to the X century.
p.000179: Petroglyphs of Saimaly Tash, one of the oldest and biggest collections of rock pictures, demonstrate a high level of
p.000179: Kyrgyz civilization. The Burana Tower and Uzgen architecture complex are examples of an amazing mastery of architects
p.000179: and builders.
...
p.000181: worldview as world- and life-asserting.
p.000181: Although the epic poem does not contain distinctly formulated precepts, moral lessons learned from centuries-long
p.000181: history formed a traditional system of moral values that has survived to our days:
p.000181: 1. unity and solidarity of the nation,
p.000181: 2. international accord,
p.000181: 3. national honour,
p.000181: 4. movement towards prosperity and well-being through a continuous labour and knowledge,
p.000181: 5. humanism, generosity, tolerance,
p.000181: 6. harmony with nature,
p.000181: 7. strengthening and protection of Kyrgyzstan state system.
p.000181: Ethical norms in “Manas” are based on four cardinal virtues (wisdom, patience, conscience and generosity) that are
p.000181: personified in images. They are opposed by four vices: laziness, wickedness, greed and arrogance. It is said that a
p.000181: clever person is always able by using one’s mind which is “the best of all treasures” to oppose positive qualities to
p.000181: negative ones and defeat the evil by kindness, wickedness by patience, greed by generosity. Hence, the person has to
p.000181: make every effort to improve his or her moral nature, to overcome evil elements and to change the surrounding world.
p.000181: Among human qualities most valued in Kyrgyz culture are health and longevity, diligence and valour, sense of duty and
p.000181: honour, modesty, self- control and wisdom. These virtues ensure a harmonious life of the individual [5]. Openness, love
p.000181: for children, hospitality, generosity, humanism, patience, firmness, goodwill, respect for old age and other qualities
p.000181: inherent in Kyrgyz people form the basis of moral and ethical principles of their life [1].
p.000181: Historical conditions dictated to Kyrgyz people the necessity to stand up for their freedom and integrity in the fight
p.000181: with stronger neighboring states. Severe war conditions required from men who were admitted to military
p.000181: of people’s life. Over many ages, people’s ideals have been associated
p.000181:
p.000181:
p.000181: with “Manas”; ethical norms and concepts of the good and the evil were exemplified by the acts and deeds of “Manas”
p.000181: characters.
p.000181: 19 The word eudemonism comes from the Greek word for happiness or flourishing
p.000181: (eudaimonia), and refers to any conception of ethics that puts human happiness and the complete life of
p.000181: the individual at the Centre of ethical concern.
p.000181:
p.000181:
p.000182: 182
p.000182:
p.000183: 183
p.000183:
p.000183: service not only physical strength, but also moral maturity. Wars depicted in “Manas” and episodes associated with
p.000183: those exemplify heroic traditions implying the observance of the rule of military necessity and an innate
p.000183: aversion to violence, as well as a wish to live in peace. Kyrgyz warriors regarded their sacred duty not to harm
p.000183: peaceful population of conquered peoples. It was forbidden to plunder or humiliate them. Thus an epic sage Bakai
p.000183: addresses his warriors:
p.000183: “Do not thou slaughter their cattle more that thou need for food, A foe today may be kinsman tomorrow,
...
p.000185: universe. They felt aversion to violence and rudeness. Throughout the course of ethics development, starting from
p.000185: legendary thinkers to akyns- democrats, the care for widows and orphans was the responsibility of all clan members.
p.000185: The next stage of development of ethics philosophy is represented by akyn-zamanists21 Kalygul Bai Uulu
p.000185: (1785-1855), Arstanbek Bailashuulu (1866-1917) and Moldo Kylych Sharymkanov (1866). They lived in the time
p.000185: of global changes resulting from the decay of patriarchal feudalism and the rise of capitalistic relations.
p.000185: Besides in 1876 the territory inhabited by Kyrgyz people was incorporated into the Russian Empire [9-11]. All
p.000185: those processes were reflected in akyns’ poetry. In their poems “Time of Downfall”, “Time of Poverty” and “Time of
p.000185: Sorrow” akyn-zamanists called their epoch the time of degradation and decay. Moldo Kylych, being a son of a learned
p.000185: man, received a good education. He was acquainted with works by eastern classics Firdousi, Navoi, Jami, Yasavi and
p.000185: others. He wrote about his time: “Morals and manners show the loss of people’s well-being”. In his poem “Time of
p.000185: Sorrow” he noted that moral bankruptcy, degradation of moral principles, moral apathy were frightening features of the
p.000185: time. In their attitudes zamanists were close to French philosophers of the Age of Enlightenment (J.-J. Russo, Voltaire
p.000185: et al.).
p.000185: At the same time akyn-zamanists’ poetry contained some optimism and faith in moral potential of Kyrgyz people that
p.000185: would help them to overcome all difficulties. Kalygul Bai Uulu associated with the image of a spiritual
p.000185: 21 Zamanism – philosophical teaching about frailty and an inevitable tragic end of the world
p.000185:
p.000186: 186
p.000186:
p.000187: 187
p.000187:
p.000187: leader expressing expectations of Kyrgyz people through his poetry inspires their hopes.
p.000187: Problems of justice are very essential for Kalygul. Being a judge, he proclaims a kind of ethical code comprising
p.000187: universal values and norms of human behaviour: honesty, unselfishness, justice, mutual respect.
p.000187: Criticizing the state system of their time as a form of social inequality akyns offered a moral characteristic of
p.000187: behaviour in different social strata. Akyn-democrats tended to give a realistic picture of the world. Thus
p.000187: Toktogul Saltyganov presents his ethical views through opposing the good to the evil. Jenijok taught that every man
p.000187: should strive for self-perfection from his young days [7].
p.000187: Akyn-zamanists were spiritual elite of Kyrgyz society and true patriots. Their laments were neither the echo of
p.000187: feudalism nor an attempt to stop the development of the society. Those were the thoughts about the traditional culture
p.000187: that in their time was at a deadlock and could not find way out of it; thoughts about the future of Kyrgyz people. They
...
p.000187: did not lose their significance to our days.
p.000187: The next stage in ethics development is associated with names of akyn- democrats Toktogul Satylganov (1864-1993),
p.000187: Togolok Moldo (1860-1942), Jenijok (1860-1918), Varna Alykulov (1884-1949). In contrast to their predecessors,
p.000187: they actively expressed ethical views of oppressed sections of Kyrgyz population.
p.000187:
p.000187: References
p.000187: 1. Abramzon S.M. Kyrgyz People and their Ethno-Genetic, Historical and Cultural Contacts. Leningrad, 1971, p. 152 (in
p.000187: Russian)
p.000187: 2. Akmoldoeva Sh. B. Spiritual World of the Early Kyrgyz (Analyzing Epos). “Manas” and Concepts of Geneva
p.000187: Conventions. Bishkek, 1999, p. 211 (in Russian)
p.000187: 3. Amanaliev A. From the History of Kyrgyz Philosophy. Frunze, 1863 (in Russian).
p.000187: 4. Asan-Kaigy. In: Anthology of Kyrgyz Portry. Bishkek, 1999 (in Kyrgyz)
p.000187: 5. Valikhanov Ch. Collected Works. Vol. 1-5. Alma-Ata, 1961-1972 (in Russian)
p.000187: 6. Kurmanjan the Mountain Queen and Her Time. Bishkek, 2002 (in Russian)
p.000187: 7. Jenijok. Poetic Works. Frunze, 1982 (in Kyrgyz)
p.000187: 8. Jusup Balasagyn “The Beneficial Knowledge”. Frunze, 1988, p. 339 (in Russian)
p.000187: 9. Kalygul Bai Uulu In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 10. Moldo Kylych. Time of Sorrow. Manuscript No 56, Library of the Kyrgyz Academy of Sciences (in Kyrgyz)
p.000187: 11. Moldo Kylych Shamyrkan Uulu. Time of Sorrow. In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 12. Tolubai-Synchi. Ibid.
p.000187: 13. http://www.peoples.ru/art/literatur...age/balasaguny.
p.000187:
p.000187: 3.6.2. Legal Regulations
p.000187:
p.000187: In Kyrgyz Republic biomedical research and protection of human rights in this sphere is regulated by a number of
p.000187: national legal acts, and first of all by Constitution.
p.000187: According to the principal Law, residents of the Kyrgyz republic have the right to health protection, free health
p.000187: care provision by a network of state healthcare institutions. The Constitution guarantees rights to healthy
p.000187: environment and to indemnification for harm caused to health or property due to actions in the sphere of nature
p.000187: management.
p.000187: Article 18 of the Constitution states that no medical, biological, and psychological experiments on human subjects
p.000187: shall be permitted unless there is a voluntary consent of the potential research subject, properly expressed and duly
p.000187: authenticated.
p.000187: The legal basis for the protection of human subjects in biomedical research are the Constitution provisions
p.000187: ensuring every individual’s right
p.000187:
p.000188: 188
p.000188:
p.000189: 189
p.000189:
p.000189: to life, physical and moral inviolability; the right to freedom and safety, the right to a free development of one’s
p.000189: personality; right to dignity and freedom of private life, confidentiality of personal and family information et al.
...
p.000195: The Dacians had medical concept according to which at treating it was necessary to take into consideration the state of
p.000195: a body in general, including mental state. Their medical knowledge for that period was excellent.
p.000195: 4 large Dacian communities existed in the first part of the 2nd century
p.000195: B.C. Each community had the army and institution of money. The union and strengthening of Dacia happened in the
p.000195: time of king Burebista (+80
p.000195: - 44 B.C.) Dechebal (87-106) was the last Dacian king. In 106 Dacia was conquered by the Romans and turned to be a
p.000195: province. That was the last province of the Roman Empire. It was followed by Roman epoch (106-
p.000195: 271) with the Romanization of Dacian population, the Latinization of the
p.000195: language and evangelization. There was the ethnogenesis of Romanians (from “Romans”) later.
p.000195: Development of feudal relationship was attested in the X century. Three principalities were formed in the one-time
p.000195: Dacian territory: Transylvania, which felt under the reign of Hungarians (Hungarians are Finno-Ugric trans- Ural tribes
p.000195: settled here by the end of the IX century) in the beginning of the X century, Ţara Românească (or Walachia, Muntenia);
p.000195: Ţara Moldovei. The first written diplomas mentioning political and military strength of Ţara Românească and
p.000195: Moldova are referred to the years 1330 and 1359, respectively.
p.000195: During the Middle Age Moldova kept suffering from raids of the Tatars, the Turks, the Hungarians and the Poles.
p.000195: Historical Moldova covered the territory between Eastern Carpathians, woody Carpathians, the Dniester, the Black
p.000195: Sea and the Danube under Roman 1 of Moldavia (1392-1394). Geographic location of the territory was favorable as
p.000195: to the nature and life resources and at the same time unfavorable as to geopolitical strategic aspect. The country
p.000195: was located in the strategic pass connecting Eastern and Western Europe, being situated between the Carpathians and the
p.000195: Black Sea. The Silk Road, i.e. the longest commercial route connecting the Far East with the western European countries
p.000195: was there in the Middle Age. Since the first centuries AD and until now great states, trying to preserve the influence
p.000195: here had strategic interests in common. Our people have never been involved in wars of aggression but only defensive
p.000195: ones. Such state of affairs left a deep track in the spiritual life of the country. Spirituality of the inhabitants,
p.000195: philosophic thoughts are of the patriotic and the humanist nature. The ideas of the Italian Renaissance were taken here
p.000195: caught on with some works of some local cultural figures.
p.000195: Ştefan cel Mare şi Sfânt (Stephen the Great and Holy) (1457-1504) ruled Moldova during the most
p.000195: difficult times. He provided a long-term unity of the state, its economical growth and prosperity of
p.000195: cultural life. Protecting his land from invasion he stopped the advance of the invaders to the Western Europe. The
p.000195: Patriarch of Rome for that time deemed him verus christianae fidei athleta (true Champion of Christian Faith) for his
p.000195: services. Soon after the king’s death in 1513 Moldova had to resign to regime of the Ottoman suzerainty.
p.000195:
p.000195:
p.000196: 196
p.000196:
p.000197: 197
p.000197:
p.000197: In 1600 Mihai Viteazul (Michael the Brave) (1595-1601) united for the first time and for a short period
p.000197: Moldavia, Wallachia and Transylvania. Several territorial breaking-ups happened after that. During the Russian-
p.000197: Turkish War of 1768–1774 Austria took the north of Moldova including the ancient capital of Suceava. However the
...
p.000213: other committees and commissions.
p.000213: Main task of the NEC is to perform high quality ethical review of planned clinical researches. The NEC is governed by
p.000213: the general international principles for the conducting clinical trials, as well as applicable laws and regulations of
p.000213: the Republic of Moldova. Prime principles of operation of the NEC at conduct of the CT ethical review are:
p.000213: independence, competence, openness, plurality as well as objectivity, confidentiality and collective nature.
p.000213: Independence of the ethics committee means independence of decisions from researches, sponsors or other excessive
p.000213: influences. The committee is independent from bodies making decision on performance of CT including governmental
p.000213: authorities, as governmental and departmental interests may as well be in conflict with interests of personality
p.000213: involved in CT.
p.000213: Competence of the Ethics Committee is expressed by high qualification of each member of the committee in its
p.000213: professional field or competence in the field of operation ensuring interdisciplinary approach at discussion of CT, in
p.000213: understanding of the CT principles and knowledge of the GCP guidelines.
p.000213: Openness of the activity of the ethics committee is ensured by transparence of operation principles,
p.000213: regulation etc. Standard operation procedures are open for all willing to get acquainted with them. Any decision of
p.000213: the committee has bona fide explanation.
p.000213: Plurality of the ethics committee is guaranteed by variety of professions, age, sex, confessions of its members. This
p.000213: principle requires participation in discussion as far as possible for all members of the committee to reflect different
p.000213: views on this or that topics.
p.000213: Principle of objectivity at consideration of the CT materials is implemented through exclusion of
p.000213: a “conflict of interests”. Besides, the rights of all participants of the research, particularly, not only
p.000213: patients but doctors as well, are taken into consideration at review.
p.000213: Adherence to confidentiality is required in respect to the CT materials, persons involved in the research.
p.000213: Collective nature is usually expressed in consensus manner of discussion and decision making.
p.000213: One more significant principle of the NEC activities, if possible to say so, an ideological principle of ethical review
p.000213: is inadmissibility of prohibitions. None of the international document devoted to the ethics committees
p.000213: include the word ‘permitted’ or ‘prohibited’. Prohibition limits the freedom of personality that is impossible to
p.000213: recognize as ethical. That is why the ethics committee makes its conclusion leaving to a researcher or sponsor to
p.000213: take into consideration or not (however, pursuant to the GCP regulations absence of the ethics committee permit is a
p.000213: ground for prohibition actions of controlling and regulatory bodies).
p.000213: General aspects of the operation of the ethics committee are as follows:
p.000213: a) independence of the parties participating in the research;
p.000213: b) non-pursuing commercial or any other tangible interests;
...
p.000223: its religion element and grounding and inspiration of freedom valued at any time by Russian minds had never died inside
p.000223: of church awareness. First of all everywhere dominance of morality evidences that. We can see it in works of nearly all
p.000223: Russian thinkers even those who had no works devoted to moral problems.
p.000223: Adoption of Christianity determined evaluation of Russian spirituality in subsequent periods. Founding on traditions of
p.000223: eastern orthodoxy, ideas of spirituality, shame and conscience, love to neighbor were brought in Old Russia, a
p.000223: spiritual foundation of charity as everyday piety was formed. Alms as early form of personnel charity was spread among
p.000223: all social classes, it was not only simple execution of commandment of love to a neighbor, but a true need. It was
p.000223: personnel charity that created the foundation necessary for helping the poor at the following times. It was forming
p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
p.000225: people social life organization on the basis of common views (19).
p.000225: Under church influence and with its participation care for people in need for medical and social help
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
...
p.000239: disregarding their financial and social status even with limited medical resources distributed. For such distribution
p.000239: to be fair the aspect of “vital requirements” should prevail over the aspect of “market relations”. The doctor should
p.000239: not see the degree of their responsibility for medical service in relation with financial reward and its amount only by
p.000239: this turning his profession into pure profit making. At the same time decent payment for medical professionals is seen
p.000239: as an essential task for the society and the state (26).
p.000239: Section 12 “Bioethical Issues” shows the official position of RCOC
p.000239: on a range of aspects which currently are concerning in the society and are brought about by blooming development of
p.000239: biomedical technology in late the
p.000239:
p.000240: 240
p.000240:
p.000241: 241
p.000241:
p.000241: XX century. These completely new challenges are once again comprehended and reinterpreted in the context of ideas of
p.000241: human life and personal dignity which are entrenched in the “Divine afflation”. It shows attitude of the
p.000241: Church to abortion, new reproductive methods, medical genetic methods of diagnostics, tissue and organ
p.000241: transplantation, reanimation and help to the parting, sexual issues. Moreover some sections of the social
p.000241: conception are devoted to the questions of marriage and family, psychological health, problems of drug and alcohol
p.000241: addiction, health care and the ecological environment (7).
p.000241: The current trend is towards younger age among religious groups of society. A study by VCIOM showed that 58% of young
p.000241: Russian citizens under the age of 25 refer to themselves as Orthodox Christians, a similar trend can be observed among
p.000241: adherents of the Islam.
p.000241: It should be particularly stressed that among young believers patriotic, pro-governmental ideas, believe that there is
p.000241: a necessity to restore the decent position of Russia in the world community, strive for order, strong power, collective
p.000241: like, collegial philosophies, support of the current government and antagonism to liberal western ideas
p.000241: prevail. A common trend among all young interviewees, disregarding distinctions in their philosophic and
p.000241: religious ideas, towards moral and spiritual values is demonstrated, for instance, the way they reacted to the
p.000241: concept of ‘morality’ (positive 87.9% among believers and 81.8% among non-believers, negative 12.1% and 18.2%
p.000241: respectively), ‘justice’(positive 96.6% and 94.3%, negative 3.4%
p.000241: and 5.7%), ‘faith’ (positive 97.1% and 85.9%, negative 2.9% and 14.1%),
p.000241: ‘prayer’ (positive 92.3% and 56.3%, negative 7.7% and 43.8%). A particular part of young believers and
p.000241: non-believers advocates the idea of paternal mode of relations, sticks to the idea of conventional patriarchal
p.000241: views in family pattern, supporting filial piety within the family, male dominance in family relations (believers 28%,
p.000241: non-believers 21.9%).
p.000241: For the Russian medicine and health care a paternal model of doctor and patient relations is a typical one. Genesis of
...
p.000265:
p.000266: 266
p.000266:
p.000267: 267
p.000267:
p.000267: requirements, to coordinate activities of university departments on teaching issues of legal and ethical control in
p.000267: medicine.
p.000267: The main task is to be planned preparation of qualified staff of professors, which requires set up of special
p.000267: post-graduate study system, including post- graduate research and vocational training at the course of general and
p.000267: topical post-graduate education, establishment of the bioethics grade.
p.000267:
p.000267: 3.8.4. System of Ethical Review
p.000267:
p.000267: The Russian legislation in the field of ethical and legal provision for biomedical research is represented with a range
p.000267: of documents. First of all, it is the Constitution of the Russian Federation (Art.21), which states: “… no one can be
p.000267: made undergo medical, scientific or other experiments without his/her consent.” Beside, there is the Basics of the
p.000267: Legislation of the Russian Federation on Protection of Health of Citizens where Article 43 considers issues on
p.000267: application of new methods of prevention, diagnostics, treatment; medical agents, immunobiological agents and
p.000267: disinfecting agents and biomedical research conduct. However, this article is declarative to a large extent: rights
p.000267: of citizens involved in biomedical studies stipulated there do not have any mechanisms of implementation and
p.000267: enforcement, including the ones via ethical review of applications for research conduct. At the same time,
p.000267: in accordance with this document children of age below 15 can participate in studies of new medicinal agents, methods,
p.000267: etc, only in case of vital indications though in real life this statement is constantly breached that is inevitable and
p.000267: determined with realia of medical practice development and scientific progress. Article 29 of this document prohibits
p.000267: involvement into studies of those arrested or convicted though, in some cases these persons can benefit from
p.000267: their participation in clinical biomedical research. In this respect the Russian legislation differs from
p.000267: European norms that allow in case of specific and clearly defined conditions to hold studies with involvement of
p.000267: those categories of citizens. Another document regulating possibility for conduct of biomedical studies in the Russian
p.000267: Federation is the Law on Psychiatric Care where Article 5 proclaims the right of a person with mental disorder to
p.000267: consent or to refuse of participation in such studies though necessity for such action is not stipulated. The Law on
p.000267: Pharmaceutical Products analyzes quite profoundly those norms regulating research on new
p.000267: medicinal agents but, regretfully, it covers only one though rather important sphere of biomedical research – studies
p.000267: of pharmaceuticals. This law as it is shown by the text is written basing on an assumption that each study is premised
p.000267: with an examination held by an ethical committee but either status, or authority, or order of creation, or composition
p.000267: of ethical committees are not stipulated by the Law; there only guidelines that “the ethical committee acts at the
...
p.000277: and fundamental freedoms in the sphere of biology and medicine application, to unite efforts of scientists
p.000277: and politicians from all CIS countries in the common legal and ethical environment for biomedical researches
p.000277: that covers all types of impacting a man, including studies on embryos in vivo. Along with that, the law
p.000277: enforcement is secured via creation of interstate and national systems of ethical review that is
p.000277: designed in accordance with ideology of the WHO program SIDCER and initiated by the Forum for Ethics Committees in
p.000277: the CIS.
p.000277: Currently we came to understanding that all biomedical projects held in the CIS countries shall undergo independent
p.000277: ethical review at the national level; there were established ethics committees forming a mechanism for provision of
p.000277: ethical review quality and research project safety through control at all stages of informed consent
p.000277: obtaining from candidate study subjects (in case of participation of subjects unable to provide such consent
p.000277: independently – from their legal representatives), ethical research support at all stages until project completion.
p.000277: Special situation of biomedical research conduct are specially controlled by ethical committees when study subjects are
p.000277: related to vulnerable population categories (due to their age, intellectual, mental, or social immaturity or
p.000277: vulnerability) or when studies stipulate obtaining information on genetic code of the study subject.
p.000277: Ethical committees of the CIS countries reached common understanding on necessity of ethical review, they
p.000277: approved common basics for their activities, and the next stage is building up the ethical control
p.000277: vertical system and making this process transparent both within the country and the Commonwealth that is possible
p.000277: through implementation of Acknowledgement program initiated by WHO and suggested for implementation in the post- Soviet
p.000277: countries by FECCIS. This program stipulated ethical committee certification that was a guarantee for
p.000277: compliance to highest quality standards of ethical review and development of a system of effective control
p.000277: over research activities in the country for the world community. Russia started preparation of ethical committees for
p.000277: participation in this procedure.
p.000277:
p.000278: 278
p.000278:
p.000279: 279
p.000279:
p.000279: Realization of significance of ethical review of biomedical studies facilitates attraction of grants from
p.000279: various funds and organizations to this field: these are foreign educational grants offered at the territory of Russia,
p.000279: for instance, by the Fogarty Fund, U.S. Civilian Research and Development Foundation (CRDF), or support for research
p.000279: projects in particular entities of the Russian Federation (for instance, a grant of the Academy of Sciences of the
p.000279: Republic of Tatarstan). They all facilitate wide spread of bioethical knowledge, realization of necessity for conduct
...
p.000295: HIV/AIDS/STD in Republic of Tajikistan in the Period to 2007” (No 475; 27 of November 2002)
p.000295: - Decree of the RT Government “On the RT Strategy for Preventing the Menace of AIDS Spreading for the Period of
p.000295: 2002-2005” (No 389; 1 of October 2002)
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
p.000295: access to the service of reproductive health, at preventing HIV/ AIDS spreading and at eliminating sex discrimination
p.000295: in the field of primary and secondary education. To ensure the national demographic policy, the Government approved
p.000295: and adopted the programme “The Concept of RT State Demographic Policy for the Period 2003-2015” (2002).
p.000295: The independent Tajikistan with its scientific potential in healthcare has reached a new, international level of
p.000295: science development, and therefore it is necessary to carry out ethical review of biomedical research in compliance
p.000295: with international regulations. The controlling body is the Committee on Medical Ethics (CME) at the RT Health
p.000295: Ministry. In its activity, the CME is guided by the Constitution of Republic Tajikistan. Documents regulating the
p.000295: CME practice comply with international legal standards and RT laws. The CME forms a part of the Forum for Ethics
p.000295: Committees in the Commonwealth of Independent States. The CME is to review and monitor scientific research in medicine
p.000295: and the compliance with ethical regulations to protect right and dignity of a research subject. Presently, the RT
p.000295: Government is considering the law “On the Protection of Human Rights and Dignity in Biomedical Research”
...
p.000305: involving human subjects provided that the research is scientifically justified and the potential benefit overweighs
p.000305: risks of harmful consequences for the research subjects’ health or life. Information on biomedical research
p.000305: should be open to public on condition that personal data are confidential. The rule of informed consent relates also
p.000305: to organ transplantation performed according to the order prescribed by the law if the use of other life-sustaining
p.000305: methods does not yield desired results, and the harm for a donor’s health is less than that threatening the recipient
p.000305: (Art. 47).
p.000305: The rule of voluntary informed consent is present in practically all special normative acts relating to medical
p.000305: interventions, use of pharmaceutical products and biomedical research.
p.000305: Article 43 of the “Basic Legislation on Public Health Service in Ukraine”, states that in case of minors
p.000305: under 15 or adults who according to
p.000305: law do not have capacity to consent any intervention may be possible only with the authorization of his or her legal
p.000305: representative. At the same time, an essential item about the opinion of the minor that, according to Convention on
p.000305: Human Rights and Biomedicine, should be taken into consideration as an increasingly determining factor in proportion to
p.000305: his or her age and degree of maturity (Convention, Art. 6) is not included into Ukrainian legislation. Neither is the
p.000305: item that adults who according to law do not have capacity to consent shall as far as possible take part in the
p.000305: decision-making procedure. However, there is a similar rule about informed consent to the application of new methods or
p.000305: pharmaceutical products concerning minors from 15 to 18 years of age and individuals with a limited capacity to consent
p.000305: (Art. 44.2 of Basic Legislation).
p.000305: The right to withdraw consent is not clearly stated either in the law or in the majority of other special
p.000305: laws but the Ukrainian law “On Pharmaceutical Products” (Art. 8). According to this law, a volunteer or the person’s
p.000305: legal representative can freely withdraw his or her consent to participate in clinical trials.
p.000305: There is no regulation relating to medical interventions for the benefit of the health of the person concerned
p.000305: in emergency situations when the appropriate informed consent cannot be obtained. For this case we need a legal
p.000305: norm stating that the previously expressed wishes relating to a medical intervention by a patient who is not, at the
p.000305: time of the intervention, in a condition to express his or her wishes should be taken into account.
p.000305: The law “On Pharmaceutical Products” states the necessity to obtain a written consent from a potential subject of a
p.000305: clinical trial or from his or her legal representative (Art. 8). This additional measure is connected with the danger
p.000305: of abuse and infringement of human rights.
p.000305: The right to information is closely related to the concept of informed consent. Recognition of this right is
...
p.000325: strength of natural warmth”. He was tireless in calling upon physicians to develop their general and special knowledge,
p.000325: to exchange professional experience and travel. In those times, travels served to extend scientific contacts. In the
p.000325: Middle Ages, there were many charlatan “healers” and even physicians deceiving their patients. Reasons for that Ibn
p.000325: Sina saw in a poor medical training, as physicians were not taught to see in each person his/her unique world of
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
p.000325: Ibn Sina’s views on childhood are noteworthy. “Canon of Medical Science” states that child’s life and health
p.000325: should be objects of care, protection and a special regimen from the moment of conception, not just from the moment of
p.000325: birth. A newborn baby needs a wet nurse with a stable nervous system. Games are essential, as all educational
p.000325: and formative processes, starting from very early years, should proceed from games. One may not punish a child, as
p.000325: the task of a tutor and physician if to protect the child’s soul, to facilitate the development of the feeling of
p.000325: self-respect. It is particularly important to prohibit any punishment for children under age of five, i.e. at the age
p.000325: when a child does not realize the meaning of his/her actions. Abu Ali Ibn Sina believed that, irrespective of state and
p.000325: public benefits, a child should receive a good intellectual, moral and ethical education in the family and at school.
p.000325: In his works, Ali Abu Ibn Sina gave much attention to school education. Kind and well-educated teachers may only
p.000325: teach at school,
p.000325: where children are brought up and educated until the age of fourteen. A teacher should know well the subject
p.000325: he teaches; he should follow the moral principles and be an honest, loving and courageous person.
p.000325: In the system of Ibn Sina’s ethical views, a concept of mizaj implying the necessity of an entirely individual approach
p.000325: to each individual, irrespective of the person’s age of health condition and considering a unique combination of
p.000325: qualities on the individual and his/her living and working conditions.
p.000325: The knowledge of human nature and temperament is the basis of a physician’s strategy when maintaining a
p.000325: proper level of health, and, if need be, planning the therapy. A comprehensive study of the “Canon” helps us to tell a
p.000325: sanguine person from a phlegmatic one or a choleric person from a melancholy one, and to mark out characteristic
p.000325: biotypes. If we translate it into the language of modern bioethics, we can see clearly the logical construct of
p.000325: Hippocrates, Galen and Avicenna; treat not a disease but a person, and not just a person but also a biotype
p.000325: whose psychological responses are subordinate to its biological nature (mizaj), or temperament. Ages later Ivan
p.000325: Pavlov mentioned the biotypological approach used widely by Ibn Sina as a fruitful one, revealing “fundamental
p.000325: features” of human nature.
p.000325: Thus, “Canon of Medical Science” written in the times of the Oriental Renaissance, and very popular during the European
p.000325: Renaissance, nowadays, if profoundly studied, can contribute essentially to the theory of bioethics, and humanize
p.000325: modern medicine and healthcare. Fundamental ethical ideas of “Canon of Medical Science” uniting medicine and a worthy
p.000325: life in the philosophy of health are still topical nowadays. Moreover, it outruns, in many respects, our
p.000325: ideas on medical ethics. Indeed, Ibn Sina’s attempts to link problems of medicine with the mode of life and to create
...
p.000329: the Civil Code of the Republic of Uzbekistan. According to the Articles mentioned, the person who has suffered undue
p.000329: harm and/or moral damage
p.000329:
p.000330: 330
p.000330:
p.000331: 331
p.000331:
p.000331: resulting from an intervention is entitled to fair financial compensation estimated according to the
p.000331: conditions and procedures prescribed by law.
p.000331: Currently, there are but single instances of suits brought by patients or their relatives against medical institutions.
p.000331: Uzbekistan has little experience in considering such complaints at court, because citizens are not properly informed
p.000331: about their rights. The lack of knowledge in this field negatively affects physician-patient relationships and the
p.000331: treatment efficiency. It is physicians’ professional duty to know patients’ and physicians’ rights and
p.000331: responsibilities. Incidentally, while the patient may be ignorant of his rights and responsibilities relating to
p.000331: medical care, the physician usually has this knowledge but intentionally conceals it from the patient,
p.000331: which is a disadvantage to both the patient and the physician.
p.000331: To involve medical professionals in educational activity aiming at informing patients about their rights, as
p.000331: well as physicians’ rights is one of urgent tasks for the healthcare system of Uzbekistan. .
p.000331: Ethical norms considering special features in relationship with patients from various age and social groups should have
p.000331: a significant place in the system regulating medical activity, particularly the rule of confidentiality relating to
p.000331: information obtained from the patient. This rule applies to adults (capable), minors (incapable or partially
p.000331: capable) and to persons with restricted capabilities who need a constant care.
p.000331: Ethical principles are essential in providing medical care to patients with sexually transmitted diseases. A
p.000331: more tolerant attitude of the society and law-enforcement bodies to patients from risk groups (sex workers,
p.000331: truckers, etc.) requires the development of legislation and social tolerance via public institutions (mahalline
p.000331: committees).
p.000331: The law of the Republic of Uzbekistan “On the Protection of Citizen’s Health” contains a number of articles concerning
p.000331: ethical issues. Thus, Article 46 sets out main principles safeguarding patents’ rights. The law of the
p.000331: Republic of Uzbekistan “On Pharmaceutical Products and Pharmaceutical Activity” (1997) also protects patients’
p.000331: rights in biomedical research. It defines the State authorities and competence of the Ministry of Public Health of
p.000331: the Republic of Uzbekistan in the sphere of clinical trials.
p.000331: Article 10 states that the decision about a clinical trial (CT) is based on
p.000331: - consent obtained from a patient or volunteer to participate in CT;
...
p.000353: Declaration on Common Bioethics Standards (UNESCO), guidelines on bioethics, legal and social consequences of genetic
p.000353: testing (the European Commission) and other universal documents and guidelines in which development members of
p.000353: the FECCIS participated.
p.000353: In general, cooperation within the framework of the FECCIS is developed with the purpose to facilitate
p.000353: creation of systems of good ethical
p.000353:
p.000354: 354
p.000354:
p.000355: 355
p.000355:
p.000355: practice and development of ethical responsibility in researchers, sponsors, authorized regulatory agencies and the
p.000355: society as a whole. This process in combination with advancements of science and social and legal trends
p.000355: facilitates appearance of constitutional society and state regulation in the CIS region. Inclusion of the CIS countries
p.000355: in the process of establishment of good practices of ethical review at international scale is focused on
p.000355: understanding of necessity of reaching independence, competence, openness and responsibility in the field of human
p.000355: rights protection when conducting biomedical studies. Development of cooperation facilitates free discussion among
p.000355: colleagues, exchange with experience, problems and successes, formation of collective recognition of ethics role
p.000355: in research and individual ethical thought of all participants of biomedical process.
p.000355: In conclusion of this chapter we consider as our priority tight to express our assurance that the given work will
p.000355: become a token and impulse of the new age of international cooperation among the region countries in the
p.000355: sphere of ethical regulation of biomedical studies. Publication of this book will provide informational access to the
p.000355: following data:
p.000355: • conditions and perspectives for development of ethical review of biomedical research in the CIS
p.000355: countries (historical and culture roots, economic and social prerequisites, regulatory legislation, staff
p.000355: training system, management);
p.000355: • description of model legislation of IPA CIS in issues of regulation of research in the field of biology and medicine
p.000355: and protection of human rights and dignity;
p.000355: • methodology and structure of national programs and their interaction in the region and beyond for implementation of a
p.000355: strategy for compliance with international ethical standards;
p.000355: • general trends and specificity of development of ethical review to form priority directions for cooperation
p.000355: at the regional and global scale;
p.000355: • information concerning experience of regional cooperation within the framework of the FECCIS;
p.000355: • approach to harmonization of norms and standards of ethical review of biomedical research in the region and at the
p.000355: global scale.
p.000355: Objective and open knowledge of wide-scaled layer of national and regional realia of ethics of biomedical
p.000355: studies in the Commonwealth countries unveils a whole range of opportunities for all stakeholders in
p.000355: regard to search for ways to further collaboration in this sphere basing on adherence to universal values and ethical
p.000355: principles.
...
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p.000039: codes in some of the Commonwealth countries should be considered as norms of general type establishing crucial
p.000039: requirements to an order of legal act execution in regard to main freedoms and rights of citizens in the Commonwealth
p.000039: countries. Statements of the given model codes were also reflected in initiation and creation of many legislator
p.000039: enactments in the CIS countries in the field of criminal law and criminal procedures. The model civil code adopted by
p.000039: IPA CIS has special values for establishing of new conditions for administration and management in all spheres of
p.000039: activities and its main statements were to some extent practically embodied in civil legislation of all CIS countries.
p.000039: Activity of the Permanent Commission on social policy and human rights of IPA CIS has a special value from the
p.000039: point of harmonizing influence on the health care field. After initiatives of the said commission model laws
p.000039: determining main statements for a complex welfare system were adopted, a list of international conventions recommended
p.000039: for immediate ratification by the CIS countries was developed, a set of model laws on rights of human beings related to
p.000039: category of vulnerable population groups was approved, such as a law On Basic Children Rights and On Additional
p.000039: Guarantees to Child-Orphans and Children without Parental Guardians, Guidelines On Childhood Protection in Member
p.000039: Nations of CIS (1998) as well as The Charter for Older People and other socially significant documents.
p.000039: In accordance with basic statements on protection of human rights and freedoms there are being prepared model
p.000039: laws related to both forming of domestic policy in the Commonwealth countries in the field of health care and
p.000039: developing of common approaches to international cooperation of the states in this field. An important role for
p.000039: legislative regulation of special situations in the area of medical practice and their potential application
p.000039: to cases of
p.000039: biomedical studies and ethical review is assigned to the following model laws: On Sanitary and Epidemic
p.000039: Well-being of the Population, On Prevention of Spread of Diseases with Social Significance, the Concept on Formation of
p.000039: Legal Basics and Mechanisms for Implementation of Social State in the CIS Countries, the Charter of Social Rights and
p.000039: Guarantees for Citizens of Independent States (adopted by IPA CIS, 29.10.1994). Also many projects of model acts
p.000039: included into perspective plan of model law development are also important for formation of state policies of the CIS
p.000039: countries in the field of health care and biomedicine such as the following: On Social Protection of Handicapped, On
...
p.000093: rights is guaranteed by independent ethics committees that review documents relating to the clinical trial in view of
p.000093: evaluation of risks for patients and protection of their rights.
p.000093: As we know from the history of clinical trials, initially the organization and performance of those was lacking
p.000093: for an ordered and systematic approach, and there were problems regarding implementation of GCP guidelines
p.000093: in different countries. At the same time, it is clear that safe and reliable research outcomes may be obtained only if
p.000093: the rules are observed.
p.000093: To protect rights and health of human subjects involved into clinical trials of new drugs, treatment methods
p.000093: and medical technologies,
p.000093: Ethics Committee at the Ministry of Health of Republic of Armenia was established in 1996 on the initiative of the
p.000093: Agency for Drugs and Medical Technologies.
p.000093: With regard to legal regulation in the sphere of human rights protection, members of Ethics Committee are guided in
p.000093: their ethical review practice by the following documents:
p.000093: • Constitution of Republic of Armenia (Article 34)
p.000093: • Law on Healthcare in Armenia
p.000093: • Law on Drugs
p.000093: • Law on Social Protection of the Disabled
p.000093: • Law on the Rights of the Child
p.000093: • Law on the Prevention of HIV Infection
p.000093: • Law on Transplantation of Human Organs and/or Tissues
p.000093: • Law on Reproductive Health
p.000093: • Law on Providing Psychiatric Care
p.000093:
p.000093: As to international legal documents, Republic of Armenia ratified Convention on the Rights of the Child.
p.000093: The practice of ethical review is regulated by principles set in the relevant WHO and WMA documents as well as in
p.000093: other international legal and ethical documents.
p.000093:
p.000093: 3.1.3. Education in Bioethics
p.000093:
p.000093: At Yerevan State University named after M.Heratsi ethics and aesthetics have been traditionally taught over many
p.000093: decades. In 2000 bioethics was introduced into the programme of the Department of Social Sciences as a compulsory
p.000093: discipline.
p.000093: In the post-Soviet space, including Armenia, a different – “home” – model of bioethics has been developed, in which
p.000093: bioethics is an interdisciplinary, orientated on biology, modern field of knowledge analyzing moral problems of human
p.000093: existence and human attitude to life and to individual living organisms. This model covers the range from the
p.000093: development of ethical norms and principles regulating human practical activity in the process of studying nature and
p.000093: human beings to the study of the role and place of the human being in the context of biological reality and the
p.000093: estimate of the status of life and death categories.
p.000093:
p.000094: 94
p.000094:
p.000095: 95
p.000095:
p.000095: In the beginning bioethics was taught only to students who were citizens of Armenia, but since 2003
p.000095: also to foreign students. The most important stimulus for introducing basics of bioethics into the syllabus was an
p.000095: essential need to harmonize our education programmes with international standards of education. Republic of Armenia
...
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
p.000169: The article 43 of the Law of the Republic of Kazakhstan “On the System of Public Health” published on 4th
p.000169: June 2003 contains the juridical definition of scientific medical expertise; in this article it is indicated that
p.000169: objects of scientific medical expertise are as follows:
p.000169: - drafts of programmes of basic and applied scientific research;
p.000169: - republican targeted scientific medical programmes;
p.000169: - results of completed scientific medical programmes and projects;
p.000169: - scientific research that were nominated for the state awards of the Republic of Kazakhstan;
p.000169: - results of scientific medical programmes that are supposed to be implemented into public health practice.
p.000169: The order of scientific medical expertise is determined by the national authority in public health area.
p.000169: The article 42 “Expertise of medical drug” of the same Law says that the expertise of medical drug represents a study
p.000169: or a trial of medical drug
p.000169: for its safety, efficacy and quality and that physical, chemical and biological tests as well as clinical trials should
...
p.000243: and inconsistencies between the Russian and western ethical systems in health care and medicine. In this respect it is
p.000243: reasonable to draw guidelines and interpret specific regulations and acts and their provisions taking into
p.000243: account two main aspects: culture and ethnical traditions of given states and their compliance with the common norms of
p.000243: international laws in the field of bioethics.
p.000243:
p.000243: References
p.000243: 1. Berdiaev N.A. Destiny of Russia: Selected Works. M., Kharkov: EKSMO Press Folio, 1998, 736 p. (herein and
p.000243: hereinafter in Russian)
p.000243: 2. Dmitrieva T.B., Polozgiy B.S. Psychological Health of Russian
p.000243: Citizens. Human, 2002, №6, p. 21-31.
p.000243: 3. Zamalaev. А.F. Lectures on history of Russian philosophy: XI –
p.000243: early XX cc. StP., 1994.
p.000243: 4. Zenkovskiy V.V. History of Russian philosophy. L., Eko, 1991, p. I,
p.000243: p. II, p. b.
p.000243: 5. Ivanjushkin A.J. Medical ethics in Russia (XIX - early XX cc.). In
p.000243: bk.: Bioethics: principles, regulations, problems. М., 1998, p. 93–110.
p.000243: 6. Ivanjushkin A.J. History of medical ethics and biomedical experiments in human and animal parties.
p.000243: In bk.: Introduction to bioethics. М., 1998, p. 95-133.
p.000243: 7. Cirill, metropolite. On «Basic social conception of Russian Orthodox Church». Anniversary Episcopal Assembly RCOC.
p.000243: StPb, 2000, p. 133-149.
p.000243: 8. Klementovskiy А.I. On application of Libikhov meat extract (broth) for a child at the breast. Moscow medical
p.000243: newspaper, 1859, №34, p. 269- 272; №35, p. 278-280; №36, p. 285-287.
p.000243: 9. Kljutchevskiy V.О. Selected Works. М., 1987, v.1, p.1, p. 78-79.
p.000243: 10. Korotkikh R.V. Legal and ethical issues of health care in Russia in period of reforms. In bk.: Biomedical
p.000243: ethics (edited by. V.I.Pokrovskiy). М., 1997, p. 47-58.
p.000243: 11. Koshtojantz Kh.S. Study on history of physiology in Russia.
p.000243: М., 1946, p. 111.
p.000243: 12. Kubar О.I. Ethical and legal issues of research in human parties: in history of Russia XX century. Human, 2001, №3.
p.000243: 13. Levit М.М. Establishing public medicine in Russia. М.: 1974,
p.000243: 231 p.
p.000243: 14. Likhatchev D.S. Russian culture. М.: Art, 2000, 438 p.
p.000243: 15. Ljubargskiy G.J. Human, 2004, №3, p. 186.
p.000243: 16. Maksimov Е.D. Study of historical development and current situation in public charity in Russia.
p.000243: In bk.: Public and personal care in Russia. StP, 1907, p. 4.
p.000243: 17. Mikirtitchan G.L., Filimonov S.V. Opinion of doctors and patients on problems of information and obtaining informed
p.000243: consent form. In bk.: Actual problems of diagnostics, treatment and disease prevention, issue. 3. StP, 2004, p.
p.000243: 291-302.
p.000243: 18. Mikirtitchan G.L., Filimonov S.V. Results of social study attitudes among doctors and patients to some
p.000243: genetic methods. International conference of CIS countries Forum for Ethics Committee. Yerevan, 2005, p. 52-56.
p.000243: 19. Mirskiy М.B. Medicine in Russia XVI - XIX cc. М., 1996, p.
p.000243: 301- 309.
...
p.000249: efficiency, the drug safety, and the degree of risks for the patient; 3) information on measures in the case of
p.000249: unforeseeable effects of pharmaceutical product on his health;
p.000249: 4) information on the terms of patient’s health insurance.
p.000249: The provision of the Law concerning the necessity of health insurance as well as insurance of civil liability of
p.000249: persons who carry out the study (items 3, 9 of the article 40, items 2 of the article 38) ensures an important
p.000249: additional guarantee of protection of subjects’ interests.
p.000249: At the same time, we cannot but mention an excessively “soft” approach to the question of terminating a clinical trial
p.000249: in the case of events that may be hazardous to the patient’s health. The Law states only that clinical trials may be
p.000249: terminated, while it should state that clinical trials must be terminated.
p.000249: Aiming at safeguarding the rights and interests of vulnerable contingents the Law forbids or
p.000249: limits their participation in clinical trials of medicines. Particularly clinical trials involving minors who
p.000249: don’t have parents, soldiers, persons under any form of detention or imprisonment is absolutely forbidden. The Law also
p.000249: sets up the limitation for the cases of clinical studies involving minors who have parents – such studies may be
p.000249: conducted only if pharmaceutical product is proposed for treatment of child diseases or if the aim of clinical trial is
p.000249: the getting the information about the best dosing of drug for therapy of minors. In latter situation the clinical trial
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
...
p.000315: also becoming a routine practice. In 2005 a compulsory ethical review of dissertation works in medicine,
p.000315: biology and veterinary medicine. The continuously growing amount of
p.000315: 47 www.pharma-Centre.kiev.ua/clinic/programm.doc
p.000315:
p.000316: 316
p.000316:
p.000317: 317
p.000317:
p.000317: work performed by ethics committees/commissions makes us think about the necessity of financing this work.
p.000317: New demands on the quality of ethical review require improving the work of existing local ethics committees. It
p.000317: is necessary to organize a continuing education of ethics committees members and to develop legal regulation of
p.000317: operation and interaction of committees at different levels.
p.000317:
p.000317: 3.10.5. Perspectives and Forms of International Cooperation
p.000317:
p.000317: World tendencies of bioethics development have an essential influence on its development in Ukraine. First local ethics
p.000317: committees in Ukraine were established in 1992. They were approved at the Board Meeting of the Ukrainian Ministry of
p.000317: Health, and thus became legitimate to carry out ethical review of scientific projects. This idea can be
p.000317: illustrated with two large international projects. The Institute of Pediatrics, Obstetrics and Gynecology of the
p.000317: Ukraine Academy of Medical Sciences participated in an international multicentre epidemiological study “Mother
p.000317: and Child”, and the Institute of Occupational Medicine of the Ukrainian Academy of Medical Sciences in cooperation
p.000317: with colleagues from USA conducted an ophthalmologic research in rescuers who had participated in the elimination of
p.000317: the Chernobyl accident. Both projects were carried out in cooperation with the University of Illinois and
p.000317: Columbia University (USA). Within the framework of the projects the teaching staff of universities provided a basic
p.000317: training in bioethics for Ukrainian medical specialists involved in the projects.
p.000317: Since 1998 Ukraine cooperates with different UN organizations including UNESCO that has initiated
p.000317: establishing the National Committee on Bioethics in Ukraine. In 1998 the Committee on Bioethics was established at the
p.000317: Presidium of the Ukraine National Academy of Sciences that had been functioning as a national agency till 2001. After
p.000317: the First National Congress on Bioethics with many participants from abroad (Kiev, 2001) the Commission on Bioethics at
p.000317: the Ukrainian Cabinet of Ministers was established. From the very beginning of its activity, the Commission established
p.000317: contacts with UNESCO, WHO, bioethics organizations at Council of Europe, European Parliament and European Union, in CIS
p.000317: countries, USA, Canada, Belgium, England and other countries. Our activity attracted attention of Vatican and
p.000317: of representatives of other confessions. Members of the Commission on Bioethics and other experts are
p.000317: taking part as delegates, participants and guests in different international congresses, conferences,
p.000317: seminars and working groups relating to bioethics.
...
p.000325: Ethical views of Ibn Sina are still topical nowadays. He saw a physician as a patient’s friend, tutor and helper.
p.000325: To fulfill this noble mission, the physician, apart from professional knowledge and experience, should have many
p.000325: positive qualities – mercy, respect for human dignity, readiness to self-sacrifice in a patient’s interests,
p.000325: etc.
p.000325: When analyzing Ibn Sina’s ethical precepts we should note that those were in line with Hippocrates’s teaching. Ibn Sina
p.000325: wrote: “The physician should read Hippocrates’s precepts so as to be able to show honesty and frankness when treating
p.000325: patients. He should keep his clothes clean, be neat and perfumed. When he visits a patient he should be amiable, and
p.000325: cheerful, and witty so that he could cheer the ill person, because support offered by the physician multiplies the
p.000325: strength of natural warmth”. He was tireless in calling upon physicians to develop their general and special knowledge,
p.000325: to exchange professional experience and travel. In those times, travels served to extend scientific contacts. In the
p.000325: Middle Ages, there were many charlatan “healers” and even physicians deceiving their patients. Reasons for that Ibn
p.000325: Sina saw in a poor medical training, as physicians were not taught to see in each person his/her unique world of
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
p.000325: Ibn Sina’s views on childhood are noteworthy. “Canon of Medical Science” states that child’s life and health
p.000325: should be objects of care, protection and a special regimen from the moment of conception, not just from the moment of
p.000325: birth. A newborn baby needs a wet nurse with a stable nervous system. Games are essential, as all educational
p.000325: and formative processes, starting from very early years, should proceed from games. One may not punish a child, as
p.000325: the task of a tutor and physician if to protect the child’s soul, to facilitate the development of the feeling of
p.000325: self-respect. It is particularly important to prohibit any punishment for children under age of five, i.e. at the age
p.000325: when a child does not realize the meaning of his/her actions. Abu Ali Ibn Sina believed that, irrespective of state and
p.000325: public benefits, a child should receive a good intellectual, moral and ethical education in the family and at school.
p.000325: In his works, Ali Abu Ibn Sina gave much attention to school education. Kind and well-educated teachers may only
p.000325: teach at school,
p.000325: where children are brought up and educated until the age of fourteen. A teacher should know well the subject
p.000325: he teaches; he should follow the moral principles and be an honest, loving and courageous person.
p.000325: In the system of Ibn Sina’s ethical views, a concept of mizaj implying the necessity of an entirely individual approach
p.000325: to each individual, irrespective of the person’s age of health condition and considering a unique combination of
p.000325: qualities on the individual and his/her living and working conditions.
p.000325: The knowledge of human nature and temperament is the basis of a physician’s strategy when maintaining a
p.000325: proper level of health, and, if need be, planning the therapy. A comprehensive study of the “Canon” helps us to tell a
p.000325: sanguine person from a phlegmatic one or a choleric person from a melancholy one, and to mark out characteristic
p.000325: biotypes. If we translate it into the language of modern bioethics, we can see clearly the logical construct of
p.000325: Hippocrates, Galen and Avicenna; treat not a disease but a person, and not just a person but also a biotype
...
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p.000009: comparison: the population in the European Union (EU) makes 7% of world population, while the average density of
p.000009: population in the EU is 114 persons per sq. km. Over 66% of Belarus, Armenia, Ukraine, and 73% of Russia population are
p.000009: city residents. In the territory of the CIS there are 24 cities with the population over 1 million.
p.000009: Since 1990, the fertility rate in all the CIS countries has been decreasing. Moreover, in Ukraine (since 1991), in
p.000009: Russia (since 1992) and in Belarus (since 1993) a natural decrease of population was registered. Thus in Russia the
p.000009: number of deaths in 1993 exceeded the number of births by 800,000. That was the lowest fertility rate (9.4 of
p.000009: births per 1000 of population) among all the CIS countries.
p.000009:
p.000010: 10
p.000010:
p.000011: 11
p.000011:
p.000011: We should note that 1993 was one of the most hard years in the demography in the CIS countries, as the
p.000011: fertility rate decreased in all CIS countries (except Tajikistan). In comparison with 1986, when the highest fertility
p.000011: rate in the USSR for the last 50 years was registered, the fertility rate in 1993 in the CIS countries decreased by 33%
p.000011: (and by 8% in comparison with 1992, which is much enough in terms of annual oscillations) and was 13.5
p.000011: births per 1000 of population. The number of deaths in 1993 in the CIS countries was 3.6 million, and increased, in
p.000011: comparison with 1992, by 429,000. The general mortality rate increased by 14% and was 12.6 deaths per 1000 of
p.000011: population2.
p.000011: The growing share of elder people and a decreasing weight of children in the total population are typical for the
p.000011: majority of the CIS countries. This is connected with worldwide tendencies to population ageing and a drop in birth
p.000011: rate, as well as with the crisis at the end of the 20th century. In six of the CIS countries even the simple
p.000011: reproduction of population is not achieved,
p.000011: i.e. the total fertility rate (see below) is equal to or less than 2.1. These countries are Armenia,
p.000011: Belarus, Georgia, Moldova, Russia and Ukraine
p.000011: Belarus, Georgia, Russia and Ukraine are noted for the ratio of persons over 65 to the so called economically
p.000011: productive persons (at the age of 15-64), and Kyrgyz Republic, Tajikistan, Turkmenistan and Uzbekistan,
p.000011: where the age-dependency ratio is 2-3 times higher than in Belarus, Russia and Ukraine, stand out for that of children
p.000011: under 15.
p.000011: The greatest reduction of the able-bodied population in comparison with 1989 is observed in Georgia (by 20% for males
p.000011: and by 18% for females) and Ukraine (by 3,8% for males and by 4,9% for females). A significant increase of the
p.000011: able-bodied citizens (by 26-47%) is registered in Azerbaijan, Kyrgyzstan, Uzbekistan, Tajikistan and Turkmenistan
p.000011: The increase in the number of young people has a favorable effect on the increase of the total population, and the
p.000011: growing number of early marriages implies a perspective of a sooner birth of the first children and the increase of the
p.000011: total fertility rate.
p.000011: During last four years in the majority of the CIS countries no decrease of the fertility rate was registered. On
p.000011: the contrary, in 2003-2004 it has slightly increased. This process can be related to some stabilization
p.000011: in
p.000011:
p.000011: 2 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 23.
p.000011: social and economic situation in the CIS countries, as well as to the fact that people, born in the middle of 1980-s
p.000011: when the birth rate in Soviet Union was relatively high reached the fertility age.3
p.000011: At the beginning of 2005, the population size in the CIS countries was 279 million people (according to the Statistic
p.000011: Committee). In comparison with the beginning of 1991, the population has reduced by 2.7 million people or
p.000011: 1.0%.4
p.000011: By the type of demographic processes in the 90-s the CIS countries were divided into two groups. In the
p.000011: first group including Ukraine, Belarus, Russia, Kazakhstan, Moldova, Georgia and Armenia the population has
p.000011: been decreasing from year to year. The second group includes Azerbaijan and Republics of Central Asia where the
p.000011: population and the demographic potential kept on increasing. At the same time, as it was mentioned above, depopulation
p.000011: processes in Belarus, Russia and Ukraine are increasing, which means that the death rate exceeds the birth rate. This
p.000011: results in the increasing polarization of the two groups of CIS countries by the demographic potential, and hence
p.000011: creates, in prospect, additional preconditions for its redistribution between countries through migration processes.
p.000011: (Table 2).
p.000011: During last years in the majority of the CIS countries, the reduction of the fertility rate was not registered. On the
p.000011: contrary, in 2003-2004 it has somewhat increased. In Azerbaijan and Kazakhstan the increase is noticed in all age
p.000011: groups, in Belarus and Ukraine – at the age of 30 and older. At the same time, the highest fertility rate is still
p.000011: registered in women at the age of 20-24 (89-95 newborns per 1000 women of fertile age in Belarus, Georgia, Moldova,
p.000011: Russia and Ukraine, over 120 newborns – in Armenia, Azerbaijan and Kyrgyzstan, 143 – in Kazakhstan).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 3 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 26.
p.000011: 4 In the previous decade – in the 1980s – the population in former Soviet Republics, except for Baltic States,
p.000011: increased by 22.6 mln of people (8.7%).
p.000011:
p.000012: 12
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: The increase of the age-specific rates results in the increase of the total birth rate (the total birth rate is the sum
p.000013: of the age-specific fertility rates in the age range of 15-49 years; it shows the average number of children born by
p.000013: one women in her life if for every age the fertility rate remained the same as it was in the year for which the
p.000013: age-specific rates were calculated). The most significant increase of the fertility rate was in Kazakhstan where the
p.000013: total fertility rate in 2004 was 2,21 versus 2,03 in 2003. According to the recent data, the average value of this
p.000013: index in the CIS countries is 1,9 of births per one woman. The half of the population of the CIS lives in the countries
p.000013: where the simple reproduction of the population is not reached, i.e. this rate is below 2,1 (1,38 in Armenia (2004),
p.000013: 1,20 in Belarus (2004), 1,40 in Georgia (2003),
p.000013: 1,22 in Moldova (2003), 1,34 in Russia (2004), 1,20 in Ukraine (2003)).6 The problem of saving life and health
p.000013: of newborns is particularly
p.000013: important especially considering the long period of fertility decrease. In spite of a marked reduction of the
p.000013: infant mortality in all CIS countries in recent years, its level remains very high. The infant mortality rate in the
p.000013: CIS countries is much higher than that in the developed countries where its value is 3-5 deaths during the first year
p.000013: per 1000 newborns. (Table 3).
p.000013: About a half of dying infants falls to the share of the babies of the first year of life, nearly 70% of which die in
p.000013: the first week. The prenatal mortality rate in the CIS countries is fluctuating from 6 to 16 deaths at the age of 0-6
p.000013: days and still-borns per every 1000 of births. The causes of these deaths are respiratory states typical for the
p.000013: prenatal period, cases of the fetal asphyxia and asphyxia at birth.
p.000013: In many respects, a high death rate registered in the majority of the CIS countries over a long period can be
p.000013: explained, by the population ageing and by the decrease of the quality of life and health. At the same time, the number
p.000013: of births per 1000 population in the countries of the European Union is less (at the average 11,1) than in Azerbaijan
p.000013: (24,2), Kyrgyzstan (26,1), Tajikistan and Turkmenistan (33,1). However, in spite of the high population ageing rate,
p.000013: the number of deaths in the EU countries is lower (10,1) than in the CIS countries (12,6), which in it’s turn, may be
p.000013: explained by the level of preventive measures and healthcare in general, and by the social-economic situation in the
p.000013: CIS countries.
p.000013:
p.000013: 6 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000013: 2005, p. 62“.
p.000013:
p.000014: 14
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: The natural increase of the population is the main source for advanced reproduction of labor resources at a certain
p.000015: territory. According to the data shown above, in the CIS countries two types of reproduction prevail that may by
p.000015: characterized as simple and reductive. If the simple population reproduction requires the numeral equality
p.000015: of the parent and children generation, the current level of survival rate (including the average life
p.000015: expectancy) requires 250-260 births per each 100 families. The birth rate corresponding to such a level is
p.000015: registered only in some CIS countries, such as Azerbaijan, Kyrgyzstan and Tajikistan. The functions of fertility
p.000015: and survival, as exogenous characteristics of the population reproduction, form its endogenous characteristics, i.e.
p.000015: age structure of population and also the measure of the population growth (net coefficient of population reproduction)
p.000015: and, hence, the actual level of the natality. The Russian Federation shows a tendency to a reductive
p.000015: reproduction of the population; however, in some years the increase due to the migration has compensated the natural
p.000015: decrease of the population, which is not so typical for Moldova, Belarus and Ukraine. Therefore, the total population
p.000015: size has not reduced. During the last five years the natural decrease of the population in the Russian
p.000015: Federation has prevailed over the increase due to the migration, which has decreased after 1994, and the total number
p.000015: of citizens began to decrease steadily.
p.000015: The population structure and the morbidity level characterize the general social-demographic situation in the
p.000015: CIS countries.
p.000015: Diseases of blood circulation system that are typical causes of death in elder people, take the leading role
p.000015: among the main causes of death. In 2003, the male mortality by this cause was 41% of deaths in Kyrgyzstan, 45% in
p.000015: Kazakhstan, 48-49% in Russia and Moldova, 50% and more in Azerbaijan, Armenia, Belarus and Ukraine. Female
...
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p.000019:
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p.000019:
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p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: 1) 2003.
p.000019: 2) 2000.
p.000019: 3) From neoplasm. 4) 1995.
p.000019: 5) 2001.
p.000019:
p.000019:
p.000019:
p.000019: 1) Life expectancy is the average number of additional years a person could expect to live if current mortality trends
p.000019: were to continue for the rest of that person’s life.
p.000019:
p.000020: 20
p.000020:
p.000021: 21
p.000021:
p.000021: The significant increase of the total mortality rate and the decrease of the life expectancy at birth, as shown above,
p.000021: affected different age and sex groups with different intensity. First, the increase of mortality concerned males more
p.000021: than females. This growing disparity resulted in the increase of the number of incomplete families and widows,
p.000021: aggravation of the existing disbalance (as will be shown below) in the sex structure, reduction of
p.000021: nuptiality and population reproduction potential, and in a growing difference of the lifespan between the sexes. In
p.000021: spite of substantiated expectations, the high mortality rate in the period of transition at the early nineteenth did
p.000021: not affect seriously those population groups that usually are considered as particularly vulnerable due to biological
p.000021: or social causes, namely children and elder people. Perhaps the most remarkable feature of this recent population
p.000021: health crisis became a significant increase of the mortality rate for age groups of gainfully employed population. The
p.000021: most drastic relative growth of the mortality rate for adult males was registered in the group of “blooming age” i.e.
p.000021: at the age of 35-49, which is most typical for Russia. As to females, the mortality changes had unequal intensity, and
p.000021: the increase of mortality here was less marked, but it affected exactly the “blooming” age group from 35 to 49 years.
p.000021: As we know, the population reproduction depends mostly on two factors: firstly – on the ratio of marriages and
p.000021: divorces; secondly – on the ratio between males and females at the fertile age. As to the first factor, in
p.000021: the conditions of the increasing youth unemployment, rapidly growing prices housing costs and uncertain prospects, the
p.000021: nuptial ratio has decreased in all nine countries from 4% (Azerbaijan) to 34% (Russian Federation). The decrease of the
p.000021: nuptial ratio for persons in the second marriage in all countries was even sharper. An average decrease of this index
p.000021: was 28%; only in Ukraine the increase of the nuptial ratio was registered, but in 1993 the fertility in this country
p.000021: has decreased dramatically (by 20%), and hence the hopes associated with the nuptial ratio were not justified. In
...
p.000021: situation in the CIS countries. The mentioned ratios have a negative impact on the generation renewal,
p.000021: and retain conditions for a narrow reproduction.
p.000021: When considering the situation we should note that the most dramatic aggravation was observed in the areas of the
p.000021: income per person, poverty, demography and social unity, which is essential for understanding social- economic
p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
p.000021: into the international system of biomedical research both from a viewpoint of interested researchers and potential
p.000021: participants.
p.000021: In the period of transition to the market economics all the CIS countries had to face such problems as considerable
p.000021: inequity in the income distribution, stratification of the society by income and increasing poverty. In 2004, the ratio
p.000021: of the total income of 10% of the most and 10% of the least well-to- do population was 3-5 times in Azerbaijan, Belarus
p.000021: and Ukraine; 11 times in Kazakhstan, Kyrgyzstan, Moldova, Russia and Tajikistan; 21 times in Armenia.
p.000021: In recent years (2005-2007), in the majority of the CIS countries some smoothing of the society stratification by
p.000021: income and the decrease of the population quota with the income beyond the cost of living (poverty line) was observed.
p.000021: Some processes were observed in the CIS countries that were not typical before. Thus, the number of the “poor” children
p.000021: usually was growing much faster than the number of poor persons in every other age group because of the rapid spread of
p.000021: the unemployment and increasing number of persons in a low-paid job, alongside with a disproportional indexation of the
p.000021: family allowances. The level of food consumption by children has considerably decreased. Presently, the change
p.000021: in the nutrition structure is expressed by transition to food products that are less expensive and richer in
p.000021: calories. There is a lack of food products that are necessary for the normal growth and development of the organism.
p.000021: Besides, a decrease in food consumption and the worsening of the sanitary situation, hygiene and living conditions have
p.000021: caused the increase of the number of diseases (tuberculosis, rachitis) traditionally associated with poverty.
p.000021: Specific features of the demographic situation and, indirectly, the amount of labor resources depend also on
p.000021: the age groups prevailing in the total population size, which, in its turn, implies special approaches to the
p.000021: healthcare structure development in the CIS countries. The increase of
p.000021:
p.000022: 22
p.000022:
p.000023: 23
p.000023:
p.000023: the elder population and the decrease of the share of children in the total population are typical for the majority of
p.000023: the CIS countries.
p.000023: In fact, during the period from 1989 to 2004 in all the CIS countries the part of population under working age
p.000023: decreased. This especially concerns the age group under four. The part of working population did not decrease due to
p.000023: the generation born in the period from the late 70s to the mid-80s (time interval characterized as a period of the
p.000023: highest fertility rate). At the same time, on the average, the part of the population over working age has increased,
p.000023: which, as shown above, alongside with the decrease of fertility and, consequently, the decrease of the population under
p.000023: the working age, can lead to the population ageing and the decrease of the population initiative and economic activity.
p.000023: The number of children under 16 in the CIS countries is nearly 80 millions. Compared with 1989, the
p.000023: part of children under 16 in the total population size of the CIS countries decreased by 11%. The youngest is
p.000023: the population of Azerbaijan and Armenia where children make 35 and 29% of the population. In the countries of
p.000023: Central Asia, due to a relatively high fertility, children make on the average 39-45% of the total population. If we
p.000023: consider the demographic situation in the Russian Federation, particularly with regard to children, it should be noted
p.000023: that during the 90-s the number of births was by 60 millions less than in the 80-s. In recent decade, the children’s
p.000023: morbidity has increased dramatically. The most disturbing is the fact of the mental health worsening, since in recent
p.000023: ten years the rate of mental diseases in children doubled, that of moronity increased in 1.5 times and imbecility in
p.000023: 1.6 times. We have to recognize the growing number of disabled children; in the CIS countries there are about 1.5
p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
p.000023: addicts. Every five years the amount of drug addicts in the “youngest” group is increasing by 100%. The children
p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
p.000023: population, and where in the case of an essential improvement of the economic situation the extended reproduction may
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
p.000023: To summarize the analysis of the demographic situation, it is necessary to note that with regard to self-preservation
p.000023: the following public processes are crucial:
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
p.000023: mortality in able-bodied population, “rejuvenation” of some diseases, spread of alcoholism and drug addiction;
...
p.000033: Republic of Kazakhstan, Art. 34 of the Constitution of the Kyrgyz Republic, Art. 36 of the Constitution of the
p.000033: Republic of Moldova, Art. 41 of the Constitution of the Russian Federation, Art. 38 of the Constitution of the
p.000033: Republic of Tajikistan, Art. 49 of the Constitution of the Republic of the Ukraine, Art. 40 of the Constitution of the
p.000033: Republic of Uzbekistan).
p.000033: Majority of the CIS countries also declared in their constitutions the right for medical care in different forms
p.000033: (excluding three republics – Armenia, Azerbaijan and Uzbekistan: in these states guarantees of availability of
p.000033: health care for people are set at the level of branch laws regulating public relationships in the health care system).
p.000033: At the same time one should note that the issue of underfunding in regard to required amount of medical care today is
p.000033: still one of the most acute problems almost in all countries of the Commonwealth.
p.000033: States implement programs on population health protection, measures for environmental protection and provision of
p.000033: free access to reliable information on its status, living and working conditions, quality of food products
p.000033: and household goods, facilitate development of physical culture and sports, create opportunities for various
p.000033: forms of health insurance. Financial support is guaranteed to pregnant women11, mothers with small children and in
p.000033: case of children with disabilities – until they become older
p.000033: – to families with many children, persons with various diseases and drug abuse. The state provides special care
p.000033: for those who broke their health protecting state and common interests. An important issue is inclusion into the
p.000033: sphere of state policy and legal regulation of an issue of preservation of national gene pool.
p.000033: It is truly important that virtually all CIS countries adopted branch laws related to issues of health care and patient
p.000033: rights – the Law of the Republic of Armenia On Medical Care and on Services for Population (1996), the Law of the
p.000033: Republic of Azerbaijan On Protection of Population Health (26.07.1997),
p.000033: 11 Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of Moldova,
p.000033: respectively.
p.000033:
p.000034: 34
p.000034:
p.000035: 35
p.000035:
p.000035: the Law of the Republic of Belarus On Health Care (1999), the Law of Georgia On Health Care (1997), the
p.000035: Law of the Republic of Kazakhstan On Protection of Population Health of the Republic of Kazakhstan (1991), the Law of
p.000035: the Kyrgyz Republic On Protection of Population Health of the Kyrgyz Republic (09.01.2005), the Law of the
p.000035: Republic of Moldova On Rights and Responsibility of Patient (27.10.2005), Basics of the Law of the Russian Federation
p.000035: On Protection of Citizen Health (22.07.1993), the Law of the Republic of Tajikistan On Protection of Population Health
p.000035: (15.05.1997), Basics of the Law of the Ukraine On Health Care (1992), the Law of the Republic of Uzbekistan On
p.000035: Protection of Citizen Health (29.08.1996). Legislation specifically related to protection of especially vulnerable
p.000035: groups of patients and subjects is of particular importance for regulation of biomedical activities including valuation
p.000035: of biomedical research. Virtually all countries adopted separate laws on psychiatric assistance to population,
p.000035: counteraction to HIV infection, donorship, transplantation, protection of children rights. These enactments reflect
p.000035: specificity of institutions of informed consent and patient confidentiality in some situations of biomedical int
p.000035: rventions as well as stipulate additional guarantees of rights of dependent groups of patients/ subjects. In many CIS
p.000035: countries laws and by-laws regulate various issues in the area of auxiliary methods of reproduction and genetic
p.000035: assistance to the population12. Two countries (the Russian Federation and the Ukraine)
p.000035: 12 For instance, in the Republic of Armenia – the Law of the Republic of Armenia On Reproductive Health
p.000035: and Reproductive Rights of Person, 12 of September 2002, in the Republic of Belarus – the Law of the
p.000035: Republic of Belarus On Safety of Gene Engineering Activities, 9 of January 2006, in the Republic of Kazakhstan – the
p.000035: Law of the Republic of Kazakhstan, 16 of July , 2004, N 565-2 On Reproductive Rights of Citizens and Guarantees of
p.000035: Implementation Thereof, in the Kyrgyz Republic – the Law of the Kyrgyz Republic, 20 of December 1999, On Reproductive
p.000035: Rights of Citizens, in the Russian Federation – the Order of the Ministry of Health of the Russian Federation. 26 of
p.000035: February 2003, N 67 On Utilization of Assisting Reproductive Technologies (ART) for Treatment of Female and Male
p.000035: Infertility, the Federal Law, 5 of July 1996, N 86-FZ On State Regulation in the Field of Gene-Engineering Activities,
p.000035: the Order of the Ministry of Health of the Russian Federation, 30 of December 1993, N 316 On Further Development of the
p.000035: Medical and Genetic Service of the Ministry of Health of the Russian Federation, in the Republic of Tajikistan – the
...
p.000039: Criminal, penal procedure and penal enforcement model codes adopted by IPA CIS being a basis for development of similar
p.000039: codes in some of the Commonwealth countries should be considered as norms of general type establishing crucial
p.000039: requirements to an order of legal act execution in regard to main freedoms and rights of citizens in the Commonwealth
p.000039: countries. Statements of the given model codes were also reflected in initiation and creation of many legislator
p.000039: enactments in the CIS countries in the field of criminal law and criminal procedures. The model civil code adopted by
p.000039: IPA CIS has special values for establishing of new conditions for administration and management in all spheres of
p.000039: activities and its main statements were to some extent practically embodied in civil legislation of all CIS countries.
p.000039: Activity of the Permanent Commission on social policy and human rights of IPA CIS has a special value from the
p.000039: point of harmonizing influence on the health care field. After initiatives of the said commission model laws
p.000039: determining main statements for a complex welfare system were adopted, a list of international conventions recommended
p.000039: for immediate ratification by the CIS countries was developed, a set of model laws on rights of human beings related to
p.000039: category of vulnerable population groups was approved, such as a law On Basic Children Rights and On Additional
p.000039: Guarantees to Child-Orphans and Children without Parental Guardians, Guidelines On Childhood Protection in Member
p.000039: Nations of CIS (1998) as well as The Charter for Older People and other socially significant documents.
p.000039: In accordance with basic statements on protection of human rights and freedoms there are being prepared model
p.000039: laws related to both forming of domestic policy in the Commonwealth countries in the field of health care and
p.000039: developing of common approaches to international cooperation of the states in this field. An important role for
p.000039: legislative regulation of special situations in the area of medical practice and their potential application
p.000039: to cases of
p.000039: biomedical studies and ethical review is assigned to the following model laws: On Sanitary and Epidemic
p.000039: Well-being of the Population, On Prevention of Spread of Diseases with Social Significance, the Concept on Formation of
p.000039: Legal Basics and Mechanisms for Implementation of Social State in the CIS Countries, the Charter of Social Rights and
p.000039: Guarantees for Citizens of Independent States (adopted by IPA CIS, 29.10.1994). Also many projects of model acts
p.000039: included into perspective plan of model law development are also important for formation of state policies of the CIS
p.000039: countries in the field of health care and biomedicine such as the following: On Social Protection of Handicapped, On
p.000039: Folk Medicine, Recommendations on National Legislations Adjustment of the CIS Member States in the Sphere of Social
...
p.000105: healthcare system began. Professional education, creation of a new pharmaceutical market, etc, and, naturally, the main
p.000105: principles of medical ethics (the physician’s duty and responsibility, relationships with patients, colleagues and
p.000105: society) underwent a strong correction. Academicians Z.A.Alieva, A.T.Amiraslanov, A.A.Namazova et al. made a great
p.000105: contribution into the development of bioethics.
p.000105: An important milestone in the history of Azerbaijan was the year of 1999, when, on the initiative of UNESCO, the
p.000105: Presidium of National Academy of Sciences established the Committee on Bioethics and Technology Ethics (Decree
p.000105: 9/1).
p.000105: 3.2.2. Legal Regulations
p.000105:
p.000105: Health is one of a few subjective human values without which many other comforts and values lose their significance.
p.000105: Today every democratic country acknowledges the importance of human rights protection in all spheres of social
p.000105: life. Within last years, the National Assembly of Azerbaijan adopted legislative acts setting forth political,
p.000105: economic, social, cultural, scientific and medical measures for maintaining and strengthening physical and mental
p.000105: health of every person and providing medical care in case of loss of health. When drawing up the documents the
p.000105: experience of other countries was used, and the following legal norms based on international legal norms were adopted:
p.000105: - UN Convention on Children’s Rights (Decree of the National Assembly of Azerbaijan Republic. No 236; 21 of July 1992)
p.000105: - Law on Sanitary-and-epidemiologic Well-being of Population (10.11.1992)
p.000105: - Law on Preventing the Spread of the Disease Caused by HIV in Azerbaijan (16.04.1996)
p.000105: - Law on Pharmaceutical Activity (05.11.1996)
p.000105: - Law on Health Protection (26.07.1997)
p.000105: - Law on Medical Insurance (1997)
p.000105: - Law on Radiation Safety (30.12.1997)
p.000105: - Law on Children’s Rights (19.05.1998)
p.000105: - Law on Transplantation of Human Organs and Tissues (28.10.1999)
p.000105: - Law on Immunoprophylaxis of Infectious Diseases (14.04.2000)
p.000105: - Law on Tuberculosis Control in Azerbaijan (05.02.2000)
p.000105: - Law on Psychiatric Care (12.06.2001)
p.000105: - Law on Narcological Service and Control (29.06.2001)
p.000105: - Law on Nutrition of Newborns and Infants (17.06.2003)
p.000105: - Law on the State Care for Patients with Diabetes (23.12.2003)
p.000105: - Law on Iodination of Sodium Chloride for the Mass Prevention of Iodine Deficiency.
p.000105: - Law on Donorship of Blood, Blood Components and Blood Donor Service (03.05.2005)
p.000105: - Law on State Care for Patients with Hereditary Diseases Such as Hemophilia and Thalassemia (03.05.2005).
p.000105:
p.000106: 106
p.000106:
p.000107: 107
p.000107:
p.000107: 3.2.3. Education in Bioethics
p.000107:
p.000107: When considering problems of education we precede from the fact that bioethics, in relation to medicine, is
p.000107: nowadays a developing academic discipline with its inherent strict standards. We should start teaching
p.000107: bioethics in the period when students pass on from theoretical subjects to practical activity.
p.000107: In accordance with recommendations of the World Health Organization to introduce courses on medical ethics into the
p.000107: syllabus of medical schools everywhere in the world, an educational programme on bioethics was developed in
p.000107: Azerbaijan in the 1990s. The programme emphasizes the universal character of principles and rules of bioethics
...
p.000115: other hand, cruelty and tendency towards violence (e.g.: attitude to the death penalty in Belarus society); acute
p.000115: self-perception and impersonal collectivism; the feeling of belonging to the humankind and national
p.000115: self-boasting; humility and inclination to a revolt; love of freedom and a need for the authoritarian State system.
p.000115: These features show themselves distinctly in social life, business relations and scientific activity. Besides,
p.000115: Orthodoxy has always supported orientation towards a strong power, as the Orthodox Church believed that only
p.000115: a strong State system could struggle against evil. At the same time, Lossky noted that in their character the
p.000115: Slavs are more disposed to democracy, which shows itself, for example, in the protest against all sorts of
p.000115: conventionalities.
p.000115: Currently the Orthodox Church still has a strong effect on the development of bioethics in Belarus,
p.000115: which has both positive and negative aspects. The programme of interaction between the Orthodox Church of the country
p.000115: and the Belarus Health Ministry of is being realized. The programme helps to introduce moral constants into the medical
p.000115: community, facilitates moral and spiritual growth of the worldview of students (future specialists in medicine, biology
p.000115: and biotechnology) and the general growth of bioethical competence in the society. A rich experience in promoting ideas
p.000115: of bioethics has the Orthodox Medical Brotherhood at the Minsk Eparchy of the Belarus Exarchate. Charity Centre has
p.000115: been organized at the Parish of the Church of All Saints in Minsk. Belarus Children’s Hospice within Children’s Cancer
p.000115: Centre provides spiritual and medico-psychological care for terminally ill children. However we should not ignore the
p.000115: conservatism of the Orthodox Church and, in particular, with regard to topical bioethical problems. In
p.000115: relation to a number of bioethical problems, the Orthodox Church adheres to a very strict position: it prohibits human
p.000115: cloning and cloning of human organs (especially heart cloning) and euthanasia; expresses censure on artificial
p.000115: fertilization, abortion, sexual education of young people. They also hold to uncompromising position regarding some
p.000115: issues of transplantation of certain organs, which showed itself in the discussion of amendments to the “Law on
p.000115: Transplantation of the Republic of Belarus”.
p.000115: Since 1995 bioethics in Republic Belarus has been developing in parallel, along two main lines — theoretical
p.000115: and practice-organizing ones, and initially the connection between these lines was rather weak.
p.000115: Theoretical trend implied the analysis of bioethics as an interdisciplinary scientific knowledge showing, most
p.000115: fully, the tendencies of science development in the XX century. On the other hand, bioethics was analyzed as a
p.000115: special field of applied ethics with its distinctive features and modifications, and, at the same time, allegiant to
p.000115: fundamental ethical principles and general human values [8, part II, 9,10,13]. In choosing priorities we are guided,
p.000115: first of all, by general tendencies in the evolution of scientific knowledge as a whole, and ethics in particular, as
...
p.000117: The National Strategy of Steady Development and the Concept of Healthcare Development in Belarus (1995) are
p.000117: the basis for adopting legal acts and national programmes and determine particular measures and resources for ethical
p.000117: and legal control of biomedical research. Laws of Belarus “On Healthcare” (1999 with subsequent amendments), “On the
p.000117: Safety of Genetic Engineering” (2005), the Draft Law “On transplantation of Human Organs and Tissues”, orders and
p.000117: instructions of the Belarus Health Ministry of are in compliance with the main principles of bioethics set out by WHO.
p.000117: The central law determining the State policy in the sphere of citizens’ health protection, legal, economical and
p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armed forces, prisoners and persons under arrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
p.000119: • Equal rights of patients and physicians to respect for their human dignity (Art. 14);
p.000119: • Mutual trust and mutual responsibility of the patient and the physician, patient is an active participant of the
p.000119: treatment process (Art. 16);
p.000119: • Compulsory consent from the patient for a medical intervention, except for cases provided by law (Art.
p.000119: 21);
p.000119: • Compulsory written consent from a patient, his/her close relatives or legal representatives for removal
...
p.000133: system of administrative and State control ensuring the protection trial subjects’ rights and interests.
p.000133: Presently, local ECs carry out ethical review, which includes the review of documents (research protocols,
p.000133: forms of individual registration cards, informed consent forms, etc.) relating to pre-registration (Phase I, II and III
p.000133: trials, generic bioequivalence studies) and post-registration (Phase
p.000133: IV) clinical trials in various fields of medicine (cardiology, oncology, gastroenterology, allergology,
p.000133: endocrinology, traumatology) including international multicentre trials.
p.000012: 12
p.000011: 11
p.000010: 10
p.000010: 10
p.000010:
p.000010:
p.000008: 8
p.000008:
p.000008:
p.000006: 6
p.000005: 5
p.000004: 4
p.000004: 4
p.000002: 2
p.000002: 2 1 1 1
p.000002:
p.000000: 0
p.000000: 1998 1999 2000 2001 2002 2003 2004
p.002005: 2005
p.002005:
p.002005:
p.002005: Multicentre clinical trials of pharmaceutical products in Belarus
p.002005: (1998-2005)
p.002005:
p.002005: When conducting ethical review ECs give a special attention to the protection of rights and interests of
p.002005: healthy volunteers involved in the Phase I clinical trials and in the clinical stage of bioequivalence studies. A
p.002005: special consideration is also given to research involving vulnerable groups (children, aged people, armed forces
p.002005: personnel, etc.).
p.002005:
p.000134: 134
p.000134:
p.000135: 135
p.000135:
p.000135: 9 8
p.000008: 8
p.000007: 7
p.000007: 7 6 6
p.000006: 6
p.000005: 5
p.000005: 5
p.000005: 5
p.000005:
p.000004: 4
p.000004:
p.000003: 3
p.000002: 2
p.000002: 2
p.000002:
p.000001: 1
p.000001:
p.000000: 0
p.000000: 1999 2000 2001 2002 2003 2004 2005
p.000000:
p.000000: Bioequivalence Studies of Pharmaceutical Products
p.000000: The review of documents referring to clinical trials, including the trial protocol, is performed by local ECs within
p.000000: 5-7 days. Without the approval from local ECs the Chairman of the Pharmacological Committee of the Health
p.000000: Ministry of Belarus may not approve the documents, and the trial may not be started. In the case of disagreement with
p.000000: the EC decision, the applicant (sponsor) may appeal against the decision to the NCBE.
p.000000: The activity of local ECs is regulated by respective normative and legal acts, the EC Statute and Standard Operational
p.000000: Procedures. These documents define the following:
p.000000: 1. Composition of the EC and membership requirements (qualification, etc.);
p.000000: 2. Operating schedule, contact telephones of the EC members, notification procedure;
p.000000: 3. A list of documents to be submitted to the EC for ethical review;
p.000000: 4. The procedure for ethical review of submitted documents;
p.000000: 5. Standard forms of the EC decisions;
p.000000: 6. The statement that all amendments to the protocol (programme) of a clinical trial come into force only after
p.000000: approval by the EC;
...
p.000167: The law “On Medical Drugs” approved on 13th of January 2004 contains articles 18, 19 and 20 that describe the
p.000167: order of development of biologically active substances and their preclinical studies or clinical trials of medical
p.000167: drugs. These articles were developed in the line with international experience (5):
p.000167: - the participation of the patient in clinical trials and (or) in testing of pharmaceutical substance or
p.000167: medical drug should be voluntary and is possible with his/her written informed consent only;
p.000167: - before clinical trials and (or) testing all information on the substance/ drug, on the contents of trials or tests,
p.000167: on safety and risks for patients health, on actions in the case of unforeseen effects of pharmaceutical substance or
p.000167: medical drug for the patient’s health as well as on patient’s health and life insurance should be provided to the
p.000167: patient;
p.000167: - the patient has a right to interrupt his/her participation in trials and (or) tests of pharmaceutical substance or
p.000167: medical drug at any phase of such trials or tests;
p.000167: - it is strictly prohibited to perform clinical trials and (or) tests of pharmaceutical substances or
p.000167: medical drugs with participation of: children and adolescents; pregnant women; military persons; imprisoned
p.000167: or incarcerated persons; non-competent persons.
p.000167: At the web-site www.medik.kz the Association of Physicians and Pharmacists of Kazakhstan has the page, where
p.000167: all legislative and regulatory documents in public health area. At present time specialists began to develop the Code
p.000167: of Republic of Kazakhstan “On Population Health and Public Health System” that will take into consideration all
p.000167: international legislative experience including legislative acts in area of biological and medical studies. For
p.000167: example, on 22nd of January 2007 the Frame Convention on Tobacco Control was officially ratified by the Republic of
p.000167: Kazakhstan; it is planned to bring laws of Kazakhstan in line with international documents that can ensure good
p.000167: clinical practice and improvement of activity of ethical committees [6].
p.000167: In 1995 according to initiative of the Association of Physicians and Pharmacists of Kazakhstan drafts of “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
p.000167: developed. In 2002 the Second Congress of Physicians and Pharmacists approved the text of “The Oath of Physician of the
p.000167: Republic of Kazakhstan” that was reflected in special Decree of the Government of the Republic of Kazakhstan No/ 1189
p.000167: published on 27th of November 2003 and in the article 50 of the Law of the Republic of Kazakhstan “On the
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan”.
p.000167: In 2006 according the law “On changes and additions to some legislative documents on public health of the Republic of
p.000167: Kazakhstan” the article 20 was supplemented with the following paragraphs:
p.000167: «it is prohibited to perform clinical trials and(or) testing of pharmaceutical substances or medical drugs with
p.000167: participation of:
p.000167:
p.000167:
p.000168: 168
p.000168:
p.000169: 169
p.000169:
p.000169: - persons before coming to age with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treatment of children diseases or when the goal of clinical trial is to collect data on the optimal dosage of this
p.000169: medical drug supposed for usage in children and adolescents. In the last case clinical studies of any medical drug in
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
p.000169: The article 43 of the Law of the Republic of Kazakhstan “On the System of Public Health” published on 4th
p.000169: June 2003 contains the juridical definition of scientific medical expertise; in this article it is indicated that
p.000169: objects of scientific medical expertise are as follows:
...
p.000173: training. For example, since 2001 the Higher School of Public Health (HSPH) began to realize training programmes for
p.000173: researches of the public health system. Starting since 2002 the Higher School of Public Health became the participant
p.000173: of the international programme “Intensive training on bioethics”. Together with Bangladesh Council on Medical
p.000173: Research with financial and technical support from the International Educational Reward in Bioethics and Carrier
p.000173: Development of the Fogarty International Centre (FIC) and National Institutes of Health (NIH), USA, several workshops
p.000173: were conducted in Almaty for physicians of Kazakhstan.
p.000173: The programme of these workshops had the following main goals:
p.000173: 1. The development of complete training plan/programme for the workshop on bioethics;
p.000173: 2. Training of young researches of different scientific specialties in the area of bioethics of scientific research.
p.000173: Many important topics were discussed during these workshops including: historical perspectives of ethics
p.000173: of scientific research in public health area; international declarations and manuals on scientific research
p.000173: with participation of human beings; informed consent; confidentiality; motivation; ethics of clinical studies;
p.000173: ethics of population and demographic studies; ethical aspects of scientific research in the area of health of children
p.000173: and reproductive health; functions of ethical committees; manuals on ethical review; organization of scientific
p.000173: research in developing countries; religion and culture in ethics and other topics.
p.000173: Around 20 specialists from different research institutions of the country participated in the development of
p.000173: programmes for workshops that were organized at the Higher School of Public Health. In future the Consultative
p.000173: Committee will be responsible for the general management of the programme, its monitoring and assessment. The programme
p.000173: was translated into English and sent for revision to international consultants.
p.000173: Recently programmes on bioethics were developed at the department of pharmaceutical management of the Higher School of
p.000173: Public Health for public health managers (18 training hours) and for public health masters (45
p.000173:
p.000174: 174
p.000174:
p.000175: 175
p.000175:
p.000175: training hours). At the same time it is necessary to mention that programmes that were developed not fulfill completely
p.000175: the growing demands of education in bioethics area.
p.000175: The level of knowledge and education on legislation among general public seeking health care improved
p.000175: recently; the network of ethical committees in research institutions of the country enlarged significantly, the
p.000175: role of Kazakhstan’s scientists in international research increased including multi-centre clinical trials of
...
p.000181: worldview as world- and life-asserting.
p.000181: Although the epic poem does not contain distinctly formulated precepts, moral lessons learned from centuries-long
p.000181: history formed a traditional system of moral values that has survived to our days:
p.000181: 1. unity and solidarity of the nation,
p.000181: 2. international accord,
p.000181: 3. national honour,
p.000181: 4. movement towards prosperity and well-being through a continuous labour and knowledge,
p.000181: 5. humanism, generosity, tolerance,
p.000181: 6. harmony with nature,
p.000181: 7. strengthening and protection of Kyrgyzstan state system.
p.000181: Ethical norms in “Manas” are based on four cardinal virtues (wisdom, patience, conscience and generosity) that are
p.000181: personified in images. They are opposed by four vices: laziness, wickedness, greed and arrogance. It is said that a
p.000181: clever person is always able by using one’s mind which is “the best of all treasures” to oppose positive qualities to
p.000181: negative ones and defeat the evil by kindness, wickedness by patience, greed by generosity. Hence, the person has to
p.000181: make every effort to improve his or her moral nature, to overcome evil elements and to change the surrounding world.
p.000181: Among human qualities most valued in Kyrgyz culture are health and longevity, diligence and valour, sense of duty and
p.000181: honour, modesty, self- control and wisdom. These virtues ensure a harmonious life of the individual [5]. Openness, love
p.000181: for children, hospitality, generosity, humanism, patience, firmness, goodwill, respect for old age and other qualities
p.000181: inherent in Kyrgyz people form the basis of moral and ethical principles of their life [1].
p.000181: Historical conditions dictated to Kyrgyz people the necessity to stand up for their freedom and integrity in the fight
p.000181: with stronger neighboring states. Severe war conditions required from men who were admitted to military
p.000181: of people’s life. Over many ages, people’s ideals have been associated
p.000181:
p.000181:
p.000181: with “Manas”; ethical norms and concepts of the good and the evil were exemplified by the acts and deeds of “Manas”
p.000181: characters.
p.000181: 19 The word eudemonism comes from the Greek word for happiness or flourishing
p.000181: (eudaimonia), and refers to any conception of ethics that puts human happiness and the complete life of
p.000181: the individual at the Centre of ethical concern.
p.000181:
p.000181:
p.000182: 182
p.000182:
p.000183: 183
p.000183:
p.000183: service not only physical strength, but also moral maturity. Wars depicted in “Manas” and episodes associated with
p.000183: those exemplify heroic traditions implying the observance of the rule of military necessity and an innate
p.000183: aversion to violence, as well as a wish to live in peace. Kyrgyz warriors regarded their sacred duty not to harm
p.000183: peaceful population of conquered peoples. It was forbidden to plunder or humiliate them. Thus an epic sage Bakai
p.000183: addresses his warriors:
...
p.000189: healthcare state institutions of Kyrgyz Republic and at healthcare institutions carry out an expert evaluation with
p.000189: regard to ethical criteria, consider moral and ethical problems arising in the course of clinical trials of
p.000189: pharmaceutical products and ensure the protection of patient’s rights.
p.000189: This Law contains important provisions concerning human rights in clinical trials of pharmaceutical
p.000189: products. In particular, it says that a patient gives his or her written consent to participate in a clinical
p.000189: trial of a pharmaceutical product and has the right to withdraw his or her consent at any stage of the research. Before
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
p.000189: out in such vulnerable patients as children without parents; military personnel; prisoners and persons under
p.000189: investigation in detention Centres; pregnant women (except for cases when clinical trials are designed specially
p.000189: for pregnant women and when the
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000191: 191
p.000191:
p.000191: necessary information can only be obtained in a clinical trial provided that the trail is not hazardous to a woman or
p.000191: to a fetus).
p.000191: Besides, the Law sets certain restrictions relating to clinical trials involving children. Thus the trials are
p.000191: only permitted if the investigational pharmaceutical product is specially indicated for use in children or to obtain
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
p.000191: trials of pharmaceutical products involving subjects with mental disorders may only be carried out after
p.000191: obtaining a written informed consent from a legally authorized representative in accordance with applicable law.
p.000191: Protection of patients’ rights in biomedical research and other interventions in Kyrgyz Republic are
p.000191: also regulated by the following laws:
p.000191: - “On Narcotic and Psychoactive Drugs and Precursors” (No 66, 22 May 1998);
p.000191: - “On Donorship of Blood and Blood Components in Kyrgyz Republic” (No 951-XII, 3 July 1992);
p.000191: - “On Tuberculosis Prevention in Kyrgyz Republic” (No 56, 18 May 1998);
p.000191: - “On Prevention of Diseases Caused by Iodine Deficit” (No 40, 8 February 2000);
p.000191: - “On Citizens’ Medical Insurance in Kyrgyz Republic” (No 208, 28 December 2006);
p.000191: - “On HIV/AIDS Prevention in Kyrgyz Republic” (No 149, 13 August 2005);
p.000191: - “On Citizens’ Reproductive Rights” (No 5, 13 January 2000).
...
p.000225: This fact explains such features of Russian doctors and scientists as democracy and patriotism, self-denying service to
p.000225: people. Activity of such scientists as C.G.Zabelin, D.S.Samoilovich, N.M.Maximovich-Ambodic, M.G.Shein,
p.000225: A.S.Shumlyanskiy exemplify it. Physicians of the XIX century such as M.Y.Muromov, E.O.Mukhin. N.I.Pirogov,
p.000225: A.M.Filomafitskiy, S.F.Hotovitskiy, F.I.Inozemtsev and others maintained this tradition. Their professional activity
p.000225: and civil position were based on moral ideals. They wrote works where they discuss qualities characterizing a
p.000225: doctor, ethical aspects of relations with society, patients and colleagues. In everyday activity they pointed and
p.000225: solved problems, which were beginnings of bioethics principles and rules. They used method of experiment,
p.000225: observing disease activity and experimented on animals. At that time ethical approaches to experiments were formed.
p.000225: So, A.M.Filomafitckiy (11807-1849), the first Russian scientist, who made vivisection and surgery method as the base
p.000225: of physiology, said: “... Experiment made by inexperienced hand and aimlessly should be severely punished,
p.000225: especially if sufferings of an animal after blood operation are lengthened without any need, but experiments made
p.000225: by hands of a skillful and loyal observer are necessary for science and saving
p.000225:
p.000226: 226
p.000226:
p.000227: 227
p.000227:
p.000227: of mankind...” (11). D.S.Samoylovich (1744-1805), founder of the Russian epidemiology, self-tested plague infection
p.000227: and its course. There were negative examples. In the middle of the XIX century in Moscow foundling hospital they
p.000227: were searching for substitute of breast milk for children, and among others Libihovskiy beef broth was studied. As a
p.000227: result many children fell ill and so it was concluded to be harmful (8).
p.000227: One of the first who began to defend rights of prisoners on health and medical help was F.P.Gaaz (1780-1853). In his
p.000227: everyday practice he defended and implemented the slogan “hurry up to make good”, displaying humane attitude to most
p.000227: miserable people such as exiles, convicts, he supported them morally and gave medical and social help, took care about
p.000227: their children. He both worked with selfless devotion and attracted unselfish assistants being of different classes and
p.000227: generations.
p.000227: Moral position of N.I.Pirogov (1810-1881) displays principle of honesty in Russia. He paid special attention to medical
p.000227: mistakes. In contrast with existing in medical society opinion he believed that every honest man should be able to
p.000227: admit and proclaim his mistakes to warn against them not well- informed people (24). Many Russian physicians became his
p.000227: followers and were able to admit and analyze their mistakes. They were A.Y.Krasovskiy, C.P.Kolomina, F.I.Sinitsin and
p.000227: others.
p.000227: An issue of patient consent for surgery was discussed by physicians in the past. N.I.Pirogov remembered in the Old
p.000227: Doctor Dairy, that an inspector of medical institutions I.Rule required from doctors in the hospital not to do any
p.000227: surgery without patient agreement.
p.000227: The time since the end of the XVIII century till beginning of the XIX century one can state as a
p.000227: birth of public medicine. First medical papers, medical societies, public hospitals and chemist’s shops,
p.000227: charity organizations were founded in Russia. One of the forms of public movement was movement of narodniks, which in
p.000227: the 60-70’s of the XIX century became mass ideology of intelligence not of gentle birth trying to be spokesman of
p.000227: peasants. At the call of members of organization Narodnaya Volya (People’s Will) Russian teachers and doctors went
p.000227: willingly “close to the people” and went to work in the depth of Russia (13).
p.000227: Conditions existing in Russia after abolition of serfdom such as quick development of capitalism and
...
p.000231: any right to cause even minute and fleeting harm to a healthy person for the sake of another human being? Whether he is
p.000231: competent to decide in every particular situation if the benefit for one patient compensates for the harm done to the
p.000231: other, having the widest sense of the words benefit and harm in mind, that means not only in relation to physical
p.000231: health of these individuals but taking into account a complex of spiritual and physical strength of both?”.
p.000231: In response to these concerns Doctor Dmitriev stated the main provisions of implementing a medical
p.000231: research, the most essential of which are providing information and obtaining a conscious consent (of a donor in this
p.000231: case) which fully complies with the modern requirements. The same article provides a text of the first Russian
p.000231: full-scale minutely formulated patient’s informed consent form which retains its actual continuity up to
p.000231: contemporary time.
p.000231: Achievements of academic medicine did not significantly influence public health factors and demographic
p.000231: processes. Mortality and morbidity rates among population were high, infant mortality was common, there were
p.000231: many physically retarded children. Russia was shaken by epidemics of epidemic typhus, cholera, smallpox, malaria, and
p.000231: diphtheria and other. Medical facilities were scattered between different authorities and were mainly financed
p.000231: through beneficent funds.
p.000231: The number of physicians and hospitals was inadequate to provide citizens with medical service. In late XIX –
p.000231: early XX centuries there were 10 hospital beds and 1.8 physicians for every 10000 people in Russia. Medical service was
p.000231: mainly available in large cities. Out of 257 sanitation physicians 135 worked in Moscow and Saint-Petersburg. According
p.000231: to the data of 1913 allocations in health care accounted for 91 kopeks, for sanitation – 1.25 kopeks per
p.000231: year per capita. The major, rural, part of Russian population was almost completely deprived of medical
p.000231: service. In these conditions the position of F.F Erisman and V.V. Veresaev is a notable one, they called for not
p.000231: staying indifferent to the reasons inducing such situation, not to “powerlessly grumble about the unfair destiny”, but
p.000231: to consider it a moral duty to “take all possible steps to prevent such undue events from happening”
p.000231: Development of country medicine was a great event, the establishing of which was tightly connected with the community
p.000231: mode of life characteristic of Russian people and with the so-called country self-administration introduced in
p.000231: the 60-s of the XIX century. Subsequently, country medicine widely implemented in 34 provinces in European part of
p.000231: Russia (in 1911 6 more were added) appeared at that time most reasonable form of medical service for rural population
p.000231: and was unique to our country.
p.000231: The most important achievement of country medicine, which was far ahead of its time, was a declared and practically
...
p.000265: programs to comply with scientific and practical
p.000265:
p.000266: 266
p.000266:
p.000267: 267
p.000267:
p.000267: requirements, to coordinate activities of university departments on teaching issues of legal and ethical control in
p.000267: medicine.
p.000267: The main task is to be planned preparation of qualified staff of professors, which requires set up of special
p.000267: post-graduate study system, including post- graduate research and vocational training at the course of general and
p.000267: topical post-graduate education, establishment of the bioethics grade.
p.000267:
p.000267: 3.8.4. System of Ethical Review
p.000267:
p.000267: The Russian legislation in the field of ethical and legal provision for biomedical research is represented with a range
p.000267: of documents. First of all, it is the Constitution of the Russian Federation (Art.21), which states: “… no one can be
p.000267: made undergo medical, scientific or other experiments without his/her consent.” Beside, there is the Basics of the
p.000267: Legislation of the Russian Federation on Protection of Health of Citizens where Article 43 considers issues on
p.000267: application of new methods of prevention, diagnostics, treatment; medical agents, immunobiological agents and
p.000267: disinfecting agents and biomedical research conduct. However, this article is declarative to a large extent: rights
p.000267: of citizens involved in biomedical studies stipulated there do not have any mechanisms of implementation and
p.000267: enforcement, including the ones via ethical review of applications for research conduct. At the same time,
p.000267: in accordance with this document children of age below 15 can participate in studies of new medicinal agents, methods,
p.000267: etc, only in case of vital indications though in real life this statement is constantly breached that is inevitable and
p.000267: determined with realia of medical practice development and scientific progress. Article 29 of this document prohibits
p.000267: involvement into studies of those arrested or convicted though, in some cases these persons can benefit from
p.000267: their participation in clinical biomedical research. In this respect the Russian legislation differs from
p.000267: European norms that allow in case of specific and clearly defined conditions to hold studies with involvement of
p.000267: those categories of citizens. Another document regulating possibility for conduct of biomedical studies in the Russian
p.000267: Federation is the Law on Psychiatric Care where Article 5 proclaims the right of a person with mental disorder to
p.000267: consent or to refuse of participation in such studies though necessity for such action is not stipulated. The Law on
p.000267: Pharmaceutical Products analyzes quite profoundly those norms regulating research on new
p.000267: medicinal agents but, regretfully, it covers only one though rather important sphere of biomedical research – studies
p.000267: of pharmaceuticals. This law as it is shown by the text is written basing on an assumption that each study is premised
p.000267: with an examination held by an ethical committee but either status, or authority, or order of creation, or composition
p.000267: of ethical committees are not stipulated by the Law; there only guidelines that “the ethical committee acts at the
...
p.000291: competent design of biomedical research in Tajikistan – a Moslem country and an officially secular State – is not
p.000291: possible. Besides, there are strong believers practicing Islam and observing all religious holidays. Thus, many
p.000291: people keep the strict fast during the Ramadan. In this period people suffering from severe diseases, refuse taking
p.000291: medicines both per os and by injection, which is harmful to their health. Thus, for example, patients who have had
p.000291: operations for glaucoma refuse courses of conservative supportive therapy or keep the fast, which weakens visual
p.000291: functions. Quite often during the Ramadan people
p.000291: get to the surgery department of the emergency station with pancreonecrosis after having a rich and fat meal (pilaw) in
p.000291: the night after fasting during the day. In some cases this situation has a lethal outcome. Islamic traditions dictate a
p.000291: respectful attitude to the human body even after a person’s death and therefore relatives of the deceased do not
p.000291: consent to the post-mortem examination and removal of organs for transplantation. According to Moslem religion, the
p.000291: soul of the embryo appears in the first week of the fourth month of pregnancy, and the law prohibits abortion after
p.000291: this term. Besides, Tajikistan population is not disposed to contraception measures or abortion, and therefore Tajik
p.000291: families are commonly having many children. When carrying out preventive health examination of strong believers, it is
p.000291: important to divide them into separate streams according to sex.
p.000291: Artificial fertilization in Tajikistan is permitted. It is desirable to use sperm of the woman’s husband provided that
p.000291: his consent has been obtained. There are no strict religious restrictions with regard to transplantation and removal
p.000291: donor organs. Sharia laws state that medical professionals should struggle for a patient’s life to the last moment and
p.000291: totally reject euthanasia. These and other similar examples emphasize the necessity to consider cultural
p.000291: aspects with regard to providing medical care and conducting biomedical research in Tajikistan.
p.000291: Biomedical research if conducted without considering cultural and religious aspects may have negative
p.000291: consequences. The physician should follow certain rules not to harm religious feelings. This is essential both in
p.000291: planned and emergency treatment. However, often, particularly in providing emergency care, the physician, voluntarily
p.000291: or not, may be in a situation when he/she is violating a religious rule.
...
p.000293: wide range of issues from a harmonious physical and spiritual development and the improvement of heredity to social and
p.000293: legal protection of the patient. The laws aim at improving conditions of work, life and rest, resolving
p.000293: ecological problems, developing the quality of medical care and promoting a healthy life-style.
p.000293: The first steps of the independent Tajikistan were accompanied with economic crisis in all fields including healthcare.
p.000293: Economic, political and social recession affected indices of the population health. Most urgent were problems
p.000293: concerning food, water supply, sanitary situation, the growth of
p.000293: infectious diseases (typhoid, malaria, tuberculosis, diphtheria, acute viral hepatitis) acute respiratory
p.000293: diseases, anemia, diseases caused by iodine deficit and reproductive health. Despite instability in
p.000293: political and socio- economic life during the first years of independence, Tajikistan Government took comprehensive
p.000293: measures on the protection of the population health. During that period, Tajikistan ratified important
p.000293: international documents referring to the protection of human rights such as the Convention on the Elimination of All
p.000293: Forms of Discrimination against Women (ratified in 1993), Convention on Children’s Rights (ratified in
p.000293: 1993). Presently, the following documents form the legislative basis in healthcare:
p.000293: - Constitution of Republic of Tajikistan (RT) (1994)
p.000293: - RT law “On AIDS Prevention” (No 904; 23 of December 1993)
p.000293: - RT law “On Donorship of Blood and its Components” (No 901; 23 December 1993)
p.000293: - RT law “On the State Sanitary Inspection” (No 987; 20 of July 1994)
p.000293: - RT law “On the Protection of Population Health” (No 419; 15 of May 1997)
p.000293: - RT Labour Code (1997).
p.000293: - Family Code (1997).
p.000293: - RT law “On Narcotic Drugs, Psychotropic and Precursors” (No 874, 10 of December 1999)
p.000293: - RT law “On Pharmaceutical Products and Pharmaceutical Activity” (No 39; 6 of August 2001)
p.000293: - RT law “On Psychiatric Care” (No 90, 2 of December 2000)
p.000293: - RT law “On Reproductive Health and Reproductive Rights” (No 72; 2 of December 2002)
p.000293: - RT law “On Private Medical Practice” (No 60; 3 of December 2000)
p.000293: - RT law “On Salt Iodination” (No 85; 2 of December 2002)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Tropical
p.000293: Diseases (Malaria) in Republic of Tajikistan in 1997-2005” (No 342, 4 of December 1997)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Viral
p.000293: Hepatitis “B” in Tajikistan in 2000- 2007” (No 100; 11 of March 2000)
p.000293:
p.000294: 294
p.000294:
p.000295: 295
p.000295:
p.000295: - Decree of the RT Government “On the Approval of the Concept of Healthcare Reformation in Republic of Tajikistan”
p.000295: (No 94; 4 of March 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Prevention and Control of
p.000295: HIV/AIDS/STD in Republic of Tajikistan in the Period to 2007” (No 475; 27 of November 2002)
p.000295: - Decree of the RT Government “On the RT Strategy for Preventing the Menace of AIDS Spreading for the Period of
p.000295: 2002-2005” (No 389; 1 of October 2002)
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
p.000295: access to the service of reproductive health, at preventing HIV/ AIDS spreading and at eliminating sex discrimination
p.000295: in the field of primary and secondary education. To ensure the national demographic policy, the Government approved
p.000295: and adopted the programme “The Concept of RT State Demographic Policy for the Period 2003-2015” (2002).
p.000295: The independent Tajikistan with its scientific potential in healthcare has reached a new, international level of
p.000295: science development, and therefore it is necessary to carry out ethical review of biomedical research in compliance
p.000295: with international regulations. The controlling body is the Committee on Medical Ethics (CME) at the RT Health
p.000295: Ministry. In its activity, the CME is guided by the Constitution of Republic Tajikistan. Documents regulating the
p.000295: CME practice comply with international legal standards and RT laws. The CME forms a part of the Forum for Ethics
p.000295: Committees in the Commonwealth of Independent States. The CME is to review and monitor scientific research in medicine
p.000295: and the compliance with ethical regulations to protect right and dignity of a research subject. Presently, the RT
p.000295: Government is considering the law “On the Protection of Human Rights and Dignity in Biomedical Research”
...
p.000325: strength of natural warmth”. He was tireless in calling upon physicians to develop their general and special knowledge,
p.000325: to exchange professional experience and travel. In those times, travels served to extend scientific contacts. In the
p.000325: Middle Ages, there were many charlatan “healers” and even physicians deceiving their patients. Reasons for that Ibn
p.000325: Sina saw in a poor medical training, as physicians were not taught to see in each person his/her unique world of
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
p.000325: Ibn Sina’s views on childhood are noteworthy. “Canon of Medical Science” states that child’s life and health
p.000325: should be objects of care, protection and a special regimen from the moment of conception, not just from the moment of
p.000325: birth. A newborn baby needs a wet nurse with a stable nervous system. Games are essential, as all educational
p.000325: and formative processes, starting from very early years, should proceed from games. One may not punish a child, as
p.000325: the task of a tutor and physician if to protect the child’s soul, to facilitate the development of the feeling of
p.000325: self-respect. It is particularly important to prohibit any punishment for children under age of five, i.e. at the age
p.000325: when a child does not realize the meaning of his/her actions. Abu Ali Ibn Sina believed that, irrespective of state and
p.000325: public benefits, a child should receive a good intellectual, moral and ethical education in the family and at school.
p.000325: In his works, Ali Abu Ibn Sina gave much attention to school education. Kind and well-educated teachers may only
p.000325: teach at school,
p.000325: where children are brought up and educated until the age of fourteen. A teacher should know well the subject
p.000325: he teaches; he should follow the moral principles and be an honest, loving and courageous person.
p.000325: In the system of Ibn Sina’s ethical views, a concept of mizaj implying the necessity of an entirely individual approach
p.000325: to each individual, irrespective of the person’s age of health condition and considering a unique combination of
p.000325: qualities on the individual and his/her living and working conditions.
p.000325: The knowledge of human nature and temperament is the basis of a physician’s strategy when maintaining a
p.000325: proper level of health, and, if need be, planning the therapy. A comprehensive study of the “Canon” helps us to tell a
p.000325: sanguine person from a phlegmatic one or a choleric person from a melancholy one, and to mark out characteristic
p.000325: biotypes. If we translate it into the language of modern bioethics, we can see clearly the logical construct of
p.000325: Hippocrates, Galen and Avicenna; treat not a disease but a person, and not just a person but also a biotype
p.000325: whose psychological responses are subordinate to its biological nature (mizaj), or temperament. Ages later Ivan
p.000325: Pavlov mentioned the biotypological approach used widely by Ibn Sina as a fruitful one, revealing “fundamental
p.000325: features” of human nature.
p.000325: Thus, “Canon of Medical Science” written in the times of the Oriental Renaissance, and very popular during the European
p.000325: Renaissance, nowadays, if profoundly studied, can contribute essentially to the theory of bioethics, and humanize
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000101: Independent States. The Conference in Armenia was also the start ground for including CIS countries in SIDCER Project
p.000101: “Recognition”. Thus, for the first time, Module 1 of the programme “Human Subject Protection” for members of the
p.000101: National Ethics Committee of Republic Armenia and Armenian medical community was launched in October 2005 due to
p.000101: efforts of FECCIS and international experts.
p.000101: As to education in bioethics, the representatives from Republic of Armenia participated in the
p.000101: International Course on Research Ethics for Countries of Central and Eastern Europe at Albany Medical College
p.000101: (USA) and Vilnius University (Lithuania). The course received support from Fogarty Foundation. There are perspectives
p.000101: for participation of other representatives from Armenia in this Course.
p.000101:
p.000102: 102
p.000102:
p.000103: 103
p.000103:
p.000103: 3.2. REPUBLIC oF AzERBAIjAn
p.000103: (А.А.Namazova, Z.G.Guseinova, T.G.Tagi-Zade)
p.000103:
p.000103: 3.2.1 Historical and Cultural Background
p.000103:
p.000103: Rich historical and cultural heritage reflected in works by progressive thinkers of the past and contemporary
p.000103: scientists, multinational and multiconfessional population of the republic are the factors contributing to the
p.000103: development of bioethics in Azerbaijan. Tolerance and respect for other national cultures and human dignity, esteem for
p.000103: elderly people, principles of mercy, concern and care for dying people, i.e. traditions that have been forming over
p.000103: centuries-long history, play a significant part in this process.
p.000103: Azerbaijan people, as many other peoples of Eastern countries find evidence of physicians’ search and
p.000103: reflection on philosophy and ethics in ancient medical manuscripts. The ancient world knew the name of a
p.000103: legendary physician Logman. In Azerbaijan secrets of medical knowledge and prescriptions for treatment and prevention
p.000103: of different diseases were passed across the generations in the name of Logman. Not long ago two Logman’s precepts
p.000103: were found. The first precept is about the noble mission of the physician: “Everything in the Earth is the
p.000103: fruit of human kindness/ And where the doctor is, there is always air of kindness”. The second one warns against
p.000103: excessive eating and drinking alcohol, i.e. advocates the culture of hygiene: “Do not thou fill thyself with vine/ Be
p.000103: moderate in eating pilaw and bread/ Or otherwise the world in which we live/ Will turn into a cattle-shed”.
p.000103: Fundamental principles of the physician’s ethical behaviour were set forth in an ancient monument of Azerbaijan
p.000103: literature – a folk epic poem “Dede Korkud”. There we find many pieces of useful advice on how to stay healthy and
p.000103: about significance of moral purity and health.
p.000103: Prominent thinkers, poets and scientists of ancient land of Azerbaijan, such as Bahmanyar Ibn Mirzaban, Nizami
p.000103: Gyandjavi, Hatib Tabrizi, Mahmud Shabustari, Omar Osmanogli, Seid Yahya Bakuvi, Nahchivani, Hagani, Fizuli,
...
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
p.000189: elderly persons, disabled persons, persons who had suffered from an emergency situation and residents of ecologically
p.000189: unfavorable regions (Art. 67, 68, 69, 70, 71).
p.000189: The Law on Pharmaceutical Products (March 2003) regulates clinical trials of pharmaceutical products.
p.000189: According to this Law, no clinical trials of pharmaceutical products in Kyrgyz Republic may be carried out
p.000189: without the permission granted by the authorized healthcare state institution of Kyrgyz Republic. Those guilty of
p.000189: violating rules of clinical trials, falsifying clinical results obtained in clinical trials of pharmaceutical
p.000189: products or conducting the trials without the permission granted by an authorized healthcare state institutions of
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
p.000189: necessary for an authorized healthcare state institutions of Kyrgyz Republic to make a decision about a clinical trial
p.000189: of a pharmaceutical product. The list includes an approval by the ethics committee of an authorized
p.000189: healthcare state institution of Kyrgyz Republic. Article 27 states that the ethics committee of an authorized
p.000189: healthcare state
p.000189: institution of Kyrgyz Republic participates in the design of a clinical trial programme.
p.000189: According to this Article, clinical trial results are referred only to the authorized healthcare state institution of
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000007: exchange of knowledge in this field for the mutual benefit. By providing information on the CIS region potential for
p.000007: cooperation and education in the sphere of bioethics and biomedical research ethics, the project makes an important
p.000007: intellectual and informational contribution into UNESCO Global Ethics Observatory.
p.000007: Chapter 1. GEnERAL tEnDEnCIES
p.000007: oF tHE SoCIAL PoLICY AnD HUMAn RIGtHS In MEDICInE In tHE CIS CoUntRIES
p.000007:
p.000007: 1.1 Social and Demographic Factors (E.Yu.Vladimirova)
p.000007:
p.000007: To develop a system for the ethical review of biomedical research, we have to consider the current social and economic
p.000007: situation in the Commonwealth of Independent Countries. A state can ensure reproduction of population and a high level
p.000007: of a living standard for its residents if it does not participate in regulation of the current demographic situation
p.000007: and labour market.
p.000007: The demographic situation in the CIS countries has both common and specific features. Common features
p.000007: result from a long-term socio- economic crisis of the 1990s, discrepancy between introduced reforms and
p.000007: social policy, a dramatic decline in living standards at various social levels, and aggravation of ecological
p.000007: conditions. Specific features in each State are determined by different styles of life in the CIS countries due to
p.000007: their historical, religious, cultural and ethnic development. All these factors resulted in a general fertility rate
p.000007: decrease, mortality growth and a fall of the health quality index. These processes affect negatively the demographic,
p.000007: labour and migration potential of the CIS countries.
p.000007: The last decade of the XX century was characterized by an essential aggravation of the demographic situation that could
p.000007: be defined as a crisis. High mortality rates had practically no precedents in the Eurasian peacetime history. The
p.000007: “excess mortality” in the period since 1989 was much higher than the mortality rate in the period of Great Depression
p.000007: in the North America (1929-1933). Besides, recent changes of mortality rate, marriage ability and fertility shifts have
p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
...
p.000177: revision date: 07.07.2006, No 28793 in the State List (Inventory).
p.000177: 5. «On Medical Drugs». The Law of the Republic of Kazakhstan N522 of 13 January 2004, the last revision date:
p.000177: 29.12.2006 No 18187 in the State List (Inventory).
p.000177: 6. «On Prevention and Control of Tobacco Use». The Law of the Republic of Kazakhstan N340 of 10 July 2002, the last
p.000177: revision date: 11.12.2006, No 12697 in the State List (Inventory).
p.000177: 7. Law PK «The Oath of Physician of the Republic of Kazakhstan». The Resolution of the Government of the Republic of
p.000177: Kazakhstan №1189 of 27.11.2003.
p.000177: 8. «On the System of Public Health». The Law of the Republic of Kazakhstan N430 of 4 June 2003, the
p.000177: last revision date: 29.12.2006, № 15742 in the State List (Inventory).
p.000177: 9. «On Changes and Additions to Several Laws of the Republic of Kazakhstan on Public Health». The Law
p.000177: of the Republic of Kazakhstan N171 of 7 July 2006, the last revision date: 07.07.2006, № 28850 in the State List
p.000177: (Inventory).
p.000177:
p.000177:
p.000178: 178
p.000178:
p.000179: 179
p.000179:
p.000179: 3.6. KYRGYz REPUBLIC (A.z.zurdinov, U.M.tilekeeva, B.A.Alisherov)
p.000179:
p.000179: 3.6.1. Historical and Cultural Background
p.000179:
p.000179: Kyrgyz Republic is a country in the middle part of Central Asia; most of it is located in the Tenir-Too
p.000179: mountainous region. The territory of Kyrgyzstan is equal to 198.5 thousands sq. km; nearly 90% of the territory is 1500
p.000179: m above the sea level. According to 1999 census, the population is 4.8 million people including 3.1 million of
p.000179: ethnic Kyrgyz. About one third of Kyrgyzstan population (35%) lives in urban areas and 65% are rural population
p.000179: (1999).
p.000179: Kyrgyzstan is a multinational unitary state. The country is divided into seven administrative regions: Batken,
p.000179: Zhalal-Abad, Naryn, Osh, Talass, Chuisk, Issyk-Kul. The capital of Kyrgyz Republic is Bishkek, the form of
p.000179: government – republic.
p.000179: The land of Kyrgyzstan, like all Central Asia, is one of the most ancient places of human civilization. Archeological
p.000179: studies show that primitive men settled there in the time of the Stone Age. Kyrgyz ethnos that was known in Central
p.000179: Asia since the first millennium BC retained its self-name to our time. First politically organized communities in the
p.000179: territory of the present-
p.000179: day Kyrgyzstan appeared in the II century BC when southern agricultural regions joined the State of Parkan.
p.000179: During the IV and III centuries BC early Kyrgyz formed part of powerful unions of nomadic tribes that were a
p.000179: serious problem for China. It was the time when the Great Wall of China began to be built. During the II and I
p.000179: centuries BC a part of Kyrgyz tribes got away from the power of Hunnu State and moved to Enisei (the Kyrzys meaning of
p.000179: “Ene-sai” is the Mother-River) and Baikal (Rich Lake) regions. There they founded their first state Kyrgyz Kaganat that
p.000179: became the centre of the Kyrgyz consolidation and the centre of their culture where their written language
p.000179: developed. Runic inscriptions still can be seen on stone monuments. Invaders destroyed the state but they could not
p.000179: destroy people’s memory, although the written language was lost.
p.000179: During the V century the transition from nomadic to settled lifestyle began in the North of Kyrgyzstan. First written
p.000179: sources mentioning Kyrgyz tribes inhabiting Tian Shan date back to the X century.
p.000179: Petroglyphs of Saimaly Tash, one of the oldest and biggest collections of rock pictures, demonstrate a high level of
p.000179: Kyrgyz civilization. The Burana Tower and Uzgen architecture complex are examples of an amazing mastery of architects
p.000179: and builders.
p.000179: From the middle of the IX century to the beginning of the X century AD the Great Kyrgyz Khanate extended to the South
p.000179: Siberia, Mongolia, Baikal, the Upper Irtysh, Issyk Kul and Talas. This period was not only the time of conquests but
p.000179: also time of an active trade with China, Tibet and peoples of South Siberia and Central Asia. It was the period when
p.000179: after defeating the Uighur Kaganat the Kyrgyz for the first time entered the Tian Shan territory. In the X century,
p.000179: however, the Kyrgyz domination had shrunk to South Siberia, Altai and South-West of Mongolia and in the XI and
p.000179: XIIcenturies to Altai and Sayan Mountains. Nevertheless, parts of Kyrgyz tribes scattered over a large territory
p.000179: participated actively in numerous historical events in Central Asia. They managed to keep their ethnic
p.000179: independence and became the centre of attraction for other ethnic groups. The final stage of ethnogenesis related
p.000179: Kyrgyz people to Oirot (Kalmats), Naiman and other peoples of Central Asia.
p.000179: Starting from the XIII century Kyrgyz people had to fight wars of independence from different invaders. In
p.000179: the second half of the XV century Kyrgyz tribes joined in an independent khanate that embraced a major part of Kyrgyz
p.000179: people. The Great Silk Road was very important for Kyrgyzstan. The town of Osh – the main city in the south of the
p.000179: present-day Kyrgyzstan
p.000179: – due to its favorable geographic location was a transit town in the Fergana line of the Great Silk Road.
p.000179: In 1863 the North Kyrgyzstan and in 1876 the South Kyrgyzstan were incorporated into the Russian Empire. After the
p.000179: Great October Revolution Kyrgyz people, as other peoples of former tsarist Russia entered the Soviet Republic
p.000179: In 1918 Kyrgyzstan formed a part of Turkistan Autonomous Soviet Socialist Republic. In 1924 the Kara-Kyrgyz
p.000179: Autonomous Region within the Russian SFSR was established. In 1926 it was transformed into the Kyrgyz Autonomous
p.000179: Republic, and in 1936 – into the Kyrgyz Republic. On 31 of August 1999, Kyrgyzstan declared its independence.
p.000179: We know that myths and legends form the base of every culture. Nomadic life-style and the loss of written
p.000179: language of early Kyrgyz people
p.000179:
p.000180: 180
p.000180:
p.000181: 181
p.000181:
p.000181: stimulated the rise of a special philosophy that revealed itself in poetic folklore. It has accumulated the
p.000181: basic problems of human existence, mental and philosophic activity and spirituality.
...
p.000241: number of interviewees proved not prepared to solving current ethical tasks and either refused to answer questions of
p.000241: the interview or found them too challenging.
p.000241: Russia has not yet determined the answer to the question of referring itself to a civilization – Western or Eastern. In
p.000241: the early 1990’s the strategy was linked to the opportunity for Russia to be integrated into the Western community, and
p.000241: it was first of all seen through attitude to values and interests. Integrity of values in Russia and in the West is
p.000241: retained today in recognition of such values as freedom, justice, material well-being and other. However, our country
p.000241: yet has not seen them implemented fully. Establishing value system in the field of medicine which represent perhaps the
p.000241: most conventional block in the general system of values is still under way. In the mentality of citizens of
p.000241:
p.000242: 242
p.000242:
p.000243: 243
p.000243:
p.000243: Russia the principles of identity typical of the West are still underdeveloped. The basis of human rights theory is yet
p.000243: being established. Majority of Russian citizens as social studies show, reject the imposed ‘alien’
p.000243: communication schemes, for instance, the Western view over various issues of personal and social life not out of
p.000243: reasonable arguments or some ideological efforts but out of their inconsistency with customary ideas and values.
p.000243: This gives grounds for discussion and implementation of the bioethical staple principles and provisions in
p.000243: countries with various ethnic, culture and religious traditions, creates challenges because of peculiarities
p.000243: and inconsistencies between the Russian and western ethical systems in health care and medicine. In this respect it is
p.000243: reasonable to draw guidelines and interpret specific regulations and acts and their provisions taking into
p.000243: account two main aspects: culture and ethnical traditions of given states and their compliance with the common norms of
p.000243: international laws in the field of bioethics.
p.000243:
p.000243: References
p.000243: 1. Berdiaev N.A. Destiny of Russia: Selected Works. M., Kharkov: EKSMO Press Folio, 1998, 736 p. (herein and
p.000243: hereinafter in Russian)
p.000243: 2. Dmitrieva T.B., Polozgiy B.S. Psychological Health of Russian
p.000243: Citizens. Human, 2002, №6, p. 21-31.
p.000243: 3. Zamalaev. А.F. Lectures on history of Russian philosophy: XI –
p.000243: early XX cc. StP., 1994.
p.000243: 4. Zenkovskiy V.V. History of Russian philosophy. L., Eko, 1991, p. I,
p.000243: p. II, p. b.
p.000243: 5. Ivanjushkin A.J. Medical ethics in Russia (XIX - early XX cc.). In
p.000243: bk.: Bioethics: principles, regulations, problems. М., 1998, p. 93–110.
p.000243: 6. Ivanjushkin A.J. History of medical ethics and biomedical experiments in human and animal parties.
p.000243: In bk.: Introduction to bioethics. М., 1998, p. 95-133.
p.000243: 7. Cirill, metropolite. On «Basic social conception of Russian Orthodox Church». Anniversary Episcopal Assembly RCOC.
p.000243: StPb, 2000, p. 133-149.
...
p.000281: republic with the city of Dushanbe as its capital. In 1991 the Soviet Union collapsed, and Tajikistan declared
p.000281: its independence.
p.000281: Tajikistan is a mountainous landlocked country in Central Asia. Afghanistan borders to the south,
p.000281: Uzbekistan to the west, Kyrgyzstan to the North, and China to the east. The total area of Tajikistan Republic is
p.000281: 143.1 thousands of square km, and it has a population of 7,163,506 citizens. Tajikistan consists of 4 administrative
p.000281: divisions: 2 provinces (Sughd in the north and Khatlon in the south), 1 autonomous province (Gorno-Badakhshan
p.000281: - Pamir), and disrtricts of republican subordination around Dushanbe.
p.000281: Tajikistan is an agrarian-industrial country and has a considerable potential. Lengthy wars caused
p.000281: devastations and human losses, which resulted in a dramatic economic recession. However, during the last peaceful
p.000281: years the economics and living standard have notably increased.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000283: 283
p.000283:
p.000283: The Tajik people have a rich and ancient culture. Since antiquity to the period of feudalism moral and
p.000283: ethical issues took an important place in religious and philosophical outlook. Until the IX century it had
p.000283: been developing in the context of Iranian philosophy, and later, since the 9th to the XV century in the
p.000283: context of Arabic philosophy. Due to the ethnic, language, social and political commonality in antiquity and the early
p.000283: Middle Ages particularly close relations were between East-Iranian (ancestors of the Tajiks) and West-Iranian
p.000283: (ancestors of the Persians) people. The Tajik- Persian philosophical thought had also a connection with Indian and
p.000283: Greek philosophy. However the closest links connected the Tajik culture and spiritual and philosophic outlook
p.000283: with cultures of Turkic peoples of Central Asia and Azerbaijan. There was a mutual enrichment of cultures, spiritual
p.000283: values and scientific achievements.
p.000283: Religious and philosophical ideas of Tajik ancestors roots back to an ancient monument of spiritual
p.000283: culture “Avesta” the holy canon of Zoroastrism (Mazdeism) containing not only religious dogmas but also
p.000283: ideas on cosmogony, philosophy, morals and law. The characteristic feature of Zoroastrianism is dualism, i.e. the view
p.000283: that two fundamental concepts exist, such as good and evil, and the struggle between these is the pivot and content of
p.000283: the universe. Zoroastrianism formulated a ternary ideal of the righteous man (“good thoughts”, “good words” and
p.000283: “good deeds”) opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked words” and “wicked deeds”). The
p.000283: Zoroastrian idea about infinite time as an initial substance gave rise to zervanism – a teaching in the framework of
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
p.000189: out in such vulnerable patients as children without parents; military personnel; prisoners and persons under
p.000189: investigation in detention Centres; pregnant women (except for cases when clinical trials are designed specially
p.000189: for pregnant women and when the
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000191: 191
p.000191:
p.000191: necessary information can only be obtained in a clinical trial provided that the trail is not hazardous to a woman or
p.000191: to a fetus).
p.000191: Besides, the Law sets certain restrictions relating to clinical trials involving children. Thus the trials are
p.000191: only permitted if the investigational pharmaceutical product is specially indicated for use in children or to obtain
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
p.000191: trials of pharmaceutical products involving subjects with mental disorders may only be carried out after
p.000191: obtaining a written informed consent from a legally authorized representative in accordance with applicable law.
p.000191: Protection of patients’ rights in biomedical research and other interventions in Kyrgyz Republic are
p.000191: also regulated by the following laws:
p.000191: - “On Narcotic and Psychoactive Drugs and Precursors” (No 66, 22 May 1998);
p.000191: - “On Donorship of Blood and Blood Components in Kyrgyz Republic” (No 951-XII, 3 July 1992);
...
p.000249: conducted only if pharmaceutical product is proposed for treatment of child diseases or if the aim of clinical trial is
p.000249: the getting the information about the best dosing of drug for therapy of minors. In latter situation the clinical trial
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
p.000249: carried out only after obtaining the written consent of legal guardians of these persons32.
p.000249: The latter Law states that all persons with mental disorders have to right for the preliminary consent or to refusal at
p.000249: any time to be used as a subject of trials of drugs and medical methods, scientific investigations or study
p.000249: process, video or photo or film shooting (item 2 of the article 2).
p.000249: Besides the Article 11 of this Law clarifies that the clinical trials involving persons under compulsory
p.000249: medical treatment or involuntarily hospitalized persons are absolutely prohibited.
p.000249: Such a key element of the ethical review as confidentiality of the information about patient and
p.000249: received from the patient throughout biomedical research is guarantied by means of the institute of medical
...
p.000269: When examining the clinical study protocol, specialists consider possibility of reaching study objectives with
p.000269: involvement of less amount of subjects, assess inclusion and exclusion criteria, early exclusion criteria from
p.000269: participating in the clinical study, conditions of the study termination, objective control methods, expected
p.000269: adverse events and inconveniences for patients.
p.000269: Reviewing the Investigator Brochure there are examined data on efficacy and safety, pharmacological, pharmaceutical and
p.000269: toxicological properties of the tested medical agent as well as data on results of previously conducted preclinical and
p.000269: clinical studies.
p.000269: Requirements for information on the study provided to a candidate subject are very strict. It must
p.000269: correspond to a level of understanding of those to be involved in the study, to be easy to read and not to
p.000269: contain many medical terms. This document must describe the following: study purpose and objectives; description of the
p.000269: tested medicinal article; concomitant treatment permitted or prohibited in the given the trial’s subjects. probability
p.000269: of random assignment in one of the study groups (including the control that might be treated with placebo. Explanations
p.000269: for all terms and concepts, for instance, placebo, is obligatory!); objectively expected benefit for the patient as
p.000269: well as inconveniences and objectively expected risks for both patients/healthy volunteers and a fetus or infants; all
p.000269: study procedures (especially accurately
p.000269:
p.000270: 270
p.000270:
p.000271: 271
p.000271:
p.000271: there shall be highlighted issues on all invasive procedures planned during the study); obligations of the
p.000271: subject-participant; compensation and/or treatment the subject might expect in case the damage is incurred to his/her
p.000271: health during the study. The information note for the patient must contain a declaration that his/her participation
p.000271: in the study is voluntary and that he/she can in any moment of time refuse of participation in the study or to
p.000271: discontinue it without any sanctions or his/her rights infringement; there shall be clearly identified a list
p.000271: of persons that will be granted with direct access to information in the primary medical documentation (investigators,
p.000271: auditors, regulatory authorities, ethical committee members), and provided assurance that data identifying
p.000271: personality of the study subject will be kept secret and its disclosure is possible only within the limits
p.000271: stipulated with corresponding laws and/or by-laws. For instance, in case of public representation and
p.000271: publication of the study results anonymity of its subjects (confidentiality of information about them) is
p.000271: guaranteed. The patient information note must indicate investigator obligations in case of appearance of new data
p.000271: in the given CT that can influence the subject decision on continuing participation in the study to
p.000271: immediately inform the study subject or his/her legal representative about them, define a list of persons that one can
...
p.000319: Sciences was registered at the Office for Human Research Protection at the USA Government and received the Federalwide
p.000319: Assurance FWA00007871. Several local committees in Ukraine also have international registration numbers.
p.000319: Since November 1995 when Ukraine became a permanent member of the Council of Europe, a Ukraine representative has been
p.000319: working actively at the Steering Committee on Bioethics in Strasbourg (France). In the framework of this activity
p.000319: Ukraine participated in the development of international documents including the revised text of the “Convention
p.000319: of Human Rights and Biomedicine” (Oviedo, 1997). In 2004 the representative of Ukraine was elected to the Board of the
p.000319: Steering Committee on Bioethics as a Committee Reporter on the activity of Ethics Committees at medical research
p.000319: institutions. Two seminars on topical ethical problems in transplantology and cell therapy were held in Ukraine with
p.000319: the assistance and participation of CE experts. The representative of Ukraine takes part as a reporter in the
p.000319: educational project of the CE on implementation of CE documents on bioethics in the countries of the former Soviet
p.000319: Union. Currently, in the framework of the Steering Committee on Bioethics at the CE, Ukraine participates in the
p.000319: development of guidelines for a fetus and embryo protection and in the design of a protocol relating to genetic
p.000319: testing.
p.000319: International Seminar “Development of the Recommendations on Application of Standard Operational Procedures
p.000319: for Ethical Review of Biomedical Research” was held in the framework of the Second National Congress on Bioethics
p.000319: (Kiev, 2004) organized in cooperation with FECCIS and UNESCO. Experts and participants from CIS, Baltic States, the USA
p.000319: and Japan attended the Seminar.
p.000319: The main objective of the seminar was to discuss ways and methods of implementing Standard Operational Procedures
p.000319: into the practice of ethical evaluation of biomedical research in the countries of the former Soviet Union
p.000319: and neighbouring Baltic countries and countries of Eastern Europe. High ethical standards and requirements outlined in
p.000319: this document should be implemented into the practice of local ethics committees. At the same time we should consider
p.000319: specific local features of a particular region. Therefore we have to focus our attention on issues of interaction
p.000319: between regional, national and local ethics committees. Another important problem
p.000319: is raising the qualification level of members of the ethics committees that review biomedical research. The seminar
p.000319: facilitated a further harmonization of international ethical standards with regard to regional conditions. It had both
p.000319: scientific and practical significance for the countries of the region.
...
p.000349: Nearly all NEC members gave their presentations at scientific symposia and conferences on bioethics held in the CIS and
p.000349: other countries. In 2005, the NEC held the First National Congress on Bioethics in Tashkent. Television, all leading
p.000349: newspapers and scientific journals broadly covered issues of biomedical ethics discussed at the Congress.
p.000349: The idea to combine scientific progress and ethics brought together about 200 medical scientists and members
p.000349: of teaching staff, investigators, physicians, biologists, experts in law, philosophers, theologists, journalists,
p.000349: deputies of the Legislative Chamber of Uzbekistan Parliament, representatives of various public organizations,
p.000349: delegates from different Uzbekistan cities, as well as from Kazakhstan, Kyrgyzstan, Tajikistan, Ukraine, Russia,
p.000349: Belgium, South Africa, Philippines, Singapore and other countries.
p.000349: The Congress participants discussed key issues of bioethics relating to the protection of human rights and dignity of
p.000349: biomedical research subjects in connection with the use of achievements in biology and medicine.
p.000349: The Congress participants made many interesting presentations. The Minister of Healthcare of Uzbekistan, prof.
p.000349: F.G.Nazirov spoke about ethical aspects of using new technologies in medicine; Doctor of Philosophy, professor Moshin
p.000349: Ebrahim from the Islamic University of South African Republic shared his opinion on the rights of a fetus; scientists
p.000349: from Philippines, Ukraine and Russia touched upon ethical problems concerning the use of embryonic and stromal human
p.000349: stem cells in treating various diseases. The Chairperson of the FECCIS, prof. O.I.Kubar from St.-Petersburg and Dr.U.
p.000349: Sharapov gave a talk
p.000349: on ethical aspects of clinical trials concerning HIV/AIDS; physicians from the Republican Specialized Surgery Centre at
p.000349: the Ministry of Public Health of Uzbekistan spoke about bioethical aspects of organ and tissue transplantation, and
p.000349: specialists from the Scientific Centre for Emergency Medical Care presented talks on similar problems in
p.000349: emergency medicine.
p.000349: J.N.Franco from Singapore and a group of physicians from Belgium spoke about problems of patient—physician relationship
p.000349: in the conditions of a rapid development of new biotechnologies and about truth-telling with regard to
p.000349: patients with terminal diseases. M.Baimukhamedov gave a talk on ethical aspects of the protection of patients’ rights
p.000349: in TV-medical consultations. The Congress participants discussed problems of ecological ethics and the use of
p.000349: genetically modified products and their effect on integral health (presentations by academician T.I.Iskanderov
p.000349: from Uzbekistan, Z.Nasyrova and Z.Akhrorova - scientists from Kazakhstan and Tajikistan). The Head of the WHO
p.000349: Office in Uzbekistan Dr. Arun Nanda, prof.
...
Searching for indicator fetuses:
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p.000249: the getting the information about the best dosing of drug for therapy of minors. In latter situation the clinical trial
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
p.000249: carried out only after obtaining the written consent of legal guardians of these persons32.
p.000249: The latter Law states that all persons with mental disorders have to right for the preliminary consent or to refusal at
p.000249: any time to be used as a subject of trials of drugs and medical methods, scientific investigations or study
p.000249: process, video or photo or film shooting (item 2 of the article 2).
p.000249: Besides the Article 11 of this Law clarifies that the clinical trials involving persons under compulsory
p.000249: medical treatment or involuntarily hospitalized persons are absolutely prohibited.
p.000249: Such a key element of the ethical review as confidentiality of the information about patient and
p.000249: received from the patient throughout biomedical research is guarantied by means of the institute of medical
p.000249: secrecy stipulated by the Fundamental principles of Legislation and by the institute of personal and family secrecy
p.000249: (privacy) provided by the Constitution of the Russian Federation (the Article 23). It is also necessary to take into
...
Searching for indicator foetus:
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p.000151: clinical phase when human beings are involved in the research programme. It requires that ethics committee to be
p.000151: created at the institution where the trial is to be carried out. Interestingly, this law specifically mentions
p.000151: recommendations set out in WMA Declaration of Helsinki to be the basis for conducting clinical trials on human beings.
p.000151: As already mentioned the most specific law on the protection of the research subjects will be the Law on
p.000151: Biomedical Research involving Human Subjects, which is being submitted to the Government this year. The aim of the
p.000151: draft law is protection of the rights, health and life of a research subject of biomedical research and provision of
p.000151: safety and respect for dignity during the research. The draft law concerns any type of research aiming at obtaining
p.000151: information and broadening knowledge in the sphere of biomedicine, which serves the interests of human health
p.000151: protection and implies:
p.000151: • Physical intervention on human being;
p.000151: • Research on biological materials which initially were taken and stored with other purpose;
p.000151: • Intervention which doesn’t imply physical intervention on human being but can pose danger to mental health or
p.000151: psychological condition of human being;
p.000151: • Research on foetus and/or embryo in vivo (The Law does not apply to research on embryos in vitro.
p.000151: The draft Law on Biomedical Research involving Human Subjects is based on the following core principles:
p.000151: • Primacy of the human being;
p.000151: • Autonomy of research subjects: information, informed consent, confidentiality and privacy;
p.000151: • Scientific quality;
p.000151: • Minimizing risks and keeping adequate risk-benefit ratio;
p.000151: • Safety;
p.000151: • Protection of vulnerable groups;
p.000151: • Multidisciplinary review of ethical acceptability of research protocol and its approval by an ethics committee.
p.000151:
p.000152: 152
p.000152:
p.000153: 153
p.000153:
p.000153: Side by side with legislation certain impact on the ethical conduct of health care providers as researchers has ethical
p.000153: regulations, which could be considered as soft legal instruments. In April 2003 the Congress of Georgian Physicians
p.000153: endorsed the Ethics Code of Physician of Georgia. The code was developed by Georgian Health Law and Bioethics Society
p.000153: (GHLBS) and the Health Legislation and Bioethics Department of the National Institute of Health. The first version of
p.000153: the Code was discussed by the participants of the Congress and was submitted to further considerations to the National
p.000153: Council on Bioethics. The letter considered the document during its three different sittings and finally published the
...
Social / Homeless Persons
Searching for indicator homeless:
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p.000209: 15 to 45 minutes each on basic themes of this type of practical philosophy. Such programs as Bioethics –
p.000209: The Science of Survival, Euthanasia from the Point of View of Bioethics, Cloning in the Contest of Bioethics,
p.000209: Bioethical Aspects of Artificial Human Reproduction, Experiments in Humans and Animals in Biomedical Sphere:
p.000209: Bioethical Aspects, Religion and Bioethics and other with participation of bioethics specialists, biologists,
p.000209: medics and religious theologists can be marked among them, as well as From Anthropocentrism to
p.000209: Biospherocentrism, Backgrounds of Bioethics, From Ethics to Biological Ethics, Abortion and Bioethics, Bioethical
p.000209: Education of Society – Requirement of the Human Survival Strategy, Transplantology and Bioethics, Human Genome and
p.000209: Bioethics, Biomedical and Spiritual World: Comparative Analysis, Principles and Imperatives of Bioethics,
p.000209: Paternalism and Antipaternalism in Human Activity, Informative Consent and Interpretation in Medical Practice and
p.000209: others.. Here we started to check the interest in some ideas from social bioethics, such as Senility and Bioethics,
p.000209: Terrorism and Bioethics, Homosexualism, Transsexualism and Travestism in the Contest of Bioethics, Suicide and
p.000209: Bioethics, Homeless in the Light of Bioethics, Bioethics and AIDS, People with Physical Incapability in the Light of
p.000209: Bioethics, Asceticism and Bioethical Knowledge, Sadism and Masochism in the Contest of Bioethics etc. All that promotes
p.000209: propaganda of bioethical knowledge among the population both of the cities and rural settlements, formation of skill to
p.000209: care about living and biosphere in general.
p.000209: Periodicals with regular publication of interviews, articles and, for
p.000209: example, such newspapers as Komsomolskaya Pravda, Argumenty i Fakty, Nezavisimaya Moldova, Făclia, Moldova
p.000209: Suverană, Literatura şi arta are used to the same extent, i.e. for propaganda and promotion of knowledge
p.000209: in bioethics. We will underline several of them: Philosophy (With Bioethics Course), the Svetoch newspaper, No.
p.000209: 14 of 5 April 2003,
p.000209: p.6 (in Romanian); Homo Sapiens, be a Human!, the Argumenty i Fakty newspaper, No. 21, May 2005, p.3 (in
p.000209: Russian); Bioethics, Philosophy,
p.000209: Economics and Medicine in the Strategy of Humane Safety Ensuring, the Literatura i Iskusstvo weekly, No. 11, 17 of
p.000209: March 2005, p.2; Philosophy and Bioethics, the Literatura i Iskusstvo weekly, No. 35, 1 of September 2005, p.7; And
p.000209: Philosophers May Safe the Mankind, the Svetoch newspaper on 19 of February 2000, p.6, etc.
p.000209: Traditions of extensive participation of the community in formation of moral principles of social life are rather
p.000209: strong in our country as in other CIS countries. As it was said before, the first public officially
...
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
p.000271: alterations of the drug introduction routes, its doses, and significant changes in number of the CT subjects. An ethics
p.000271: committee can approve amendments to the clinical study conduct only if presented changes do not lead to worsening of
p.000271: conditions for subjects.
...
Social / Incarcerated
Searching for indicator incarcerated:
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p.000167: - the participation of the patient in clinical trials and (or) in testing of pharmaceutical substance or
p.000167: medical drug should be voluntary and is possible with his/her written informed consent only;
p.000167: - before clinical trials and (or) testing all information on the substance/ drug, on the contents of trials or tests,
p.000167: on safety and risks for patients health, on actions in the case of unforeseen effects of pharmaceutical substance or
p.000167: medical drug for the patient’s health as well as on patient’s health and life insurance should be provided to the
p.000167: patient;
p.000167: - the patient has a right to interrupt his/her participation in trials and (or) tests of pharmaceutical substance or
p.000167: medical drug at any phase of such trials or tests;
p.000167: - it is strictly prohibited to perform clinical trials and (or) tests of pharmaceutical substances or
p.000167: medical drugs with participation of: children and adolescents; pregnant women; military persons; imprisoned
p.000167: or incarcerated persons; non-competent persons.
p.000167: At the web-site www.medik.kz the Association of Physicians and Pharmacists of Kazakhstan has the page, where
p.000167: all legislative and regulatory documents in public health area. At present time specialists began to develop the Code
p.000167: of Republic of Kazakhstan “On Population Health and Public Health System” that will take into consideration all
p.000167: international legislative experience including legislative acts in area of biological and medical studies. For
p.000167: example, on 22nd of January 2007 the Frame Convention on Tobacco Control was officially ratified by the Republic of
p.000167: Kazakhstan; it is planned to bring laws of Kazakhstan in line with international documents that can ensure good
p.000167: clinical practice and improvement of activity of ethical committees [6].
p.000167: In 1995 according to initiative of the Association of Physicians and Pharmacists of Kazakhstan drafts of “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
p.000167: developed. In 2002 the Second Congress of Physicians and Pharmacists approved the text of “The Oath of Physician of the
p.000167: Republic of Kazakhstan” that was reflected in special Decree of the Government of the Republic of Kazakhstan No/ 1189
p.000167: published on 27th of November 2003 and in the article 50 of the Law of the Republic of Kazakhstan “On the
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan”.
p.000167: In 2006 according the law “On changes and additions to some legislative documents on public health of the Republic of
...
Searching for indicator liberty:
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p.000333: Bioethics (13 of June 2003)
p.000333: 16. UNESCO Programme on Bioethics: Priorities and Perspectives (17 of October 1999)
p.000333: 17. Implementation of the Universal Declaration on the Human. Genome and Human Rights (17 of November
p.000333: 1999)
p.000333: A number of national laws of the Republic of Uzbekistan relating to the implementation of international agreements in
p.000333: healthcare imply a possibility of a joint regulation by the national Uzbekistan legislation and international norms.
p.000333: Article 1 of the Law “on the Protection of Citizen’s Health” (No 265-I; 29 of August 1996) states that “if
p.000333: an international agreement sets out rules others than those in the national legislation, norms of the international
p.000333: agreement are applied”.
p.000333: Substantiation of certain approaches to resolving bioethics problems is nowadays in the centre of political,
p.000333: philosophical and religious investigations that are to offer guiding lines in our rapidly changing world. Thus, the
p.000333: necessity to consider existing religious moral norms and cultural traditions in making decisions on key bioethical
p.000333: problems was discussed at the International Congress of Bioethics (Teheran, 2005). For the independent the
p.000333: Republic of Uzbekistan this issue is particularly topical. Despite the secular character of Uzbekistan, many residents
p.000333: are practicing Islam and other religions. The clause on the liberty of conscience in the Constitution of the
p.000333: Republic of Uzbekistan reflects the respect for the feelings of believers in our country, and therefore specific
p.000333: features of religious thinking are to be considered in
p.000333:
p.000334: 334
p.000334:
p.000335: 335
p.000335:
p.000335: adopting the Code of the Republic of Uzbekistan on Bioethical Problems (Mukhamedova Z.M. Islamic Bioethics in
p.000335: Historical Context. In: “Materials of the First National Congress on Bioethics”, Tashkent, 2005, pp. 98-100).
p.000335: It is necessary to note that nowadays there is a number of ethical codes interpreting teachings of the Koran and Sunnah
p.000335: with regard to complicated medical and biological problems. Thus, there are the Islamic Code of Medical
p.000335: Ethics48 and Islamic Bioethics49 correlating their statements with the Islam teachings: the Koran, Shariat and
p.000335: Hasid.50 These Codes are used in Kuwait, Egypt, Saudi Arabia, Iran, Pakistan and in other countries with Moslem
p.000335: communities (Canada, USA et al.). These documents pave the way to the development of ethical and religious regulations
p.000335: for biomedicine in Uzbekistan.
p.000335: Despite measures taken in our country, there remain problems relating to the protection of human rights in healthcare.
p.000335: Monitoring surveys carried out by the Ombudsman of the Republic of Uzbekistan showed that citizens apply to different
p.000335: state structures not only because of a poor material and technical basis of healthcare institutions or lack of
p.000335: pharmaceuticals, but also because the violation of patients’ rights to information about their diseases and
...
Searching for indicator restricted:
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p.000149: Georgia has little experience in building the civil society. However, it has definitively moves towards the
p.000149: integration with the Western World and harmonisation with the western law. The legislative basis apparently is one
p.000149: of the most important points in the process of establishing common anthropocentric values and viewpoint of the civil,
p.000149: open society.
p.000149: The history of the Georgian state and law dates back to ancient times. Due to the historical misfortunes Georgia never
p.000149: participated in the process of great codifications. In this connection legislative activity of the King
p.000149: Vakhtang VI (XVII-XVIII cc) deserves major attention. Chronologically this period coincides with the epoch of
p.000149: creation of the basis for the modern law and state in Western Europe. Drafting of King Vakhtang’s Law Book can be
p.000149: considered to be an attempt to get closer to the cultural world, at which Georgia aspired during its whole history. In
p.000149: some regions of Georgia the code of Vakhtang’s Laws was in force up to the second half of the XIX century.
p.000149: An attempt to build a modern independent state in 1918-1921 was not successful due to the expansion of Russia. As a
p.000149: result Georgia became the part of the communistic space for the next 70 years. Thus, formation of the civil
p.000149: society in Georgia started within the borders of another country (Soviet Union), making Georgia unable to develop
p.000149: its own legislation independently.
p.000149: During aforementioned 70 years legislative activity in Georgia was restricted to the slight alteration or, at
p.000149: best, adaptation of the frame laws, provided by the central authorities (Moscow). As well as in other republics of the
p.000149: Soviet Union there was no tradition of training the legal professionals for the health care system in Georgia. Before
p.000149: re-establishment of Georgia’s sovereignty, the Law on Health Care, adopted in 1972 by Soviet Government, was in force.
p.000149: This document showed significant negligence of individual rights of patients. Almost none of the basic principles of
p.000149: ensuring patients’
p.000149: autonomy and self-determination (except the right to keep personal data confidentially) were even declared.
p.000149: The creation of national legislation is an essential condition for building the national and democratic state and a
p.000149: civil society. Adoption of Georgian Constitution (24 of August 1995) and Georgian Civil Code (26 of June 1997) is
p.000149: definitely significant step toward establishment of national state.
p.000149:
p.000149: 3.4.2 Legal Regulations
p.000149:
p.000149: Legislation of Georgia related to health, biomedicine and human rights comprise laws which regulate
p.000149: various aspects of medicine/health care: rights of patients and research subjects (including vulnerable groups; such
p.000149: as minors, persons with mental disorders, patients with HIV/AIDS etc.), duties and responsibilities of health
p.000149: care professionals, human organ transplantation, assisted reproductive technologies etc.
...
p.000305: time of the intervention, in a condition to express his or her wishes should be taken into account.
p.000305: The law “On Pharmaceutical Products” states the necessity to obtain a written consent from a potential subject of a
p.000305: clinical trial or from his or her legal representative (Art. 8). This additional measure is connected with the danger
p.000305: of abuse and infringement of human rights.
p.000305: The right to information is closely related to the concept of informed consent. Recognition of this right is
p.000305: particularly essential for former soviet republics with their traditional paternalistic approach to physician-patient
p.000305: relationship. The transition to the concept of cooperation signifies the respect for the patient’s will, for his or her
p.000305: dignity and free choice. This is especially important for the sphere of biomedical research involving human subjects.
p.000305: The general rule is fixed in Ukrainian legislation – in Basic Legislation and in special laws. However,
p.000305: Basic Legislation says nothing about the confidentiality of private information, and corresponding
p.000305: statements can
p.000305:
p.000306: 306
p.000306:
p.000307: 307
p.000307:
p.000307: be found only in the Ukrainian laws “On Prevention of AIDS Disease and Social Protection of Population” (Art. 8) and
p.000307: “On Providing Psychiatric Care” where only the patient or his/her legal representative have the right to private
p.000307: information.
p.000307: The Ukrainian law “On Prohibition of Reproductive Human Cloning” is restricted to the sphere defined in the law title
p.000307: and does not regulate in any way embryo cloning “for therapeutic purposes”. It only prohibits importing cloned human
p.000307: embryos into Ukraine and exporting them from the country.
p.000307: Apart from abovementioned laws, there are many other legislative acts regulating, one way or another, issues relating
p.000307: to biomedical experiments. These are Ukrainian laws “On Scientific and Scientific/Technical Expertise”, “On Ensuring
p.000307: Sanitary and Epidemiologic Well-Being of the Population”, “On Healthcare”, “On Protection of People from
p.000307: Ionizing Radiation”, “On Measures against Tuberculosis”, “On Implantation of Pace-makers”, “On the Animal World” and
p.000307: “On Veterinary Medicine” and a number of other laws and Decrees of the Ukrainian Cabinet of Ministers,
p.000307: President’s Decrees and orders of the Ministry of Health. Noteworthy is the order of the Ukrainian Ministry of Health
p.000307: No 66 on February 2006 “On Rules of Conducting Clinical Trials of Pharmaceutical Products and Reviewing
p.000307: Materials of Clinical Trials”.
p.000307: With all this considerable number of regulating documents, there is no legislation in the sphere of human
p.000307: genome with regard to both general and specific principles. Almost unregulated is one of the most significant bioethics
p.000307: fields - in vitro research on embryos. Article 19 of the law “On Transplantation of Organs and Other Anatomical
p.000307: Materials” stipulates that it may be possible to use fetal material for transplantation, while issues relating to
p.000307: research on embryos and creation of human embryos for research purposes are not regulated.
...
p.000309: teaching bioethics.
p.000309: On the other hand, in Ukraine, as in other European countries, there is a tendency of teaching bioethics as an
p.000309: applied biomedical ethics of a narrow professional character. At UNESCO seminar on problems of
p.000309:
p.000310: 310
p.000310:
p.000311: 311
p.000311:
p.000311: teaching bioethics in East European countries (Moscow, January 2005) it was mentioned that 70% of those who teach
p.000311: bioethics are physicians with a classical medical education. Thus, the majority of bioethics teachers have not studied
p.000311: ethics as an independent or philosophical discipline, which certainly affects the general tendency of education in
p.000311: bioethics and interpretation of basic bioethics problems.
p.000311: Currently there is an urgent need to teach bioethics as a special form of worldview, as an interdisciplinary science
p.000311: uniting separate fields of natural sciences and humanities. Bioethics should be considered and studied as
p.000311: global ethics (knowledge of humanity global problems and ways how to resolve those) and as a field involving
p.000311: different cultural traditions.
p.000311: Today opportunities for education in the field bioethics and Good Clinical Practice on the international level
p.000311: for specialists from Ukraine are restricted to separate training courses and seminars (including conferences,
p.000311: symposiums or congresses on bioethics and clinical research) held by public organizations, institutes of higher
p.000311: medical education, research institutes, National Academy of Sciences, National Academy of Medical Sciences and State
p.000311: Pharmacological centre of Ukraine.
p.000311: We do not have a system of education in GCP principles. The only course for training members of ethics committees
p.000311: “Organization and Performance of Ethical Review of Biomedical research” (36 h) was designed and adopted at the
p.000311: Department of Philosophy of National Academy for Postgraduate Training named after P.L.Shupik (Kiev).
p.000311: Over last 5 years several PhD dissertations in specialties “science philosophy” and “public management”
p.000311: directly related to medical and ecological ethics have been defended.
p.000311: Nowadays teaching bioethics as an academic discipline requires the combination of instrumental principles,
p.000311: approaches and standards of natural sciences with theoretical models and principles of humanities.
p.000311: Although teaching bioethics as a separate discipline has begun only 5-6 years ago, a high level of higher
p.000311: medical and humanitarian education, highly professional teachers, a sufficient number of libraries, internet
...
p.000331:
p.000331: resulting from an intervention is entitled to fair financial compensation estimated according to the
p.000331: conditions and procedures prescribed by law.
p.000331: Currently, there are but single instances of suits brought by patients or their relatives against medical institutions.
p.000331: Uzbekistan has little experience in considering such complaints at court, because citizens are not properly informed
p.000331: about their rights. The lack of knowledge in this field negatively affects physician-patient relationships and the
p.000331: treatment efficiency. It is physicians’ professional duty to know patients’ and physicians’ rights and
p.000331: responsibilities. Incidentally, while the patient may be ignorant of his rights and responsibilities relating to
p.000331: medical care, the physician usually has this knowledge but intentionally conceals it from the patient,
p.000331: which is a disadvantage to both the patient and the physician.
p.000331: To involve medical professionals in educational activity aiming at informing patients about their rights, as
p.000331: well as physicians’ rights is one of urgent tasks for the healthcare system of Uzbekistan. .
p.000331: Ethical norms considering special features in relationship with patients from various age and social groups should have
p.000331: a significant place in the system regulating medical activity, particularly the rule of confidentiality relating to
p.000331: information obtained from the patient. This rule applies to adults (capable), minors (incapable or partially
p.000331: capable) and to persons with restricted capabilities who need a constant care.
p.000331: Ethical principles are essential in providing medical care to patients with sexually transmitted diseases. A
p.000331: more tolerant attitude of the society and law-enforcement bodies to patients from risk groups (sex workers,
p.000331: truckers, etc.) requires the development of legislation and social tolerance via public institutions (mahalline
p.000331: committees).
p.000331: The law of the Republic of Uzbekistan “On the Protection of Citizen’s Health” contains a number of articles concerning
p.000331: ethical issues. Thus, Article 46 sets out main principles safeguarding patents’ rights. The law of the
p.000331: Republic of Uzbekistan “On Pharmaceutical Products and Pharmaceutical Activity” (1997) also protects patients’
p.000331: rights in biomedical research. It defines the State authorities and competence of the Ministry of Public Health of
p.000331: the Republic of Uzbekistan in the sphere of clinical trials.
p.000331: Article 10 states that the decision about a clinical trial (CT) is based on
p.000331: - consent obtained from a patient or volunteer to participate in CT;
p.000331: - findings of a pre-clinical study of safety and efficiency of pharmaceutical products;
p.000331: - available data testifying that a potential risk is essentially lower than an expected benefit.
p.000331: Article 11 sets out provisions with regard to the patient’s or a volunteer’s rights in a clinical trial. Before the
...
Social / Infant
Searching for indicator infant:
(return to top)
p.000011: increased by 22.6 mln of people (8.7%).
p.000011:
p.000012: 12
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: The increase of the age-specific rates results in the increase of the total birth rate (the total birth rate is the sum
p.000013: of the age-specific fertility rates in the age range of 15-49 years; it shows the average number of children born by
p.000013: one women in her life if for every age the fertility rate remained the same as it was in the year for which the
p.000013: age-specific rates were calculated). The most significant increase of the fertility rate was in Kazakhstan where the
p.000013: total fertility rate in 2004 was 2,21 versus 2,03 in 2003. According to the recent data, the average value of this
p.000013: index in the CIS countries is 1,9 of births per one woman. The half of the population of the CIS lives in the countries
p.000013: where the simple reproduction of the population is not reached, i.e. this rate is below 2,1 (1,38 in Armenia (2004),
p.000013: 1,20 in Belarus (2004), 1,40 in Georgia (2003),
p.000013: 1,22 in Moldova (2003), 1,34 in Russia (2004), 1,20 in Ukraine (2003)).6 The problem of saving life and health
p.000013: of newborns is particularly
p.000013: important especially considering the long period of fertility decrease. In spite of a marked reduction of the
p.000013: infant mortality in all CIS countries in recent years, its level remains very high. The infant mortality rate in the
p.000013: CIS countries is much higher than that in the developed countries where its value is 3-5 deaths during the first year
p.000013: per 1000 newborns. (Table 3).
p.000013: About a half of dying infants falls to the share of the babies of the first year of life, nearly 70% of which die in
p.000013: the first week. The prenatal mortality rate in the CIS countries is fluctuating from 6 to 16 deaths at the age of 0-6
p.000013: days and still-borns per every 1000 of births. The causes of these deaths are respiratory states typical for the
p.000013: prenatal period, cases of the fetal asphyxia and asphyxia at birth.
p.000013: In many respects, a high death rate registered in the majority of the CIS countries over a long period can be
p.000013: explained, by the population ageing and by the decrease of the quality of life and health. At the same time, the number
p.000013: of births per 1000 population in the countries of the European Union is less (at the average 11,1) than in Azerbaijan
p.000013: (24,2), Kyrgyzstan (26,1), Tajikistan and Turkmenistan (33,1). However, in spite of the high population ageing rate,
p.000013: the number of deaths in the EU countries is lower (10,1) than in the CIS countries (12,6), which in it’s turn, may be
p.000013: explained by the level of preventive measures and healthcare in general, and by the social-economic situation in the
p.000013: CIS countries.
p.000013:
p.000013: 6 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000013: 2005, p. 62“.
p.000013:
p.000014: 14
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015:
...
p.000231: expertise was based on the consultation that the author obtained from A.F. Kony (12). Considering legal aspect of
p.000231: a doctor’s right for transplanting organs and tissues B.V. Dmitriev asked: “Whether a physician is granted
p.000231: any right to cause even minute and fleeting harm to a healthy person for the sake of another human being? Whether he is
p.000231: competent to decide in every particular situation if the benefit for one patient compensates for the harm done to the
p.000231: other, having the widest sense of the words benefit and harm in mind, that means not only in relation to physical
p.000231: health of these individuals but taking into account a complex of spiritual and physical strength of both?”.
p.000231: In response to these concerns Doctor Dmitriev stated the main provisions of implementing a medical
p.000231: research, the most essential of which are providing information and obtaining a conscious consent (of a donor in this
p.000231: case) which fully complies with the modern requirements. The same article provides a text of the first Russian
p.000231: full-scale minutely formulated patient’s informed consent form which retains its actual continuity up to
p.000231: contemporary time.
p.000231: Achievements of academic medicine did not significantly influence public health factors and demographic
p.000231: processes. Mortality and morbidity rates among population were high, infant mortality was common, there were
p.000231: many physically retarded children. Russia was shaken by epidemics of epidemic typhus, cholera, smallpox, malaria, and
p.000231: diphtheria and other. Medical facilities were scattered between different authorities and were mainly financed
p.000231: through beneficent funds.
p.000231: The number of physicians and hospitals was inadequate to provide citizens with medical service. In late XIX –
p.000231: early XX centuries there were 10 hospital beds and 1.8 physicians for every 10000 people in Russia. Medical service was
p.000231: mainly available in large cities. Out of 257 sanitation physicians 135 worked in Moscow and Saint-Petersburg. According
p.000231: to the data of 1913 allocations in health care accounted for 91 kopeks, for sanitation – 1.25 kopeks per
p.000231: year per capita. The major, rural, part of Russian population was almost completely deprived of medical
p.000231: service. In these conditions the position of F.F Erisman and V.V. Veresaev is a notable one, they called for not
p.000231: staying indifferent to the reasons inducing such situation, not to “powerlessly grumble about the unfair destiny”, but
p.000231: to consider it a moral duty to “take all possible steps to prevent such undue events from happening”
p.000231: Development of country medicine was a great event, the establishing of which was tightly connected with the community
p.000231: mode of life characteristic of Russian people and with the so-called country self-administration introduced in
p.000231: the 60-s of the XIX century. Subsequently, country medicine widely implemented in 34 provinces in European part of
...
p.000235: to sustain public attention to staple points of humanism in medical practice.
p.000235: In the 60-70’s the interest towards medical deontology grew. Five All- Soviet Union conferences were devoted to the
p.000235: issues of medical deontology, first of which took place in Moscow on January, 28-29 in 1969. One could then observe a
p.000235: singular outburst of publications on aspects of deontology in different fields. A two volume manual “Deontology
p.000235: in Medicine”, published in 1988 and edited by academician B.V. Petrovskiy exercised great influence.
p.000235: Management and funding in medicine and health care in the Soviet years were of centralized character and were
p.000235: characterized by well developed intrabranch links, which were mainly supported by administrative and
p.000235: bureaucratic type of management and planning gaining a narrow corporate nature and becoming almost unavailable to
p.000235: public control. A medical doctor became a civil servant, whose activities were regulated by great number of
p.000235: departmental guidelines and to a large scale were limited to drawing reports.
p.000235: Nevertheless, within relatively short time period based on virtually efficient grounds and principles of
p.000235: public health care system a coherent framework of medical, preventive treatment and epidemiological services was
p.000235: organized. Assessment of health care system developments was done primarily quantitatively, but qualitative data
p.000235: within this field showed impressive success. Many infectious fevers were eradicated, infant mortality drastically
p.000235: dropped, average life expectancy increased. Effectiveness of primary medical was distinguished by the
p.000235: medical community in 1978 during the WHO and UNICEF international conference in Alma-Ata (Kazakhstan).
p.000235: Many achievements in medicine and health care were made due to enthusiasm and responsible attitude of medical
p.000235: professionals, retaining ideas of self-denying and generosity in medical community, pursuit of classical ideas of
p.000235: medical ethics.
p.000235: Gradually in the 70-80’s in the society there started to occur shortcomings underpinned by lack of
p.000235: attention that the government paid to social spheres including health care, insufficient budget allocation that led to
p.000235: decline in provision of up-to-date technical equipment and medications, failure to comply with capital construction
p.000235: projects and health care facilities reconstruction plans, low and leveling salaries for medical staff, lack
p.000235: of opportunities to immediately apply recent developments of medical science,
p.000235:
p.000236: 236
p.000236:
p.000237: 237
p.000237:
p.000237: low availability of quality medical service and other. There were indicated adverse trends in public health, in medical
p.000237: and demographic values: drop in birth rate, growth in mortality rate, decrease of mean life expectancy.
p.000237: Retaining an essential principle of free medical care health care system found itself unable to meet the
p.000237: citizens’ needs in provision of high quality of service. Various forms of financing medical service started to be
p.000237: implemented. Apart from that the declared idea of free service brought up consumptive attitude to medicine among
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000029: A very important factor determining particularities and complexity of relationship development during a research
p.000029: process was characteristic for the entire medical community in the USSR paternalistic attitude among doctors
p.000029: and patients, peculiar standoff of health care professions (no public discussion on problems and errors, corporate
p.000029: spirit of medical workers) and strict vertical pattern of administration resulting in dependence of actions and making
p.000029: decisions.
p.000029: The common features being found at appearance and development of bioethics in the region are worth of specific
p.000029: attention. For a long time the region countries were out of global international dialogue on bioethics issues,
p.000029: therefore, they despite of their particular experience and specific approach to ethical issues in health care
p.000029: were not represented in the international bioethical society at a long run. Such isolation brought forth
p.000029: several considerable consequences: relatively poor development of major bioethical potential in the CIS countries and
p.000029: deficiency of capabilities for maintaining direct contacts with members of international bioethical community,
p.000029: in particular, due to limited knowledge of foreign languages for professional use and insufficient acquaintance with
p.000029: basic foreign publications.
p.000029: At the same time, within the community of the CIS countries there is a unique opportunity for international
p.000029: communication since not only majority of citizens but also specialists use a single instrument for communication, the
p.000029: Russian language. Development of bioethics in the CIS countries started about 20 years ago; one of the strongest
p.000029: impulses emerged after the first contacts of Soviet philosophers and medical researchers with their foreign colleagues
p.000029: at the end of the 1980’s. After the USSR break-up bioethics in the region developed in different conditions but, at
p.000029: that, there were present both stable cultural peculiarity and links among the region countries. The most important
p.000029: instrument influencing rates and pattern of the bioethics development is creation of special national facilities
p.000029: that having different structure and functions in some cases are entitled to adopt and implement mandatory decisions
p.000029: in the field of bioethics. Besides, all CIS countries have more or less main and similar resources for dynamic
p.000029: development of
p.000029: bioethics, and among them – teaching bioethics as a subject (mandatory or optional) in medical colleges and
p.000029: universities as well as at departments of philosophy in some of state universities; definite (though, in
p.000029: general, far from being sufficient) interest to ethical issues from the side of those working on legislation in the
p.000029: field of science and health care; development of corporate ethics and national associations on ethics;
p.000029: stimulating influence of research ethics; wider public interest to the bioethics issues being discussed in mass media.
...
p.000033: Constitution of Russia; P.1, Art. 36, Constitution of Moldova, etc.). Free development of a person is
p.000033: protected by law and independent court. Person dignity is acknowledged as a special value to be protected by the state
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
p.000033: state becomes a guarantor for protection of personal rights and freedoms. Other directions of the state
p.000033: policy in social sphere are also extremely important for provision of human rights in the area of health care and
p.000033: biomedical research.
p.000033: 9 The Constitution of Kyrgyz Republic also mentions psychological tests in this list (Art.18 of the Constitution of
p.000033: Kyrgyz Republic). Since there is almost no special legal regulations within the regions of the CIS countries for such
p.000033: sphere of biomedical research as psychological studies this fact has a special value. Such constitutional statement can
p.000033: become a basis for independent regulation of the given type of experiments.
p.000033: 10 Art. 16 and Art. 24 of the Constitutions of Kyrgyz Republic and the Republic of Moldova, respectively.
p.000033: The right for protection of health and its state support are legally fixed in all Commonwealth countries (Art. 34 of
p.000033: the Constitution of the Republic of Armenia, Art. 41 of the Constitution of the Republic of Azerbaijan, Art. 45 of the
p.000033: Constitution of the Republic of Belarus, Art. 37 of the Constitution of Georgia, Art. 29 of the Constitution of the
...
p.000037: subjects is played by the Code of Islam medical ethics. Countries with prevailing Orthodox religious tradition showed
p.000037: that a significant role for ethical consideration of medical science and practices is dedicated to Basics of the Social
p.000037: Concept of the Russian Orthodox Church (2000) containing official position on many of the most arguable bioethical
p.000037: issues.
p.000037: 15 For instance, The Code of Medical Ethics of Armenia, The Ethical Code of Medical Doctor of Georgia, The Ethical
p.000037: Code of Pharmacists of the Kyrgyz Republic, The Ethical Code of Nurse of Russia, The Oath of Medical Doctor of Russia,
p.000037: The Medical Ethics Code of Russia. In Uzbekistan the code on bioethics issues is under development, in Kazakhstan they
p.000037: started to develop The Code on National Health and the Health Care System, in 2007 it is planned to adopt The Ethical
p.000037: Code of Medical Doctor of the Republic of Kazakhstan.
p.000037: Features mentioned above illustrating specific properties of legal and ethical regulation are, mostly, in accord
p.000037: with general direction in legal development of the Commonwealth countries as socially-oriented states.
p.000037: Considering a social state as the most beneficial way for combination of fundamentals of freedom and power for
p.000037: provision of personal well-being and social wealth there is a real possibility for reaching social justice and
p.000037: solidarity. Translating the given point at the language of conflicts of interests that appear at the pace of scientific
p.000037: and technological progress in any sphere of human activities (including biology and medicine), one can notice
p.000037: crystallization of the main advantage of a social state being acknowledgement of the role of ethics for resolution of
p.000037: conflicts and interpretation of ethical principles as state control mechanisms.
p.000037: However, it is worth stressing that in order to protect social rights of citizens only legal mechanisms and procedures
p.000037: for prevention of breaching of these rights are far from being sufficient. Along with aforementioned versatile
p.000037: state activities aimed on development of conditions for execution of these rights and freedoms as well as readiness of
p.000037: society for their conscious perception and compliance are required.
p.000037: This process takes prolonged gradual movement on development of a complex mechanism for protection of
p.000037: human rights and constitutes of legal, administrative, economic and humanitarian means. Such objective is
p.000037: implemented in the most consistent fashion by the Inter-Parliamentary Assembly of the Commonwealth of Independent
p.000037: States, which as one of the main objectives takes development of mechanisms for interstate regulation of respect for
p.000037: human rights in the region. IPA CIS as an agency for inter- parliamentary cooperation accumulates information on
p.000037: political, economic, social and cultural, ecological, demographic and other constituents of life of the Commonwealth
...
p.000089: Garni.
p.000089: Adoption of Christianity (III century) imparted new content and new trends to Armenian art. Antique steles were
p.000089: transformed into an entirely new sculpture style: “khachkary” (cross stones). These marvelous stone plates with tracery
p.000089: all over the surface surrounding carved crosses were erected as headstones or in honor of outstanding people or events.
p.000089: In medieval Armenian painting, alongside with frescoes, book illustrations (miniatures) are of great value. We find
p.000089: them in thousands of manuscripts starting from the VI century. Highly developed and widely spread art of
p.000089: Armenian miniature had its Centres (Van, Cilicia, Gladzor et al.). There were original schools representing different
p.000089: trends of one national style. Among miniaturists Toros Roslin (the XIII century) was particularly famous, in whose
p.000089: miniatures one may see many features of the Renaissance art.
p.000089: Armenian classical medicine that emerged in the great antiquity based on the experience of folk medicine during its
p.000089: centuries-old history had come a long way from empiricism to scientific knowledge. Being closely connected at the dawn
p.000089: of its development with the experience of traditional systems of the East (Mesopotamia, Egypt and India), later, in the
p.000089: period of establishing scientific basics of medicine, Armenian classical medicine had a beneficial impact from
p.000089: antique science. The influence of antique philosophers and physicians (Plato, Aristotle, Empedocles,
p.000089: Hippocrates and Galen) on the development of Armenian classical medicine was particularly strong. Due to the active
p.000089: translation from Greek language, during the period of the V- VII centuries texts of antique scientists had been
p.000089: translated into Armenian. Those texts inspired medieval Armenian physicians and naturalists, e.g. Grigor
p.000089: Magistros (X-XI c.), Mekhitar Heratsi (XII c.), Amirdovlat Amasiatsi (XV c.) et al.
p.000089: It is noteworthy that great Armenian philosophers (David the Invincible, Anania Shirakatsi et al.) placed high
p.000089: emphasis on the problems of good and evil, suffering and compassion, life and death. They considered those issues
p.000089: in light of Christian morals. Today Armenian Apostolic Church is continuing this tradition. Suffice it to say,
p.000089: that the Ararat Eparchy with its rich experience in propagating ideas of bioethics is planning to establish a Church
p.000089: Public Council for Medical Ethics. Armenian Apostolic Church takes a rather strict position on some problems of
p.000089: bioethics: it prohibits human cloning and cloning of human organs, euthanasia, artificial fertilization and abortion,
p.000089: which is considered as infringement of human life.
p.000089: In this context the views of David Anhaght (the Invincible) formulated in his works (“Definition of Philosophy”,
p.000089: “Commentary on Aristotle’s Analytics” and “Commentary on Porphyry’s Introduction”) are of much interest.
p.000089: David Anhaght took problems of medical ethics very much to heart. His ideas on the value of human life are of
p.000089: particular importance. In his book “Definition of Medicine” he mentioned views of the Stoics who tended to justify
p.000089: suicide under certain conditions: starvation, loss of close relatives, natural cataclysms, violation of human dignity,
...
p.000093: human beings to the study of the role and place of the human being in the context of biological reality and the
p.000093: estimate of the status of life and death categories.
p.000093:
p.000094: 94
p.000094:
p.000095: 95
p.000095:
p.000095: In the beginning bioethics was taught only to students who were citizens of Armenia, but since 2003
p.000095: also to foreign students. The most important stimulus for introducing basics of bioethics into the syllabus was an
p.000095: essential need to harmonize our education programmes with international standards of education. Republic of Armenia
p.000095: enters the Council of Europe, and, accordingly, takes an active part in the work of its social and legal, healthcare,
p.000095: economical and culturological structures.
p.000095: At Yerevan State University lectures on bioethics are read in the first year at all faculties. Unfortunately, during
p.000095: last two years the time assigned for bioethics was reduced from 36 to 17 hours. Besides, now bioethics is an elective
p.000095: course for citizens of Armenia, while it is a compulsory discipline for foreign students (Russian- and
p.000095: English-speaking students from 18 countries). Thus, since the academic year 2006-2007 bioethics is included into the
p.000095: list of elective courses, and hence a number of students get their medical diplomas without training in bioethics.
p.000095: During the last two years the Chair of Social Sciences did its best in providing students with necessary teaching
p.000095: materials. Most of them were received from the Russian Federation, Belarus and Israel. However, as the new generation
p.000095: of students does not know either Russian or English language well enough, there is an urgent need for teaching
p.000095: materials on bioethics in Armenian language. The Department of Social Sciences has developed a brief course on
p.000095: bioethics in Armenian language. The course aims at:
p.000095: - providing students with some fundamental knowledge on the essence and principal problems of bioethics so that
p.000095: they would be capable to comprehend problems of life and death, health and life;
p.000095: - acquainting future physicians with moral aspects of topical problems of modern medicine and biomedical research
p.000095: associated with the application of modern technologies.
p.000095: The Manual has the following distinctive features:
p.000095: 1. It contains views and ideas of medieval Armenian thinkers, philosophers and physicians relating to
p.000095: the problems of life and death, good and evil, etc. In particular, it presents views of David Anhaght whose 1500th
p.000095: anniversary was celebrated by UNESCO in 1980 in Saloniki (Greece) and Yerevan.
p.000095: 2. It should be noted that the Manual presents results of sociological research on some issues conducted among
p.000095: the University students and
p.000095: teaching staff. The research was initiated by the Centre for the Study of Public Opinion on Bioethics
p.000095: Problems at the Chair of Social Sciences. It allowed the authors to enrich the theoretical material with the
p.000095: results of sociological studies.
p.000095: 3. The Supplement includes main legislative acts adopted not only by the international community but also by the
p.000095: National Assembly of Republic of Armenia.
p.000095: 4. The Supplement also contains different tests and questionnaires for the self-analysis, so that students could test
p.000095: to what extent they are morally and physiologically ready to follow rules and requirements of modern
p.000095: bioethics. Besides, there are Case Studies arousing lively discussions. Prof.
p.000095: A. Karmy from Israel kindly sent these Case Studies to us.
...
p.000095: framework of international student conferences, the Medical University organized round table
p.000095: discussions. In 2001 and 2003 two international student conferences on the fundamental principles and norms of
p.000095: bioethics were held. The majority of both foreign and Armenian students for the first time began to learn
p.000095: elements of bioethics. For a more comprehensive study of such topics as patient—physician relationship, the
p.000095: culture of physician’s speech and professional communication, compulsory hospitalization, etc., we give several
p.000095: lectures in Yerevan theatres instead of University lecture halls. These theatres show specially and only
p.000095: for our students, such plays as “Psychosis” and “The Street-Car Named Desire” (Sandukian Academic Theatre),
p.000095: “The Dentist from the East” (Akop Paronian Theatre of Musical Comedy) and “Physiology of Family” (Malian Theatre). Each
p.000095: performance is followed by a vivid discussion with actors and directors, and after that students write their essays
p.000095: on a suggested topic. In addition to theatre performances, students are invited to watch relevant films
p.000095: (documentaries and feature films).
p.000095: Together with the Institute of Philosophy, Sociology and Law of the Academy of Science of Republic of Armenia
p.000095: our Chair is writing a brochure “Albert Schweizer: A Great Humanist”. We also prepare for publication the glossary on
p.000095: bioethics in Armenian language. We give a special attention to practical aspects of teaching bioethics. Thus we began
p.000095: to design special training programmes on bioethics for students of medical institutes in Armenia.
p.000095:
p.000096: 96
p.000096:
p.000097: 97
p.000097:
p.000097: TV programmes on cloning, euthanasia and other problems with participation of associate professor S.Davtyan
p.000097: evoked a wide public response. If we manage to resolve the problem of sponsorship in the nearest future, we shall
p.000097: be able to give a series of TV programmes on topical issues of bioethics. This would facilitate a more active
p.000097: propagation of bioethical knowledge in various strata of Armenian society. UNESCO Office in Yerevan may
p.000097: participate in financing of the projects.
p.000097: Despite all this work a considerable part of Armenian medical community are skeptical about bioethics.
p.000097: Some physicians and University professors believe that teaching bioethics is something needless, to put it mildly.
p.000097: Apart from implicit forms of discrediting teaching of bioethics, there are cases when lecturers openly tell students
p.000097: that there is no need to study bioethics, which, actually, creates the atmosphere of dislike and distrust for the
p.000097: discipline, and puts a psychological barrier between students and the teaching staff.
p.000097: Another problem is a shortage of young teachers who might lecture in English, Russian and Armenian and the
p.000097: absence of a system for training specialists on bioethics.
p.000097: In the period from September 2004 until February 2005 the Society for Bioethics Development of Republic of Armenia
p.000097: implemented the project aiming at acquainting medical community of Armenia with the principles and norms of
p.000097: bioethics. The Democracy Committee of the USA Embassy in Armenia sponsored the project. Within the framework of the
p.000097: project, the Committee published brochures in Armenian language distributed in the medical community and made
p.000097: a 30-minute publicistic film demonstrated on two national TV channels. At the same time specialists from
p.000097: Society for Bioethics Development held seminars where explained norms and principles of bioethics, discussed
p.000097: specific bioethical problems and focused the attention of the medical community on different bioethical issues. It is
p.000097: necessary to underline that this programme was developed according to recommendations of this fund. The main
p.000097: idea of the project was to develop foundations of democratic society and to raise the level of legal competence in the
p.000097: medical community and in public at large.
p.000097: Results of the research in the medical community (1600 participants from all regional municipal clinics in Armenia and
p.000097: Yerevan) revealed the scarcity of information on bioethics and the fact that the interest to bioethical
p.000097: problems rose sharply after the seminars. However, it is necessary to mention that literature on bioethics is
p.000097: available, if any, only in Russian and in English, which essentially hampers the access to information on bioethics for
p.000097: the medical community.
p.000097: Unfortunately, our experience shows that with regard to financing of different programs (international grants) Armenia
p.000097: is currently outside the zone of interests of donor organizations, while funds functioning in Armenia have mandates
p.000097: that do not correspond to our goals and tasks. Personal initiatives are also unrealizable for technical
p.000097: or financial reasons (e.g. implementation of a programme, attending international training seminars and conferences,
p.000097: etc.).
p.000097: It would be reasonable that The Division of Science and Technology Ethics within the Social and Human Sciences Sector
p.000097: at UNESCO did not confine its activity to providing information for national ethics and bioethics committees, but also
p.000097: furnished a financial support for our organization and for implementation of training courses as well as for
p.000097: publication of teaching materials on bioethics in Armenian language.
p.000097: It is clear that the development of teaching programmes on bioethics and research ethics in Armenia should be adapted
p.000097: to its national, social and spiritual traditions and its healthcare system. At the same time, it should correlate with
p.000097: actual models of modern bioethics, and therefore we make steps towards integrating Yerevan Medical University
p.000097: named after M. Heratsi into the system of UNESCO International Committee for Medical Schools.
p.000097: Universityadministrationdoesitsbestforinternationalacknowledgement of our University as a member of UNESCO
p.000097: International Committee for medical Schools by introducing new disciplines, including bioethics, into the syllabus. It
p.000097: would be expedient that out lecturers and professors could have a financial support to participate in the work of
p.000097: international conferences and seminars on bioethics.
p.000097: We would like to emphasize that here we mentioned only some of the most acute problems of teaching bioethics in
p.000097: Armenian medical institutes. However, this is enough to conclude that bioethics needs more attention from
p.000097: Health Ministry and Ministry of Education of Republic of Armenia, and from the Armenian Institute of Protection of
p.000097: Human Rights.
p.000097:
p.000098: 98
p.000098:
p.000099: 99
p.000099:
p.000099: 3.1.4 The System of Ethical Review
p.000099:
p.000099: In its activity Ethics Committee of Health Ministry of Armenia is guider by “The Order of Conducting Clinical
p.000099: Trials of New Drugs in Republic Armenia” approved by the Decree of Armenian Government (No 63, 24 of January
...
p.000099: about an unwarranted risk. Ethics Committee has the right to reject the planned research if it repeats a similar
p.000099: research, and yields no new results.
p.000099: Risk/benefit balance. The main ethical requirement for clinical trials of new drugs is to gain benefit with the
p.000099: minimum risk for the patient. It is necessary to monitor clinical trials, and register all complications, not only
p.000099: physical but such as discomfort, invasion of participant’s privacy, etc. In many cases risks are unavoidable, but it
p.000099: must be minimum and under control.
p.000099: Informed consent. The main method of protecting the individual involved in the clinical trial is his/her
p.000099: informed consent and its approval by Ethics Committee.
p.000099: The procedure of obtaining informed consent is evaluated with regard to the following requirements:
p.000099: - the potential clinical trial participant must be provided with comprehensive information on the
p.000099: goals, methods, nature of the clinical trial and its expected results, as well as on recommended and alternative
p.000099: treatment and patients’ rights and measures for their protection; information should be given in a clear and
p.000099: understandable language;
p.000099: - the potential participant must not be coerced to participate in the clinical trial;
p.000099: - the potential participant must know that he/she may refuse to participate or voluntarily withdraw at any time without
p.000099: any harmful repercussions;
p.000099: - the clinical trial participant should receive all information that appears during the course of the trial.
p.000099: The clinical trial participant should be also informed about verification of reliability of his/her personal data by
p.000099: official persons or sponsors, and
p.000099:
p.000100: 100
p.000100:
p.000101: 101
p.000101:
p.000101: his/her consent should be sought (the right for confidentiality of personal information).
p.000101: If the clinical trial participant is unable to give his/her personal consent Ethics committee agrees to the following
p.000101: procedure: the consent form should be signed be the participant’s legal representative.
p.000101: In addition to that, Ethics Committee of Health Ministry of Republic of Armenia is obliged to review all amendments to
p.000101: the Protocol and to consider all cases of unfavorable events and changes of ethical aspects of the clinical trial.
p.000101: Ethics Committee of Health Ministry of Republic of Armenia has the right to invite independent consultants without
p.000101: granting them the right to vote.
p.000101: The procedure of decision-making in Armenia has several stages. At the first stage the documents relating to the
...
p.000179: m above the sea level. According to 1999 census, the population is 4.8 million people including 3.1 million of
p.000179: ethnic Kyrgyz. About one third of Kyrgyzstan population (35%) lives in urban areas and 65% are rural population
p.000179: (1999).
p.000179: Kyrgyzstan is a multinational unitary state. The country is divided into seven administrative regions: Batken,
p.000179: Zhalal-Abad, Naryn, Osh, Talass, Chuisk, Issyk-Kul. The capital of Kyrgyz Republic is Bishkek, the form of
p.000179: government – republic.
p.000179: The land of Kyrgyzstan, like all Central Asia, is one of the most ancient places of human civilization. Archeological
p.000179: studies show that primitive men settled there in the time of the Stone Age. Kyrgyz ethnos that was known in Central
p.000179: Asia since the first millennium BC retained its self-name to our time. First politically organized communities in the
p.000179: territory of the present-
p.000179: day Kyrgyzstan appeared in the II century BC when southern agricultural regions joined the State of Parkan.
p.000179: During the IV and III centuries BC early Kyrgyz formed part of powerful unions of nomadic tribes that were a
p.000179: serious problem for China. It was the time when the Great Wall of China began to be built. During the II and I
p.000179: centuries BC a part of Kyrgyz tribes got away from the power of Hunnu State and moved to Enisei (the Kyrzys meaning of
p.000179: “Ene-sai” is the Mother-River) and Baikal (Rich Lake) regions. There they founded their first state Kyrgyz Kaganat that
p.000179: became the centre of the Kyrgyz consolidation and the centre of their culture where their written language
p.000179: developed. Runic inscriptions still can be seen on stone monuments. Invaders destroyed the state but they could not
p.000179: destroy people’s memory, although the written language was lost.
p.000179: During the V century the transition from nomadic to settled lifestyle began in the North of Kyrgyzstan. First written
p.000179: sources mentioning Kyrgyz tribes inhabiting Tian Shan date back to the X century.
p.000179: Petroglyphs of Saimaly Tash, one of the oldest and biggest collections of rock pictures, demonstrate a high level of
p.000179: Kyrgyz civilization. The Burana Tower and Uzgen architecture complex are examples of an amazing mastery of architects
p.000179: and builders.
p.000179: From the middle of the IX century to the beginning of the X century AD the Great Kyrgyz Khanate extended to the South
p.000179: Siberia, Mongolia, Baikal, the Upper Irtysh, Issyk Kul and Talas. This period was not only the time of conquests but
p.000179: also time of an active trade with China, Tibet and peoples of South Siberia and Central Asia. It was the period when
p.000179: after defeating the Uighur Kaganat the Kyrgyz for the first time entered the Tian Shan territory. In the X century,
p.000179: however, the Kyrgyz domination had shrunk to South Siberia, Altai and South-West of Mongolia and in the XI and
p.000179: XIIcenturies to Altai and Sayan Mountains. Nevertheless, parts of Kyrgyz tribes scattered over a large territory
p.000179: participated actively in numerous historical events in Central Asia. They managed to keep their ethnic
p.000179: independence and became the centre of attraction for other ethnic groups. The final stage of ethnogenesis related
p.000179: Kyrgyz people to Oirot (Kalmats), Naiman and other peoples of Central Asia.
p.000179: Starting from the XIII century Kyrgyz people had to fight wars of independence from different invaders. In
p.000179: the second half of the XV century Kyrgyz tribes joined in an independent khanate that embraced a major part of Kyrgyz
p.000179: people. The Great Silk Road was very important for Kyrgyzstan. The town of Osh – the main city in the south of the
p.000179: present-day Kyrgyzstan
p.000179: – due to its favorable geographic location was a transit town in the Fergana line of the Great Silk Road.
p.000179: In 1863 the North Kyrgyzstan and in 1876 the South Kyrgyzstan were incorporated into the Russian Empire. After the
p.000179: Great October Revolution Kyrgyz people, as other peoples of former tsarist Russia entered the Soviet Republic
p.000179: In 1918 Kyrgyzstan formed a part of Turkistan Autonomous Soviet Socialist Republic. In 1924 the Kara-Kyrgyz
p.000179: Autonomous Region within the Russian SFSR was established. In 1926 it was transformed into the Kyrgyz Autonomous
p.000179: Republic, and in 1936 – into the Kyrgyz Republic. On 31 of August 1999, Kyrgyzstan declared its independence.
p.000179: We know that myths and legends form the base of every culture. Nomadic life-style and the loss of written
p.000179: language of early Kyrgyz people
p.000179:
p.000180: 180
p.000180:
p.000181: 181
p.000181:
p.000181: stimulated the rise of a special philosophy that revealed itself in poetic folklore. It has accumulated the
p.000181: basic problems of human existence, mental and philosophic activity and spirituality.
p.000181: To reconstruct spiritual life of the Kyrgyz ancestors, we should mention an epic poem “Manas” that depicted
p.000181: historical events and ethnographic details, different aspects of the Kyrgyz life, worldview and national outlook
p.000181: from the III century BC (the Hunnu period) and to the beginning of the XX century. As a concentrated representation
p.000181: of folk philosophy, “Manas” is both the result of creative thinking across generations and the evidence of ancient
p.000181: Kyrgyz civilization. In fact, “Manas” is a moral code of the nomads and still a source of morals and humanism,
p.000181: as it describes customs and moral traditions, philosophical and aesthetic views, moral principles and norms
p.000181: of behaviour. With regard to its moral significance, “Manas” may be compared to Confucian Pentateuch. Like
p.000181: Confucian ethics, “Manas” depicts a model of putting the world into good order. Much attention is given
p.000181: to the struggle against chaos, which is expressed through regulation of human relationships, i.e. by establishing norms
p.000181: of behaviour, the system of prohibitions and social stratification.
p.000181: “Manas” is called a “cultural encyclopedia” of Kyrgyz people. It ranks among outstanding monuments of world
...
p.000195: with 1.1 mln inhabitants. The largest cities of the country are Tiraspol, Beltsy (Bălţi), Bendery.
p.000195: Getae (Dacians) and Romans are considered to be ancestors of local ethnos. Thracians were ancestors of Dacians. They
p.000195: inhabited a wide-spreading territory from the Aegean Sea to upstream of the Dniester River, from the Bug to the Tisza.
p.000195: Thracian tribes of the north Danube were called Dacians; Romans called them Dacians and Greeks – Getaes. We draw
p.000195: information on cultural life of Dacians from multiple archaeological sources and evidences of outstanding persons of
p.000195: the ancient world (Herodotus, Strabo, Thucydides, Plato, Joseph Flavius, Dio Cassius, Jordanes etc.). Farming
p.000195: was a prime activity of the Dacians. 72 fortresses were discovered.
p.000195: The Dacians had medical concept according to which at treating it was necessary to take into consideration the state of
p.000195: a body in general, including mental state. Their medical knowledge for that period was excellent.
p.000195: 4 large Dacian communities existed in the first part of the 2nd century
p.000195: B.C. Each community had the army and institution of money. The union and strengthening of Dacia happened in the
p.000195: time of king Burebista (+80
p.000195: - 44 B.C.) Dechebal (87-106) was the last Dacian king. In 106 Dacia was conquered by the Romans and turned to be a
p.000195: province. That was the last province of the Roman Empire. It was followed by Roman epoch (106-
p.000195: 271) with the Romanization of Dacian population, the Latinization of the
p.000195: language and evangelization. There was the ethnogenesis of Romanians (from “Romans”) later.
p.000195: Development of feudal relationship was attested in the X century. Three principalities were formed in the one-time
p.000195: Dacian territory: Transylvania, which felt under the reign of Hungarians (Hungarians are Finno-Ugric trans- Ural tribes
p.000195: settled here by the end of the IX century) in the beginning of the X century, Ţara Românească (or Walachia, Muntenia);
p.000195: Ţara Moldovei. The first written diplomas mentioning political and military strength of Ţara Românească and
p.000195: Moldova are referred to the years 1330 and 1359, respectively.
p.000195: During the Middle Age Moldova kept suffering from raids of the Tatars, the Turks, the Hungarians and the Poles.
p.000195: Historical Moldova covered the territory between Eastern Carpathians, woody Carpathians, the Dniester, the Black
p.000195: Sea and the Danube under Roman 1 of Moldavia (1392-1394). Geographic location of the territory was favorable as
p.000195: to the nature and life resources and at the same time unfavorable as to geopolitical strategic aspect. The country
p.000195: was located in the strategic pass connecting Eastern and Western Europe, being situated between the Carpathians and the
p.000195: Black Sea. The Silk Road, i.e. the longest commercial route connecting the Far East with the western European countries
p.000195: was there in the Middle Age. Since the first centuries AD and until now great states, trying to preserve the influence
...
p.000222: 222
p.000222:
p.000223: 223
p.000223:
p.000223: had the great influence on formation of the Russian national character. Humanity, placability and openness
p.000223: of our ancestors soul were formed under the influence of their main activities such as arable farming, cattle
p.000223: breeding and workmanship, and of community social order, which had been lasting longer then at other peoples. Among
p.000223: values of community it should be mentioned justice, power of “world”, thrifty housekeeping, knowing of folk wisdom,
p.000223: bogatyr (a Russian hero) strength, etc. Having given voluntary his destiny over to the community, man condemned himself
p.000223: to be tolerant and obedient. The community, by means of which the Russian people were able to keep their ethnos
p.000223: independent in spite of numerous invasions, had also the high value. For the sake of the community a Russian was ready
p.000223: to suffer, tolerate and sacrifice almost everything. Nevertheless, historical facts demonstrated examples of “Slavic
p.000223: freedom” from Cossacks, drinking- bouts, revelries, disorder, “fantastically fast life” to rebel and revolutions.
p.000223: The Russian culture is well known to exist inasmuch as Russian (and Old Russian) words meaning cultural
p.000223: contents exist. Contemporary analysis of the word “personality” (autonomy of “personality” is one of the
p.000223: principles of bioethics) in Russian and European languages showed that word “personality” is rather young
p.000223: for the Russian language, it was absent in the Old Russian language and in the modern Russian it handed its
p.000223: meaning to word “person” (15). As regards the notion “individuality” it has been adopted slowly and hardly in modern
p.000223: word usage. This fact differs Russia from Western Europe where individuality became the main value of the Modern time.
p.000223: The idea of person, personality itself began to form here in XIII century. And today in Western Europe the notion of
p.000223: personality is central, important as daily bread, and it is not high but everyday, though in Russia the word
p.000223: “personality” is in one row with the high notions and its meanings are not everyday.
p.000223: Speaking about language as means of communication one should note one more feature which is important for
p.000223: doctor-patient relations. The Russian language in contrast with the Romance and German languages is synthetic, not
p.000223: analytical, i.e. it may be axiomatizated hardly but is able to express emotions and feelings (22,27).
p.000223: Folk proverbs are very important feature of ethnos awareness and national mentality. They accumulate important
p.000223: conclusions and observations about nature and society laws. Many of them assert group priority over
p.000223: personality, collective things priority over individual, necessity to obey any group law. Man strength is in his group
p.000223: membership, whilst his personnel responsibility is vogue (25).
p.000223: Russians were characterized to have many interethnic contacts with people of different origin, cultural
p.000223: traditions and language that influenced undoubtedly the general Slavic culture foundation. Connections with
p.000223: Byzantine, a godmother and keeper of ancient civilization where Orthodoxy became a state religion, were the most
p.000223: fruitful for the Old Russian culture. Together with adoption of Christianity a Byzantine philosophy related to the
p.000223: Plato’s Hellenism, which gave it anthropological and historiosophy orientation, had penetrated to
p.000223: Russia. Anthropocentrism of Russian philosophical researches became one of characteristic principles of Russian
p.000223: philosophy. From Nil Sorskiy to A.N.Radischev, from Radischev to Soloviev and Berdiaev a Russian thought has been
p.000223: always attracted by cognition of mystery of person, his death and immortality (3). The Russian philosophy created
p.000223: “philosophy of life” long before birth of western European existentialism and pragmatism. Peculiarity
p.000223: of the Russian philosophy is in the fact that the Russian thought has always been (and will be forever) connected with
p.000223: its religion element and grounding and inspiration of freedom valued at any time by Russian minds had never died inside
p.000223: of church awareness. First of all everywhere dominance of morality evidences that. We can see it in works of nearly all
p.000223: Russian thinkers even those who had no works devoted to moral problems.
...
p.000281: its independence.
p.000281: Tajikistan is a mountainous landlocked country in Central Asia. Afghanistan borders to the south,
p.000281: Uzbekistan to the west, Kyrgyzstan to the North, and China to the east. The total area of Tajikistan Republic is
p.000281: 143.1 thousands of square km, and it has a population of 7,163,506 citizens. Tajikistan consists of 4 administrative
p.000281: divisions: 2 provinces (Sughd in the north and Khatlon in the south), 1 autonomous province (Gorno-Badakhshan
p.000281: - Pamir), and disrtricts of republican subordination around Dushanbe.
p.000281: Tajikistan is an agrarian-industrial country and has a considerable potential. Lengthy wars caused
p.000281: devastations and human losses, which resulted in a dramatic economic recession. However, during the last peaceful
p.000281: years the economics and living standard have notably increased.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000283: 283
p.000283:
p.000283: The Tajik people have a rich and ancient culture. Since antiquity to the period of feudalism moral and
p.000283: ethical issues took an important place in religious and philosophical outlook. Until the IX century it had
p.000283: been developing in the context of Iranian philosophy, and later, since the 9th to the XV century in the
p.000283: context of Arabic philosophy. Due to the ethnic, language, social and political commonality in antiquity and the early
p.000283: Middle Ages particularly close relations were between East-Iranian (ancestors of the Tajiks) and West-Iranian
p.000283: (ancestors of the Persians) people. The Tajik- Persian philosophical thought had also a connection with Indian and
p.000283: Greek philosophy. However the closest links connected the Tajik culture and spiritual and philosophic outlook
p.000283: with cultures of Turkic peoples of Central Asia and Azerbaijan. There was a mutual enrichment of cultures, spiritual
p.000283: values and scientific achievements.
p.000283: Religious and philosophical ideas of Tajik ancestors roots back to an ancient monument of spiritual
p.000283: culture “Avesta” the holy canon of Zoroastrism (Mazdeism) containing not only religious dogmas but also
p.000283: ideas on cosmogony, philosophy, morals and law. The characteristic feature of Zoroastrianism is dualism, i.e. the view
p.000283: that two fundamental concepts exist, such as good and evil, and the struggle between these is the pivot and content of
p.000283: the universe. Zoroastrianism formulated a ternary ideal of the righteous man (“good thoughts”, “good words” and
p.000283: “good deeds”) opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked words” and “wicked deeds”). The
p.000283: Zoroastrian idea about infinite time as an initial substance gave rise to zervanism – a teaching in the framework of
...
p.000283: feudalism, Manichaeism (Mani, 215-276) and Mazdakism (Mazdak, the end of the V - the beginning of the VI century)
p.000283: became very influential. Those philosophical trends assimilated the Zoroastrian ideal about the struggle
p.000283: between the good and the evil. The social doctrine of Mazdakism proclaimed ideas of justice and equality.
p.000283: The earliest written evidence that peoples of Central Asia had a good knowledge of mathematics and astronomy is
p.000283: “Avesta” containing data on the movement of celestial bodies, the system of time count and some mathematical rules.
p.000283: In that period, early states in Central Asia achieved a high
p.000283: level of material production and culture: crafts, agriculture, architecture and art. That was the time when many
p.000283: written monuments of religious, political and scientific thought were created, many of which were destroyed during the
p.000283: invasion of the army of the Arab Caliphate (VII-VIII centuries).
p.000283: During the VIII-XV centuries philosophical, social and political ideas were developing in the atmosphere of
p.000283: Arabian conquests and a forcible spreading of Islam. Spiritual cultures of Iranian and Arabic peoples became most
p.000283: closely linked. During the VIII-IX centuries, in Maverannahr (the right bank of Amudarya) and Khorosan the tendency to
p.000283: the territorial, language and cultural integration broken by the Arabian conquest had been growing. During the period
p.000283: of the Samanids rule (874-1005 AD), the Tajiks developed as a nation with its State system and
p.000283: literary language. In the IX-XI centuries, Central Asia was one of the most important centres of oriental
p.000283: science. That was the time when astronomical observatories, “Houses of Wisdom” and libraries were built.
p.000283: Scientists from Central Asia translated and commented the scientific heritage of ancient Greece and India and
p.000283: wrote original works on mathematics, astronomy, mineralogy, applied mechanics, physics, chemistry and medicine.
p.000283: Mohammed ibn Musa al-Khorezmi, Abdul Marvazi, Usman Balhi al-Fergani (IX c.), Abul-Vefa al-Buzjani, Abulmahmud Hudjani
p.000283: (X c.) and many others made an essential contribution to science. In the XI-XIV centuries Khorezm, Bukhara,
p.000283: Merv, Gazna and other towns, and later, in the XV century, Samarkand with the Ulugbek’s observatory,
p.000283: were outstanding scientific centres. The names of Biruni (X-XI c.), Omar Khayyam (XI-XII c.), al-Djurjani
p.000283: (XII c.), Naseeruddin Tusi, Shamsiddine Samarkandi, Djamaleddine Bukhoroi, Alishakh Buhoroi (XIIc.), Mohammed
p.000283: Samarkandi, Ansori (XIV c.) and others are associated with medieval towns. The leading scientists of the
p.000283: Samarkand scientific school were Kazi-zade ar-Rumi, Djemshid al-Kashi
p.000283: (XIV-XV c.), Ali Kushchi (XV c.), Abu Ali Ibn Sina and others.
p.000283: Ethics as a scientific trend had a significant place in works of prominent oriental thinkers, and Ali Ibn Sina
p.000283: (Abu Ali al-Husain ibn Sina-e Balkhi (Latinized Avicenna) one of them; a philosopher, musician, poet, physician,
p.000283: the follower of Aristotle, he was a scientist of encyclopaedic knowledge and one of the greatest minds of the Middle
...
p.000309: Since 2004 the Department of Valeology at the Faculty of Philosophy of Kharkov National University named after
p.000309: V.Karazin has been offering a special course “Bioethics as the Ethics of Health” (90 hours). The course
p.000309: was designed for students of the 2nd year who are trained as teachers in valeology. At all faculties of Kharkov
p.000309: Medical University bioethics is taught as an elective seminar course. Kharkov Zoo-Veterinary Academy has a
p.000309: noteworthy experience of teaching bioethics based on the use of alternative methods of studying anatomy and physiology
p.000309: of human beings and animals.
p.000309: At Vinnitsa National Medical University named after N.I. Pirogov bioethics is taught to students of the 3rd
p.000309: year (Faculty of Dentistry, 27h) and to students of the 5th year (Faculty of Pharmacology, 54 h). Both courses end with
p.000309: a test. Bioethics is also taught at institutes of higher education in Dnepropetrovsk, Zaporozhye, Lugansk, Odessa,
p.000309: Poltava, Sumy et al.
p.000309: Different public associations play an essential role in distribution of bioethical knowledge - such as
p.000309: All-Ukraine Public Organization “Ukraine Association on Bioethics”; Kiev Ecological and Cultural Centre; Kharkov
p.000309: Regional Society for Animal Protection and others. Due to their efforts a number of foreign materials were translated
p.000309: into Ukrainian language, books and manuals on teaching bioethics were written to be used in Ukrainian
p.000309: universities and institutes.
p.000309: The existing experience of teaching bioethics at Ukrainian institutes of higher education allows us to draw the
p.000309: following conclusions.
p.000309: The introduction of courses in bioethics in Ukraine, as in other post- soviet countries, is complicated by the fact
p.000309: that for a long time scientists and teachers had no opportunity to study foreign materials on the subject. The lack of
p.000309: home studies in the field of bioethics and the lack of comprehensive knowledge on theoretical, methodological,
p.000309: historical and cultural contexts of the development of bioethical discourse affects negatively the level and quality of
p.000309: teaching bioethics.
p.000309: On the other hand, in Ukraine, as in other European countries, there is a tendency of teaching bioethics as an
p.000309: applied biomedical ethics of a narrow professional character. At UNESCO seminar on problems of
p.000309:
p.000310: 310
p.000310:
p.000311: 311
p.000311:
p.000311: teaching bioethics in East European countries (Moscow, January 2005) it was mentioned that 70% of those who teach
p.000311: bioethics are physicians with a classical medical education. Thus, the majority of bioethics teachers have not studied
p.000311: ethics as an independent or philosophical discipline, which certainly affects the general tendency of education in
...
p.000325: when a child does not realize the meaning of his/her actions. Abu Ali Ibn Sina believed that, irrespective of state and
p.000325: public benefits, a child should receive a good intellectual, moral and ethical education in the family and at school.
p.000325: In his works, Ali Abu Ibn Sina gave much attention to school education. Kind and well-educated teachers may only
p.000325: teach at school,
p.000325: where children are brought up and educated until the age of fourteen. A teacher should know well the subject
p.000325: he teaches; he should follow the moral principles and be an honest, loving and courageous person.
p.000325: In the system of Ibn Sina’s ethical views, a concept of mizaj implying the necessity of an entirely individual approach
p.000325: to each individual, irrespective of the person’s age of health condition and considering a unique combination of
p.000325: qualities on the individual and his/her living and working conditions.
p.000325: The knowledge of human nature and temperament is the basis of a physician’s strategy when maintaining a
p.000325: proper level of health, and, if need be, planning the therapy. A comprehensive study of the “Canon” helps us to tell a
p.000325: sanguine person from a phlegmatic one or a choleric person from a melancholy one, and to mark out characteristic
p.000325: biotypes. If we translate it into the language of modern bioethics, we can see clearly the logical construct of
p.000325: Hippocrates, Galen and Avicenna; treat not a disease but a person, and not just a person but also a biotype
p.000325: whose psychological responses are subordinate to its biological nature (mizaj), or temperament. Ages later Ivan
p.000325: Pavlov mentioned the biotypological approach used widely by Ibn Sina as a fruitful one, revealing “fundamental
p.000325: features” of human nature.
p.000325: Thus, “Canon of Medical Science” written in the times of the Oriental Renaissance, and very popular during the European
p.000325: Renaissance, nowadays, if profoundly studied, can contribute essentially to the theory of bioethics, and humanize
p.000325: modern medicine and healthcare. Fundamental ethical ideas of “Canon of Medical Science” uniting medicine and a worthy
p.000325: life in the philosophy of health are still topical nowadays. Moreover, it outruns, in many respects, our
p.000325: ideas on medical ethics. Indeed, Ibn Sina’s attempts to link problems of medicine with the mode of life and to create
p.000325: conditions for maintaining spiritual harmony throughout a person’s life are particularly significant nowadays.
p.000325: According Ibn Sina’s precepts, the physician should do not only his/her professional duties but also his/her moral duty
p.000325: (Kasymov
p.000325: A.I. Ethical Views of Abu Ali Ibn Sina (Avicenna). In: “Bioethics in Uzbekistan – Clinical, Philosophical
p.000325: and Legal Aspects.” Tashkent, 2006, pp. 57-62).
p.000325: In 2003, the Islamic Republic of Iran and UNESCO instituted the Avicenna prize for the development of modern
p.000325: bioethics in science. The role of Avicenna in the development of current bioethical views runs all through the book
...
p.000335: 2. Issues concerning an appropriate quality of medical assistance, its availability, social justice, equality and
p.000335: non-discrimination in healthcare are also essential.
p.000335: 3. It is necessary to create a model of patient—physician relationship that would imply cooperation and dialogue
p.000335: between two parties equal in rights based on the respect for a person’s autonomy.
p.000335: 4. A patient has certain rights the violation of which entails not only moral but also judicial responsibility.
p.000335: Appropriate sanctions should be applied to a physician in the event of a damage done to a patient that resulted from
p.000335: unqualified and careless actions.
p.000335: 5. In setting out principles of medical practice, we have to think not only about an individual’s rights and freedoms
p.000335: but also about his/her dignity and integrity. The concept of human integrity covers an individual’s genetic structures,
p.000335: intellect and psyche. Any medical intervention is only possible with a voluntary and informed consent obtained from a
p.000335: person.
p.000335: 6. A necessary condition for a medical intervention is a patient’s voluntary and informed consent. A
p.000335: voluntary consent implies that it has been
p.000335:
p.000336: 336
p.000336:
p.000337: 337
p.000337:
p.000337: obtained without deception, concealing information or pressure. Consent is informed when it is given by a person who
p.000337: has been informed, in a plain and understandable language, about the purpose and nature of the suggested intervention,
p.000337: its possible risks and alternative treatment methods.
p.000337: 7. It is necessary to define in national legislation the status of embryos at different stages of their
p.000337: development. The lack of legal regulation here opens up opportunities for their commercial use or for a groundless
p.000337: accusation of physicians studying embryos. We need laws on human reproduction, human genetic structures,
p.000337: confidentiality of information obtained in genetic testing, etc.
p.000337: 8. Any restrictions of rights and freedoms of a patient with socially dangerous diseases may only be introduced in
p.000337: compliance with laws, but not following subordinate legislation adopted by healthcare bodies.
p.000337: 9. To improve legislation referring to healthcare, it is essential to remove merely declarative norms having
p.000337: no mechanisms or procedures for their implementation. The lack of mechanisms and procedures for a practical
p.000337: implementation of legal regulations results in violation of patients’ rights, an insufficient level of healthcare
p.000337: system efficiency, and, consequently, lowers patients’ trust in healthcare reforms carried out by the State.
p.000337: In the light of the above said, the draft project of the Law “On Medical Practice” has been designed. Chapter III of
p.000337: the Law (Articles 29-50) defines patients’ rights and responsibilities:
p.000337: • Article 29 sets out provisions for implementing patients’ rights;
p.000337: • Article 30 declares patients’ right to life;
p.000337: • Article 31 states patients’ right to non-discrimination;
p.000337: • Article 32 states patients’ right to a free choice;
p.000337: • Article 33 ensures patients’ safety in the field of healthcare;
...
p.000353: In the field of development of bioethical education and training for members of ethical committees there
p.000353: is well established system of interregional cooperation. Significant contribution is made by creation of national
p.000353: UNESCO commissions in the region countries with common policy aimed on the following priorities:
p.000353: - access to information and intellectual exchange;
p.000353: - development of educational programs and approaches;
p.000353: - strengthening capacities of national agencies working on ethical issues;
p.000353: - implementation of ethical norms aimed on protection of human rights in the sphere of biomedicine;
p.000353: - improvement of information awareness and training in the sphere of bioethics;
p.000353: - distribution of knowledge on bioethics among professional and public groups including via mass media;
p.000353: - counseling and education to bioethics issues among social sphere facilities;
p.000353: - extension of availability of information about regulatory documents, human rights and procedures of their protection;
p.000353: - development of training programs on ethics and their integration into educational process.
p.000353: It is noteworthy that cooperation in this sphere becomes both bilateral and multilateral. Advantage of the region
p.000353: in this sphere is preservation of communication on one language and traditional mutual penetration of
p.000353: cultures and standards becoming a root system of information bases, educational materials and educational
p.000353: testing.
p.000353: Especially advantageous situation for cooperation is created in the sphere of development and
p.000353: establishment of the system of ethical examination. Simultaneous start of development of this field and
p.000353: unique support of the global community through establishment of the Forum for Ethics Committees in the CIS and
p.000353: inclusion of this region as a single constituent of the global WHO Project SIDCER provided permanent
p.000353: international dialogue on key issues of research ethics with international agencies leading in this sphere –
p.000353: such as WHO, the European Commission, the Council of Europe, UNESCO, the European Forum for Good Clinical Practice,
p.000353: the World Medical Association as well as authoritative national agencies: DHHS, USA and Ethics Committees of
p.000353: countries of all Continents. Such dialogue became a basis for experience exchange and real integration of ethical
p.000353: examination systems of the CIS countries into global discussion and research process.
p.000353: Integrity and value of cooperation with international organization is also presented with equal access for
...
Social / Marital Status
Searching for indicator single:
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p.000029: simply no time to highlight medical deontology issues.
p.000029: A very important factor determining particularities and complexity of relationship development during a research
p.000029: process was characteristic for the entire medical community in the USSR paternalistic attitude among doctors
p.000029: and patients, peculiar standoff of health care professions (no public discussion on problems and errors, corporate
p.000029: spirit of medical workers) and strict vertical pattern of administration resulting in dependence of actions and making
p.000029: decisions.
p.000029: The common features being found at appearance and development of bioethics in the region are worth of specific
p.000029: attention. For a long time the region countries were out of global international dialogue on bioethics issues,
p.000029: therefore, they despite of their particular experience and specific approach to ethical issues in health care
p.000029: were not represented in the international bioethical society at a long run. Such isolation brought forth
p.000029: several considerable consequences: relatively poor development of major bioethical potential in the CIS countries and
p.000029: deficiency of capabilities for maintaining direct contacts with members of international bioethical community,
p.000029: in particular, due to limited knowledge of foreign languages for professional use and insufficient acquaintance with
p.000029: basic foreign publications.
p.000029: At the same time, within the community of the CIS countries there is a unique opportunity for international
p.000029: communication since not only majority of citizens but also specialists use a single instrument for communication, the
p.000029: Russian language. Development of bioethics in the CIS countries started about 20 years ago; one of the strongest
p.000029: impulses emerged after the first contacts of Soviet philosophers and medical researchers with their foreign colleagues
p.000029: at the end of the 1980’s. After the USSR break-up bioethics in the region developed in different conditions but, at
p.000029: that, there were present both stable cultural peculiarity and links among the region countries. The most important
p.000029: instrument influencing rates and pattern of the bioethics development is creation of special national facilities
p.000029: that having different structure and functions in some cases are entitled to adopt and implement mandatory decisions
p.000029: in the field of bioethics. Besides, all CIS countries have more or less main and similar resources for dynamic
p.000029: development of
p.000029: bioethics, and among them – teaching bioethics as a subject (mandatory or optional) in medical colleges and
p.000029: universities as well as at departments of philosophy in some of state universities; definite (though, in
p.000029: general, far from being sufficient) interest to ethical issues from the side of those working on legislation in the
p.000029: field of science and health care; development of corporate ethics and national associations on ethics;
...
p.000029: advanced humanistic traditions of medicine and on capabilities for interaction and mutual influence of
p.000029: different cultures in the given territorial and historical space. Such specifics exist despite considerable cultural
p.000029: and religious differences between populations of European and Central-Asian countries of CIS. In particular, it
p.000029: is necessary to mention influence of religious traditions in the Commonwealth countries on forming of bioethics
p.000029: models currently acting there as well as models of research ethics. Likeness in perception of moral and cultural values
p.000029: is built on the fact that among population of the CIS countries (mostly it is related to the Russian population) one
p.000029: can meet representatives of virtually all ethnical, religious and cultural groups existing in the region in general. It
p.000029: means that multiplicity that can be observed within the CIS countries to some extent repeats multiplicity of population
p.000029: of separate countries that is especially characteristic for scientific and medical creative environment formed during
p.000029: many years.
p.000029: It is really hard to overestimate a role, which is played by the factor of involvement of all Commonwealth
p.000029: countries in the process of global international interaction, for creation of single approaches to collaboration
p.000029: in ethical and legal sphere. It is related both to incorporation by the new independent states into their legal systems
p.000029: of a set of international ethical and legal acts which they joined to during existence of a single country, the USSR,
p.000029: and to modern involvement of the CIS countries into international legal and informational environment. It appears to be
p.000029: of tremendous importance that officially each of the countries declared adherence to all major norms and principles
p.000029: stipulated by such international and legal documents as the Nuremberg Code of 1947, the Declaration of Helsinki of the
p.000029: World Medical
p.000029:
p.000030: 30
p.000030:
p.000031: 31
p.000031:
p.000031: Association (WMA) of 1964 with amendments, International Ethical Guidelines for Biomedical Research Involving
p.000031: Human Subjects developed by CIOMS and WHO in 1982 and amended in 1993 and 2000, International Guidelines for Ethical
p.000031: Review of Epidemiological Studies, CIOMS, 1991, Guidelines for Good Clinical Practice (ICH GCP), 1996;
p.000031: Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000) with additional document
p.000031: of 2002, Convention for the Protection of Human Rights and Dignity with Regard to the Application of
p.000031: Biology and Medicine: Convention of Human Rights and Biomedicine (Council of Europe, 1997) and adopted in addition
p.000031: thereof Additional Protocols including the Protocol on Biomedical Research, Universal Declaration on Bioethics and
p.000031: Human Rights (UNESCO, 2005), Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), International
p.000031: Declaration on Human Genetic Data (UNESCO, 2003) and a number of other documents which current total list includes
...
p.000049: Technoscience. – Perspectives on Science: Historical, Philosophical, Social. Vol. 13, Issue 2 – Technoscientific
p.000049: Productivity, Summer 2005, pp. 142-165). The most evident sign of technoscience is considerably more profound
p.000049: than before built-in pattern of scientific cognition into activities on development and promotion of new technologies.
p.000049: According to the German sociologist and political scientist, Wolf Schäfer: “Technoscience is a hybrid of science-based
p.000049: technology and technology-based science. Global phone communications and genetically modified products are
p.000049: para-scientific things: their invasion into our world is due to complex interweaving of particular human
p.000049: interests with modern understanding of electricity, on one hand, and genetics, on the other.” (W.Schäfer. Global
p.000049: technoscience: the dark matter of social theory.Univ. of Maryland conf. on globalizations, April 2002.
p.000049: www.bsos.umd.edu/socy/conference). Here, as you can see, our attention is drawn to the fact that technoscience is not
p.000049: only the tightest link between science and technology, but also such symbiosis that includes also human aspirations and
p.000049: interests.
p.000049: However, relationships of science and technique in this symbiosis are internally contradictive. On one
p.000049: hand, science is a generator of new technologies and due to stable demand on these new technologies science
p.000049: enjoys some, and sometimes quite generous support. On the other hand, production of new technologies dictates
p.000049: demand on science of specific, if you wish limited, single-sided type, therefore, many potentials of science being
p.000049: used this way are still outstanding. Roughly speaking, science is required neither to explain, nor to
p.000049: understand things – it is quite sufficient that it makes possible to alter them effectively.
p.000049: Besides, it assumes understanding of human cognitive activities including the scientific one, as an
p.000049: activity being secondary to some extent, subjected to practical transformation, changing of both the world
p.000049: around and a man. Thus, reminding the said above, there is an opportunity for rethinking, or, being more
p.000049: specific – reversion – of the balance of science and technology established before. If traditionally this balance was
p.000049: perceived as technological application, utilization by someone and at some time produced scientific knowledge, now it
p.000049: turns out that the very activity for obtaining of
p.000049:
p.000050: 50
p.000050:
p.000051: 51
p.000051:
p.000051: such knowledge is built in into processes of creation and development of these or those technologies.
p.000051: It is interesting not only how such transformations take place in reality but also how they are comprehended. On the
p.000051: surface things seem to be the same: it is proclaimed that science is a leading force of the technological progress
p.000051: that, in turn, uses scientific achievements.
p.000051: This is the background for realization that so-called applied science deals with those problems that are
p.000051: determined with the very development of technologies, and, along with that, such “servicing” science becomes
p.000051: determinative both as to quantitative and financial or other supplies, and as to social recognition. As we already
...
p.000053: most impressive are those symbols of the technical progress that are proportional to a man. One can relate to them
p.000053: growing versatility of information technologies that are implemented within the scale of a personal computer, and
p.000053: biomedical technologies that, as to their definition, are of the similar scale with a man and that today make possible
p.000053: manipulations with human genes at the molecular level. Moreover, in the nearest time more attention is started to be
p.000053: drawn to nanotechnologies that allows influencing processes and events taking place at the level of separate
p.000053: atoms. It is significant that one of the most important directions for nanotechnology development becomes a search
p.000053: for possibilities of using
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000055: 55
p.000055:
p.000055: them in biomedicine; also it is peculiar that, first of all, in this very aspect of their development appears within
p.000055: the sphere of ethical analysis.
p.000055: Thus, scientific and technological progress is more and more oriented on interests and needs of an individual who is a
p.000055: main consumer of what is provided by the progress. New technologies turn to be such commodities oriented on mass
p.000055: consumption; without this large-scale involvement it would be impossible to provide effectiveness of a
p.000055: laboratory. In turn, interests and needs of consumers become strong drivers determining, to a large extent,
p.000055: directions and urging rates of the scientific and technical progress. As a result, there is a two-way connection
p.000055: between the laboratory producing new technologies and individuals being their consumers. The laboratory and mass
p.000055: individual consumer, in other words, are included into a single circuit.
p.000055: However, such closing of science to needs of a man does not come on its own – everything has the price. One of the most
p.000055: serious constituents of this payment is more and more acute necessity to study specifically what are actually human
p.000055: needs and requirements and how exactly to meet them. And it means that a man becomes more and more an object
p.000055: for various scientific researches. And to the extent, at which strength of scientific cognition is focused
p.000055: on him, with which newer, finer and more effective means of influencing on him are developed, elements of risk and
p.000055: hazard he is exposed to are growing inevitably. Therefore, a task of protecting a man, in whose direct interests
p.000055: science and technique is advancing, is actualized from negative consequences of this very project.
p.000055: The next constituent of the circuit described herein is business, enterprise capital. It funds the laboratory,
p.000055: thus, providing opportunities for development of new technologies. In turn, the mass consumer paying for technological
p.000055: novelties allows business not only to reimburse for incurred expenditures but also to gain profit, which often is again
p.000055: invested into the laboratory and development of other new technologies. It is important to stress stable type of
p.000055: connections among three discussed elements – business is involved into this circuit not every once in a while but
p.000055: becomes an integral part of permanently acting and steadily growing circuit. In society based on knowledge investments
p.000055: into the laboratory are the most promising ones.
p.000055: Science and Mass Media
...
p.000061: are never published and are a matter of corporate “trade secret”.
p.000061: Contradiction between two types of scientific activity ethos is an essence of a conflict of interests – a moral issue
p.000061: which individual scientists often face at the sphere of development of biotechnologies. As a member of the scientific
p.000061: society he is obliged to adhere to the Merton’s ethos principles but as an employee of a biotech company he should
p.000061: follow principles described by J.Mitroff. This conflict appears to be the most acute when assessing risks associated
p.000061: with biotechnological activities. It is quite sufficient to point out to the still unfinished discussion among
p.000061: biotech companies producing genetically modified products and their opponents from a camp of ecological movement
p.000061: activists.
p.000061: 2.2 Characteristic of the Biomedical Research in the Region (o.I.Kubar, E.A.Malysheva)
p.000061:
p.000061: A biomedical study is a study involving human subjects held to investigate new diagnostic, therapeutic
p.000061: and/or preventive means and methods, gaining new knowledge on physiology and psychology of man in conditions of
p.000061: norm, disease and extreme situations. The biomedical research can stipulate both interests of a specific study
p.000061: participant and being held without direct use for a persons taking part in the study.
p.000061: Necessity of the biomedical research involving men as study subjects is obvious in general scientific and historical
p.000061: sense as the only objective, real and the most fruitful way for discovery of laws of physiology and pathology of man
p.000061: and the most important condition for successful struggle for health of every single individual and the humanity as a
p.000061: whole.
p.000061: In the XXI century the words of one of the founders of bioethics, Claude Bernand, he said at the end of the XIX
p.000061: century, sound quite fatefully: “a doctor of future is a doctor-experimenter” that convincingly coincides with novel
p.000061: capacities of modern medical science and practice not only to prevent and treat diseases but also to control human
p.000061: life.
p.000061: An issue of community of the biomedical research in the CIS region from the point of view of philosophical
p.000061: consideration of community of knowledge assumes, first of all, addressing characteristic of biomedical research on the
p.000061: basis of integral scientific, social and value-vision phenomenon.
p.000061: Since in the context herein there is no objective to describe structure and order of conduct as it is that is resolved
p.000061: in many of special methodical and regulatory documents we permit ourselves to utilize commonly accepted in
p.000061: international practice definitions and concepts that, by itself, demonstrates supranational scale in the CIS members
p.000061: states and makes possible to form some perspective characteristics and prognoses.
p.000061: However, both in any sphere of human activity and in the sphere of biomedical research to forecast future in a
p.000061: correct way it is necessary to have memory of the past and knowledge of the present. In this connection,
p.000061: consideration of main stages of establishment of biomedical research in the analyzed regional space at stages of
p.000061: its varying political and economical development gains fundamental value being governed with historical frames
p.000061: selected within the aspect of the given publication.
p.000061:
p.000062: 62
p.000062:
p.000063: 63
p.000063:
...
p.000329: of Consumers’ Rights”. The title reflects the essence of the law – to protect consumers of any services (general,
p.000329: community, trade services, etc.) including medical ones. According to the Law, “a consumer is a citizen (natural
p.000329: person) who purchases, orders or has an intention to purchase or order goods or a service for personal use or a private
p.000329: non-profit household”.
p.000329: A consumer of medical services is a patient having certain rights defined by the Law. It is difficult
p.000329: enough to put a patient on the same level as the consumer of general, community or trade services. To provide a
p.000329: comprehensive protection of a patient’s rights a special law is needed, however, in the absence of such a
p.000329: law, provisions of the law “On Protection of Consumers’ Rights” are applied.
p.000329: It is noteworthy that in the events of a damage to a patient’s life and health the guilty part (medical professionals)
p.000329: are liable to criminal prosecution or to disciplinary or financial sanctions as prescribed by Articles 989 and 1022 of
p.000329: the Civil Code of the Republic of Uzbekistan. According to the Articles mentioned, the person who has suffered undue
p.000329: harm and/or moral damage
p.000329:
p.000330: 330
p.000330:
p.000331: 331
p.000331:
p.000331: resulting from an intervention is entitled to fair financial compensation estimated according to the
p.000331: conditions and procedures prescribed by law.
p.000331: Currently, there are but single instances of suits brought by patients or their relatives against medical institutions.
p.000331: Uzbekistan has little experience in considering such complaints at court, because citizens are not properly informed
p.000331: about their rights. The lack of knowledge in this field negatively affects physician-patient relationships and the
p.000331: treatment efficiency. It is physicians’ professional duty to know patients’ and physicians’ rights and
p.000331: responsibilities. Incidentally, while the patient may be ignorant of his rights and responsibilities relating to
p.000331: medical care, the physician usually has this knowledge but intentionally conceals it from the patient,
p.000331: which is a disadvantage to both the patient and the physician.
p.000331: To involve medical professionals in educational activity aiming at informing patients about their rights, as
p.000331: well as physicians’ rights is one of urgent tasks for the healthcare system of Uzbekistan. .
p.000331: Ethical norms considering special features in relationship with patients from various age and social groups should have
p.000331: a significant place in the system regulating medical activity, particularly the rule of confidentiality relating to
p.000331: information obtained from the patient. This rule applies to adults (capable), minors (incapable or partially
p.000331: capable) and to persons with restricted capabilities who need a constant care.
p.000331: Ethical principles are essential in providing medical care to patients with sexually transmitted diseases. A
...
p.000353: - improvement of information awareness and training in the sphere of bioethics;
p.000353: - distribution of knowledge on bioethics among professional and public groups including via mass media;
p.000353: - counseling and education to bioethics issues among social sphere facilities;
p.000353: - extension of availability of information about regulatory documents, human rights and procedures of their protection;
p.000353: - development of training programs on ethics and their integration into educational process.
p.000353: It is noteworthy that cooperation in this sphere becomes both bilateral and multilateral. Advantage of the region
p.000353: in this sphere is preservation of communication on one language and traditional mutual penetration of
p.000353: cultures and standards becoming a root system of information bases, educational materials and educational
p.000353: testing.
p.000353: Especially advantageous situation for cooperation is created in the sphere of development and
p.000353: establishment of the system of ethical examination. Simultaneous start of development of this field and
p.000353: unique support of the global community through establishment of the Forum for Ethics Committees in the CIS and
p.000353: inclusion of this region as a single constituent of the global WHO Project SIDCER provided permanent
p.000353: international dialogue on key issues of research ethics with international agencies leading in this sphere –
p.000353: such as WHO, the European Commission, the Council of Europe, UNESCO, the European Forum for Good Clinical Practice,
p.000353: the World Medical Association as well as authoritative national agencies: DHHS, USA and Ethics Committees of
p.000353: countries of all Continents. Such dialogue became a basis for experience exchange and real integration of ethical
p.000353: examination systems of the CIS countries into global discussion and research process.
p.000353: Integrity and value of cooperation with international organization is also presented with equal access for
p.000353: the CIS countries to discussion and development of international documents and guidelines on ethics of
p.000353: biomedical studies such as the Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000,
p.000353: 2002); work on new edition of the Declaration of Helsinki, documents of the Council of Europe, new version of the
p.000353: International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS), the Universal
p.000353: Declaration on the Human Genome and Human Rights, the International Declaration on Human Genetic Data, the
p.000353: Declaration on Common Bioethics Standards (UNESCO), guidelines on bioethics, legal and social consequences of genetic
...
Social / Mothers
Searching for indicator mothers:
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p.000023: part of children under 16 in the total population size of the CIS countries decreased by 11%. The youngest is
p.000023: the population of Azerbaijan and Armenia where children make 35 and 29% of the population. In the countries of
p.000023: Central Asia, due to a relatively high fertility, children make on the average 39-45% of the total population. If we
p.000023: consider the demographic situation in the Russian Federation, particularly with regard to children, it should be noted
p.000023: that during the 90-s the number of births was by 60 millions less than in the 80-s. In recent decade, the children’s
p.000023: morbidity has increased dramatically. The most disturbing is the fact of the mental health worsening, since in recent
p.000023: ten years the rate of mental diseases in children doubled, that of moronity increased in 1.5 times and imbecility in
p.000023: 1.6 times. We have to recognize the growing number of disabled children; in the CIS countries there are about 1.5
p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
...
p.000033: Constitution of the Republic of Belarus, Art. 37 of the Constitution of Georgia, Art. 29 of the Constitution of the
p.000033: Republic of Kazakhstan, Art. 34 of the Constitution of the Kyrgyz Republic, Art. 36 of the Constitution of the
p.000033: Republic of Moldova, Art. 41 of the Constitution of the Russian Federation, Art. 38 of the Constitution of the
p.000033: Republic of Tajikistan, Art. 49 of the Constitution of the Republic of the Ukraine, Art. 40 of the Constitution of the
p.000033: Republic of Uzbekistan).
p.000033: Majority of the CIS countries also declared in their constitutions the right for medical care in different forms
p.000033: (excluding three republics – Armenia, Azerbaijan and Uzbekistan: in these states guarantees of availability of
p.000033: health care for people are set at the level of branch laws regulating public relationships in the health care system).
p.000033: At the same time one should note that the issue of underfunding in regard to required amount of medical care today is
p.000033: still one of the most acute problems almost in all countries of the Commonwealth.
p.000033: States implement programs on population health protection, measures for environmental protection and provision of
p.000033: free access to reliable information on its status, living and working conditions, quality of food products
p.000033: and household goods, facilitate development of physical culture and sports, create opportunities for various
p.000033: forms of health insurance. Financial support is guaranteed to pregnant women11, mothers with small children and in
p.000033: case of children with disabilities – until they become older
p.000033: – to families with many children, persons with various diseases and drug abuse. The state provides special care
p.000033: for those who broke their health protecting state and common interests. An important issue is inclusion into the
p.000033: sphere of state policy and legal regulation of an issue of preservation of national gene pool.
p.000033: It is truly important that virtually all CIS countries adopted branch laws related to issues of health care and patient
p.000033: rights – the Law of the Republic of Armenia On Medical Care and on Services for Population (1996), the Law of the
p.000033: Republic of Azerbaijan On Protection of Population Health (26.07.1997),
p.000033: 11 Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of Moldova,
p.000033: respectively.
p.000033:
p.000034: 34
p.000034:
p.000035: 35
p.000035:
p.000035: the Law of the Republic of Belarus On Health Care (1999), the Law of Georgia On Health Care (1997), the
p.000035: Law of the Republic of Kazakhstan On Protection of Population Health of the Republic of Kazakhstan (1991), the Law of
p.000035: the Kyrgyz Republic On Protection of Population Health of the Kyrgyz Republic (09.01.2005), the Law of the
...
p.000189: personality; right to dignity and freedom of private life, confidentiality of personal and family information et al.
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
p.000189: elderly persons, disabled persons, persons who had suffered from an emergency situation and residents of ecologically
p.000189: unfavorable regions (Art. 67, 68, 69, 70, 71).
p.000189: The Law on Pharmaceutical Products (March 2003) regulates clinical trials of pharmaceutical products.
p.000189: According to this Law, no clinical trials of pharmaceutical products in Kyrgyz Republic may be carried out
p.000189: without the permission granted by the authorized healthcare state institution of Kyrgyz Republic. Those guilty of
p.000189: violating rules of clinical trials, falsifying clinical results obtained in clinical trials of pharmaceutical
p.000189: products or conducting the trials without the permission granted by an authorized healthcare state institutions of
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
p.000189: necessary for an authorized healthcare state institutions of Kyrgyz Republic to make a decision about a clinical trial
p.000189: of a pharmaceutical product. The list includes an approval by the ethics committee of an authorized
p.000189: healthcare state institution of Kyrgyz Republic. Article 27 states that the ethics committee of an authorized
p.000189: healthcare state
p.000189: institution of Kyrgyz Republic participates in the design of a clinical trial programme.
p.000189: According to this Article, clinical trial results are referred only to the authorized healthcare state institution of
...
p.000295: HIV/AIDS/STD in Republic of Tajikistan in the Period to 2007” (No 475; 27 of November 2002)
p.000295: - Decree of the RT Government “On the RT Strategy for Preventing the Menace of AIDS Spreading for the Period of
p.000295: 2002-2005” (No 389; 1 of October 2002)
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
p.000295: access to the service of reproductive health, at preventing HIV/ AIDS spreading and at eliminating sex discrimination
p.000295: in the field of primary and secondary education. To ensure the national demographic policy, the Government approved
p.000295: and adopted the programme “The Concept of RT State Demographic Policy for the Period 2003-2015” (2002).
p.000295: The independent Tajikistan with its scientific potential in healthcare has reached a new, international level of
p.000295: science development, and therefore it is necessary to carry out ethical review of biomedical research in compliance
p.000295: with international regulations. The controlling body is the Committee on Medical Ethics (CME) at the RT Health
p.000295: Ministry. In its activity, the CME is guided by the Constitution of Republic Tajikistan. Documents regulating the
p.000295: CME practice comply with international legal standards and RT laws. The CME forms a part of the Forum for Ethics
p.000295: Committees in the Commonwealth of Independent States. The CME is to review and monitor scientific research in medicine
p.000295: and the compliance with ethical regulations to protect right and dignity of a research subject. Presently, the RT
p.000295: Government is considering the law “On the Protection of Human Rights and Dignity in Biomedical Research”
...
Social / Occupation
Searching for indicator job:
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p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
p.000021: into the international system of biomedical research both from a viewpoint of interested researchers and potential
p.000021: participants.
p.000021: In the period of transition to the market economics all the CIS countries had to face such problems as considerable
p.000021: inequity in the income distribution, stratification of the society by income and increasing poverty. In 2004, the ratio
p.000021: of the total income of 10% of the most and 10% of the least well-to- do population was 3-5 times in Azerbaijan, Belarus
p.000021: and Ukraine; 11 times in Kazakhstan, Kyrgyzstan, Moldova, Russia and Tajikistan; 21 times in Armenia.
p.000021: In recent years (2005-2007), in the majority of the CIS countries some smoothing of the society stratification by
p.000021: income and the decrease of the population quota with the income beyond the cost of living (poverty line) was observed.
p.000021: Some processes were observed in the CIS countries that were not typical before. Thus, the number of the “poor” children
p.000021: usually was growing much faster than the number of poor persons in every other age group because of the rapid spread of
p.000021: the unemployment and increasing number of persons in a low-paid job, alongside with a disproportional indexation of the
p.000021: family allowances. The level of food consumption by children has considerably decreased. Presently, the change
p.000021: in the nutrition structure is expressed by transition to food products that are less expensive and richer in
p.000021: calories. There is a lack of food products that are necessary for the normal growth and development of the organism.
p.000021: Besides, a decrease in food consumption and the worsening of the sanitary situation, hygiene and living conditions have
p.000021: caused the increase of the number of diseases (tuberculosis, rachitis) traditionally associated with poverty.
p.000021: Specific features of the demographic situation and, indirectly, the amount of labor resources depend also on
p.000021: the age groups prevailing in the total population size, which, in its turn, implies special approaches to the
p.000021: healthcare structure development in the CIS countries. The increase of
p.000021:
p.000022: 22
p.000022:
p.000023: 23
p.000023:
p.000023: the elder population and the decrease of the share of children in the total population are typical for the majority of
p.000023: the CIS countries.
p.000023: In fact, during the period from 1989 to 2004 in all the CIS countries the part of population under working age
p.000023: decreased. This especially concerns the age group under four. The part of working population did not decrease due to
...
p.000103: Azerbaijan people, as many other peoples of Eastern countries find evidence of physicians’ search and
p.000103: reflection on philosophy and ethics in ancient medical manuscripts. The ancient world knew the name of a
p.000103: legendary physician Logman. In Azerbaijan secrets of medical knowledge and prescriptions for treatment and prevention
p.000103: of different diseases were passed across the generations in the name of Logman. Not long ago two Logman’s precepts
p.000103: were found. The first precept is about the noble mission of the physician: “Everything in the Earth is the
p.000103: fruit of human kindness/ And where the doctor is, there is always air of kindness”. The second one warns against
p.000103: excessive eating and drinking alcohol, i.e. advocates the culture of hygiene: “Do not thou fill thyself with vine/ Be
p.000103: moderate in eating pilaw and bread/ Or otherwise the world in which we live/ Will turn into a cattle-shed”.
p.000103: Fundamental principles of the physician’s ethical behaviour were set forth in an ancient monument of Azerbaijan
p.000103: literature – a folk epic poem “Dede Korkud”. There we find many pieces of useful advice on how to stay healthy and
p.000103: about significance of moral purity and health.
p.000103: Prominent thinkers, poets and scientists of ancient land of Azerbaijan, such as Bahmanyar Ibn Mirzaban, Nizami
p.000103: Gyandjavi, Hatib Tabrizi, Mahmud Shabustari, Omar Osmanogli, Seid Yahya Bakuvi, Nahchivani, Hagani, Fizuli,
p.000103: Vagif, and many others described in their works a hard unselfish and dedicated work of ancient physicians and fruitful
p.000103: results of their job [6]. They all contributed into the development of medical ethics in Azerbaijan.
p.000103: In the XI century the first madrasah schools were established in Azerbaijan where theology and medicine
p.000103: were taught. Those schools
p.000103: trained mullahs, imams and physicians. In the XII century a specialized medical school was founded in
p.000103: Azerbaijan. There under the direction of Omar Osmanogli, future physicians were provided medical education. Omar
p.000103: Osmanogli with his profound knowledge followed moral principles proclaimed by Logman, and he always taught his
p.000103: disciples that in his work the physician should be guided by love to the human being. His demands even went contrary to
p.000103: deep-rooted customs: “Do not thou turn you back on the enemy. Cure him.” Omar Osmanogli educated his pupils
p.000103: in the spirit of moral purity and patriotism. ”Be useful to your people even if it is contrary to your own interest”,
p.000103: “Do not be selfish”, “Work not just in order to make your way to paradise, and do not be afraid of hell” -- such were
p.000103: his mottos.
p.000103: In line with Omar Osman’s traditions, the famous poet Khagani wrote: “If you want your heart to be clear like a mirror,
p.000103: rid it of ten qualities: avarice, hypocrisy, envy, slander, anger, haughtiness, breach of the laws, duplicity,
p.000103: hostility and lie”. Nizami, a great poet and writer of Azerbaijan, who was one of the most educated men of his period,
p.000103: thought highly of medicine and medical profession. In his works he set forth a number of scientific ideas and
p.000103: conclusions characterizing some ways and means used in Azerbaijan folk medicine. He also wrote on nutrition hygiene,
...
p.000113: development of theoretical concepts of bioethics and biomedical ethics were formed (T.V.Mishatkina, Ya.S.Yaskevich,
p.000113: S.D.Denisov). First publications and presentations at scientific conferences on different levels appeared;
p.000113: ideas of bioethics find their reflection in the system of medical education [2-6]. Since that time, the ethical
p.000113: thought in Belarus steadily began to approach leading world tendencies in scientific bioethics.
p.000113: Important factors in this process have been specific features of national world-perception and spiritual culture of
p.000113: Belarus people, which revealed itself in such moral qualities as the tendency to self-determination, inherent
p.000113: feeling of self-respect in combination with tolerance and good-nature, as well as hospitality and openness, etc.
p.000113: Moral qualities of Belarus people are in a direct relation to specific features of Slavic national
p.000113: character. Nikolai Lossky, a Russian philosopher, proved this by associating those with such factors as vast
p.000113: expanses of East-European Plain and its climate (short summer), forming “the habit of excessive short-term
p.000113: strain of efforts” and “the ‘non-habit’ of a regular, continuous labour” [7]. Lossky’s comments on the Russian national
p.000113: character
p.000113:
p.000114: 114
p.000114:
p.000115: 115
p.000115:
p.000115: may be fully attributed to Belarus people: “Obeying the call of duty, Russian people develop in themselves an ability
p.000115: to fulfill a compulsory job accurately and honestly. However, if the job is not strictly compulsory, then they may be
p.000115: careless and inaccurate… Hence, there is often a loss of interest in the work begun and aversion for continuing it; the
p.000115: initial intention, idea and the general outline is often quite valuable, but inevitable imperfections would dim the
p.000115: enthusiasm, and people would be lazy to proceed with a thorough and detailed work.” Nevertheless, some effect of
p.000115: European Protestant ethics resulted in a more developed diligence and thoroughness in Belarus people. Nikolai Lossky
p.000115: mentioned also some other contradictory qualities of the Slavic soul: humaneness, mildness, kindness and, on the
p.000115: other hand, cruelty and tendency towards violence (e.g.: attitude to the death penalty in Belarus society); acute
p.000115: self-perception and impersonal collectivism; the feeling of belonging to the humankind and national
p.000115: self-boasting; humility and inclination to a revolt; love of freedom and a need for the authoritarian State system.
p.000115: These features show themselves distinctly in social life, business relations and scientific activity. Besides,
p.000115: Orthodoxy has always supported orientation towards a strong power, as the Orthodox Church believed that only
p.000115: a strong State system could struggle against evil. At the same time, Lossky noted that in their character the
p.000115: Slavs are more disposed to democracy, which shows itself, for example, in the protest against all sorts of
p.000115: conventionalities.
p.000115: Currently the Orthodox Church still has a strong effect on the development of bioethics in Belarus,
p.000115: which has both positive and negative aspects. The programme of interaction between the Orthodox Church of the country
...
p.000233: deprived country physicians, in particular, of an opportunity to detect contagious cases in due time and efficiently
p.000233: combat epidemics, which meant undermining social and sanitary significance of country medicine as such.
p.000233: The key features of country medicine were determined by country physicians who were greatly influenced by
p.000233: ideas of democracy, had deep community links with peasants, and considered it to be their duty to protect the peasants’
p.000233: interests. That is why one can say that the period went a long way with reinforcement of pattern like approach in
p.000233: Russian medicine.
p.000233: Many of the practicing country doctors were active both medically and socially and grew into eminent
p.000233: representatives of public medicine (E.A Osipov, I.I. Molleson, P.I. Kurkin, F.F. Erisman and others). The main
p.000233: treasure of country medicine were medical doctors, whose itinerant activities were described by such remarkable
p.000233: Russian writers and physicians, who themselves received first-hand experience of country medicine, as A.P.
p.000233: Tchekhov, V.V. Veresaev, M.A. Bulgakov.
p.000233: “Country medicine with its relative freedom and opportunity to study, educate, and serve people
p.000233: attracted good number of conscientious, ideologically aware colleagues, - noted country doctor S. Igumnov during the
p.000233: 11th Pirogov conference - neglecting personal comfort, abandoning attractive and profitable careers, went
p.000233: into country medicine, moved to remote rural areas, dark and cold shanties; some doctors hired themselves as
p.000233: medical assistants, worked for salaries of medical assistants; some shared one job and salary; sometimes refused part
p.000233: of the salary for the sake of building a hospital or organizing a new health locality; perceived country medicine not
p.000233: as employment but rather as a moral duty”. However, Igumnov mentioned:
p.000233: “I am far from idealizing that time and certainly far from thinking that all physicians of those times were
p.000233: ideologically aware and inspired by ideas of populism. Those were a minority and even a tiny minority, but it was that
p.000233: minority that coined country medicine”.
p.000233: Russian physicians more than once informed the international community about achievements of country medicine and it
p.000233: obtained due reputation and recognition overseas. Thus in 1934 the League of Nations Committee for Hygiene advised
p.000233: other nations to adopt the practice of country medicine in order to provide rural population with due medical service.
p.000233: It was confirmed in 1952 in the World Health Organization Assembly guidelines on country medicine development.
p.000233: Importance of organizing medical service by health localities, the approach introduced alongside with country medicine,
p.000233: was well demonstrated at the WHO conference on primary medical and sanitary care issues in Alma-Ata in 1978.
p.000233: It is important stress the role of country medicine in public health care system setup after October 1917. Almost all
p.000233: of its main trends – such as free service and accessibility, preventive trend, involving the community, the citizens
p.000233: themselves into health care, integrity of academic and practical medicine – became determining aspects of the Soviet
p.000233: health care.
...
Searching for indicator occupation:
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p.000023: consider the demographic situation in the Russian Federation, particularly with regard to children, it should be noted
p.000023: that during the 90-s the number of births was by 60 millions less than in the 80-s. In recent decade, the children’s
p.000023: morbidity has increased dramatically. The most disturbing is the fact of the mental health worsening, since in recent
p.000023: ten years the rate of mental diseases in children doubled, that of moronity increased in 1.5 times and imbecility in
p.000023: 1.6 times. We have to recognize the growing number of disabled children; in the CIS countries there are about 1.5
p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
p.000023: addicts. Every five years the amount of drug addicts in the “youngest” group is increasing by 100%. The children
p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
...
Social / Police Officer
Searching for indicator police:
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p.000197: Divan or The Wise Man’s Parley with the World; Metaphysics; General Brief Logics; Research of the Nature of Monarchies;
p.000197: The History of the Growth and Decay of the Ottoman Empire; Geographical, Ethnographical and Economic Description of
p.000197: Moldavia; The Life of Constantine Cantemir; Events from the Life of the Cantacusins and the Brunkovyans; The System or
p.000197: the State of Muhammad Religion; The Hieroglyphic History. Works of Cantemir on the history of the Ottoman Empire
p.000197: were considered classic research and were translated into English, German, and French. Voltaire called this
p.000197: work his reference book on the East. His works are of high value until today.
p.000197: Constantin Virnav is one of the scientists-medics of the XIX century, whose activity as the doctor and civilian
p.000197: had a great significance for development of the public health care and medical ideas in the area. He is
p.000197: the first doctor of medicine in Moldova (he defended his dissertation in 1836 in the city of Buda, Hungary). He is the
p.000197: author of numerous scientific researches. His ethical ideas, application in treatment practice are especially valuable.
p.000197: Zamfir Ralli Arbore was a doctor, the Encyclopaedist, writer and public figure, graduate of the Saint Petersburg
p.000197: Medical and Surgery Academy, a person of encyclopedic learning. During his student years he jointed the
p.000197: narodnik movement and was jailed in St. Peter and Paul Fortress. He went back to Bessarabia. Later, being afraid
p.000197: of new prosecution of the tsar’s secret political police he settled in Romania. He is the author of numerous
p.000197: scientific researches. His encyclopedias are highly valuable. He was an excellent humanist and moralist. He
p.000197: supported active propaganda of high moral values on different levels.
p.000197: Anatolie Kotovski – leading doctor, reformer of the mental health service in Bessarabia, scientist, public figure who
p.000197: made plenty for the development of the social medicine of Moldavia. Many of rules considered bioethical today
p.000197: were applied to his activity.
p.000197:
p.000198: 198
p.000198:
p.000199: 199
p.000199:
p.000199: Toma Chorbe is considered as one of the great doctors-humanists, founder of sanitary and epidemiologic service
p.000199: in the area. He won the name of the unmercenary doctor rightfully. He advocated strongly spreading and efficient
p.000199: introduction of ethic norms and values in medicine.
p.000199: Nicoale Testemitanu is an outstanding scientist, public figure and manager of modern medicine, Doctor of
p.000199: Medicine, professor. He served as: Chief of the Traumatic Surgery Department of the Republican Territory Hospital,
p.000199: the Minister of Public Health, President of the Chisinau State Medical Institute, Chief of the Department
p.000199: of Public Health and Social Medicine Department. He is the most prominent organizer of national medicine
p.000199: of the second part of the XX century. His works on organization of public health care examining medical ethics and
p.000199: deontology are especially valuable. He strongly supported introduction to the practice of moral medical principles. In
p.000199: this respect his everyday activity was a bright example.
...
Social / Presence of Coercion
Searching for indicator coerced:
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p.000099: research, and yields no new results.
p.000099: Risk/benefit balance. The main ethical requirement for clinical trials of new drugs is to gain benefit with the
p.000099: minimum risk for the patient. It is necessary to monitor clinical trials, and register all complications, not only
p.000099: physical but such as discomfort, invasion of participant’s privacy, etc. In many cases risks are unavoidable, but it
p.000099: must be minimum and under control.
p.000099: Informed consent. The main method of protecting the individual involved in the clinical trial is his/her
p.000099: informed consent and its approval by Ethics Committee.
p.000099: The procedure of obtaining informed consent is evaluated with regard to the following requirements:
p.000099: - the potential clinical trial participant must be provided with comprehensive information on the
p.000099: goals, methods, nature of the clinical trial and its expected results, as well as on recommended and alternative
p.000099: treatment and patients’ rights and measures for their protection; information should be given in a clear and
p.000099: understandable language;
p.000099: - the potential participant must not be coerced to participate in the clinical trial;
p.000099: - the potential participant must know that he/she may refuse to participate or voluntarily withdraw at any time without
p.000099: any harmful repercussions;
p.000099: - the clinical trial participant should receive all information that appears during the course of the trial.
p.000099: The clinical trial participant should be also informed about verification of reliability of his/her personal data by
p.000099: official persons or sponsors, and
p.000099:
p.000100: 100
p.000100:
p.000101: 101
p.000101:
p.000101: his/her consent should be sought (the right for confidentiality of personal information).
p.000101: If the clinical trial participant is unable to give his/her personal consent Ethics committee agrees to the following
p.000101: procedure: the consent form should be signed be the participant’s legal representative.
p.000101: In addition to that, Ethics Committee of Health Ministry of Republic of Armenia is obliged to review all amendments to
p.000101: the Protocol and to consider all cases of unfavorable events and changes of ethical aspects of the clinical trial.
p.000101: Ethics Committee of Health Ministry of Republic of Armenia has the right to invite independent consultants without
p.000101: granting them the right to vote.
p.000101: The procedure of decision-making in Armenia has several stages. At the first stage the documents relating to the
p.000101: clinical trial undergo a multistage review at the Centre for Expertise of Drugs and Medical Technologies. In case of
...
Social / Property Ownership
Searching for indicator home:
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p.000093: With regard to legal regulation in the sphere of human rights protection, members of Ethics Committee are guided in
p.000093: their ethical review practice by the following documents:
p.000093: • Constitution of Republic of Armenia (Article 34)
p.000093: • Law on Healthcare in Armenia
p.000093: • Law on Drugs
p.000093: • Law on Social Protection of the Disabled
p.000093: • Law on the Rights of the Child
p.000093: • Law on the Prevention of HIV Infection
p.000093: • Law on Transplantation of Human Organs and/or Tissues
p.000093: • Law on Reproductive Health
p.000093: • Law on Providing Psychiatric Care
p.000093:
p.000093: As to international legal documents, Republic of Armenia ratified Convention on the Rights of the Child.
p.000093: The practice of ethical review is regulated by principles set in the relevant WHO and WMA documents as well as in
p.000093: other international legal and ethical documents.
p.000093:
p.000093: 3.1.3. Education in Bioethics
p.000093:
p.000093: At Yerevan State University named after M.Heratsi ethics and aesthetics have been traditionally taught over many
p.000093: decades. In 2000 bioethics was introduced into the programme of the Department of Social Sciences as a compulsory
p.000093: discipline.
p.000093: In the post-Soviet space, including Armenia, a different – “home” – model of bioethics has been developed, in which
p.000093: bioethics is an interdisciplinary, orientated on biology, modern field of knowledge analyzing moral problems of human
p.000093: existence and human attitude to life and to individual living organisms. This model covers the range from the
p.000093: development of ethical norms and principles regulating human practical activity in the process of studying nature and
p.000093: human beings to the study of the role and place of the human being in the context of biological reality and the
p.000093: estimate of the status of life and death categories.
p.000093:
p.000094: 94
p.000094:
p.000095: 95
p.000095:
p.000095: In the beginning bioethics was taught only to students who were citizens of Armenia, but since 2003
p.000095: also to foreign students. The most important stimulus for introducing basics of bioethics into the syllabus was an
p.000095: essential need to harmonize our education programmes with international standards of education. Republic of Armenia
p.000095: enters the Council of Europe, and, accordingly, takes an active part in the work of its social and legal, healthcare,
p.000095: economical and culturological structures.
p.000095: At Yerevan State University lectures on bioethics are read in the first year at all faculties. Unfortunately, during
p.000095: last two years the time assigned for bioethics was reduced from 36 to 17 hours. Besides, now bioethics is an elective
p.000095: course for citizens of Armenia, while it is a compulsory discipline for foreign students (Russian- and
p.000095: English-speaking students from 18 countries). Thus, since the academic year 2006-2007 bioethics is included into the
...
p.000115: framework principles, standards and norms for the functioning of relevant structures. And here comes the organization
p.000115: ethics with its main task to understand how to make correct ethical decisions. All these principles, standards and
p.000115: norms are addressed not to an individual but to institutions as organized groups with their tasks, specific features
p.000115: and cultural traditions. Therefore ethics committees and ethical competence take on special significance.
p.000115: The Western model of bioethics is an institutionally organized social technology with a system of standardized
p.000115: liberal values ensuring the protection of human rights and freedoms in biomedicine. The protection of human rights
p.000115: from negative consequences resulting from the application of modern biomedical technologies is performed through
p.000115: ethic codes, laws, extending the sphere of responsibility of medical professionals and biologists
p.000115:
p.000116: 116
p.000116:
p.000117: 117
p.000117:
p.000117: and their social obligations not only fixed on their personal moral level but also stated by law. Mechanisms
p.000117: controlling ethical aspects in the activity of physicians and scientists are supplemented with a developed system of
p.000117: legal regulation, a special system of bioethics committees and education.
p.000117: In the post-Soviet space, including Belarus, a different – “home” – model of bioethics has been created, in which
p.000117: bioethics is an interdisciplinary, orientated on biology, field of theoretical knowledge analyzing moral
p.000117: problems of human existence and human attitude to life and to different living organisms. This model
p.000117: covers the range from the development of ethical norms and principles regulating human practical activity
p.000117: in the process of studying nature and human beings to the study of the role and place of the human being in the
p.000117: context of biological reality and the estimate of the status of life and death categories.
p.000117: At the same time, for Belarus with its post-Chernobyl crisis level of the balance in the “nature--society” system, when
p.000117: the data of biomedical studies prove a direct and evident threat to the public health and to the safety of gene pool
p.000117: because of the complex radiochemical pollution, practical measures are extremely important. Besides, the majority of
p.000117: physicians in Belarus still stick to the conventional paternalistic model of patient—physician relationships, which
p.000117: goes with a widespread legal and ethical nihilism in the medical community. Therefore the modern model of
p.000117: bioethics, as well as programmes of biomedical research, should be adapted to the national healthcare system, its
p.000117: scientific, socio-cultural, legal and spiritual traditions.
p.000117: At present, we have objective and subjective conditions for the development of bioethics in the form that is
p.000117: accepted in the West. We are developing ethical and legal norms regulating biomedical research and aiming to create
...
p.000227: Conditions existing in Russia after abolition of serfdom such as quick development of capitalism and
p.000227: industrial and urban growth changed medicine very much. In the second half of the XIX century medicine became
p.000227: scientific and based on experimental methods. Medicine was differenced and integrated. Owing to scientific and
p.000227: technical progress many discoveries were made in biology and medicine, they changed conceptions of etiology and
p.000227: pathogenesis of diseases, diagnostics and treatments methods were improved. At this time many outstanding
p.000227: scientists, who gave us lessons of morality, lived, and scientific medical schools were established. They
p.000227: could not exist without succession between generations of researchers of traditions of handling not only knowledge and
p.000227: ideas but skills of research and truth comprehension, way of thinking and work, peculiar cooperation and creative work.
p.000227: The Pirogov’s medical association became a Centre of public medical thinking in Russia in the beginning of the
p.000227: 80’s. It grew from narrow professional community of physicians into a specific forum of Russian
p.000227: intelligence discussing social, political and moral problems. Its founders and leaders were famous
p.000227: physicians N.V. Sklifosovskiy, S,S, Korsakov,
p.000227: A.Y. Krasovskiy, F.F. Arisman, E.A. Osipov, G,E. Rain and others. The association held Pirogov’s congresses where
p.000227: the most urgent problems of medicine health protection such as fight against epidemics, management of medical
p.000227: care, medical organization at the front and home front and others were discussed. Congresses sent to the
p.000227: government decisions and applications and though most of them were not answered some of them were
p.000227: followed by orders. They were: decision on foundation of the Women Medical Institute (1902), manifest of corporal
p.000227: punishment abolition for all peasants in Russia and some others. Many times the Pirogov association discussed ethic
p.000227: issues such as status of physicians in Russia, problems of private practice and treatment payment, physicians’ mutual
p.000227: aid, physician right to treat without patient and his relatives’ consent and others (12).
p.000227: One more considerable page of Russian public medicine history has moral accent and is connected with struggle
p.000227: of progressive public persons for women rights and their political emancipation, the right for higher medical education
p.000227: and independent practice. Progressive university professors, scientists and writers supported these demands.
p.000227: Supporters of equal rights for women were S.P. Botkin, I.M. Sechenov, A.L. Krasovskiy, P.F. Lesgaft,
p.000227: V.L. Gruber, etc. They opened the door of their classes for first women and give them equal opportunities with men.
p.000227: Progressive media magazines and newspapers such as Medicine bulletin, Modern medicine, Saint-Petersburg
p.000227:
p.000228: 228
p.000228:
p.000229: 229
p.000229:
...
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
p.000271: alterations of the drug introduction routes, its doses, and significant changes in number of the CT subjects. An ethics
p.000271: committee can approve amendments to the clinical study conduct only if presented changes do not lead to worsening of
...
p.000289: of which was a disappearance of such a state as the USSR on the map of the world. Instead, about 15
p.000289: new independent states appeared, and Tajikistan among those. Thus, within a short historical interval Tajikistan
p.000289: moved from one historical period to another; the state and power structure changed, as well as its
p.000289: attributes. The former political system was destroyed, which resulted in the change of ownership patterns and social
p.000289: relations.
p.000289: The development of Tajikistan as an independent secular republic in the post-Soviet space was accompanied
p.000289: with economic, political and social instability. A significant support from the international community was
p.000289: directed to the needs associated with the civil was (1992-1995) and its consequences. Emergency measures of
p.000289: providing medicines, vaccines, bandaging material taken by the international community made an essential contribution
p.000289: into the solution of healthcare problems. At the same time, there was a need in more thorough structural changes that
p.000289: would help to overcome existing problems and facilitate the development of safe mechanisms for providing
p.000289: healthcare and safeguarding patients’ rights.
p.000289: As current biomedical researches are carried out at a large scale and at many Centres, they affect interests of many
p.000289: people and many countries. New problems emerge, because “rich” countries carry over their biomedical research to other,
p.000289: “poorer” countries, and use the results of the research at home, as, “poor” countries cannot afford to use the research
p.000289: findings for economic reasons. To eliminate this injustice, the medical community took certain measures. The WMA
p.000289: Declaration of Helsinki and the additional Protocol to the CE Convention on Human Rights and Biomedicine require
p.000289: that in the countries where a biomedical research is planned the permission should be sought from state structures, and
p.000289: interests of people who live there and who are potential research subjects should be considered.
p.000289: The involvement of Republic of Tajikistan, as an independent state, in international research projects
p.000289: requiring ethical review to ensure the compliance with international regulations triggered the process of
p.000289: establishing in Tajikistan the Committee on Medical Ethics and developing the system
p.000289: of State registration of pharmaceutical products, medical facilities and other medical goods.
p.000289: For a further development of medical ethical review of scientific-research projects, the Ministry of Health established
p.000289: the Republican Committee on Medical Ethics at the Department of the Management of Medical Personnel and Science (Order
p.000289: No 250; 4 of June 2004). The first research project that had to undergo ethical review to ensure the compliance
p.000289: with documents setting international rules in ethics was a joint Tajik-American research on AIDS and hepatitis C in
...
p.000309: noteworthy experience of teaching bioethics based on the use of alternative methods of studying anatomy and physiology
p.000309: of human beings and animals.
p.000309: At Vinnitsa National Medical University named after N.I. Pirogov bioethics is taught to students of the 3rd
p.000309: year (Faculty of Dentistry, 27h) and to students of the 5th year (Faculty of Pharmacology, 54 h). Both courses end with
p.000309: a test. Bioethics is also taught at institutes of higher education in Dnepropetrovsk, Zaporozhye, Lugansk, Odessa,
p.000309: Poltava, Sumy et al.
p.000309: Different public associations play an essential role in distribution of bioethical knowledge - such as
p.000309: All-Ukraine Public Organization “Ukraine Association on Bioethics”; Kiev Ecological and Cultural Centre; Kharkov
p.000309: Regional Society for Animal Protection and others. Due to their efforts a number of foreign materials were translated
p.000309: into Ukrainian language, books and manuals on teaching bioethics were written to be used in Ukrainian
p.000309: universities and institutes.
p.000309: The existing experience of teaching bioethics at Ukrainian institutes of higher education allows us to draw the
p.000309: following conclusions.
p.000309: The introduction of courses in bioethics in Ukraine, as in other post- soviet countries, is complicated by the fact
p.000309: that for a long time scientists and teachers had no opportunity to study foreign materials on the subject. The lack of
p.000309: home studies in the field of bioethics and the lack of comprehensive knowledge on theoretical, methodological,
p.000309: historical and cultural contexts of the development of bioethical discourse affects negatively the level and quality of
p.000309: teaching bioethics.
p.000309: On the other hand, in Ukraine, as in other European countries, there is a tendency of teaching bioethics as an
p.000309: applied biomedical ethics of a narrow professional character. At UNESCO seminar on problems of
p.000309:
p.000310: 310
p.000310:
p.000311: 311
p.000311:
p.000311: teaching bioethics in East European countries (Moscow, January 2005) it was mentioned that 70% of those who teach
p.000311: bioethics are physicians with a classical medical education. Thus, the majority of bioethics teachers have not studied
p.000311: ethics as an independent or philosophical discipline, which certainly affects the general tendency of education in
p.000311: bioethics and interpretation of basic bioethics problems.
p.000311: Currently there is an urgent need to teach bioethics as a special form of worldview, as an interdisciplinary science
p.000311: uniting separate fields of natural sciences and humanities. Bioethics should be considered and studied as
p.000311: global ethics (knowledge of humanity global problems and ways how to resolve those) and as a field involving
p.000311: different cultural traditions.
...
p.000339: ethics”, “research ethics”; subject and tasks of bioethics; theory, principles and methods of biomedical ethics, etc.);
p.000339: international legislation on bioethics; history of medical ethics (including issues of spiritual development
p.000339: and
p.000339:
p.000340: 340
p.000340:
p.000341: 341
p.000341:
p.000341: education, of life and death reflected in works by scientists of different times and peoples; secular and religious
p.000341: aspects of modern biomedical ethics; specific features of biomedical ethics in Islamic countries and
p.000341: Zoroastrian medicine), etc. In addition to that, students should study the Constitution of the Republic of Uzbekistan
p.000341: (1992), as well as laws and normative documents regulating public relations in healthcare. All cardinal problems of
p.000341: theoretical and applied bioethics are considered including ethical problems in clinical trials and biomedical research
p.000341: involving human subjects and animals. Specific ethical problems associated with students’ specialization are also
p.000341: considered.
p.000341: The NEC of the Republic of Uzbekistan is carrying on an essential work on the development of a regular education in
p.000341: bioethics and on training home specialists in the field of modern bioethics.
p.000341: Since 2000, members of the NEC and of regional and local ethics committees have participated in training
p.000341: seminars on bioethics (2001 – Saint- Petersburg, Russia; 2001 – Kiev, Ukraine; 2002 – Almaty, Kazakhstan; 2003
p.000341: – Saint-Petersburg, Russia and Tashkent, Uzbekistan; 2004 – Kiev, Ukraine and Baku, Azerbaijan; 2005 – Yerevan,
p.000341: Armenia; Almaty, Kazakhstan and Tashkent, Uzbekistan; 2006 – Tashkent, Uzbekistan). Training seminars were organized by
p.000341: the Forum for Ethics in the Commonwealth of Independent States, US National Healthcare Union and American Centers for
p.000341: Disease Control and Prevention (CDCP) in collaboration with UNDP (World Bank/WHO), IPA CIS, EFGCP, UNESCO, EC
p.000341: and other international and national organizations. Training seminar on research ethics for members of NEC and local
p.000341: ECs of Uzbekistan that was held in Tashkent, Uzbekistan was conducted in the framework of SIDCER “Recognition
p.000341: Programme”. Within this seminar there were a training courses “Standard Operational Procedures” and “Human
p.000341: Subject Protection”. The training seminars covered the following issues:
p.000341: - The role of ethical review in biomedical research;
p.000341: - The role of SOPs in conducting ethical review, establishing ECs, choosing independent consultants and
p.000341: confidentiality agreement.
...
p.000343: France, 2006.
p.000343: 5. Zagrytdinova F. On Biomedical Ethical Problems. Tashkent, 2005, p. 131 (in Russian).
p.000343: 6. Mukhamedova Z.M. Introduction in Bioethics. Tashkent, 2004, p. 110 (in Russian).
p.000343: 7. Mukhamedova Z.M. Bioethics. Tashkent, 2006, p. 148.
p.000343: 8. Zagrytdinova F. Ethics: A Manual. Tashkent, 2005, p. 134.
p.000343:
p.000343: 3.11.4. The System of Ethical Review
p.000343:
p.000343: A rapid development of biology, pharmaceutical industry and new biotechnologies for diseases diagnostics,
p.000343: treatment and prevention required the review of clinical efficiency of new and generic pharmaceutical products and put
p.000343: in the forefront the necessity to protect human rights in biomedical research involving human subjects.
p.000343: The establishment of national, regional and local ECs facilitated a wide implementation of ethical review of
p.000343: biomedical research performed in Uzbekistan in compliance with international ethical principles and WHO Operational
p.000343: Guidelines for Ethics Committees that Review Biomedical Research (2000).
p.000343: The necessity to establish EC for conducting ethical review of clinical trials (CT) emerged in Uzbekistan in the
p.000343: end of the nineteenth. It was connected with involvement of Uzbekistan in international scientific projects, which
p.000343: implied conducting an ethical review in conformity with international ethical norms. Another important reason was the
p.000343: establishment of the State Registration of Pharmaceutical Products and Medical Facilities. Presently, the NEC conducts
p.000343: ethical review of CT of home and foreign pharmaceutical products and multi-centre research. From the very beginning the
p.000343: NEC has been conducted ethical review of biomedical research involving human
p.000343: subjects. The NEC controls the procedure of obtaining informed consent and other ethical aspects including the
p.000343: safety of research participants’ insurance and monitors the process of medical research to check the risks of the
p.000343: research. The NEC also controls educational programmes on bioethics in institutes of higher education, training
p.000343: seminars and conferences on bioethics and publications in medical journals and mass media. It is responsible for a
p.000343: prompt notification of authorized bodies in the case of any unexpected adverse effects that are hazardous to research
p.000343: participants or other persons associated with the research, in the event of any serious violation of ethical norms or
p.000343: in the case of the suspension/termination of a research involving human subjects that was previously approved by the
p.000343: NEC and conducted in Uzbekistan or with the participation of Uzbekistan.
p.000343: In 2000, the minister of public health approved the document Regulations for the National Ethics Committee at the
p.000343: Medical Scientific Council of the Ministry of Public Health of the Republic of Uzbekistan”. The Regulations define the
p.000343: tasks, responsibilities and rights of the Committee, as well as its structure and procedures.
p.000343: In 2003, the document was revised. It included a wider range of tasks, a more detailed description of the NEC
...
Searching for indicator property:
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p.000033: protected by law and independent court. Person dignity is acknowledged as a special value to be protected by the state
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
p.000033: state becomes a guarantor for protection of personal rights and freedoms. Other directions of the state
p.000033: policy in social sphere are also extremely important for provision of human rights in the area of health care and
p.000033: biomedical research.
p.000033: 9 The Constitution of Kyrgyz Republic also mentions psychological tests in this list (Art.18 of the Constitution of
p.000033: Kyrgyz Republic). Since there is almost no special legal regulations within the regions of the CIS countries for such
p.000033: sphere of biomedical research as psychological studies this fact has a special value. Such constitutional statement can
p.000033: become a basis for independent regulation of the given type of experiments.
p.000033: 10 Art. 16 and Art. 24 of the Constitutions of Kyrgyz Republic and the Republic of Moldova, respectively.
p.000033: The right for protection of health and its state support are legally fixed in all Commonwealth countries (Art. 34 of
p.000033: the Constitution of the Republic of Armenia, Art. 41 of the Constitution of the Republic of Azerbaijan, Art. 45 of the
p.000033: Constitution of the Republic of Belarus, Art. 37 of the Constitution of Georgia, Art. 29 of the Constitution of the
p.000033: Republic of Kazakhstan, Art. 34 of the Constitution of the Kyrgyz Republic, Art. 36 of the Constitution of the
...
p.000051: sectors; c) and in the limit case – fusion of state- funded scientific research with venture capital interested
p.000051: in investments
p.000051: for development of extended base of molecular and biological studies” (P.Rabinov. Making PCR: a story of
p.000051: biotechnology. Univ.of Chicago Press. 1996. p. 19). Commercialization made possible consolidation of resources
p.000051: necessary for breakthrough in biotechnologies that occurred at the end of XX – beginning of the XXI centuries. It has
p.000051: also resulted in reconstruction of self-identity of science and scientists we observe these days changing
p.000051: self-comprehension of science and creating new identity of “a businessman scientist”.
p.000051: Another important consequence of commercialization was changes of patenting practices. In 1980 the US Supreme Court
p.000051: decided that creation of new forms of life is subjected to the Federal Patent Law. It made possible, after some time,
p.000051: to start patenting of not only artificially developed organisms or laboratory animals, but also patenting of human
p.000051: genes, DNA sequences, embryo stem cells, etc. Pragmatic interest for investment protection has changed
p.000051: the world perception. In the form of a patent it provided fundamental scientific knowledge with a form
p.000051: of merchandise. From the point of view of philosophy it means radical fusion of cultural and natural horizons, ideas
p.000051: of discovery and invention. Science commercialization in the sphere of biotechnologies created a new market, a new type
p.000051: of goods, new property rights, boosting synchronous similar processes in other branches of biomedicine. And at
p.000051: that, not only living organisms or elements of human body (genes and cells) become objects of commercial utilization
p.000051: but genomes of entire nations. For instance, in 2000 in Iceland one private biotechnological company, DeCode Genetics
p.000051: “purchased” an exclusive right for commercial use of genome materials and data of the Iceland population for 12 years.
p.000051: Along with structural changes of scientific activities its main checkpoints are altered as well.
p.000051:
p.000051: Constructing a Human
p.000051: One of the main vectors that can be used to characterize direction in development of science and technologies in
p.000051: the last decade is its steady approaching to a man, his needs, aspirations, desires. As a result we can see, if
p.000051: one can say so, tighter “enveloping” of a man, his immersion into the world projected and equipped for him by
p.000051: science and technologies. Naturally, the case is not limited with only “servicing” for a man – science
p.000051:
p.000052: 52
p.000052:
p.000053: 53
p.000053:
p.000053: and technologies approach him not only from outside, but, seemingly, from inside, in a sense making him their creation,
p.000053: projecting not only for him but also projecting himself. Literally speaking, it is done in some modern genetic,
p.000053: embryologic and other biomedical research, for instance, related to cloning16. As a result initially in the USA
p.000053: and then in the countries of Western Europe the range of expectations from the society considerably
p.000053: transformed along with scientific and technical policies of a state. Now scientific researches are
p.000053: required more and more that their results are to satisfy social needs and personal requirements.
...
p.000187: Conventions. Bishkek, 1999, p. 211 (in Russian)
p.000187: 3. Amanaliev A. From the History of Kyrgyz Philosophy. Frunze, 1863 (in Russian).
p.000187: 4. Asan-Kaigy. In: Anthology of Kyrgyz Portry. Bishkek, 1999 (in Kyrgyz)
p.000187: 5. Valikhanov Ch. Collected Works. Vol. 1-5. Alma-Ata, 1961-1972 (in Russian)
p.000187: 6. Kurmanjan the Mountain Queen and Her Time. Bishkek, 2002 (in Russian)
p.000187: 7. Jenijok. Poetic Works. Frunze, 1982 (in Kyrgyz)
p.000187: 8. Jusup Balasagyn “The Beneficial Knowledge”. Frunze, 1988, p. 339 (in Russian)
p.000187: 9. Kalygul Bai Uulu In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 10. Moldo Kylych. Time of Sorrow. Manuscript No 56, Library of the Kyrgyz Academy of Sciences (in Kyrgyz)
p.000187: 11. Moldo Kylych Shamyrkan Uulu. Time of Sorrow. In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 12. Tolubai-Synchi. Ibid.
p.000187: 13. http://www.peoples.ru/art/literatur...age/balasaguny.
p.000187:
p.000187: 3.6.2. Legal Regulations
p.000187:
p.000187: In Kyrgyz Republic biomedical research and protection of human rights in this sphere is regulated by a number of
p.000187: national legal acts, and first of all by Constitution.
p.000187: According to the principal Law, residents of the Kyrgyz republic have the right to health protection, free health
p.000187: care provision by a network of state healthcare institutions. The Constitution guarantees rights to healthy
p.000187: environment and to indemnification for harm caused to health or property due to actions in the sphere of nature
p.000187: management.
p.000187: Article 18 of the Constitution states that no medical, biological, and psychological experiments on human subjects
p.000187: shall be permitted unless there is a voluntary consent of the potential research subject, properly expressed and duly
p.000187: authenticated.
p.000187: The legal basis for the protection of human subjects in biomedical research are the Constitution provisions
p.000187: ensuring every individual’s right
p.000187:
p.000188: 188
p.000188:
p.000189: 189
p.000189:
p.000189: to life, physical and moral inviolability; the right to freedom and safety, the right to a free development of one’s
p.000189: personality; right to dignity and freedom of private life, confidentiality of personal and family information et al.
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
...
Social / Racial Minority
Searching for indicator minority:
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p.000233: interests. That is why one can say that the period went a long way with reinforcement of pattern like approach in
p.000233: Russian medicine.
p.000233: Many of the practicing country doctors were active both medically and socially and grew into eminent
p.000233: representatives of public medicine (E.A Osipov, I.I. Molleson, P.I. Kurkin, F.F. Erisman and others). The main
p.000233: treasure of country medicine were medical doctors, whose itinerant activities were described by such remarkable
p.000233: Russian writers and physicians, who themselves received first-hand experience of country medicine, as A.P.
p.000233: Tchekhov, V.V. Veresaev, M.A. Bulgakov.
p.000233: “Country medicine with its relative freedom and opportunity to study, educate, and serve people
p.000233: attracted good number of conscientious, ideologically aware colleagues, - noted country doctor S. Igumnov during the
p.000233: 11th Pirogov conference - neglecting personal comfort, abandoning attractive and profitable careers, went
p.000233: into country medicine, moved to remote rural areas, dark and cold shanties; some doctors hired themselves as
p.000233: medical assistants, worked for salaries of medical assistants; some shared one job and salary; sometimes refused part
p.000233: of the salary for the sake of building a hospital or organizing a new health locality; perceived country medicine not
p.000233: as employment but rather as a moral duty”. However, Igumnov mentioned:
p.000233: “I am far from idealizing that time and certainly far from thinking that all physicians of those times were
p.000233: ideologically aware and inspired by ideas of populism. Those were a minority and even a tiny minority, but it was that
p.000233: minority that coined country medicine”.
p.000233: Russian physicians more than once informed the international community about achievements of country medicine and it
p.000233: obtained due reputation and recognition overseas. Thus in 1934 the League of Nations Committee for Hygiene advised
p.000233: other nations to adopt the practice of country medicine in order to provide rural population with due medical service.
p.000233: It was confirmed in 1952 in the World Health Organization Assembly guidelines on country medicine development.
p.000233: Importance of organizing medical service by health localities, the approach introduced alongside with country medicine,
p.000233: was well demonstrated at the WHO conference on primary medical and sanitary care issues in Alma-Ata in 1978.
p.000233: It is important stress the role of country medicine in public health care system setup after October 1917. Almost all
p.000233: of its main trends – such as free service and accessibility, preventive trend, involving the community, the citizens
p.000233: themselves into health care, integrity of academic and practical medicine – became determining aspects of the Soviet
p.000233: health care.
p.000233: After the revolution of 1917 medical ethics in the USSR underwent it way of development and was influenced by a range
p.000233: of factors.
p.000233: Medicine started to be perceived from a position of class, individualistic bourgeois medicine being matched against
p.000233: collectivist and proletarian, which led to neglecting a personal value of a human being and it absolute humility to
p.000233: social use. In terms of ethics and morality key significance also belonged to class approach. It was promoted that
...
p.000335: state structures not only because of a poor material and technical basis of healthcare institutions or lack of
p.000335: pharmaceuticals, but also because the violation of patients’ rights to information about their diseases and
p.000335: methods of their treatment. The majority of patients, particularly in rural areas, do not have any knowledge on
p.000335: their rights, as healthcare institutions have not established procedures for providing relevant information. Mostly,
p.000335: patients are informed of their responsibilities and regulations the patient has to observe at a healthcare institution.
p.000335: Violation patients’ rights frequently result also from a low level of legal knowledge in medical professionals. The
p.000335: analysis of complaints submitted
p.000335: 48 The Islamic code of medical ethics. World Med J 1982, Kuwait Document, Islamic Code of Medical Ethics,
p.000335: International Organization of Islamic Medicine, 1981, Proposed Medical Research Projects, edited by: Abdul Jawad M. As
p.000335: Sawai, Commission on Scientific Signs of Qur,an and Sunnah, 1992.
p.000335: 49 Abdallah S. Daar, A.Binsumeit Al Khitamy. Bioethics for clinicians: 21. Islamic bioethics CMAJ 2001; 164(1):60-3
p.000335: 50 Hathout H. Why an Islamic perspective? In: El-Gindy AR, editor. Health policy, ethics and human values:
p.000335: Islamic perspective. Kuwait: Islamic Organization of Medical Sciences; 1995. p. 81- 5.;Hamdani DH. Canadian
p.000335: Muslims on the eve of the twenty-first century. J Muslim Minority Affairs 1999; 19(2):197-209.
p.000335: to various state structures with regard to violation of citizens’ rights in healthcare show that conditions
p.000335: causing violation of citizens’ rights in this sphere are determined by a number of factors, such as:
p.000335: 1. imperfection of legislation referring to medical practice;
p.000335: 2. a low level of implementing normative and legal documents regulating the practice of healthcare system;
p.000335: 3. an inadequate level of citizens’ awareness of their rights and responsibilities in medicine.
p.000335: All abovementioned problems are the object of bioethics – a new field of knowledge rapidly developing all over the
p.000335: world for working out ways and methods for resolving problem situations in healthcare and in the sphere of new
p.000335: medical technologies. To improve the situation, the Republic of Uzbekistan worked out a draft law on medical
p.000335: practice.
p.000335: When designing the law attention has been paid to the following issues:
p.000335: 1. Modern medicine is a high-tech field; a rapid development of new biotechnologies, new treatment methods is
p.000335: continuously expanding ways of medical intervention in human body. Therefore, an individual needs new mechanisms of
p.000335: protection in the sphere of medicine, because a person’s health, life and dignity depend on them.
p.000335: 2. Issues concerning an appropriate quality of medical assistance, its availability, social justice, equality and
p.000335: non-discrimination in healthcare are also essential.
p.000335: 3. It is necessary to create a model of patient—physician relationship that would imply cooperation and dialogue
...
Searching for indicator race:
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p.000033: Art. 13, Constitution of Azerbaijan; Art. 2, Constitution of Belarus, Art. 3, Constitution of the Ukraine, Art. 2,
p.000033: Constitution of Russia; P.1, Art. 36, Constitution of Moldova, etc.). Free development of a person is
p.000033: protected by law and independent court. Person dignity is acknowledged as a special value to be protected by the state
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
p.000033: state becomes a guarantor for protection of personal rights and freedoms. Other directions of the state
p.000033: policy in social sphere are also extremely important for provision of human rights in the area of health care and
p.000033: biomedical research.
p.000033: 9 The Constitution of Kyrgyz Republic also mentions psychological tests in this list (Art.18 of the Constitution of
p.000033: Kyrgyz Republic). Since there is almost no special legal regulations within the regions of the CIS countries for such
p.000033: sphere of biomedical research as psychological studies this fact has a special value. Such constitutional statement can
p.000033: become a basis for independent regulation of the given type of experiments.
p.000033: 10 Art. 16 and Art. 24 of the Constitutions of Kyrgyz Republic and the Republic of Moldova, respectively.
p.000033: The right for protection of health and its state support are legally fixed in all Commonwealth countries (Art. 34 of
p.000033: the Constitution of the Republic of Armenia, Art. 41 of the Constitution of the Republic of Azerbaijan, Art. 45 of the
...
Social / Religion
Searching for indicator faith:
(return to top)
p.000043: found at the following web sites: www. feccis.net and www.pasteur-nii.spb.ru
p.000043:
p.000044: 44
p.000044:
p.000045: 45
p.000045:
p.000045: Chapter 2. CURREnt StAtUS AnD PERSPECtIVE oF tHE CIS’ REGIon PARtICIPAtIon
p.000045: In tHE IntERnAtIonAL BIoMEDICAL RESEARCH
p.000045:
p.000045: 2.1 Philosophical Aspects of the Biomedical Research (P.D.tishchenko, B.G.Yudin)
p.000045:
p.000045:
p.000045: Philosophy of modern biomedical research (BMR) is a limitless topic with multiplicity of versatile aspects. Here we
p.000045: would like to dwell on those of them that are to some extent are related to issues of ethical examination
p.000045:
p.000045: Specific Position of Science in the Modern Culture
p.000045: Understanding of trends of development of the modern biomedical research is impossible without taking
p.000045: into account on-going general civilization transformations of our days. First of all, let’s take a look at the
p.000045: most general context of the issue.
p.000045: In this respect it is necessary to remind about a central role that science have played and still plays in the modern
p.000045: culture. As to exact expression by E. Husserl: “When at the beginning of the New Age religious belief began
p.000045: to degenerate more and more into lifeless convention, intellectual humanity stood in a new great faith –
p.000045: faith into autonomous philosophy and science. Scientific judgments were to highlight and guide entire human culture
p.000045: providing it with new autonomous form.” (Husserl E. Cartesian Meditations, p.14). If to take into account that
p.000045: ideology of new European education to a large extent is a gradual process of mastering the system of scientific
p.000045: knowledge, then without exaggeration one can say that the modern man (unlike a person in the Christian culture) is
p.000045: created “in the image and likeness of a scientist”.
p.000045: The leading position of science is retained and considerably strengthened gaining qualitatively new forms. Along
p.000045: with that, in the modern cultural situation science becomes more tolerant to other forms of cognition
p.000045: and comprehending of the reality. Ideas, concepts and practices that several decades ago were considered
p.000045: as superstitions are rehabilitated and gain status of fully-developed modern doctrines. In the whole world
p.000045: one can
p.000045: observe revival of archaic (shamanism, cabala and other esoteric practices) and creation of new non-scientific
p.000045: (and often anti-scientific) ideologies. Appear new bridges for cooperation between science and traditional religions
p.000045: appear.
p.000045: Another process is ongoing along with this paradoxical one. Science is still a mainstream for resolution of human
p.000045: problems, protection of a man against unfavorable natural impacts (for instance, diseases). But the mightier is
p.000045: scientific control over the nature, the clearer hazards are – that is, risks, related to development of science and
...
p.000185: legendary thinkers to akyns- democrats, the care for widows and orphans was the responsibility of all clan members.
p.000185: The next stage of development of ethics philosophy is represented by akyn-zamanists21 Kalygul Bai Uulu
p.000185: (1785-1855), Arstanbek Bailashuulu (1866-1917) and Moldo Kylych Sharymkanov (1866). They lived in the time
p.000185: of global changes resulting from the decay of patriarchal feudalism and the rise of capitalistic relations.
p.000185: Besides in 1876 the territory inhabited by Kyrgyz people was incorporated into the Russian Empire [9-11]. All
p.000185: those processes were reflected in akyns’ poetry. In their poems “Time of Downfall”, “Time of Poverty” and “Time of
p.000185: Sorrow” akyn-zamanists called their epoch the time of degradation and decay. Moldo Kylych, being a son of a learned
p.000185: man, received a good education. He was acquainted with works by eastern classics Firdousi, Navoi, Jami, Yasavi and
p.000185: others. He wrote about his time: “Morals and manners show the loss of people’s well-being”. In his poem “Time of
p.000185: Sorrow” he noted that moral bankruptcy, degradation of moral principles, moral apathy were frightening features of the
p.000185: time. In their attitudes zamanists were close to French philosophers of the Age of Enlightenment (J.-J. Russo, Voltaire
p.000185: et al.).
p.000185: At the same time akyn-zamanists’ poetry contained some optimism and faith in moral potential of Kyrgyz people that
p.000185: would help them to overcome all difficulties. Kalygul Bai Uulu associated with the image of a spiritual
p.000185: 21 Zamanism – philosophical teaching about frailty and an inevitable tragic end of the world
p.000185:
p.000186: 186
p.000186:
p.000187: 187
p.000187:
p.000187: leader expressing expectations of Kyrgyz people through his poetry inspires their hopes.
p.000187: Problems of justice are very essential for Kalygul. Being a judge, he proclaims a kind of ethical code comprising
p.000187: universal values and norms of human behaviour: honesty, unselfishness, justice, mutual respect.
p.000187: Criticizing the state system of their time as a form of social inequality akyns offered a moral characteristic of
p.000187: behaviour in different social strata. Akyn-democrats tended to give a realistic picture of the world. Thus
p.000187: Toktogul Saltyganov presents his ethical views through opposing the good to the evil. Jenijok taught that every man
p.000187: should strive for self-perfection from his young days [7].
p.000187: Akyn-zamanists were spiritual elite of Kyrgyz society and true patriots. Their laments were neither the echo of
p.000187: feudalism nor an attempt to stop the development of the society. Those were the thoughts about the traditional culture
p.000187: that in their time was at a deadlock and could not find way out of it; thoughts about the future of Kyrgyz people. They
p.000187: understood well a close connection between the destiny of their people and the integrity of ethno- cultural space.
p.000187: Today we may rightly say that zamanism is a special king of creative work of poetry initially establishing in set
...
p.000195: Sea and the Danube under Roman 1 of Moldavia (1392-1394). Geographic location of the territory was favorable as
p.000195: to the nature and life resources and at the same time unfavorable as to geopolitical strategic aspect. The country
p.000195: was located in the strategic pass connecting Eastern and Western Europe, being situated between the Carpathians and the
p.000195: Black Sea. The Silk Road, i.e. the longest commercial route connecting the Far East with the western European countries
p.000195: was there in the Middle Age. Since the first centuries AD and until now great states, trying to preserve the influence
p.000195: here had strategic interests in common. Our people have never been involved in wars of aggression but only defensive
p.000195: ones. Such state of affairs left a deep track in the spiritual life of the country. Spirituality of the inhabitants,
p.000195: philosophic thoughts are of the patriotic and the humanist nature. The ideas of the Italian Renaissance were taken here
p.000195: caught on with some works of some local cultural figures.
p.000195: Ştefan cel Mare şi Sfânt (Stephen the Great and Holy) (1457-1504) ruled Moldova during the most
p.000195: difficult times. He provided a long-term unity of the state, its economical growth and prosperity of
p.000195: cultural life. Protecting his land from invasion he stopped the advance of the invaders to the Western Europe. The
p.000195: Patriarch of Rome for that time deemed him verus christianae fidei athleta (true Champion of Christian Faith) for his
p.000195: services. Soon after the king’s death in 1513 Moldova had to resign to regime of the Ottoman suzerainty.
p.000195:
p.000195:
p.000196: 196
p.000196:
p.000197: 197
p.000197:
p.000197: In 1600 Mihai Viteazul (Michael the Brave) (1595-1601) united for the first time and for a short period
p.000197: Moldavia, Wallachia and Transylvania. Several territorial breaking-ups happened after that. During the Russian-
p.000197: Turkish War of 1768–1774 Austria took the north of Moldova including the ancient capital of Suceava. However the
p.000197: painful and drastic re-allotment of Moldova happened in 1812 when as a result of the other Russian-
p.000197: Turkish War the Russian Empire took the territory between the Prut, the Dniester, the Danube and the
p.000197: north-eastern part of Bucovina, having called it Bessarabia.
p.000197: In 1859 the rest of Moldova was united with Muntenia (Wallachia) forming a new state - Romania.
p.000197: In 1917 Sfatul Ţării was formed as a representative body of Bessarabia, which during World War I and revolution in
p.000197: Russia declared Bessarabia’s independence as the Moldavian People’s Republic. In 1918 Sfatul Ţării declared
p.000197: consolidation with Romania. Transylvania joined Romania being under the Austro-Hungarian Empire the same year.
p.000197: Clause 3 of the secret Annex to the Molotov-Ribbentrop Pact signed on 23 of August, 1939, was devoted to the
p.000197: south-east of Europe and Bessarabia in particular: as a result Soviet government required Romania to cede Bessarabia
p.000197: and the demand was satisfied. On 2 of August 1940, a Moldavian Soviet Socialist Republic was established. On 23 of May
p.000197: 1991, it was renamed to the Republic of Moldova.
...
p.000241: conception are devoted to the questions of marriage and family, psychological health, problems of drug and alcohol
p.000241: addiction, health care and the ecological environment (7).
p.000241: The current trend is towards younger age among religious groups of society. A study by VCIOM showed that 58% of young
p.000241: Russian citizens under the age of 25 refer to themselves as Orthodox Christians, a similar trend can be observed among
p.000241: adherents of the Islam.
p.000241: It should be particularly stressed that among young believers patriotic, pro-governmental ideas, believe that there is
p.000241: a necessity to restore the decent position of Russia in the world community, strive for order, strong power, collective
p.000241: like, collegial philosophies, support of the current government and antagonism to liberal western ideas
p.000241: prevail. A common trend among all young interviewees, disregarding distinctions in their philosophic and
p.000241: religious ideas, towards moral and spiritual values is demonstrated, for instance, the way they reacted to the
p.000241: concept of ‘morality’ (positive 87.9% among believers and 81.8% among non-believers, negative 12.1% and 18.2%
p.000241: respectively), ‘justice’(positive 96.6% and 94.3%, negative 3.4%
p.000241: and 5.7%), ‘faith’ (positive 97.1% and 85.9%, negative 2.9% and 14.1%),
p.000241: ‘prayer’ (positive 92.3% and 56.3%, negative 7.7% and 43.8%). A particular part of young believers and
p.000241: non-believers advocates the idea of paternal mode of relations, sticks to the idea of conventional patriarchal
p.000241: views in family pattern, supporting filial piety within the family, male dominance in family relations (believers 28%,
p.000241: non-believers 21.9%).
p.000241: For the Russian medicine and health care a paternal model of doctor and patient relations is a typical one. Genesis of
p.000241: these relations can not be seen apart either from economic and cultural development of Russia on the whole or from the
p.000241: ethical staples of medical activity in Russia. Orthodox theological ideas and Russian religious philosophy to a
p.000241: significant extent reinforced the paternal model of doctor and patient relations, promoting ideas of humbling,
p.000241: non-resistance, and respect to universal hierarchy.
p.000241: Developments in medical science and biotechnology increased the power and responsibility of a medical doctor in
p.000241: terms of understanding what life and death and use harm mean. A simultaneous turn of mind in social ideas and mentality
p.000241: of people brought about by a wide spread liberal ideas gave a great impetus to new attitudes based on ideas of personal
...
p.000323: euthanasia. The person’s right to euthanasia, both active and passive still remains a topic of heated debates. Islam
p.000323: may not approve of either kind of euthanasia, as it is nothing but a conscious murder of a human being (even if he/she
p.000323: has a terminal illness) committed by another person, particularly by a physician. If the patient has a terminal
p.000323: illness, the physician’s duty is to relieve his/her suffering with various analgesics and to render moral support
p.000323: in the face of impending death, so that the patient would leave this world as a sensible person who
p.000323: completed all his/her earthy tasks, bid farewell to his/her relatives and repented before the Almighty Allah.
p.000323: Abu Ali Ibn Sina (980-1037) expressed his attitude to euthanasia in his “Biography” wrote that a
p.000323: seriously ill person consciously “broke the regimen for the last time”, which hastened his death. Here
p.000323: we have to mention his views on medical and ethical problems of dying and natural death. These views expand the scope
p.000323: of modern bioethics, which allows us to retransmit from the past entire strata of knowledge about the physician’s duty
p.000323: and search of new ways for applying ethics when it is necessary to care for a dying patient, to form behaviour
p.000323: standards in seriously ill patients, to safeguard their rights for a good death and to maintain their faith in
p.000323: spiritual and moral immortality of human soul.
p.000323: In the light of the aforesaid, Ibn Sina’s treatise “Illumination” that is not widely known among researches is of a
p.000323: particular interest. The treatise adds to concepts of natural death presented in “Canon”. In modern terms, the treatise
p.000323: suggests that the philosophy of death ensues logically from a moral comprehension of life. Ibn Sina offers a systemic
p.000323: substantiation of the natural death from the viewpoint of the right to a good death and in the light of the theory that
p.000323: death means “the return” to an origin. This idea was developed in many works, particularly in works by Ilya Mechnikov
p.000323: (1845- 1916) who attempted to explain the concept of “the instinct of natural death” from the viewpoint of biology and
p.000323: psychophysiology.
p.000323: With regard to ethical principles, “Canon of medical Science” is a literary source containing elements of
p.000323: bioethics. It differs from its antiquity analogues in the attempt to characterize medicine not only as a system of
p.000323: medical and biological knowledge, but also as a canon of spiritual and ethical basis of the entire medical science
p.000323: (“Avicenna and the ethics of science and technology today”. Division of Science and Technology Ethics, UNESCO, France,
p.000323: 2006, p. 1-16). There were many reasons why “Canon” excited much interest in different historical periods including the
p.000323: European Renaissance. However, there are no doubts that in “Canon of Medical Science” a human being for the first time
p.000323: becomes not merely a subject of an anatomical or physiological research but a person. It is noteworthy that the “Canon”
...
Searching for indicator belief:
(return to top)
p.000043: law of IPA CIS On Protection of Human Rights and Dignity in Biomedical Researches in the CIS and the text of
p.000043: the model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS can be also
p.000043: found at the following web sites: www. feccis.net and www.pasteur-nii.spb.ru
p.000043:
p.000044: 44
p.000044:
p.000045: 45
p.000045:
p.000045: Chapter 2. CURREnt StAtUS AnD PERSPECtIVE oF tHE CIS’ REGIon PARtICIPAtIon
p.000045: In tHE IntERnAtIonAL BIoMEDICAL RESEARCH
p.000045:
p.000045: 2.1 Philosophical Aspects of the Biomedical Research (P.D.tishchenko, B.G.Yudin)
p.000045:
p.000045:
p.000045: Philosophy of modern biomedical research (BMR) is a limitless topic with multiplicity of versatile aspects. Here we
p.000045: would like to dwell on those of them that are to some extent are related to issues of ethical examination
p.000045:
p.000045: Specific Position of Science in the Modern Culture
p.000045: Understanding of trends of development of the modern biomedical research is impossible without taking
p.000045: into account on-going general civilization transformations of our days. First of all, let’s take a look at the
p.000045: most general context of the issue.
p.000045: In this respect it is necessary to remind about a central role that science have played and still plays in the modern
p.000045: culture. As to exact expression by E. Husserl: “When at the beginning of the New Age religious belief began
p.000045: to degenerate more and more into lifeless convention, intellectual humanity stood in a new great faith –
p.000045: faith into autonomous philosophy and science. Scientific judgments were to highlight and guide entire human culture
p.000045: providing it with new autonomous form.” (Husserl E. Cartesian Meditations, p.14). If to take into account that
p.000045: ideology of new European education to a large extent is a gradual process of mastering the system of scientific
p.000045: knowledge, then without exaggeration one can say that the modern man (unlike a person in the Christian culture) is
p.000045: created “in the image and likeness of a scientist”.
p.000045: The leading position of science is retained and considerably strengthened gaining qualitatively new forms. Along
p.000045: with that, in the modern cultural situation science becomes more tolerant to other forms of cognition
p.000045: and comprehending of the reality. Ideas, concepts and practices that several decades ago were considered
p.000045: as superstitions are rehabilitated and gain status of fully-developed modern doctrines. In the whole world
p.000045: one can
p.000045: observe revival of archaic (shamanism, cabala and other esoteric practices) and creation of new non-scientific
p.000045: (and often anti-scientific) ideologies. Appear new bridges for cooperation between science and traditional religions
p.000045: appear.
...
p.000283: (ancestors of the Persians) people. The Tajik- Persian philosophical thought had also a connection with Indian and
p.000283: Greek philosophy. However the closest links connected the Tajik culture and spiritual and philosophic outlook
p.000283: with cultures of Turkic peoples of Central Asia and Azerbaijan. There was a mutual enrichment of cultures, spiritual
p.000283: values and scientific achievements.
p.000283: Religious and philosophical ideas of Tajik ancestors roots back to an ancient monument of spiritual
p.000283: culture “Avesta” the holy canon of Zoroastrism (Mazdeism) containing not only religious dogmas but also
p.000283: ideas on cosmogony, philosophy, morals and law. The characteristic feature of Zoroastrianism is dualism, i.e. the view
p.000283: that two fundamental concepts exist, such as good and evil, and the struggle between these is the pivot and content of
p.000283: the universe. Zoroastrianism formulated a ternary ideal of the righteous man (“good thoughts”, “good words” and
p.000283: “good deeds”) opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked words” and “wicked deeds”). The
p.000283: Zoroastrian idea about infinite time as an initial substance gave rise to zervanism – a teaching in the framework of
p.000283: which a materialistic trend developed that denied the creation, and god as the creator of the universe, and
p.000283: affirmed the belief in the eternity of the world. In the end of the slave-owning system and in the beginning of
p.000283: feudalism, Manichaeism (Mani, 215-276) and Mazdakism (Mazdak, the end of the V - the beginning of the VI century)
p.000283: became very influential. Those philosophical trends assimilated the Zoroastrian ideal about the struggle
p.000283: between the good and the evil. The social doctrine of Mazdakism proclaimed ideas of justice and equality.
p.000283: The earliest written evidence that peoples of Central Asia had a good knowledge of mathematics and astronomy is
p.000283: “Avesta” containing data on the movement of celestial bodies, the system of time count and some mathematical rules.
p.000283: In that period, early states in Central Asia achieved a high
p.000283: level of material production and culture: crafts, agriculture, architecture and art. That was the time when many
p.000283: written monuments of religious, political and scientific thought were created, many of which were destroyed during the
p.000283: invasion of the army of the Arab Caliphate (VII-VIII centuries).
p.000283: During the VIII-XV centuries philosophical, social and political ideas were developing in the atmosphere of
p.000283: Arabian conquests and a forcible spreading of Islam. Spiritual cultures of Iranian and Arabic peoples became most
p.000283: closely linked. During the VIII-IX centuries, in Maverannahr (the right bank of Amudarya) and Khorosan the tendency to
...
p.000321:
p.000322: 322
p.000322:
p.000323: 323
p.000323:
p.000323: that uses ethical argumentation as such. Sacred texts offer a comprehensive collection of thoughts, and one may find in
p.000323: them confirmation from “above” of nearly any statement.
p.000323: Moslem teaching has developed special canons of the attitude to patients and disabled persons that, to a large
p.000323: extent, formed the basis for patient-physician relationship. First of all, Al Bukhari’s khadises remind Moslems
p.000323: that the Prophet suffered severely, and therefore, who, if not Him, knows better what it means to be ill and suffer
p.000323: (Abu Abdullah Muhammad ibn Ismoil al-Bukhoriy. Khadis. Al-jomi’ ac-cokhikh 4. Ishornali tiuplam. Tashkent, Komuslar
p.000323: bosh takhririiati, 1992. B. 3 – in Uzbek). Everything that befalls human beings is of God’s will. To visit the sick,
p.000323: even infants, is a duty of each Moslem. It is a tradition not to ask about the disease or name the disease aloud; one
p.000323: should ask about the general state of health and use euphemisms in telling the diagnosis: “that very illness”, “caught
p.000323: some cold”, “a bad illness”, etc. There are many variants. This is a kind of medical secrecy observed by persons in the
p.000323: patient’s environment. In the end of the visit the physician should say some words of support, to express his firm
p.000323: belief that the patient will recover, even if the physician knows that it is hardly possible. Moslems should support
p.000323: all disabled people and have mercy to ugly persons, because they are what they are of God’s will. To care for the
p.000323: disabled is the duty of all relatives and people from the community.
p.000323: Patients too have their duties. They have to bear their suffering as much as they can, not to grumble or fall into
p.000323: despair, to suppress one’s moans, not to ask for death. If a Moslem anticipates his death he should pay his debts,
p.000323: make his will and directions concerning funerals, beg everyone’s forgiveness and to repent of his sins
p.000323: (Sadyk-i-Kashgari M. Oriental Code of Decencies. Adab-ul-Salikhyn. Tashkent, 1992, pp. 35-37; in Uzbek). The precept
p.000323: “Thou should not ask for your death” suggests a direct answer to the question what Islamic teaching says about
p.000323: euthanasia. The person’s right to euthanasia, both active and passive still remains a topic of heated debates. Islam
p.000323: may not approve of either kind of euthanasia, as it is nothing but a conscious murder of a human being (even if he/she
p.000323: has a terminal illness) committed by another person, particularly by a physician. If the patient has a terminal
p.000323: illness, the physician’s duty is to relieve his/her suffering with various analgesics and to render moral support
p.000323: in the face of impending death, so that the patient would leave this world as a sensible person who
...
Searching for indicator religion:
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p.000119: that euthanasia is
p.000119: unacceptable:
p.000119: - “The physician should relieve sufferings of a dying patient by every available and legal means. Euthanasia as an
p.000119: act of an intentional taking of one’s life is not permissible at the patient’s or his/her relative’s
p.000119: request” (Art. 25 CME).
p.000119: - “Medical or pharmaceutical professionals are not permitted to perform euthanasia. A person who
p.000119: consciously induces the patient to euthanasia and/or performs euthanasia shall bear criminal responsibility
p.000119: according to legislation of Republic of Belarus” (Art. 38 of the Law on Healthcare).
p.000119: Priority of a person’s interests implies that interests and well-being of an individual should prevail over scientific
p.000119: and public interests:
p.000119: - “In his/her scientific and research activity the physician should be guided by the priority of the
p.000119: patient’s benefit over scientific interests; clinical trials and research may only be carried out in compliance with
p.000119: the rules established by law and with the patient’s consent” (Art. 36 CME).
p.000119: Principle of tolerance implies that all citizens, with no exception, are guaranteed that the individual’s integrity,
p.000119: principal rights and freedoms shall be respected:
p.000119: - “The main goal of physician’s professional activity is to save an individual’s life and health…
p.000119: regardless of the patient’s sex, age, nationality, social and financial status, political convictions and religion”
p.000119: (Art. 2, CME);
p.000119: - “Physician shall in every possible way contribute into protection of population health and to
p.000119: struggle against any forms of cruelty and disparagement” (Art. 5 CME).
p.000119: Equal rights and cooperation in physician-patient relationship as a cardinal principle of modern deontology
p.000119: implies the following:
p.000119: - “Physician and patient have equal rights to respect for their human dignity and may protect it according to
p.000119: current legislation” (Art. 14 CME).
p.000119: Principle of physician’s and patient’s autonomy following from the above statement reveals itself in recognizing the
p.000119: autonomy of the physician:
p.000119:
p.000120: 120
p.000120:
p.000121: 121
p.000121:
p.000121: - “Physician shall bear responsibility for all his/her professional decisions and has the right to reject
p.000121: any attempts of pressure from colleagues, patients and other persons if their requests contradict ethical
p.000121: principles, professional duty and law.” (Art. 11 CME).
p.000121: Secondly, the principle of autonomy implies the patient’s autonomy:
p.000121: - “Patient is an active participant of the treatment process” (Art. 16 CME).
p.000121: - “Patient has the right to choose the physician. In case of a disagreement with the physician the
p.000121: patient may apply to the head of the institution, to the commission on medical ethics and to other governing
...
p.000173: of the international programme “Intensive training on bioethics”. Together with Bangladesh Council on Medical
p.000173: Research with financial and technical support from the International Educational Reward in Bioethics and Carrier
p.000173: Development of the Fogarty International Centre (FIC) and National Institutes of Health (NIH), USA, several workshops
p.000173: were conducted in Almaty for physicians of Kazakhstan.
p.000173: The programme of these workshops had the following main goals:
p.000173: 1. The development of complete training plan/programme for the workshop on bioethics;
p.000173: 2. Training of young researches of different scientific specialties in the area of bioethics of scientific research.
p.000173: Many important topics were discussed during these workshops including: historical perspectives of ethics
p.000173: of scientific research in public health area; international declarations and manuals on scientific research
p.000173: with participation of human beings; informed consent; confidentiality; motivation; ethics of clinical studies;
p.000173: ethics of population and demographic studies; ethical aspects of scientific research in the area of health of children
p.000173: and reproductive health; functions of ethical committees; manuals on ethical review; organization of scientific
p.000173: research in developing countries; religion and culture in ethics and other topics.
p.000173: Around 20 specialists from different research institutions of the country participated in the development of
p.000173: programmes for workshops that were organized at the Higher School of Public Health. In future the Consultative
p.000173: Committee will be responsible for the general management of the programme, its monitoring and assessment. The programme
p.000173: was translated into English and sent for revision to international consultants.
p.000173: Recently programmes on bioethics were developed at the department of pharmaceutical management of the Higher School of
p.000173: Public Health for public health managers (18 training hours) and for public health masters (45
p.000173:
p.000174: 174
p.000174:
p.000175: 175
p.000175:
p.000175: training hours). At the same time it is necessary to mention that programmes that were developed not fulfill completely
p.000175: the growing demands of education in bioethics area.
p.000175: The level of knowledge and education on legislation among general public seeking health care improved
p.000175: recently; the network of ethical committees in research institutions of the country enlarged significantly, the
p.000175: role of Kazakhstan’s scientists in international research increased including multi-centre clinical trials of
p.000175: medical drugs. That is why educational programmes in the area of bioethics should be revised and improved for
p.000175: medical students and graduate physicians, researches, nurses, members of ethical committees and other specialists.
p.000175:
p.000175: 3.5.4. The System of Ethical Review
p.000175:
...
p.000197: Declaration of Independence of the Republic of Moldova. On 2 of March 1992 the Republic of Moldova became a full member
p.000197: of the U.N.
p.000197: It is possible to find ethic attitude to life, living beings, covering some aspects of medical treatment or medicine in
p.000197: works or actions to some extent of a number of persons. Such as:
p.000197: Neagoe Basarab (ruled - 1512-1521), Dimitrie Cantemir (1673-1723), Constantin Virnav (1806-1877), Zamfir Ralli
p.000197: Arbore (1848-1933), Toma Chorbe (1864-1936), Anatolie Kotovski (1864-1937), Nicoale Testemitanu (1927-1986).
p.000197: Neagoe Basarab was one of the rulers of the XVI century whose works influenced various issues of the ethics of life. It
p.000197: is necessary to mention his fundamental work called Advice of Neagoe Basarab to his Son Theodosius.
p.000197: Dimitrie Cantemir was a talented ruler of Moldova of the 18th century and at the same time an outstanding
p.000197: scientist and man of culture. It is necessary to state that he was a member of two Academies – Berlin and Saint-
p.000197: Petersburg, spoke 12 languages. He is considered to be the first national philosopher, first theorist and historian of
p.000197: medicine. Cantemir is known as the author of philosophic and physiological works. The works of Cantemir include The
p.000197: Divan or The Wise Man’s Parley with the World; Metaphysics; General Brief Logics; Research of the Nature of Monarchies;
p.000197: The History of the Growth and Decay of the Ottoman Empire; Geographical, Ethnographical and Economic Description of
p.000197: Moldavia; The Life of Constantine Cantemir; Events from the Life of the Cantacusins and the Brunkovyans; The System or
p.000197: the State of Muhammad Religion; The Hieroglyphic History. Works of Cantemir on the history of the Ottoman Empire
p.000197: were considered classic research and were translated into English, German, and French. Voltaire called this
p.000197: work his reference book on the East. His works are of high value until today.
p.000197: Constantin Virnav is one of the scientists-medics of the XIX century, whose activity as the doctor and civilian
p.000197: had a great significance for development of the public health care and medical ideas in the area. He is
p.000197: the first doctor of medicine in Moldova (he defended his dissertation in 1836 in the city of Buda, Hungary). He is the
p.000197: author of numerous scientific researches. His ethical ideas, application in treatment practice are especially valuable.
p.000197: Zamfir Ralli Arbore was a doctor, the Encyclopaedist, writer and public figure, graduate of the Saint Petersburg
p.000197: Medical and Surgery Academy, a person of encyclopedic learning. During his student years he jointed the
p.000197: narodnik movement and was jailed in St. Peter and Paul Fortress. He went back to Bessarabia. Later, being afraid
p.000197: of new prosecution of the tsar’s secret political police he settled in Romania. He is the author of numerous
p.000197: scientific researches. His encyclopedias are highly valuable. He was an excellent humanist and moralist. He
p.000197: supported active propaganda of high moral values on different levels.
p.000197: Anatolie Kotovski – leading doctor, reformer of the mental health service in Bessarabia, scientist, public figure who
...
p.000207: educational institutions of the country.
p.000207: Since 2002 the Department offers post-gradual studies (daily and distant training), doctor of science (distant) and
p.000207: master (daily) training in bioethical sphere where graduates of philosophic, medical, theological, agricultural and
p.000207: other department study. After graduation and successful defense of works they are conferred the degree of doctor or
p.000207: doctor habilitate of philosophic science (majoring in bioethics) and master on bioethics, respectively.
p.000207: If we are to continue to develop our ideas related to organization of training process in bioethical knowledge in
p.000207: our country it is necessary
p.000207:
p.000208: 208
p.000208:
p.000209: 209
p.000209:
p.000209: to especially stress the work of the Department, Association and the National Bioethics Centre in
p.000209: popularization of this phenomenon among the population of the Republic and primarily among the youth.
p.000209: Introduction into Bioethics program is of special popularity among the radio and television auditoria. Over
p.000209: last 3 years the personnel of the Centre and the Department organized and held about 20 talks (radio and television) of
p.000209: 15 to 45 minutes each on basic themes of this type of practical philosophy. Such programs as Bioethics –
p.000209: The Science of Survival, Euthanasia from the Point of View of Bioethics, Cloning in the Contest of Bioethics,
p.000209: Bioethical Aspects of Artificial Human Reproduction, Experiments in Humans and Animals in Biomedical Sphere:
p.000209: Bioethical Aspects, Religion and Bioethics and other with participation of bioethics specialists, biologists,
p.000209: medics and religious theologists can be marked among them, as well as From Anthropocentrism to
p.000209: Biospherocentrism, Backgrounds of Bioethics, From Ethics to Biological Ethics, Abortion and Bioethics, Bioethical
p.000209: Education of Society – Requirement of the Human Survival Strategy, Transplantology and Bioethics, Human Genome and
p.000209: Bioethics, Biomedical and Spiritual World: Comparative Analysis, Principles and Imperatives of Bioethics,
p.000209: Paternalism and Antipaternalism in Human Activity, Informative Consent and Interpretation in Medical Practice and
p.000209: others.. Here we started to check the interest in some ideas from social bioethics, such as Senility and Bioethics,
p.000209: Terrorism and Bioethics, Homosexualism, Transsexualism and Travestism in the Contest of Bioethics, Suicide and
p.000209: Bioethics, Homeless in the Light of Bioethics, Bioethics and AIDS, People with Physical Incapability in the Light of
p.000209: Bioethics, Asceticism and Bioethical Knowledge, Sadism and Masochism in the Contest of Bioethics etc. All that promotes
p.000209: propaganda of bioethical knowledge among the population both of the cities and rural settlements, formation of skill to
p.000209: care about living and biosphere in general.
p.000209: Periodicals with regular publication of interviews, articles and, for
...
p.000223: The idea of person, personality itself began to form here in XIII century. And today in Western Europe the notion of
p.000223: personality is central, important as daily bread, and it is not high but everyday, though in Russia the word
p.000223: “personality” is in one row with the high notions and its meanings are not everyday.
p.000223: Speaking about language as means of communication one should note one more feature which is important for
p.000223: doctor-patient relations. The Russian language in contrast with the Romance and German languages is synthetic, not
p.000223: analytical, i.e. it may be axiomatizated hardly but is able to express emotions and feelings (22,27).
p.000223: Folk proverbs are very important feature of ethnos awareness and national mentality. They accumulate important
p.000223: conclusions and observations about nature and society laws. Many of them assert group priority over
p.000223: personality, collective things priority over individual, necessity to obey any group law. Man strength is in his group
p.000223: membership, whilst his personnel responsibility is vogue (25).
p.000223: Russians were characterized to have many interethnic contacts with people of different origin, cultural
p.000223: traditions and language that influenced undoubtedly the general Slavic culture foundation. Connections with
p.000223: Byzantine, a godmother and keeper of ancient civilization where Orthodoxy became a state religion, were the most
p.000223: fruitful for the Old Russian culture. Together with adoption of Christianity a Byzantine philosophy related to the
p.000223: Plato’s Hellenism, which gave it anthropological and historiosophy orientation, had penetrated to
p.000223: Russia. Anthropocentrism of Russian philosophical researches became one of characteristic principles of Russian
p.000223: philosophy. From Nil Sorskiy to A.N.Radischev, from Radischev to Soloviev and Berdiaev a Russian thought has been
p.000223: always attracted by cognition of mystery of person, his death and immortality (3). The Russian philosophy created
p.000223: “philosophy of life” long before birth of western European existentialism and pragmatism. Peculiarity
p.000223: of the Russian philosophy is in the fact that the Russian thought has always been (and will be forever) connected with
p.000223: its religion element and grounding and inspiration of freedom valued at any time by Russian minds had never died inside
p.000223: of church awareness. First of all everywhere dominance of morality evidences that. We can see it in works of nearly all
p.000223: Russian thinkers even those who had no works devoted to moral problems.
p.000223: Adoption of Christianity determined evaluation of Russian spirituality in subsequent periods. Founding on traditions of
p.000223: eastern orthodoxy, ideas of spirituality, shame and conscience, love to neighbor were brought in Old Russia, a
p.000223: spiritual foundation of charity as everyday piety was formed. Alms as early form of personnel charity was spread among
p.000223: all social classes, it was not only simple execution of commandment of love to a neighbor, but a true need. It was
p.000223: personnel charity that created the foundation necessary for helping the poor at the following times. It was forming
p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
...
p.000239: voluntary basis. Local and regional ethical committees are set up with lower activity but their number gradually grows
p.000239: (22).
p.000239: The current stage is characterized by booming information and communication technology, rapid
p.000239: development of market economy, drastic changes in demography, persistent urbanization process, and trends towards
p.000239: development of open society. Signs of two controversial tendencies: globalization on the one hand and on
p.000239: the other – increased attention of people to their national and cultural traditions.
p.000239: After seventy years of atheism as state ideology and withdrawal from those ideas and values that the society was
p.000239: governed by, the caused moral vacuum in Russia failed to be compensated with a more or less integral
p.000239: framework of secular ideas and values clear and conventional to people and capable of appealing to people and give them
p.000239: hope. A distinguishing feature of the Russian society is that conventional factors invariably play significant role in
p.000239: many walks of social life, adherence to traditional ideological and social values which saw little influence
p.000239: of the changing social and economic systems, political regimes as well as fresh social and ideological paradigms for
p.000239: development declared in the recent decades of the XX century. Under any state system – monarchical or collective type,
p.000239: totalitarian or liberal – an impact of a number of constants which determine a civilization portrait of Russia is
p.000239: feasibly evident. Among them a crucial role belongs to religion, first and foremost the Orthodox Christian Church which
p.000239: by masses of population is perceived not only as an institution with the main function of not just disseminating the
p.000239: ideas of Christianity but mostly as preserver of the Russian national values and traditions (by different social
p.000239: studies three fourths of believers who are almost half of the population in Russia are Orthodox Christians). The same
p.000239: can be said about the Islam – second confession in Russia in terms of adherents’ number and influence (about 19% among
p.000239: believers) (20).
p.000239: Today religious organizations prove active in most different fields: religion itself, education, health care,
p.000239: culture, charity and mercy, business and economic. Changes occurring in the society and the Church demanded for a
p.000239: comprehensive philosophy that would reflect general attitude of the Church to issues of state and the Church
p.000239: relations and concerns of the modern society on the whole.
p.000239: At the Anniversary Episcopal Assembly in 2000 the Basic Social Conception of Russian Orthodox Church was
p.000239: adopted. The conception falls into 16 sections covering most various issues related to life of a Christian believer in
p.000239: secular world. In section 11 – “Public and Individual Health” – the attitude of Orthodox Church to disease and health
p.000239: is rendered, importance of church activities in health care is stressed, necessity of society and church cooperation in
p.000239: public health care issues is emphasized. It covers such vital from religious viewpoint principles as doctor and patient
p.000239: relationship which should be based with respect to integrity, free choice and “personal dignity”. In particular it
p.000239: stresses: “We should by all means encourage a dialogue between a doctor and a patient that is
p.000239: characteristic of current medical approach. This approach is undoubtedly engrained in the Christian tradition,
p.000239: although there is a temptation to relegate it to a level of merely agreement relationship. At the same time one should
p.000239: admit that a more conventional “pattern like” model of physician and patient relationship which is fairly criticized
...
p.000283: (XIV-XV c.), Ali Kushchi (XV c.), Abu Ali Ibn Sina and others.
p.000283: Ethics as a scientific trend had a significant place in works of prominent oriental thinkers, and Ali Ibn Sina
p.000283: (Abu Ali al-Husain ibn Sina-e Balkhi (Latinized Avicenna) one of them; a philosopher, musician, poet, physician,
p.000283: the follower of Aristotle, he was a scientist of encyclopaedic knowledge and one of the greatest minds of the Middle
p.000283: Ages. Roger Bacon was certainly right when he wrote that Ibn Sina was “the greatest teacher of philosophy after
p.000283: Aristotle”. The Tajik by birth, he was born in the suburb of Bukhara
p.000283:
p.000284: 284
p.000284:
p.000285: 285
p.000285:
p.000285: (Afshon) in 980, lived in different cities of the Central Asia and Iran, served various rulers as a court
p.000285: physician and vizier, and died in 1037 near Hamadan.
p.000285: Abu Ali Ibn Sina wrote in the Arabic and Tajik languages. He left a rich scientific heritage – about 300 works, and
p.000285: among those “Book of Healing”, “Book of Knowledge”, “Book of Directions and Remarks”, “Book of Salvation” and
p.000285: “Canon of Medical Science”. The latter had been considered as one of the fundamental medical guidelines during
p.000285: five centuries. He was the author of works on philosophy (e.g. commentaries on Aristotle’s “Poetics”), wrote lyrical
p.000285: poetry, and some poems have survived to out time. Ibn Sina’s “Book of Healing” was the highest achievement of the
p.000285: medieval philosophy, particularly, as it tried to reconcile rationalistic thinking and religion. A great
p.000285: number of his works were translated into Latin in the second half of the XII century.
p.000285: “Book of Healing” in 18 volumes included “Logic”, “Poetics”, “Rhetoric”, “Physics” (in eight
p.000285: chapters; the sixth chapter was entitled “On the Soul”) and “Metaphysics”. Dominique Gundisalvi from
p.000285: Toledo completed the latter in 1180.
p.000285: Following Aristotle, Abu Ali Ibn Sina classified knowledge into theoretical and practical trends, and
p.000285: attributed ethics, economics and politics to the practical area. He considered problems of essence and existence in the
p.000285: light of Neoplatonism.
p.000285: The starting point of Aristotle’s ethical teaching was the theory that social life of human beings is realized
p.000285: in actions and in their interaction. Already in the first paragraph of “Great Ethics” Aristotle wrote that to act in
p.000285: social life, one should have certain ethical qualities and be a worthy man. To be a worthy man means to have virtues.
p.000285: Therefore, the one who intends to act in social and political life should be a virtuous man. Substance and form cannot
p.000285: exist independently, they are interconnected. In the so called “dispute of universalia”– one of the fundamental
p.000285: problems in medieval scholasticism – Abu Ali Ibn Sina followed Aristotle’s theory of interrelation of substance and
p.000285: form and believed that universalia exist both in things and in human mind. The latter elicits universalia from
...
p.000291: individual’s convictions. One of the factors that might limit the physician’s freedom in decision-making is the
p.000291: religious and cultural milieu that formed an individual’s consciousness. Without the knowledge of cultural details, a
p.000291: competent design of biomedical research in Tajikistan – a Moslem country and an officially secular State – is not
p.000291: possible. Besides, there are strong believers practicing Islam and observing all religious holidays. Thus, many
p.000291: people keep the strict fast during the Ramadan. In this period people suffering from severe diseases, refuse taking
p.000291: medicines both per os and by injection, which is harmful to their health. Thus, for example, patients who have had
p.000291: operations for glaucoma refuse courses of conservative supportive therapy or keep the fast, which weakens visual
p.000291: functions. Quite often during the Ramadan people
p.000291: get to the surgery department of the emergency station with pancreonecrosis after having a rich and fat meal (pilaw) in
p.000291: the night after fasting during the day. In some cases this situation has a lethal outcome. Islamic traditions dictate a
p.000291: respectful attitude to the human body even after a person’s death and therefore relatives of the deceased do not
p.000291: consent to the post-mortem examination and removal of organs for transplantation. According to Moslem religion, the
p.000291: soul of the embryo appears in the first week of the fourth month of pregnancy, and the law prohibits abortion after
p.000291: this term. Besides, Tajikistan population is not disposed to contraception measures or abortion, and therefore Tajik
p.000291: families are commonly having many children. When carrying out preventive health examination of strong believers, it is
p.000291: important to divide them into separate streams according to sex.
p.000291: Artificial fertilization in Tajikistan is permitted. It is desirable to use sperm of the woman’s husband provided that
p.000291: his consent has been obtained. There are no strict religious restrictions with regard to transplantation and removal
p.000291: donor organs. Sharia laws state that medical professionals should struggle for a patient’s life to the last moment and
p.000291: totally reject euthanasia. These and other similar examples emphasize the necessity to consider cultural
p.000291: aspects with regard to providing medical care and conducting biomedical research in Tajikistan.
p.000291: Biomedical research if conducted without considering cultural and religious aspects may have negative
...
Searching for indicator religious:
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p.000007: of the current conditions and perspectives of ethical review development in the CIS countries and will facilitate free
p.000007: exchange of knowledge in this field for the mutual benefit. By providing information on the CIS region potential for
p.000007: cooperation and education in the sphere of bioethics and biomedical research ethics, the project makes an important
p.000007: intellectual and informational contribution into UNESCO Global Ethics Observatory.
p.000007: Chapter 1. GEnERAL tEnDEnCIES
p.000007: oF tHE SoCIAL PoLICY AnD HUMAn RIGtHS In MEDICInE In tHE CIS CoUntRIES
p.000007:
p.000007: 1.1 Social and Demographic Factors (E.Yu.Vladimirova)
p.000007:
p.000007: To develop a system for the ethical review of biomedical research, we have to consider the current social and economic
p.000007: situation in the Commonwealth of Independent Countries. A state can ensure reproduction of population and a high level
p.000007: of a living standard for its residents if it does not participate in regulation of the current demographic situation
p.000007: and labour market.
p.000007: The demographic situation in the CIS countries has both common and specific features. Common features
p.000007: result from a long-term socio- economic crisis of the 1990s, discrepancy between introduced reforms and
p.000007: social policy, a dramatic decline in living standards at various social levels, and aggravation of ecological
p.000007: conditions. Specific features in each State are determined by different styles of life in the CIS countries due to
p.000007: their historical, religious, cultural and ethnic development. All these factors resulted in a general fertility rate
p.000007: decrease, mortality growth and a fall of the health quality index. These processes affect negatively the demographic,
p.000007: labour and migration potential of the CIS countries.
p.000007: The last decade of the XX century was characterized by an essential aggravation of the demographic situation that could
p.000007: be defined as a crisis. High mortality rates had practically no precedents in the Eurasian peacetime history. The
p.000007: “excess mortality” in the period since 1989 was much higher than the mortality rate in the period of Great Depression
p.000007: in the North America (1929-1933). Besides, recent changes of mortality rate, marriage ability and fertility shifts have
p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
...
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
p.000025: efficiency of social assistance programs by weight of amounts received by families beyond the poverty line in total
p.000025: amounts of social support).
p.000025: 1.2 Ethical and Legal Issues
p.000025: in the Field of Biology and Medicine (o.I.Kubar, B.G.Yudin, A.E.nikitina, E.Yu.Vladimirova)
p.000025:
p.000025: Characterizing trends of legal and ethical control in the sphere of practical health care and biomedical
p.000025: research in the CIS member states it is necessary to emphasize a multilevel system of factors determining common
p.000025: pattern of directions, characteristics, features and mechanisms of national and international, retrospective and
p.000025: perspective influence. A rationale for forming of the given community is geographical closeness, unity of political
p.000025: history of the pre-Soviet and Soviet periods, contingency and interpenetration of cultures and traditions, forming
p.000025: extreme ethnical, cultural and religious multiplicity making countries in the region different.
p.000025: By itself such multiplicity leads, in particular, to the following - the set of actual ethical norms being a basis for
p.000025: medical care in the region countries is a historical foundation and a clear reflection of tolerance concepts both to
p.000025: cultural differences as they are and to their particular carriers. Moreover, in this case we can talk not just about
p.000025: tolerance but also about respectful relationship to differences of that kind.
p.000025: One more factor, which should be taken into account when explaining closeness of ethical and legal basis of health
p.000025: care, is that other countries in the region inherited legal base that was established in the Soviet period of their
p.000025: history. It should be noted that the legal system existing in the USSR in the field of medicine and health care,
p.000025: first, was of declarative nature, and, second, paid insufficient attention to issues of protection of rights and
p.000025: dignity of both patients and participants of biomedical research.
p.000025: Therefore, after the USSR breakup and appearance of new independent states they faced tasks of development of new legal
p.000025: framework in the field of practical and experimental biomedicine. All CIS countries in different forms proclaimed such
p.000025: basic norms of state development as adherence to principles of a social state, which policy is directed for creation of
p.000025: conditions providing dignified life and free development of a man, acknowledgement of a person, his rights and freedoms
p.000025: as top values, while compliance with and protection of human and citizen rights and freedoms is a state obligation. In
...
p.000029: in the field of bioethics. Besides, all CIS countries have more or less main and similar resources for dynamic
p.000029: development of
p.000029: bioethics, and among them – teaching bioethics as a subject (mandatory or optional) in medical colleges and
p.000029: universities as well as at departments of philosophy in some of state universities; definite (though, in
p.000029: general, far from being sufficient) interest to ethical issues from the side of those working on legislation in the
p.000029: field of science and health care; development of corporate ethics and national associations on ethics;
p.000029: stimulating influence of research ethics; wider public interest to the bioethics issues being discussed in mass media.
p.000029: Besides factors of general social and economic development influencing peculiarity and unity of the situation in
p.000029: this sphere, global impact was provided by common cultural and educational environment based on both
p.000029: advanced humanistic traditions of medicine and on capabilities for interaction and mutual influence of
p.000029: different cultures in the given territorial and historical space. Such specifics exist despite considerable cultural
p.000029: and religious differences between populations of European and Central-Asian countries of CIS. In particular, it
p.000029: is necessary to mention influence of religious traditions in the Commonwealth countries on forming of bioethics
p.000029: models currently acting there as well as models of research ethics. Likeness in perception of moral and cultural values
p.000029: is built on the fact that among population of the CIS countries (mostly it is related to the Russian population) one
p.000029: can meet representatives of virtually all ethnical, religious and cultural groups existing in the region in general. It
p.000029: means that multiplicity that can be observed within the CIS countries to some extent repeats multiplicity of population
p.000029: of separate countries that is especially characteristic for scientific and medical creative environment formed during
p.000029: many years.
p.000029: It is really hard to overestimate a role, which is played by the factor of involvement of all Commonwealth
p.000029: countries in the process of global international interaction, for creation of single approaches to collaboration
p.000029: in ethical and legal sphere. It is related both to incorporation by the new independent states into their legal systems
p.000029: of a set of international ethical and legal acts which they joined to during existence of a single country, the USSR,
p.000029: and to modern involvement of the CIS countries into international legal and informational environment. It appears to be
p.000029: of tremendous importance that officially each of the countries declared adherence to all major norms and principles
p.000029: stipulated by such international and legal documents as the Nuremberg Code of 1947, the Declaration of Helsinki of the
p.000029: World Medical
p.000029:
p.000030: 30
p.000030:
p.000031: 31
p.000031:
p.000031: Association (WMA) of 1964 with amendments, International Ethical Guidelines for Biomedical Research Involving
p.000031: Human Subjects developed by CIOMS and WHO in 1982 and amended in 1993 and 2000, International Guidelines for Ethical
...
p.000031: approved by all Commonwealth countries. International cooperation in the field of bioethics is implemented also
p.000031: through formation of regional programs and Centres of bioethics and research ethics with involvement of
p.000031: international organizations being leaders in this field. A convincing example of such cooperation is a setup of
p.000031: national committees of bioethics with UNESCO support in some of the Commonwealth countries and planned scientific and
p.000031: educational activities of the UNESCO office in Moscow and some other countries in the region
p.000031: being held in context of national, social and cultural, historical and political traditions and utilization of the
p.000031: world experience in the field of bioethics.
p.000031: In 2001 animportant bioethical resource, the Forumfor Ethics Committees in the CIS (FECCIS), was established in the
p.000031: region. The FECCIS is one of five regional forums created within the framework of the WHO project, the Strategic
p.000031: Initiative for Developing Capacity in Ethical Review (SIDCER). Sharing main priorities of the WHO SIDCER project on
p.000031: protection of the rights and dignity of research subjects in all countries in the world basing on respect to cultural,
p.000031: religious and national differences the FECCIS seeks the main task of facilitating development of bioethics in the
p.000031: region of the CIS countries, paying specific attention to ethics of biomedical research involving human
p.000031: subjects. During all its years of existence (2001–2007) the Forum activities were directed on development of regulatory
p.000031: and methodical basis on research ethics; development and implementation of education programs for members of
p.000031: ethical committees; development of information space and extensive dialogue with various parties involved in ethical
p.000031: review of biomedical research that, certainly, facilitated harmonization of both regional and global
p.000031: international approaches to establishment of ethical standards in biology and medicine. Besides, notable value for
p.000031: adaptation and improvement of universal ethical principles has the representation of some of the CIS countries in
p.000031: several international entities, for instance, such highly respected agency as the Council of Europe, in particular, in
p.000031: the structure of the Steering Committee on Bioethics (CDBI) responsible for development of multiple documents, mainly,
p.000031: the legal ones, on protection of rights and dignity of human subjects in research and medical care.
p.000031: Consolidation of efforts and mutually enriching knowledge exchange take place also at the stage of regional or
p.000031: bilateral cooperation with international facilities and leading world specialists in the field of ethics through
p.000031: trainings, joint researches and discussions.
...
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
p.000033: state becomes a guarantor for protection of personal rights and freedoms. Other directions of the state
p.000033: policy in social sphere are also extremely important for provision of human rights in the area of health care and
p.000033: biomedical research.
p.000033: 9 The Constitution of Kyrgyz Republic also mentions psychological tests in this list (Art.18 of the Constitution of
p.000033: Kyrgyz Republic). Since there is almost no special legal regulations within the regions of the CIS countries for such
p.000033: sphere of biomedical research as psychological studies this fact has a special value. Such constitutional statement can
p.000033: become a basis for independent regulation of the given type of experiments.
p.000033: 10 Art. 16 and Art. 24 of the Constitutions of Kyrgyz Republic and the Republic of Moldova, respectively.
p.000033: The right for protection of health and its state support are legally fixed in all Commonwealth countries (Art. 34 of
p.000033: the Constitution of the Republic of Armenia, Art. 41 of the Constitution of the Republic of Azerbaijan, Art. 45 of the
p.000033: Constitution of the Republic of Belarus, Art. 37 of the Constitution of Georgia, Art. 29 of the Constitution of the
p.000033: Republic of Kazakhstan, Art. 34 of the Constitution of the Kyrgyz Republic, Art. 36 of the Constitution of the
p.000033: Republic of Moldova, Art. 41 of the Constitution of the Russian Federation, Art. 38 of the Constitution of the
...
p.000037:
p.000037: usually, perform ethical examination of research projects are created and work subjected to central executive
p.000037: authorities (usually these are ministries regulating activities in the sphere of health care, labor, social policy,
p.000037: etc.; in some of the countries these are national academies of sciences). There are also regional and local ethical
p.000037: committees at scientific medical Centres as well as committees at professional medical societies. In some of the
p.000037: countries the research ethics committees have a function of consulting higher state authorities on issues for
p.000037: development of policies in health care as well as resolving conflicts associated with routine medical practice.
p.000037: Participation of all CIS countries in the process of moral and ethical professional resolution of medical practical and
p.000037: research activities appears to be important. Many of the Commonwealth countries have already adopted or are developing
p.000037: ethical codes for medical and pharmaceutical workers, have approved national oaths for medical school graduates,
p.000037: ethical codes for medical doctors15. These codes and oaths provide higher vs. the legal enactments ethical
p.000037: standards for behavior of representatives of medical profession and are related to both relationships of doctors with
p.000037: their patients, with third party persons and to intracorporate relations.
p.000037: Analyzing trends in development of ethical and legal control of biomedical activities in the Commonwealth
p.000037: countries one cannot but mention influence of religious tradition on this process. For instance, in some
p.000037: of the Central Middle Asia countries daily practice of medical workers and researchers to a large extent is based on
p.000037: norms of the Koran, Shariat, Hadises. An important role as a guideline for national policy formation in the field of
p.000037: ethical examination development of biomedical studies as well as for protection of the rights of patients and study
p.000037: subjects is played by the Code of Islam medical ethics. Countries with prevailing Orthodox religious tradition showed
p.000037: that a significant role for ethical consideration of medical science and practices is dedicated to Basics of the Social
p.000037: Concept of the Russian Orthodox Church (2000) containing official position on many of the most arguable bioethical
p.000037: issues.
p.000037: 15 For instance, The Code of Medical Ethics of Armenia, The Ethical Code of Medical Doctor of Georgia, The Ethical
p.000037: Code of Pharmacists of the Kyrgyz Republic, The Ethical Code of Nurse of Russia, The Oath of Medical Doctor of Russia,
p.000037: The Medical Ethics Code of Russia. In Uzbekistan the code on bioethics issues is under development, in Kazakhstan they
p.000037: started to develop The Code on National Health and the Health Care System, in 2007 it is planned to adopt The Ethical
p.000037: Code of Medical Doctor of the Republic of Kazakhstan.
p.000037: Features mentioned above illustrating specific properties of legal and ethical regulation are, mostly, in accord
p.000037: with general direction in legal development of the Commonwealth countries as socially-oriented states.
p.000037: Considering a social state as the most beneficial way for combination of fundamentals of freedom and power for
p.000037: provision of personal well-being and social wealth there is a real possibility for reaching social justice and
p.000037: solidarity. Translating the given point at the language of conflicts of interests that appear at the pace of scientific
p.000037: and technological progress in any sphere of human activities (including biology and medicine), one can notice
...
p.000043: Texts of the model laws of IPA CIS are available at the web site: www.iacis.ru/html, the text of the model
p.000043: law of IPA CIS On Protection of Human Rights and Dignity in Biomedical Researches in the CIS and the text of
p.000043: the model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS can be also
p.000043: found at the following web sites: www. feccis.net and www.pasteur-nii.spb.ru
p.000043:
p.000044: 44
p.000044:
p.000045: 45
p.000045:
p.000045: Chapter 2. CURREnt StAtUS AnD PERSPECtIVE oF tHE CIS’ REGIon PARtICIPAtIon
p.000045: In tHE IntERnAtIonAL BIoMEDICAL RESEARCH
p.000045:
p.000045: 2.1 Philosophical Aspects of the Biomedical Research (P.D.tishchenko, B.G.Yudin)
p.000045:
p.000045:
p.000045: Philosophy of modern biomedical research (BMR) is a limitless topic with multiplicity of versatile aspects. Here we
p.000045: would like to dwell on those of them that are to some extent are related to issues of ethical examination
p.000045:
p.000045: Specific Position of Science in the Modern Culture
p.000045: Understanding of trends of development of the modern biomedical research is impossible without taking
p.000045: into account on-going general civilization transformations of our days. First of all, let’s take a look at the
p.000045: most general context of the issue.
p.000045: In this respect it is necessary to remind about a central role that science have played and still plays in the modern
p.000045: culture. As to exact expression by E. Husserl: “When at the beginning of the New Age religious belief began
p.000045: to degenerate more and more into lifeless convention, intellectual humanity stood in a new great faith –
p.000045: faith into autonomous philosophy and science. Scientific judgments were to highlight and guide entire human culture
p.000045: providing it with new autonomous form.” (Husserl E. Cartesian Meditations, p.14). If to take into account that
p.000045: ideology of new European education to a large extent is a gradual process of mastering the system of scientific
p.000045: knowledge, then without exaggeration one can say that the modern man (unlike a person in the Christian culture) is
p.000045: created “in the image and likeness of a scientist”.
p.000045: The leading position of science is retained and considerably strengthened gaining qualitatively new forms. Along
p.000045: with that, in the modern cultural situation science becomes more tolerant to other forms of cognition
p.000045: and comprehending of the reality. Ideas, concepts and practices that several decades ago were considered
p.000045: as superstitions are rehabilitated and gain status of fully-developed modern doctrines. In the whole world
p.000045: one can
p.000045: observe revival of archaic (shamanism, cabala and other esoteric practices) and creation of new non-scientific
...
p.000059: an owner of knowledge was an individual scientist. Idea of his personal responsibility corresponded to
p.000059: such state of affairs. In biotech companies there appears corporate ownership of gained knowledge. Space of
p.000059: personal responsibility shrinks dramatically. But at the same time there emerges idea of collective (corporate)
p.000059: responsibility or accountability to the society. From the point of view of ethics there appears a new type
p.000059: of a moral subject (“businessman scientist”), for whom similarly doubled ethos is characteristic. In English
p.000059: publications oppositions of these two ethos’s features is sometimes fixed in terminological sense as a relation of
p.000059: personal responsibility and corporate accountability for the society.
p.000059: From the R.Merton’s point of view scientific society ethos includes the following principles:
p.000059: 1. “Communism (collectivism)” – knowledge as a result of scientific activity is a public domain. Any scientific
p.000059: knowledge is built upon results of previous studies. Therefore, a scientist should comprehend himself as a
p.000059: member of scientific society who is able of implementing his destiny only cooperating with other. His duty is
p.000059: to share unselfishly his scientific results with other scientists and publish them in publications available to the
p.000059: public.
p.000059: 2. “Universalism” – assessment of importance of scientific achievements of a scientist should be based exclusively upon
p.000059: their objective assessments, irrelevantly to his nationality, association with this or that scientific
p.000059: institution, personal features, religious or political views.
p.000059: 3. “Disinterest” – scientific research shall be motivated only with a desire to arrive at the truth. It is
p.000059: necessary to exclude all non-scientific interests – economical, political, religious, and etc.
p.000059: 4. “Established skepticism” – researchers must be critical to results of work not only of others but also of their own.
p.000059: Only basing on systematical criticism scientific ideas can get rid of errors and come closer to the truth. A duty of a
p.000059: scientist is to question constantly obtained results.
p.000059: These aforementioned four Merton’s principles form scientific society ethos. The word “ethos” underlines the fact that
p.000059: principles are, at the same time, ethical standards for self-perfection of a scientist and methodological rules
p.000059: providing arrival at the truth.
p.000059: What is specificity of scientific ethos as a corporate activity at the market of knowledge and technologies?
p.000059: In other words, what is specificity of scientific society ethos where a hybrid of a scientist and a businessman is a
p.000059: subject?
p.000059: Ethos of this two-faced Janus is also similarly two-faced. Since science does not terminate to be science, than
p.000059: self-consciousness of scientists retains moral and methodological importance of principles formulated by Merton.
p.000059: However, these principles in cases when “a scientist” starts to play a role of a businessman are limited and appended
p.000059: with a system of other principles. This system was for the first time described by the American sociologist of
p.000059: science, Jan Mitroff, at the 70’s of the last century when a policy of commercialization in various
p.000059: spheres of scientific studies was launched. To some extent, these principles are directly opposite to the
p.000059: ones stated
p.000059:
p.000060: 60
p.000060:
p.000061: 61
p.000061:
p.000061: by Merton. In regard to reality of biotechnological science the Mitroff’s principles can be stated as
p.000061: follows:
...
p.000083: field with potentials for a differential education of various population groups aiming at raising the
p.000083: level of public knowledge about human rights and moral responsibility in biomedical research.
p.000083: In the history of establishing a system of ethical review and ethics committees in the region the
p.000083: performance of the mentioned Forum for Ethics Committees in the Commonwealth of Independent States takes a
p.000083: special place as a public movement aiming at fulfilling this task in the region via creating a possibility for the
p.000083: access to the world experience in the development of ethical concept of biomedical research considering national
p.000083: cultural and moral values.
p.000083: The FECCIS was established on 21 of March 2001 according to the Resolution of the Conference for representatives of
p.000083: ethics committees and others authorized bodies from the CIS countries held in Saint-Petersburg, Russia. The FECCIS is
p.000083: one of the five regional forums, established in the framework of the WHO/SIDCER project.
p.000083: Sharing the basic priorities of the SIDCER project referring to the protection of human rights and dignity in
p.000083: biomedical research all over the world with respect to cultural, historical, religious and social differences, the
p.000083: FECCIS has defined as its the main objective to support the development of bioethics in the region with an emphasis on
p.000083: ethics of biomedical research involving human subjects.
p.000083: Over the period 2001-2006, the FECCIS activity has been directed to developing legislative and normative
p.000083: system in the field of research ethics, working out and implementing educational programmes for the EC
p.000083: members, developing informational space and a dialogue with all interested parties participating in the review of
p.000083: biomedical research.
p.000083: With regard to the legislative initiative, FECCIS, as mentioned above, has been concentrating its efforts on
p.000083: working out a legislative basis for protecting human rights in biomedical research through collaboration with the
p.000083: Permanent Commission on Social Policy and Human Rights of the Inter– Parliamentary Assembly of the Confederation of
p.000083: the Independent States. This collaboration resulted in the development of the IPA CIS model Law ‘On the Protection
p.000083: of Human Rights and Dignity in Biomedical Research in the CIS’ adopted in 2005 (see Chapters 1.2 and 2.2). In
p.000083: collaboration with the Permanent Commission on Science and Education of the IPA CIS the FECCIS worked out Model
p.000083: recommendations “ On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS “.
...
p.000085: medical practice in the region;
p.000085: • the performance as a regional centre for cooperation in the field of ethical review development;
p.000085:
p.000086: 86
p.000086:
p.000087: 87
p.000087:
p.000087: • assistance in the practical application of the SOPs for ethical review in the region in compliance with
p.000087: Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO, 2002);
p.000087: • coordination of the CIS countries in the sphere of bioethical issues and ethical review of biomedical research in
p.000087: the region.
p.000087: Summarizing the above said we should recognize that the history of the development of the system for ethical review of
p.000087: biomedical research in the CIS countries is a dialectic process of ethical and legal development of the national
p.000087: consciousness and legislation directed towards protecting rights, dignity and autonomy of an individual as a
p.000087: biomedical research subject, and providing moral and ethical guarantees to the society that biomedical research is
p.000087: conducted in a strict conformity with universal ethical standards.
p.000087: Chapter 3. EtHICAL REVIEW SYStEM FoR BIoMEDICAL RESEARCH
p.000087: In tHE CIS CoUntRIES
p.000087:
p.000087: 3.1 REPUBLIC oF ARMEnIA (G.D.Aslanyan, S.A.Davtyan)
p.000087:
p.000087: 3.1.1 Historical and Cultural Background
p.000087:
p.000087: Like any new field of knowledge related to the rise or appearance in the foreground of some new realities in the life
p.000087: of our society, bioethics needs to be considered first of all from the historical, cultural and religious perspective.
p.000087: Republic of Armenia is rich in objects of unsurpassed art. There are over 4000 monuments of architecture at the
p.000087: territory of today’s Armenia. “Armenian history, – wrote Valery Briusov, a Russian poet, – is as noteworthy as the
p.000087: history of the most famous peoples of the world, including Egyptians and peoples of today’s Europe, who made their
p.000087: unique contributions into the world culture”.
p.000087: “If asked in what place of the world one is likely to find the greatest number of wonders, I would name Armenia first
p.000087: of all. Here, in this tiny
p.000087: corner of the world, you can see monuments and meet people which can become treasure and pride for the world” (Rockwell
p.000087: Kent).
p.000087: Although much of cultural and artistic wealth of Medieval Armenia, including manuscripts, had been destroyed over ages
p.000087: by different invaders, around 24 thousands of manuscripts have survived to our time, and about half of them is
p.000087: currently kept at the Matenadaran Institute of Ancient Manuscripts named after Mesrop Mashtots in Yerevan. According to
p.000087: historian Ghazar Parbetsi (V c.) that was the most ancient collection formed already in the Vc. in Echmiadzin
p.000087: Patriarchy. One third of the survived manuscript collection is illuminated manuscripts. Among those, many concern
p.000087: problems of ethics, morals and law.
p.000087: Armenian culture roots back to the great antiquity, which is proved by numerous petroglyphs in Armenian Plateau,
p.000087: stone and bronze statuettes, skillfully decorated wooden carts, ornamented arm, ceramic and glass ware. In
...
p.000113: its leading representatives of ethical and philosophical thought inherited the most essential tendencies in
p.000113: the development of European ethical theories, while the applied moral was, to a certain extent, influenced by
p.000113: Eastern traditions.
p.000113: Ethical ideology in Belarus roots back to the IX-XI centuries, and initially it was based on primitive
p.000113: magic, shamanism, pagan worship. Ethical ideas as such began to form only in the XI-XII centuries after the adoption
p.000113: of Christianity. Such thinkers as Evfrosinia Polotskaya and Kirill Turovsky, who were instilling Christian ideas in
p.000113: Byelorussia and polemized with heresy and paganism, were widely known for their enlightening activity. They
p.000113: were preaching the Bible commandments of love, kindness and unity. In the XIII-XVI centuries, when the territory of
p.000113: Belarus became a part of the Grand Duchy of Lithuania that later united with the Kingdom of Poland and formed the
p.000113: Polish-Lithuanian Commonwealth, works of Belarus philosophers Francis Scorina, Symon Budny and Vasily Tiapinsky
p.000113: reflected topical ideas of West-European culture, particularly, the idea of humanism. In the period of
p.000113: counter-Reformation (XVI-XVII c) Jesuit colleges and catholic universities actively used the rationalistic
p.000113: heritage of medieval scholastic ethics, and ethical teachings of Aristotle and Thomas of Aquinas were very popular
p.000113: among the educated part of Belarus population. The idea of the Unia (union) of Orthodoxy and Catholicism under the
p.000113: aegis of the Pope carried in itself ethical and philosophical values of religious tolerance. In the XVI-XVII
p.000113: centuries Orthodox communities also did extensive teaching popularizing the most important achievements of
p.000113: West-European countries among Orthodox believers in Belarus. Simeon Polotsky, one of the most outstanding figures in
p.000113: Belarus culture of that period, compiled a collection of poems that formulated, in a poetic form, basic ethical and
p.000113: moral principles of the Orthodoxy. The end of the XVIII and the beginning of the
p.000113: XIX century was marked by naturalistic ethical concepts that resulted from the development of exact and natural
p.000113: sciences and considered ethics in the spirit of theories of “natural law”, “social contract” and “rational egoism”
p.000113: asserting the necessity of universal secular education.
p.000113: After the October revolution and the collapse of the Russian Empire Belarus became Belarusian People’s Republic. The
p.000113: second decade of the XX century was characterized by a rapid growth of national self-awareness. Specific ethical
p.000113: traditions of the Belarusian ethnos and moral aspects of the revival of the Belarusian culture, as well as closeness to
p.000113: nature and healthy moral relations, were widely discussed and reflected in works by such thinkers and poets
p.000113: as F.Bogushevich, A.Pashkevich, Y.Kupala, Y.Kolas. However later, during the Soviet period, ethical thought in
p.000113: Belarusian SSR had been in conformity with the general authoritarian trend.
p.000113: In the last decade of the XX century the developments of Belarus ethics was marked with pluralism and
...
p.000125:
p.000126: 126
p.000126:
p.000127: 127
p.000127:
p.000127: With regard to bioethical education, we believe that it is essential to develop the ability to reflect on
p.000127: problems of human life and death, to form an understanding of the necessity to follow principles and rules of
p.000127: biomedical ethics in professional activity, to combine reason and feelings, intuition and logic, emotions and
p.000127: intellectual efforts. To achieve this goal, we have to define the problems we choose for bioethical education. From a
p.000127: variety of topics arising due to the development of biology, medicine and practical healthcare we chose
p.000127: most essential problems consistent with the principles of a system and holistic approach. Besides, to analyze
p.000127: ethical situations, we need to select from the whole volume of special knowledge sections that are most
p.000127: ethics-orientated and provide ethical and humanitarian comments by ethicists.
p.000127: At the same time, we are searching for interdisciplinary approaches to bring moral and ethical norms in conformity with
p.000127: the current medical and biological reality.
p.000127: An important achievement of the BSMU is that already at the stage of pre- clinical training medical students
p.000127: participate in resolving ethical problems relating to using dead human bodies in the teaching process and experiments
p.000127: on animals [14, 20]. In the course on human anatomy students are informed about legal, ethical and religious aspects of
p.000127: using a dead body of separate organs for an educational or scientific purpose. Learning ethical norms of handling
p.000127: anatomic preparations facilitates the development of the most essential humanistic quality – respect for a human
p.000127: being. Humane attitude to animals involved in experiments is very important for the development of compassion and
p.000127: empathy. Implementation of teaching aids alternative to experiments (computer programmes of experiments on virtual
p.000127: animals, video-films, CDs, three-dimensional models, etc.) allowed to exclude or minimize experiments on
p.000127: animals. As the result, students see that ethical principles are not merely postulated but implemented in practice.
p.000127: Medical students acquire bioethical knowledge out of class as well. Students of BSMU participate actively in
p.000127: the hospice movement. During several years they have been taking part in the BACCUP Programme at the Cardiff
p.000127: Medical University working as volunteers together with British medical students in summer holidays.
p.000127: Problems of bioethics, medical deontology and clinical ethics in medical practice can be successfully resolved only if
p.000127: medical professionals know the
p.000127: current legislation referring to healthcare. Therefore it is necessary, firstly, to regulate norms of medical activity
p.000127: according to new conditions in practical healthcare, and, secondly, to provide legal knowledge to medical specialists.
p.000127: Sociological surveys carried out in Belarus showed that, unfortunately, medical students, as a rule, do
...
p.000171: 4) development and implementation of measures for improvement of the process of ethical assessment.
p.000171: The main functions of regional commissions are as follows:
p.000171: 1) assessment and coordination of the activity of local commissions responsible for ethical reviews of
p.000171: clinical trials;
p.000171: 2) arbitration of complex aspects on ethical assessment performed by local commissions;
p.000171: 3) registration of clinical trials that are performed in the province or in the city;
p.000171: 4) counseling of members of local commissions.
p.000171: The main functions of local commissions responsible for ethical reviews are as follows:
p.000171: 1) performance of ethical assessment of all documentation on clinical trials;
p.000171:
p.000171:
p.000172: 172
p.000172:
p.000173: 173
p.000173:
p.000173: 2) performance of ethical assessment of all changes and additions to documentation on clinical trials;
p.000173: 3) conclusions on agreement or refusal for the beginning or continuation of clinical trials;
p.000173: 4) assessment of following ethical, moral and juridical norms in the process of clinical trials and after
p.000173: their end.
p.000173: The commission should include sufficient number of members that would have the necessary experience and
p.000173: qualification to be able to assess all ethical, moral and juridical aspects of planned research; besides commission
p.000173: members should be independent of researches and sponsors and should not participate in the planned
p.000173: clinical research. The commission should include at least 5 members, namely specialists that are competent
p.000173: in the area of clinical trials as well as persons who are not researches themselves, specialist in legislation,
p.000173: representatives of religious community and of non- governmental organizations; the commission should include
p.000173: males and females of different age groups.
p.000173:
p.000173: 3.5.3. Education in Bioethics
p.000173:
p.000173: During the last decades due to new approaches to moral and ethical problems in medicine and science,
p.000173: development of bioethics as a interdisciplinary field, it was necessary to revise the respective educational
p.000173: programmes at all levels.
p.000173: The science “Bioethics” as a separate science was not included in the State standard of university medical education in
p.000173: the Republic of Kazakhstan, but many aspects related to bioethics were included in other programmes (specialties). For
p.000173: example, at the Semipalatinsk State Medical Academy problems of biomedical ethics were included in the programme
p.000173: of discipline “Communicative skills” at the department of internal diseases. At the moment special training
p.000173: programme is under the process of development. At the Kazakhstan State Medical Academy (in Astana) problems of
p.000173: biomedical ethics were included in the training programme at the department of public health. Similar situation took
p.000173: place in other medical universities of the country. In December 2006 the Scientific Council of the Almaty
p.000173: Institute for Postgraduate Training has decided to organize the Department of health legislation and bioethics in
p.000173: 2007. It will allow to introduce widely into
...
p.000181: with stronger neighboring states. Severe war conditions required from men who were admitted to military
p.000181: of people’s life. Over many ages, people’s ideals have been associated
p.000181:
p.000181:
p.000181: with “Manas”; ethical norms and concepts of the good and the evil were exemplified by the acts and deeds of “Manas”
p.000181: characters.
p.000181: 19 The word eudemonism comes from the Greek word for happiness or flourishing
p.000181: (eudaimonia), and refers to any conception of ethics that puts human happiness and the complete life of
p.000181: the individual at the Centre of ethical concern.
p.000181:
p.000181:
p.000182: 182
p.000182:
p.000183: 183
p.000183:
p.000183: service not only physical strength, but also moral maturity. Wars depicted in “Manas” and episodes associated with
p.000183: those exemplify heroic traditions implying the observance of the rule of military necessity and an innate
p.000183: aversion to violence, as well as a wish to live in peace. Kyrgyz warriors regarded their sacred duty not to harm
p.000183: peaceful population of conquered peoples. It was forbidden to plunder or humiliate them. Thus an epic sage Bakai
p.000183: addresses his warriors:
p.000183: “Do not thou slaughter their cattle more that thou need for food, A foe today may be kinsman tomorrow,
p.000183: Do not thou harm them”.
p.000183: The early Kyrgyzstan was located on the crossroad of the Great Silk Road routs, which made it “a bastion of
p.000183: religious syncretism” where representatives of different confessions could coexist. This is, perhaps, the
p.000183: reason for a remarkable tolerance in the Kyrgyz in relation to other confessions and cultures of people
p.000183: inhabiting Kyrgyzstan.
p.000183: “The Beneficial Knowledge” by Jusup Balasagyn (XI c.) is another treasure of the Kyrgyz. The treatise was so
p.000183: perfect that in China it was titled “The Code of Decent Men”, in Iran – “The Book of Shahs” and in Turania
p.000183: – “The Book of Precepts for Rulers”. For Turkic peoples “The Beneficial Knowledge” “was as much important as “Lay of
p.000183: Igor’s Warfare” for Slavic peoples” (Naum Grebnev).
p.000183: “The Beneficial Knowledge” covers problems of sociology, ethics, aesthetics, theology and social psychology. It
p.000183: presents a sum of knowledge in different fields of science and culture of that time. The treatise presents a
p.000183: comprehensive system setting forth and analyzing philosophical problems relating to sense and meaning of human life. It
p.000183: defines human duties and norms of behaviour in the community and reflects “moral and ethical ideals with regard to
p.000183: life-style, culture and ideology of settled Turkic peoples still retaining the memories about their nomadic
p.000183: civilization” [13].
p.000183: According to “The Beneficial Knowledge” just and fair laws are the cardinal mechanism ensuring stability in the
p.000183: society, and everyone, be it a ruler or a subject should follow the laws.
p.000183: Law rules the world – we shan’t forget this, It is a sign of humanity inherent in people.
p.000183: In its character, “The Beneficial Knowledge” is an ethical and didactic poem written with the purpose to show the way
p.000183: towards learning the wisdom
...
p.000207: master (daily) training in bioethical sphere where graduates of philosophic, medical, theological, agricultural and
p.000207: other department study. After graduation and successful defense of works they are conferred the degree of doctor or
p.000207: doctor habilitate of philosophic science (majoring in bioethics) and master on bioethics, respectively.
p.000207: If we are to continue to develop our ideas related to organization of training process in bioethical knowledge in
p.000207: our country it is necessary
p.000207:
p.000208: 208
p.000208:
p.000209: 209
p.000209:
p.000209: to especially stress the work of the Department, Association and the National Bioethics Centre in
p.000209: popularization of this phenomenon among the population of the Republic and primarily among the youth.
p.000209: Introduction into Bioethics program is of special popularity among the radio and television auditoria. Over
p.000209: last 3 years the personnel of the Centre and the Department organized and held about 20 talks (radio and television) of
p.000209: 15 to 45 minutes each on basic themes of this type of practical philosophy. Such programs as Bioethics –
p.000209: The Science of Survival, Euthanasia from the Point of View of Bioethics, Cloning in the Contest of Bioethics,
p.000209: Bioethical Aspects of Artificial Human Reproduction, Experiments in Humans and Animals in Biomedical Sphere:
p.000209: Bioethical Aspects, Religion and Bioethics and other with participation of bioethics specialists, biologists,
p.000209: medics and religious theologists can be marked among them, as well as From Anthropocentrism to
p.000209: Biospherocentrism, Backgrounds of Bioethics, From Ethics to Biological Ethics, Abortion and Bioethics, Bioethical
p.000209: Education of Society – Requirement of the Human Survival Strategy, Transplantology and Bioethics, Human Genome and
p.000209: Bioethics, Biomedical and Spiritual World: Comparative Analysis, Principles and Imperatives of Bioethics,
p.000209: Paternalism and Antipaternalism in Human Activity, Informative Consent and Interpretation in Medical Practice and
p.000209: others.. Here we started to check the interest in some ideas from social bioethics, such as Senility and Bioethics,
p.000209: Terrorism and Bioethics, Homosexualism, Transsexualism and Travestism in the Contest of Bioethics, Suicide and
p.000209: Bioethics, Homeless in the Light of Bioethics, Bioethics and AIDS, People with Physical Incapability in the Light of
p.000209: Bioethics, Asceticism and Bioethical Knowledge, Sadism and Masochism in the Contest of Bioethics etc. All that promotes
p.000209: propaganda of bioethical knowledge among the population both of the cities and rural settlements, formation of skill to
p.000209: care about living and biosphere in general.
p.000209: Periodicals with regular publication of interviews, articles and, for
p.000209: example, such newspapers as Komsomolskaya Pravda, Argumenty i Fakty, Nezavisimaya Moldova, Făclia, Moldova
p.000209: Suverană, Literatura şi arta are used to the same extent, i.e. for propaganda and promotion of knowledge
...
p.000213: take into consideration or not (however, pursuant to the GCP regulations absence of the ethics committee permit is a
p.000213: ground for prohibition actions of controlling and regulatory bodies).
p.000213: General aspects of the operation of the ethics committee are as follows:
p.000213: a) independence of the parties participating in the research;
p.000213: b) non-pursuing commercial or any other tangible interests;
p.000213: c) being a public body with certain authorities provided by the law, such as:
p.000213: • to review documents related to conduct of clinical researches and, when necessary, to require amending or altering
p.000213: the documents;
p.000213: • to make decision on possibility to perform or to continue clinical research;
p.000213: • to control how CT is performed.
p.000213: For its work the NEC elaborated and observes strictly its standard operation procedures governed by
p.000213: international and national laws for clinical researches. SOP are fixed on paper, create principles and regulations
p.000213: for committee activities. That is why researches and study sponsors pay to them more attention. Published collections
p.000213: of SOP allow improvement of the ethics review process by means of methodological and legal integrity of structure and
p.000213: functions of the Ethics Committee.
p.000213:
p.000214: 214
p.000214:
p.000215: 215
p.000215:
p.000215: Ethical standard for operation of the NEC in the country is worked out based on mutual respect to cultural,
p.000215: religious, national differences and acknowledgement of universal values. Elaborated national collection of SOP is a
p.000215: logical stage of the further introduction of Operational Guidelines for Ethics Committees that review of biomedical
p.000215: researches (WHO, 2000) into daily practice of the NEC that provides methodological uniformity of these documents and
p.000215: their grounding on fundamental international principles of ethical review.
p.000215: The NEC consists of people with experience and qualification for valuation of scientific, medical and ethical
p.000215: aspects of CT, well acquainted with cultural and ethnical traditions of the country population, which supposedly would
p.000215: be involved in research. To solve special issues an ethical committee attracts when necessary experts – not members of
p.000215: the committee.
p.000215: Clinical research materials are presented to a committee by researchers responsible for scientific and ethical
p.000215: aspects of the research or by the client representatives (qualified specialist capable to explain all aspects of
p.000215: the research). An applicant shall provide all documentation necessary for complete and detailed valuation by the
p.000215: Committee. Pursuant to the GCP requirements the following documents are filed to the ethics committee:
p.000215: - application for review of clinical research materials;
p.000215: - clinical research protocol with all annexes and supplements
p.000215: - brief description of the protocol;
p.000215: - investigator’s brochure;
p.000215: - information on researches including curriculum vitae and other necessary data;
...
p.000221:
p.000221: some experience in this sphere was gained. At least, our Department as well as plenty of other groups from other
p.000221: countries are ready to participate in such project. It would be rational and useful to organize regular educational and
p.000221: methodical workshops for professors lecturing bioethics in scientific Centres of different CIS countries (Kiev, Moscow,
p.000221: Chisinau, Baku, Yerevan, etc.)
p.000221: We also consider as useful the initiative of Moscow colleagues with participation of other CIS countries on
p.000221: development of a training course in bioethics for highest qualification specialists with duration of 320 academic hours
p.000221: (it is possible to reduce the time if to consider that information sciences and foreign languages were already taught
p.000221: to young university professors of higher educational facilities). This is the beginning of the large work and we hope
p.000221: to see it finished in the nearest future as a good example of cooperation among the CIS countries.
p.000221: 3.8 RUSSIAn FEDERAtIon (G.L.Mikirtichian, A.F.nikitina, A.S.Sozinov,
p.000221: M.E.Guryleva, E.A.Malysheva)
p.000221:
p.000221: 3.8.1 Historical and Cultural Background
p.000221:
p.000221: During the period of its existence Russian medicine has accumulated the great volume of ethic knowledge both in
p.000221: theoretical research and in practice. Founding and development of medical ethics as predecessor of bioethics in Russia
p.000221: was determined by social and economical factors, historical, cultural and national features, religious and moral
p.000221: traditions of the peoples living over the country.
p.000221: Chapter 5 From the beginning Russia was multinational state with multinational neighbors. This
p.000221: multinationality influenced the foundation of Russian culture. Geographical position of the state at the junction of
p.000221: Europe and Asia resulted in ambivalence of people nature and state organization as European as Asian and gave birth to
p.000221: a philosophical concept of eurasianism, that was founded by one of the most universal Russian thinkers
p.000221: abroad N.S.Trubetskoy (1890-1938). D.L.Lihachev believed that universality and belonging to East and West were
p.000221: the most characteristic features of the Russian culture (14). Junction of East and West civilizations, crossing of
p.000221: two pole streams of culture, which pushed off each other and could not be joined but co-existed, have determined such
p.000221: features of Russian soul, as its polarity, apocalyptic character and nihilism, which “do not admit a middle kingdom of
p.000221: the culture” (1).
p.000221: Habitat, the geographical position, nature and climate where people were settled in the result of
p.000221: historical processes of moving and settling, determined the formation of Russian national character. Famous
p.000221: historian V.O.Kluchevskiy believed that external nature always and everywhere determines the mankind in
p.000221: different way. The different determination specified features of people, first of all everyday and mental, which
p.000221: form the national character; in this case they are the humanitarian foundations characterizing Russians (9).
p.000221: Russian ethnos originated and evaluated on great Russian plains that determined particular life style and view on
...
p.000223: of church awareness. First of all everywhere dominance of morality evidences that. We can see it in works of nearly all
p.000223: Russian thinkers even those who had no works devoted to moral problems.
p.000223: Adoption of Christianity determined evaluation of Russian spirituality in subsequent periods. Founding on traditions of
p.000223: eastern orthodoxy, ideas of spirituality, shame and conscience, love to neighbor were brought in Old Russia, a
p.000223: spiritual foundation of charity as everyday piety was formed. Alms as early form of personnel charity was spread among
p.000223: all social classes, it was not only simple execution of commandment of love to a neighbor, but a true need. It was
p.000223: personnel charity that created the foundation necessary for helping the poor at the following times. It was forming
p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
p.000225: people social life organization on the basis of common views (19).
p.000225: Under church influence and with its participation care for people in need for medical and social help
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
...
p.000225: hospices and receive odd and poor people. At the same time representatives of different social classes donated money
p.000225: for church and charity needs.
p.000225: Breakup between secular and church ideologies that began in the second half of the XVII century became wider in the
p.000225: XVIII century. Peter I activity is characterized with two mutually exclusive tendencies: strengthening
p.000225: of absolutism and europeisation of Russia. Implementing reforms for strengthening of role of the state in all
p.000225: spheres Peter I included the Orthodox church in government structure and strengthen state control on it and
p.000225: consequently on church charity. On Peter’s initiative social charity became state one. At Peter I times they took
p.000225: measures against beggary, parish as self- organized church and social unit was abolished.
p.000225: At the same time in the XVIII century higher medical education was formed in Russia. Hospital schools, medical
p.000225: department of the Moscow University, surgery academies were founded. In these circumstances the following
p.000225: feature of Russian nature revealed: to study and to alter forms and methods of organization appeared in other
p.000225: countries. For example, based on medical education system in Western Europe, in Holland particularly, in Russia it
p.000225: certainly had disadvantages but it had no breakup between interns and sergeants, between theoretical and clinical
p.000225: educations, students were trained “at patient bed”.
p.000225: Students of religious schools were studying medicine because of specific features of the Russian society
p.000225: of the XVIII century. They were raznochinets, Russian intellectuals not of gentle birth, they knew Greek and Latin.
p.000225: This fact explains such features of Russian doctors and scientists as democracy and patriotism, self-denying service to
p.000225: people. Activity of such scientists as C.G.Zabelin, D.S.Samoilovich, N.M.Maximovich-Ambodic, M.G.Shein,
p.000225: A.S.Shumlyanskiy exemplify it. Physicians of the XIX century such as M.Y.Muromov, E.O.Mukhin. N.I.Pirogov,
p.000225: A.M.Filomafitskiy, S.F.Hotovitskiy, F.I.Inozemtsev and others maintained this tradition. Their professional activity
p.000225: and civil position were based on moral ideals. They wrote works where they discuss qualities characterizing a
p.000225: doctor, ethical aspects of relations with society, patients and colleagues. In everyday activity they pointed and
p.000225: solved problems, which were beginnings of bioethics principles and rules. They used method of experiment,
p.000225: observing disease activity and experimented on animals. At that time ethical approaches to experiments were formed.
p.000225: So, A.M.Filomafitckiy (11807-1849), the first Russian scientist, who made vivisection and surgery method as the base
p.000225: of physiology, said: “... Experiment made by inexperienced hand and aimlessly should be severely punished,
p.000225: especially if sufferings of an animal after blood operation are lengthened without any need, but experiments made
p.000225: by hands of a skillful and loyal observer are necessary for science and saving
p.000225:
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p.000226:
p.000227: 227
p.000227:
p.000227: of mankind...” (11). D.S.Samoylovich (1744-1805), founder of the Russian epidemiology, self-tested plague infection
...
p.000239: governed by, the caused moral vacuum in Russia failed to be compensated with a more or less integral
p.000239: framework of secular ideas and values clear and conventional to people and capable of appealing to people and give them
p.000239: hope. A distinguishing feature of the Russian society is that conventional factors invariably play significant role in
p.000239: many walks of social life, adherence to traditional ideological and social values which saw little influence
p.000239: of the changing social and economic systems, political regimes as well as fresh social and ideological paradigms for
p.000239: development declared in the recent decades of the XX century. Under any state system – monarchical or collective type,
p.000239: totalitarian or liberal – an impact of a number of constants which determine a civilization portrait of Russia is
p.000239: feasibly evident. Among them a crucial role belongs to religion, first and foremost the Orthodox Christian Church which
p.000239: by masses of population is perceived not only as an institution with the main function of not just disseminating the
p.000239: ideas of Christianity but mostly as preserver of the Russian national values and traditions (by different social
p.000239: studies three fourths of believers who are almost half of the population in Russia are Orthodox Christians). The same
p.000239: can be said about the Islam – second confession in Russia in terms of adherents’ number and influence (about 19% among
p.000239: believers) (20).
p.000239: Today religious organizations prove active in most different fields: religion itself, education, health care,
p.000239: culture, charity and mercy, business and economic. Changes occurring in the society and the Church demanded for a
p.000239: comprehensive philosophy that would reflect general attitude of the Church to issues of state and the Church
p.000239: relations and concerns of the modern society on the whole.
p.000239: At the Anniversary Episcopal Assembly in 2000 the Basic Social Conception of Russian Orthodox Church was
p.000239: adopted. The conception falls into 16 sections covering most various issues related to life of a Christian believer in
p.000239: secular world. In section 11 – “Public and Individual Health” – the attitude of Orthodox Church to disease and health
p.000239: is rendered, importance of church activities in health care is stressed, necessity of society and church cooperation in
p.000239: public health care issues is emphasized. It covers such vital from religious viewpoint principles as doctor and patient
p.000239: relationship which should be based with respect to integrity, free choice and “personal dignity”. In particular it
p.000239: stresses: “We should by all means encourage a dialogue between a doctor and a patient that is
p.000239: characteristic of current medical approach. This approach is undoubtedly engrained in the Christian tradition,
p.000239: although there is a temptation to relegate it to a level of merely agreement relationship. At the same time one should
p.000239: admit that a more conventional “pattern like” model of physician and patient relationship which is fairly criticized
p.000239: for numerous attempts to justify medical power abuse may as well represent a truly fatherly attitude to patient that
p.000239: depend on doctor’s morality. Not giving preference to any of the health care organization models the Church
p.000239: considers that this service should work efficiently at its maximum and must be available to all members of society
p.000239: disregarding their financial and social status even with limited medical resources distributed. For such distribution
p.000239: to be fair the aspect of “vital requirements” should prevail over the aspect of “market relations”. The doctor should
p.000239: not see the degree of their responsibility for medical service in relation with financial reward and its amount only by
p.000239: this turning his profession into pure profit making. At the same time decent payment for medical professionals is seen
p.000239: as an essential task for the society and the state (26).
p.000239: Section 12 “Bioethical Issues” shows the official position of RCOC
p.000239: on a range of aspects which currently are concerning in the society and are brought about by blooming development of
p.000239: biomedical technology in late the
p.000239:
p.000240: 240
p.000240:
p.000241: 241
p.000241:
p.000241: XX century. These completely new challenges are once again comprehended and reinterpreted in the context of ideas of
p.000241: human life and personal dignity which are entrenched in the “Divine afflation”. It shows attitude of the
p.000241: Church to abortion, new reproductive methods, medical genetic methods of diagnostics, tissue and organ
p.000241: transplantation, reanimation and help to the parting, sexual issues. Moreover some sections of the social
p.000241: conception are devoted to the questions of marriage and family, psychological health, problems of drug and alcohol
p.000241: addiction, health care and the ecological environment (7).
p.000241: The current trend is towards younger age among religious groups of society. A study by VCIOM showed that 58% of young
p.000241: Russian citizens under the age of 25 refer to themselves as Orthodox Christians, a similar trend can be observed among
p.000241: adherents of the Islam.
p.000241: It should be particularly stressed that among young believers patriotic, pro-governmental ideas, believe that there is
p.000241: a necessity to restore the decent position of Russia in the world community, strive for order, strong power, collective
p.000241: like, collegial philosophies, support of the current government and antagonism to liberal western ideas
p.000241: prevail. A common trend among all young interviewees, disregarding distinctions in their philosophic and
p.000241: religious ideas, towards moral and spiritual values is demonstrated, for instance, the way they reacted to the
p.000241: concept of ‘morality’ (positive 87.9% among believers and 81.8% among non-believers, negative 12.1% and 18.2%
p.000241: respectively), ‘justice’(positive 96.6% and 94.3%, negative 3.4%
p.000241: and 5.7%), ‘faith’ (positive 97.1% and 85.9%, negative 2.9% and 14.1%),
p.000241: ‘prayer’ (positive 92.3% and 56.3%, negative 7.7% and 43.8%). A particular part of young believers and
p.000241: non-believers advocates the idea of paternal mode of relations, sticks to the idea of conventional patriarchal
p.000241: views in family pattern, supporting filial piety within the family, male dominance in family relations (believers 28%,
p.000241: non-believers 21.9%).
p.000241: For the Russian medicine and health care a paternal model of doctor and patient relations is a typical one. Genesis of
p.000241: these relations can not be seen apart either from economic and cultural development of Russia on the whole or from the
p.000241: ethical staples of medical activity in Russia. Orthodox theological ideas and Russian religious philosophy to a
p.000241: significant extent reinforced the paternal model of doctor and patient relations, promoting ideas of humbling,
p.000241: non-resistance, and respect to universal hierarchy.
p.000241: Developments in medical science and biotechnology increased the power and responsibility of a medical doctor in
p.000241: terms of understanding what life and death and use harm mean. A simultaneous turn of mind in social ideas and mentality
p.000241: of people brought about by a wide spread liberal ideas gave a great impetus to new attitudes based on ideas of personal
p.000241: rights and freedom. All this entailed a necessity to seek for such grounds in doctor and patient
p.000241: communication as recognizing patients’ autonomy, their right for identity and decision making. Process of shifting
p.000241: towards non-paternal model in our country is not a smooth one.
p.000241: One can judge about the steadiness of paternal model by numerous interviews among doctors and patients
p.000241: carried out in recent years. The results of medical and social study in the St-Petersburg Pediatric Academy in 2002-
p.000241: 2004, viewpoints of doctors and citizens on the staple issues of medical ethics (bioethics) depending on
p.000241: their status revealed that currently only few doctors as well as their patients are prepared to apply an
p.000241: antipaternal relationship model in practice (17, 18). Big number of doctors sticks to paternal positions
p.000241: in communication with patients. This situation is also seen as psychologically favorable by many patients who
p.000241: lack desire to take decisions for their own health issues either partly or completely, they are happy to shift this
p.000241: responsibility to doctors.
p.000241: The study reveals that attitude of many doctors and patients to current biotechnology is not yet coined; there is no
p.000241: solid ethical basis. Opinions of church-going interviewees differs drastically from that of non-believers’ and to
p.000241: greater extent meets the provisions of religious and medical ethics. At the same time among church-going doctors great
p.000241: number of interviewees proved not prepared to solving current ethical tasks and either refused to answer questions of
p.000241: the interview or found them too challenging.
p.000241: Russia has not yet determined the answer to the question of referring itself to a civilization – Western or Eastern. In
p.000241: the early 1990’s the strategy was linked to the opportunity for Russia to be integrated into the Western community, and
p.000241: it was first of all seen through attitude to values and interests. Integrity of values in Russia and in the West is
p.000241: retained today in recognition of such values as freedom, justice, material well-being and other. However, our country
p.000241: yet has not seen them implemented fully. Establishing value system in the field of medicine which represent perhaps the
p.000241: most conventional block in the general system of values is still under way. In the mentality of citizens of
p.000241:
p.000242: 242
p.000242:
p.000243: 243
p.000243:
p.000243: Russia the principles of identity typical of the West are still underdeveloped. The basis of human rights theory is yet
p.000243: being established. Majority of Russian citizens as social studies show, reject the imposed ‘alien’
p.000243: communication schemes, for instance, the Western view over various issues of personal and social life not out of
p.000243: reasonable arguments or some ideological efforts but out of their inconsistency with customary ideas and values.
p.000243: This gives grounds for discussion and implementation of the bioethical staple principles and provisions in
p.000243: countries with various ethnic, culture and religious traditions, creates challenges because of peculiarities
p.000243: and inconsistencies between the Russian and western ethical systems in health care and medicine. In this respect it is
p.000243: reasonable to draw guidelines and interpret specific regulations and acts and their provisions taking into
p.000243: account two main aspects: culture and ethnical traditions of given states and their compliance with the common norms of
p.000243: international laws in the field of bioethics.
p.000243:
p.000243: References
p.000243: 1. Berdiaev N.A. Destiny of Russia: Selected Works. M., Kharkov: EKSMO Press Folio, 1998, 736 p. (herein and
p.000243: hereinafter in Russian)
p.000243: 2. Dmitrieva T.B., Polozgiy B.S. Psychological Health of Russian
p.000243: Citizens. Human, 2002, №6, p. 21-31.
p.000243: 3. Zamalaev. А.F. Lectures on history of Russian philosophy: XI –
p.000243: early XX cc. StP., 1994.
p.000243: 4. Zenkovskiy V.V. History of Russian philosophy. L., Eko, 1991, p. I,
p.000243: p. II, p. b.
p.000243: 5. Ivanjushkin A.J. Medical ethics in Russia (XIX - early XX cc.). In
p.000243: bk.: Bioethics: principles, regulations, problems. М., 1998, p. 93–110.
p.000243: 6. Ivanjushkin A.J. History of medical ethics and biomedical experiments in human and animal parties.
p.000243: In bk.: Introduction to bioethics. М., 1998, p. 95-133.
p.000243: 7. Cirill, metropolite. On «Basic social conception of Russian Orthodox Church». Anniversary Episcopal Assembly RCOC.
p.000243: StPb, 2000, p. 133-149.
...
p.000243: 9. Kljutchevskiy V.О. Selected Works. М., 1987, v.1, p.1, p. 78-79.
p.000243: 10. Korotkikh R.V. Legal and ethical issues of health care in Russia in period of reforms. In bk.: Biomedical
p.000243: ethics (edited by. V.I.Pokrovskiy). М., 1997, p. 47-58.
p.000243: 11. Koshtojantz Kh.S. Study on history of physiology in Russia.
p.000243: М., 1946, p. 111.
p.000243: 12. Kubar О.I. Ethical and legal issues of research in human parties: in history of Russia XX century. Human, 2001, №3.
p.000243: 13. Levit М.М. Establishing public medicine in Russia. М.: 1974,
p.000243: 231 p.
p.000243: 14. Likhatchev D.S. Russian culture. М.: Art, 2000, 438 p.
p.000243: 15. Ljubargskiy G.J. Human, 2004, №3, p. 186.
p.000243: 16. Maksimov Е.D. Study of historical development and current situation in public charity in Russia.
p.000243: In bk.: Public and personal care in Russia. StP, 1907, p. 4.
p.000243: 17. Mikirtitchan G.L., Filimonov S.V. Opinion of doctors and patients on problems of information and obtaining informed
p.000243: consent form. In bk.: Actual problems of diagnostics, treatment and disease prevention, issue. 3. StP, 2004, p.
p.000243: 291-302.
p.000243: 18. Mikirtitchan G.L., Filimonov S.V. Results of social study attitudes among doctors and patients to some
p.000243: genetic methods. International conference of CIS countries Forum for Ethics Committee. Yerevan, 2005, p. 52-56.
p.000243: 19. Mirskiy М.B. Medicine in Russia XVI - XIX cc. М., 1996, p.
p.000243: 301- 309.
p.000243: 20. Mtchedlov М.P. Are young citizens of Russia religious? Human, 2005, №6, p. 111-118.
p.000243: 21. Nikolay Ivanovitch Pirogov and his heritage. Pirogov’s conferences.
p.000243: B/м. B/g. 253 p.
p.000243: 22. Petrov V., Sedova N. Bioethics in practice. М., 2002, p. 60-89.
p.000243: 23. Petukhov V.V. The proper and the real in moral mentality of Russian
p.000243: citizens. Human, 2006, №3, p. 148-149.
p.000243: 24. Pirogov N.I. Selected works. М., v.2, p. 286.
p.000243: 25. Savina E.А., Degtjarenko L.J. Life psychology in Russian sayings and proverbs. Human, 2001, №5, p.186-192.
p.000243: 26. Anniversary Episcopal Assembly RCOC August, 13-16, 2000.
p.000243: Digest of abstracts and documents. Chapters Х-ХII. SPb, 2000, p. 192-200.
p.000243:
p.000244: 244
p.000244:
p.000245: 245
p.000245:
p.000245: 27. Judin B.G. National specific of establishing bioethics in Russia. In
p.000245: bk.: Philosophy of biomedical research. М., 2004, p. 71-90.
p.000245: 28. Jarovinskiy М.J. Lectures on medical ethics (bioethics). М., 2004,
p.000245: 528 p.
p.000245:
p.000245: 3.8.2 Legal Regulations
p.000245:
p.000245: The ethical review of biomedical research involving human subjects is the important component in rights, interests and
p.000245: dignity of human subjects and in the same time is the necessary condition for further development of medical science
p.000245: and technology.
p.000245: The basis for legal regulation of biomedical research and its ethical evaluation is laid by a complex of
p.000245: international acts both of legal and ethical character.
p.000245: First of all we could mention Nuremberg Code (1947), the Declaration of Helsinki (1964, with all further
...
p.000281: Khan Mongol Empire: 1220-1370; the State of Timurids: 1370-1740; Bukhara Khanate – the so called East
p.000281: Bukhara: 1747-1920). In 1867 northern territories of Tajikistan with the city of Khodjent entered the
p.000281: Russian Empire and were industrialized. In 1925 the Tajik Autonomous Soviet Socialist Republic was created as a
p.000281: part of Uzbekistan Republic, but in 1929 the Tajik Soviet Socialist Republic was made a separate constituent
p.000281: republic with the city of Dushanbe as its capital. In 1991 the Soviet Union collapsed, and Tajikistan declared
p.000281: its independence.
p.000281: Tajikistan is a mountainous landlocked country in Central Asia. Afghanistan borders to the south,
p.000281: Uzbekistan to the west, Kyrgyzstan to the North, and China to the east. The total area of Tajikistan Republic is
p.000281: 143.1 thousands of square km, and it has a population of 7,163,506 citizens. Tajikistan consists of 4 administrative
p.000281: divisions: 2 provinces (Sughd in the north and Khatlon in the south), 1 autonomous province (Gorno-Badakhshan
p.000281: - Pamir), and disrtricts of republican subordination around Dushanbe.
p.000281: Tajikistan is an agrarian-industrial country and has a considerable potential. Lengthy wars caused
p.000281: devastations and human losses, which resulted in a dramatic economic recession. However, during the last peaceful
p.000281: years the economics and living standard have notably increased.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000283: 283
p.000283:
p.000283: The Tajik people have a rich and ancient culture. Since antiquity to the period of feudalism moral and
p.000283: ethical issues took an important place in religious and philosophical outlook. Until the IX century it had
p.000283: been developing in the context of Iranian philosophy, and later, since the 9th to the XV century in the
p.000283: context of Arabic philosophy. Due to the ethnic, language, social and political commonality in antiquity and the early
p.000283: Middle Ages particularly close relations were between East-Iranian (ancestors of the Tajiks) and West-Iranian
p.000283: (ancestors of the Persians) people. The Tajik- Persian philosophical thought had also a connection with Indian and
p.000283: Greek philosophy. However the closest links connected the Tajik culture and spiritual and philosophic outlook
p.000283: with cultures of Turkic peoples of Central Asia and Azerbaijan. There was a mutual enrichment of cultures, spiritual
p.000283: values and scientific achievements.
p.000283: Religious and philosophical ideas of Tajik ancestors roots back to an ancient monument of spiritual
p.000283: culture “Avesta” the holy canon of Zoroastrism (Mazdeism) containing not only religious dogmas but also
p.000283: ideas on cosmogony, philosophy, morals and law. The characteristic feature of Zoroastrianism is dualism, i.e. the view
p.000283: that two fundamental concepts exist, such as good and evil, and the struggle between these is the pivot and content of
p.000283: the universe. Zoroastrianism formulated a ternary ideal of the righteous man (“good thoughts”, “good words” and
p.000283: “good deeds”) opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked words” and “wicked deeds”). The
p.000283: Zoroastrian idea about infinite time as an initial substance gave rise to zervanism – a teaching in the framework of
p.000283: which a materialistic trend developed that denied the creation, and god as the creator of the universe, and
p.000283: affirmed the belief in the eternity of the world. In the end of the slave-owning system and in the beginning of
p.000283: feudalism, Manichaeism (Mani, 215-276) and Mazdakism (Mazdak, the end of the V - the beginning of the VI century)
p.000283: became very influential. Those philosophical trends assimilated the Zoroastrian ideal about the struggle
p.000283: between the good and the evil. The social doctrine of Mazdakism proclaimed ideas of justice and equality.
p.000283: The earliest written evidence that peoples of Central Asia had a good knowledge of mathematics and astronomy is
p.000283: “Avesta” containing data on the movement of celestial bodies, the system of time count and some mathematical rules.
p.000283: In that period, early states in Central Asia achieved a high
p.000283: level of material production and culture: crafts, agriculture, architecture and art. That was the time when many
p.000283: written monuments of religious, political and scientific thought were created, many of which were destroyed during the
p.000283: invasion of the army of the Arab Caliphate (VII-VIII centuries).
p.000283: During the VIII-XV centuries philosophical, social and political ideas were developing in the atmosphere of
p.000283: Arabian conquests and a forcible spreading of Islam. Spiritual cultures of Iranian and Arabic peoples became most
p.000283: closely linked. During the VIII-IX centuries, in Maverannahr (the right bank of Amudarya) and Khorosan the tendency to
p.000283: the territorial, language and cultural integration broken by the Arabian conquest had been growing. During the period
p.000283: of the Samanids rule (874-1005 AD), the Tajiks developed as a nation with its State system and
p.000283: literary language. In the IX-XI centuries, Central Asia was one of the most important centres of oriental
p.000283: science. That was the time when astronomical observatories, “Houses of Wisdom” and libraries were built.
p.000283: Scientists from Central Asia translated and commented the scientific heritage of ancient Greece and India and
p.000283: wrote original works on mathematics, astronomy, mineralogy, applied mechanics, physics, chemistry and medicine.
p.000283: Mohammed ibn Musa al-Khorezmi, Abdul Marvazi, Usman Balhi al-Fergani (IX c.), Abul-Vefa al-Buzjani, Abulmahmud Hudjani
...
p.000285: itself most fully in the analysis of Neoplatonism philosophy. His works “Book of Healing” and “Book of Salvation” are
p.000285: still considered encyclopaedias of Muslim Neoplatonism. Another work by Ibn Sina “The Justice” that has not survived to
p.000285: our days presented an analysis and comparison of views of Alexandria and Baghdad schools of Neoplatonism. In “The
p.000285: Justice” Abu Ali Ibn Sina is an arbitrator between the two quite famous medieval philosophical schools. His book
p.000285: “Oriental Wisdom”, probably, also offered an analysis of works by oriental philosophers who commented on
p.000285: Neoplatonism considering views of Alexandria scientists. “Book of Directions” that was, by legend, Ibn Sina’s last
p.000285: work shows the author’s Sufi views. A number of works consider the problem of free will. Abu Ibn Sina associated
p.000285: free will with active, practical intellect, which stressed a purely ethical, not psychological, nature of his
p.000285: theory. A.K.Zakuev rightly noted that Ibn Sina’s teaching covers problems of regulating human behaviour, moral
p.000285: judgments, and of ethical compliance of human behaviour with commonly recognized moral principles and with an
p.000285: individual’s own views derived from those principles for regulating his/her behaviour of his/
p.000285: her own volition.
p.000285: Some works by Ibn Sina show us his adherence to certain aspects of Sufism and mystical symbolism. Famous for its
p.000285: encyclopaedic character, his philosophy served for reconciliation of religious views and rationalistic sciences, which
p.000285: alone would suffice to consider him an original philosopher. Avicenna had a noticeable influence on views of
p.000285: Thomas d’Aquin and Albert the Great – the two prominent medieval philosophers. Agiographic texts abound in
p.000285: evidences on remarkable abilities of Hadji Naseeruddin Obaidullah Ahmar from Maverannahr (1404-1490), a religious
p.000285: figure, who worked miracles to protect order, justice and the oppressed. His actions
p.000285:
p.000286: 286
p.000286:
p.000287: 287
p.000287:
p.000287: showed his mercy to the oppressed and sternness towards oppressors and their accomplices who forgot the moral norms of
p.000287: Sharia. His style of behaviour demonstrated norms of righteousness, good deeds and ethical conduct.
p.000287: Abu Ali Ibn Sina was very popular among European scholastics (especially in the XIII c.). In the Middle
p.000287: Ages separate chapters from Avicenna’s “Book of Healing”, such as “Logic”, “On the Soul” and
p.000287: “Metaphysics” were translated into Latin, and Christian philosophers all over Europe considered themselves
p.000287: either followers of admirers of Abu Ali Ibn Sina.
p.000287: Ethical views of another great Tajik scientist, thinker and political figure of the XIII century Naseeruddin
p.000287: Tusi on the essence and norms of morals we find in his work “Ahloki Nosiri” composed of two parts: “On the fundamentals
p.000287: of morals” and “Doctrine of the purpose”. For him ethics as a science of behaviour is an essence of not only innate but
p.000287: also of acquired qualities, and being a product of social relations it may change according to social events. The
p.000287: author describes factors causing ethical changes.
p.000287: Ar-Razi proceeded from the materialistic tradition of Democritus who recognized natural regularities of nature
p.000287: and society and affirmed the cognoscibility of the world. Advanced ideas of Biruni who opposed the
p.000287: natural-science approach to the religious worldview were widespread. During the IX-XIV century, kalam, a scholastic
p.000287: philosophy of Islam that emerged in the VIII century, gained popularity and was opposing progressive views of Ibn Sina
p.000287: and his followers. Kalam defenders (Gazalii Fahruddin Rosi) advocated the idea of the Creation and believed that the
p.000287: world depends on the divine will. In the XI century, the teachings of Ismailism (a philosophical doctrine of Ismailism
p.000287: based on Neoplatonic and Aristotle’s views) became very influential (Nasir Hisrov). In their teaching on the
p.000287: harmony of the universe the Ismailis likened the constitution of the universe (“macrocosm”) to the constitution of
p.000287: human body (“microcosm”).
p.000287: Continuous internal wars in khanates of the Central Asia over XVI-XIX centuries resulted in the decline of productive
p.000287: forces, and living conditions of working masses changed for the worse. During that period, reactionary clergy was
p.000287: extremely influential, and repressed any scientific thought. The main attention was given to Muslim theology and
p.000287: ethics. The influence of the Sufi doctrine and literature with biographies of Sufi sheikhs and moral regulations of
p.000287: various Sufi Orders was particularly strong. Progressive
p.000287: tendencies and anti-feudal views were expressed in works by Tajik poets and thinkers, such as Binoi (1453-1512), Vasifi
p.000287: (1485-1551), Hiloli (executed in 1529), Saiido Nasafi (died in 1707 or in 1711), Bedil (1644-1721) and others. Their
p.000287: works reflected interests of working people and their protest against a feudal exploitation.
...
p.000287: ideas of national progress and social justice and criticized medieval feudal system. Scientific centres of Moscow,
p.000287: Leningrad and other cities were helpful in rising Tajik philosophers. The study of the history of Tajik philosophy and
p.000287: teachings of ancient peoples of the Central Asia was also very important. S.Aini, A.A.Semenov, A.M.Bogoutdinov,
p.000287: Z.Sh.Radzhabov, M.Boltaev, G.A.Ashurov, M.Dinorshoev, M.Radjabov and others analyzed in their works problems of the
p.000287: unity of the national and the international in the history of Tajik culture and philosophy, revealed special
p.000287: regularities of their development, the character of interaction with other philosophical trends and unmasked
p.000287: reactionary nature of Europocentric and Asiacentric concepts. Tajik scientists carried out studies in the
p.000287: sphere of dialectical, historical materialism and philosophy of natural sciences; they analyzed laws and categories of
p.000287: materialistic dialectics, objective regularities of historical development and conscious human activity,
p.000287: problems of education, formation of socialist nations, methodology of modern science, etc. (S.Umarov, M.S.Asimov,
p.000287: S.B.Morochnik, V.I.Pripisnov, M.Gafarova, A.Tursunov, I.Sharipov, S.A.Radjabov, K.Sabirov, M.Kamilov). The works on
p.000287: scientific atheism analyzed problems of developing a scientific and materialistic worldview, causes for
p.000287: survival of religious views and ways
p.000287:
p.000288: 288
p.000288:
p.000289: 289
p.000289:
p.000289: to overcome the problem; gave a critical analysis of various religious concepts (A.Bazarov, R.Madjiev). There
p.000289: were also new studies in the field of sociology, ethics and aesthetics.
p.000289: The late eighties and early nineties were marked with complicated and contradictory events, the most significant
p.000289: of which was a disappearance of such a state as the USSR on the map of the world. Instead, about 15
p.000289: new independent states appeared, and Tajikistan among those. Thus, within a short historical interval Tajikistan
p.000289: moved from one historical period to another; the state and power structure changed, as well as its
p.000289: attributes. The former political system was destroyed, which resulted in the change of ownership patterns and social
p.000289: relations.
p.000289: The development of Tajikistan as an independent secular republic in the post-Soviet space was accompanied
p.000289: with economic, political and social instability. A significant support from the international community was
p.000289: directed to the needs associated with the civil was (1992-1995) and its consequences. Emergency measures of
p.000289: providing medicines, vaccines, bandaging material taken by the international community made an essential contribution
p.000289: into the solution of healthcare problems. At the same time, there was a need in more thorough structural changes that
p.000289: would help to overcome existing problems and facilitate the development of safe mechanisms for providing
p.000289: healthcare and safeguarding patients’ rights.
p.000289: As current biomedical researches are carried out at a large scale and at many Centres, they affect interests of many
...
p.000291: Commonwealth of Independent States such as International Ethical Guidelines for Biomedical Research Involving Human
p.000291: Subjects and Guidance on Good Clinical Practice developed by the World Health Organization and International Conference
p.000291: on Harmonization of Technical Requirements got the Registration of Pharmaceuticals for Human Use, materials of FECCIS
p.000291: international conferences (2003-2005). Compliance with these documents ensures the protection of rights, honour,
p.000291: dignity, safety and well-being of research participants, as well as reliability of research findings. We were also
p.000291: guided by the Constitution of Republic of Tajikistan and by Tajikistan Laws “On the Protection of the Population
p.000291: Health”, “On Pharmaceutical Products and Pharmaceutical Practice”, “On Narcotic Drugs, Psychoactive Drugs and
p.000291: Precursors”, “The Concept of Healthcare Reformation in Republic of Tajikistan” (2002). These documents are
p.000291: focused on the international practice; implementation of new, more efficient organization approaches,
p.000291: improving the quality and availability of medical and sanitary care and a further development of international
p.000291: cooperation.
p.000291: In the context of democratization processes in Tajikistan, when conducting a biomedical research we have to proceed
p.000291: from the principle of the respect for a person’s freedom and, hence, from the principle of the respect for an
p.000291: individual’s convictions. One of the factors that might limit the physician’s freedom in decision-making is the
p.000291: religious and cultural milieu that formed an individual’s consciousness. Without the knowledge of cultural details, a
p.000291: competent design of biomedical research in Tajikistan – a Moslem country and an officially secular State – is not
p.000291: possible. Besides, there are strong believers practicing Islam and observing all religious holidays. Thus, many
p.000291: people keep the strict fast during the Ramadan. In this period people suffering from severe diseases, refuse taking
p.000291: medicines both per os and by injection, which is harmful to their health. Thus, for example, patients who have had
p.000291: operations for glaucoma refuse courses of conservative supportive therapy or keep the fast, which weakens visual
p.000291: functions. Quite often during the Ramadan people
p.000291: get to the surgery department of the emergency station with pancreonecrosis after having a rich and fat meal (pilaw) in
p.000291: the night after fasting during the day. In some cases this situation has a lethal outcome. Islamic traditions dictate a
p.000291: respectful attitude to the human body even after a person’s death and therefore relatives of the deceased do not
p.000291: consent to the post-mortem examination and removal of organs for transplantation. According to Moslem religion, the
p.000291: soul of the embryo appears in the first week of the fourth month of pregnancy, and the law prohibits abortion after
p.000291: this term. Besides, Tajikistan population is not disposed to contraception measures or abortion, and therefore Tajik
p.000291: families are commonly having many children. When carrying out preventive health examination of strong believers, it is
p.000291: important to divide them into separate streams according to sex.
p.000291: Artificial fertilization in Tajikistan is permitted. It is desirable to use sperm of the woman’s husband provided that
p.000291: his consent has been obtained. There are no strict religious restrictions with regard to transplantation and removal
p.000291: donor organs. Sharia laws state that medical professionals should struggle for a patient’s life to the last moment and
p.000291: totally reject euthanasia. These and other similar examples emphasize the necessity to consider cultural
p.000291: aspects with regard to providing medical care and conducting biomedical research in Tajikistan.
p.000291: Biomedical research if conducted without considering cultural and religious aspects may have negative
p.000291: consequences. The physician should follow certain rules not to harm religious feelings. This is essential both in
p.000291: planned and emergency treatment. However, often, particularly in providing emergency care, the physician, voluntarily
p.000291: or not, may be in a situation when he/she is violating a religious rule.
p.000291: When developing legislative acts referring to healthcare in Tajikistan we have followed the fundamental principles of
p.000291: the protection of human rights and dignity in biomedicine. The basic document is the Constitution of Tajikistan. The
p.000291: current Constitution is ensuring the priority of providing healthcare to the population of Tajikistan.
p.000291: The Constitution of Tajikistan proclaims citizens’ rights and freedoms and determines responsibilities of natural
p.000291: and juridical persons. One of the rights guaranteed by the Constitution is the right for health protection implying
p.000291: the following:
p.000291: - medical care and social protection;
p.000291:
p.000292: 292
p.000292:
p.000293: 293
p.000293:
p.000293: - safe environment, food products and drinking water;
p.000293: - qualified medical and sanitary care including a free choice of a physician and healthcare institution;
p.000293: - safe and healthy living and working conditions, as well as safe and healthy conditions for rest, education and
p.000293: upbringing;
p.000293: - sanitary and epidemiologic well-being in the territory where a person lives;
p.000293: - truthful and timely information about an individual’s health including existing and potential risks and the degree of
p.000293: risk;
p.000293: - participation in measures on health protection and public expertise with regard to these issues;
...
p.000321: birth terms “ethics” and “adabnoma” are not identical; they differ in the approach to the study of ethics, in
p.000321: argumentation and in the focus of their attention (general abstract principles and/or a code of behaviour). Central
p.000321: Asian codes of behaviour “Kobusnoma” by Unsurmaol Kaykovus, the treatise “On Ethics” by Ibn Sina, “Four
p.000321: Conversations” be Arusi Samarkandi, “The Oriental Code of Decencies” by Sadyk Kashgari and many other works are
p.000321: fundamental methodological sources of Uzbek model of bioethics. Adabnoma, rather than Islam, provided a
p.000321: basis for the development of research ethics and medical practice in pre-Soviet time. Thus, distinctive features
p.000321: of national historical and cultural, philosophical and methodological sources of biomedical ethics in
p.000321: Uzbekistan are the pedagogical orientation and a pronounced didactic character. Such were traditions, norms
p.000321: and values of Zoroastrism and Islam and achievements in medicine and philosophy of the Moslem (Arabic)
p.000321: Renaissance, creative heritage of Central Asian thinkers and physicians Abu Ali Ibn Sina, Abu Abdullah
p.000321: Khorezmi, Abu Nasr Mohammed al-Farabi, Abu Raihan Beruni and other prominent figures representing Islamic
p.000321: philosophical and religious thought (Al Kindi, Abu Hamida Gazali, Ibn Rushda, Abu Bakra Ar-Razi). However,
p.000321: nowadays syncretism of oriental philosophy reveals itself in the fact that modern Uzbek philosophers and physicians do
p.000321: not make a clear distinction between secular and religious argumentation. Sacred texts have traditionally been a source
p.000321: of philosophical thought for Uzbek investigators. Western scientists usually state their positions. The Western
p.000321: bio[medical] ethics distinguishes between biomedical ethics based on religious teachings and secular biomedical ethics
p.000321:
p.000322: 322
p.000322:
p.000323: 323
p.000323:
p.000323: that uses ethical argumentation as such. Sacred texts offer a comprehensive collection of thoughts, and one may find in
p.000323: them confirmation from “above” of nearly any statement.
p.000323: Moslem teaching has developed special canons of the attitude to patients and disabled persons that, to a large
p.000323: extent, formed the basis for patient-physician relationship. First of all, Al Bukhari’s khadises remind Moslems
p.000323: that the Prophet suffered severely, and therefore, who, if not Him, knows better what it means to be ill and suffer
p.000323: (Abu Abdullah Muhammad ibn Ismoil al-Bukhoriy. Khadis. Al-jomi’ ac-cokhikh 4. Ishornali tiuplam. Tashkent, Komuslar
p.000323: bosh takhririiati, 1992. B. 3 – in Uzbek). Everything that befalls human beings is of God’s will. To visit the sick,
p.000323: even infants, is a duty of each Moslem. It is a tradition not to ask about the disease or name the disease aloud; one
p.000323: should ask about the general state of health and use euphemisms in telling the diagnosis: “that very illness”, “caught
p.000323: some cold”, “a bad illness”, etc. There are many variants. This is a kind of medical secrecy observed by persons in the
p.000323: patient’s environment. In the end of the visit the physician should say some words of support, to express his firm
...
p.000323: substantiation of the natural death from the viewpoint of the right to a good death and in the light of the theory that
p.000323: death means “the return” to an origin. This idea was developed in many works, particularly in works by Ilya Mechnikov
p.000323: (1845- 1916) who attempted to explain the concept of “the instinct of natural death” from the viewpoint of biology and
p.000323: psychophysiology.
p.000323: With regard to ethical principles, “Canon of medical Science” is a literary source containing elements of
p.000323: bioethics. It differs from its antiquity analogues in the attempt to characterize medicine not only as a system of
p.000323: medical and biological knowledge, but also as a canon of spiritual and ethical basis of the entire medical science
p.000323: (“Avicenna and the ethics of science and technology today”. Division of Science and Technology Ethics, UNESCO, France,
p.000323: 2006, p. 1-16). There were many reasons why “Canon” excited much interest in different historical periods including the
p.000323: European Renaissance. However, there are no doubts that in “Canon of Medical Science” a human being for the first time
p.000323: becomes not merely a subject of an anatomical or physiological research but a person. It is noteworthy that the “Canon”
p.000323: is really permeated with humanistic ideas. It has a powerful spiritual and moral potential for the development of
p.000323: medical science the subject of which is not just a human being but also his/her life style with all the variety of
p.000323: cultural,
p.000323:
p.000324: 324
p.000324:
p.000325: 325
p.000325:
p.000325: legal, religious and other features. According to Ibn Sina, it is essential to humanize the process of bringing up
p.000325: healthy people and to find the ways for maintaining and developing spiritual harmony throughout a person’s life.
p.000325: Ethical views of Ibn Sina are still topical nowadays. He saw a physician as a patient’s friend, tutor and helper.
p.000325: To fulfill this noble mission, the physician, apart from professional knowledge and experience, should have many
p.000325: positive qualities – mercy, respect for human dignity, readiness to self-sacrifice in a patient’s interests,
p.000325: etc.
p.000325: When analyzing Ibn Sina’s ethical precepts we should note that those were in line with Hippocrates’s teaching. Ibn Sina
p.000325: wrote: “The physician should read Hippocrates’s precepts so as to be able to show honesty and frankness when treating
p.000325: patients. He should keep his clothes clean, be neat and perfumed. When he visits a patient he should be amiable, and
p.000325: cheerful, and witty so that he could cheer the ill person, because support offered by the physician multiplies the
p.000325: strength of natural warmth”. He was tireless in calling upon physicians to develop their general and special knowledge,
p.000325: to exchange professional experience and travel. In those times, travels served to extend scientific contacts. In the
p.000325: Middle Ages, there were many charlatan “healers” and even physicians deceiving their patients. Reasons for that Ibn
p.000325: Sina saw in a poor medical training, as physicians were not taught to see in each person his/her unique world of
...
p.000325:
p.000326: 326
p.000326:
p.000327: 327
p.000327:
p.000327: by UNESCO in 2006. Avicenna’s life and works invite us to think about the ethics of science. (“Avicenna and the Ethics
p.000327: of Science and Technology Today”. UNESCO, France, 2006, pp.1-18).
p.000327: The Moslem etiquette of attitude to the patient has been and is certainly influencing the content of professional
p.000327: ethics of Uzbekistan physicians. However, a transformation of the socio-economic development model that
p.000327: began after Uzbekistan had declared its independence in 1991, and, as a consequence, commercialization of
p.000327: medicine, resulted in a too rapid and radical transition to the principles of informed consent. In particularly
p.000327: difficult cases, Uzbekistan physicians prefer an indirect informing – they inform not the patient but his/her
p.000327: relatives. Physicians in countries with the domination of Roman Catholicism act in a similar way.
p.000327: Indeed, we find Moslem views on certain dilemmas of modern biomedical ethics have much in common with
p.000327: views of other orthodox religions. Islam having undergone many trials by the Soviet atheism and political extremism
p.000327: provides an ideological foundation for the development of bioethical values. However, it would be incorrect
p.000327: merely to reduce Uzbekistan ethical norms to Islamic ones. Uzbekistan is a secular state, and Islam adherents form
p.000327: but one of society segments, and religious norms are but one of the components of biomedical ethics in Uzbekistan. Many
p.000327: ethical and medical rules of social life exist not only in form of religious dogmas but also as traditions, rituals and
p.000327: folklore, which helps to observe the norms across generations.
p.000327: Biomedical ethics in Uzbekistan is open to world tendencies, such as globalization and westernization that have a
p.000327: strong impact on Uzbekistan science. Achievements in the field of informed consent, reproductive behaviour,
p.000327: etc. prove the response to world tendencies. The protection of universal human values, as well as traditional values is
p.000327: a key issue of the contemporary medical ethics in Uzbekistan.
p.000327: Thus, the Uzbekistan model of biomedical ethics is at the stage of intensive development. The intensity
p.000327: of research development in this field is predetermined by ethical tendencies in Uzbekistan education and
p.000327: philosophy existing throughout the history of Uzbekistan (Zagyrtdinove
p.000327: F.B. Peculiarities of Biomedical Ethics in Uzbekistan. In: “”Bioethics in Uzbekistan – Clinical, Philosophical
p.000327: and Legal Aspects.” Tashkent, 2006, pp. pp. 122-128).
p.000327: 3.11.2. Legal Regulations
p.000327:
p.000327: The State plays a key role in safeguarding social and economic rights of its citizens, and therefore
p.000327: the State social policy should be directed at maintaining social health, which is described by three groups of
...
p.000333: 10. Convention on Human Rights and Biomedicine (Council of Europe, 1996)
p.000333: 11. Note for Guidance on Good Clinical Practice (ICH, 1996)
p.000333: 12. WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
p.000333: 13. Model Law of IPA CIS “On the Protection of Human Rights and Dignity in Biomedical Research in the CIS” (2005)
p.000333: 14. International Ethical guidelines for Biomedical research Involving Human Subjects (WHO/CIOMS, 13 of June 1993/2003)
p.000333: 15. Report of the International Bioethics Committee on the Possibility of Elaborating a Universal Instrument on
p.000333: Bioethics (13 of June 2003)
p.000333: 16. UNESCO Programme on Bioethics: Priorities and Perspectives (17 of October 1999)
p.000333: 17. Implementation of the Universal Declaration on the Human. Genome and Human Rights (17 of November
p.000333: 1999)
p.000333: A number of national laws of the Republic of Uzbekistan relating to the implementation of international agreements in
p.000333: healthcare imply a possibility of a joint regulation by the national Uzbekistan legislation and international norms.
p.000333: Article 1 of the Law “on the Protection of Citizen’s Health” (No 265-I; 29 of August 1996) states that “if
p.000333: an international agreement sets out rules others than those in the national legislation, norms of the international
p.000333: agreement are applied”.
p.000333: Substantiation of certain approaches to resolving bioethics problems is nowadays in the centre of political,
p.000333: philosophical and religious investigations that are to offer guiding lines in our rapidly changing world. Thus, the
p.000333: necessity to consider existing religious moral norms and cultural traditions in making decisions on key bioethical
p.000333: problems was discussed at the International Congress of Bioethics (Teheran, 2005). For the independent the
p.000333: Republic of Uzbekistan this issue is particularly topical. Despite the secular character of Uzbekistan, many residents
p.000333: are practicing Islam and other religions. The clause on the liberty of conscience in the Constitution of the
p.000333: Republic of Uzbekistan reflects the respect for the feelings of believers in our country, and therefore specific
p.000333: features of religious thinking are to be considered in
p.000333:
p.000334: 334
p.000334:
p.000335: 335
p.000335:
p.000335: adopting the Code of the Republic of Uzbekistan on Bioethical Problems (Mukhamedova Z.M. Islamic Bioethics in
p.000335: Historical Context. In: “Materials of the First National Congress on Bioethics”, Tashkent, 2005, pp. 98-100).
p.000335: It is necessary to note that nowadays there is a number of ethical codes interpreting teachings of the Koran and Sunnah
p.000335: with regard to complicated medical and biological problems. Thus, there are the Islamic Code of Medical
p.000335: Ethics48 and Islamic Bioethics49 correlating their statements with the Islam teachings: the Koran, Shariat and
p.000335: Hasid.50 These Codes are used in Kuwait, Egypt, Saudi Arabia, Iran, Pakistan and in other countries with Moslem
p.000335: communities (Canada, USA et al.). These documents pave the way to the development of ethical and religious regulations
p.000335: for biomedicine in Uzbekistan.
p.000335: Despite measures taken in our country, there remain problems relating to the protection of human rights in healthcare.
p.000335: Monitoring surveys carried out by the Ombudsman of the Republic of Uzbekistan showed that citizens apply to different
p.000335: state structures not only because of a poor material and technical basis of healthcare institutions or lack of
p.000335: pharmaceuticals, but also because the violation of patients’ rights to information about their diseases and
p.000335: methods of their treatment. The majority of patients, particularly in rural areas, do not have any knowledge on
p.000335: their rights, as healthcare institutions have not established procedures for providing relevant information. Mostly,
p.000335: patients are informed of their responsibilities and regulations the patient has to observe at a healthcare institution.
p.000335: Violation patients’ rights frequently result also from a low level of legal knowledge in medical professionals. The
p.000335: analysis of complaints submitted
p.000335: 48 The Islamic code of medical ethics. World Med J 1982, Kuwait Document, Islamic Code of Medical Ethics,
p.000335: International Organization of Islamic Medicine, 1981, Proposed Medical Research Projects, edited by: Abdul Jawad M. As
p.000335: Sawai, Commission on Scientific Signs of Qur,an and Sunnah, 1992.
p.000335: 49 Abdallah S. Daar, A.Binsumeit Al Khitamy. Bioethics for clinicians: 21. Islamic bioethics CMAJ 2001; 164(1):60-3
p.000335: 50 Hathout H. Why an Islamic perspective? In: El-Gindy AR, editor. Health policy, ethics and human values:
...
p.000337: development. The lack of legal regulation here opens up opportunities for their commercial use or for a groundless
p.000337: accusation of physicians studying embryos. We need laws on human reproduction, human genetic structures,
p.000337: confidentiality of information obtained in genetic testing, etc.
p.000337: 8. Any restrictions of rights and freedoms of a patient with socially dangerous diseases may only be introduced in
p.000337: compliance with laws, but not following subordinate legislation adopted by healthcare bodies.
p.000337: 9. To improve legislation referring to healthcare, it is essential to remove merely declarative norms having
p.000337: no mechanisms or procedures for their implementation. The lack of mechanisms and procedures for a practical
p.000337: implementation of legal regulations results in violation of patients’ rights, an insufficient level of healthcare
p.000337: system efficiency, and, consequently, lowers patients’ trust in healthcare reforms carried out by the State.
p.000337: In the light of the above said, the draft project of the Law “On Medical Practice” has been designed. Chapter III of
p.000337: the Law (Articles 29-50) defines patients’ rights and responsibilities:
p.000337: • Article 29 sets out provisions for implementing patients’ rights;
p.000337: • Article 30 declares patients’ right to life;
p.000337: • Article 31 states patients’ right to non-discrimination;
p.000337: • Article 32 states patients’ right to a free choice;
p.000337: • Article 33 ensures patients’ safety in the field of healthcare;
p.000337: • Article 34 protects patients’ right to physical integrity with regard to medical interventions;
p.000337: • Article 35 ensures patients’ rights to religious freedom;
p.000337: • Article 36 states patients’ rights to pain relief;
p.000337: • Article 37 prohibits any measures putting pressure on patients for behavioural reasons;
p.000337: • Article 38 sets out patients’ right to participate in planning and conducting a treatment;
p.000337: • Article 39 states the right to receive medical information;
p.000337: • Article 40 sets out the right to introduce changes and amendments into medical information;
p.000337: • Article 41 ensures personal immunity when providing medical assistance;
p.000337: • Article 42 sets out the rule of informed consent;
p.000337: • Article 43 states patients’ right to refuse medical treatment;
p.000337: • Article 44 ensures patients’ right to receive a necessary medical care and its availability;
p.000337: • Article 45 states patients’ right to receive all necessary types and forms of medical care;
p.000337: • Article 46 sets out the right to medical care for non-residents of the Republic of Uzbekistan;
p.000337: • Article 47 ensures the right to medical care for residents of the Republic of Uzbekistan staying in the
p.000337: territory of other countries.
p.000337: The draft project of the Law includes provisions referring to the protection of patients’ rights in medical
p.000337: research. Thus, Article 48 states that any biomedical research involving human subjects may only be carried out after
p.000337: the person concerned has given consent to it, and the research project has been approved by the National Ethics
p.000337: Committee (NEC).
...
p.000339: Their knowledge of bioethics will help them to avoid deontological and professional mistakes and to make decisions in
p.000339: difficult situations.
p.000339: The working group of the NEC in collaboration with the TMA professionals teaching bioethics has designed a
p.000339: programme on biomedical ethics for baccalaureate students. The course consists of five lectures (10 hours), 8
p.000339: seminars (17 hours) and 54 hours are given to individual work. The course ends up with a test.
p.000339: Themes vary depending on the course. The syllabus on bioethics covers the following topics: categorical issues of
p.000339: bioethics as a science (relation of the concepts “bioethics”, “biomedical ethics”, “medical ethics”, “ecological
p.000339: ethics”, “research ethics”; subject and tasks of bioethics; theory, principles and methods of biomedical ethics, etc.);
p.000339: international legislation on bioethics; history of medical ethics (including issues of spiritual development
p.000339: and
p.000339:
p.000340: 340
p.000340:
p.000341: 341
p.000341:
p.000341: education, of life and death reflected in works by scientists of different times and peoples; secular and religious
p.000341: aspects of modern biomedical ethics; specific features of biomedical ethics in Islamic countries and
p.000341: Zoroastrian medicine), etc. In addition to that, students should study the Constitution of the Republic of Uzbekistan
p.000341: (1992), as well as laws and normative documents regulating public relations in healthcare. All cardinal problems of
p.000341: theoretical and applied bioethics are considered including ethical problems in clinical trials and biomedical research
p.000341: involving human subjects and animals. Specific ethical problems associated with students’ specialization are also
p.000341: considered.
p.000341: The NEC of the Republic of Uzbekistan is carrying on an essential work on the development of a regular education in
p.000341: bioethics and on training home specialists in the field of modern bioethics.
p.000341: Since 2000, members of the NEC and of regional and local ethics committees have participated in training
p.000341: seminars on bioethics (2001 – Saint- Petersburg, Russia; 2001 – Kiev, Ukraine; 2002 – Almaty, Kazakhstan; 2003
p.000341: – Saint-Petersburg, Russia and Tashkent, Uzbekistan; 2004 – Kiev, Ukraine and Baku, Azerbaijan; 2005 – Yerevan,
p.000341: Armenia; Almaty, Kazakhstan and Tashkent, Uzbekistan; 2006 – Tashkent, Uzbekistan). Training seminars were organized by
p.000341: the Forum for Ethics in the Commonwealth of Independent States, US National Healthcare Union and American Centers for
...
p.000343: the First National Congress on Bioethics with international participation. The Regulations state that local ECs
p.000343: are created under the aegis of the NEC at patient care institutions and research institutes in form of a public unit
p.000343: that is not registered as a juridical person. Local ECs are responsible for monitoring biomedical research approved by
p.000343: the NEC at the site of the research with regard to compliance with the review procedures, obtaining informed consent
p.000343: from the research subjects, research safety (serious adverse effects, inadequate reaction) and notifying
p.000343: NEC if the
p.000343:
p.000344: 344
p.000344:
p.000345: 345
p.000345:
p.000345: research should be terminated because of complications arising in the course of the biomedical research). Local ECs
p.000345: describe the results of their activity in form of an annual report that are archived and retained at local
p.000345: ECs. Operational procedures and rules relating to documenting and archiving should ensure confidentiality of
p.000345: local ECs performance. At the same time the activity of ECs at all levels should be open to the society, which is
p.000345: stated in relevant documents. Information about ECs members, work schedule and decisions may not be confidential.
p.000345: Thus, Republic of Uzbekistan created a multilevel system for ethical review of biomedical research. In compliance with
p.000345: WHO recommendations the NEC members are leading Uzbekistan scientists with experience in various fields of medical
p.000345: and other sciences (biology, law, genetics, philosophy) and representatives of religious and public institutions,
p.000345: ombudsmen and a representative of the National Centre for Human Rights. Regional and local ECs established at regional
p.000345: centers (Samarkand, Bukhara, Andijan, Nukus) and large clinical sites at institutes of higher medical education and
p.000345: research institutes are also headed by eminent Uzbekistan scientists.
p.000345: The NEC reviews international research projects involving human subjects and makes its decisions about the
p.000345: project. The NEC of Republic Uzbekistan has been registered at American Centers for Information Disease Control
p.000345: (Atlanta) and American Centers for Disease Control and Prevention (NAMRO-3, Cairo).
p.000345: The NEC functions in conformity with Standard Operational Procedures (SOPs) designed in the process of a regular work.
p.000345: According to the NEC procedures, the documents should be reviewed within 7-30 days (expedited or regular review). Since
p.000345: the time of its establishment, the NEC has reviewed over 320 various projects including joint international
p.000345: research projects, research projects designed by Uzbekistan scientists and dissertations based on biomedical research
p.000345: involving human subjects.
p.000345: The NEC review also projects of clinical trials of pharmaceutical products, of medical equipment and other products for
p.000345: medical needs. Usually research projects meet ethical requirements, and the NEC makes positive decisions. Sometimes,
p.000345: however, there are cases when the NEC declines a project. This usually concerns clinical trials of a non-registered
p.000345: pharmaceutical product or of a new rout of a known drug administration when there is no approval by the Pharmacological
...
Social / Soldier
Searching for indicator armed forces:
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p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armed forces, prisoners and persons under arrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
p.000119: • Equal rights of patients and physicians to respect for their human dignity (Art. 14);
p.000119: • Mutual trust and mutual responsibility of the patient and the physician, patient is an active participant of the
p.000119: treatment process (Art. 16);
p.000119: • Compulsory consent from the patient for a medical intervention, except for cases provided by law (Art.
p.000119: 21);
p.000119: • Compulsory written consent from a patient, his/her close relatives or legal representatives for removal
p.000119: organs or tissues for diagnostic or therapeutic purposes; removal of organs and tissues for other purposes may not
p.000119: be carried out (Art. 23);
...
p.000133: Presently, local ECs carry out ethical review, which includes the review of documents (research protocols,
p.000133: forms of individual registration cards, informed consent forms, etc.) relating to pre-registration (Phase I, II and III
p.000133: trials, generic bioequivalence studies) and post-registration (Phase
p.000133: IV) clinical trials in various fields of medicine (cardiology, oncology, gastroenterology, allergology,
p.000133: endocrinology, traumatology) including international multicentre trials.
p.000012: 12
p.000011: 11
p.000010: 10
p.000010: 10
p.000010:
p.000010:
p.000008: 8
p.000008:
p.000008:
p.000006: 6
p.000005: 5
p.000004: 4
p.000004: 4
p.000002: 2
p.000002: 2 1 1 1
p.000002:
p.000000: 0
p.000000: 1998 1999 2000 2001 2002 2003 2004
p.002005: 2005
p.002005:
p.002005:
p.002005: Multicentre clinical trials of pharmaceutical products in Belarus
p.002005: (1998-2005)
p.002005:
p.002005: When conducting ethical review ECs give a special attention to the protection of rights and interests of
p.002005: healthy volunteers involved in the Phase I clinical trials and in the clinical stage of bioequivalence studies. A
p.002005: special consideration is also given to research involving vulnerable groups (children, aged people, armed forces
p.002005: personnel, etc.).
p.002005:
p.000134: 134
p.000134:
p.000135: 135
p.000135:
p.000135: 9 8
p.000008: 8
p.000007: 7
p.000007: 7 6 6
p.000006: 6
p.000005: 5
p.000005: 5
p.000005: 5
p.000005:
p.000004: 4
p.000004:
p.000003: 3
p.000002: 2
p.000002: 2
p.000002:
p.000001: 1
p.000001:
p.000000: 0
p.000000: 1999 2000 2001 2002 2003 2004 2005
p.000000:
p.000000: Bioequivalence Studies of Pharmaceutical Products
p.000000: The review of documents referring to clinical trials, including the trial protocol, is performed by local ECs within
p.000000: 5-7 days. Without the approval from local ECs the Chairman of the Pharmacological Committee of the Health
p.000000: Ministry of Belarus may not approve the documents, and the trial may not be started. In the case of disagreement with
p.000000: the EC decision, the applicant (sponsor) may appeal against the decision to the NCBE.
p.000000: The activity of local ECs is regulated by respective normative and legal acts, the EC Statute and Standard Operational
p.000000: Procedures. These documents define the following:
p.000000: 1. Composition of the EC and membership requirements (qualification, etc.);
p.000000: 2. Operating schedule, contact telephones of the EC members, notification procedure;
p.000000: 3. A list of documents to be submitted to the EC for ethical review;
p.000000: 4. The procedure for ethical review of submitted documents;
p.000000: 5. Standard forms of the EC decisions;
p.000000: 6. The statement that all amendments to the protocol (programme) of a clinical trial come into force only after
p.000000: approval by the EC;
...
Searching for indicator army:
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p.000163: treatment of different diseases. It is well known that even ancient healers used infusions, decoctions, blood-
p.000163: lettings and other traditional methods of treatment (1).
p.000163: Multiple archeological findings on the territory of Kazakhstan proves the existence of drug therapy, surgery,
p.000163: neurosurgery. For example, the scull with marks of trepanation was found in Karagandinskaya province and the origin of
p.000163: this scull was dated by V-IV centuries B.C. Mortars for preparation of medical drugs from the same epoch were
p.000163: found not far away from Shymkent. Due to achievements of Arabic and Greek medicine, Kazakh healers’
p.000163: medicine in middle ages was characterized with deep knowledge in the area of disease prognosis, prevention and timely
p.000163: treatment. There are definite data that healers of that era used already laparathomy, abdomen punctures, and
p.000163: surgery for hernias and cataract surgery.
p.000163: The great scientist and healer Oteyboidak Tleukabyl uly (1397-1492) underlined the importance of combination use
p.000163: of traditional treatment with innovation methods and considered that such approach improved the diagnostics of
p.000163: diseases and increased the efficacy of treatment.
p.000163: In the middle of XVIII century when Kazakh territories began tom unite with Russia the first
p.000163: professional health care workers appeared on the territory of Kazakhstan and together with them the first
p.000163: health care institutions were created – such as hospitals and military medical units of the Siberian Cossack army.
p.000163: In 1827 and in 1831 several epidemics of smallpox spread in Kazakhs steps. To take urgent measures, khan Zhangir had
p.000163: sent Sarlybay Zhanibekov for medical studies to Orenburg and in 1828 Sarlybay returned to Kazakhstan as professional
p.000163: smallpox vaccinator and surgeon’s assistant. Since that time mass immunization of local population against smallpox
p.000163: started.
p.000163: In 1920 special anti-plague laboratories were organized to control social diseases in the country. In 1922 the
p.000163: Scientific Medical Council was created under the Commissariat of Public Health.
p.000163: On 10 of October 1925 the first scientific institution was founded in Kzyl-Orda – The Regional Institute of Sanitation
p.000163: and Bacteriology. In meant
p.000163: the organization of the national medical science of Kazakhstan. Konstantin Ivanovich Skryabin gave very valuable help
p.000163: in the process of medical science development; due to his initiative anti-helminthic unit was organized in the city of
p.000163: Kzyl-Orda, special laboratory in the city of Dzhambul, parasitological laboratory at the Institute of Zoology of the
p.000163: Academy of Sciences of the Kazakhstan Soviet Socialist Republic. Special scientific journal “Public Health of
p.000163: Kazakhstan” was founded in for dissemination of scientific knowledge and best practice; this journal played the
p.000163: distinguished role in the development of Kazakhstan’s science.
p.000163: In 1930s several research institutions were organized actively; these Centres began to develop
p.000163: scientifically based recommendations on prevention, early diagnostics and treatment of diseases.
...
p.000195: The country spreads from the north to the south to 350 km, from the east to the west to 150 km. Territory of the
p.000195: Republic of Moldova is 33.8 thousand square km.
p.000195: Population is 4,320 thousand inhabitants including Moldavans – 64.5%, Ukrainians – 13.8%, Russians – 13%, Gagauzians –
p.000195: 3,5%, Bulgarians – 2%. Correlation of urban/rural population is 45/55. Settlement network of the country is represented
p.000195: by 4 municipalities, 61 cities, 1,611 villages united into 925 communes. Kishinev (Chişinău) is the capital of Moldova
p.000195: with 1.1 mln inhabitants. The largest cities of the country are Tiraspol, Beltsy (Bălţi), Bendery.
p.000195: Getae (Dacians) and Romans are considered to be ancestors of local ethnos. Thracians were ancestors of Dacians. They
p.000195: inhabited a wide-spreading territory from the Aegean Sea to upstream of the Dniester River, from the Bug to the Tisza.
p.000195: Thracian tribes of the north Danube were called Dacians; Romans called them Dacians and Greeks – Getaes. We draw
p.000195: information on cultural life of Dacians from multiple archaeological sources and evidences of outstanding persons of
p.000195: the ancient world (Herodotus, Strabo, Thucydides, Plato, Joseph Flavius, Dio Cassius, Jordanes etc.). Farming
p.000195: was a prime activity of the Dacians. 72 fortresses were discovered.
p.000195: The Dacians had medical concept according to which at treating it was necessary to take into consideration the state of
p.000195: a body in general, including mental state. Their medical knowledge for that period was excellent.
p.000195: 4 large Dacian communities existed in the first part of the 2nd century
p.000195: B.C. Each community had the army and institution of money. The union and strengthening of Dacia happened in the
p.000195: time of king Burebista (+80
p.000195: - 44 B.C.) Dechebal (87-106) was the last Dacian king. In 106 Dacia was conquered by the Romans and turned to be a
p.000195: province. That was the last province of the Roman Empire. It was followed by Roman epoch (106-
p.000195: 271) with the Romanization of Dacian population, the Latinization of the
p.000195: language and evangelization. There was the ethnogenesis of Romanians (from “Romans”) later.
p.000195: Development of feudal relationship was attested in the X century. Three principalities were formed in the one-time
p.000195: Dacian territory: Transylvania, which felt under the reign of Hungarians (Hungarians are Finno-Ugric trans- Ural tribes
p.000195: settled here by the end of the IX century) in the beginning of the X century, Ţara Românească (or Walachia, Muntenia);
p.000195: Ţara Moldovei. The first written diplomas mentioning political and military strength of Ţara Românească and
p.000195: Moldova are referred to the years 1330 and 1359, respectively.
p.000195: During the Middle Age Moldova kept suffering from raids of the Tatars, the Turks, the Hungarians and the Poles.
p.000195: Historical Moldova covered the territory between Eastern Carpathians, woody Carpathians, the Dniester, the Black
p.000195: Sea and the Danube under Roman 1 of Moldavia (1392-1394). Geographic location of the territory was favorable as
...
p.000283: the universe. Zoroastrianism formulated a ternary ideal of the righteous man (“good thoughts”, “good words” and
p.000283: “good deeds”) opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked words” and “wicked deeds”). The
p.000283: Zoroastrian idea about infinite time as an initial substance gave rise to zervanism – a teaching in the framework of
p.000283: which a materialistic trend developed that denied the creation, and god as the creator of the universe, and
p.000283: affirmed the belief in the eternity of the world. In the end of the slave-owning system and in the beginning of
p.000283: feudalism, Manichaeism (Mani, 215-276) and Mazdakism (Mazdak, the end of the V - the beginning of the VI century)
p.000283: became very influential. Those philosophical trends assimilated the Zoroastrian ideal about the struggle
p.000283: between the good and the evil. The social doctrine of Mazdakism proclaimed ideas of justice and equality.
p.000283: The earliest written evidence that peoples of Central Asia had a good knowledge of mathematics and astronomy is
p.000283: “Avesta” containing data on the movement of celestial bodies, the system of time count and some mathematical rules.
p.000283: In that period, early states in Central Asia achieved a high
p.000283: level of material production and culture: crafts, agriculture, architecture and art. That was the time when many
p.000283: written monuments of religious, political and scientific thought were created, many of which were destroyed during the
p.000283: invasion of the army of the Arab Caliphate (VII-VIII centuries).
p.000283: During the VIII-XV centuries philosophical, social and political ideas were developing in the atmosphere of
p.000283: Arabian conquests and a forcible spreading of Islam. Spiritual cultures of Iranian and Arabic peoples became most
p.000283: closely linked. During the VIII-IX centuries, in Maverannahr (the right bank of Amudarya) and Khorosan the tendency to
p.000283: the territorial, language and cultural integration broken by the Arabian conquest had been growing. During the period
p.000283: of the Samanids rule (874-1005 AD), the Tajiks developed as a nation with its State system and
p.000283: literary language. In the IX-XI centuries, Central Asia was one of the most important centres of oriental
p.000283: science. That was the time when astronomical observatories, “Houses of Wisdom” and libraries were built.
p.000283: Scientists from Central Asia translated and commented the scientific heritage of ancient Greece and India and
p.000283: wrote original works on mathematics, astronomy, mineralogy, applied mechanics, physics, chemistry and medicine.
p.000283: Mohammed ibn Musa al-Khorezmi, Abdul Marvazi, Usman Balhi al-Fergani (IX c.), Abul-Vefa al-Buzjani, Abulmahmud Hudjani
p.000283: (X c.) and many others made an essential contribution to science. In the XI-XIV centuries Khorezm, Bukhara,
p.000283: Merv, Gazna and other towns, and later, in the XV century, Samarkand with the Ulugbek’s observatory,
...
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p.000039: Legal Basics and Mechanisms for Implementation of Social State in the CIS Countries, the Charter of Social Rights and
p.000039: Guarantees for Citizens of Independent States (adopted by IPA CIS, 29.10.1994). Also many projects of model acts
p.000039: included into perspective plan of model law development are also important for formation of state policies of the CIS
p.000039: countries in the field of health care and biomedicine such as the following: On Social Protection of Handicapped, On
p.000039: Folk Medicine, Recommendations on National Legislations Adjustment of the CIS Member States in the Sphere of Social
p.000039: Protection and Medical Service for Liquidation Participants of the Disaster Consequences at the Chernobyl NPS, On
p.000039: Counteracting HIV/AIDS in the CIS Member States, Medical Code of the CIS Member States, On Preventing
p.000039: Distribution of Forged and Low-quality Drugs, On Natural Medical Resources, Medicinal- sanitary Areas and Resorts, and
p.000039: many others.
p.000039: Activity of IPA CIS also facilitates development of regional legal cooperation in the field of health care and
p.000039: social protection of the population at the level of heads of states and governments. As per initiatives of this
p.000039: authority the member states executed the following basic agreements:
p.000039: - Agreement on Cooperation in the Field of Protection of Population Health (Minsk, 26 of June 1992),
p.000039: - Agreement on Medical Services for Military Personnel and Their Family Members, Workers and Servants of
p.000039: Frontier Troops (Minsk, 26 of June, 1992),
p.000039: - Agreement on Provision for Population of Medicinal Drugs, Vaccines and Other Immunobiological Agents, Goods for
p.000039: Medicinal Use and Medical Equipment Manufactured at the Territory of the CIS Member States (Ashkhabat, 24 of
p.000039: December 1993),
p.000039: - Agreement on Social Security and Health Protection of Citizens Exposed to Ionizing Radiation as a Result of
p.000039: Chernobyl and Other Radiation Catastrophes and Accidents as well as Nuclear Testing (Moscow, 9 of September
p.000039: 1994),
p.000039: - Agreement on Cooperation for Resolution of Issues of Disability and Disabled (Moscow, 12 of April 1996),
p.000039:
p.000040: 40
p.000040:
p.000041: 41
p.000041:
p.000041: - Agreement on Provision of Medical Care to Citizens of the CIS Member States (Moscow, 27 of March 1997),
p.000041: - Convention on Transfer of Persons with Mental Disorders for Compulsory Treatment (Moscow, 28 of March 1997),
p.000041: - Agreement on Cooperation for Resolution of Issues of HIV Infection (Moscow, 25 of November 1998),
p.000041: - Agreement on Prevention of Iodine-deficient Disorders among Citizens of the CIS Member States (Minsk, 31
p.000041: of May, 2001),
p.000041: - Agreement on Cooperation of the CIS Member States in the Field of Protection of Population Health (Yalta, 18 of
p.000041: September 2003),
...
p.000069: its global effect on the development of ethical ideas and on the ways of their implementation at the
p.000069: general level of civilization in the history of humankind is quite obvious. From the theoretical viewpoint, it is
p.000069: impossible to speak about the history of medical ethics without considering interdependent processes of the
p.000069: development of various ethical concepts and an essential role of main landmarks in the history of world ethical
p.000069: practice that have determined a harmonious and comprehensive understanding of general ethical principles of the
p.000069: research.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000071: 71
p.000071:
p.000071: From the practical point of view, the history of biomedical research ethics is inseparable from
p.000071: understanding the essence and process of the biomedical research as such.
p.000071: According to the main research subject, the biomedical research may be divided into the following categories:
p.000071: • Research that physicians carry out on themselves (autoexperiments);
p.000071: • Research involving healthy people;
p.000071: • Research involving patients.
p.000071: In historical context, the concept of informed and voluntary consent of a research subject requires subdividing
p.000071: into separate groups within these categories
p.000071: Besides, both in healthy (e.g. prisoners and military men) and ill (e.g. persons with mental disorders or ill
p.000071: minors) research subjects, groups of vulnerable contingents should be distinguished, i.e. groups of persons who for
p.000071: social, legal, age-specific, intellectual, mental or other reasons have a limited capacity or do not
p.000071: have the capacity to make an independent, informed and voluntary decision to participate in a clinical research.
p.000071: It is also essential to distinguish different types of biomedical research depending on the character of the connection
p.000071: between the research goal and its actual clinical motivation.
p.000071: Research of the first type, defined in international documents as “therapeutic” (or clinical) biomedical
p.000071: research, implies the application of new diagnostic, therapeutic or preventive pharmaceuticals or methods, i.e.
p.000071: research conducted in the interests of a particular research subject.
p.000071: Research of the second type, defined as “non-therapeutic” (or non- clinical) biomedical research, does not
p.000071: imply actions in the interests of ill or healthy subjects. Biomedical research is carried out with the purpose of
p.000071: obtaining some scientific knowledge or studying how the human organism would respond to one or another condition or
p.000071: factor (pharmokinetic studies, studies in the field of normal physiology, in cosmonautics and sport, etc.).
...
p.000071: reflected in chapters describing the cultural and historical background of ethics development in each
p.000071: country. On the whole, the scientific feat of those people is of a supranational character, and arouses feelings of a
p.000071: deep respect and admiration. Their work served the purpose of scientific knowledge, saving people’s life and making
p.000071: achievements for the welfare of the humankind.
p.000071: Inhuman experiments on concentration camp prisoners carried out on an appallingly large scale and sanctioned by the
p.000071: state law of the Nazi regime arouse opposite emotions, and the very word “experiment” with regard to a human being has
p.000071: a dismal echo.
p.000071: However, the development of biomedical research is based not only on those polar, in terms of ethics, examples.
p.000071: International standards of implementation into the medical practice of new therapeutic, diagnostic and preventive
p.000071: pharmaceuticals and methods, as well as their scientific and moral resonance are reflected in historical stages of
p.000071: setting out legal concepts of bioethics.
p.000071: Currently, the list of international recommendations, declarations, codes, resolutions and other documents relating to
p.000071: bioethics is very extensive, and in the last decades it has a tendency to increase.
p.000071: One of the most important events in the history of bioethics in the XX century was the Nuremberg Code adopted by
p.000071: the International Military Tribunal in 1947. When commenting on this historical document, the world press emphasized
p.000071: that the accusatory sentence of the Nuremberg Trial “speaks on behalf of insulted human conscience”. The
p.000071: Nuremberg Code was the first document based on the “judgment of the victorious truth”, which declared the
p.000071: cardinal ethical principles with regard to an individual and stimulated the growth of public awareness and peoples’
p.000071: responsibility.
p.000071: Among international documents in which the ethical principles in medicine and their actual application were
p.000071: further developed, the Declaration
p.000071:
p.000072: 72
p.000072:
p.000073: 73
p.000073:
p.000073: of Helsinki is certainly the most important. It was adopted by World Medical Association in 1964, and has been
p.000073: continuously revised and updated.
p.000073: Recognizing the key role of the Nuremberg Code and the Helsinki Declaration with regard to ethical
p.000073: regulation of biomedical research, we should mention also some important documents that set up a kind of
p.000073: a base for those, and a number of documents facilitating the development and interpretation of the
p.000073: general principles set out in the Declaration of Helsinki and its actualization in connection with new
p.000073: conditions caused by the progress in biology and biomedicine in the last decades of the XX and in the beginning of the
p.000073: XXI century.
p.000073: The current concept of ethical regulation of biomedical research, asserting that an individual, and the
...
p.000079: regulations. As to its contents, the Statute illustrates a number of cardinal principles regulating the modem
p.000079: practice of biomedical research. However, the Statute did not declare the need to establish ethics committees, nor
p.000079: emphasize the need for independent ethical review, and the decisions on
p.000079: both professional and ethical aspects of the review were still the responsibility of the institutional organizations.
p.000079: On the whole, the significance of all these documents (considering their content and the time when they
p.000079: had been adopted) consists in the fact that the requirements concerning scientific justification and
p.000079: preliminary experiments on animals, research participants’ informed and conscious consent, high qualification of a
p.000079: physician-investigator and his responsibility in relation to research subjects fully coincide with modern norms of
p.000079: research ethics. The other important and positive aspect with regard to the analyzed documents is that the
p.000079: motivation to create those and their content has a protective legal character.
p.000079: At the same time, it should be noted that the Soviet legislation had a legal mechanism for the attribution
p.000079: of criminal liability for committing “crimes against Humankind”. (Decree of Presidium of the Supreme Council of the
p.000079: USSR on 19 of April 1943. Art. 1). There is an important historical document that reflected moral and legal
p.000079: understanding of experiments on live human beings – the protocols of a legal action conducted by the Military Tribunal
p.000079: of the USSR in Khabarovsk in 1949. It concerned the case of former Japanese military men accused of the development and
p.000079: use of biological weapons (“Indictment on the case of the former Japanese military men”; a supplement to Novoe Vremia
p.000079: (New Time) Journal, No 1, 1 of January 1950). The importance of the Conclusion adopted by the Tribunal in Khabarovsk is
p.000079: comparable with the importance of the Nuremberg Trials and the Code adopted there. In both cases the moral aspects of
p.000079: decisions concerned not only the individuals guilсссty of the crimes, but also the governmental policy and
p.000079: ideology which made these crimes possible.
p.000079: In the context of this Chapter the above documents are mentioned for the following purposes:
p.000079: • to eliminate informational vacuum existing in relation to the ethics of biomedical research in the former Soviet
p.000079: Union;
p.000079: • to clarify the reason of including the abovementioned documents into the international list on important documents
p.000079: of “pre-Helsinki” era to the CIOMS list;
p.000079: • to illustrate mutually enriching and complementary values of studying fundamentals of moral and cultural
p.000079: heritage;
p.000079:
p.000080: 80
p.000080:
p.000081: 81
p.000081:
p.000081: • to define the basis for a timely and harmonious assimilation of international universal norms of
p.000081: biomedical research ethics by the CIS countries.
p.000081: Summarizing the data on the ethical component of biomedical research at the time of the Soviet Union
p.000081: disintegration and formation of new independent states in the end of the nineteenths of the last century, we have
...
p.000163: Medicine as a part of population culture is the result of practical and scientific selection of methods for the
p.000163: treatment of different diseases. It is well known that even ancient healers used infusions, decoctions, blood-
p.000163: lettings and other traditional methods of treatment (1).
p.000163: Multiple archeological findings on the territory of Kazakhstan proves the existence of drug therapy, surgery,
p.000163: neurosurgery. For example, the scull with marks of trepanation was found in Karagandinskaya province and the origin of
p.000163: this scull was dated by V-IV centuries B.C. Mortars for preparation of medical drugs from the same epoch were
p.000163: found not far away from Shymkent. Due to achievements of Arabic and Greek medicine, Kazakh healers’
p.000163: medicine in middle ages was characterized with deep knowledge in the area of disease prognosis, prevention and timely
p.000163: treatment. There are definite data that healers of that era used already laparathomy, abdomen punctures, and
p.000163: surgery for hernias and cataract surgery.
p.000163: The great scientist and healer Oteyboidak Tleukabyl uly (1397-1492) underlined the importance of combination use
p.000163: of traditional treatment with innovation methods and considered that such approach improved the diagnostics of
p.000163: diseases and increased the efficacy of treatment.
p.000163: In the middle of XVIII century when Kazakh territories began tom unite with Russia the first
p.000163: professional health care workers appeared on the territory of Kazakhstan and together with them the first
p.000163: health care institutions were created – such as hospitals and military medical units of the Siberian Cossack army.
p.000163: In 1827 and in 1831 several epidemics of smallpox spread in Kazakhs steps. To take urgent measures, khan Zhangir had
p.000163: sent Sarlybay Zhanibekov for medical studies to Orenburg and in 1828 Sarlybay returned to Kazakhstan as professional
p.000163: smallpox vaccinator and surgeon’s assistant. Since that time mass immunization of local population against smallpox
p.000163: started.
p.000163: In 1920 special anti-plague laboratories were organized to control social diseases in the country. In 1922 the
p.000163: Scientific Medical Council was created under the Commissariat of Public Health.
p.000163: On 10 of October 1925 the first scientific institution was founded in Kzyl-Orda – The Regional Institute of Sanitation
p.000163: and Bacteriology. In meant
p.000163: the organization of the national medical science of Kazakhstan. Konstantin Ivanovich Skryabin gave very valuable help
p.000163: in the process of medical science development; due to his initiative anti-helminthic unit was organized in the city of
p.000163: Kzyl-Orda, special laboratory in the city of Dzhambul, parasitological laboratory at the Institute of Zoology of the
p.000163: Academy of Sciences of the Kazakhstan Soviet Socialist Republic. Special scientific journal “Public Health of
p.000163: Kazakhstan” was founded in for dissemination of scientific knowledge and best practice; this journal played the
p.000163: distinguished role in the development of Kazakhstan’s science.
p.000163: In 1930s several research institutions were organized actively; these Centres began to develop
p.000163: scientifically based recommendations on prevention, early diagnostics and treatment of diseases.
p.000163: During the first years of the Great Patriotic War 112 military hospitals were organized at the territory of Kazakhstan.
p.000163: During the war in spite of very complicated situation medical scientists of Kazakhstan continued their research
p.000163: activity and enriched the practice with very important discoveries and patents that did not loose their
p.000163: actuality even after the war. Academician N.F.Gamaleya – the founder of the Russian microbiology
p.000163: – after experiments on himself developed the drug for the treatment of tuberculosis. Professor
p.000163: A.P.Polosukhin developed an effective drug for shock treatment; Dr. A. N. Syzganov proposed and scientifically
p.000163: based the use of salicylic acid and acidophilic cream for the treatment of infected wounds and frostbites;
p.000163: Dr. V.V.Zikeev used formalized bone transplants for the treatment of pseudo-arthroses.
p.000163: During the war research institutions of Kazakhstan did not interrupt their activity; immediately after the war
p.000163: several medical research institutions were organized under the Academy of Sciences of Kazakhstan Republic: the
p.000163: Institute of Regional Pathology, the Institute of Clinical and Experimental Surgery, the Institute of Physiology.
p.000163: World-known academician Nikolai Dmitrievich Beklemishev – doctor of medical sciences, professor, honored scientist of
p.000163: Kazakhstan Republic and the winner of the State Prize – made a great input in the study and control of
p.000163: brucellosis. His monograph “Chronic brucellosis” was included as big section in the manual «Die brucellose des
p.000163: Menschen» that was edited and published in Berlin by J.Parms and in recommendations published by the World Health
p.000163: Organization.
p.000163:
p.000164: 164
p.000164:
...
p.000167: drugs. These articles were developed in the line with international experience (5):
p.000167: - the participation of the patient in clinical trials and (or) in testing of pharmaceutical substance or
p.000167: medical drug should be voluntary and is possible with his/her written informed consent only;
p.000167: - before clinical trials and (or) testing all information on the substance/ drug, on the contents of trials or tests,
p.000167: on safety and risks for patients health, on actions in the case of unforeseen effects of pharmaceutical substance or
p.000167: medical drug for the patient’s health as well as on patient’s health and life insurance should be provided to the
p.000167: patient;
p.000167: - the patient has a right to interrupt his/her participation in trials and (or) tests of pharmaceutical substance or
p.000167: medical drug at any phase of such trials or tests;
p.000167: - it is strictly prohibited to perform clinical trials and (or) tests of pharmaceutical substances or
p.000167: medical drugs with participation of: children and adolescents; pregnant women; military persons; imprisoned
p.000167: or incarcerated persons; non-competent persons.
p.000167: At the web-site www.medik.kz the Association of Physicians and Pharmacists of Kazakhstan has the page, where
p.000167: all legislative and regulatory documents in public health area. At present time specialists began to develop the Code
p.000167: of Republic of Kazakhstan “On Population Health and Public Health System” that will take into consideration all
p.000167: international legislative experience including legislative acts in area of biological and medical studies. For
p.000167: example, on 22nd of January 2007 the Frame Convention on Tobacco Control was officially ratified by the Republic of
p.000167: Kazakhstan; it is planned to bring laws of Kazakhstan in line with international documents that can ensure good
p.000167: clinical practice and improvement of activity of ethical committees [6].
p.000167: In 1995 according to initiative of the Association of Physicians and Pharmacists of Kazakhstan drafts of “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
p.000167: developed. In 2002 the Second Congress of Physicians and Pharmacists approved the text of “The Oath of Physician of the
p.000167: Republic of Kazakhstan” that was reflected in special Decree of the Government of the Republic of Kazakhstan No/ 1189
p.000167: published on 27th of November 2003 and in the article 50 of the Law of the Republic of Kazakhstan “On the
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan”.
...
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
p.000169: The article 43 of the Law of the Republic of Kazakhstan “On the System of Public Health” published on 4th
p.000169: June 2003 contains the juridical definition of scientific medical expertise; in this article it is indicated that
p.000169: objects of scientific medical expertise are as follows:
p.000169: - drafts of programmes of basic and applied scientific research;
p.000169: - republican targeted scientific medical programmes;
p.000169: - results of completed scientific medical programmes and projects;
p.000169: - scientific research that were nominated for the state awards of the Republic of Kazakhstan;
p.000169: - results of scientific medical programmes that are supposed to be implemented into public health practice.
p.000169: The order of scientific medical expertise is determined by the national authority in public health area.
p.000169: The article 42 “Expertise of medical drug” of the same Law says that the expertise of medical drug represents a study
p.000169: or a trial of medical drug
p.000169: for its safety, efficacy and quality and that physical, chemical and biological tests as well as clinical trials should
...
p.000181: 2. international accord,
p.000181: 3. national honour,
p.000181: 4. movement towards prosperity and well-being through a continuous labour and knowledge,
p.000181: 5. humanism, generosity, tolerance,
p.000181: 6. harmony with nature,
p.000181: 7. strengthening and protection of Kyrgyzstan state system.
p.000181: Ethical norms in “Manas” are based on four cardinal virtues (wisdom, patience, conscience and generosity) that are
p.000181: personified in images. They are opposed by four vices: laziness, wickedness, greed and arrogance. It is said that a
p.000181: clever person is always able by using one’s mind which is “the best of all treasures” to oppose positive qualities to
p.000181: negative ones and defeat the evil by kindness, wickedness by patience, greed by generosity. Hence, the person has to
p.000181: make every effort to improve his or her moral nature, to overcome evil elements and to change the surrounding world.
p.000181: Among human qualities most valued in Kyrgyz culture are health and longevity, diligence and valour, sense of duty and
p.000181: honour, modesty, self- control and wisdom. These virtues ensure a harmonious life of the individual [5]. Openness, love
p.000181: for children, hospitality, generosity, humanism, patience, firmness, goodwill, respect for old age and other qualities
p.000181: inherent in Kyrgyz people form the basis of moral and ethical principles of their life [1].
p.000181: Historical conditions dictated to Kyrgyz people the necessity to stand up for their freedom and integrity in the fight
p.000181: with stronger neighboring states. Severe war conditions required from men who were admitted to military
p.000181: of people’s life. Over many ages, people’s ideals have been associated
p.000181:
p.000181:
p.000181: with “Manas”; ethical norms and concepts of the good and the evil were exemplified by the acts and deeds of “Manas”
p.000181: characters.
p.000181: 19 The word eudemonism comes from the Greek word for happiness or flourishing
p.000181: (eudaimonia), and refers to any conception of ethics that puts human happiness and the complete life of
p.000181: the individual at the Centre of ethical concern.
p.000181:
p.000181:
p.000182: 182
p.000182:
p.000183: 183
p.000183:
p.000183: service not only physical strength, but also moral maturity. Wars depicted in “Manas” and episodes associated with
p.000183: those exemplify heroic traditions implying the observance of the rule of military necessity and an innate
p.000183: aversion to violence, as well as a wish to live in peace. Kyrgyz warriors regarded their sacred duty not to harm
p.000183: peaceful population of conquered peoples. It was forbidden to plunder or humiliate them. Thus an epic sage Bakai
p.000183: addresses his warriors:
p.000183: “Do not thou slaughter their cattle more that thou need for food, A foe today may be kinsman tomorrow,
p.000183: Do not thou harm them”.
p.000183: The early Kyrgyzstan was located on the crossroad of the Great Silk Road routs, which made it “a bastion of
p.000183: religious syncretism” where representatives of different confessions could coexist. This is, perhaps, the
p.000183: reason for a remarkable tolerance in the Kyrgyz in relation to other confessions and cultures of people
p.000183: inhabiting Kyrgyzstan.
p.000183: “The Beneficial Knowledge” by Jusup Balasagyn (XI c.) is another treasure of the Kyrgyz. The treatise was so
p.000183: perfect that in China it was titled “The Code of Decent Men”, in Iran – “The Book of Shahs” and in Turania
p.000183: – “The Book of Precepts for Rulers”. For Turkic peoples “The Beneficial Knowledge” “was as much important as “Lay of
p.000183: Igor’s Warfare” for Slavic peoples” (Naum Grebnev).
p.000183: “The Beneficial Knowledge” covers problems of sociology, ethics, aesthetics, theology and social psychology. It
p.000183: presents a sum of knowledge in different fields of science and culture of that time. The treatise presents a
p.000183: comprehensive system setting forth and analyzing philosophical problems relating to sense and meaning of human life. It
p.000183: defines human duties and norms of behaviour in the community and reflects “moral and ethical ideals with regard to
p.000183: life-style, culture and ideology of settled Turkic peoples still retaining the memories about their nomadic
p.000183: civilization” [13].
p.000183: According to “The Beneficial Knowledge” just and fair laws are the cardinal mechanism ensuring stability in the
p.000183: society, and everyone, be it a ruler or a subject should follow the laws.
p.000183: Law rules the world – we shan’t forget this, It is a sign of humanity inherent in people.
p.000183: In its character, “The Beneficial Knowledge” is an ethical and didactic poem written with the purpose to show the way
p.000183: towards learning the wisdom
p.000183: of government, every-day life and relationships between people on different occasions. Jusup Balasagyn describes
p.000183: qualities necessary for viziers, military commanders, secretaries, ambassadors, penmen and copyists,
p.000183: treasurers, cooks, cup-bearers, scientists, physicians, dream interpreters, magi, astrologers, merchants,
p.000183: cattle-breeders, craftsmen and others. He also writes how people should behave, reflects on human
p.000183: responsibilities and duties, virtues and vices. For Balasagyn sees “dissolution of morals and depreciation
p.000183: of spiritual values as one of the worst vices of his time” [8].
p.000183: A peculiar feature of “The Beneficial Knowledge” is that the author allows the reader to himself to gain an
p.000183: understanding of sense of life, of virtues and vices. Jusup Balasagyn argues that everyone should know and observe
p.000183: moral norms and rules of behaviour. “The Beneficial Knowledge” is a peculiar moral code of its time. Over a long time
p.000183: Kyrgyz ethnos had been existing in form of clans. Relationships within the community had been forming during
p.000183: a long historical period. Changes, if any, occurred due to the influence of external environment forming the worldview:
p.000183: the sense of sharing needs and interests of other people, feelings of mutual aid and collectivism. Kyrgyz people
p.000183: survived in crisis situations only due to spiritual and genetic health of their ancestors. People retained and
p.000183: developed clan traditions, upbringing practices, code of ancestral honour. Clan honour for Kyrgyz people is one of
p.000183: the most essential concepts. Every Kyrgyz had his ancestors, his land and his clan. Each clan had its hierarchy
p.000183: at the head of which was the most respected clan member. Collectivism, mutual aid, empathy, respect for other
p.000183: people – those were the qualities inherent in Kyrgyz mentality.
...
p.000189: healthcare state institutions of Kyrgyz Republic and at healthcare institutions carry out an expert evaluation with
p.000189: regard to ethical criteria, consider moral and ethical problems arising in the course of clinical trials of
p.000189: pharmaceutical products and ensure the protection of patient’s rights.
p.000189: This Law contains important provisions concerning human rights in clinical trials of pharmaceutical
p.000189: products. In particular, it says that a patient gives his or her written consent to participate in a clinical
p.000189: trial of a pharmaceutical product and has the right to withdraw his or her consent at any stage of the research. Before
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
p.000189: out in such vulnerable patients as children without parents; military personnel; prisoners and persons under
p.000189: investigation in detention Centres; pregnant women (except for cases when clinical trials are designed specially
p.000189: for pregnant women and when the
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000191: 191
p.000191:
p.000191: necessary information can only be obtained in a clinical trial provided that the trail is not hazardous to a woman or
p.000191: to a fetus).
p.000191: Besides, the Law sets certain restrictions relating to clinical trials involving children. Thus the trials are
p.000191: only permitted if the investigational pharmaceutical product is specially indicated for use in children or to obtain
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
...
p.000195: the ancient world (Herodotus, Strabo, Thucydides, Plato, Joseph Flavius, Dio Cassius, Jordanes etc.). Farming
p.000195: was a prime activity of the Dacians. 72 fortresses were discovered.
p.000195: The Dacians had medical concept according to which at treating it was necessary to take into consideration the state of
p.000195: a body in general, including mental state. Their medical knowledge for that period was excellent.
p.000195: 4 large Dacian communities existed in the first part of the 2nd century
p.000195: B.C. Each community had the army and institution of money. The union and strengthening of Dacia happened in the
p.000195: time of king Burebista (+80
p.000195: - 44 B.C.) Dechebal (87-106) was the last Dacian king. In 106 Dacia was conquered by the Romans and turned to be a
p.000195: province. That was the last province of the Roman Empire. It was followed by Roman epoch (106-
p.000195: 271) with the Romanization of Dacian population, the Latinization of the
p.000195: language and evangelization. There was the ethnogenesis of Romanians (from “Romans”) later.
p.000195: Development of feudal relationship was attested in the X century. Three principalities were formed in the one-time
p.000195: Dacian territory: Transylvania, which felt under the reign of Hungarians (Hungarians are Finno-Ugric trans- Ural tribes
p.000195: settled here by the end of the IX century) in the beginning of the X century, Ţara Românească (or Walachia, Muntenia);
p.000195: Ţara Moldovei. The first written diplomas mentioning political and military strength of Ţara Românească and
p.000195: Moldova are referred to the years 1330 and 1359, respectively.
p.000195: During the Middle Age Moldova kept suffering from raids of the Tatars, the Turks, the Hungarians and the Poles.
p.000195: Historical Moldova covered the territory between Eastern Carpathians, woody Carpathians, the Dniester, the Black
p.000195: Sea and the Danube under Roman 1 of Moldavia (1392-1394). Geographic location of the territory was favorable as
p.000195: to the nature and life resources and at the same time unfavorable as to geopolitical strategic aspect. The country
p.000195: was located in the strategic pass connecting Eastern and Western Europe, being situated between the Carpathians and the
p.000195: Black Sea. The Silk Road, i.e. the longest commercial route connecting the Far East with the western European countries
p.000195: was there in the Middle Age. Since the first centuries AD and until now great states, trying to preserve the influence
p.000195: here had strategic interests in common. Our people have never been involved in wars of aggression but only defensive
p.000195: ones. Such state of affairs left a deep track in the spiritual life of the country. Spirituality of the inhabitants,
p.000195: philosophic thoughts are of the patriotic and the humanist nature. The ideas of the Italian Renaissance were taken here
p.000195: caught on with some works of some local cultural figures.
p.000195: Ştefan cel Mare şi Sfânt (Stephen the Great and Holy) (1457-1504) ruled Moldova during the most
p.000195: difficult times. He provided a long-term unity of the state, its economical growth and prosperity of
...
p.000229: left behind almost all European states, besides Switzerland and the USA (the College of 1864). Courses could exist
p.000229: only on private donations. Means were collected in favor of the Courses. Zemskiy doctors sent part of their
p.000229: salary in favor of the courses. Association of mutual aid of women-doctors founded in 1890 was very useful. In 1897
p.000229: efforts of progressive society resulted in foundation of the first Russian Women Medical Institute, which was opened in
p.000229: Saint- Petersburg (now the Saint-Petersburg Medical University named after I.P. Pavlov).
p.000229: Events in medicine and health protection happened in period from 2nd half of the XIX — beginning of the XX century
p.000229: stimulated development of medical ethical ideas. Many old problems became more acute and new ones appeared, relations
p.000229: of doctor and society, doctor and patient, intercolleagueal relations in medicine were changed. Russian physicians were
p.000229: characteristic of not only speeches and declarations, talks about duty and morality but of deeds, behavior, example,
p.000229: and demonstration – quite often during dozens of years or even during their whole life - of what a doctor should be.
p.000229: Open discussion of “complicated” medical issues not only inside of medical society can be considered as
p.000229: a root of such bioethics feature as openness, transparency, necessity in public monitoring of biological
p.000229: researches.
p.000229: Development of a method of chronic experiment in animals is linked to the name of I.P.Pavlov (1849-1936). In 1876 at
p.000229: the Botkin’s clinic of the Medical Military Academy in Saint-Petersburg an experimental laboratory was founded. In
p.000229: 1878-1889 I.P.Pavlov made his researches here. Approval of experiments with animals as a basis of medicine
p.000229: resulted in usage of many animals and their death. It caused reproaches to experimentalists in cruelty, their
p.000229: accusation in misuse of vivisection. In reply to the letter of the Russian association of animal patronage “On
p.000229: vivisection as shocking and useless misused in the sake of science” of January 17, 1904, the commission
p.000229: consisting of professors P.M. Albitskiy, I.P. Pavlov and N.P. Kravkov was founded in the Medical Military
p.000229: Academy. This commission
p.000229: presented its conclusions on this letter. Conclusions showed disagreements with accusations, the statements of the
p.000229: letter were named anti-scientific and sanctimonious. Nevertheless this case forced to think about humanity of
p.000229: experiments in animals and improvements of conditions of their keeping.
p.000229: At the same time legitimacy of trials with human subjects is under discussion in the society. In connection
p.000229: with achievements in microbiology doctors by way of self-experimenting researched contagiousness of infectious diseases
p.000229: even the highly harmful ones. Self-experimentations carried out by physicians have never been disapproved of; they were
p.000229: rather perceived as acts of heroism and admired. There were a great number of such examples. In 70-s of the XIX century
p.000229: O.O. Motchutkovskiy, a physician from Odessa, several times made self injections with blood samples from patients
p.000229: infected with epidemic typhus and got severely diseased. After injecting themselves with blood samples from patients
p.000229: infected with relapsing fever, G. N. Mikh and N.I. Mechnikov also suffered through severe illnesses. N.F. Gamaleja,
p.000229: N.I. Metchnikov, D.K. Zabolotnyi, M. Pettnkofer took pure culture of cholera vibrio. Such examples can be
p.000229: continued.
p.000229: In relation to experiments with other human subjects many researchers were guided by the respectful opinion of
p.000229: S.P. Botkin (1832-1889): “It is evident that trials with human subjects are permitted only in extraordinary cases
p.000229: when we can be sure of their harmlessness otherwise we resort to experiments with animals, conditions for
p.000229: our observations being significantly simplified”.
...
p.000261: Biology and Bioecology (a part of general vocational subjects). As a negative sign it should be noted that
p.000261: bioethics education is not stipulated for such major as Philosophy. Existence of national and regional (school-
p.000261: related) component in state standards and the right to some extent to alter curriculum content allows for many of
p.000261: educational facilities in Russia to include bioethics into education of future agriculture workers, veterinaries,
p.000261: teachers, philosophers and other trades.
p.000261: At the same time there is no trade of bioethics in the All-Russian Classifier of Educational Trades as well
p.000261: as it is not mentioned in the List of Scientific Specialist Trades. Therefore, targeted training of specialists
p.000261: including specialists of higher qualification (masters and doctors of science) in regard to bioethics is not
p.000261: provided. However, theses or dissertations for master or doctor degree covering to some extent bioethics
p.000261: issues are defended using reference numbers of other trades such as philosophy, sociology, public health.
p.000261: Currently training of medical doctors and pharmacists is conducted in 47 universities and academies subjected to the
p.000261: Federal Agency on health care and social development as well as 25 departments and institutions of the Russian
p.000261: education ministry, 5 military medical educational facilities, 10 private higher educational facilities as well as in
p.000261: the Kyrgyz-Russian Slavic University accredited in Russia.
p.000261: Typical unified program of education in higher medical educational facilities in Russia was developed in 2001 by the
p.000261: group of Moscow scientists, and in 2003 the reference curriculum on bioethics for Pharmacy trade was published (authors
p.000261: – workers of the Moscow Medical Academy named after Sechenov I.M.), which are planned for 36 academic hours of class
p.000261: work (18 hours of lectures and 18 hours of seminars) and 18 hours of independent work in the 2nd semester. The
p.000261: curriculum stipulates learning of history and traditions of Russian ethics, theoretical basics of biomedical ethics,
p.000261: models and rules of relationships between doctor and patient, patient rights, analysis of bioethical issues of
p.000261: experimental medicine, reproductive technologies, euthanasia, transplantology and medical genetics, HIV infection,
p.000261: ethics in psychiatry, moral issues of distribution of health care resources. Working educational programs that the
p.000261: education is based upon are developed by departments implementing them.
...
p.000271: duration of the study, and approximate number of the subjects in different regions and in the given clinical site. The
p.000271: information provided to the patient shall be logically completed with the informed consent form, which exhibits, if
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
...
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p.000095: they would be capable to comprehend problems of life and death, health and life;
p.000095: - acquainting future physicians with moral aspects of topical problems of modern medicine and biomedical research
p.000095: associated with the application of modern technologies.
p.000095: The Manual has the following distinctive features:
p.000095: 1. It contains views and ideas of medieval Armenian thinkers, philosophers and physicians relating to
p.000095: the problems of life and death, good and evil, etc. In particular, it presents views of David Anhaght whose 1500th
p.000095: anniversary was celebrated by UNESCO in 1980 in Saloniki (Greece) and Yerevan.
p.000095: 2. It should be noted that the Manual presents results of sociological research on some issues conducted among
p.000095: the University students and
p.000095: teaching staff. The research was initiated by the Centre for the Study of Public Opinion on Bioethics
p.000095: Problems at the Chair of Social Sciences. It allowed the authors to enrich the theoretical material with the
p.000095: results of sociological studies.
p.000095: 3. The Supplement includes main legislative acts adopted not only by the international community but also by the
p.000095: National Assembly of Republic of Armenia.
p.000095: 4. The Supplement also contains different tests and questionnaires for the self-analysis, so that students could test
p.000095: to what extent they are morally and physiologically ready to follow rules and requirements of modern
p.000095: bioethics. Besides, there are Case Studies arousing lively discussions. Prof.
p.000095: A. Karmy from Israel kindly sent these Case Studies to us.
p.000095: In spite of all difficulties in teaching bioethics, we have a noteworthy experience of student’s work. Within the
p.000095: framework of international student conferences, the Medical University organized round table
p.000095: discussions. In 2001 and 2003 two international student conferences on the fundamental principles and norms of
p.000095: bioethics were held. The majority of both foreign and Armenian students for the first time began to learn
p.000095: elements of bioethics. For a more comprehensive study of such topics as patient—physician relationship, the
p.000095: culture of physician’s speech and professional communication, compulsory hospitalization, etc., we give several
p.000095: lectures in Yerevan theatres instead of University lecture halls. These theatres show specially and only
p.000095: for our students, such plays as “Psychosis” and “The Street-Car Named Desire” (Sandukian Academic Theatre),
p.000095: “The Dentist from the East” (Akop Paronian Theatre of Musical Comedy) and “Physiology of Family” (Malian Theatre). Each
p.000095: performance is followed by a vivid discussion with actors and directors, and after that students write their essays
p.000095: on a suggested topic. In addition to theatre performances, students are invited to watch relevant films
p.000095: (documentaries and feature films).
p.000095: Together with the Institute of Philosophy, Sociology and Law of the Academy of Science of Republic of Armenia
p.000095: our Chair is writing a brochure “Albert Schweizer: A Great Humanist”. We also prepare for publication the glossary on
...
p.000125: practitioners and teaching staff of medical institutes (18—36 h). Academy for Post-Graduate Education of Republic
p.000125: Belarus offers a course “Biomedical Ethics in Psychiatry” (for teaching professionals, clinical psychiatrists
p.000125: and investigators – 24 h).
p.000125: • In the framework of Russia—Belarus scientific-and-practical conferences on the problem of
p.000125: developing professional knowledge in bioethics (Kirov, 2003; Minsk, 2004) problems of teaching bioethics to
p.000125: medical students were discussed [17].
p.000125: In 2003 a second revised and amended edition of the text-book “Biomedical Ethics” is published [8]. The
p.000125: text-book supplement contains international guidelines, methodical recommendations for teachers, tests and
p.000125: case-studies.
p.000125: • In January (Moscow) and March (Minsk) 2005 in the framework of regional consultations for professionals in the
p.000125: field of education in ethics and bioethics held under the aegis of UNESCO experts from Belarus presented their relevant
p.000125: teaching programmes.
p.000125: • Since February 2005 BSMU offers a 64-hour course “Problems of Biomedical Ethics in Modern Theory and Practice” for
p.000125: BSMU teaching staff.
p.000125: • In May 2005 the republican student conference “Bioethics: Theory, Practice and Perspectives” was held and a volume
p.000125: of student papers was published.
p.000125: • In autumn 2005 BSMU held the student conference “AIDS: Information Practice. Formation of Positive Moral
p.000125: Values in Youth”.
p.000125: • In September 2005 BSMU organized a round table with Dr. Henry Williams (Head of the Tennessee Hospital, USA) and
p.000125: Dr. Joy Raily (Director of the Centre for Bioethics and Cell Technologies).
p.000125: • In May 2006 the Republican Scientific-and-Practical Conference “Medicine and Christianity” was held
p.000125: with a Section where bioethical problems were discussed in the context of the Orthodox worldview.
p.000125: • In November 2006 young scientists from the Institute for Post- Graduate Education of Belarus in
p.000125: cooperation with NCBE organized the scientific-and-practical conference “Humanization in the Education of
p.000125: Specialists in Medicine and Biology”; proceedings of conference were published [21].
p.000125: • The republican scientific-and-practical student conference “Culture and Medicine: interaction Paradigm” was held
p.000125: in May 2007.
p.000125: Thus, today we have relevant methodical materials including manuals, and national manuals.
p.000125: Besides, there are following teaching programmes for the system of high (undergraduate) medical education
p.000125: [11]:
p.000125: a. “General Ethics” (with sections “Bioethics” and “Ecological Ethics”)
p.000125: – for students of all specialties (Mishatkina T.V., Belyaeva E.V.) – 36 h;
p.000125: b. “Basics of Biomedical Ethics” – for medical undergraduate students (Mishatkina T.V., Denisov S.D., Kevra V.K.,
p.000125: Lugais N.E.) – 36 h;
p.000125: c. “Humanitarian Aspects of Modern Science (with Elements of Bioethics)” - for students of humanitarian
p.000125: specialties (Yaskevich Ya. S.) - 18 h;
p.000125: d. “The Conception of Modern Natural Sciences” – for students studying natural sciences (Yaskevich Ya.S.,
p.000125: Viazovkin V.S.) – 18 h;
p.000125: e. “Human Rights” – for students of all specialties (Yaskevich Ya.S., Gusev A.D., Gafarova Yu.Yu.) – 18 h;
p.000125: f. “Basics of Ecological Ethics” – for students in specialties “Ecology”, “Agricultural Science”, “Veterinary
p.000125: Science” (Mishatkina T.V., Boronnikova V.T., Silich T.V.) – 18 h.
p.000125: Today there are four institutes of higher medical education (in Minsk, Grodno, Gomel and Vitebsk)
p.000125: and the Faculty of Biomedicine at the International State Ecological University named after A.D. Sakharov.
...
p.000145: training course. Ibid., 23rd issue, pp. 355-360.
p.000145: 12. Biomedical ethics. Teaching manual. Ed. by T.V.Mishatkina, S.D.Denisov. Minsk, MSMU publications, 2001.
p.000145: 256 pp. (in Russian)
p.000145: 13. Yaskevich Ya.S., Kuznetsova L.F., Barkovskaya А.V. Contemporary
p.000145: science: value orientation. Teaching manual. Minsk, 2003. (in Russian)
p.000145: 14. Denisov S.D. Humanistic attitude to animals – one of main goals in humanization of higher medical education.
p.000145: Abstracts of Belarus-Britain symposium “Ethical aspects of animal use in training process and in research”
p.000145: (October 1997, Minsk, MSMI). Ed. by S.D.Denisov. Minsk, 1998. (in Russian)
p.000145: 15. Denisov S.D. Medical students should not kill. Proceedings of the international symposium “Bioethics on the eve of
p.000145: XXI century”. Kharkov, October 2000. (in Russian)
p.000145: 16. Denisov S.D. Requirements to scientific experiment with animals. Public Health, 2001, N 4. (in Russian)
p.000145: 17. Morozkina T.S. Deontological aspects of animal use in teaching process. Higher School, 1996, N 1, p. 30-35.
p.000145: (in Russian)
p.000145: 18. Morozkina T.S., Denisov S.D. Implementation of the principles of the three RS in Belarus: reality and perspective.
p.000145: Abstracts of the 3th World Congress on Alternatives and Animal Use in the Life Sciences. Bologna, Italy, 1999, p. 397.
p.000145: 19. National and local bioethics committees: the experience of Central and Eastern Europe. Materials of
p.000145: international conferences on bioethics. Minsk, 2006. (in English)
p.000145: 20. Bioethics: theory, practice, perspectives. Proceedings of the Republican student conference. Ed. by
p.000145: S.D.Denisov. Minsk, BSMU, 2005. (in Russian)
p.000145: 21. Mishatkina Т.V. Ethical and humanistic bases of contemporary biomedical education. Humanization of teaching
p.000145: of medical and biological specialists (in Russian)
p.000145: 22. Ethical training in Belarus (Programmes of bioethics courses). UNESCO web-site www.bioethics.ru (in Russian)
p.000145: 23. Mishatkina Т.V. Three circles of ethics. “Chelovek”, 2006, N 5, p.
p.000145: 89-98. (in Russian)
p.000145: 24. Mishatkina Т.V., Yaskevich Ya.S. Collaboration of ethics committees with patients during biomedical research
p.000145: in Belarus. Proceedings of the international conference of FEC CIS. Erevan, 2005. (in Russian)
p.000145: 25. Yaskevich Ya.S. Moral, ethical, legislative and organizational bases of organ and tissue transplantation. Materials
p.000145: of round-table of the Belarus National Assembly for discussion of the druft of Belarussian Law “On
p.000145:
p.000145:
p.000146: 146
p.000146:
p.000147: 147
p.000147:
p.000147: transplantation of human organs and tissues”. Minsk, 2006, p. 27-31. (in Russian)
p.000147: 26. Mishatkina Т.V. Biomedical ethics as a science and as teaching discipline. Values of the world: ethics and
p.000147: bioethics. Scientific Forum. Kiev, 2005. (in Russian)
p.000147: 27. Mishatkina Т.V. Existencial meaning of suffering and compassion in biomedical ethics. Proceedings of the Russian
p.000147: scientific conference with international participation “Anthropological bases for bioethics”. Tomsk, 2006,
...
p.000197: Petersburg, spoke 12 languages. He is considered to be the first national philosopher, first theorist and historian of
p.000197: medicine. Cantemir is known as the author of philosophic and physiological works. The works of Cantemir include The
p.000197: Divan or The Wise Man’s Parley with the World; Metaphysics; General Brief Logics; Research of the Nature of Monarchies;
p.000197: The History of the Growth and Decay of the Ottoman Empire; Geographical, Ethnographical and Economic Description of
p.000197: Moldavia; The Life of Constantine Cantemir; Events from the Life of the Cantacusins and the Brunkovyans; The System or
p.000197: the State of Muhammad Religion; The Hieroglyphic History. Works of Cantemir on the history of the Ottoman Empire
p.000197: were considered classic research and were translated into English, German, and French. Voltaire called this
p.000197: work his reference book on the East. His works are of high value until today.
p.000197: Constantin Virnav is one of the scientists-medics of the XIX century, whose activity as the doctor and civilian
p.000197: had a great significance for development of the public health care and medical ideas in the area. He is
p.000197: the first doctor of medicine in Moldova (he defended his dissertation in 1836 in the city of Buda, Hungary). He is the
p.000197: author of numerous scientific researches. His ethical ideas, application in treatment practice are especially valuable.
p.000197: Zamfir Ralli Arbore was a doctor, the Encyclopaedist, writer and public figure, graduate of the Saint Petersburg
p.000197: Medical and Surgery Academy, a person of encyclopedic learning. During his student years he jointed the
p.000197: narodnik movement and was jailed in St. Peter and Paul Fortress. He went back to Bessarabia. Later, being afraid
p.000197: of new prosecution of the tsar’s secret political police he settled in Romania. He is the author of numerous
p.000197: scientific researches. His encyclopedias are highly valuable. He was an excellent humanist and moralist. He
p.000197: supported active propaganda of high moral values on different levels.
p.000197: Anatolie Kotovski – leading doctor, reformer of the mental health service in Bessarabia, scientist, public figure who
p.000197: made plenty for the development of the social medicine of Moldavia. Many of rules considered bioethical today
p.000197: were applied to his activity.
p.000197:
p.000198: 198
p.000198:
p.000199: 199
p.000199:
p.000199: Toma Chorbe is considered as one of the great doctors-humanists, founder of sanitary and epidemiologic service
p.000199: in the area. He won the name of the unmercenary doctor rightfully. He advocated strongly spreading and efficient
p.000199: introduction of ethic norms and values in medicine.
p.000199: Nicoale Testemitanu is an outstanding scientist, public figure and manager of modern medicine, Doctor of
p.000199: Medicine, professor. He served as: Chief of the Traumatic Surgery Department of the Republican Territory Hospital,
p.000199: the Minister of Public Health, President of the Chisinau State Medical Institute, Chief of the Department
p.000199: of Public Health and Social Medicine Department. He is the most prominent organizer of national medicine
...
p.000199: practical Centre of bioethics development in the Republic of Moldova. We need to stress great support of the
p.000199: National Commission for UNESCO Affairs in organization of the National Bioethics Centre in the Republic of Moldova on
p.000199: 10 of November 2004, and holding of different events. Mission of the Centre includes first of all the following: 1)
p.000199: harmonization and coordination of joint actions in this field between the Department, Bioethics Association and
p.000199: National Commission for UNESCO Affairs in the Republic of Moldova and the Ministry of Health
p.000199:
p.000200: 200
p.000200:
p.000201: 201
p.000201:
p.000201: Care and Social Security; 2) consolidation of all competent bodies at the national level to organize different events
p.000201: and implementations; 3) effectual promotion of bioethical knowledge; 4) facilitation of implementation of
p.000201: research results into different activities’ areas; 5) coordination of various activities in the bioethics at the
p.000201: national level.
p.000201: Since 2005 expansion of different activities connected with further establishing of bioethical ideas in our
p.000201: country is noticed: increase of academic hours in subject block for bioethics for students, doctoral
p.000201: candidates, applicants and residents, introduction of bioethical training for medical and nursery medical personnel of
p.000201: medical institutions of the Republic; publication of text-books and set of training materials; expansion of scientific
p.000201: research themes; holding of topical workshops; regular organization of round-tables with invitation of experts in
p.000201: gynecology, transplantology, resuscitation science, intensive care, biology, genetics, forensic medicine, psychiatry
p.000201: etc.; increase of student’s interest to bioethical issues through participation in student philosophic study
p.000201: groups, extending of international relations.
p.000201: Other advances were rather marked as well. However, the main achievement of this stage was foundation of true
p.000201: scientific bioethical school in our country.
p.000201: Prime bioethics development trends in the Republic of Moldova:
p.000201: 1) organization of training process in bioethics; 2) organizational and practical events; 3) scientific
p.000201: activity.
p.000201: Organizational and practical events include the whole set of activities: holding of different workshops and
p.000201: lectures in medical institutions, organization of programs on the Republic’s television and radio channels;
p.000201: presentation of books, information exchange with foreign organizations involved in bioethical issues; permanent
p.000201: advisory service for executives of medical institutions, drug stores, laboratories, sanitary and epidemiological
p.000201: stations on issues of documentation creation and set-up of bioethics committees; development and
p.000201: improvement of regulations, provisions, participation in adoption of laws; sample by-laws for bioethics committees
p.000201: under hospitals of our country were worked out.
p.000201: Main tasks of scientific activity: elaboration of comprehensive bioethical researches; intensification of
p.000201: researches on theoretical bioethics; examination of bioethical issues of clinical medicine (i.e. practical bioethics);
p.000201: identification set of issues of related subjects, where bioethics development
p.000201: is a catalyst of their demonstration; creation of practical teaching aids for bioethics intended for doctors majoring
p.000201: in other fields.
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
p.000009: stability and to the whole process of reformation; however, there is a certain stabilization of the situation.
p.000009: Let us consider changes in resident population of the CIS countries and Turkmenistan in the period from 1991 to 2006.
p.000009: (Table 1).
p.000009: The presented data show the increase of population in Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan,
p.000009: Turkmenistan and Uzbekistan considering the change in the tendencies of population reproduction.
p.000009: The population in the CIS member-countries is about 5% of world population. The population density in
p.000009: the CIS countries varies from 6- 9 persons per sq. km in Kazakhstan, Russia and Turkmenistan to 126-129 persons in
p.000009: Armenia and Moldova. Thus, the average population density in the CIS countries is 13 persons per sq. km. For
p.000009: comparison: the population in the European Union (EU) makes 7% of world population, while the average density of
p.000009: population in the EU is 114 persons per sq. km. Over 66% of Belarus, Armenia, Ukraine, and 73% of Russia population are
p.000009: city residents. In the territory of the CIS there are 24 cities with the population over 1 million.
p.000009: Since 1990, the fertility rate in all the CIS countries has been decreasing. Moreover, in Ukraine (since 1991), in
p.000009: Russia (since 1992) and in Belarus (since 1993) a natural decrease of population was registered. Thus in Russia the
p.000009: number of deaths in 1993 exceeded the number of births by 800,000. That was the lowest fertility rate (9.4 of
p.000009: births per 1000 of population) among all the CIS countries.
p.000009:
p.000010: 10
p.000010:
p.000011: 11
p.000011:
...
p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
p.000023: addicts. Every five years the amount of drug addicts in the “youngest” group is increasing by 100%. The children
p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
p.000023: population, and where in the case of an essential improvement of the economic situation the extended reproduction may
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
...
p.000115: from negative consequences resulting from the application of modern biomedical technologies is performed through
p.000115: ethic codes, laws, extending the sphere of responsibility of medical professionals and biologists
p.000115:
p.000116: 116
p.000116:
p.000117: 117
p.000117:
p.000117: and their social obligations not only fixed on their personal moral level but also stated by law. Mechanisms
p.000117: controlling ethical aspects in the activity of physicians and scientists are supplemented with a developed system of
p.000117: legal regulation, a special system of bioethics committees and education.
p.000117: In the post-Soviet space, including Belarus, a different – “home” – model of bioethics has been created, in which
p.000117: bioethics is an interdisciplinary, orientated on biology, field of theoretical knowledge analyzing moral
p.000117: problems of human existence and human attitude to life and to different living organisms. This model
p.000117: covers the range from the development of ethical norms and principles regulating human practical activity
p.000117: in the process of studying nature and human beings to the study of the role and place of the human being in the
p.000117: context of biological reality and the estimate of the status of life and death categories.
p.000117: At the same time, for Belarus with its post-Chernobyl crisis level of the balance in the “nature--society” system, when
p.000117: the data of biomedical studies prove a direct and evident threat to the public health and to the safety of gene pool
p.000117: because of the complex radiochemical pollution, practical measures are extremely important. Besides, the majority of
p.000117: physicians in Belarus still stick to the conventional paternalistic model of patient—physician relationships, which
p.000117: goes with a widespread legal and ethical nihilism in the medical community. Therefore the modern model of
p.000117: bioethics, as well as programmes of biomedical research, should be adapted to the national healthcare system, its
p.000117: scientific, socio-cultural, legal and spiritual traditions.
p.000117: At present, we have objective and subjective conditions for the development of bioethics in the form that is
p.000117: accepted in the West. We are developing ethical and legal norms regulating biomedical research and aiming to create
p.000117: adequate models of education. In compliance with the Order of the Health Ministry of Belarus “On Establishing Rules for
p.000117: Conducting Clinical Trials of Pharmaceutical Products”, a Republican Unitary Institution “The Centre of Expertise and
p.000117: Trials in Healthcare” was founded in 1999. A serious work has been carried out on organizing institutional activity of
p.000117: local ethics committees. Scientists, governing structures and public organizations put their efforts in creating
p.000117: the basis for establishing in Belarus the National Committee for Bioethics similar to those existing in many countries.
p.000117: The Committee can rightly represent Belarus on the international level and take initiatives in the protection of
...
p.000229: In early XX century a book by V.V. Veresaev “Doctor’s notes” produced great social aftersound. It can be
p.000229: regarded as social and cultural assessment of many problems in medical ethics which are of concern even today in the
p.000229: rise of the XXI century. It contained sharp criticism towards a common practice of that time to neglect patients’
p.000229: rights and needs including subjects of biomedical research. V.V. Veresaev (1867-1945) provides ample evidence of
p.000229: cruel experiments with human subjects and puts under question the researchers’ reports that these trials were performed
p.000229: with those people’s consent. V.V. Veresaev was courageous to disclose and put under public scrutiny the secrets of
p.000229: medical community. Thoroughly, providing great number of examples he showed the destitute position of an average
p.000229: practicing doctor, his vulnerability. And at the same time he stressed the high requirements that the
p.000229: community imposed over a physician (5, 6).
p.000229:
p.000230: 230
p.000230:
p.000231: 231
p.000231:
p.000231: V.A. Manassein (1841-1901), a noted general practitioner, editor of “The Doctor” magazine, a person who won a
p.000231: name of a ‘knight of medical ethics’, ‘conscience of medical community’ stressed the necessity for a doctor to
p.000231: comply with medical confidentiality even at the expense of his own benefits. A contrary position was expressed by a
p.000231: denoted lawyer A.F. Kony (1844-1927), who considered that in situations of grave threat needs of the society should
p.000231: prevail over the ban to disclose patients’ secrets. At the same time he advocated the idea of sticking to medical
p.000231: confidentiality after a patient’s death. A.F. Kony also stipulated the conditions which allowed active euthanasia both
p.000231: legally and ethically.
p.000231: In he beginning of the XX century it was acknowledged that relationship of physicians with the community require
p.000231: dramatic revision especially when it comes to correlation of a doctor’s right to perform medical assistance essential
p.000231: for a patient and consent of the latter to have it in terms of observing or violating the principle of physical
p.000231: integrity (“Court newspaper”, 1901, №№ 51, 52) and also about the legal grounds and limits of criminal responsibility
p.000231: for the harm caused to patients health (‘Law”, 1902, №51). The issue to what extent the patient’s consent for medical
p.000231: treatment should be based upon his conscious understanding of the nature of this treatment especially if it is
p.000231: performed not only for the benefit of a patient but out of experimental needs. Prominent law experts A.F. Kony, N.G.
p.000231: Tagantsev, I.G. Sceglovitov, S.N. Tregubov and others come to join this discussion. According to Professor of Criminal
p.000231: Law N.G. Tagantsev “patients consent is incapable of setting impunity to all medical cases”. The fundamental principles
...
p.000247: treatment, as well as pharmaceutical products are not officially permitted but are under consideration
p.000247: according to the established procedure can be applied in the interests of a patient. Hence, we may conclude that
p.000247: Fundamentals of Legislation relate only to clinical (therapeutic) research. The mentioned Act also demands as an
p.000247: obligatory condition for biomedical research the written voluntary consent of a subject for participating in the study
p.000247: and guaranties his right to withdraw the consent at any moment of the study. Before the obtaining of consent for
p.000247: biomedical research the patient should be informed about goals, methods, side effects, possible risk, duration and
p.000247: expected results of the investigation.
p.000247:
p.000247: 28 Constitution of the Russian Federation, St-Pb, 1995.
p.000247: 29 Fundamental principals of Legislation of Russian Federation Concerning Public Healthcare?
p.000247: on 22 of July 1993// Rossiyskaya Gaseta, August 18, 1993. № 158.
p.000247: The given Article sets rather strict limitations on research involving minors (under 15 – in general
p.000247: cases, and under 16 in the case of drug addicts). In this case, the methods of disease prevention, diagnostics
p.000247: and treatment, as well as pharmaceuticals that are not officially permitted but are under consideration may only be
p.000247: applied for the treatment of minors if there is a direct threat to their life and with a written consent
p.000247: of their legal representatives. Here we should mention the Act “On Applying Pharmaceutical Products according
p.000247: to the Necessities of life” adopted by the Order of Ministry of Health and Social Development (09.08.2005, No. 494).30
p.000247: This Act regulates issues relating to the individual case of application, according to the necessities of life, of a
p.000247: pharmaceutical product that is not registered in Russian Federation. This is a matter of non-interventional
p.000247: research. The decision about the use of a pharmaceutical product in this case is made via the Federal
p.000247: specialized medical commission; the protocol is documented and signed by the medical director of the director of the
p.000247: Federal specialized medical commission. This document emphasizes again the need to seek the patient’s voluntary written
p.000247: consent (in cases provided by law the consent from the patient’s legal representatives) to apply an
p.000247: unregistered pharmaceutical product. The physician should inform the patient about the pharmaceutical product, its
p.000247: expected benefit, safety and the degree of risk. The physician should also explain measures that will be taken in the
p.000247: case of unexpected effect of the pharmaceutical product on the patient’s health.
p.000247: The Article 29 of the Fundamental principles of Legislation also imposes the ban on biomedical trials involving persons
p.000247: under any form of detention or imprisonment.
...
Searching for indicator stigmatization:
(return to top)
p.000329:
p.000329: - voluntary consent to a medical intervention or refusal of it;
p.000329: - receiving information about his/her rights and responsibilities and his/
p.000329:
p.000329: the activity of state structures, national enterprises, institutions and public unions in the field of healthcare
p.000329: (Kolesnikova L. Some Legal Aspects of Regulating Physician--Patient Relationship. Materials of the First National
p.000329: Congress on Bioethics with International Participation. Tashkent, 2005, pp. 58-59; Kolesnikova L. Relations of Doctor
p.000329: and Patient in the Light of Laws in Force in Uzbekistan: Clinical, Philosophical and Legal Aspects. Tashkent, 2006, pp.
p.000329: 129-135).
p.000329: Article 3 of the Law defines main principles of citizens’ health protection:
p.000329: - observance of human rights in the field of health protection;
p.000329: - availability of medical care for all social strata;
p.000329: - the priority of preventive measures;
p.000329: - social protection of citizens in cases of health loss;
p.000329: - the unity of medical science and practice.
p.000329: According to Article 13 of the Law, “…the State ensures the protection against discrimination irrespective of a disease
p.000329: the citizen has. Appropriate sanctions should be applied in the event of infringement of the provisions contained in
p.000329: this Article”.
p.000329: Nevertheless, in current practice of physician—patient relationship there are cases of marginalization and
p.000329: stigmatization, which shows itself in relation to most vulnerable social groups – drug and alcohol addicts, sex
p.000329: workers, etc. In the event of diagnosing an “improper disease” (venereal diseases, AIDS) a patient is labeled as
p.000329: “shameful”. A suspicious attitude of medical staff to patients with such a diagnosis infringes patients’ rights, which
p.000329: affects their moral and psychological state and, consequently, has a negative impact on the treatment efficiency.
p.000329: According to Article 24 of the Law, the patient has the right to:
p.000329: - respectful and humane attitude of medical staff;
p.000329: - choice of a physician;
p.000329: - medical aid (examination, treatment, etc.) provided in compliance with relevant sanitary requirements;
p.000329: - consultation by a medical specialist on the patient’s request;
p.000329: her health condition;
p.000329: - compensation in the event of a damage to his/her health;
p.000329: - access to a lawyer or another representative for the protection of his/ her rights.
p.000329: In case of infringement of a patient’s rights, his/her legal representative may make a complaint to any instance.
p.000329: Article 34 of the law “On the Protection of Citizens’ Health” permits to conduct biomedical research involving human
p.000329: subjects at state institutions after laboratory experiments and with informed consent from a research
p.000329: participant.
...
Social / Threat of Violence
Searching for indicator violence:
(return to top)
p.000113: feeling of self-respect in combination with tolerance and good-nature, as well as hospitality and openness, etc.
p.000113: Moral qualities of Belarus people are in a direct relation to specific features of Slavic national
p.000113: character. Nikolai Lossky, a Russian philosopher, proved this by associating those with such factors as vast
p.000113: expanses of East-European Plain and its climate (short summer), forming “the habit of excessive short-term
p.000113: strain of efforts” and “the ‘non-habit’ of a regular, continuous labour” [7]. Lossky’s comments on the Russian national
p.000113: character
p.000113:
p.000114: 114
p.000114:
p.000115: 115
p.000115:
p.000115: may be fully attributed to Belarus people: “Obeying the call of duty, Russian people develop in themselves an ability
p.000115: to fulfill a compulsory job accurately and honestly. However, if the job is not strictly compulsory, then they may be
p.000115: careless and inaccurate… Hence, there is often a loss of interest in the work begun and aversion for continuing it; the
p.000115: initial intention, idea and the general outline is often quite valuable, but inevitable imperfections would dim the
p.000115: enthusiasm, and people would be lazy to proceed with a thorough and detailed work.” Nevertheless, some effect of
p.000115: European Protestant ethics resulted in a more developed diligence and thoroughness in Belarus people. Nikolai Lossky
p.000115: mentioned also some other contradictory qualities of the Slavic soul: humaneness, mildness, kindness and, on the
p.000115: other hand, cruelty and tendency towards violence (e.g.: attitude to the death penalty in Belarus society); acute
p.000115: self-perception and impersonal collectivism; the feeling of belonging to the humankind and national
p.000115: self-boasting; humility and inclination to a revolt; love of freedom and a need for the authoritarian State system.
p.000115: These features show themselves distinctly in social life, business relations and scientific activity. Besides,
p.000115: Orthodoxy has always supported orientation towards a strong power, as the Orthodox Church believed that only
p.000115: a strong State system could struggle against evil. At the same time, Lossky noted that in their character the
p.000115: Slavs are more disposed to democracy, which shows itself, for example, in the protest against all sorts of
p.000115: conventionalities.
p.000115: Currently the Orthodox Church still has a strong effect on the development of bioethics in Belarus,
p.000115: which has both positive and negative aspects. The programme of interaction between the Orthodox Church of the country
p.000115: and the Belarus Health Ministry of is being realized. The programme helps to introduce moral constants into the medical
p.000115: community, facilitates moral and spiritual growth of the worldview of students (future specialists in medicine, biology
p.000115: and biotechnology) and the general growth of bioethical competence in the society. A rich experience in promoting ideas
p.000115: of bioethics has the Orthodox Medical Brotherhood at the Minsk Eparchy of the Belarus Exarchate. Charity Centre has
p.000115: been organized at the Parish of the Church of All Saints in Minsk. Belarus Children’s Hospice within Children’s Cancer
...
p.000181: honour, modesty, self- control and wisdom. These virtues ensure a harmonious life of the individual [5]. Openness, love
p.000181: for children, hospitality, generosity, humanism, patience, firmness, goodwill, respect for old age and other qualities
p.000181: inherent in Kyrgyz people form the basis of moral and ethical principles of their life [1].
p.000181: Historical conditions dictated to Kyrgyz people the necessity to stand up for their freedom and integrity in the fight
p.000181: with stronger neighboring states. Severe war conditions required from men who were admitted to military
p.000181: of people’s life. Over many ages, people’s ideals have been associated
p.000181:
p.000181:
p.000181: with “Manas”; ethical norms and concepts of the good and the evil were exemplified by the acts and deeds of “Manas”
p.000181: characters.
p.000181: 19 The word eudemonism comes from the Greek word for happiness or flourishing
p.000181: (eudaimonia), and refers to any conception of ethics that puts human happiness and the complete life of
p.000181: the individual at the Centre of ethical concern.
p.000181:
p.000181:
p.000182: 182
p.000182:
p.000183: 183
p.000183:
p.000183: service not only physical strength, but also moral maturity. Wars depicted in “Manas” and episodes associated with
p.000183: those exemplify heroic traditions implying the observance of the rule of military necessity and an innate
p.000183: aversion to violence, as well as a wish to live in peace. Kyrgyz warriors regarded their sacred duty not to harm
p.000183: peaceful population of conquered peoples. It was forbidden to plunder or humiliate them. Thus an epic sage Bakai
p.000183: addresses his warriors:
p.000183: “Do not thou slaughter their cattle more that thou need for food, A foe today may be kinsman tomorrow,
p.000183: Do not thou harm them”.
p.000183: The early Kyrgyzstan was located on the crossroad of the Great Silk Road routs, which made it “a bastion of
p.000183: religious syncretism” where representatives of different confessions could coexist. This is, perhaps, the
p.000183: reason for a remarkable tolerance in the Kyrgyz in relation to other confessions and cultures of people
p.000183: inhabiting Kyrgyzstan.
p.000183: “The Beneficial Knowledge” by Jusup Balasagyn (XI c.) is another treasure of the Kyrgyz. The treatise was so
p.000183: perfect that in China it was titled “The Code of Decent Men”, in Iran – “The Book of Shahs” and in Turania
p.000183: – “The Book of Precepts for Rulers”. For Turkic peoples “The Beneficial Knowledge” “was as much important as “Lay of
p.000183: Igor’s Warfare” for Slavic peoples” (Naum Grebnev).
p.000183: “The Beneficial Knowledge” covers problems of sociology, ethics, aesthetics, theology and social psychology. It
p.000183: presents a sum of knowledge in different fields of science and culture of that time. The treatise presents a
p.000183: comprehensive system setting forth and analyzing philosophical problems relating to sense and meaning of human life. It
...
p.000185: them” and gave everyone the right to be understood. Only if a person follows this rule, he will rid his soul of evil
p.000185: and find harmony. Asan Kaigy was telling people that they should love and respect others and thus to contribute to
p.000185: their happiness [4].
p.000185: Tolubai Synchi also focused his attention on analyzing relationships between people and cultivating
p.000185: magnanimity that, in his view, was a combination of such virtues as nobleness, generosity, justice in compassion,
p.000185: love and respect for people. For him greed is the worst vice: “A generous man is a good man; a greedy man is a
p.000185: good-for-nothing man” [12]. Like Asan Kaigy, Tolubai-Synchi was also searching after ways to happiness. His maxims
p.000185: based on opposing the good and the evil, kind and wicked acts have
p.000185: the form of edifications. Like Asan Kaigy he tried to avoid blaming actively the existing state system.
p.000185: Another humanist-philosopher was Sanchi-Synchi. Unlike Asan-Kaigy and Tolubai-Synchi, he mostly valued the active
p.000185: elements of human nature: strong will, strength of mind, persistency in the struggle against the evil. Sanchi-Synchi
p.000185: called people for an active struggle for the sake of Justice. In his songs he developed the idea of righteous
p.000185: retribution and blamed the oppressors.
p.000185: The heritage of legendary thinkers allows us to return to forgotten spiritual values of Kyrgyz people
p.000185: based on love, compassion, empathy, clear conscience, peaceable disposition and feeling that they are a part of the
p.000185: universe. They felt aversion to violence and rudeness. Throughout the course of ethics development, starting from
p.000185: legendary thinkers to akyns- democrats, the care for widows and orphans was the responsibility of all clan members.
p.000185: The next stage of development of ethics philosophy is represented by akyn-zamanists21 Kalygul Bai Uulu
p.000185: (1785-1855), Arstanbek Bailashuulu (1866-1917) and Moldo Kylych Sharymkanov (1866). They lived in the time
p.000185: of global changes resulting from the decay of patriarchal feudalism and the rise of capitalistic relations.
p.000185: Besides in 1876 the territory inhabited by Kyrgyz people was incorporated into the Russian Empire [9-11]. All
p.000185: those processes were reflected in akyns’ poetry. In their poems “Time of Downfall”, “Time of Poverty” and “Time of
p.000185: Sorrow” akyn-zamanists called their epoch the time of degradation and decay. Moldo Kylych, being a son of a learned
p.000185: man, received a good education. He was acquainted with works by eastern classics Firdousi, Navoi, Jami, Yasavi and
p.000185: others. He wrote about his time: “Morals and manners show the loss of people’s well-being”. In his poem “Time of
p.000185: Sorrow” he noted that moral bankruptcy, degradation of moral principles, moral apathy were frightening features of the
p.000185: time. In their attitudes zamanists were close to French philosophers of the Age of Enlightenment (J.-J. Russo, Voltaire
p.000185: et al.).
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
p.000009: stability and to the whole process of reformation; however, there is a certain stabilization of the situation.
p.000009: Let us consider changes in resident population of the CIS countries and Turkmenistan in the period from 1991 to 2006.
p.000009: (Table 1).
p.000009: The presented data show the increase of population in Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan,
p.000009: Turkmenistan and Uzbekistan considering the change in the tendencies of population reproduction.
p.000009: The population in the CIS member-countries is about 5% of world population. The population density in
p.000009: the CIS countries varies from 6- 9 persons per sq. km in Kazakhstan, Russia and Turkmenistan to 126-129 persons in
p.000009: Armenia and Moldova. Thus, the average population density in the CIS countries is 13 persons per sq. km. For
p.000009: comparison: the population in the European Union (EU) makes 7% of world population, while the average density of
p.000009: population in the EU is 114 persons per sq. km. Over 66% of Belarus, Armenia, Ukraine, and 73% of Russia population are
p.000009: city residents. In the territory of the CIS there are 24 cities with the population over 1 million.
p.000009: Since 1990, the fertility rate in all the CIS countries has been decreasing. Moreover, in Ukraine (since 1991), in
p.000009: Russia (since 1992) and in Belarus (since 1993) a natural decrease of population was registered. Thus in Russia the
p.000009: number of deaths in 1993 exceeded the number of births by 800,000. That was the lowest fertility rate (9.4 of
p.000009: births per 1000 of population) among all the CIS countries.
p.000009:
p.000010: 10
p.000010:
p.000011: 11
p.000011:
p.000011: We should note that 1993 was one of the most hard years in the demography in the CIS countries, as the
p.000011: fertility rate decreased in all CIS countries (except Tajikistan). In comparison with 1986, when the highest fertility
p.000011: rate in the USSR for the last 50 years was registered, the fertility rate in 1993 in the CIS countries decreased by 33%
p.000011: (and by 8% in comparison with 1992, which is much enough in terms of annual oscillations) and was 13.5
p.000011: births per 1000 of population. The number of deaths in 1993 in the CIS countries was 3.6 million, and increased, in
p.000011: comparison with 1992, by 429,000. The general mortality rate increased by 14% and was 12.6 deaths per 1000 of
p.000011: population2.
p.000011: The growing share of elder people and a decreasing weight of children in the total population are typical for the
p.000011: majority of the CIS countries. This is connected with worldwide tendencies to population ageing and a drop in birth
...
p.000011: where the age-dependency ratio is 2-3 times higher than in Belarus, Russia and Ukraine, stand out for that of children
p.000011: under 15.
p.000011: The greatest reduction of the able-bodied population in comparison with 1989 is observed in Georgia (by 20% for males
p.000011: and by 18% for females) and Ukraine (by 3,8% for males and by 4,9% for females). A significant increase of the
p.000011: able-bodied citizens (by 26-47%) is registered in Azerbaijan, Kyrgyzstan, Uzbekistan, Tajikistan and Turkmenistan
p.000011: The increase in the number of young people has a favorable effect on the increase of the total population, and the
p.000011: growing number of early marriages implies a perspective of a sooner birth of the first children and the increase of the
p.000011: total fertility rate.
p.000011: During last four years in the majority of the CIS countries no decrease of the fertility rate was registered. On
p.000011: the contrary, in 2003-2004 it has slightly increased. This process can be related to some stabilization
p.000011: in
p.000011:
p.000011: 2 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 23.
p.000011: social and economic situation in the CIS countries, as well as to the fact that people, born in the middle of 1980-s
p.000011: when the birth rate in Soviet Union was relatively high reached the fertility age.3
p.000011: At the beginning of 2005, the population size in the CIS countries was 279 million people (according to the Statistic
p.000011: Committee). In comparison with the beginning of 1991, the population has reduced by 2.7 million people or
p.000011: 1.0%.4
p.000011: By the type of demographic processes in the 90-s the CIS countries were divided into two groups. In the
p.000011: first group including Ukraine, Belarus, Russia, Kazakhstan, Moldova, Georgia and Armenia the population has
p.000011: been decreasing from year to year. The second group includes Azerbaijan and Republics of Central Asia where the
p.000011: population and the demographic potential kept on increasing. At the same time, as it was mentioned above, depopulation
p.000011: processes in Belarus, Russia and Ukraine are increasing, which means that the death rate exceeds the birth rate. This
p.000011: results in the increasing polarization of the two groups of CIS countries by the demographic potential, and hence
p.000011: creates, in prospect, additional preconditions for its redistribution between countries through migration processes.
p.000011: (Table 2).
p.000011: During last years in the majority of the CIS countries, the reduction of the fertility rate was not registered. On the
p.000011: contrary, in 2003-2004 it has somewhat increased. In Azerbaijan and Kazakhstan the increase is noticed in all age
p.000011: groups, in Belarus and Ukraine – at the age of 30 and older. At the same time, the highest fertility rate is still
...
p.000013: index in the CIS countries is 1,9 of births per one woman. The half of the population of the CIS lives in the countries
p.000013: where the simple reproduction of the population is not reached, i.e. this rate is below 2,1 (1,38 in Armenia (2004),
p.000013: 1,20 in Belarus (2004), 1,40 in Georgia (2003),
p.000013: 1,22 in Moldova (2003), 1,34 in Russia (2004), 1,20 in Ukraine (2003)).6 The problem of saving life and health
p.000013: of newborns is particularly
p.000013: important especially considering the long period of fertility decrease. In spite of a marked reduction of the
p.000013: infant mortality in all CIS countries in recent years, its level remains very high. The infant mortality rate in the
p.000013: CIS countries is much higher than that in the developed countries where its value is 3-5 deaths during the first year
p.000013: per 1000 newborns. (Table 3).
p.000013: About a half of dying infants falls to the share of the babies of the first year of life, nearly 70% of which die in
p.000013: the first week. The prenatal mortality rate in the CIS countries is fluctuating from 6 to 16 deaths at the age of 0-6
p.000013: days and still-borns per every 1000 of births. The causes of these deaths are respiratory states typical for the
p.000013: prenatal period, cases of the fetal asphyxia and asphyxia at birth.
p.000013: In many respects, a high death rate registered in the majority of the CIS countries over a long period can be
p.000013: explained, by the population ageing and by the decrease of the quality of life and health. At the same time, the number
p.000013: of births per 1000 population in the countries of the European Union is less (at the average 11,1) than in Azerbaijan
p.000013: (24,2), Kyrgyzstan (26,1), Tajikistan and Turkmenistan (33,1). However, in spite of the high population ageing rate,
p.000013: the number of deaths in the EU countries is lower (10,1) than in the CIS countries (12,6), which in it’s turn, may be
p.000013: explained by the level of preventive measures and healthcare in general, and by the social-economic situation in the
p.000013: CIS countries.
p.000013:
p.000013: 6 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000013: 2005, p. 62“.
p.000013:
p.000014: 14
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: The natural increase of the population is the main source for advanced reproduction of labor resources at a certain
p.000015: territory. According to the data shown above, in the CIS countries two types of reproduction prevail that may by
p.000015: characterized as simple and reductive. If the simple population reproduction requires the numeral equality
p.000015: of the parent and children generation, the current level of survival rate (including the average life
p.000015: expectancy) requires 250-260 births per each 100 families. The birth rate corresponding to such a level is
p.000015: registered only in some CIS countries, such as Azerbaijan, Kyrgyzstan and Tajikistan. The functions of fertility
p.000015: and survival, as exogenous characteristics of the population reproduction, form its endogenous characteristics, i.e.
...
p.000061: consideration of main stages of establishment of biomedical research in the analyzed regional space at stages of
p.000061: its varying political and economical development gains fundamental value being governed with historical frames
p.000061: selected within the aspect of the given publication.
p.000061:
p.000062: 62
p.000062:
p.000063: 63
p.000063:
p.000063: To retain integrity of perception of materials herein as when defining common elements of ethical and legal trends in
p.000063: the sphere of biology and medicine there will be used similar parameters of chronological and logical consideration due
p.000063: to priority of their influence.
p.000063: Thus, from the point of view of historical community based on common ideological and social and economic
p.000063: inheritance of the countries in the region we should distinguish a set of important elements determining both
p.000063: closeness of positions in the region in regard to international participation in biomedical research and their
p.000063: specificity. First of all, one should note that the USSR had a regulated state system of organizing,
p.000063: examination, registration of medical use products that included regulatory and methodical requirements and standards
p.000063: for study conduct. From administrative point of view the system was purely “vertical” assuming a whole set for
p.000063: management, approval and setup only at the All-Soviet level excluding possibility for independent approving
p.000063: and executive structures to conduct biomedical research in individual republics of the former Soviet
p.000063: Union. Regulations determining this order were clearly determined and strictly controlled. Studies could be
p.000063: conducted only at clinical sites of the Pharmacological Committee being a central approving authority, and a
p.000063: list of the clinical sites was centrally approved. The clinical site list included only research medical facilities
p.000063: with corresponding staff and technical capacities. Representatives of developing entities were prohibited from
p.000063: contacting directly with facilities and performers of clinical studies. Representatives of sponsoring entities
p.000063: including accredited foreign pharmaceutical companies had contacts only at the level of central approving authorities.
p.000063: From research methodical point of view the system for setup and conduct of biomedical studies had clear pharmacological
p.000063: bias. Existing methodical guidelines and regulations on biomedical research conduct were developed for particular
p.000063: pharmacological groups of medicinal agents and took into account all specifics of their biological and
p.000063: pharmacological action. Such documents were produced with participation of only leading specialists in the
p.000063: corresponding field of pharmacology, biology and medicine. Then these documents were strictly examined at the level of
p.000063: specialized commissions (also distinguished as per a principle of pharmacological orientation of candidate
p.000063: agents) and later were to be discussed and approved at the international level (within the system for
p.000063: international cooperation defined
p.000063: by borders of the former socialist camp). At this level specialized, specialized profile approach for consideration and
...
p.000067: the territory of the state in case of participation in a biomedical study can enjoy all rights established with
p.000067: the given law equally to citizens of this state. Such statement is quite significant in regard to situation in the
p.000067: CIS region due to openness of borders and notable migration processes.
p.000067: In regard to harmonization both within CIS and at the international level it is important that the law
p.000067: unifies terminology in compliance with GCP-approved definitions creating attitude for mutual understanding and
p.000067: development of a united information field of biomedical research. Some articles of the law stipulate the state
p.000067: policy standard and rights of participants of biomedical studies. Separate chapters are dedicated to study safety and
p.000067: an ethical review system, a format of an informed consent and compliance with confidentiality requirements, therefore,
p.000067: corresponding to the core of all international enactments in the sphere of biomedical research. There is a separate
p.000067: chapter on special situations of the biomedical study conduct including articles regarding biomedical
p.000067: research involving vulnerable persons, research in emergency clinical situations, epidemiological and social
p.000067: studies. In general, force of the law covers all types of biomedical research involving human subjects including the
p.000067: ones with embryos in vivo, but excluding research on embryos in vitro. Liability for breaching the law is also
p.000067: stipulated.
p.000067: Beside regulatory model regulation there is a functioning union for executive authorities of the
p.000067: Commonwealth countries as the Council on Cooperation in the Field of Health Care mentioned above which
p.000067: has the interstate commission on standardization, registration and control of quality
p.000067: of medicinal agents, products for medical use and medical equipment in the CIS member states.
p.000067: By the order of the Council on Cooperation in the Field of Health Care the CIS Executive Committee prepared and
p.000067: submitted final information of regulatory and legal documents in the field of sanitary and epidemiological regulations
p.000067: and provision of sanitary and epidemiological well-being of population in the CIS member states as well as
p.000067: concerning agreements and decisions on provision of coordinated actions of the CIS member states in the field of
p.000067: standardization, registration and quality control of medicinal agents, products for medical use and medical
p.000067: equipment.
p.000067: Acknowledging logic of closeness of conditions and problems of biomedical study conduct in the CIS region
p.000067: the coordinated harmonized actions include not only authorized state agencies but also public entities (for
p.000067: instance, the FECCIS) and professional associations of manufacturers of medicinal agents and pharmaceutical companies
p.000067: working at the market of the CIS member states. Within the framework of activity of the interstate commission on
p.000067: standardization, registration and quality control of medicinal agents, products of medical use and medical equipment
p.000067: along with the CIS Executive Committee there are being prepared documents for harmonization of requirements at all
p.000067: levels of medicinal agent promotion within the region space and globally through collaboration with corresponding
p.000067: international structures.
...
p.000079: motivation to create those and their content has a protective legal character.
p.000079: At the same time, it should be noted that the Soviet legislation had a legal mechanism for the attribution
p.000079: of criminal liability for committing “crimes against Humankind”. (Decree of Presidium of the Supreme Council of the
p.000079: USSR on 19 of April 1943. Art. 1). There is an important historical document that reflected moral and legal
p.000079: understanding of experiments on live human beings – the protocols of a legal action conducted by the Military Tribunal
p.000079: of the USSR in Khabarovsk in 1949. It concerned the case of former Japanese military men accused of the development and
p.000079: use of biological weapons (“Indictment on the case of the former Japanese military men”; a supplement to Novoe Vremia
p.000079: (New Time) Journal, No 1, 1 of January 1950). The importance of the Conclusion adopted by the Tribunal in Khabarovsk is
p.000079: comparable with the importance of the Nuremberg Trials and the Code adopted there. In both cases the moral aspects of
p.000079: decisions concerned not only the individuals guilсссty of the crimes, but also the governmental policy and
p.000079: ideology which made these crimes possible.
p.000079: In the context of this Chapter the above documents are mentioned for the following purposes:
p.000079: • to eliminate informational vacuum existing in relation to the ethics of biomedical research in the former Soviet
p.000079: Union;
p.000079: • to clarify the reason of including the abovementioned documents into the international list on important documents
p.000079: of “pre-Helsinki” era to the CIOMS list;
p.000079: • to illustrate mutually enriching and complementary values of studying fundamentals of moral and cultural
p.000079: heritage;
p.000079:
p.000080: 80
p.000080:
p.000081: 81
p.000081:
p.000081: • to define the basis for a timely and harmonious assimilation of international universal norms of
p.000081: biomedical research ethics by the CIS countries.
p.000081: Summarizing the data on the ethical component of biomedical research at the time of the Soviet Union
p.000081: disintegration and formation of new independent states in the end of the nineteenths of the last century, we have
p.000081: to state that there existed efficient moral and ethical norms of medical practice and the governmental system
p.000081: regulating biomedical research. Although there were separate cases of establishing ethics committees at
p.000081: medical centres taking part in international studies, those were but of a “decorative” or “declarative” character, as
p.000081: they were established to meet the requirements of foreign pharmaceutical companies and did not have a legal status.
p.000081: The actual process of entering into the international system of ethical review began for the CIS countries also in the
p.000081: nineteenths of the last century. The rhythm and procedure for different CIS countries depended on their
p.000081: involvement in international biomedical research. As to the documents and international regulations that formed
p.000081: the basis for the development of national legislation, they were quite comparable. Materials presented for this
p.000081: book by the CIS country show all the details (See Chapter 3).
p.000081: To analyze common and specific features in the CIS region with regard to the topic, we have chosen key elements of the
p.000081: ethical concept of biomedical research. According to the interpretation of a number of international (adopted
p.000081: in the CIS countries) and national documents that have been usually developed on the basis of existing
p.000081: national legislation, the ethical review of biomedical research is performed by independent bodies – ethical committees
p.000081: (ECs). The ECs activity aims at protecting research subjects’ rights, well-being and health, as well as at providing
...
p.000105: N.Narimanov (1870-1925) in his numerous works wrote about the social role of physicians: “Physicians should
p.000105: strictly criticize all medical institutions and their own actions, so as to extirpate everything that is not meeting
p.000105: patients’ interests, and, especially, what might hurt them. Patients’ interests should always be a priority, and all
p.000105: intellectual efforts should be devoted to meeting their needs” [1].
p.000105: Making good use of their rich heritage in the field of ethics medical professionals of Azerbaijan followed the
p.000105: traditions in later years. Today we may speak of a new historical situation in the development of medical ethics as an
p.000105: area of medical knowledge aimed at education of medical personnel.
p.000105: We know that the social environment plays an essential part in the development of medical ethics. Moral
p.000105: qualities of medical professionals are not innate but acquired. They reveal themselves in the social milieu in which a
p.000105: person grew up, studied and worked.
p.000105: Academician Zarifa Alieva (1923-1985), a well-known scientist, in her excellent work “The Noble Mission”
p.000105: emphasized the fundamental importance of ethics in the physician’s professional activity: “Medicine is
p.000105: progressing day by day, it cannot stay unchanged, and only one thing remains constant – high moral, ethical
p.000105: and professional standards demanded from the physician”.
p.000105: After the disintegration of the Soviet Union and declaration of Azerbaijan independence, the reformation of the
p.000105: healthcare system began. Professional education, creation of a new pharmaceutical market, etc, and, naturally, the main
p.000105: principles of medical ethics (the physician’s duty and responsibility, relationships with patients, colleagues and
p.000105: society) underwent a strong correction. Academicians Z.A.Alieva, A.T.Amiraslanov, A.A.Namazova et al. made a great
p.000105: contribution into the development of bioethics.
p.000105: An important milestone in the history of Azerbaijan was the year of 1999, when, on the initiative of UNESCO, the
p.000105: Presidium of National Academy of Sciences established the Committee on Bioethics and Technology Ethics (Decree
p.000105: 9/1).
p.000105: 3.2.2. Legal Regulations
p.000105:
p.000105: Health is one of a few subjective human values without which many other comforts and values lose their significance.
p.000105: Today every democratic country acknowledges the importance of human rights protection in all spheres of social
p.000105: life. Within last years, the National Assembly of Azerbaijan adopted legislative acts setting forth political,
p.000105: economic, social, cultural, scientific and medical measures for maintaining and strengthening physical and mental
p.000105: health of every person and providing medical care in case of loss of health. When drawing up the documents the
p.000105: experience of other countries was used, and the following legal norms based on international legal norms were adopted:
...
p.000113: geopolitical features. Belarus Republic stands at the juncture of the Western and Eastern civilizations, and therefore
p.000113: its leading representatives of ethical and philosophical thought inherited the most essential tendencies in
p.000113: the development of European ethical theories, while the applied moral was, to a certain extent, influenced by
p.000113: Eastern traditions.
p.000113: Ethical ideology in Belarus roots back to the IX-XI centuries, and initially it was based on primitive
p.000113: magic, shamanism, pagan worship. Ethical ideas as such began to form only in the XI-XII centuries after the adoption
p.000113: of Christianity. Such thinkers as Evfrosinia Polotskaya and Kirill Turovsky, who were instilling Christian ideas in
p.000113: Byelorussia and polemized with heresy and paganism, were widely known for their enlightening activity. They
p.000113: were preaching the Bible commandments of love, kindness and unity. In the XIII-XVI centuries, when the territory of
p.000113: Belarus became a part of the Grand Duchy of Lithuania that later united with the Kingdom of Poland and formed the
p.000113: Polish-Lithuanian Commonwealth, works of Belarus philosophers Francis Scorina, Symon Budny and Vasily Tiapinsky
p.000113: reflected topical ideas of West-European culture, particularly, the idea of humanism. In the period of
p.000113: counter-Reformation (XVI-XVII c) Jesuit colleges and catholic universities actively used the rationalistic
p.000113: heritage of medieval scholastic ethics, and ethical teachings of Aristotle and Thomas of Aquinas were very popular
p.000113: among the educated part of Belarus population. The idea of the Unia (union) of Orthodoxy and Catholicism under the
p.000113: aegis of the Pope carried in itself ethical and philosophical values of religious tolerance. In the XVI-XVII
p.000113: centuries Orthodox communities also did extensive teaching popularizing the most important achievements of
p.000113: West-European countries among Orthodox believers in Belarus. Simeon Polotsky, one of the most outstanding figures in
p.000113: Belarus culture of that period, compiled a collection of poems that formulated, in a poetic form, basic ethical and
p.000113: moral principles of the Orthodoxy. The end of the XVIII and the beginning of the
p.000113: XIX century was marked by naturalistic ethical concepts that resulted from the development of exact and natural
p.000113: sciences and considered ethics in the spirit of theories of “natural law”, “social contract” and “rational egoism”
p.000113: asserting the necessity of universal secular education.
p.000113: After the October revolution and the collapse of the Russian Empire Belarus became Belarusian People’s Republic. The
p.000113: second decade of the XX century was characterized by a rapid growth of national self-awareness. Specific ethical
p.000113: traditions of the Belarusian ethnos and moral aspects of the revival of the Belarusian culture, as well as closeness to
p.000113: nature and healthy moral relations, were widely discussed and reflected in works by such thinkers and poets
p.000113: as F.Bogushevich, A.Pashkevich, Y.Kupala, Y.Kolas. However later, during the Soviet period, ethical thought in
p.000113: Belarusian SSR had been in conformity with the general authoritarian trend.
...
p.000147: the society.
p.000147: However, there is a lot of work to be done to effectively implement aforementioned legislation, particularly in the
p.000147: field of biomedical research. The most topical issue for Georgia now is the development of effective system
p.000147: of ethical review of research projects. Although, certain type of system is operating, it needs
p.000147: improvement in terms of accessibility and quality.
p.000147:
p.000147: 3.4.1 Historical and Cultural Background
p.000147:
p.000147: Georgia is situated on the border of Europe and Asia. It occupies the Central and Western parts of the Caucasus. The
p.000147: Western part of the country is washed by the Black Sea. The Northern boundaries of Georgia run along the Great
p.000147: Caucasian Range. Citizens of Georgian nationality comprise about 70% of the whole population. Other nationalities
p.000147: are Russians, Osetians, Abkhazians, Azerbaijanis, Armenians, Greeks.
p.000147: Georgia is a newly independent Republic (It restored its independence in April 1991). At the same time it has
p.000147: a long history of Statehood.
p.000147:
p.000148: 148
p.000148:
p.000149: 149
p.000149:
p.000149: Georgian slave-owning kingdoms Kolkheti and Iberia emerged in the 6th- 4th centuries BC. The unification of
p.000149: Georgia in the form of the united kingdom started in XI century. In 1801 Georgia lost its independence as a
p.000149: result of the expansive policy of Russian Empire. In 1918 independence of Georgia was re-announced (Republic of
p.000149: Georgia), which lasted only up to 1921, when intervention of Russia resulted in incorporation of Georgia in the Soviet
p.000149: Union.
p.000149: Georgia has little experience in building the civil society. However, it has definitively moves towards the
p.000149: integration with the Western World and harmonisation with the western law. The legislative basis apparently is one
p.000149: of the most important points in the process of establishing common anthropocentric values and viewpoint of the civil,
p.000149: open society.
p.000149: The history of the Georgian state and law dates back to ancient times. Due to the historical misfortunes Georgia never
p.000149: participated in the process of great codifications. In this connection legislative activity of the King
p.000149: Vakhtang VI (XVII-XVIII cc) deserves major attention. Chronologically this period coincides with the epoch of
p.000149: creation of the basis for the modern law and state in Western Europe. Drafting of King Vakhtang’s Law Book can be
p.000149: considered to be an attempt to get closer to the cultural world, at which Georgia aspired during its whole history. In
p.000149: some regions of Georgia the code of Vakhtang’s Laws was in force up to the second half of the XIX century.
p.000149: An attempt to build a modern independent state in 1918-1921 was not successful due to the expansion of Russia. As a
p.000149: result Georgia became the part of the communistic space for the next 70 years. Thus, formation of the civil
p.000149: society in Georgia started within the borders of another country (Soviet Union), making Georgia unable to develop
p.000149: its own legislation independently.
p.000149: During aforementioned 70 years legislative activity in Georgia was restricted to the slight alteration or, at
p.000149: best, adaptation of the frame laws, provided by the central authorities (Moscow). As well as in other republics of the
p.000149: Soviet Union there was no tradition of training the legal professionals for the health care system in Georgia. Before
p.000149: re-establishment of Georgia’s sovereignty, the Law on Health Care, adopted in 1972 by Soviet Government, was in force.
p.000149: This document showed significant negligence of individual rights of patients. Almost none of the basic principles of
p.000149: ensuring patients’
p.000149: autonomy and self-determination (except the right to keep personal data confidentially) were even declared.
p.000149: The creation of national legislation is an essential condition for building the national and democratic state and a
p.000149: civil society. Adoption of Georgian Constitution (24 of August 1995) and Georgian Civil Code (26 of June 1997) is
p.000149: definitely significant step toward establishment of national state.
p.000149:
p.000149: 3.4.2 Legal Regulations
p.000149:
p.000149: Legislation of Georgia related to health, biomedicine and human rights comprise laws which regulate
p.000149: various aspects of medicine/health care: rights of patients and research subjects (including vulnerable groups; such
p.000149: as minors, persons with mental disorders, patients with HIV/AIDS etc.), duties and responsibilities of health
p.000149: care professionals, human organ transplantation, assisted reproductive technologies etc.
p.000149: From the above-mentioned laws the Law of Georgia on Health Care (adopted by the Parliament of Georgia in 1997)
p.000149: is considered to be the framework law, which determines the priorities and sets out fundamental principles of the
...
p.000191: and research works in bioethics as an allied subject are planned.
p.000191: Today we do not have manuals on bioethics by national authors. Monographs and guidelines on bioethics we
p.000191: use have been published in Russia and Ukraine.
p.000191:
p.000191:
p.000192: 192
p.000192:
p.000193: 193
p.000193:
p.000193: 3.6.4. The System of Ethical Review
p.000193:
p.000193: In Kyrgyz Republic the Ministry of Health is responsible for establishing ethics committees at all levels. At present
p.000193: we lack a developed system of ethical review. Therefore functions and authorities of ethics committees on
p.000193: different levels have not been outlined, and activities relating to ethical review are performed on the national level.
p.000193: The National Ethics Committee responsible for decisions concerning ethical review of both national and international
p.000193: biomedical research was established in 1998 at the Ministry of Health of Kyrgyz Republic to implement state policy in
p.000193: providing pharmaceutical products. The Committee was established as a separate and independent body registered at
p.000193: the Ministry of Justice of Kyrgyz Republic. The Committee consists of 13 members and includes medical professionals
p.000193: representing practical healthcare, medical research institutions and medical laboratory service, as well as
p.000193: a lawyer, leading specialists from the Health Ministry, representatives of the Medical Association and Trade-Union
p.000193: Federation.
p.000193: The procedure of ethical review is regulated by legal and normative documents of Kyrgyz Republic. Thus, the rules
p.000193: regulating tasks and activity of ethics committees are set out in the Law “On Pharmaceutical Products” adopted in 1997
p.000193: and revised and amended in 2003 in compliance with general provisions, tasks and operations of the Ethics
p.000193: Committee at the Health Ministry of Kyrgyz Republic. Chapter 7 of the Law “On Pharmaceutical Products” entitled
p.000193: “Design, Pre-Clinical and Clinical Trials of Pharmaceutical Products” includes 5 Articles, 3 of which directly
p.000193: concern clinical trials. Article 28 emphasizes rights of the patients involved into clinical trials of pharmaceutical
p.000193: products stating that boards at authorized healthcare state institutions of Kyrgyz Republic “are guarantees for
p.000193: the patients’ rights”. Besides a set of documents has been designed in compliance with GCP international
p.000193: standards.
p.000193: All documents relating to pharmaceutical products submitted to the Pharmacological Committee (the
p.000193: institution responsible for ethical review of research protocols) are simultaneously submitted to the
p.000193: Ethics Committee for ethical review. There is a certain algorithm of conducting ethical review using standard
p.000193: operational procedures; however we lack a complete and comprehensive SOP system. According to the Statute of the
p.000193: Ethics Committee, a decision is made within 30 days after submitting the complete set of documents.
...
p.000195: Republic of Moldova is 33.8 thousand square km.
p.000195: Population is 4,320 thousand inhabitants including Moldavans – 64.5%, Ukrainians – 13.8%, Russians – 13%, Gagauzians –
p.000195: 3,5%, Bulgarians – 2%. Correlation of urban/rural population is 45/55. Settlement network of the country is represented
p.000195: by 4 municipalities, 61 cities, 1,611 villages united into 925 communes. Kishinev (Chişinău) is the capital of Moldova
p.000195: with 1.1 mln inhabitants. The largest cities of the country are Tiraspol, Beltsy (Bălţi), Bendery.
p.000195: Getae (Dacians) and Romans are considered to be ancestors of local ethnos. Thracians were ancestors of Dacians. They
p.000195: inhabited a wide-spreading territory from the Aegean Sea to upstream of the Dniester River, from the Bug to the Tisza.
p.000195: Thracian tribes of the north Danube were called Dacians; Romans called them Dacians and Greeks – Getaes. We draw
p.000195: information on cultural life of Dacians from multiple archaeological sources and evidences of outstanding persons of
p.000195: the ancient world (Herodotus, Strabo, Thucydides, Plato, Joseph Flavius, Dio Cassius, Jordanes etc.). Farming
p.000195: was a prime activity of the Dacians. 72 fortresses were discovered.
p.000195: The Dacians had medical concept according to which at treating it was necessary to take into consideration the state of
p.000195: a body in general, including mental state. Their medical knowledge for that period was excellent.
p.000195: 4 large Dacian communities existed in the first part of the 2nd century
p.000195: B.C. Each community had the army and institution of money. The union and strengthening of Dacia happened in the
p.000195: time of king Burebista (+80
p.000195: - 44 B.C.) Dechebal (87-106) was the last Dacian king. In 106 Dacia was conquered by the Romans and turned to be a
p.000195: province. That was the last province of the Roman Empire. It was followed by Roman epoch (106-
p.000195: 271) with the Romanization of Dacian population, the Latinization of the
p.000195: language and evangelization. There was the ethnogenesis of Romanians (from “Romans”) later.
p.000195: Development of feudal relationship was attested in the X century. Three principalities were formed in the one-time
p.000195: Dacian territory: Transylvania, which felt under the reign of Hungarians (Hungarians are Finno-Ugric trans- Ural tribes
p.000195: settled here by the end of the IX century) in the beginning of the X century, Ţara Românească (or Walachia, Muntenia);
p.000195: Ţara Moldovei. The first written diplomas mentioning political and military strength of Ţara Românească and
p.000195: Moldova are referred to the years 1330 and 1359, respectively.
p.000195: During the Middle Age Moldova kept suffering from raids of the Tatars, the Turks, the Hungarians and the Poles.
p.000195: Historical Moldova covered the territory between Eastern Carpathians, woody Carpathians, the Dniester, the Black
p.000195: Sea and the Danube under Roman 1 of Moldavia (1392-1394). Geographic location of the territory was favorable as
p.000195: to the nature and life resources and at the same time unfavorable as to geopolitical strategic aspect. The country
...
p.000235: policy, ideology and conformist ideas.
p.000235: Repressive measures taken against genetics, pedology; campaigns restricting research in physiology, psychology
p.000235: and other areas that impeded and even set back many promising academic and applied directions of science can
p.000235: serve us a good example.
p.000235: There was a target to stipulate ideology for a physician of a new type. The contrast in moral portrait of doctors in
p.000235: capitalist and socialist societies is rendered in the lines by first People’s Commissar for health care N.A. Semashko:
p.000235: “Certainly among foreign physicians there are doctors who perceive there duties the way their humane profession
p.000235: suggests them. But is it a rule and what is an exception? This would depend on the ground where these phenomena bud.
p.000235: Capitalistic ground is rocky and not suited to growing humanistic ideas. If in a capitalistic society “dog eats dogs”,
p.000235: how can we speak of any humanistic feelings? All this finds its way into a physician’s behavior… It is clear that the
p.000235: problems of the so called medical ethics are solved completely differently in our country and in the
p.000235: capitalist world. Ethics for a soviet physician means the ethics of our socialist Motherland, the ethics appropriate
p.000235: for a creator of communism; it is communist morality which is above class distinctions. That is why we see the concept
p.000235: of medical ethics and high ethical standards of a Soviet Union citizen as integral”.
p.000235: Many achievements of ideas in medical ethics were declared left-overs of capitalistic approach to medicine and
p.000235: should have been dumped to a landfill of history. In this respect a bringing under discussion an issue of medical
p.000235: confidentiality is natural and N. A. Semashko claimed “firm course towards eradicating medical secrecy”, although in
p.000235: the years to follow he came back to classical understanding of this problem.
p.000235: Ambiguous attitude of governmental bodies to medical ethics brought to life medical deontology (28). A prominent
p.000235: surgeon in oncology N.N. Petrov in 1944 came to publish his work “Issues of Surgical Deontology” which was reedited
p.000235: several times. It saw into many problems of doctor patient relationship like providing information and
p.000235: obtaining an informed consent form, which are first and foremost principles today. Deontology provided an opportunity
p.000235: to sustain public attention to staple points of humanism in medical practice.
p.000235: In the 60-70’s the interest towards medical deontology grew. Five All- Soviet Union conferences were devoted to the
p.000235: issues of medical deontology, first of which took place in Moscow on January, 28-29 in 1969. One could then observe a
p.000235: singular outburst of publications on aspects of deontology in different fields. A two volume manual “Deontology
p.000235: in Medicine”, published in 1988 and edited by academician B.V. Petrovskiy exercised great influence.
p.000235: Management and funding in medicine and health care in the Soviet years were of centralized character and were
p.000235: characterized by well developed intrabranch links, which were mainly supported by administrative and
p.000235: bureaucratic type of management and planning gaining a narrow corporate nature and becoming almost unavailable to
p.000235: public control. A medical doctor became a civil servant, whose activities were regulated by great number of
p.000235: departmental guidelines and to a large scale were limited to drawing reports.
p.000235: Nevertheless, within relatively short time period based on virtually efficient grounds and principles of
p.000235: public health care system a coherent framework of medical, preventive treatment and epidemiological services was
p.000235: organized. Assessment of health care system developments was done primarily quantitatively, but qualitative data
p.000235: within this field showed impressive success. Many infectious fevers were eradicated, infant mortality drastically
p.000235: dropped, average life expectancy increased. Effectiveness of primary medical was distinguished by the
p.000235: medical community in 1978 during the WHO and UNICEF international conference in Alma-Ata (Kazakhstan).
...
p.000257: consequences of human cloning the above-mentioned law put temporary ban on the biomedical trial on human
p.000257: cloning.
p.000257: The attention of legislators to the ethical side of biomedicine is also demonstrated by the Draft Technical Regulations
p.000257: “On requirements for the safety of medicines, the processes of their development, manufacturing, production,
p.000257: testing, storage, transportation, realization, application and utilization”.
p.000257: In contrast to current federal laws, this bill proposes the more detailed regulation of process of the clinical
p.000257: drug research ethical review. It also constitutes research subjects’ rights and guarantees of these rights
p.000257: in accordance with the most progressive international standards in this field.
p.000257: Legislation initiatives in the sphere of protection of patients’ rights40, activity directed to adaptation of
p.000257: international guidelines, as well as transformation of the positions of international declarations and conventions
p.000257: in the sphere of biomedicine into the domestic legal acts, give us the reason to expect the strengthening and
p.000257: development of the institute of ethical review in our country.
p.000257:
p.000257: 3.8.3 Education in Bioethics
p.000257:
p.000257: Issues on education of medical ethics and deontology in medical schools and colleges of the USSR were
p.000257: started to discuss in the 60’s of the XX century after the 1st All-Union Conference on issues of medical
p.000257: deontology in 1969 being a kind of triggering point for revival of talks on them. The final resolution, in particular,
p.000257: said: “The Conference would like to draw attention of the Chief Agency on Educational Facilities of the Ministry of
p.000257: Health of the USSR on necessity to implement medical deontology into education process”.
p.000257:
p.000257:
p.000257: 40 For example, Draft Law “On legal basis of bioethics and its guaranties”, “On reproductive rights of citizens”,
p.000257: “On additions to Criminal Code of the Russian Federation regarding to criminal liability for conducting
p.000257: medical trials involving human subjects without their voluntary consent” and others.
p.000257: Many medical schools developed medical oaths based on the Hippocratic Oath. In 1971 the Presidium of the Supreme Soviet
p.000257: of the USSR approved an official text of the Oath of Medical Doctor of the Soviet Union.
p.000257: In 1976 the Ministry of Health of the USSR approved interdepartmental curriculum on medical ethics (deontology)
p.000257: for higher medical and pharmaceutical educational facilities. The curriculum distributed the course along the
p.000257: entire educational process basing on that “concepts of morals and morality, development of higher feelings and medical
p.000257: ethics is an integral part of the entire educational process and should be implemented in various aspects during all
p.000257: years of training at all departments“.
p.000257: The curriculum stipulated one lecture for the 1 year students: “Medical ethics and medical
p.000257: deontology, their role for formation of a medical doctor and pharmacist” (Introduction for the subject);
p.000257: 5 lectures for the 2 year students: “Soviet health care as qualitatively new system“ (Department of
p.000257: Social Hygiene and Health Care Management), “Main peculiarities of deontology development at different stages of
p.000257: health care formation” (Department of History of Medicine), “Categories of medical ethics” (Department of Marx and
p.000257: Lenin Philosophy), “Modern concepts on medical and psychological aspects of an individuality” (Course on medical
p.000257: psychology), “Deontological issues in disease diagnostics” (Department of Preliminary Studies of Internal
p.000257: Diseases); 1 lecture for 3 year students: “Deontological issues of treatment” (Department of Faculty Therapy); 2
p.000257: lectures for 5 year students: “Deontological issues for work of district physician” (Department of
p.000257: Hospital Therapy) and “Legal principles of medical services for working population in the USSR”
p.000257: (Department of Forensics Medicine). The curriculum was widely discussed in mass media and majority of comments were
p.000257: that it was inefficient, did not cover many important issues, which are of tremendous value for medical practice, for
p.000257: instance, no definition of patient rights was given, it did not dwell on issues of brain death, refusal of
p.000257: extraordinary treatment for dying patients, it never mentioned the Nuremberg Code or the Declaration of Helsinki, etc.
p.000257: In 1977 and 1982 two other All-Union conferences on medical deontology were held. There were published
p.000257: multiple books on issues of medical ethics and deontology for various medical fields. It indicated that in 70-80’s
p.000257: the system of Soviet higher medical education had professors who not only fully understood a role of medical
p.000257: deontology for education
p.000257:
p.000258: 258
p.000258:
p.000259: 259
p.000259:
p.000259: and training of undergraduate doctors but also contributed considerably for development of the content of this
p.000259: subject (Evlashko Y.P., Kosarev I. I., Leschinsky L.A., Orlov A.N., Suvorova R.V., Rokitsky M.R., Shamov I. A.,
p.000259: Jarovinsky M.Ya., etc.). In 1988 two volume manual Deontology on Medicine was published edited by Petrovsky
p.000259: B.V.
p.000259: In the 80’s the educational curriculum of medical nurse colleges had some academic hours assigned to medical
p.000259: deontology – the course was called as Basics of medical psychology, ethics and deontology. In 1992 the Pledge of
p.000259: Medical Doctor of Russia came into force.
p.000259: In 1993 the Vrach (Doctor) magazine published an appeal to scientific community and heads of the Russian science from
p.000259: members of the Russian national committee on bioethics (“Bioethics in Russia: Beginning of the way”). The Appeal
p.000259: stated: “Modern medicine requires modern moral consciousness. In the whole world principles of bioethics for a
p.000259: long time are an integral part of professional life of medical workers ... Absence in our country of the said
...
p.000265: who, in their majority, never studied biomedical ethics, as it is currently understood, quite often do not
p.000265: express any determined opinion.
p.000265: Importance of specific training for doctors with more than 10-year professional experience, and they are
p.000265: the basis of the industry human resources, in regard to ethical and legal issues, is rather
p.000265: considerable. It is confirmed with the questionnaire data we obtained. “Is there a need in ethical committees in
p.000265: treatment and prevention facilities?” The answer is “No” among more than 25% (!) of MD’s vs. students. Such prevalence
p.000265: of answers is caused, naturally, not by neglecting of ethical values but with ignorance of the subject. Obviously,
p.000265: post-graduate education shall become a foremost objective.
p.000265: Nowadays, there is no practice of systematic organization of training course on bioethics issues for medical doctors
p.000265: and other specialists at the post- graduate period. The exclusion is a regular topical post-graduate education cycle
p.000265: for medical doctors and researchers Methods for Set-up and Conduct
p.000265: of Clinical Studies of Pharmaceutical Products in the Russian State Medical University. On their own Russian
p.000265: specialists can get bioethical training within the framework of programs supported by international organizations
p.000265: or universities, for instance in the school on bioethics in Vilnius at the Vilnius University and Albany
p.000265: Medical College-Graduate College of Union University Bioethics Program (Schenectady, New York).
p.000265: Improvement of doctor and researcher knowledge in regard to protection of rights of biomedical research participants is
p.000265: significantly facilitated with the conduct of training cycles on rules of Good Clinical Practice by medical
p.000265: universities (Moscow Medical Academy, Russian State Medical University) and large contract research organizations
p.000265: (Smolensk, Saint-Petersburg).
p.000265: A specific value for ethical review system setup in the country is provided by training of the ethical
p.000265: committee members. Such trainings are organized under the aegis of the Forum for Ethics Committees in CIS Countries
p.000265: as well as by initiatives of particular ethical committees.
p.000265: The Russian Federation joining to the Bologna Club (September, 2004), that is, to states participating in processes of
p.000265: reforming of European education on the basis of Bologna Declaration principles (1998), raised necessity in resolving
p.000265: of some new issues by those organizing bioethical education. It includes struggle for the place of the subject
p.000265: of bioethics in the part of curriculums that is compiled in accordance with the Bologna Declaration requirements to be
p.000265: implemented on mandatory rather than optional basis; for appropriate rate of work content and assessment in the system
p.000265: of ECTS credits; preparation of various educational and methodical materials for independent work of students
...
p.000277: approach is a notable barrier non-admitting researches with high probability for making harm to the
p.000277: biomedical research potential subjects.
p.000277:
p.000277: 3.8.5. Perspectives and Forms of International Cooperation
p.000277:
p.000277: Perspectives for cooperation in the field of ethical review are related to creation of common ethical and legal
p.000277: environment in the countries of the Commonwealth of Independent States, Europe and the world. There are
p.000277: three main areas of activities in cooperation with foreign partners are especially important for Russia:
p.000277: legislation harmonization, joint research and educational activities.
p.000277: In regard to legislation unification quite significant event was adoption in 2005 of the National Standard of the
p.000277: Russian Federation GOST R 52379- 2005 “Good Clinical Practice” (approved by the Order of the Federal Agency on
p.000277: technical regulations and metrology of September 27, 2005, No.232). This document completely implemented GCP, which is
p.000277: an international ethical and scientific standard of design and conduct of research involving human subjects as well as
p.000277: a standard of documentary registration and presentation of results of such studies, into the Russian legislation. It
p.000277: was identical to the Guidelines for Good Clinical Practice of the International Conference on Harmonization of
p.000277: Technical Requirements for Registration Pharmaceuticals for Human Use, which, in turn, was developed with consideration
p.000277: of acting requirements of good clinical practice of the European Union, the USA and Japan, as well as
p.000277: Australia, Canada and WHO. Compliance with this document makes possible to our country to adhere to united
p.000277: rules with countries of the European Union, the USA and Japan, that should facilitate mutual recognition of
p.000277: clinical study results with authorized agencies in these countries and become a basis to extend conduct of
p.000277: multicentre studies, eliminate practice of duplicating medical and biological studies in different regions of the world
p.000277: allowing to Russia to become full-fledged participant in process of international studies and, eventually, to
p.000277: result in mutual acknowledgement of pharmaceuticals approval.
p.000277: To secure state guarantees for protection of personal rights, dignity, autonomy and integrity conducting biomedical
p.000277: research in the CIS member
p.000277: states in 2005 there was issuesd a model Law On Protection of Human Rights and Dignity in Biomedical Researches in the
p.000277: CIS, which corresponded to all principles of biomedical ethics and medical law, interstate agreements in the field of
p.000277: biomedical research ethics. This document allows attaining common understanding of protection of human rights
p.000277: and fundamental freedoms in the sphere of biology and medicine application, to unite efforts of scientists
p.000277: and politicians from all CIS countries in the common legal and ethical environment for biomedical researches
p.000277: that covers all types of impacting a man, including studies on embryos in vivo. Along with that, the law
p.000277: enforcement is secured via creation of interstate and national systems of ethical review that is
...
p.000281: respectful attitude to human rights and dignity in the sphere of bioethics, depend on general legal culture of
p.000281: people, their bioethical “maturity”.
p.000281: 3.9 REPUBLIC oF tAjIKIStAn (S.D.Achrorova)
p.000281:
p.000281: 3.9.1 Historical and Cultural Background
p.000281:
p.000281: Nowadays in Republic of Tajikistan, like all over the world, the need for biomedical research is growing steadily, as
p.000281: well as the concern for such human values as a person’s health, rights and dignity. Therefore, people of
p.000281: different professions, religions and nationalities have come together to form medical ethics committees that would
p.000281: perform ethical review of each research involving human subjects.
p.000281: The first Tajik State with the centre in Bukhara was founded by Ismail Samani in 875. In 999 the Samanide State
p.000281: was destroyed because of dissensions concerning territorial claims of Ismail Samani’s heirs.
p.000281: Later the land of Tajikistan formed a part of different states (Iran: 1212-1220 and 1740-1747; Genghis
p.000281: Khan Mongol Empire: 1220-1370; the State of Timurids: 1370-1740; Bukhara Khanate – the so called East
p.000281: Bukhara: 1747-1920). In 1867 northern territories of Tajikistan with the city of Khodjent entered the
p.000281: Russian Empire and were industrialized. In 1925 the Tajik Autonomous Soviet Socialist Republic was created as a
p.000281: part of Uzbekistan Republic, but in 1929 the Tajik Soviet Socialist Republic was made a separate constituent
p.000281: republic with the city of Dushanbe as its capital. In 1991 the Soviet Union collapsed, and Tajikistan declared
p.000281: its independence.
p.000281: Tajikistan is a mountainous landlocked country in Central Asia. Afghanistan borders to the south,
p.000281: Uzbekistan to the west, Kyrgyzstan to the North, and China to the east. The total area of Tajikistan Republic is
p.000281: 143.1 thousands of square km, and it has a population of 7,163,506 citizens. Tajikistan consists of 4 administrative
p.000281: divisions: 2 provinces (Sughd in the north and Khatlon in the south), 1 autonomous province (Gorno-Badakhshan
p.000281: - Pamir), and disrtricts of republican subordination around Dushanbe.
p.000281: Tajikistan is an agrarian-industrial country and has a considerable potential. Lengthy wars caused
p.000281: devastations and human losses, which resulted in a dramatic economic recession. However, during the last peaceful
p.000281: years the economics and living standard have notably increased.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000283: 283
p.000283:
p.000283: The Tajik people have a rich and ancient culture. Since antiquity to the period of feudalism moral and
p.000283: ethical issues took an important place in religious and philosophical outlook. Until the IX century it had
p.000283: been developing in the context of Iranian philosophy, and later, since the 9th to the XV century in the
p.000283: context of Arabic philosophy. Due to the ethnic, language, social and political commonality in antiquity and the early
...
p.000317: Health, and thus became legitimate to carry out ethical review of scientific projects. This idea can be
p.000317: illustrated with two large international projects. The Institute of Pediatrics, Obstetrics and Gynecology of the
p.000317: Ukraine Academy of Medical Sciences participated in an international multicentre epidemiological study “Mother
p.000317: and Child”, and the Institute of Occupational Medicine of the Ukrainian Academy of Medical Sciences in cooperation
p.000317: with colleagues from USA conducted an ophthalmologic research in rescuers who had participated in the elimination of
p.000317: the Chernobyl accident. Both projects were carried out in cooperation with the University of Illinois and
p.000317: Columbia University (USA). Within the framework of the projects the teaching staff of universities provided a basic
p.000317: training in bioethics for Ukrainian medical specialists involved in the projects.
p.000317: Since 1998 Ukraine cooperates with different UN organizations including UNESCO that has initiated
p.000317: establishing the National Committee on Bioethics in Ukraine. In 1998 the Committee on Bioethics was established at the
p.000317: Presidium of the Ukraine National Academy of Sciences that had been functioning as a national agency till 2001. After
p.000317: the First National Congress on Bioethics with many participants from abroad (Kiev, 2001) the Commission on Bioethics at
p.000317: the Ukrainian Cabinet of Ministers was established. From the very beginning of its activity, the Commission established
p.000317: contacts with UNESCO, WHO, bioethics organizations at Council of Europe, European Parliament and European Union, in CIS
p.000317: countries, USA, Canada, Belgium, England and other countries. Our activity attracted attention of Vatican and
p.000317: of representatives of other confessions. Members of the Commission on Bioethics and other experts are
p.000317: taking part as delegates, participants and guests in different international congresses, conferences,
p.000317: seminars and working groups relating to bioethics.
p.000317: Ukraine is actively participating in conducting clinical trials of pharmaceutical products in the
p.000317: framework of multicentre international research. The National Pharmacological Centre of the Ukraine Ministry of
p.000317: Health, in cooperation with WHO, organizes clinical trials according GCP regulations in which compliance with
p.000317: bioethics principles is one of the cardinal elements.
p.000317: In the framework of national congresses, conferences and bilateral working groups with participants
p.000317: from Ukraine and the European Parliament joint seminars and workshops are held. Thus in March 2006,
p.000317: with the support of the Revival Foundation, in the framework of the Project “East-East: Partnership Beyond Borders” an
p.000317: international seminar was held where problems of standardization of rules for ethical review and ethics
p.000317: committees practice were considered with a particular emphasis on the issue of compliance with GCP
p.000317: requirements. Representatives from Latvia, Lithuania, Moldova, Estonia, the European Council and the GCP Alliance-
p.000317: Europe took part in the seminar. The seminar was held in the format of SIDCER “Recognition Programme” in
p.000317: the CIS. Such events are a unique experience for many countries of CIS, East and Central Europe.
...
p.000317: of ethical review of international projects which later is extended
p.000317:
p.000318: 318
p.000318:
p.000319: 319
p.000319:
p.000319: to the national level. Thus in 2005 the Ethics Committee of the Occupational Medicine at the Ukraine Academy of Medical
p.000319: Sciences was registered at the Office for Human Research Protection at the USA Government and received the Federalwide
p.000319: Assurance FWA00007871. Several local committees in Ukraine also have international registration numbers.
p.000319: Since November 1995 when Ukraine became a permanent member of the Council of Europe, a Ukraine representative has been
p.000319: working actively at the Steering Committee on Bioethics in Strasbourg (France). In the framework of this activity
p.000319: Ukraine participated in the development of international documents including the revised text of the “Convention
p.000319: of Human Rights and Biomedicine” (Oviedo, 1997). In 2004 the representative of Ukraine was elected to the Board of the
p.000319: Steering Committee on Bioethics as a Committee Reporter on the activity of Ethics Committees at medical research
p.000319: institutions. Two seminars on topical ethical problems in transplantology and cell therapy were held in Ukraine with
p.000319: the assistance and participation of CE experts. The representative of Ukraine takes part as a reporter in the
p.000319: educational project of the CE on implementation of CE documents on bioethics in the countries of the former Soviet
p.000319: Union. Currently, in the framework of the Steering Committee on Bioethics at the CE, Ukraine participates in the
p.000319: development of guidelines for a fetus and embryo protection and in the design of a protocol relating to genetic
p.000319: testing.
p.000319: International Seminar “Development of the Recommendations on Application of Standard Operational Procedures
p.000319: for Ethical Review of Biomedical Research” was held in the framework of the Second National Congress on Bioethics
p.000319: (Kiev, 2004) organized in cooperation with FECCIS and UNESCO. Experts and participants from CIS, Baltic States, the USA
p.000319: and Japan attended the Seminar.
p.000319: The main objective of the seminar was to discuss ways and methods of implementing Standard Operational Procedures
p.000319: into the practice of ethical evaluation of biomedical research in the countries of the former Soviet Union
p.000319: and neighbouring Baltic countries and countries of Eastern Europe. High ethical standards and requirements outlined in
p.000319: this document should be implemented into the practice of local ethics committees. At the same time we should consider
p.000319: specific local features of a particular region. Therefore we have to focus our attention on issues of interaction
p.000319: between regional, national and local ethics committees. Another important problem
p.000319: is raising the qualification level of members of the ethics committees that review biomedical research. The seminar
p.000319: facilitated a further harmonization of international ethical standards with regard to regional conditions. It had both
p.000319: scientific and practical significance for the countries of the region.
p.000319: The next step in this direction may be the Interregional Seminar “Exchange of Experience in Implementing
p.000319: Standard Operational Procedures into the Practice of Ethical Review of Biomedical Research” within the
p.000319: framework of the Third National Congress on Bioethics that is to be held in autumn 2007 with the support of UNESCO. A
p.000319: certain experience that has been accumulated during several years in different countries of the region should
p.000319: be analyzed and evaluated for a further adaptation of SOPs, development of an efficient network of ethics
p.000319: committees and a system of training members of ethics committees on a national and international level.
...
p.000319: Main directions of a future international cooperation in the field of bioethics are the extension and
p.000319: intensification of contacts with the CE Commission for Ethics in Science and Commission for Ethics at the European
p.000319: Parliament; organization of bilateral conferences on topical bioethics issues with the Ethics Committee of the European
p.000319: Commission. We are planning to organize interregional training seminars for raising the professional level of members
p.000319: of ethics committees (with the support of UNESCO and other
p.000319:
p.000320: 320
p.000320:
p.000321: 321
p.000321:
p.000321: organizations). The work on the development of an efficient network of ethics committees and on the
p.000321: harmonization of international and national standards for ethical review of biomedical research will be continued.
p.000321:
p.000321: References
p.000321: 1. Programme in Bioethics. General Course for Students of Higher
p.000321: medical Institutes. - М., 2001. 40 p. (in Russian)
p.000321: 2. An Outline of the Programme in BIOETHICS for the speciality
p.000321: 040500 -Pharmacia. М., 2003. 18 p. (in Russian)
p.000321: 3. http://www.med-law.ru
p.000321: 4. Bioethics Manual. / Ed. P.V. Lopatin. М., 2005. 240 p. (in Russian)
p.000321: 5. Medical Ethics Manual. Translated from English. /Ed. Yu.M.
p.000321: Lopukhin, B.G.Yudin. М., 2004. 400 p. (in Russian)
p.000321: 6. http://www.bioethics.union.edu
p.000321: 3.11 REPUBLIC oF UzBEKIStAn (M.S. Abdullakhodjaeva)
p.000321:
p.000321: 3.11.1. Historical and Cultural Background
p.000321:
p.000321: The history of bioethics in Uzbekistan roots back to interpretations of ethical teachings in pre-Islamic tradition and
p.000321: in the Koran.
p.000321: Syncretism of the oriental philosophical tradition gave rise to a term that has no analogues in European culture –
p.000321: “adab” and “adabnoma” – a teaching describing the due behaviour of a well-brought-up person. The term combines the
p.000321: general education, the theory of ethics and norms of a polite behaviour. Both in a strictly scientific sense and by
p.000321: birth terms “ethics” and “adabnoma” are not identical; they differ in the approach to the study of ethics, in
p.000321: argumentation and in the focus of their attention (general abstract principles and/or a code of behaviour). Central
p.000321: Asian codes of behaviour “Kobusnoma” by Unsurmaol Kaykovus, the treatise “On Ethics” by Ibn Sina, “Four
p.000321: Conversations” be Arusi Samarkandi, “The Oriental Code of Decencies” by Sadyk Kashgari and many other works are
p.000321: fundamental methodological sources of Uzbek model of bioethics. Adabnoma, rather than Islam, provided a
p.000321: basis for the development of research ethics and medical practice in pre-Soviet time. Thus, distinctive features
...
p.000341: aspects of modern biomedical ethics; specific features of biomedical ethics in Islamic countries and
p.000341: Zoroastrian medicine), etc. In addition to that, students should study the Constitution of the Republic of Uzbekistan
p.000341: (1992), as well as laws and normative documents regulating public relations in healthcare. All cardinal problems of
p.000341: theoretical and applied bioethics are considered including ethical problems in clinical trials and biomedical research
p.000341: involving human subjects and animals. Specific ethical problems associated with students’ specialization are also
p.000341: considered.
p.000341: The NEC of the Republic of Uzbekistan is carrying on an essential work on the development of a regular education in
p.000341: bioethics and on training home specialists in the field of modern bioethics.
p.000341: Since 2000, members of the NEC and of regional and local ethics committees have participated in training
p.000341: seminars on bioethics (2001 – Saint- Petersburg, Russia; 2001 – Kiev, Ukraine; 2002 – Almaty, Kazakhstan; 2003
p.000341: – Saint-Petersburg, Russia and Tashkent, Uzbekistan; 2004 – Kiev, Ukraine and Baku, Azerbaijan; 2005 – Yerevan,
p.000341: Armenia; Almaty, Kazakhstan and Tashkent, Uzbekistan; 2006 – Tashkent, Uzbekistan). Training seminars were organized by
p.000341: the Forum for Ethics in the Commonwealth of Independent States, US National Healthcare Union and American Centers for
p.000341: Disease Control and Prevention (CDCP) in collaboration with UNDP (World Bank/WHO), IPA CIS, EFGCP, UNESCO, EC
p.000341: and other international and national organizations. Training seminar on research ethics for members of NEC and local
p.000341: ECs of Uzbekistan that was held in Tashkent, Uzbekistan was conducted in the framework of SIDCER “Recognition
p.000341: Programme”. Within this seminar there were a training courses “Standard Operational Procedures” and “Human
p.000341: Subject Protection”. The training seminars covered the following issues:
p.000341: - The role of ethical review in biomedical research;
p.000341: - The role of SOPs in conducting ethical review, establishing ECs, choosing independent consultants and
p.000341: confidentiality agreement.
p.000341: The teaching programmes on ethics for EC members and programmes on GCP for postgraduate education were discussed at the
p.000341: seminars (C.Jankw, Austria) as well as Fogarty Programme (B.Yudin, Russia):
p.000341: - the procedure of establishing an EC and EC meetings;
p.000341: - legislative basis for the ethical review of biomedical research;
p.000341: - the procedure of obtaining informed consent.
p.000341: There were also training seminars for EC members from countries of Central Asia. Tashkent hosted training seminars
p.000341: “Principles of Ethics in Biomedical Research”(CDCP, 2003), “Principles of Conducting Ethical Review and
...
Social / Unemployment
Searching for indicator unemployed:
(return to top)
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
p.000023: mortality in able-bodied population, “rejuvenation” of some diseases, spread of alcoholism and drug addiction;
p.000023: - the change in consumption of genetically habitual food products, decrease in food calorie content for the
p.000023: considerable part of the society;
p.000023: - reduced access to social services in conditions of a large-scale commercialization, which negatively
p.000023: affects the quality of human resources, intellectual, scientific and physical potential of the country;
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000025: 25
p.000025:
p.000025: - the decreasing number of medical institutions; a level of the population morbidity and mortality still remains
p.000025: high; the number of handicapped people is increasing;
p.000025: - stratification of the society by income, when 10% of the most well- to-do population have incomes more than 10 times
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
p.000025: efficiency of social assistance programs by weight of amounts received by families beyond the poverty line in total
p.000025: amounts of social support).
p.000025: 1.2 Ethical and Legal Issues
p.000025: in the Field of Biology and Medicine (o.I.Kubar, B.G.Yudin, A.E.nikitina, E.Yu.Vladimirova)
p.000025:
p.000025: Characterizing trends of legal and ethical control in the sphere of practical health care and biomedical
p.000025: research in the CIS member states it is necessary to emphasize a multilevel system of factors determining common
p.000025: pattern of directions, characteristics, features and mechanisms of national and international, retrospective and
p.000025: perspective influence. A rationale for forming of the given community is geographical closeness, unity of political
p.000025: history of the pre-Soviet and Soviet periods, contingency and interpenetration of cultures and traditions, forming
p.000025: extreme ethnical, cultural and religious multiplicity making countries in the region different.
p.000025: By itself such multiplicity leads, in particular, to the following - the set of actual ethical norms being a basis for
p.000025: medical care in the region countries is a historical foundation and a clear reflection of tolerance concepts both to
...
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
p.000271: alterations of the drug introduction routes, its doses, and significant changes in number of the CT subjects. An ethics
p.000271: committee can approve amendments to the clinical study conduct only if presented changes do not lead to worsening of
p.000271: conditions for subjects.
...
Searching for indicator unemployment:
(return to top)
p.000007: result from a long-term socio- economic crisis of the 1990s, discrepancy between introduced reforms and
p.000007: social policy, a dramatic decline in living standards at various social levels, and aggravation of ecological
p.000007: conditions. Specific features in each State are determined by different styles of life in the CIS countries due to
p.000007: their historical, religious, cultural and ethnic development. All these factors resulted in a general fertility rate
p.000007: decrease, mortality growth and a fall of the health quality index. These processes affect negatively the demographic,
p.000007: labour and migration potential of the CIS countries.
p.000007: The last decade of the XX century was characterized by an essential aggravation of the demographic situation that could
p.000007: be defined as a crisis. High mortality rates had practically no precedents in the Eurasian peacetime history. The
p.000007: “excess mortality” in the period since 1989 was much higher than the mortality rate in the period of Great Depression
p.000007: in the North America (1929-1933). Besides, recent changes of mortality rate, marriage ability and fertility shifts have
p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
...
p.000021: nuptiality and population reproduction potential, and in a growing difference of the lifespan between the sexes. In
p.000021: spite of substantiated expectations, the high mortality rate in the period of transition at the early nineteenth did
p.000021: not affect seriously those population groups that usually are considered as particularly vulnerable due to biological
p.000021: or social causes, namely children and elder people. Perhaps the most remarkable feature of this recent population
p.000021: health crisis became a significant increase of the mortality rate for age groups of gainfully employed population. The
p.000021: most drastic relative growth of the mortality rate for adult males was registered in the group of “blooming age” i.e.
p.000021: at the age of 35-49, which is most typical for Russia. As to females, the mortality changes had unequal intensity, and
p.000021: the increase of mortality here was less marked, but it affected exactly the “blooming” age group from 35 to 49 years.
p.000021: As we know, the population reproduction depends mostly on two factors: firstly – on the ratio of marriages and
p.000021: divorces; secondly – on the ratio between males and females at the fertile age. As to the first factor, in
p.000021: the conditions of the increasing youth unemployment, rapidly growing prices housing costs and uncertain prospects, the
p.000021: nuptial ratio has decreased in all nine countries from 4% (Azerbaijan) to 34% (Russian Federation). The decrease of the
p.000021: nuptial ratio for persons in the second marriage in all countries was even sharper. An average decrease of this index
p.000021: was 28%; only in Ukraine the increase of the nuptial ratio was registered, but in 1993 the fertility in this country
p.000021: has decreased dramatically (by 20%), and hence the hopes associated with the nuptial ratio were not justified. In
p.000021: contrast to the number of marriages the number of the divorces was growing. The second factor is also unfavorable. The
p.000021: female population exceeds male population, and this ratio becomes worse with every new age group.
p.000021: Thus, the marriage/divorce ratio, as well as male/female ratio determines negative tendencies in demographic
p.000021: situation in the CIS countries. The mentioned ratios have a negative impact on the generation renewal,
p.000021: and retain conditions for a narrow reproduction.
p.000021: When considering the situation we should note that the most dramatic aggravation was observed in the areas of the
p.000021: income per person, poverty, demography and social unity, which is essential for understanding social- economic
p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
p.000021: into the international system of biomedical research both from a viewpoint of interested researchers and potential
p.000021: participants.
p.000021: In the period of transition to the market economics all the CIS countries had to face such problems as considerable
p.000021: inequity in the income distribution, stratification of the society by income and increasing poverty. In 2004, the ratio
p.000021: of the total income of 10% of the most and 10% of the least well-to- do population was 3-5 times in Azerbaijan, Belarus
p.000021: and Ukraine; 11 times in Kazakhstan, Kyrgyzstan, Moldova, Russia and Tajikistan; 21 times in Armenia.
p.000021: In recent years (2005-2007), in the majority of the CIS countries some smoothing of the society stratification by
p.000021: income and the decrease of the population quota with the income beyond the cost of living (poverty line) was observed.
p.000021: Some processes were observed in the CIS countries that were not typical before. Thus, the number of the “poor” children
p.000021: usually was growing much faster than the number of poor persons in every other age group because of the rapid spread of
p.000021: the unemployment and increasing number of persons in a low-paid job, alongside with a disproportional indexation of the
p.000021: family allowances. The level of food consumption by children has considerably decreased. Presently, the change
p.000021: in the nutrition structure is expressed by transition to food products that are less expensive and richer in
p.000021: calories. There is a lack of food products that are necessary for the normal growth and development of the organism.
p.000021: Besides, a decrease in food consumption and the worsening of the sanitary situation, hygiene and living conditions have
p.000021: caused the increase of the number of diseases (tuberculosis, rachitis) traditionally associated with poverty.
p.000021: Specific features of the demographic situation and, indirectly, the amount of labor resources depend also on
p.000021: the age groups prevailing in the total population size, which, in its turn, implies special approaches to the
p.000021: healthcare structure development in the CIS countries. The increase of
p.000021:
p.000022: 22
p.000022:
p.000023: 23
p.000023:
p.000023: the elder population and the decrease of the share of children in the total population are typical for the majority of
p.000023: the CIS countries.
p.000023: In fact, during the period from 1989 to 2004 in all the CIS countries the part of population under working age
...
p.000023: the following public processes are crucial:
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
p.000023: mortality in able-bodied population, “rejuvenation” of some diseases, spread of alcoholism and drug addiction;
p.000023: - the change in consumption of genetically habitual food products, decrease in food calorie content for the
p.000023: considerable part of the society;
p.000023: - reduced access to social services in conditions of a large-scale commercialization, which negatively
p.000023: affects the quality of human resources, intellectual, scientific and physical potential of the country;
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000025: 25
p.000025:
p.000025: - the decreasing number of medical institutions; a level of the population morbidity and mortality still remains
p.000025: high; the number of handicapped people is increasing;
p.000025: - stratification of the society by income, when 10% of the most well- to-do population have incomes more than 10 times
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
p.000025: efficiency of social assistance programs by weight of amounts received by families beyond the poverty line in total
p.000025: amounts of social support).
p.000025: 1.2 Ethical and Legal Issues
p.000025: in the Field of Biology and Medicine (o.I.Kubar, B.G.Yudin, A.E.nikitina, E.Yu.Vladimirova)
p.000025:
p.000025: Characterizing trends of legal and ethical control in the sphere of practical health care and biomedical
p.000025: research in the CIS member states it is necessary to emphasize a multilevel system of factors determining common
p.000025: pattern of directions, characteristics, features and mechanisms of national and international, retrospective and
p.000025: perspective influence. A rationale for forming of the given community is geographical closeness, unity of political
p.000025: history of the pre-Soviet and Soviet periods, contingency and interpenetration of cultures and traditions, forming
p.000025: extreme ethnical, cultural and religious multiplicity making countries in the region different.
p.000025: By itself such multiplicity leads, in particular, to the following - the set of actual ethical norms being a basis for
p.000025: medical care in the region countries is a historical foundation and a clear reflection of tolerance concepts both to
p.000025: cultural differences as they are and to their particular carriers. Moreover, in this case we can talk not just about
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000023: ten years the rate of mental diseases in children doubled, that of moronity increased in 1.5 times and imbecility in
p.000023: 1.6 times. We have to recognize the growing number of disabled children; in the CIS countries there are about 1.5
p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
p.000023: addicts. Every five years the amount of drug addicts in the “youngest” group is increasing by 100%. The children
p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
...
p.000033: Republic of Uzbekistan).
p.000033: Majority of the CIS countries also declared in their constitutions the right for medical care in different forms
p.000033: (excluding three republics – Armenia, Azerbaijan and Uzbekistan: in these states guarantees of availability of
p.000033: health care for people are set at the level of branch laws regulating public relationships in the health care system).
p.000033: At the same time one should note that the issue of underfunding in regard to required amount of medical care today is
p.000033: still one of the most acute problems almost in all countries of the Commonwealth.
p.000033: States implement programs on population health protection, measures for environmental protection and provision of
p.000033: free access to reliable information on its status, living and working conditions, quality of food products
p.000033: and household goods, facilitate development of physical culture and sports, create opportunities for various
p.000033: forms of health insurance. Financial support is guaranteed to pregnant women11, mothers with small children and in
p.000033: case of children with disabilities – until they become older
p.000033: – to families with many children, persons with various diseases and drug abuse. The state provides special care
p.000033: for those who broke their health protecting state and common interests. An important issue is inclusion into the
p.000033: sphere of state policy and legal regulation of an issue of preservation of national gene pool.
p.000033: It is truly important that virtually all CIS countries adopted branch laws related to issues of health care and patient
p.000033: rights – the Law of the Republic of Armenia On Medical Care and on Services for Population (1996), the Law of the
p.000033: Republic of Azerbaijan On Protection of Population Health (26.07.1997),
p.000033: 11 Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of Moldova,
p.000033: respectively.
p.000033:
p.000034: 34
p.000034:
p.000035: 35
p.000035:
p.000035: the Law of the Republic of Belarus On Health Care (1999), the Law of Georgia On Health Care (1997), the
p.000035: Law of the Republic of Kazakhstan On Protection of Population Health of the Republic of Kazakhstan (1991), the Law of
p.000035: the Kyrgyz Republic On Protection of Population Health of the Kyrgyz Republic (09.01.2005), the Law of the
p.000035: Republic of Moldova On Rights and Responsibility of Patient (27.10.2005), Basics of the Law of the Russian Federation
p.000035: On Protection of Citizen Health (22.07.1993), the Law of the Republic of Tajikistan On Protection of Population Health
p.000035: (15.05.1997), Basics of the Law of the Ukraine On Health Care (1992), the Law of the Republic of Uzbekistan On
...
p.000239: culture, charity and mercy, business and economic. Changes occurring in the society and the Church demanded for a
p.000239: comprehensive philosophy that would reflect general attitude of the Church to issues of state and the Church
p.000239: relations and concerns of the modern society on the whole.
p.000239: At the Anniversary Episcopal Assembly in 2000 the Basic Social Conception of Russian Orthodox Church was
p.000239: adopted. The conception falls into 16 sections covering most various issues related to life of a Christian believer in
p.000239: secular world. In section 11 – “Public and Individual Health” – the attitude of Orthodox Church to disease and health
p.000239: is rendered, importance of church activities in health care is stressed, necessity of society and church cooperation in
p.000239: public health care issues is emphasized. It covers such vital from religious viewpoint principles as doctor and patient
p.000239: relationship which should be based with respect to integrity, free choice and “personal dignity”. In particular it
p.000239: stresses: “We should by all means encourage a dialogue between a doctor and a patient that is
p.000239: characteristic of current medical approach. This approach is undoubtedly engrained in the Christian tradition,
p.000239: although there is a temptation to relegate it to a level of merely agreement relationship. At the same time one should
p.000239: admit that a more conventional “pattern like” model of physician and patient relationship which is fairly criticized
p.000239: for numerous attempts to justify medical power abuse may as well represent a truly fatherly attitude to patient that
p.000239: depend on doctor’s morality. Not giving preference to any of the health care organization models the Church
p.000239: considers that this service should work efficiently at its maximum and must be available to all members of society
p.000239: disregarding their financial and social status even with limited medical resources distributed. For such distribution
p.000239: to be fair the aspect of “vital requirements” should prevail over the aspect of “market relations”. The doctor should
p.000239: not see the degree of their responsibility for medical service in relation with financial reward and its amount only by
p.000239: this turning his profession into pure profit making. At the same time decent payment for medical professionals is seen
p.000239: as an essential task for the society and the state (26).
p.000239: Section 12 “Bioethical Issues” shows the official position of RCOC
p.000239: on a range of aspects which currently are concerning in the society and are brought about by blooming development of
p.000239: biomedical technology in late the
p.000239:
p.000240: 240
p.000240:
p.000241: 241
p.000241:
p.000241: XX century. These completely new challenges are once again comprehended and reinterpreted in the context of ideas of
p.000241: human life and personal dignity which are entrenched in the “Divine afflation”. It shows attitude of the
p.000241: Church to abortion, new reproductive methods, medical genetic methods of diagnostics, tissue and organ
p.000241: transplantation, reanimation and help to the parting, sexual issues. Moreover some sections of the social
...
p.000247: This Act regulates issues relating to the individual case of application, according to the necessities of life, of a
p.000247: pharmaceutical product that is not registered in Russian Federation. This is a matter of non-interventional
p.000247: research. The decision about the use of a pharmaceutical product in this case is made via the Federal
p.000247: specialized medical commission; the protocol is documented and signed by the medical director of the director of the
p.000247: Federal specialized medical commission. This document emphasizes again the need to seek the patient’s voluntary written
p.000247: consent (in cases provided by law the consent from the patient’s legal representatives) to apply an
p.000247: unregistered pharmaceutical product. The physician should inform the patient about the pharmaceutical product, its
p.000247: expected benefit, safety and the degree of risk. The physician should also explain measures that will be taken in the
p.000247: case of unexpected effect of the pharmaceutical product on the patient’s health.
p.000247: The Article 29 of the Fundamental principles of Legislation also imposes the ban on biomedical trials involving persons
p.000247: under any form of detention or imprisonment.
p.000247: The strict character of legal norms relating to biomedical trials involving two categories of vulnerable subjects –
p.000247: minors and persons under detention or imprisonment – from the one hand is the sign of the law-maker’s intention to
p.000247: prevent the possibility of abuse of depending persons, from the other hand
p.000247: - it actually means the limitation of rights of mentioned persons to access to new medicines, diagnostic and
p.000247: prophylactic methods.
p.000247: At the same time it is to be taken into account that the Federal aw of the Russian Federation ”On Pharmaceutical
p.000247: Products” on 22 of June 1998
p.000247: 30 Order “On Applying Pharmaceutical Products according to the Necessities of life” adopted by the Order of Ministry
p.000247: of Health and Social Development (09.08.2005, No. 494) //Bulletin of normative acts of Federal Executive Authorities.
p.000247: No 36, 05.09.2005.
p.000247:
p.000248: 248
p.000248:
p.000249: 249
p.000249:
p.000249: N86-FZ fixes another approach towards some vulnerable contingents31. This document takes the central place in
p.000249: legal regulation of preclinical and clinical study of pharmaceutical products.
p.000249: The issues concerning rights of patients participating in clinical trials are touched on by the Article 40 of the
p.000249: mentioned law. The general rules of obtaining the informed consent for participating in research constituted by this
p.000249: article correspond in a whole with the discussed provisions of the Fundamental principles of Legislation. The
p.000249: noteworthy point is the more detailed description of information which should be given to subject, namely: 1)
p.000249: information on pharmaceutical products and nature of clinical trials of this drugs; 2) information on anticipated
p.000249: efficiency, the drug safety, and the degree of risks for the patient; 3) information on measures in the case of
...
p.000305: pharmaceutical products concerning minors from 15 to 18 years of age and individuals with a limited capacity to consent
p.000305: (Art. 44.2 of Basic Legislation).
p.000305: The right to withdraw consent is not clearly stated either in the law or in the majority of other special
p.000305: laws but the Ukrainian law “On Pharmaceutical Products” (Art. 8). According to this law, a volunteer or the person’s
p.000305: legal representative can freely withdraw his or her consent to participate in clinical trials.
p.000305: There is no regulation relating to medical interventions for the benefit of the health of the person concerned
p.000305: in emergency situations when the appropriate informed consent cannot be obtained. For this case we need a legal
p.000305: norm stating that the previously expressed wishes relating to a medical intervention by a patient who is not, at the
p.000305: time of the intervention, in a condition to express his or her wishes should be taken into account.
p.000305: The law “On Pharmaceutical Products” states the necessity to obtain a written consent from a potential subject of a
p.000305: clinical trial or from his or her legal representative (Art. 8). This additional measure is connected with the danger
p.000305: of abuse and infringement of human rights.
p.000305: The right to information is closely related to the concept of informed consent. Recognition of this right is
p.000305: particularly essential for former soviet republics with their traditional paternalistic approach to physician-patient
p.000305: relationship. The transition to the concept of cooperation signifies the respect for the patient’s will, for his or her
p.000305: dignity and free choice. This is especially important for the sphere of biomedical research involving human subjects.
p.000305: The general rule is fixed in Ukrainian legislation – in Basic Legislation and in special laws. However,
p.000305: Basic Legislation says nothing about the confidentiality of private information, and corresponding
p.000305: statements can
p.000305:
p.000306: 306
p.000306:
p.000307: 307
p.000307:
p.000307: be found only in the Ukrainian laws “On Prevention of AIDS Disease and Social Protection of Population” (Art. 8) and
p.000307: “On Providing Psychiatric Care” where only the patient or his/her legal representative have the right to private
p.000307: information.
p.000307: The Ukrainian law “On Prohibition of Reproductive Human Cloning” is restricted to the sphere defined in the law title
p.000307: and does not regulate in any way embryo cloning “for therapeutic purposes”. It only prohibits importing cloned human
p.000307: embryos into Ukraine and exporting them from the country.
p.000307: Apart from abovementioned laws, there are many other legislative acts regulating, one way or another, issues relating
...
Social / Women
Searching for indicator women:
(return to top)
p.000011: At the beginning of 2005, the population size in the CIS countries was 279 million people (according to the Statistic
p.000011: Committee). In comparison with the beginning of 1991, the population has reduced by 2.7 million people or
p.000011: 1.0%.4
p.000011: By the type of demographic processes in the 90-s the CIS countries were divided into two groups. In the
p.000011: first group including Ukraine, Belarus, Russia, Kazakhstan, Moldova, Georgia and Armenia the population has
p.000011: been decreasing from year to year. The second group includes Azerbaijan and Republics of Central Asia where the
p.000011: population and the demographic potential kept on increasing. At the same time, as it was mentioned above, depopulation
p.000011: processes in Belarus, Russia and Ukraine are increasing, which means that the death rate exceeds the birth rate. This
p.000011: results in the increasing polarization of the two groups of CIS countries by the demographic potential, and hence
p.000011: creates, in prospect, additional preconditions for its redistribution between countries through migration processes.
p.000011: (Table 2).
p.000011: During last years in the majority of the CIS countries, the reduction of the fertility rate was not registered. On the
p.000011: contrary, in 2003-2004 it has somewhat increased. In Azerbaijan and Kazakhstan the increase is noticed in all age
p.000011: groups, in Belarus and Ukraine – at the age of 30 and older. At the same time, the highest fertility rate is still
p.000011: registered in women at the age of 20-24 (89-95 newborns per 1000 women of fertile age in Belarus, Georgia, Moldova,
p.000011: Russia and Ukraine, over 120 newborns – in Armenia, Azerbaijan and Kyrgyzstan, 143 – in Kazakhstan).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 3 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 26.
p.000011: 4 In the previous decade – in the 1980s – the population in former Soviet Republics, except for Baltic States,
p.000011: increased by 22.6 mln of people (8.7%).
p.000011:
p.000012: 12
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: The increase of the age-specific rates results in the increase of the total birth rate (the total birth rate is the sum
p.000013: of the age-specific fertility rates in the age range of 15-49 years; it shows the average number of children born by
p.000013: one women in her life if for every age the fertility rate remained the same as it was in the year for which the
p.000013: age-specific rates were calculated). The most significant increase of the fertility rate was in Kazakhstan where the
p.000013: total fertility rate in 2004 was 2,21 versus 2,03 in 2003. According to the recent data, the average value of this
p.000013: index in the CIS countries is 1,9 of births per one woman. The half of the population of the CIS lives in the countries
p.000013: where the simple reproduction of the population is not reached, i.e. this rate is below 2,1 (1,38 in Armenia (2004),
p.000013: 1,20 in Belarus (2004), 1,40 in Georgia (2003),
p.000013: 1,22 in Moldova (2003), 1,34 in Russia (2004), 1,20 in Ukraine (2003)).6 The problem of saving life and health
p.000013: of newborns is particularly
p.000013: important especially considering the long period of fertility decrease. In spite of a marked reduction of the
p.000013: infant mortality in all CIS countries in recent years, its level remains very high. The infant mortality rate in the
p.000013: CIS countries is much higher than that in the developed countries where its value is 3-5 deaths during the first year
p.000013: per 1000 newborns. (Table 3).
p.000013: About a half of dying infants falls to the share of the babies of the first year of life, nearly 70% of which die in
p.000013: the first week. The prenatal mortality rate in the CIS countries is fluctuating from 6 to 16 deaths at the age of 0-6
p.000013: days and still-borns per every 1000 of births. The causes of these deaths are respiratory states typical for the
...
p.000200: 200
p.000200:
p.000000: 0
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000: Picture 1. Diseases of blood circulation system (per 100 000 of
p.000000: population)
p.000000: Malignant tumors (respiratory organs diseases – in Kyrgyzstan) are in the second place among female death causes.
p.000000: Malignant tumors as a death cause in men are in the second place in Azerbaijan (88 deaths per 100000 of
p.000000: population in 2003) and Armenia (160). The male mortality rate from suicides and other external causes in
p.000000: other countries is higher than the mortality rate from cancer. In 2004 this index in Belarus was 281 deaths from
p.000000: external causes10 per 100000 of population, which is slightly higher than the mortality rate from the
p.000000: malignant tumors (240); in Kazakhstan – 232 (142), in Kyrgyzstan – 110
p.000000: (64), in Moldova – 162 (158), in Russia – 390 (236), in Ukraine – 258
p.000000: (236). (Table 4).
p.000000: In Belarus, Kazakhstan and Russia the mortality rate for males from external causes is 4-5 times higher than that from
p.000000: diseases of respiratory and digestion organs. Nearly 40% of deaths by these causes falls to the share of working
p.000000: citizens.
p.000000: On the average, in recent 15 years (in comparison to 1989) the male mortality rate at the age of 15-64 has
p.000000: increased: in Belarus – by 41%, in Kazakhstan – by 46%, in Russia – by 70%, in Ukraine – by 46%. In Kyrgyzstan and
p.000000: Moldova the mortality rate of males at the age of 35-64 has been increased by 20% and 25% respectively.
p.000000: The female mortality rate in women of working age is somewhat lower than that for men, but the scale
p.000000: of its increase is the same. Thus in the indicated period the mortality rate for females in the age
p.000000: 15-64 has increased in Kazakhstan by 32%, in Russia – by 62%, in Belarus and Kyrgyzstan (for the age of 30-64) – by 30%
p.000000: and 14% respectively, and in Ukraine (for the age of 20-64) – by 42%.
p.000000:
p.000000:
p.000000: 2000. 2004 (Georgia – 2003).
p.000000:
p.000000:
p.000000:
p.000000:
p.000000: Picture 2. Mortality from diseases of blood circulation system (per 100 000 of population)
p.000000: The most comprehensive index of the population health and of the labor resources is the life expectancy.
p.000000: Since the beginning of the transition period, it has decreased in the majority of the countries. (Table 5).
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000018: 18
p.000018:
p.000019: 19
p.000019:
p.000019:
p.000019: Mortality by main groups of death causes in 2004
p.000019: Table 4
p.000019: Table 5
p.000019: Life expectancy in people of certain age1) in several CIS countries
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: 1) 2003.
p.000019: 2) 2000.
...
p.000117: Bioethics Committees” (2005); UNESCO Guide No 2 “Bioethics Committees at Work: Procedures and Policies” (2005).
p.000117: The National Strategy of Steady Development and the Concept of Healthcare Development in Belarus (1995) are
p.000117: the basis for adopting legal acts and national programmes and determine particular measures and resources for ethical
p.000117: and legal control of biomedical research. Laws of Belarus “On Healthcare” (1999 with subsequent amendments), “On the
p.000117: Safety of Genetic Engineering” (2005), the Draft Law “On transplantation of Human Organs and Tissues”, orders and
p.000117: instructions of the Belarus Health Ministry of are in compliance with the main principles of bioethics set out by WHO.
p.000117: The central law determining the State policy in the sphere of citizens’ health protection, legal, economical and
p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armed forces, prisoners and persons under arrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
...
p.000167: order of development of biologically active substances and their preclinical studies or clinical trials of medical
p.000167: drugs. These articles were developed in the line with international experience (5):
p.000167: - the participation of the patient in clinical trials and (or) in testing of pharmaceutical substance or
p.000167: medical drug should be voluntary and is possible with his/her written informed consent only;
p.000167: - before clinical trials and (or) testing all information on the substance/ drug, on the contents of trials or tests,
p.000167: on safety and risks for patients health, on actions in the case of unforeseen effects of pharmaceutical substance or
p.000167: medical drug for the patient’s health as well as on patient’s health and life insurance should be provided to the
p.000167: patient;
p.000167: - the patient has a right to interrupt his/her participation in trials and (or) tests of pharmaceutical substance or
p.000167: medical drug at any phase of such trials or tests;
p.000167: - it is strictly prohibited to perform clinical trials and (or) tests of pharmaceutical substances or
p.000167: medical drugs with participation of: children and adolescents; pregnant women; military persons; imprisoned
p.000167: or incarcerated persons; non-competent persons.
p.000167: At the web-site www.medik.kz the Association of Physicians and Pharmacists of Kazakhstan has the page, where
p.000167: all legislative and regulatory documents in public health area. At present time specialists began to develop the Code
p.000167: of Republic of Kazakhstan “On Population Health and Public Health System” that will take into consideration all
p.000167: international legislative experience including legislative acts in area of biological and medical studies. For
p.000167: example, on 22nd of January 2007 the Frame Convention on Tobacco Control was officially ratified by the Republic of
p.000167: Kazakhstan; it is planned to bring laws of Kazakhstan in line with international documents that can ensure good
p.000167: clinical practice and improvement of activity of ethical committees [6].
p.000167: In 1995 according to initiative of the Association of Physicians and Pharmacists of Kazakhstan drafts of “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
p.000167: developed. In 2002 the Second Congress of Physicians and Pharmacists approved the text of “The Oath of Physician of the
p.000167: Republic of Kazakhstan” that was reflected in special Decree of the Government of the Republic of Kazakhstan No/ 1189
p.000167: published on 27th of November 2003 and in the article 50 of the Law of the Republic of Kazakhstan “On the
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan”.
...
p.000167: Kazakhstan” the article 20 was supplemented with the following paragraphs:
p.000167: «it is prohibited to perform clinical trials and(or) testing of pharmaceutical substances or medical drugs with
p.000167: participation of:
p.000167:
p.000167:
p.000168: 168
p.000168:
p.000169: 169
p.000169:
p.000169: - persons before coming to age with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treatment of children diseases or when the goal of clinical trial is to collect data on the optimal dosage of this
p.000169: medical drug supposed for usage in children and adolescents. In the last case clinical studies of any medical drug in
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
p.000169: The article 43 of the Law of the Republic of Kazakhstan “On the System of Public Health” published on 4th
p.000169: June 2003 contains the juridical definition of scientific medical expertise; in this article it is indicated that
p.000169: objects of scientific medical expertise are as follows:
p.000169: - drafts of programmes of basic and applied scientific research;
p.000169: - republican targeted scientific medical programmes;
p.000169: - results of completed scientific medical programmes and projects;
p.000169: - scientific research that were nominated for the state awards of the Republic of Kazakhstan;
p.000169: - results of scientific medical programmes that are supposed to be implemented into public health practice.
p.000169: The order of scientific medical expertise is determined by the national authority in public health area.
...
p.000183: cattle-breeders, craftsmen and others. He also writes how people should behave, reflects on human
p.000183: responsibilities and duties, virtues and vices. For Balasagyn sees “dissolution of morals and depreciation
p.000183: of spiritual values as one of the worst vices of his time” [8].
p.000183: A peculiar feature of “The Beneficial Knowledge” is that the author allows the reader to himself to gain an
p.000183: understanding of sense of life, of virtues and vices. Jusup Balasagyn argues that everyone should know and observe
p.000183: moral norms and rules of behaviour. “The Beneficial Knowledge” is a peculiar moral code of its time. Over a long time
p.000183: Kyrgyz ethnos had been existing in form of clans. Relationships within the community had been forming during
p.000183: a long historical period. Changes, if any, occurred due to the influence of external environment forming the worldview:
p.000183: the sense of sharing needs and interests of other people, feelings of mutual aid and collectivism. Kyrgyz people
p.000183: survived in crisis situations only due to spiritual and genetic health of their ancestors. People retained and
p.000183: developed clan traditions, upbringing practices, code of ancestral honour. Clan honour for Kyrgyz people is one of
p.000183: the most essential concepts. Every Kyrgyz had his ancestors, his land and his clan. Each clan had its hierarchy
p.000183: at the head of which was the most respected clan member. Collectivism, mutual aid, empathy, respect for other
p.000183: people – those were the qualities inherent in Kyrgyz mentality.
p.000183: Cultural and historical sources reveal respect to women in nomadic tribes, however there were conflicting
p.000183: traditions with regard to this issue. It is noteworthy that women had a high social status in Kyrgyz society [6].
p.000183: Ethical ideas in works by Kyrgyz thinkers. Spiritual culture of Kyrgyz people reflected in philosophical and poetic art
p.000183: of akyns20 is characterized by the search for perfection. Problems of upbringing and education, of humanism
p.000183: and love for people have a significant place in philosophical poetry of Kyrgyz thinkers, and therefore there
p.000183: is every reason to consider
p.000183: 20 Akyn is an improvising poet and singer in the Kazakh and Kyrgyz cultures. Akyns played and important role in terms
p.000183: of expressing people’s thoughts and feelings, exposing social vices, and glorifying heroes.
p.000183:
p.000184: 184
p.000184:
p.000185: 185
p.000185:
p.000185: it as a code of moral and ethical norms on human behaviour in Kyrgyz culture. Some scientists associate
p.000185: this special attention to moral issues with an access to Chinese sources known for their interest in ethics. The
p.000185: history of development of ethical and philosophical ideas in Kyrgyz culture may be divided into three stages. The first
p.000185: stage is associated with names of late medieval Kyrgyz thinkers: Asan-Kaigy (XV c), Tolubai Synchi and Sanch- Synchi
p.000185: (XIII c) [3]. Kyrgyz people justly call them legendary thinkers, folk sages (akylmanam). We know about these
p.000185: Kyrgyz thinkers from folk legends. Only fragments of their sayings survived to our time.
p.000185: The epoch of late Middle Ages with its patriarchal and feudal system sets a number of moral tasks. Undoubtedly, moral
...
p.000189: to life, physical and moral inviolability; the right to freedom and safety, the right to a free development of one’s
p.000189: personality; right to dignity and freedom of private life, confidentiality of personal and family information et al.
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
p.000189: elderly persons, disabled persons, persons who had suffered from an emergency situation and residents of ecologically
p.000189: unfavorable regions (Art. 67, 68, 69, 70, 71).
p.000189: The Law on Pharmaceutical Products (March 2003) regulates clinical trials of pharmaceutical products.
p.000189: According to this Law, no clinical trials of pharmaceutical products in Kyrgyz Republic may be carried out
p.000189: without the permission granted by the authorized healthcare state institution of Kyrgyz Republic. Those guilty of
p.000189: violating rules of clinical trials, falsifying clinical results obtained in clinical trials of pharmaceutical
p.000189: products or conducting the trials without the permission granted by an authorized healthcare state institutions of
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
p.000189: necessary for an authorized healthcare state institutions of Kyrgyz Republic to make a decision about a clinical trial
p.000189: of a pharmaceutical product. The list includes an approval by the ethics committee of an authorized
p.000189: healthcare state institution of Kyrgyz Republic. Article 27 states that the ethics committee of an authorized
p.000189: healthcare state
p.000189: institution of Kyrgyz Republic participates in the design of a clinical trial programme.
...
p.000189: pharmaceutical products and ensure the protection of patient’s rights.
p.000189: This Law contains important provisions concerning human rights in clinical trials of pharmaceutical
p.000189: products. In particular, it says that a patient gives his or her written consent to participate in a clinical
p.000189: trial of a pharmaceutical product and has the right to withdraw his or her consent at any stage of the research. Before
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
p.000189: out in such vulnerable patients as children without parents; military personnel; prisoners and persons under
p.000189: investigation in detention Centres; pregnant women (except for cases when clinical trials are designed specially
p.000189: for pregnant women and when the
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000191: 191
p.000191:
p.000191: necessary information can only be obtained in a clinical trial provided that the trail is not hazardous to a woman or
p.000191: to a fetus).
p.000191: Besides, the Law sets certain restrictions relating to clinical trials involving children. Thus the trials are
p.000191: only permitted if the investigational pharmaceutical product is specially indicated for use in children or to obtain
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
p.000191: trials of pharmaceutical products involving subjects with mental disorders may only be carried out after
p.000191: obtaining a written informed consent from a legally authorized representative in accordance with applicable law.
p.000191: Protection of patients’ rights in biomedical research and other interventions in Kyrgyz Republic are
...
p.000227: technical progress many discoveries were made in biology and medicine, they changed conceptions of etiology and
p.000227: pathogenesis of diseases, diagnostics and treatments methods were improved. At this time many outstanding
p.000227: scientists, who gave us lessons of morality, lived, and scientific medical schools were established. They
p.000227: could not exist without succession between generations of researchers of traditions of handling not only knowledge and
p.000227: ideas but skills of research and truth comprehension, way of thinking and work, peculiar cooperation and creative work.
p.000227: The Pirogov’s medical association became a Centre of public medical thinking in Russia in the beginning of the
p.000227: 80’s. It grew from narrow professional community of physicians into a specific forum of Russian
p.000227: intelligence discussing social, political and moral problems. Its founders and leaders were famous
p.000227: physicians N.V. Sklifosovskiy, S,S, Korsakov,
p.000227: A.Y. Krasovskiy, F.F. Arisman, E.A. Osipov, G,E. Rain and others. The association held Pirogov’s congresses where
p.000227: the most urgent problems of medicine health protection such as fight against epidemics, management of medical
p.000227: care, medical organization at the front and home front and others were discussed. Congresses sent to the
p.000227: government decisions and applications and though most of them were not answered some of them were
p.000227: followed by orders. They were: decision on foundation of the Women Medical Institute (1902), manifest of corporal
p.000227: punishment abolition for all peasants in Russia and some others. Many times the Pirogov association discussed ethic
p.000227: issues such as status of physicians in Russia, problems of private practice and treatment payment, physicians’ mutual
p.000227: aid, physician right to treat without patient and his relatives’ consent and others (12).
p.000227: One more considerable page of Russian public medicine history has moral accent and is connected with struggle
p.000227: of progressive public persons for women rights and their political emancipation, the right for higher medical education
p.000227: and independent practice. Progressive university professors, scientists and writers supported these demands.
p.000227: Supporters of equal rights for women were S.P. Botkin, I.M. Sechenov, A.L. Krasovskiy, P.F. Lesgaft,
p.000227: V.L. Gruber, etc. They opened the door of their classes for first women and give them equal opportunities with men.
p.000227: Progressive media magazines and newspapers such as Medicine bulletin, Modern medicine, Saint-Petersburg
p.000227:
p.000228: 228
p.000228:
p.000229: 229
p.000229:
p.000229: Bulletin wrote about a need for the country to have women-doctors, about their role in propagation of hygiene,
p.000229: necessity of treatment of women whose shame often “results in great evil in medical practice”. Foundation of the Higher
p.000229: Women Medical Courses (1872, 1876) was the beginning of higher women medical education in our country, thus, Russia
p.000229: left behind almost all European states, besides Switzerland and the USA (the College of 1864). Courses could exist
p.000229: only on private donations. Means were collected in favor of the Courses. Zemskiy doctors sent part of their
p.000229: salary in favor of the courses. Association of mutual aid of women-doctors founded in 1890 was very useful. In 1897
p.000229: efforts of progressive society resulted in foundation of the first Russian Women Medical Institute, which was opened in
p.000229: Saint- Petersburg (now the Saint-Petersburg Medical University named after I.P. Pavlov).
p.000229: Events in medicine and health protection happened in period from 2nd half of the XIX — beginning of the XX century
p.000229: stimulated development of medical ethical ideas. Many old problems became more acute and new ones appeared, relations
p.000229: of doctor and society, doctor and patient, intercolleagueal relations in medicine were changed. Russian physicians were
p.000229: characteristic of not only speeches and declarations, talks about duty and morality but of deeds, behavior, example,
p.000229: and demonstration – quite often during dozens of years or even during their whole life - of what a doctor should be.
p.000229: Open discussion of “complicated” medical issues not only inside of medical society can be considered as
p.000229: a root of such bioethics feature as openness, transparency, necessity in public monitoring of biological
p.000229: researches.
p.000229: Development of a method of chronic experiment in animals is linked to the name of I.P.Pavlov (1849-1936). In 1876 at
p.000229: the Botkin’s clinic of the Medical Military Academy in Saint-Petersburg an experimental laboratory was founded. In
p.000229: 1878-1889 I.P.Pavlov made his researches here. Approval of experiments with animals as a basis of medicine
p.000229: resulted in usage of many animals and their death. It caused reproaches to experimentalists in cruelty, their
p.000229: accusation in misuse of vivisection. In reply to the letter of the Russian association of animal patronage “On
...
p.000249: persons who carry out the study (items 3, 9 of the article 40, items 2 of the article 38) ensures an important
p.000249: additional guarantee of protection of subjects’ interests.
p.000249: At the same time, we cannot but mention an excessively “soft” approach to the question of terminating a clinical trial
p.000249: in the case of events that may be hazardous to the patient’s health. The Law states only that clinical trials may be
p.000249: terminated, while it should state that clinical trials must be terminated.
p.000249: Aiming at safeguarding the rights and interests of vulnerable contingents the Law forbids or
p.000249: limits their participation in clinical trials of medicines. Particularly clinical trials involving minors who
p.000249: don’t have parents, soldiers, persons under any form of detention or imprisonment is absolutely forbidden. The Law also
p.000249: sets up the limitation for the cases of clinical studies involving minors who have parents – such studies may be
p.000249: conducted only if pharmaceutical product is proposed for treatment of child diseases or if the aim of clinical trial is
p.000249: the getting the information about the best dosing of drug for therapy of minors. In latter situation the clinical trial
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
p.000249: carried out only after obtaining the written consent of legal guardians of these persons32.
p.000249: The latter Law states that all persons with mental disorders have to right for the preliminary consent or to refusal at
p.000249: any time to be used as a subject of trials of drugs and medical methods, scientific investigations or study
p.000249: process, video or photo or film shooting (item 2 of the article 2).
p.000249: Besides the Article 11 of this Law clarifies that the clinical trials involving persons under compulsory
p.000249: medical treatment or involuntarily hospitalized persons are absolutely prohibited.
...
p.000271: duration of the study, and approximate number of the subjects in different regions and in the given clinical site. The
p.000271: information provided to the patient shall be logically completed with the informed consent form, which exhibits, if
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
...
p.000293: Tajikistan population. The current legislation is regulating social relations in the sphere of healthcare covering a
p.000293: wide range of issues from a harmonious physical and spiritual development and the improvement of heredity to social and
p.000293: legal protection of the patient. The laws aim at improving conditions of work, life and rest, resolving
p.000293: ecological problems, developing the quality of medical care and promoting a healthy life-style.
p.000293: The first steps of the independent Tajikistan were accompanied with economic crisis in all fields including healthcare.
p.000293: Economic, political and social recession affected indices of the population health. Most urgent were problems
p.000293: concerning food, water supply, sanitary situation, the growth of
p.000293: infectious diseases (typhoid, malaria, tuberculosis, diphtheria, acute viral hepatitis) acute respiratory
p.000293: diseases, anemia, diseases caused by iodine deficit and reproductive health. Despite instability in
p.000293: political and socio- economic life during the first years of independence, Tajikistan Government took comprehensive
p.000293: measures on the protection of the population health. During that period, Tajikistan ratified important
p.000293: international documents referring to the protection of human rights such as the Convention on the Elimination of All
p.000293: Forms of Discrimination against Women (ratified in 1993), Convention on Children’s Rights (ratified in
p.000293: 1993). Presently, the following documents form the legislative basis in healthcare:
p.000293: - Constitution of Republic of Tajikistan (RT) (1994)
p.000293: - RT law “On AIDS Prevention” (No 904; 23 of December 1993)
p.000293: - RT law “On Donorship of Blood and its Components” (No 901; 23 December 1993)
p.000293: - RT law “On the State Sanitary Inspection” (No 987; 20 of July 1994)
p.000293: - RT law “On the Protection of Population Health” (No 419; 15 of May 1997)
p.000293: - RT Labour Code (1997).
p.000293: - Family Code (1997).
p.000293: - RT law “On Narcotic Drugs, Psychotropic and Precursors” (No 874, 10 of December 1999)
p.000293: - RT law “On Pharmaceutical Products and Pharmaceutical Activity” (No 39; 6 of August 2001)
p.000293: - RT law “On Psychiatric Care” (No 90, 2 of December 2000)
p.000293: - RT law “On Reproductive Health and Reproductive Rights” (No 72; 2 of December 2002)
p.000293: - RT law “On Private Medical Practice” (No 60; 3 of December 2000)
p.000293: - RT law “On Salt Iodination” (No 85; 2 of December 2002)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Tropical
p.000293: Diseases (Malaria) in Republic of Tajikistan in 1997-2005” (No 342, 4 of December 1997)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Viral
p.000293: Hepatitis “B” in Tajikistan in 2000- 2007” (No 100; 11 of March 2000)
p.000293:
p.000294: 294
p.000294:
p.000295: 295
p.000295:
p.000295: - Decree of the RT Government “On the Approval of the Concept of Healthcare Reformation in Republic of Tajikistan”
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000077: of successful operation or especially if the wound suppurates I will have a scar for life on my neck about 7.5-10 cm
p.000077: long. And, despite all the facts mentioned above, I agree to the surgery, and whatever happens, I will never have any
p.000077: claims either against the doctors who will perform the surgery, or the patient who will receive my thyroid gland. I am
p.000077: signing this paper in the presence of doctors B.V.Dmitriev, E.K.Vinakurova, M.P.Alexeev and the nurse
p.000077: E.V.Shevchenko (signature); we witnessed the reading and signing of this paper and hereby certify that E.P. is an adult
p.000077: and mentally capacitated person (signatures of doctors and nurse)”.
p.000077: This document dated 1917, contains all elements of current ethical concept relating to biomedical
p.000077: research: confidentiality, respect for a person’s autonomy, information about all risks associated with the
p.000077: research, freedom of a voluntary choice, verification of the research subject’s social and mental maturity.
p.000077: All statements in Dmitriev’s article base on a legal concept of a famous lawyer A.F.Kony who testified to the
p.000077: absence of criminal deed in the case of the sale of organs for treatment purposes in accordance with the contract
p.000077: between the donor (seller) and recipient (buyer). At the same time he noted that “under these circumstances the
p.000077: only ethical issue that might arise concerned the permissibility of such a deal in a situation where the
p.000077: “seller” was a minor, imbecile, or a person in a state of artificial excitation, and where the “buyer” was a
p.000077: person who acted through psychological compulsion, deception, seduction, promise of profit or suggestion by authority.
p.000077: On the whole, the analysis of legal and ethical principles referring to biomedical research existing in the tsarist
p.000077: Russia in the beginning of the XX century shows that humanistic concepts of a voluntary and conscious choice made by
p.000077: the research subject and confidentiality have been combined with a responsible and merciful attitude on the part of a
p.000077: physician-investigator, and reinforced with accepted moral and ethical norms and legislative acts in force.
p.000077: Turning to a more recent period in national history, the following stages of Soviet law development illustrate how the
p.000077: issues in ethical and legal regulation of medical and biological research were interpreted in the USSR.
p.000077: In the law of the Russian Soviet Federal Socialistic Republic (RSFSR) on 1 of December 1924 “On the Professional
p.000077: Activity and Rights of Health Professionals” the need to obtain the patient’s consent, in particular when surgery is
p.000077: being planned, was declared. It was also stated that “with respect to those under 16 years of age or mentally disabled,
p.000077: the consent of their parents or care-givers”, i.e., their legal representatives, was necessary. Similar laws were
...
p.000187: shall be permitted unless there is a voluntary consent of the potential research subject, properly expressed and duly
p.000187: authenticated.
p.000187: The legal basis for the protection of human subjects in biomedical research are the Constitution provisions
p.000187: ensuring every individual’s right
p.000187:
p.000188: 188
p.000188:
p.000189: 189
p.000189:
p.000189: to life, physical and moral inviolability; the right to freedom and safety, the right to a free development of one’s
p.000189: personality; right to dignity and freedom of private life, confidentiality of personal and family information et al.
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
p.000189: elderly persons, disabled persons, persons who had suffered from an emergency situation and residents of ecologically
p.000189: unfavorable regions (Art. 67, 68, 69, 70, 71).
p.000189: The Law on Pharmaceutical Products (March 2003) regulates clinical trials of pharmaceutical products.
p.000189: According to this Law, no clinical trials of pharmaceutical products in Kyrgyz Republic may be carried out
p.000189: without the permission granted by the authorized healthcare state institution of Kyrgyz Republic. Those guilty of
p.000189: violating rules of clinical trials, falsifying clinical results obtained in clinical trials of pharmaceutical
p.000189: products or conducting the trials without the permission granted by an authorized healthcare state institutions of
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
...
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
p.000271: alterations of the drug introduction routes, its doses, and significant changes in number of the CT subjects. An ethics
p.000271: committee can approve amendments to the clinical study conduct only if presented changes do not lead to worsening of
p.000271: conditions for subjects.
p.000271: After the application review an ethics committee can make one of the following decisions: to approve study
p.000271: conduct; to approve a study with minor changes, and after they are introduced the EC decision on the study can be
p.000271: granted to an investigator with no need of repeated examination; to require amendments of study
p.000271: procedures and materials and to submit documents once again for examination; not to approve study conduct
p.000271: (indicating reasons for refusal, if necessary – with recommendations on elimination of identified defects).
p.000271: When reviewing amendments the EC decisions can vary as well: as an approval for amendments and continuance of the
p.000271: study, a request for additional information with or without the study suspension, non-approval of amendments. The EC
p.000271: decision has to contain
p.000271:
p.000272: 272
p.000272:
p.000273: 273
p.000273:
p.000273: how often the particular project shall undergo interim reviews. Usually in case of low risk for subjects ethical review
p.000273: during a study is performed once a year; if decreed population groups are involved into CT, in case of high risk due
p.000273: to peculiarities of a protocol, other decisions are possible (once every 1, 3, 6 months, with enrollment
p.000273: of each new subject). EC obtains information on all cases of adverse events and reviews them, produces
p.000273: current decisions on suspension/prohibition of study conduct on supervised sites if serious adverse events emerged.
p.000273: Interim review can be conducted via remote examination of the study data and by visiting clinical sites. The latter is
p.000273: utilized when a Principal investigator is a person that carries out such functions for the 1st time; if it is the 1st
p.000273: time for the given study site to participate in the study; if there are reports on serious adverse events in the given
...
p.000305: application, in the patient’s best interests, of new and scientifically justified medicinal products or methods not yet
p.000305: authorized for general use (Art. 44.2). The rule concerns also blood transfusion (46) and biomedical research
p.000305: involving human subjects provided that the research is scientifically justified and the potential benefit overweighs
p.000305: risks of harmful consequences for the research subjects’ health or life. Information on biomedical research
p.000305: should be open to public on condition that personal data are confidential. The rule of informed consent relates also
p.000305: to organ transplantation performed according to the order prescribed by the law if the use of other life-sustaining
p.000305: methods does not yield desired results, and the harm for a donor’s health is less than that threatening the recipient
p.000305: (Art. 47).
p.000305: The rule of voluntary informed consent is present in practically all special normative acts relating to medical
p.000305: interventions, use of pharmaceutical products and biomedical research.
p.000305: Article 43 of the “Basic Legislation on Public Health Service in Ukraine”, states that in case of minors
p.000305: under 15 or adults who according to
p.000305: law do not have capacity to consent any intervention may be possible only with the authorization of his or her legal
p.000305: representative. At the same time, an essential item about the opinion of the minor that, according to Convention on
p.000305: Human Rights and Biomedicine, should be taken into consideration as an increasingly determining factor in proportion to
p.000305: his or her age and degree of maturity (Convention, Art. 6) is not included into Ukrainian legislation. Neither is the
p.000305: item that adults who according to law do not have capacity to consent shall as far as possible take part in the
p.000305: decision-making procedure. However, there is a similar rule about informed consent to the application of new methods or
p.000305: pharmaceutical products concerning minors from 15 to 18 years of age and individuals with a limited capacity to consent
p.000305: (Art. 44.2 of Basic Legislation).
p.000305: The right to withdraw consent is not clearly stated either in the law or in the majority of other special
p.000305: laws but the Ukrainian law “On Pharmaceutical Products” (Art. 8). According to this law, a volunteer or the person’s
p.000305: legal representative can freely withdraw his or her consent to participate in clinical trials.
p.000305: There is no regulation relating to medical interventions for the benefit of the health of the person concerned
...
Searching for indicator youth:
(return to top)
p.000021: aggravation of the existing disbalance (as will be shown below) in the sex structure, reduction of
p.000021: nuptiality and population reproduction potential, and in a growing difference of the lifespan between the sexes. In
p.000021: spite of substantiated expectations, the high mortality rate in the period of transition at the early nineteenth did
p.000021: not affect seriously those population groups that usually are considered as particularly vulnerable due to biological
p.000021: or social causes, namely children and elder people. Perhaps the most remarkable feature of this recent population
p.000021: health crisis became a significant increase of the mortality rate for age groups of gainfully employed population. The
p.000021: most drastic relative growth of the mortality rate for adult males was registered in the group of “blooming age” i.e.
p.000021: at the age of 35-49, which is most typical for Russia. As to females, the mortality changes had unequal intensity, and
p.000021: the increase of mortality here was less marked, but it affected exactly the “blooming” age group from 35 to 49 years.
p.000021: As we know, the population reproduction depends mostly on two factors: firstly – on the ratio of marriages and
p.000021: divorces; secondly – on the ratio between males and females at the fertile age. As to the first factor, in
p.000021: the conditions of the increasing youth unemployment, rapidly growing prices housing costs and uncertain prospects, the
p.000021: nuptial ratio has decreased in all nine countries from 4% (Azerbaijan) to 34% (Russian Federation). The decrease of the
p.000021: nuptial ratio for persons in the second marriage in all countries was even sharper. An average decrease of this index
p.000021: was 28%; only in Ukraine the increase of the nuptial ratio was registered, but in 1993 the fertility in this country
p.000021: has decreased dramatically (by 20%), and hence the hopes associated with the nuptial ratio were not justified. In
p.000021: contrast to the number of marriages the number of the divorces was growing. The second factor is also unfavorable. The
p.000021: female population exceeds male population, and this ratio becomes worse with every new age group.
p.000021: Thus, the marriage/divorce ratio, as well as male/female ratio determines negative tendencies in demographic
p.000021: situation in the CIS countries. The mentioned ratios have a negative impact on the generation renewal,
p.000021: and retain conditions for a narrow reproduction.
p.000021: When considering the situation we should note that the most dramatic aggravation was observed in the areas of the
p.000021: income per person, poverty, demography and social unity, which is essential for understanding social- economic
p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
p.000021: into the international system of biomedical research both from a viewpoint of interested researchers and potential
p.000021: participants.
...
p.000125: and investigators – 24 h).
p.000125: • In the framework of Russia—Belarus scientific-and-practical conferences on the problem of
p.000125: developing professional knowledge in bioethics (Kirov, 2003; Minsk, 2004) problems of teaching bioethics to
p.000125: medical students were discussed [17].
p.000125: In 2003 a second revised and amended edition of the text-book “Biomedical Ethics” is published [8]. The
p.000125: text-book supplement contains international guidelines, methodical recommendations for teachers, tests and
p.000125: case-studies.
p.000125: • In January (Moscow) and March (Minsk) 2005 in the framework of regional consultations for professionals in the
p.000125: field of education in ethics and bioethics held under the aegis of UNESCO experts from Belarus presented their relevant
p.000125: teaching programmes.
p.000125: • Since February 2005 BSMU offers a 64-hour course “Problems of Biomedical Ethics in Modern Theory and Practice” for
p.000125: BSMU teaching staff.
p.000125: • In May 2005 the republican student conference “Bioethics: Theory, Practice and Perspectives” was held and a volume
p.000125: of student papers was published.
p.000125: • In autumn 2005 BSMU held the student conference “AIDS: Information Practice. Formation of Positive Moral
p.000125: Values in Youth”.
p.000125: • In September 2005 BSMU organized a round table with Dr. Henry Williams (Head of the Tennessee Hospital, USA) and
p.000125: Dr. Joy Raily (Director of the Centre for Bioethics and Cell Technologies).
p.000125: • In May 2006 the Republican Scientific-and-Practical Conference “Medicine and Christianity” was held
p.000125: with a Section where bioethical problems were discussed in the context of the Orthodox worldview.
p.000125: • In November 2006 young scientists from the Institute for Post- Graduate Education of Belarus in
p.000125: cooperation with NCBE organized the scientific-and-practical conference “Humanization in the Education of
p.000125: Specialists in Medicine and Biology”; proceedings of conference were published [21].
p.000125: • The republican scientific-and-practical student conference “Culture and Medicine: interaction Paradigm” was held
p.000125: in May 2007.
p.000125: Thus, today we have relevant methodical materials including manuals, and national manuals.
p.000125: Besides, there are following teaching programmes for the system of high (undergraduate) medical education
p.000125: [11]:
p.000125: a. “General Ethics” (with sections “Bioethics” and “Ecological Ethics”)
p.000125: – for students of all specialties (Mishatkina T.V., Belyaeva E.V.) – 36 h;
p.000125: b. “Basics of Biomedical Ethics” – for medical undergraduate students (Mishatkina T.V., Denisov S.D., Kevra V.K.,
p.000125: Lugais N.E.) – 36 h;
...
p.000205: Ministry of Health Care (No. 54-r par.12 of 09.07.2002 On Creation of National Ethics Commission).
p.000205: International pharmaceutical companies performing CT and interested in creation of GCP-compliant conditions were
p.000205: initiators of its creation as well. Operation of the said Committee, in fact, is a part of control and permission
p.000205: system of the Ministry of Health Care and Social Security. To obtain permit of the Ministry of Health Care for CT it is
p.000205: necessary to receive an approval of this Committee.
p.000205: An attribute of this Committee is availability of detailed standards for its work – “standard operation
p.000205: procedures”. Meeting requirements of international laws, these procedures at the same time take into
p.000205: account statements of Moldova laws and peculiarities of conduct of clinical researches in our country.
p.000205: So, the network of ethics committees targeted on ethical review of CT is currently developing smoothly.
p.000205: There is a necessary background for their development: necessity in their functioning from the side of
p.000205: researches willing to perform qualified clinical researches in accordance with international regulations and
p.000205: legal base. Experience of ethical review subject to future interpretation is being accumulated.
p.000205:
p.000205: 3.7.3. Education in Bioethics
p.000205:
p.000205: There is no doubts that training and education in bioethics for population and firstly for youth has become a
p.000205: necessity, a requirement of the time and not a fashion or somebody’s ambition. This imperative is caused
p.000205: by anthropoecological and anthropogenic crisis sweeping today the Earth as a result of natural and even
p.000205: unrestrained activities of a man and world community in general to provide human existence. In this connection
p.000205: it is necessary concentrate human powers firstly intellectual ones for safety
p.000205:
p.000206: 206
p.000206:
p.000207: 207
p.000207:
p.000207: development of modern civilization. This is the time to elaborate new approaches to human survival strategy,
p.000207: which would provide opportunities of more efficient handling of global anthropoecological crisis, exclude
p.000207: planetary omnicide that closely follows tracks of the modern world.
p.000207: Bioethics as it is well known is an efficient mechanism in securing safety development of the society. That
p.000207: means that well-established training and education of population in this practical philosophy would facilitate
p.000207: solutions for many issues related to survival of mankind. The Republic of Moldova performs a lot as to the issue:
p.000207: Firstly, for purposeful coordination of this work the Bioethics Association of the Republic of
p.000207: Moldova was created in the country in 2001 (31 of May), and the National Bioethics Centre was founded (10 of
p.000207: November 2004) uniting experts in this science and practical philosophy of all country higher educational
...
p.000207: Federation, Bulgaria, Romania, Canada, the USA, the Republic of Moldova, etc.) and other specialties (philosophers,
p.000207: medics, biologists, ecologists, engineers, economists, agronomists etc.) participate in such workshops
p.000207: contributing to bioethical development in close connection with biomedicine, philosophy, ecology, economy, technique,
p.000207: other fields of knowledge. This promoted development of researches in ethics of life not only in the Department of
p.000207: Philosophy and Bioethics of State University of Medicine and Pharmacy named after Testemitianu N.A. but in other higher
p.000207: educational institutions of the country.
p.000207: Since 2002 the Department offers post-gradual studies (daily and distant training), doctor of science (distant) and
p.000207: master (daily) training in bioethical sphere where graduates of philosophic, medical, theological, agricultural and
p.000207: other department study. After graduation and successful defense of works they are conferred the degree of doctor or
p.000207: doctor habilitate of philosophic science (majoring in bioethics) and master on bioethics, respectively.
p.000207: If we are to continue to develop our ideas related to organization of training process in bioethical knowledge in
p.000207: our country it is necessary
p.000207:
p.000208: 208
p.000208:
p.000209: 209
p.000209:
p.000209: to especially stress the work of the Department, Association and the National Bioethics Centre in
p.000209: popularization of this phenomenon among the population of the Republic and primarily among the youth.
p.000209: Introduction into Bioethics program is of special popularity among the radio and television auditoria. Over
p.000209: last 3 years the personnel of the Centre and the Department organized and held about 20 talks (radio and television) of
p.000209: 15 to 45 minutes each on basic themes of this type of practical philosophy. Such programs as Bioethics –
p.000209: The Science of Survival, Euthanasia from the Point of View of Bioethics, Cloning in the Contest of Bioethics,
p.000209: Bioethical Aspects of Artificial Human Reproduction, Experiments in Humans and Animals in Biomedical Sphere:
p.000209: Bioethical Aspects, Religion and Bioethics and other with participation of bioethics specialists, biologists,
p.000209: medics and religious theologists can be marked among them, as well as From Anthropocentrism to
p.000209: Biospherocentrism, Backgrounds of Bioethics, From Ethics to Biological Ethics, Abortion and Bioethics, Bioethical
p.000209: Education of Society – Requirement of the Human Survival Strategy, Transplantology and Bioethics, Human Genome and
p.000209: Bioethics, Biomedical and Spiritual World: Comparative Analysis, Principles and Imperatives of Bioethics,
p.000209: Paternalism and Antipaternalism in Human Activity, Informative Consent and Interpretation in Medical Practice and
p.000209: others.. Here we started to check the interest in some ideas from social bioethics, such as Senility and Bioethics,
...
p.000209: mechanisms embodiment for ensuring of secure development strategy for our region, further democratization of
p.000209: social life. From the other side, the experience of the Bioethics Association of the Republic of Moldova,
p.000209: the National Bioethics Centre on bioethics and the Department of Philosophy and Bioethics of the State University of
p.000209: Medicine and Pharmacy named after Testemitianu N.A. on set up of trainings and education of inhabitants in
p.000209: bioethical interconnections and interactions among humans, society and biosphere, i.e. in implementation of one of
p.000209: the significant principles of bioethics – the co-evolutional one.
p.000209:
p.000210: 210
p.000210:
p.000211: 211
p.000211:
p.000211: And finally, wide spread of the experience and practice of the state and public formations in training and educational
p.000211: process of bioethical knowledge will favor integration in social life of new ethical and legal approaches,
p.000211: principles and values, the help of which may not only reasonably use achievements of current scientific and
p.000211: technological progress but promote implementation of modern strategy of the world community meaning survival of
p.000211: the mankind through steady and safe development.
p.000211: These are summary results of our works during the last 10-12 years in organization of training, education and promotion
p.000211: of bioethical knowledge among people of our country, and, first of all, among the youth. The work we have performed
p.000211: undoubtedly will be a serious base for further extension and strengthening of the developed system especially in
p.000211: carrying on of bioethical education of young students, future specialists of all types.
p.000211:
p.000211: References
p.000211: 1. Bioethics: principles, rules, issues. Edited by Yudin B.G. М., 1998,
p.000211: 472 p. (in Russian)
p.000211: 2. Vekovshinina S.V., Kulinichenko V.L. Bioethics: onset and rationale (philosophy and methodological analysis).
p.000211: Kiev, 2002, 152 p. (in Russian)
p.000211: 3. Second National Congress on Bioethics. 29.09 – 2.10 2004. Kiev, 2004, 305 p. (in Russian)
p.000211: 4. Testemitsanu N.A., Popushoy Ye.P., Ioksa V.A. Famous Doctors of Moldavia. Chisinau, 1985, 231 p. (in Russian)
p.000211: 5. Tsirdya T.N., Berlinsky P.V. Philosophy (with course on bioethics). Chisinau, 2002, 553 p. (in Russian)
p.000211: 6. Development of Bioethics Ideas in the European Context. Mater. of the IV International symposium on
p.000211: bioethics. Kiev, 2006, 160 p. (in Ukrainian)
p.000211: 7. Dicţionar de Filosofie şi Bioetică. T.Ţîrdea, P.Berlinschi, A.Eşanu et al. Chişinău, 2004, 441 p. (in Rumanian)
p.000211: 8. D’Onofrio F., Giunta R. La Bioetica nel futuro dell’uomo. Napoli, 1999, 224 p.
p.000211: 9. Istoria medicinei româneşti. Red. V.Bologa et al. Bucuresti, 1972,
p.000211: 565 p.
p.000211: 10. Istoria şi Filosofia culturii. Coord. Gr. Socolov. Chişinău, 1998,
p.000211: 398 p. (in Rumanian)
p.000211: 11. Nistor Ion. Istoria Basarabiei. Chişinău, 1991. 295 p.
p.000211: (in Rumanian)
...
Social / education
Searching for indicator education:
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p.000001: Editor: Nikolay Chaika, PhD
p.000001: Translation: Olga Ochkur & Dr.Valery Zvonarev
p.000001:
p.000001: Design: Maria Krasnova
p.000001: Page Print: Oksana Achmitzanova
p.000001: ContEntS
p.000001: INTRODUCTION (O.I.Kubar, H. ten Have) 7
p.000001: Chapter 1 - General tendencies of the social policy and human rights in medicine in the CIS countries.
p.000009: 9
p.000009: 1.1. Social and Demographic Factors (E.Yu.Vladimirova). 9
p.000009: 1.2. Ethical and Legal Issues in the Field of Biology and Medicine (O.I.Kubar, B.G.Yudin, A.E.Nikitina,
p.000009: E.Yu.Vladimirova). 27
p.000009: Chapter 2 - Current Status and Perspective of the CIS’ Region Participation in the International
p.000009: Biomedical Research 46
p.000009: 2.1. Philosophical Aspects of the Biomedical Research (P.D.Tishchenko, B.G.Yudin).
p.000046: 46
p.000046: 2.2. Characteristic of the Biomedical Research in the Region (O.I.Kubar, E.A.Malysheva).
p.000063: 63
p.000063: 2.3. Establishment of the Ethical Review System & Ethics Committees in the Region (O.I.Kubar, A.G.Asatryan).
p.000071: 71
p.000071: Chapter 3 - Ethical Review System for Biomedical Research in the CIS Countries
p.000089: 89
p.000089: 3.1. Republic of Armenia (G.D.Aslanyan, S.A.Davtyan). 89
p.000089: 3.1.1. Historical and Cultural Background 89
p.000089: 3.1.2. Legal Regulations. 93
p.000089: 3.1.3. Education in Bioethics. 95
p.000089: 3.1.4. The System of Ethical Review 100
p.000089: 3.1.5. Perspectives and Forms of International Cooperation. 103
p.000089: 3.2. Republic of Azerbaijan (A.A.Namazova, Z.G.Guseinova,
p.000089:
p.000089: ISBN 978-5-98240-033-8
p.000089: © All rights are reserved by UNESCO
p.000089: © Design. Phoenix, Ltd.
p.000089: T.G.Tagi-Zade). 104
p.000089: 3.2.1. Historical and Cultural Background 104
p.000002: 2
p.000002:
p.000003: 3
p.000003:
p.000003: 3.2.2. Legal Regulations. 107
p.000003: 3.2.3. Education in Bioethics. 108
p.000003: 3.2.4. The System of Ethical Review 110
p.000003: 3.2.5. Perspectives and Forms of International Cooperation. 112
p.000003: 3.3. Republic of Belarus (T.V.Mishatkina, Ya.S.Yaskevich). 114
p.000003: 3.3.1. Historical and Cultural Background 114
p.000003: 3.3.2. Legal Regulations. 119
p.000003: 3.3.3. Education in Bioethics. 125
p.000003: 3.3.4. The System of Ethical Review 132
p.000003: 3.3.5. Perspectives and Forms of International Cooperation. 140
p.000003: 3.4. Georgia (G.Kiknadze, G.Dgaviashvily, T.Kurtanidze) 149
p.000003: 3.4.1. Historical and Cultural Background 149
p.000003: 3.4.2. Legal Regulations. 151
p.000003: 3.4.3. Education in Bioethics. 154
p.000003: 3.4.4. The System of Ethical Review 156
p.000003: 3.4.5. Perspectives and Forms of International Cooperation. 162
p.000003: 3.5. Republic of Kazakhstan (A.B.Sadykova, B.E.Sarymsakova). 163
p.000003: 3.5.1. Historical and Cultural Background. 163
p.000003: 3.5.2. Legal Regulations. 166
p.000003: 3.5.3. Education in Bioethics. 174
p.000003: 3.5.4. The System of Ethical Review 176
p.000003: 3.5.5. Perspectives and Forms of International Cooperation. 177
p.000003: 3.6. Kyrgyz Republic (A.Z.Zurdinov, U.M.Tilekeeva, B.A.Alisherov).
p.000180: 180
p.000180: 3.6.1. Historical and Cultural Background 180
p.000180: 3.6.2. Legal Regulations. 189
p.000180: 3.6.3. Education in Bioethics. 193
p.000180: 3.6.4. The System of Ethical Review 194
p.000180: 3.6.5. Perspectives and Forms of International Cooperation. 195
p.000180: 3.7. Republic of Moldova (V. I.Gikavyi, I.N.Pogonea,
p.000180: T.N.Tirdea, V.I.Ojovanu). 196
p.000180: 3.7.1. Historical and Cultural Background 196
p.000180: 3.7.2. Legal Regulations. 203
p.000180: 3.7.3. Education in Bioethics. 207
p.000180: 3.7.4. The System of Ethical Review 213
p.000180: 3.7.5. Perspectives and Forms of International Cooperation 219
p.000180: 3.8. Russian Federation (G.L.Mikirtichian, A.F.Nikitina, A.S.Sozinov, M.E.Guryleva, E.A.Malysheva)
p.000223: 223
p.000223: 3.8.1. Historical and Cultural Background 223
p.000223: 3.8.2. Legal Regulations. 246
p.000223: 3.8.3. Education in Bioethics. 258
p.000223: 3.8.4. The System of Ethical Review 268
p.000223: 3.8.5. Perspectives and Forms of International Cooperation. 278
p.000223: 3.9. Republic of Tajikistan (S.D.Achrorova) 283
p.000223: 3.9.1. Historical and Cultural Background 283
p.000223: 3.9.2. Legal Regulations. 291
p.000223: 3.9.3. Education in Bioethics. 297
p.000223: 3.9.4. The System of Ethical Review 299
p.000223: 3.9.5. Perspectives and Forms of International Cooperation. 301
p.000223: 3.10. Ukraine (Yu.I.Kundiev, N.A.Chaschin,
p.000223: A.N.Chaschin, S.V.Pustovit, P.N.Vitte) 302
p.000223: 3.10.1. Historical and Cultural Background 302
p.000223: 3.10.2. Legal Regulations. 305
p.000223: 3.10.3. Education in Bioethics. 309
p.000223: 3.10.4. The System of Ethical Review 313
p.000223: 3.10.5. Perspectives and Forms of International Cooperation. 318
p.000223: 3.11. Republic of Uzbekistan (M.S.Abdullakhodjaeva). 323
p.000223: 3.11.1. Historical and Cultural Background 323
p.000004: 4
p.000004:
p.000005: 5
p.000005:
p.000005: 3.11.2. Legal Regulations. 329
p.000005: 3.11.3. Education in Bioethics. 340
p.000005: 3.11.4. The System of Ethical Review 344
p.000005: 3.11.5. Perspectives and Forms of International Cooperation. 349
p.000005: Chapter 4 - The Perspectives for Global International Harmonization the Ethical Review of Biomedical Research in CIS
p.000005: Countries (O.I.Kubar, G.L.Mikirtichian)
p.000353: 353
p.000353: IntRoDUCtIon (olga Kubar, Henk ten Have)
p.000353:
p.000353: The current scientific and technological evolution in the field of biomedicine is characterized by the
p.000353: growing importance of the role of universal ethical values relating to the protection of human rights
p.000353: and dignity. This tendency becomes particularly essential in the course of deep social and cultural changes that have
p.000353: been happening during the last decades in the post-Soviet space. The development and implementation of the new
p.000353: countries’ national policies in the field of ethics and bioethics by bringing up initiatives and consolidating
p.000353: activities in lawmaking, education, creation of the system for the ethical review and international cooperation is
p.000353: presently one of the topical issues. Thus the process of forming the Commonwealth of Independent States (CIS), as a new
p.000353: concept of multilateral cooperation that has united eleven member countries (Republic of Armenia, Republic of
p.000353: Azerbaijan, Republic of Belarus, Georgia, Republic of Kazakhstan, Kyrgyz Republic, Republic of Moldova, Russian
p.000353: Federation, Republic of Tajikistan, Ukraine and Republic of Uzbekistan), gave rise to a unique experience of a dynamic
p.000353: legislative, administrative and informational development in the sphere of ethical regulation in biomedicine.
p.000353: The actual necessity to analyze and systematize factors and conditions influencing the development of ethical
p.000353: review in CIS countries with the view of understanding perspectives and potentials of their interaction in the
p.000353: global aspect of research ethics stimulated the Forum for Ethics Committees in the CIS (FECCIS) to initiate the project
p.000353: of writing this book. The project was presented within the framework of regional expert consultations on the
p.000353: development of cooperation in the field of ethics and bioethics in CIS and Baltic States organized by the UNESCO Moscow
p.000353: Office. The Division of Science and Technology Ethics within the Social and Human Sciences Sector at UNESCO
p.000353: Headquarters supported the project.
p.000353: The structure of the book is intended to present a socio-demographic characteristic of the CIS countries and their
p.000353: current situation, as well as the perspectives of their involvement in the international system of biomedical research
p.000353: as the basis of setting out ethical and legal tendencies in biomedicine. Chapters presenting the analysis of the
p.000353: development of ethical review system
p.000353:
p.000353:
p.000006: 6
p.000006:
p.000007: 7
p.000007:
p.000007: in CIS member countries describe all the variety of historical and cultural tendencies and specific national
p.000007: experiences in this sphere.
p.000007: Authors have used the results of the interaction between the CIS countries in the framework of FECCIS and the
p.000007: Permanent Commission on Social Policy and Human Rights of the Inter-Parliamentary Assembly of the Commonwealth of
p.000007: Independent States (IPA CIS). Elements of UNESCO and WHO programmes that outline general frames and set out
p.000007: fundamental principles and conditions for international cooperation in working out and implementation of national
p.000007: policies in bioethics formed the conceptual basis of the book.
p.000007: We do hope that the materials presented in this book make a comprehensive and realistic picture
p.000007: of the current conditions and perspectives of ethical review development in the CIS countries and will facilitate free
p.000007: exchange of knowledge in this field for the mutual benefit. By providing information on the CIS region potential for
p.000007: cooperation and education in the sphere of bioethics and biomedical research ethics, the project makes an important
p.000007: intellectual and informational contribution into UNESCO Global Ethics Observatory.
p.000007: Chapter 1. GEnERAL tEnDEnCIES
p.000007: oF tHE SoCIAL PoLICY AnD HUMAn RIGtHS In MEDICInE In tHE CIS CoUntRIES
p.000007:
p.000007: 1.1 Social and Demographic Factors (E.Yu.Vladimirova)
p.000007:
p.000007: To develop a system for the ethical review of biomedical research, we have to consider the current social and economic
p.000007: situation in the Commonwealth of Independent Countries. A state can ensure reproduction of population and a high level
p.000007: of a living standard for its residents if it does not participate in regulation of the current demographic situation
p.000007: and labour market.
p.000007: The demographic situation in the CIS countries has both common and specific features. Common features
p.000007: result from a long-term socio- economic crisis of the 1990s, discrepancy between introduced reforms and
p.000007: social policy, a dramatic decline in living standards at various social levels, and aggravation of ecological
p.000007: conditions. Specific features in each State are determined by different styles of life in the CIS countries due to
p.000007: their historical, religious, cultural and ethnic development. All these factors resulted in a general fertility rate
p.000007: decrease, mortality growth and a fall of the health quality index. These processes affect negatively the demographic,
p.000007: labour and migration potential of the CIS countries.
...
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
p.000009: stability and to the whole process of reformation; however, there is a certain stabilization of the situation.
p.000009: Let us consider changes in resident population of the CIS countries and Turkmenistan in the period from 1991 to 2006.
p.000009: (Table 1).
p.000009: The presented data show the increase of population in Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan,
p.000009: Turkmenistan and Uzbekistan considering the change in the tendencies of population reproduction.
p.000009: The population in the CIS member-countries is about 5% of world population. The population density in
p.000009: the CIS countries varies from 6- 9 persons per sq. km in Kazakhstan, Russia and Turkmenistan to 126-129 persons in
p.000009: Armenia and Moldova. Thus, the average population density in the CIS countries is 13 persons per sq. km. For
p.000009: comparison: the population in the European Union (EU) makes 7% of world population, while the average density of
p.000009: population in the EU is 114 persons per sq. km. Over 66% of Belarus, Armenia, Ukraine, and 73% of Russia population are
p.000009: city residents. In the territory of the CIS there are 24 cities with the population over 1 million.
p.000009: Since 1990, the fertility rate in all the CIS countries has been decreasing. Moreover, in Ukraine (since 1991), in
p.000009: Russia (since 1992) and in Belarus (since 1993) a natural decrease of population was registered. Thus in Russia the
p.000009: number of deaths in 1993 exceeded the number of births by 800,000. That was the lowest fertility rate (9.4 of
...
p.000025: accordance with these principles reflecting statements of both the Universal Declaration
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000027: 27
p.000027:
p.000027: of Human Rights adopted by UN in 1948 and other international documents in this field, the legal framework of the CIS
p.000027: countries started to be formed. Certainly, today far from all provisions and principles are actually
p.000027: implemented into the practice of health care and biomedical research; the same should be noted about more specific
p.000027: enactments being directly related to the given sphere. They are more of being a kind of beacons that one
p.000027: should focus on either developing legal and ethical norms and on their daily
p.000027: implementation than as an actual measurement of achievements.
p.000027: Thus, determining approaches to analysis of trends and tendencies in building up a system for legal and ethical
p.000027: regulation in the sphere of practical health care and biomedical researches in the CIS countries the following most
p.000027: important factors shall be distinguished:
p.000027: 1. Historical community based on socio-cultural and economic inheritance being present among the
p.000027: Commonwealth countries;
p.000027: 2. Global international interaction;
p.000027: 3. Realia of regional cooperation among the member states.
p.000027: Among elements defining starting positions of new concept development for ethical and legal regulation in the
p.000027: CIS countries as carriers of the historical community, first of all, it is necessary to note a common health care
p.000027: model and a common standard for an education system. Closeness of these fundamental systems in many aspects is
p.000027: determined with various conceptual and legal factors, which action is exhibited even under current circumstances and
p.000027: that bear both positive and negative issues.
p.000027: If one takes into account that in any society actually implemented (but not only declared) medical ethics is a set of
p.000027: interrelated factors such as status of medical and biological knowledge and its development rate, structure of
p.000027: relationships between physicians and patients, physicians and patient relatives, relationship pattern within a
p.000027: professional medical community, attitude of medical workers to medical confidentiality and professional duties and
p.000027: so on, it is necessary to emphasize both affinity of the CIS countries basing on these parameters and their uniqueness
p.000027: comparing to other world regions.
p.000027: Historically the leading ethical theory in the regions was ethics of virtue within which framework the
p.000027: leading role is given to moral qualities of a person – in medical context of personality of a physician who
p.000027: developing relations with patients and patient relatives should possess not only professional skills and
p.000027: knowledge but also such moral qualities
p.000027: as sympathy, amicability, responsibility, ability to listen to, to understand arguments, apprehensions and doubts of
p.000027: their patients. In its entirety these qualities were commonly considered as medical (or physician) ethics which
p.000027: development was the mostly intense in pre-revolution Russia at the edge of the XIX-XX centuries.
...
p.000031: being held in context of national, social and cultural, historical and political traditions and utilization of the
p.000031: world experience in the field of bioethics.
p.000031: In 2001 animportant bioethical resource, the Forumfor Ethics Committees in the CIS (FECCIS), was established in the
p.000031: region. The FECCIS is one of five regional forums created within the framework of the WHO project, the Strategic
p.000031: Initiative for Developing Capacity in Ethical Review (SIDCER). Sharing main priorities of the WHO SIDCER project on
p.000031: protection of the rights and dignity of research subjects in all countries in the world basing on respect to cultural,
p.000031: religious and national differences the FECCIS seeks the main task of facilitating development of bioethics in the
p.000031: region of the CIS countries, paying specific attention to ethics of biomedical research involving human
p.000031: subjects. During all its years of existence (2001–2007) the Forum activities were directed on development of regulatory
p.000031: and methodical basis on research ethics; development and implementation of education programs for members of
p.000031: ethical committees; development of information space and extensive dialogue with various parties involved in ethical
p.000031: review of biomedical research that, certainly, facilitated harmonization of both regional and global
p.000031: international approaches to establishment of ethical standards in biology and medicine. Besides, notable value for
p.000031: adaptation and improvement of universal ethical principles has the representation of some of the CIS countries in
p.000031: several international entities, for instance, such highly respected agency as the Council of Europe, in particular, in
p.000031: the structure of the Steering Committee on Bioethics (CDBI) responsible for development of multiple documents, mainly,
p.000031: the legal ones, on protection of rights and dignity of human subjects in research and medical care.
p.000031: Consolidation of efforts and mutually enriching knowledge exchange take place also at the stage of regional or
p.000031: bilateral cooperation with international facilities and leading world specialists in the field of ethics through
p.000031: trainings, joint researches and discussions.
p.000031: Another priority component with considerable contribution in forming
p.000031: of ethical and legal unity in medical care is trends and mechanisms based on
p.000031: realia of regional cooperation of the CIS member states.
p.000031: Due to international and regional legal collaboration the constitutional regulation of a legal status of a
p.000031: person in the Commonwealth countries is adjusted to international standards creating legal opportunities
p.000031: for implementing such important ethical principles of biomedical research as
p.000031:
p.000032: 32
p.000032:
p.000033: 33
...
p.000037: However, it is worth stressing that in order to protect social rights of citizens only legal mechanisms and procedures
p.000037: for prevention of breaching of these rights are far from being sufficient. Along with aforementioned versatile
p.000037: state activities aimed on development of conditions for execution of these rights and freedoms as well as readiness of
p.000037: society for their conscious perception and compliance are required.
p.000037: This process takes prolonged gradual movement on development of a complex mechanism for protection of
p.000037: human rights and constitutes of legal, administrative, economic and humanitarian means. Such objective is
p.000037: implemented in the most consistent fashion by the Inter-Parliamentary Assembly of the Commonwealth of Independent
p.000037: States, which as one of the main objectives takes development of mechanisms for interstate regulation of respect for
p.000037: human rights in the region. IPA CIS as an agency for inter- parliamentary cooperation accumulates information on
p.000037: political, economic, social and cultural, ecological, demographic and other constituents of life of the Commonwealth
p.000037: countries that provides effectiveness, timeliness and demand for produced recommendations on harmonization and
p.000037: convergence of legislation of the CIS countries. Activity of IPA CIS in this respect is versatile and includes a range
p.000037: of spheres and areas determined with specifics and competence of permanent commissions such as commission on social
p.000037: policy and human rights, on legal issues, on science and education, on foreign policy issues, on defense
p.000037: and security, etc. In 1998 the Council of IPA CIS as the higher leading authority of the Assembly approved the
p.000037: declaration that emphasized solidarity of national parliaments with ideology
p.000037:
p.000038: 38
p.000038:
p.000039: 39
p.000039:
p.000039: of the Universal Declaration of Human Rights and stressed that since the moment of its proclamation the field of human
p.000039: rights exhibited considerable progress in general and that efforts in the field of human rights undertaken within CIS
p.000039: are also directed on provision of common respect for them, facilitation of strengthening of atmosphere of
p.000039: friendship and trust, effective implementation of multi-party agreements where a special place is given to the CIS
p.000039: Convention on Human Rights and Fundamental Freedoms adopted in Minsk in 1995.
p.000039: Criminal, penal procedure and penal enforcement model codes adopted by IPA CIS being a basis for development of similar
p.000039: codes in some of the Commonwealth countries should be considered as norms of general type establishing crucial
p.000039: requirements to an order of legal act execution in regard to main freedoms and rights of citizens in the Commonwealth
p.000039: countries. Statements of the given model codes were also reflected in initiation and creation of many legislator
p.000039: enactments in the CIS countries in the field of criminal law and criminal procedures. The model civil code adopted by
...
p.000043: to bring forth comprehensive dialogue with various social layers having final goal of reaching social and individual
p.000043: ethical legal sense in the space of the CIS member states and their full-grown inclusion in the global
p.000043: international regulatory framework on adherence and preservation of human rights and freedoms. It is gratifying to
p.000043: claim that value of the given model law for the international community was time and again demonstrated at its
p.000043: development by representatives of such international organizations as WHO, the Council of Europe, the European
p.000043: Commission, the European Forum for Good Clinical Practice, UNESCO, the World Medical Association, etc. Need for the
p.000043: model law implementation into national legislation of the CIS countries and readiness of corresponding structures for
p.000043: provision of enforcement of these statements was exhibited with universal response of leading specialists in the field
p.000043: of medicine, biology, ethics, legislation and sociology desiring to participate in promotion of the given regulatory
p.000043: document in their countries and to facilitate to parliaments and governments of their countries in reaching the said
p.000043: goal.
p.000043: In regard to continuation of regulatory initiatives of the FECCIS with IPA CIS there is work on-going on forming
p.000043: regulatory and ethical standards for counteraction against HIV/AIDS at the CIS space as well as development of the
p.000043: model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS within the
p.000043: framework of cooperation with the Permanent Commission of IPA CIS on Science and Education.
p.000043: Summarizing statements in common trends in ethical and legal regulation of public relationships on the
p.000043: field of medicine and biology in the CIS countries one should note that the policy of the Commonwealth countries
p.000043: including rational features of previous rich and versatile historical and cultural experience is open to
p.000043: interaction with world bioethical community and ready for rational collaboration in the region directed to development
p.000043: of optimal conditions for reaching ethical comfort in medicine and in research
p.000043: via building up of the society’s ethical self-consciousness, legal sense and attaining of a new type of relationships
p.000043: among individuals, social groups and states based on social partnership and dialogue in regard to the most crucial
p.000043: issues of ethical content.
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: References to international documents mentioned in the text are provided in the chapter for the member states.
p.000043: Texts of the model laws of IPA CIS are available at the web site: www.iacis.ru/html, the text of the model
p.000043: law of IPA CIS On Protection of Human Rights and Dignity in Biomedical Researches in the CIS and the text of
p.000043: the model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS can be also
p.000043: found at the following web sites: www. feccis.net and www.pasteur-nii.spb.ru
p.000043:
p.000044: 44
p.000044:
p.000045: 45
p.000045:
...
p.000045:
p.000045: 2.1 Philosophical Aspects of the Biomedical Research (P.D.tishchenko, B.G.Yudin)
p.000045:
p.000045:
p.000045: Philosophy of modern biomedical research (BMR) is a limitless topic with multiplicity of versatile aspects. Here we
p.000045: would like to dwell on those of them that are to some extent are related to issues of ethical examination
p.000045:
p.000045: Specific Position of Science in the Modern Culture
p.000045: Understanding of trends of development of the modern biomedical research is impossible without taking
p.000045: into account on-going general civilization transformations of our days. First of all, let’s take a look at the
p.000045: most general context of the issue.
p.000045: In this respect it is necessary to remind about a central role that science have played and still plays in the modern
p.000045: culture. As to exact expression by E. Husserl: “When at the beginning of the New Age religious belief began
p.000045: to degenerate more and more into lifeless convention, intellectual humanity stood in a new great faith –
p.000045: faith into autonomous philosophy and science. Scientific judgments were to highlight and guide entire human culture
p.000045: providing it with new autonomous form.” (Husserl E. Cartesian Meditations, p.14). If to take into account that
p.000045: ideology of new European education to a large extent is a gradual process of mastering the system of scientific
p.000045: knowledge, then without exaggeration one can say that the modern man (unlike a person in the Christian culture) is
p.000045: created “in the image and likeness of a scientist”.
p.000045: The leading position of science is retained and considerably strengthened gaining qualitatively new forms. Along
p.000045: with that, in the modern cultural situation science becomes more tolerant to other forms of cognition
p.000045: and comprehending of the reality. Ideas, concepts and practices that several decades ago were considered
p.000045: as superstitions are rehabilitated and gain status of fully-developed modern doctrines. In the whole world
p.000045: one can
p.000045: observe revival of archaic (shamanism, cabala and other esoteric practices) and creation of new non-scientific
p.000045: (and often anti-scientific) ideologies. Appear new bridges for cooperation between science and traditional religions
p.000045: appear.
p.000045: Another process is ongoing along with this paradoxical one. Science is still a mainstream for resolution of human
p.000045: problems, protection of a man against unfavorable natural impacts (for instance, diseases). But the mightier is
p.000045: scientific control over the nature, the clearer hazards are – that is, risks, related to development of science and
p.000045: scientifically-targeted technologies. Along with realization of these risks there are two directions being formed that
p.000045: influence in ideological sense establishment of procedures of ethical examination for biomedical studies. We are
...
p.000047: and accenting utilitarian and pragmatic sides of scientific activity; it was expressed with neutral attitude to the
p.000047: social role of science. Now science critics interpreted it as a power closely linked to establishment, positioned too
p.000047: far from vital interests of common people and, moreover, even hostile to them, facilitating not democratic but
p.000047: totalitarian trends, dehumanizing the world, begetting and strengthening human alienation and enslavement.
p.000047: In this case we are not interested in one or another point of view for these counter-cultural and counter-scientific
p.000047: movements. But among many consequences they caused it is worth to note rather basic and distressful
p.000047: reappraisal of many values. It is characteristic that the criticism of science by these new lefts was quite effective
p.000047: although as it often happens in the history its further development took not the pace they dreamt of.
p.000047: As a result initially in the USA and then in the countries of Western Europe the range of expectations from the society
p.000047: considerably transformed along with scientific and technical policies of a state. Now scientific researches
p.000047: are required more and more that their results are to satisfy social needs and personal requirements.
p.000047:
p.000047: Science in the “Society of Knowledge”
p.000047: One of the developers of the term “society of knowledge” is the American sociologist, Piter Drucker, who in 1994
p.000047: set a question on developing in modern culture deep social transformations he determined as establishing of new
p.000047: institutions of the “society of knowledge”. The society of knowledge has altered nature of labor, higher education and
p.000047: ways of functioning for the entire society as a complicated interrelated system (P. Drucker. The Age of Social
p.000047: Transformation. The Atlantic Monthly, 274 – November 1994, 53-80). In our analysis we are going to use
p.000047: the Drucker’s ideas to some extent adding them with useful, from our point of view, results from other researchers.
p.000047: P.Drucker proceeded from that transformation of scientific knowledge into a main source of new technologies started as
p.000047: per historical measurements quite recently. He stated that yet in the XVIII century “no one even tried to talk over
p.000047: application of science for development of instruments of production, technologies and goods, i.e. about use of
p.000047: scientific knowledge in the field of techniques and technology. This idea matured only … in 1830 when the German
p.000047: chemist, Justus von Libikh (1803-1873), first invented
p.000047: artificial manure and then a method for storing animal proteins (P. Drucker. From Capitalism to Society of Knowledge.
p.000047: In: New Post-Industrial Wave in the West, edited by Inozemtsev V.L., M., 1999). According to Drucker that time the
p.000047: industrial revolution as a process of global transformation of the society and civilization on the basis of technical
p.000047: development began. At that, scientific knowledge took new, previously not characteristic role – as a factor actively
p.000047: influencing life of a man and society and dynamicizing it.
p.000047: In the context of technological application of science a research is not only an investigation of the
p.000047: world as it is, the natural world, but as transformation of this world, that is, as development of an
...
p.000063: Structure of the conducted biomedical research included also studies involving volunteers in specifically established
p.000063: sites. There was an instruction on the order for conduct of studies involving volunteers approved by the Ministry of
p.000063: Health of the USSR with a list of facilities where such studies could be conducted. And in the 60’s of the last century
p.000063: there were established hospitals for testing vaccine strain candidates and for space-related studies. The order of
p.000063: participation of volunteers in these studies assumed their informed written consent and reimbursement for their
p.000063: participation.
p.000063: From the point of view of international status the USSR participated in all significant international conventions in
p.000063: this field, was a partner with WHO and some other international organizations, conventions of narcotics (1961),
p.000063: psychotropic agents (1971) were signed. In regard to patent protection the
p.000063:
p.000064: 64
p.000064:
p.000065: 65
p.000065:
p.000065: country was a member of the Paris Convention (1965), protection of patent rights covered invention, utility models and
p.000065: industrial designs and it lasted for 20 years for the whole world. At the beginning of the 90’s first (approved by
p.000065: authorized agencies) contract research organizations appeared.
p.000065: The entire set of these elements in combination with peculiarities of the system of health care and medical education
p.000065: determined unique features inherited from the former USSR providing motivation for pharmaceutical companies to conduct
p.000065: biomedical research in the CIS countries. All analytical reviews from all representatives of world pharmaceutical
p.000065: industry interested in conduct of studies made in the beginning of the 90’s of the XX century noted their interest for
p.000065: conduct of biomedical research in this region, first of all, due to the following reasons:
p.000065: - existence of centralized specialized Centres capable of inclusion large number of patients into a study within short
p.000065: term;
p.000065: - epidemiology of infectious and non-infectious diseases in conditions of absence of treatment standards approved
p.000065: for foreign practices (“naïve patients”);
p.000065: - high scientific and medical potential of researchers and research Centres;
p.000065: - knowledge of foreign languages by leading specialists, high quality of documenting;
p.000065: - interest of all stakeholders involved into a research process (state authorities, researchers and research
p.000065: Centres, high degree of trust of patients to medical personnel);
p.000065: - perspectives of future pharmaceutical market and low competitive strength of local pharmaceutical industry.
p.000065: Naturally, these capacities were not evenly distributed in all CIS countries but general trends were explicitly present
p.000065: and determined attractiveness of this region.
p.000065: However, it is necessary to introduce significant correction in the course of events presented above that
p.000065: coincided in time with deep social and economic depression of the initial stage of independence of the CIS countries
...
p.000081: • to separate power (responsibilities and rights) in the performance of EC on different levels (national, regional,
p.000081: local);
p.000081: • to create the system of EC interaction inside the country and on the international level;
p.000081: • to develop the demand for ethical review in all research subjects;
p.000081: • to eliminate informational vacuum with regard to issues of the protection of human rights and dignity in
p.000081: biomedical research;
p.000081: • to create an educational and informational programme on bioethics for medical professionals and other persons
p.000081: associated with the research;
p.000081:
p.000082: 82
p.000082:
p.000083: 83
p.000083:
p.000083: • to develop a special system for training EC members;
p.000083: • to introduce the practice of the state inspection and independent audit of EC performance;
p.000083: • to develop legal regulations for the EC economic activity.
p.000083: The analysis of the current state from the viewpoint of the principle of obtaining research subjects’ informed
p.000083: consent shows that a principal achievement of the CIS countries is a legal regulation of this procedure.
p.000083: Among issues requiring a further development we should mention first the need to work out guidelines and norms for
p.000083: interpreting separate statements in legislative acts, terms of their application and their harmonization with norms of
p.000083: international law in the field of bioethics. There is a particularly urgent need to create bioethics information
p.000083: field with potentials for a differential education of various population groups aiming at raising the
p.000083: level of public knowledge about human rights and moral responsibility in biomedical research.
p.000083: In the history of establishing a system of ethical review and ethics committees in the region the
p.000083: performance of the mentioned Forum for Ethics Committees in the Commonwealth of Independent States takes a
p.000083: special place as a public movement aiming at fulfilling this task in the region via creating a possibility for the
p.000083: access to the world experience in the development of ethical concept of biomedical research considering national
p.000083: cultural and moral values.
p.000083: The FECCIS was established on 21 of March 2001 according to the Resolution of the Conference for representatives of
p.000083: ethics committees and others authorized bodies from the CIS countries held in Saint-Petersburg, Russia. The FECCIS is
p.000083: one of the five regional forums, established in the framework of the WHO/SIDCER project.
p.000083: Sharing the basic priorities of the SIDCER project referring to the protection of human rights and dignity in
p.000083: biomedical research all over the world with respect to cultural, historical, religious and social differences, the
p.000083: FECCIS has defined as its the main objective to support the development of bioethics in the region with an emphasis on
p.000083: ethics of biomedical research involving human subjects.
p.000083: Over the period 2001-2006, the FECCIS activity has been directed to developing legislative and normative
p.000083: system in the field of research ethics, working out and implementing educational programmes for the EC
p.000083: members, developing informational space and a dialogue with all interested parties participating in the review of
p.000083: biomedical research.
p.000083: With regard to the legislative initiative, FECCIS, as mentioned above, has been concentrating its efforts on
p.000083: working out a legislative basis for protecting human rights in biomedical research through collaboration with the
p.000083: Permanent Commission on Social Policy and Human Rights of the Inter– Parliamentary Assembly of the Confederation of
p.000083: the Independent States. This collaboration resulted in the development of the IPA CIS model Law ‘On the Protection
p.000083: of Human Rights and Dignity in Biomedical Research in the CIS’ adopted in 2005 (see Chapters 1.2 and 2.2). In
p.000083: collaboration with the Permanent Commission on Science and Education of the IPA CIS the FECCIS worked out Model
p.000083: recommendations “ On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS “.
p.000083: An important direction of the FECCIS activity is the development of mechanisms, fundamentals and conditions for an
p.000083: internal monitoring and independent surveying, and evaluating the EC performance, to ensure a due quality of ethical
p.000083: review.
p.000083: This direction of the FECCIS activity includes working out the Collection of model Standard Operational
p.000083: Procedures. Independent and competent representatives of the CIS countries and experts from all over the world took
p.000083: part in this work. Consultations, discussions and analysis of the main statements on the establishment,
p.000083: structure and operation of EC and advanced methods of ethical review in international practice laid the foundation for
p.000083: a dynamic development of standards and criteria for EC activity that are described in this book.
p.000083: The integrity of the model SOPs is achieved through the use of universal terminology, commonly accepted norms of
p.000083: bioethics reflected in documents that have been used and a consistent description of the EC operation at
p.000083: different stages and in different situations of ethical review of biomedical research.
p.000083: The Collection of model SOPs prepared at the FECCIS Secretariat is to become an available practical
p.000083: manual on working out SOPs as a universal instrument for achieving professionalism, openness, pluralism and
p.000083: independence of the EC practices and for ensuring a common methodological space for the CIS countries and the world
p.000083: community, which will facilitate the protection of rights and dignity of individuals and communities in
p.000083:
p.000084: 84
p.000084:
p.000085: 85
p.000085:
p.000085: biomedical research. The process of SOP implementation was accompanied with a thorough consideration for specific
p.000085: features and the potential of their practical applications. The Collection of model SOPs was presented and
p.000085: discussed at the FECCIS Workshops in St.-Petersburg, Russia (2003); Kiev, Ukraine (2004, 2006); Minsk, Republic Belarus
p.000085: (2005). Two editions of the Collection of model SOPs were published in 2004 and 2005. The development and
p.000085: publication of the Collection of model SOPs stimulates writing national manuals and methodical standards for ECs
p.000085: functioning on different levels. Publication of methodical guidelines in Ukraine (2006, in Ukrainian) is one of the
p.000085: examples.
p.000085: The other priority in the FECCIS activity is the design and development of educational programmes for training EC
p.000085: members that could be integrated into national programmes of professional education of cardinal problems of bioethics.
p.000085: The programmes can also be helpful in formation of a database on practical teaching materials referring to biomedical
p.000085: research ethics.
p.000085: To form the database, national programmes on bioethics adopted in the CIS countries have been displayed in the FECCIS
p.000085: website. New programmes have been developed by a FECCIS working group headed by professor
p.000085: B.G. Yudin in the framework of the Fogarty grant. Representatives of five CIS countries have attended the course
p.000085: “E-Education in Research Ethics: Central and Eastern Europe” organized by Albany Medical College (USA) in partnership
p.000085: with the Department of Medical History and Ethics of Vilnius University (Lithuania) and sponsored by the Fogarty
p.000085: International Centre.
p.000085: A special attention has been paid to a direct participation in organizing and conducting training seminars for the EC
p.000085: members in the framework of the SIDCER “Recognition Programme”. The Project objective is to promote the highest ethical
p.000085: and scientific standards of conducting ethical review of biomedical research. The Project includes the procedure
p.000085: of the EC self- evaluation, preparation for a follow-up survey and the survey that results in granting the
p.000085: “Recognition” status if the EC meets the standards of ethical review. The EC members are trained according
p.000085: programmes including lectures and seminars in working groups. Programmes offer the following Modules: “Human Subject
p.000085: Protection”, “Standard Operational Procedures” and “Inspection and Survey of the Ethics Committee”. This
p.000085: Project is actually the first stage of implementing the system of the EC accreditation, certification and survey in
p.000085: the CIS countries.
p.000085: Organization of 17 international seminars and conferences in 8 of 11 CIS countries has been very important with regard
p.000085: to the formation of the common informational field. Conference and seminars have been held in cooperation with
p.000085: different national and international structures. Conference materials have been published in Russian, English and
p.000085: national languages of the CIS countries.
p.000085: The conferences and seminars aimed at exchanging information and discussing topical issues of the development
p.000085: of regulation and educational standards relating to the protection of research participants’ rights, to the development
p.000085: of national systems of ethical review and to the creation of a harmonized legislation and methodology referring to
p.000085: biomedical research ethics both in the CIS region and in the global international space.
p.000085: Due to the development of these main initiatives, the following has been achieved and accomplished:
p.000085: • information exchange in the field of bioethics in the CIS region;
p.000085: • the analysis of issues relating to bioethical education in the region;
p.000085: • an open access to and discussion of international documents and guidelines on bioethics and research
p.000085: ethics (translation into national languages);
p.000085: • implementation of SOPs into the process of ethical review;
p.000085: • stimulation of efforts directed towards the development of national systems of ethical review in compliance
p.000085: with the GCP standards and international guidelines;
p.000085: • assistance in the organization of the EC members education and training in the region;
p.000085: • the EC preparation for the survey and evaluation of their performance;
p.000085: • raising the EC authority and their role in the development of international standards concerning the
p.000085: protection of research subjects’ rights;
p.000085: • assistance in the development of national Forums for Ethics Committees in the CIS countries;
p.000085: • the evaluation of the current legislation referring to the protection of human rights in biomedical research and
p.000085: medical practice in the region;
p.000085: • the performance as a regional centre for cooperation in the field of ethical review development;
p.000085:
p.000086: 86
p.000086:
p.000087: 87
p.000087:
p.000087: • assistance in the practical application of the SOPs for ethical review in the region in compliance with
p.000087: Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO, 2002);
p.000087: • coordination of the CIS countries in the sphere of bioethical issues and ethical review of biomedical research in
p.000087: the region.
p.000087: Summarizing the above said we should recognize that the history of the development of the system for ethical review of
p.000087: biomedical research in the CIS countries is a dialectic process of ethical and legal development of the national
p.000087: consciousness and legislation directed towards protecting rights, dignity and autonomy of an individual as a
...
p.000093: To protect rights and health of human subjects involved into clinical trials of new drugs, treatment methods
p.000093: and medical technologies,
p.000093: Ethics Committee at the Ministry of Health of Republic of Armenia was established in 1996 on the initiative of the
p.000093: Agency for Drugs and Medical Technologies.
p.000093: With regard to legal regulation in the sphere of human rights protection, members of Ethics Committee are guided in
p.000093: their ethical review practice by the following documents:
p.000093: • Constitution of Republic of Armenia (Article 34)
p.000093: • Law on Healthcare in Armenia
p.000093: • Law on Drugs
p.000093: • Law on Social Protection of the Disabled
p.000093: • Law on the Rights of the Child
p.000093: • Law on the Prevention of HIV Infection
p.000093: • Law on Transplantation of Human Organs and/or Tissues
p.000093: • Law on Reproductive Health
p.000093: • Law on Providing Psychiatric Care
p.000093:
p.000093: As to international legal documents, Republic of Armenia ratified Convention on the Rights of the Child.
p.000093: The practice of ethical review is regulated by principles set in the relevant WHO and WMA documents as well as in
p.000093: other international legal and ethical documents.
p.000093:
p.000093: 3.1.3. Education in Bioethics
p.000093:
p.000093: At Yerevan State University named after M.Heratsi ethics and aesthetics have been traditionally taught over many
p.000093: decades. In 2000 bioethics was introduced into the programme of the Department of Social Sciences as a compulsory
p.000093: discipline.
p.000093: In the post-Soviet space, including Armenia, a different – “home” – model of bioethics has been developed, in which
p.000093: bioethics is an interdisciplinary, orientated on biology, modern field of knowledge analyzing moral problems of human
p.000093: existence and human attitude to life and to individual living organisms. This model covers the range from the
p.000093: development of ethical norms and principles regulating human practical activity in the process of studying nature and
p.000093: human beings to the study of the role and place of the human being in the context of biological reality and the
p.000093: estimate of the status of life and death categories.
p.000093:
p.000094: 94
p.000094:
p.000095: 95
p.000095:
p.000095: In the beginning bioethics was taught only to students who were citizens of Armenia, but since 2003
p.000095: also to foreign students. The most important stimulus for introducing basics of bioethics into the syllabus was an
p.000095: essential need to harmonize our education programmes with international standards of education. Republic of Armenia
p.000095: enters the Council of Europe, and, accordingly, takes an active part in the work of its social and legal, healthcare,
p.000095: economical and culturological structures.
p.000095: At Yerevan State University lectures on bioethics are read in the first year at all faculties. Unfortunately, during
p.000095: last two years the time assigned for bioethics was reduced from 36 to 17 hours. Besides, now bioethics is an elective
p.000095: course for citizens of Armenia, while it is a compulsory discipline for foreign students (Russian- and
p.000095: English-speaking students from 18 countries). Thus, since the academic year 2006-2007 bioethics is included into the
p.000095: list of elective courses, and hence a number of students get their medical diplomas without training in bioethics.
p.000095: During the last two years the Chair of Social Sciences did its best in providing students with necessary teaching
p.000095: materials. Most of them were received from the Russian Federation, Belarus and Israel. However, as the new generation
p.000095: of students does not know either Russian or English language well enough, there is an urgent need for teaching
p.000095: materials on bioethics in Armenian language. The Department of Social Sciences has developed a brief course on
p.000095: bioethics in Armenian language. The course aims at:
p.000095: - providing students with some fundamental knowledge on the essence and principal problems of bioethics so that
p.000095: they would be capable to comprehend problems of life and death, health and life;
p.000095: - acquainting future physicians with moral aspects of topical problems of modern medicine and biomedical research
...
p.000097: It would be reasonable that The Division of Science and Technology Ethics within the Social and Human Sciences Sector
p.000097: at UNESCO did not confine its activity to providing information for national ethics and bioethics committees, but also
p.000097: furnished a financial support for our organization and for implementation of training courses as well as for
p.000097: publication of teaching materials on bioethics in Armenian language.
p.000097: It is clear that the development of teaching programmes on bioethics and research ethics in Armenia should be adapted
p.000097: to its national, social and spiritual traditions and its healthcare system. At the same time, it should correlate with
p.000097: actual models of modern bioethics, and therefore we make steps towards integrating Yerevan Medical University
p.000097: named after M. Heratsi into the system of UNESCO International Committee for Medical Schools.
p.000097: Universityadministrationdoesitsbestforinternationalacknowledgement of our University as a member of UNESCO
p.000097: International Committee for medical Schools by introducing new disciplines, including bioethics, into the syllabus. It
p.000097: would be expedient that out lecturers and professors could have a financial support to participate in the work of
p.000097: international conferences and seminars on bioethics.
p.000097: We would like to emphasize that here we mentioned only some of the most acute problems of teaching bioethics in
p.000097: Armenian medical institutes. However, this is enough to conclude that bioethics needs more attention from
p.000097: Health Ministry and Ministry of Education of Republic of Armenia, and from the Armenian Institute of Protection of
p.000097: Human Rights.
p.000097:
p.000098: 98
p.000098:
p.000099: 99
p.000099:
p.000099: 3.1.4 The System of Ethical Review
p.000099:
p.000099: In its activity Ethics Committee of Health Ministry of Armenia is guider by “The Order of Conducting Clinical
p.000099: Trials of New Drugs in Republic Armenia” approved by the Decree of Armenian Government (No 63, 24 of January
p.000099: 2002). This document regulates the practice of clinical trials in our country. According to the set order, clinical
p.000099: trials can be conducted only when approved by Ethics Committee. The entire responsibility for the accuracy and
p.000099: reliability of data obtained in the trial rests on the investigator.
p.000099: Presently, Ethics Committee of Armenian Health Ministry has 12 members who are independent experts
p.000099: and represent different social communities: physicians of different specialties, clinical pharmacologists, lawyers,
p.000099: nurses, representatives of culture, etc.
p.000099: Ethics Committee of Health Ministry of Republic of Armenia has the following responsibilities:
p.000099: - ethical review of clinical trials;
p.000099: - control of the trial process through a regular monitoring;
p.000099: - review of research protocol amendments;
p.000099: - protection of confidentiality.
p.000099: For a thorough and complete ethical review of clinical trials in Armenia the following documents are required:
p.000099: - research protocol,
...
p.000101: Bulletin of Supreme Certifying Commission.
p.000101: Within last years local ethics committees have been established at medical institutions. Ethics Committee is
p.000101: functioning at the Yerevan State
p.000101: University. Since 2006 Ethics Committee perform ethical review of projects and works conducted at the University chairs
p.000101: and clinics.
p.000101:
p.000101: 3.1.5 Perspectives and Forms of International Cooperation
p.000101:
p.000101: With regard to international cooperation, Armenia as a member of FECCIS has all possibilities for
p.000101: a wide interaction and international cooperation on research ethics and bioethics offered by this organization.
p.000101: In 2005 FECCIS International Conference “Cooperation between Ethics Committees and Authorities,
p.000101: Investigators, Sponsors and Patients in Biomedical Research in CIS (the share of ethical problems related to genetic
p.000101: research)” was held in Yerevan. The Conference was organized with a wide international support (WHO, European
p.000101: Commission, UNESCO, European Forum for Good Clinical Practice, World Medical Association, Department of Health &
p.000101: Human Service (DHHS), USA, and also representatives of Ethics Committees from Italy, Latvia, Lithuania and
p.000101: Estonia). Within the framework of the conference a join meeting of FECCIS and Permanent Commission on
p.000101: Science and Education of the Inter-Parliamentary Assembly of the Commonwealth of Independent States took place. At the
p.000101: conference the question about the development of model guidelines On Ethical and Legal Regulation and Safety of Medical
p.000101: Genetic Research in the CIS was raised for the first time, which later found its reflection in joint activities of
p.000101: FECCIS and Permanent Commission on Science and Education of the Inter-Parliamentary Assembly of the Commonwealth of
p.000101: Independent States. The Conference in Armenia was also the start ground for including CIS countries in SIDCER Project
p.000101: “Recognition”. Thus, for the first time, Module 1 of the programme “Human Subject Protection” for members of the
p.000101: National Ethics Committee of Republic Armenia and Armenian medical community was launched in October 2005 due to
p.000101: efforts of FECCIS and international experts.
p.000101: As to education in bioethics, the representatives from Republic of Armenia participated in the
p.000101: International Course on Research Ethics for Countries of Central and Eastern Europe at Albany Medical College
p.000101: (USA) and Vilnius University (Lithuania). The course received support from Fogarty Foundation. There are perspectives
p.000101: for participation of other representatives from Armenia in this Course.
p.000101:
p.000102: 102
p.000102:
p.000103: 103
p.000103:
p.000103: 3.2. REPUBLIC oF AzERBAIjAn
p.000103: (А.А.Namazova, Z.G.Guseinova, T.G.Tagi-Zade)
p.000103:
p.000103: 3.2.1 Historical and Cultural Background
p.000103:
p.000103: Rich historical and cultural heritage reflected in works by progressive thinkers of the past and contemporary
p.000103: scientists, multinational and multiconfessional population of the republic are the factors contributing to the
p.000103: development of bioethics in Azerbaijan. Tolerance and respect for other national cultures and human dignity, esteem for
p.000103: elderly people, principles of mercy, concern and care for dying people, i.e. traditions that have been forming over
p.000103: centuries-long history, play a significant part in this process.
p.000103: Azerbaijan people, as many other peoples of Eastern countries find evidence of physicians’ search and
p.000103: reflection on philosophy and ethics in ancient medical manuscripts. The ancient world knew the name of a
...
p.000103: were found. The first precept is about the noble mission of the physician: “Everything in the Earth is the
p.000103: fruit of human kindness/ And where the doctor is, there is always air of kindness”. The second one warns against
p.000103: excessive eating and drinking alcohol, i.e. advocates the culture of hygiene: “Do not thou fill thyself with vine/ Be
p.000103: moderate in eating pilaw and bread/ Or otherwise the world in which we live/ Will turn into a cattle-shed”.
p.000103: Fundamental principles of the physician’s ethical behaviour were set forth in an ancient monument of Azerbaijan
p.000103: literature – a folk epic poem “Dede Korkud”. There we find many pieces of useful advice on how to stay healthy and
p.000103: about significance of moral purity and health.
p.000103: Prominent thinkers, poets and scientists of ancient land of Azerbaijan, such as Bahmanyar Ibn Mirzaban, Nizami
p.000103: Gyandjavi, Hatib Tabrizi, Mahmud Shabustari, Omar Osmanogli, Seid Yahya Bakuvi, Nahchivani, Hagani, Fizuli,
p.000103: Vagif, and many others described in their works a hard unselfish and dedicated work of ancient physicians and fruitful
p.000103: results of their job [6]. They all contributed into the development of medical ethics in Azerbaijan.
p.000103: In the XI century the first madrasah schools were established in Azerbaijan where theology and medicine
p.000103: were taught. Those schools
p.000103: trained mullahs, imams and physicians. In the XII century a specialized medical school was founded in
p.000103: Azerbaijan. There under the direction of Omar Osmanogli, future physicians were provided medical education. Omar
p.000103: Osmanogli with his profound knowledge followed moral principles proclaimed by Logman, and he always taught his
p.000103: disciples that in his work the physician should be guided by love to the human being. His demands even went contrary to
p.000103: deep-rooted customs: “Do not thou turn you back on the enemy. Cure him.” Omar Osmanogli educated his pupils
p.000103: in the spirit of moral purity and patriotism. ”Be useful to your people even if it is contrary to your own interest”,
p.000103: “Do not be selfish”, “Work not just in order to make your way to paradise, and do not be afraid of hell” -- such were
p.000103: his mottos.
p.000103: In line with Omar Osman’s traditions, the famous poet Khagani wrote: “If you want your heart to be clear like a mirror,
p.000103: rid it of ten qualities: avarice, hypocrisy, envy, slander, anger, haughtiness, breach of the laws, duplicity,
p.000103: hostility and lie”. Nizami, a great poet and writer of Azerbaijan, who was one of the most educated men of his period,
p.000103: thought highly of medicine and medical profession. In his works he set forth a number of scientific ideas and
p.000103: conclusions characterizing some ways and means used in Azerbaijan folk medicine. He also wrote on nutrition hygiene,
p.000103: and his ideas did not lose their importance to present day.
p.000103: Not many know that in the XIII century there was a “Dar-Ash-Shafa” University (the House of Cure) in Azerbaijan, in
p.000103: which 5-7 thousands of students were educated. Many scientists from Iran, India, China, Syria, Egypt and from
p.000103: Central Asia were happy to visit this University. The ancient Azerbaijan capital attracted foreign scientists not only
p.000103: with its wealth and luxury but also with the possibility for scientific research and education.
p.000103: In many works of eminent Azerbaijan thinkers, such as Mirza Fatali Akhundov (1812-1814), Gasanbek Zardabi, Nariman
p.000103: Narimanov, Jalil Mamedguluzadeh known under the name of Molla Nasreddin (1866-1932) et al., we can find progressive
p.000103: views on medicine.
p.000103: Mirza Fatali Akhundov [3] is the author of immortal works on politics, natural sciences, medicine, ethics and
p.000103: aesthetics. When describing historical events, traditions and ways of life Mirza Fatali Akhundov always mentioned those
p.000103: national customs that negatively affected human health and moral qualities [5].
p.000103:
p.000104: 104
p.000104:
p.000105: 105
p.000105:
p.000105: Gasanbek Melikov Zardabi (1842-1907) followed Akhundov on the thorny path of asserting the best moral qualities.
p.000105: In his book “Hygiene”, he wrote that physicians should be warm-hearted and honest; they should keep to the rules of
p.000105: personal hygiene, and watch over the hygiene of their patients and their homes.
p.000105: N.Narimanov (1870-1925) in his numerous works wrote about the social role of physicians: “Physicians should
p.000105: strictly criticize all medical institutions and their own actions, so as to extirpate everything that is not meeting
p.000105: patients’ interests, and, especially, what might hurt them. Patients’ interests should always be a priority, and all
p.000105: intellectual efforts should be devoted to meeting their needs” [1].
p.000105: Making good use of their rich heritage in the field of ethics medical professionals of Azerbaijan followed the
p.000105: traditions in later years. Today we may speak of a new historical situation in the development of medical ethics as an
p.000105: area of medical knowledge aimed at education of medical personnel.
p.000105: We know that the social environment plays an essential part in the development of medical ethics. Moral
p.000105: qualities of medical professionals are not innate but acquired. They reveal themselves in the social milieu in which a
p.000105: person grew up, studied and worked.
p.000105: Academician Zarifa Alieva (1923-1985), a well-known scientist, in her excellent work “The Noble Mission”
p.000105: emphasized the fundamental importance of ethics in the physician’s professional activity: “Medicine is
p.000105: progressing day by day, it cannot stay unchanged, and only one thing remains constant – high moral, ethical
p.000105: and professional standards demanded from the physician”.
p.000105: After the disintegration of the Soviet Union and declaration of Azerbaijan independence, the reformation of the
p.000105: healthcare system began. Professional education, creation of a new pharmaceutical market, etc, and, naturally, the main
p.000105: principles of medical ethics (the physician’s duty and responsibility, relationships with patients, colleagues and
p.000105: society) underwent a strong correction. Academicians Z.A.Alieva, A.T.Amiraslanov, A.A.Namazova et al. made a great
p.000105: contribution into the development of bioethics.
p.000105: An important milestone in the history of Azerbaijan was the year of 1999, when, on the initiative of UNESCO, the
p.000105: Presidium of National Academy of Sciences established the Committee on Bioethics and Technology Ethics (Decree
p.000105: 9/1).
p.000105: 3.2.2. Legal Regulations
p.000105:
p.000105: Health is one of a few subjective human values without which many other comforts and values lose their significance.
p.000105: Today every democratic country acknowledges the importance of human rights protection in all spheres of social
p.000105: life. Within last years, the National Assembly of Azerbaijan adopted legislative acts setting forth political,
p.000105: economic, social, cultural, scientific and medical measures for maintaining and strengthening physical and mental
p.000105: health of every person and providing medical care in case of loss of health. When drawing up the documents the
p.000105: experience of other countries was used, and the following legal norms based on international legal norms were adopted:
p.000105: - UN Convention on Children’s Rights (Decree of the National Assembly of Azerbaijan Republic. No 236; 21 of July 1992)
p.000105: - Law on Sanitary-and-epidemiologic Well-being of Population (10.11.1992)
p.000105: - Law on Preventing the Spread of the Disease Caused by HIV in Azerbaijan (16.04.1996)
p.000105: - Law on Pharmaceutical Activity (05.11.1996)
p.000105: - Law on Health Protection (26.07.1997)
p.000105: - Law on Medical Insurance (1997)
p.000105: - Law on Radiation Safety (30.12.1997)
p.000105: - Law on Children’s Rights (19.05.1998)
p.000105: - Law on Transplantation of Human Organs and Tissues (28.10.1999)
p.000105: - Law on Immunoprophylaxis of Infectious Diseases (14.04.2000)
p.000105: - Law on Tuberculosis Control in Azerbaijan (05.02.2000)
p.000105: - Law on Psychiatric Care (12.06.2001)
p.000105: - Law on Narcological Service and Control (29.06.2001)
p.000105: - Law on Nutrition of Newborns and Infants (17.06.2003)
p.000105: - Law on the State Care for Patients with Diabetes (23.12.2003)
p.000105: - Law on Iodination of Sodium Chloride for the Mass Prevention of Iodine Deficiency.
p.000105: - Law on Donorship of Blood, Blood Components and Blood Donor Service (03.05.2005)
p.000105: - Law on State Care for Patients with Hereditary Diseases Such as Hemophilia and Thalassemia (03.05.2005).
p.000105:
p.000106: 106
p.000106:
p.000107: 107
p.000107:
p.000107: 3.2.3. Education in Bioethics
p.000107:
p.000107: When considering problems of education we precede from the fact that bioethics, in relation to medicine, is
p.000107: nowadays a developing academic discipline with its inherent strict standards. We should start teaching
p.000107: bioethics in the period when students pass on from theoretical subjects to practical activity.
p.000107: In accordance with recommendations of the World Health Organization to introduce courses on medical ethics into the
p.000107: syllabus of medical schools everywhere in the world, an educational programme on bioethics was developed in
p.000107: Azerbaijan in the 1990s. The programme emphasizes the universal character of principles and rules of bioethics
p.000107: and covers all basic problems of bioethics with due consideration for the international experience and national
p.000107: traditions. The method of teaching aims at enabling medical professionals to acquire ethical skills in
p.000107: physician-patient relationships, professional decision-making and conducting scientific research.
p.000107: Education in bioethics at Azerbaijan Medical University (8,000 students) began in 2000. Considering an
p.000107: interdisciplinary character of the programme, issues of biomedical ethics are normally introduced into the
p.000107: teaching process of all faculties, especially, clinical ones.
p.000107: In 2000 an international conference “Methods of Teaching Medical Ethics” was held in Baku. On that occasion
p.000107: numerous methodical materials were prepared: methodical plans, textbooks, brochures and glossaries of
p.000107: bioethical terminology. The materials have been very helpful in training specialists with an experience in
p.000107: research and applied ethics who have received appropriate certificates.
p.000107: To improve the quality of teaching bioethics and to increase educational level of medical students, the initiative
p.000107: group of Azerbaijan Medical University including the academician of the Russian Academy of Medical Sciences and the
p.000107: National Academy of Sciences professor A.A.Namazova, professor G.A.Aliev, assistant professor Z.G.Guseinova,
p.000107: candidate of medical sciences T.G.Tagi-Zade developed a teaching and methodical programme “Introduction of
p.000107: Teaching Materials on Biomedical Ethics Into the Syllabus of Higher Educational Institutes”. For that purpose the group
p.000107: has made up the following materials: the first Azerbaijan manual on medical ethics «Tiabaiat etikasy», a number of
p.000107: methodical recommendations and
p.000107: such texts as “Ethical Principles in Medicine”, “Euthanasia: Bioethical Aspects”, “Deontology in Medicine” et
p.000107: al.
p.000107: Alongside with the abovementioned, sociological surveys in medical community and public at large were conducted in
p.000107: Azerbaijan with the aim to assess the level of awareness and knowledge about legal aspects of bioethical issues. The
p.000107: surveys are helpful in outlining ways of further activity in the field of education and scientific research.
p.000107: With the assistance of Azerbaijan Ministry of Health and international organizations, especially the Forum for
p.000107: Ethics Committees in the Commonwealth of Independent States, the initiative group develops standard operational
p.000107: procedures and protocols for ethics committees and proposals on adaptation and implementation of international
p.000107: standards for biomedicine in Azerbaijan.
p.000107:
p.000107: References
p.000107: 1. Ethical Problems in Azerbaijan. In: Materials of Regional Swiss Conference on Medical Ethics. Tbilisi,
p.000107: Georgia, 1999 (in Russian).
p.000107: 2. Implementation of Teaching Materials on Medical Ethics into the Syllabus of the Medical University. In:
p.000107: Materials of the International Seminar “Methods of Teaching Medical Ethics”. Baku, Republic of Azerbaijan, 2000 (in
p.000107: Russian).
p.000107: 3. The Role of Bioethics in Training Future Physicians. In: Materials of the First National Congress on Bioethics.
p.000107: Kiev, Ukraine, 2001, pp. 41-44 (in Russian).
p.000107: 4. The State of Ethical Review of Biomedical Research in Azerbaijan. In: Ethics Committees in Russia and other
p.000107: CIS Countries. International Seminar. St.-Petersburg, Russia, 2001, pp. 41-44 (in Russian).
p.000107: 5. Ethics’ in Pediatric Clinics. First International Conference «Clinical Trails in Russia». Moscow, Russia, 2001 (in
p.000107: Russian).
p.000107: 6. Medical Ethics and Deontology. - Medical Journal “Vita”, 2001, pp. 3-4.
p.000107: 7. Bioethical Aspects of Education in Medical Institutes. In: Good Ethical Practice in Biomedical
p.000107: Research. International Conference of the CIS Countries. Almaty, Republic of Kazakhstan, 2002, p. 87 (in Russian).
p.000107: 8. Ethical Principles in Medicine. Part 1. Methodical Manual. Baku, Republic of Azerbaijan, 2002, p. 32 (in
p.000107: Russian).
p.000107:
p.000108: 108
p.000108:
p.000109: 109
p.000109:
p.000109: 9. Euthanasia. Medical Journal «Vita», 2002, pp. 3-4.
p.000109: 10. Ethical Principles in Medicine. Part 2. Bioethical Aspects of Euthanasia. Methodical Manual. Baku,
p.000109: Republic of Azerbaijan, 2002, 32 p. (in Russian).
p.000109: 11. Ethical Standard Operational Procedures in Azerbaijan. “Ethics Committees in Russia and Other CIS Countries.
p.000109: International Seminar. St.- Petersburg, Russia, 2003, p. 15 (in Russian).
p.000109: 12. Medical Ethics. Baku, Republic of Azerbaijan, 2004, 100 p. (in Russian).
p.000109: 13. The Role and Meaning of Ethical Education of Medical University Graduates in the Protection of Patients’
p.000109: Rights in Biomedical Research. International Conference of CIS Countries. Kiev, Ukraine, 2004, pp. 23-25 (in
p.000109: Russian).
p.000109: 14. Ethical Education and Protection of Human Rights in Biomedical Research. Baku, Republic of Azerbaijan, 2004, pp.
p.000109: 65-67 (in Russian).
p.000109: 15. Moral and ethical aspects of healing. Azerbaijan Medical Journal, 2005, 1, p. 34.
p.000109: 16. Dictionary of Biomedical Ethics. Baku, Republic of Azerbaijan, 2007, 96 p. (in Russian).
p.000109:
p.000109: 3.2.4. The System of Ethical Review
p.000109:
p.000109: During the last years the issues of arranging conditions for the development of ethical review which is to
p.000109: safeguard rights and safety of patients and other persons involved into clinical trials are widely discussed.
p.000109: State regulation and control of drug quality is one of the principal ways to ensure protection of rights of individuals
p.000109: participating in trials.
p.000109: With that purpose, a Pharmaceutical Committee based on GCP principles was established at the Ministry of Health
p.000109: of Azerbaijan. Good clinical trials guarantee observance of ethical and other fundamental principles and
p.000109: requirements for organizing the research. Legal aspects are set forth in the “Law on Pharmaceutical Products”.
p.000109: In line with GCP principles, Azerbaijan Pharmacological Committee developed and endorsed a number of
p.000109: recommendations on the review of documents submitted for drug registration, on pre-clinical drug trials,
p.000109: on clinical drug trials, etc.
...
p.000113: Belarus became a part of the Grand Duchy of Lithuania that later united with the Kingdom of Poland and formed the
p.000113: Polish-Lithuanian Commonwealth, works of Belarus philosophers Francis Scorina, Symon Budny and Vasily Tiapinsky
p.000113: reflected topical ideas of West-European culture, particularly, the idea of humanism. In the period of
p.000113: counter-Reformation (XVI-XVII c) Jesuit colleges and catholic universities actively used the rationalistic
p.000113: heritage of medieval scholastic ethics, and ethical teachings of Aristotle and Thomas of Aquinas were very popular
p.000113: among the educated part of Belarus population. The idea of the Unia (union) of Orthodoxy and Catholicism under the
p.000113: aegis of the Pope carried in itself ethical and philosophical values of religious tolerance. In the XVI-XVII
p.000113: centuries Orthodox communities also did extensive teaching popularizing the most important achievements of
p.000113: West-European countries among Orthodox believers in Belarus. Simeon Polotsky, one of the most outstanding figures in
p.000113: Belarus culture of that period, compiled a collection of poems that formulated, in a poetic form, basic ethical and
p.000113: moral principles of the Orthodoxy. The end of the XVIII and the beginning of the
p.000113: XIX century was marked by naturalistic ethical concepts that resulted from the development of exact and natural
p.000113: sciences and considered ethics in the spirit of theories of “natural law”, “social contract” and “rational egoism”
p.000113: asserting the necessity of universal secular education.
p.000113: After the October revolution and the collapse of the Russian Empire Belarus became Belarusian People’s Republic. The
p.000113: second decade of the XX century was characterized by a rapid growth of national self-awareness. Specific ethical
p.000113: traditions of the Belarusian ethnos and moral aspects of the revival of the Belarusian culture, as well as closeness to
p.000113: nature and healthy moral relations, were widely discussed and reflected in works by such thinkers and poets
p.000113: as F.Bogushevich, A.Pashkevich, Y.Kupala, Y.Kolas. However later, during the Soviet period, ethical thought in
p.000113: Belarusian SSR had been in conformity with the general authoritarian trend.
p.000113: In the last decade of the XX century the developments of Belarus ethics was marked with pluralism and
p.000113: attempts to pass from authoritarian to humanistic ethics. National features of moral self-awareness were analyzed;
p.000113: attempts were made to revise the fundamental moral values. It was the time, when new systems of substantiation of
p.000113: ethical ideas came into being, and trends of applied ethics began to develop. In the 1900s preconditions for the
p.000113: development of theoretical concepts of bioethics and biomedical ethics were formed (T.V.Mishatkina, Ya.S.Yaskevich,
p.000113: S.D.Denisov). First publications and presentations at scientific conferences on different levels appeared;
p.000113: ideas of bioethics find their reflection in the system of medical education [2-6]. Since that time, the ethical
p.000113: thought in Belarus steadily began to approach leading world tendencies in scientific bioethics.
p.000113: Important factors in this process have been specific features of national world-perception and spiritual culture of
p.000113: Belarus people, which revealed itself in such moral qualities as the tendency to self-determination, inherent
p.000113: feeling of self-respect in combination with tolerance and good-nature, as well as hospitality and openness, etc.
p.000113: Moral qualities of Belarus people are in a direct relation to specific features of Slavic national
p.000113: character. Nikolai Lossky, a Russian philosopher, proved this by associating those with such factors as vast
p.000113: expanses of East-European Plain and its climate (short summer), forming “the habit of excessive short-term
p.000113: strain of efforts” and “the ‘non-habit’ of a regular, continuous labour” [7]. Lossky’s comments on the Russian national
p.000113: character
p.000113:
p.000114: 114
p.000114:
p.000115: 115
p.000115:
p.000115: may be fully attributed to Belarus people: “Obeying the call of duty, Russian people develop in themselves an ability
p.000115: to fulfill a compulsory job accurately and honestly. However, if the job is not strictly compulsory, then they may be
p.000115: careless and inaccurate… Hence, there is often a loss of interest in the work begun and aversion for continuing it; the
p.000115: initial intention, idea and the general outline is often quite valuable, but inevitable imperfections would dim the
p.000115: enthusiasm, and people would be lazy to proceed with a thorough and detailed work.” Nevertheless, some effect of
...
p.000115: Slavs are more disposed to democracy, which shows itself, for example, in the protest against all sorts of
p.000115: conventionalities.
p.000115: Currently the Orthodox Church still has a strong effect on the development of bioethics in Belarus,
p.000115: which has both positive and negative aspects. The programme of interaction between the Orthodox Church of the country
p.000115: and the Belarus Health Ministry of is being realized. The programme helps to introduce moral constants into the medical
p.000115: community, facilitates moral and spiritual growth of the worldview of students (future specialists in medicine, biology
p.000115: and biotechnology) and the general growth of bioethical competence in the society. A rich experience in promoting ideas
p.000115: of bioethics has the Orthodox Medical Brotherhood at the Minsk Eparchy of the Belarus Exarchate. Charity Centre has
p.000115: been organized at the Parish of the Church of All Saints in Minsk. Belarus Children’s Hospice within Children’s Cancer
p.000115: Centre provides spiritual and medico-psychological care for terminally ill children. However we should not ignore the
p.000115: conservatism of the Orthodox Church and, in particular, with regard to topical bioethical problems. In
p.000115: relation to a number of bioethical problems, the Orthodox Church adheres to a very strict position: it prohibits human
p.000115: cloning and cloning of human organs (especially heart cloning) and euthanasia; expresses censure on artificial
p.000115: fertilization, abortion, sexual education of young people. They also hold to uncompromising position regarding some
p.000115: issues of transplantation of certain organs, which showed itself in the discussion of amendments to the “Law on
p.000115: Transplantation of the Republic of Belarus”.
p.000115: Since 1995 bioethics in Republic Belarus has been developing in parallel, along two main lines — theoretical
p.000115: and practice-organizing ones, and initially the connection between these lines was rather weak.
p.000115: Theoretical trend implied the analysis of bioethics as an interdisciplinary scientific knowledge showing, most
p.000115: fully, the tendencies of science development in the XX century. On the other hand, bioethics was analyzed as a
p.000115: special field of applied ethics with its distinctive features and modifications, and, at the same time, allegiant to
p.000115: fundamental ethical principles and general human values [8, part II, 9,10,13]. In choosing priorities we are guided,
p.000115: first of all, by general tendencies in the evolution of scientific knowledge as a whole, and ethics in particular, as
p.000115: well as by historical and cultural grounds for the development of bioethics.
p.000115: Organizational and practical trend of bioethics development in Republic of Belarus focuses on searching and working out
p.000115: mechanisms of institutional regulation of biomedical research.
p.000115: Today the society demands a socially responsible behaviour from investigators and obliges them to accept
p.000115: framework principles, standards and norms for the functioning of relevant structures. And here comes the organization
p.000115: ethics with its main task to understand how to make correct ethical decisions. All these principles, standards and
p.000115: norms are addressed not to an individual but to institutions as organized groups with their tasks, specific features
p.000115: and cultural traditions. Therefore ethics committees and ethical competence take on special significance.
p.000115: The Western model of bioethics is an institutionally organized social technology with a system of standardized
p.000115: liberal values ensuring the protection of human rights and freedoms in biomedicine. The protection of human rights
p.000115: from negative consequences resulting from the application of modern biomedical technologies is performed through
p.000115: ethic codes, laws, extending the sphere of responsibility of medical professionals and biologists
p.000115:
p.000116: 116
p.000116:
p.000117: 117
p.000117:
p.000117: and their social obligations not only fixed on their personal moral level but also stated by law. Mechanisms
p.000117: controlling ethical aspects in the activity of physicians and scientists are supplemented with a developed system of
p.000117: legal regulation, a special system of bioethics committees and education.
p.000117: In the post-Soviet space, including Belarus, a different – “home” – model of bioethics has been created, in which
p.000117: bioethics is an interdisciplinary, orientated on biology, field of theoretical knowledge analyzing moral
p.000117: problems of human existence and human attitude to life and to different living organisms. This model
p.000117: covers the range from the development of ethical norms and principles regulating human practical activity
p.000117: in the process of studying nature and human beings to the study of the role and place of the human being in the
p.000117: context of biological reality and the estimate of the status of life and death categories.
p.000117: At the same time, for Belarus with its post-Chernobyl crisis level of the balance in the “nature--society” system, when
p.000117: the data of biomedical studies prove a direct and evident threat to the public health and to the safety of gene pool
p.000117: because of the complex radiochemical pollution, practical measures are extremely important. Besides, the majority of
p.000117: physicians in Belarus still stick to the conventional paternalistic model of patient—physician relationships, which
p.000117: goes with a widespread legal and ethical nihilism in the medical community. Therefore the modern model of
p.000117: bioethics, as well as programmes of biomedical research, should be adapted to the national healthcare system, its
p.000117: scientific, socio-cultural, legal and spiritual traditions.
p.000117: At present, we have objective and subjective conditions for the development of bioethics in the form that is
p.000117: accepted in the West. We are developing ethical and legal norms regulating biomedical research and aiming to create
p.000117: adequate models of education. In compliance with the Order of the Health Ministry of Belarus “On Establishing Rules for
p.000117: Conducting Clinical Trials of Pharmaceutical Products”, a Republican Unitary Institution “The Centre of Expertise and
p.000117: Trials in Healthcare” was founded in 1999. A serious work has been carried out on organizing institutional activity of
p.000117: local ethics committees. Scientists, governing structures and public organizations put their efforts in creating
p.000117: the basis for establishing in Belarus the National Committee for Bioethics similar to those existing in many countries.
p.000117: The Committee can rightly represent Belarus on the international level and take initiatives in the protection of
p.000117: human rights in biomedicine, coordinate
p.000117: activity of local ECs and develop main concepts of professional and public education. The National Committee for
p.000117: Bioethics (NCBE) at the Health Ministry of Belarus was established in 2005 with the support of the National
p.000117: Commission of Belarus for UNESCO.
p.000117: At the same time there are still organizational and legislative problems in the development of bioethics in Belarus.
p.000117: This concerns an under-developed system of legal regulation of bioethics, a low level of ethical knowledge and legal
p.000117: culture in the medical community and in the population, and a high level of bureaucracy and conservatism in
p.000117: institutions that are to make decisions. Thus during a year, due to delays and impediments of the law, the question of
p.000117: the legal status of NCBE established on the instructions of Council of Ministers (26.07.2005) could not be
p.000117: decided, which certainly hampered NCBE activity.
p.000117:
p.000117: 3.3.2 Legal Regulations
p.000117:
p.000117: Like in the healthcare as a whole, in establishing local ECs and the NCBE
p.000117: Belarusfollowsinternationallegalandethicaldocuments. Thesedocumentsare: The Nuremberg Code (1947); Declaration of
p.000117: Helsinki (1964, with subsequent amendments); ICH GCP (1996); WHO Operational Guidelines for Ethics Committees
p.000117: That Review Medical Research (2002); UNESCO documents “The Declaration on the Principles of Tolerance”
p.000117: (1995); “The Universal Declaration on the Human Genome and Human Rights” (1997); UNESCO Guide No 1 “Establishing
p.000117: Bioethics Committees” (2005); UNESCO Guide No 2 “Bioethics Committees at Work: Procedures and Policies” (2005).
p.000117: The National Strategy of Steady Development and the Concept of Healthcare Development in Belarus (1995) are
...
p.000123: Alongside with medical and pharmaceutical professionals, other persons to whom the information was
p.000123: disclosed in accordance with current legislation should also safeguard the confidentiality of information.
p.000123: “Healthcare organizations ensure archiving and storing medical documents in compliance with the
p.000123: confidentiality requirements.
p.000123: Medical and pharmaceutical professionals bear the responsibility for a breach of confidentiality in
p.000123: accordance with the current legislation of Belarus.” (Law on Healthcare, Art. 60)
p.000123: Besides basic principles of biomedical ethics, legislative acts of Belarus state that any intervention into a human
p.000123: body for research purposes should be performed in compliance with existing requirements and professional
p.000123: standards. Thus, Law on Healthcare states that:
p.000123: - “The permission to carry out clinical trials and biomedical research involving human subjects is granted by
p.000123: Health Ministry of Belarus.” (Art. 31).
p.000123: - “The procedure and conditions of anatomical donation are determined by the Health Ministry of
p.000123: Belarus” (Art. 39).
p.000123: - “The procedure of post-mortem examination and a list of cases for a compulsory post-mortem examination
p.000123: are determined by the Health Ministry of Belarus” (Art. 52).
p.000123: -“Regulations for an independent ethical review are approved by the Council of Ministers of Belarus” (Art. 53).
p.000123: Like the procedures of treatment and care provided to patients, clinical trials and biomedical research are also
p.000123: regulated by the above-mentioned documents.
p.000123:
p.000123: 3.3.3. Education in Bioethics
p.000123:
p.000123: Alongside with establishing local ECs, improving legislation referring to biomedical research and carrying out a
p.000123: theoretical analysis, we have been developing education in bioethics. Here is the chronology of establishing a system
p.000123: of education in bioethics in Belarus**:
p.000123: • In October 1997, on the initiative of the Minsk State Medical Institute and with the support from
p.000123: the Health Ministry of Belarus, the European Parliament, The Embassy of United Kingdom in Belarus,
p.000123: and World Association for the Protection of Animals, the international symposium “Ethical Problems of Using
p.000123: Animals in Teaching and Scientific Research” was held in Belarus. The Symposium stimulated the study of the problems of
p.000123: humanizing medical education. Members of the teaching staff and students from Belarus, Russia, United Kingdom and
p.000123: Sweden took part in the Symposium [14,16,18,19].
p.000123: • In 1999 recommendations “Teaching Basics of Medical Ethics and Deontology in the Course on Human Anatomy” (Denisov
p.000123: S.D., Yaroshevich S.P.) were published, as well as other works relating to ethical norms of handling
p.000123: anatomic preparations [3,15,17].
p.000123: • In 2000 Minsk hosted the international scientific-and-practical conference “Biomedical Ethics: Problems and
p.000123: Perspectives”; a volume of conference proceedings was published [9].
p.000123: • In 2000 one of the first text-books in CIS countries “Biomedical Ethics” (220 p.) for students studying
p.000123: medicine and biology approved by the Ministry of Education of Belarus was published [12]. The text-book includes a
p.000123: supplement in which leading scientists and physicians of Belarus of different age and specialties give their
p.000123: professional opinion on ethical problems.
p.000123: • In 2001 the International State Ecological University named after A.D.Sakharov introduced a course “Basics of
p.000123: Biomedical Ethics” (20 h) into the syllabus for students studying medicine and biology. Since 2003
p.000123:
p.000123: * Data by N.E. Luigas and C.D. Denisov
p.000123:
p.000124: 124
p.000124:
p.000125: 125
p.000125:
p.000125: the course in biomedical ethics (36 h) is taught at the Belarus State Medical University (BSMU) and other
p.000125: institutes of higher medical education. Teaching programmes “Basics of Biomedical Ethics” for undergraduate
p.000125: students and “Topical Problems of Biomedical Ethics” for medical post- graduates have been designed.
p.000125: • A programme in biomedical ethics has been developed for the system of raising the professional level of medical
p.000125: practitioners and teaching staff of medical institutes (18—36 h). Academy for Post-Graduate Education of Republic
p.000125: Belarus offers a course “Biomedical Ethics in Psychiatry” (for teaching professionals, clinical psychiatrists
p.000125: and investigators – 24 h).
p.000125: • In the framework of Russia—Belarus scientific-and-practical conferences on the problem of
p.000125: developing professional knowledge in bioethics (Kirov, 2003; Minsk, 2004) problems of teaching bioethics to
p.000125: medical students were discussed [17].
p.000125: In 2003 a second revised and amended edition of the text-book “Biomedical Ethics” is published [8]. The
p.000125: text-book supplement contains international guidelines, methodical recommendations for teachers, tests and
p.000125: case-studies.
p.000125: • In January (Moscow) and March (Minsk) 2005 in the framework of regional consultations for professionals in the
p.000125: field of education in ethics and bioethics held under the aegis of UNESCO experts from Belarus presented their relevant
p.000125: teaching programmes.
p.000125: • Since February 2005 BSMU offers a 64-hour course “Problems of Biomedical Ethics in Modern Theory and Practice” for
p.000125: BSMU teaching staff.
p.000125: • In May 2005 the republican student conference “Bioethics: Theory, Practice and Perspectives” was held and a volume
p.000125: of student papers was published.
p.000125: • In autumn 2005 BSMU held the student conference “AIDS: Information Practice. Formation of Positive Moral
p.000125: Values in Youth”.
p.000125: • In September 2005 BSMU organized a round table with Dr. Henry Williams (Head of the Tennessee Hospital, USA) and
p.000125: Dr. Joy Raily (Director of the Centre for Bioethics and Cell Technologies).
p.000125: • In May 2006 the Republican Scientific-and-Practical Conference “Medicine and Christianity” was held
p.000125: with a Section where bioethical problems were discussed in the context of the Orthodox worldview.
p.000125: • In November 2006 young scientists from the Institute for Post- Graduate Education of Belarus in
p.000125: cooperation with NCBE organized the scientific-and-practical conference “Humanization in the Education of
p.000125: Specialists in Medicine and Biology”; proceedings of conference were published [21].
p.000125: • The republican scientific-and-practical student conference “Culture and Medicine: interaction Paradigm” was held
p.000125: in May 2007.
p.000125: Thus, today we have relevant methodical materials including manuals, and national manuals.
p.000125: Besides, there are following teaching programmes for the system of high (undergraduate) medical education
p.000125: [11]:
p.000125: a. “General Ethics” (with sections “Bioethics” and “Ecological Ethics”)
p.000125: – for students of all specialties (Mishatkina T.V., Belyaeva E.V.) – 36 h;
p.000125: b. “Basics of Biomedical Ethics” – for medical undergraduate students (Mishatkina T.V., Denisov S.D., Kevra V.K.,
p.000125: Lugais N.E.) – 36 h;
p.000125: c. “Humanitarian Aspects of Modern Science (with Elements of Bioethics)” - for students of humanitarian
p.000125: specialties (Yaskevich Ya. S.) - 18 h;
p.000125: d. “The Conception of Modern Natural Sciences” – for students studying natural sciences (Yaskevich Ya.S.,
p.000125: Viazovkin V.S.) – 18 h;
p.000125: e. “Human Rights” – for students of all specialties (Yaskevich Ya.S., Gusev A.D., Gafarova Yu.Yu.) – 18 h;
p.000125: f. “Basics of Ecological Ethics” – for students in specialties “Ecology”, “Agricultural Science”, “Veterinary
p.000125: Science” (Mishatkina T.V., Boronnikova V.T., Silich T.V.) – 18 h.
p.000125: Today there are four institutes of higher medical education (in Minsk, Grodno, Gomel and Vitebsk)
p.000125: and the Faculty of Biomedicine at the International State Ecological University named after A.D. Sakharov.
p.000125: “Bioethics” as a subject is not included into the State Standard for Education, and, hence, there is no State system of
p.000125: education in bioethics.
p.000125: Therefore, bioethics is mostly taught within the Ethics Course (course duration depends on the decision of the
p.000125: Institute Council). At the BSMU bioethics is taught in the 1st and 2nd years (36 h). For senior students issues on
p.000125: biomedical ethics and deontology are included into courses on medical disciplines.
p.000125:
p.000126: 126
p.000126:
p.000127: 127
p.000127:
p.000127: With regard to bioethical education, we believe that it is essential to develop the ability to reflect on
p.000127: problems of human life and death, to form an understanding of the necessity to follow principles and rules of
p.000127: biomedical ethics in professional activity, to combine reason and feelings, intuition and logic, emotions and
p.000127: intellectual efforts. To achieve this goal, we have to define the problems we choose for bioethical education. From a
p.000127: variety of topics arising due to the development of biology, medicine and practical healthcare we chose
p.000127: most essential problems consistent with the principles of a system and holistic approach. Besides, to analyze
p.000127: ethical situations, we need to select from the whole volume of special knowledge sections that are most
p.000127: ethics-orientated and provide ethical and humanitarian comments by ethicists.
p.000127: At the same time, we are searching for interdisciplinary approaches to bring moral and ethical norms in conformity with
p.000127: the current medical and biological reality.
p.000127: An important achievement of the BSMU is that already at the stage of pre- clinical training medical students
p.000127: participate in resolving ethical problems relating to using dead human bodies in the teaching process and experiments
p.000127: on animals [14, 20]. In the course on human anatomy students are informed about legal, ethical and religious aspects of
p.000127: using a dead body of separate organs for an educational or scientific purpose. Learning ethical norms of handling
p.000127: anatomic preparations facilitates the development of the most essential humanistic quality – respect for a human
p.000127: being. Humane attitude to animals involved in experiments is very important for the development of compassion and
p.000127: empathy. Implementation of teaching aids alternative to experiments (computer programmes of experiments on virtual
p.000127: animals, video-films, CDs, three-dimensional models, etc.) allowed to exclude or minimize experiments on
p.000127: animals. As the result, students see that ethical principles are not merely postulated but implemented in practice.
p.000127: Medical students acquire bioethical knowledge out of class as well. Students of BSMU participate actively in
p.000127: the hospice movement. During several years they have been taking part in the BACCUP Programme at the Cardiff
p.000127: Medical University working as volunteers together with British medical students in summer holidays.
p.000127: Problems of bioethics, medical deontology and clinical ethics in medical practice can be successfully resolved only if
p.000127: medical professionals know the
p.000127: current legislation referring to healthcare. Therefore it is necessary, firstly, to regulate norms of medical activity
p.000127: according to new conditions in practical healthcare, and, secondly, to provide legal knowledge to medical specialists.
p.000127: Sociological surveys carried out in Belarus showed that, unfortunately, medical students, as a rule, do
p.000127: not have systematic knowledge in either deontology or medical ethics, or in medical and common law.
p.000127: A low level of education in ethics is typical of other categories: medical specialists and investigators, members of
p.000127: ECs, representatives of governing and legal institutions adopting laws and making decisions in healthcare and
p.000127: biomedicine, general public. This is a problem not only in Belarus or all regions of the post-Soviet space but in many
p.000127: other countries. Even when the level of education in bioethics may seem quite satisfactory, there is much of
p.000127: traditional paternalism. Thus, we still cannot get used to the idea that an individual’s right to life and
p.000127: death is his/her right and not the right of a physician, investigator or a legislator. Paternalism, in its turn, roots
p.000127: back to the authoritarian ethics in which interests of the society, State, science prevail over interests of an
p.000127: individual. Therefore we face the necessity to form new humanistic ethical way of thinking, which may be achieved
p.000127: through bioethical education.
p.000127: Today there are three levels of bioethical education in Belarus.
p.000127: The first level is teaching bioethics to medical undergraduates. The course “Basics of Biomedical Ethics” aims
p.000127: at forming a consciously ethical attitude to the alive and a devout attitude to human life. After completing the
p.000127: course, students have to:
p.000127: - know key conceptual models of bioethics and biomedical ethics, the history of their development and current
p.000127: state; understand their main concepts and categories;
p.000127: - be able to characterize the essence and basic problems of bioethics and biomedical ethics, their principles and
p.000127: values, moral aspects of topical problems of modern medicine and biomedical research;
p.000127: - be able to analyze specific character of bioethical knowledge and its role in resolving professional problems;
p.000127: - be able to analyze actual ethical situations in the context of the highest moral values and use normative and applied
p.000127: aspects of ethical knowledge in professional communication;
p.000127: - be able to make their own moral choice and bear the responsibility.
p.000127:
p.000128: 128
p.000128:
p.000129: 129
p.000129:
p.000129: It is desirable that during the Course medical students would acquire skill of ethical discussion and dialogue; would
p.000129: be able to prevent and resolve conflicts, develop an adequate self-evaluation, tolerance in evaluating their colleagues
p.000129: and an appropriate style of professional and personal behavior.
p.000129: Education at the second level aims at providing bioethical knowledge for medical practitioners through the system
p.000129: of raising their professional knowledge and post-graduate education. Here the situation is more
p.000129: complicated as the system is yet to be developed, though there are some achievements. At the Academy for Post-Graduate
p.000129: Education of Belarus at least four aspects of education in biomedical ethics are considered, though time given to these
p.000129: issues is insufficient (2-4 h). The four aspects are:
p.000129: – raising professional level of specialists with higher and secondary special education in medicine and
p.000129: pharmacy through education in bioethics
p.000129: – introducing courses on bioethics into syllabi and teaching programmes for retraining specialists with higher and
p.000129: secondary special education in medicine and pharmacy;
p.000129: - teaching bioethics within a programme for training teaching staff of high qualification (postgraduates, doctoral
p.000129: students);
p.000129: – raising professional level of professionals who organize and carry out clinical trials so that they could be admitted
p.000129: to this activity.
p.000129: However, we do not have a separate course on bioethics at the graduate and post-graduate levels. We also lack a State
p.000129: system of teaching GCP and a systematic training for EC members. Training courses in ethical review of clinical drug
p.000129: trials are held at the Republican Centre of Expertise and Trials in Healthcare. The course is very short (2-4 hours).
p.000129: There are no dissertation boards, and no dissertation on bioethics has been defended, as the Higher Certifying
p.000129: Commission does not have this discipline on the list of specialties. The first dissertation on bioethics as a basis of
p.000129: the physician’s professional culture is planned in the section of “Culturology”. Therefore, currently the question of
p.000129: introducing differentiated specialized courses on bioethics for different categories of postgraduate audience is under
p.000129: consideration.
p.000129: We also use some other opportunities to raise graduates’ and postgraduates’ professional level in
p.000129: bioethics, particularly, international grants received on one’s personal initiative. Thus V.K.Kevra participated in
p.000129: an Educational Project at the Lithuanian National Committee on Bioethics;
p.000129: O.P.Aizberg attended the Seminar on Bioethical Problems in Narcology organized by the “AWEF—AIDS: East-West”
p.000129: Foundation (Kiev, 2006).
p.000129: The third level – providing bioethical knowledge for the population
p.000129: – is the most “deserted” field of work. A low level of public awareness affecting the public opinion and
p.000129: decision making with regard to vitally important issues – from informed consent to adoption of laws – requires
p.000129: taking immediate measures to change the situation.
p.000129: Here we have high hopes for the Project “Education in Bioethics and Promotion of Bioethical Knowledge in Belarus”
p.000129: approved and supported by the Division of the Social Sciences and Humanities of the UNESCO Moscow Office.
p.000129: Within the next few years, the Project will help us to resolve the mentioned problems.
p.000129: The Project includes:
p.000129: • the development of teaching programmes in bioethics for ECs members considering their qualification and
p.000129: the content of EC work;
p.000129: • the development of guidelines for the system of raising the expertise level for EC members, organization of
p.000129: seminars on international documents relating to bioethics (UNESCO, WHO, Council of Europe, etc.);
p.000129: • the development of methodological basis and a long-term programme for raising the level of public awareness in
p.000129: bioethics.
p.000129: We hope that due to the use of necessary facilities, resources and ways of implementing the Project we shall be able to
p.000129: create a harmonious, logical and comprehensive theoretical model of biomedical ethics and a system programme
p.000129: of continuing education.
p.000129: Today in Belarus a number of highly qualified specialists are involved in theoretical work and in teaching
p.000129: bioethics. In the framework of the UNESCO Project, a list of experts in bioethics and bioethical education from
p.000129: Belarus has been compiled (49 experts). Among them, there are such leading specialists as Vismont F.I., Dr. of Medical
p.000129: Sciences, professor, corresponding member of the National Academy of Sciences, vice-chairman of the NCBE;
p.000129: Aizberg O.P., Candidate of Medical Sciences; Godovalnikov G.V., Candidate of Pharmaceutical Science, the director of
p.000129: the Republican Centre of Expertise and Trials in Healthcare; Denisov S.D., professor, prorector of BSMU; Lugais N.E.,
p.000129: Candidate of Historical Science, the secretary of NCBE; Mishatkina T.V., Ph.B., assistant professor, NCBE member;
p.000129: Morozkina T.S., professor, the State Prize laureate; Mosse I.B., Dr. of Biological Science,
p.000129:
p.000130: 130
p.000130:
p.000131: 131
p.000131:
p.000131: professor; Okeanov A.E., Dr. of Biological Science, professor; Silich T.V., senior staff scientist of the Central
p.000131: Scientific-and-Research Laboratory at the Medical Academy for Postgraduate Education of Belarus; Sliadneva N.E., the
p.000131: chief editor of newspapers “Animal World” and “Ecologist and Myself”; Yaskevich Ya.S., Ph.D., professor,
p.000131: vice-chairman of NCBE. Information about some of them is in the UNESCO site [22].
p.000131:
p.000131: 3.3.4. the System of Ethical Review*.
p.000131:
p.000131: Ethical review of clinical trials in Belarus is performed by Ethics Committees (local committees) at
p.000131: healthcare institutions authorized to carry out clinical trials, and at some institutions of the system of higher
p.000131: medical education (e.g.: BSMU and Medical Academy for Postgraduate Education of Belarus). National Committee on
p.000131: Bioethics (NCBE) established in April 2006 ensures public control with regard to the observance of ethical
p.000131: regulations in conducting clinical trials involving human subjects and experiments on animals.
p.000131: The process of establishing local ECs at healthcare institutions (hospital, out-patient clinic,
p.000131: scientific-and-research institute, scientific-an-practical centre) goes in parallel with the accreditation allowing
p.000131: to conduct clinical trials and in compliance with the Law on Healthcare (1993; amended in 2001); the Law on
p.000131: Pharmaceutical Products (2006); the Order No 254 of the Health Ministry of Belarus “On Approval of Guidelines for
p.000131: Clinical Trials of Pharmaceutical Products” (1999); Methodical Recommendations on Establishing ECs and their
p.000131: Operation (2000); Guidelines on Accreditation of Healthcare Institutions and Certification of Specialists
p.000131: Conducting Clinical Trials of Pharmaceutical Products, Medical Equipment and other Medical Goods (2004). The control of
p.000131: the process rests with the Republican Centre of Expertise and Trials in Healthcare authorized hereto by the Health
p.000131: Ministry of Belarus.
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: * This section has been written with the assistance of G.G. Voronov and G.V. Godovalnikov (Republican Centre of
p.000131: Expertise and Trials in Healthcare)
p.000131:
p.000132: 132
p.000132:
p.000133: 133
p.000133:
p.000133: In Belarus a gradual implementation of the procedure for a compulsory ethical review of clinical trials performed by
p.000133: ECs began in 1999 when the Order No 254 of the Health Ministry of Belarus was issued. The Order No 161 on 14 of May
...
p.000137: amendments to the text of the subject’s IC; amendments to the investigator’s brochure; information on safety (serious
p.000137: undesirable events); interim trial reports (especially in the case of long-term trials).
p.000137: When the ethical review is completed, the EC may make the following decisions: a positive decision (approval of
p.000137: the clinical trial); conditional decision (with clear suggestions for amendments); a negative decision (with clearly
p.000137: stated reasons);
p.000137: The Centre of Expertise and Clinical Trials in Healthcare surveys and evaluates ECs practices via inspections at the
p.000137: site of the trial. In the period from September 2004 to February 2006, the Centre carried out 76 inspections to survey
p.000137: EC practices in Minsk and all regional Centres.
p.000137: Thus, Republic Belarus has created quite an efficient system for ethical review of the CT documents that forms a part
p.000137: of a system for public and State control, which ensures the protection of human rights and interests in the Republic.
p.000137: Today we have different types of committees for bioethics (ethical committees, commissions on ethics, associations,
p.000137: etc.) functioning at different regulatory levels (national, regional, local). Committees belonging to
p.000137: each of these types have their goals and functions and find a common ground in solving ethical dilemmas arising
p.000137: in different fields of research and healthcare. The creation of the National Committee for
p.000137: Bioethics (NCBE) and its efficient functioning in compliance with the Project Proposal “Establishing the
p.000137: National Committee for Bioethics and Providing Bioethical Education to Specialists in Republic of Belarus” (in
p.000137: the framework of the Programme of Social Sciences and Humanities, UNESCO Moscow Office) aims to provide a competent
p.000137: ethical review of scientific research in healthcare, to organize forums for discussing problems of bioethics on a
p.000137: national level, and to have an impact on the development of legislation policy in the field of bioethics.
p.000137: The NCBE has been established as an advisory body to exercise public control of compliance with ethical norms and
p.000137: regulations in experiments on animals and research involving human subjects in order to safeguard human rights and
p.000137: freedoms when applying to them modern scientific achievements, and in educational, treatment-and-preventive and
p.000137: other activities. The Statement on the National Committee for Bioethics has been approved by the Order of the Health
p.000137: Ministry of Republic Belarus. The Statement sets out a wide range of the NCBE functions with regard to:
p.000137: - providing healthcare, monitoring clinical trials and registration of new pharmaceutical products and medical
p.000137: technologies;
p.000137: - disease treatment and prevention and scientific-research activity;
p.000137: - providing bioethical education to professionals and public at large;
p.000137: - legislative initiatives concerning healthcare and biomedical research;
p.000137: - resolving social and legal problems in nature-conservative activities [20].
p.000137: The NCBE is independent in its appraisals, opinions and decisions. It has the status of an advisory
p.000137: body, and does not make legal decisions but actively cooperates with legislative and executive bodies and
p.000137: with public organizations. In autumn 2006 the NCBE members T.V. Mishatkina and Ya.S. Yaskevich took part in the
p.000137: meeting of the Round Table at the National Assembly of Republic Belarus, where the Law Project “On the
p.000137: Transplantation of Human Organs and Tissues” was discussed [25,26]. The Law was adopted in March 2007.
p.000137: Thus, the NCBE should facilitate:
p.000137: - the development of a democratic mechanism for the discussion and analysis of difficult moral problems
p.000137: relating to the achievements in biomedical science and technology;
p.000137:
p.000138: 138
p.000138:
p.000139: 139
p.000139:
p.000139: - public control ensuring the protection of human rights according to criteria of biomedical ethics;
p.000139: - the development of proposals relating to the legal regulation in biomedicine;
p.000139: - EC establishing, regulation and coordination of their activity at different levels; education of the EC
p.000139: members;
p.000139: - raising the level of a continuing bioethical education in professional medical community (from undergraduate to
p.000139: postgraduate education);
p.000139: - creating the opportunity for international cooperation in bioethics;
p.000139: - promoting a healthy life-style and informing the population about achievements and current problems in
p.000139: bioethics.
p.000139:
p.000139: 3.3.5. Perspectives and Forms of International Cooperation
p.000139:
p.000139: Republic of Belarus has developed an effective partnership with the leading international organizations such
p.000139: as UNESCO and Forum for Ethics Committees in the Commonwealth of Independent States, as well as bilateral cooperation
p.000139: with The Institute of Philosophy of the Russian Academy of Sciences, the Ukraine State Medical University named after
p.000139: Bogomolets, the Ukrainian Association on Bioethics, Higher Medical School of Hanover, the Committee for Ethics in
p.000139: Science of the Warsaw University, the National Committee for Bioethics of Lithuania, the Lithuanian Association
p.000139: of Psychiatrists, the Fogarty International Centre and National Institute of Health (USA), etc. Results of
p.000139: scientific and teaching-and-methodical work are presented at international conferences. In particular,
p.000139: professionals from Belarus participated in the International Scientific Conference on Humanities in the
p.000139: Contemporary World (Saint-Petersburg, 2002) [10] in the International Scientific and Practical Seminar on Bioethics in
p.000139: the framework of the programme of Fogarty International Centre (Bulgaria, 2003) and in regular international seminars
p.000139: and symposia held in Kiev Materials prepared by Belarusian scientists in the framework of international cooperation are
p.000139: published in Russian and Ukrainian scientific journals and in volumes of conference proceedings [27-29].
p.000139: Participation of Belarus professionals in the FECCIS and, particularly, in meetings and symposia of the FECCIS in
p.000139: St.-Petersburg, Baku, Yerevan and Kiev is very essential for the development of bioethical thought and
p.000139: bioethics in Belarus. Seminars organized in the framework of the FECCIS and reports by leading specialists and experts
p.000139: of the international level are certainly very helpful for a more profound understanding of bioethical problems
p.000139: and dilemmas and facilitate education of persons concerned.
p.000139: During the last years, specialists in bioethics from Belarus have been taking part in activities undertaken by UNESCO,
p.000139: particularly, in meetings of regional experts in bioethics (January 2005, Moscow; March 2005, Minsk; September 2005,
p.000139: Vilnius). On the request of UNESCO, T.V.Mishatkina, an expert in ethics from Belarus, designed and submitted to
p.000139: the UNESCO Headquarters 11 educational programmes on the fundamentals of education in ethics and bioethics.
p.000139: Today the international cooperation in implementing bioethical principles and developing ethical review of
p.000139: biomedical research goes along three directions supported by UNESCO:
p.000139: – theoretical development of a conceptual model of bioethics;
p.000139: – practical work on the organization of the National Committee and on the development of local ECs activity;
p.000139: – providing bioethical education to professionals and general public in accordance with the Project Proposal
p.000139: within the Programme for Social Sciences and Humanities(UNESCO Moscow Office) “Bioethics Education in Republic of
p.000139: Belarus”.
p.000139: Cooperation in developing the theory of the ethics of biomedical research. A joint project “Social,
p.000139: Philosophical and Ethical Problems of Genomic Research and Clinical Medicine” is carried out in
p.000139: cooperation with the Institute of Philosophy of the Russian Academy of Sciences. The theme of the Project has been
p.000139: approved by the Belarusian Republican Fund of Fundamental Research at the National Academy of Science of Belarus and
p.000139: Russian Foundation for the Humanities (Project Directors: B.G. Yudin and T.V. Mishatkina; the term of the Project – two
p.000139: years).
p.000139:
p.000139: Project objectives:
p.000139: 1. on the basis of the interdisciplinary approach to make an inventory, description and analysis of social,
p.000139: philosophical and ethical problems in genomics, modern biotechnologies and clinical medicine;
p.000139: 2. to trace global and national tendencies of principles of bioethical regulation in research and medical practices;
p.000139:
p.000140: 140
p.000140:
p.000141: 141
p.000141:
p.000141: 3. to work out recommendations on methodology and procedures of humanitarian review in the above-mentioned
p.000141: fields;
p.000141: 4. to specify the conceptual model of biomedical ethics. To achieve the goals, we have to solve the following tasks:
p.000141: - theoretical and methodological analysis of interdisciplinary approaches and finding mechanisms for
p.000141: interaction between humanities and natural sciences;
...
p.000141: bioethical knowledge; investigation of its structure, functions, principles and specific nature of moral values;
p.000141: development of a conceptual model of bioethical ethics;
p.000141: - development of operational standards for a complex humanitarian expertise and control in the field of genomics,
p.000141: biotechnologies and clinical;
p.000141: - theoretical and methodological substantiation of the activity of the National Committee on Bioethics of Republic
p.000141: Belarus, the development of its Statute and recommendations for stimulating the activity of regional and local
p.000141: bioethics committees.
p.000141: Project Outcomes: the inventory and analysis of social, philosophical and ethical problems caused by the
p.000141: development of genomics, modern biotechnologies and clinical medicine as a methodological basis for the
p.000141: development of a conceptual model of biomedical ethics, and for working out recommendations for a complex
p.000141: humanitarian expertise and ethical regulations guiding the practice of biomedical research.
p.000141: The practical application of the Project results is possible in the following directions:
p.000141: а) in establishing and regulating practices of bioethical committees to conduct a complex humanitarian
p.000141: expertise and to monitor biomedical research and pharmacological trials involving human subjects, the process of
p.000141: implementing results of new biotechnologies and the compliance with ethical regulations in clinical practice;
p.000141: б) in developing the strategy and tactics of bioethical education and the system of a continual
p.000141: education to raise the professional level of specialists in medicine and biology; in designing manuals and
p.000141: methodical
p.000141: recommendations for teaching fundamentals of biomedical ethics to undergraduate medical students;
p.000141: в) in raising the level of bioethical culture and competence in the
p.000141: population.
p.000141: Results of this cooperation will be presented at an international scientific conference in 2007; the work on a
p.000141: collective monograph is under way.
p.000141: In the framework of international cooperation, we continue the analysis of bioethical consequences of genetic
p.000141: research. In October 2006 Minsk hosted the International Conference “The Evaluation of Risks from a
p.000141: Combined Effect of Anthropogenic Factors: Prognosis for the Future”. Co- Directors of the Conference were prof.
p.000141: C.Mazersill (McMaster University, Hamilton, Canada) and prof. I.B.Mosse (Minsk, National Academy of Science,
p.000141: Republic Belarus). Leading specialists from 16 countries (USA, Canada, England, Norway, Italy, Portugal, Ireland,
p.000141: Russia, Belarus and other countries of East Europe, Asia and Africa) attended the Conference. Forty- five presentations
p.000141: made at the Conference reflected the current situation with regard to the environment pollution with radiation and
p.000141: chemical products. The speakers suggested possible ways of preventing negative consequences caused by anthropogenic
p.000141: factors. Reported data are of a great interest for the Belarusian science. They also are helpful in outlining ways for
p.000141: the use of achievements of modern science taking into account bioethical problems. Joint scientific projects aiming at
p.000141: the elimination of consequences from a combined effect of anthropogenic factors were designed in the framework of
p.000141: international scientific-and-technical programmes. Full texts of the Conference reports (about 1000 pages) will
p.000141: be published in a monograph. The co-editor of the monograph from Belarus is prof. I.B. Mosse.
p.000141: Cooperation in the field of bioethical education is focused on the development of teaching programmes and
p.000141: on the exchange of methods, materials and experience in bioethical education with countries which are most
p.000141: developed in this respect. In the post-Soviet space, our partners are Russia, Lithuania (Lithuanian Bioethical
p.000141: Committee, Medical Faculty of the Vilnius University, Kaunas Medical University), Ukraine (Ukrainian
p.000141: Association on Bioethics, the Medical Academy of Post-Graduate Education of Ukraine); Moldova and Armenia are our
p.000141: prospective partners.
p.000141: Cooperation in this field aims at enhancing the access to existing information resources and widening
p.000141: contacts between experts in bioethics.
p.000141:
p.000142: 142
p.000142:
p.000143: 143
p.000143:
p.000143: Another objective is to develop and introduce into practice teaching programmes, methods and approaches
p.000143: ensuring the acknowledgement and understanding of principal bioethical problems in medical community and in public at
p.000143: large.
p.000143: Main ways of cooperation here are the design and subsequent use of modules of teaching programmes on biomedical ethics
p.000143: for a differentiated ethical education in different social communities.
p.000143: One of the last events demonstrating the cooperation in bioethical education was a Scientific-and-Practical
p.000143: Seminar “Humanization in the Education of Specialists in Medicine and Biology” held by young scientists of the
p.000143: Belarus Academy of Post-Graduate Education. The Seminar was supported by the Health Ministry of Republic
p.000143: Belarus, the National Committee on Bioethics and the Belarusian Republican Fund of Fundamental Research at the National
p.000143: Academy of Science of Belarus. Experts from UNESCO, InterNICHE (United Kingdom) and Centre for Protection Animals’
p.000143: Rights “Vita” (Russia) participated in the Seminar. The main objectives of the seminar were the
p.000143: discussions relating to the observance of principles of bioethics in scientific and educational activity,
p.000143: and, in particular, the use of laboratory animals in science and education and the application of new alternative
p.000143: technologies in education and in scientific experiments [39-42].
p.000143: International cooperation on establishing the National Committee on Bioethics in Belarus. The starting
p.000143: point in establishing the National Committee on Bioethics in Belarus was an International Seminar “The
p.000143: National Committee on Bioethics of Belarus Republic and the Activity of Local (Regional) Committees on
p.000143: Bioethics: the Experience of the East and Central Europe”. The seminar aimed at providing knowledge on ECs operation
p.000143: and the procedure of ethical review of biomedical research in the context of European experience. The
p.000143: Seminar was supported by the UNESCO Moscow Office and the Belarusian Commission for UNESCO. Other partners in
p.000143: organization and holding the Seminar were the FECCIS, GCP Alliance – Europe, the Health Ministry of Republic of
p.000143: Belarus, the Centre for Expertise and Trials in Healthcare, Belarus State Medical University, the State
p.000143: Economical University of Belarus (Institute of Education in Social Sciences and Humanities), the
p.000143: Belarus Academy of Post-Graduate Education, International State Ecological University named after A.D. Sakharov.
p.000143: International experts in bioethics and research ethics, prof. O.I. Kubar
p.000143: – the Chairperson of the FECCIS, prof. B.G.Yudin and representatives from Latvia, Lithuania, Moldova, Poland,
p.000143: Russia and Ukraine attended the Seminar. Members of Belarus local and regional ECs also took part in the Seminar.
p.000143: Participants discussed issues relating to the creation and functioning of National Committees on Bioethics in the light
p.000143: of Universal Declaration on Bioethics and Human Rights adopted by UNESCO in 2005. Other issues discussed at the Seminar
p.000143: were the perspectives of establishing the NCBE of Belarus; its main objectives, tasks and functions; coordinating its
p.000143: activity with the Centre of Expertise and Clinical Trials of Republic Belarus and local ECs in the context of the
p.000143: relevant experience in countries of East and Central Europe. There was much discussion on the NCBE functions, rights
p.000143: and responsibilities, its possible impact on the activity of local ECs and providing assistance and support
p.000143: to them. Independence of financing of the NCBE and problems of raising the public awareness in bioethics were also
p.000143: topics of an active discussion. The experience of countries of the Central and East Europe in the development of
p.000143: bioethics and in the ECs practices was discussed at one of the Seminar sessions. In the course of the Seminar FECCIS
p.000143: presented the SIDCER “Recognition Programme “ and organized a training course for members of Belarus local and regional
p.000143: ECs and all other participants. After the course, the participants received course certificates. At the closing session
...
p.000143: administrative decision-making. Bioethics ensures the moral climate in scientific and medical communities
p.000143:
p.000144: 144
p.000144:
p.000145: 145
p.000145:
p.000145: and adequate choices made by physicians, biologists and biotechnologists by determining the measure of their
p.000145: intervention into the sphere of the live, and the measure of their responsibility for the results of their scientific
p.000145: and practical activity before the society.
p.000145:
p.000145: References
p.000145: 1. Ethics. Teaching manual. Ed. By T.V.Mishatkina, Ya.S.Yaskevich, 3rd edition. Minsk, 2002. (in Russian)
p.000145: 2. Boyko Yu.G., Silyaeva N.F. The problem of physicians’ mistakes in medical deonthology. Medical News, 1999, No. 9.
p.000145: (in Russian)
p.000145: 3. Denisov S.D., Yaroshevich S.P. Teaching of medical ethics and deontology bases in the course of human
p.000145: anatomy. Guidelines. Minsk, 1999. (in Russian)
p.000145: 4. Makshanov I.Ya. Physician’s deothology. Teaching manual for medical institutes. Minsk, 1998.
p.000145: 5. Medical ethics and deonthology. Teaching manual for students and young physicians. Compiled by N.I.Artishevskaya
p.000145: et al. Minsk, 1997. (in Russian)
p.000145: 6. Stanchits М.А. Etics of charity. Minsk, 1996. (in Russian)
p.000145: 7. Lossky N.О. The character of Russian people. In: Lossky N.О. Conditions of an absolute good. Мoscow,
p.000145: 1991. (in Russian)
p.000145: 8. Biomedical ethics. Teaching manual. (Ministry of education of Belarus). Ed. by T.V.Mishatkina,
p.000145: S.D.Denisov, Ya.S.Yaskevich. Minsk, 2003, 320 p. (in Russian)
p.000145: 9. Biomedical ethics: problems and perspectives. Proceedings of international conference, Minsk, 12-13 October
p.000145: 2000. Ed. by T.V.Mishatkina, S.D.Denisov, Ya.S.Yaskevich. Minsk, 2000. (in Russian)
p.000145: 10. Mishatkina Т.V. Biomedical ethics: status and the round of problems.
p.000145: Ibid.
p.000145: 11. Mishatkina Т.V. Bases of biomedical ethics: the programme of
p.000145: training course. Ibid., 23rd issue, pp. 355-360.
p.000145: 12. Biomedical ethics. Teaching manual. Ed. by T.V.Mishatkina, S.D.Denisov. Minsk, MSMU publications, 2001.
p.000145: 256 pp. (in Russian)
p.000145: 13. Yaskevich Ya.S., Kuznetsova L.F., Barkovskaya А.V. Contemporary
p.000145: science: value orientation. Teaching manual. Minsk, 2003. (in Russian)
p.000145: 14. Denisov S.D. Humanistic attitude to animals – one of main goals in humanization of higher medical education.
p.000145: Abstracts of Belarus-Britain symposium “Ethical aspects of animal use in training process and in research”
p.000145: (October 1997, Minsk, MSMI). Ed. by S.D.Denisov. Minsk, 1998. (in Russian)
p.000145: 15. Denisov S.D. Medical students should not kill. Proceedings of the international symposium “Bioethics on the eve of
p.000145: XXI century”. Kharkov, October 2000. (in Russian)
p.000145: 16. Denisov S.D. Requirements to scientific experiment with animals. Public Health, 2001, N 4. (in Russian)
p.000145: 17. Morozkina T.S. Deontological aspects of animal use in teaching process. Higher School, 1996, N 1, p. 30-35.
p.000145: (in Russian)
p.000145: 18. Morozkina T.S., Denisov S.D. Implementation of the principles of the three RS in Belarus: reality and perspective.
p.000145: Abstracts of the 3th World Congress on Alternatives and Animal Use in the Life Sciences. Bologna, Italy, 1999, p. 397.
p.000145: 19. National and local bioethics committees: the experience of Central and Eastern Europe. Materials of
p.000145: international conferences on bioethics. Minsk, 2006. (in English)
p.000145: 20. Bioethics: theory, practice, perspectives. Proceedings of the Republican student conference. Ed. by
p.000145: S.D.Denisov. Minsk, BSMU, 2005. (in Russian)
p.000145: 21. Mishatkina Т.V. Ethical and humanistic bases of contemporary biomedical education. Humanization of teaching
p.000145: of medical and biological specialists (in Russian)
p.000145: 22. Ethical training in Belarus (Programmes of bioethics courses). UNESCO web-site www.bioethics.ru (in Russian)
p.000145: 23. Mishatkina Т.V. Three circles of ethics. “Chelovek”, 2006, N 5, p.
p.000145: 89-98. (in Russian)
p.000145: 24. Mishatkina Т.V., Yaskevich Ya.S. Collaboration of ethics committees with patients during biomedical research
p.000145: in Belarus. Proceedings of the international conference of FEC CIS. Erevan, 2005. (in Russian)
p.000145: 25. Yaskevich Ya.S. Moral, ethical, legislative and organizational bases of organ and tissue transplantation. Materials
p.000145: of round-table of the Belarus National Assembly for discussion of the druft of Belarussian Law “On
p.000145:
p.000145:
p.000146: 146
p.000146:
p.000147: 147
p.000147:
p.000147: transplantation of human organs and tissues”. Minsk, 2006, p. 27-31. (in Russian)
p.000147: 26. Mishatkina Т.V. Biomedical ethics as a science and as teaching discipline. Values of the world: ethics and
p.000147: bioethics. Scientific Forum. Kiev, 2005. (in Russian)
p.000147: 27. Mishatkina Т.V. Existencial meaning of suffering and compassion in biomedical ethics. Proceedings of the Russian
p.000147: scientific conference with international participation “Anthropological bases for bioethics”. Tomsk, 2006,
p.000147: p.125-127. (in Russian)
p.000147: 28. Yaskevich Ya.S. Anthropological, social and cultural bases for bioethics. Ibid, p. 232-237. (in Russian)
...
p.000153: Council on Bioethics. The letter considered the document during its three different sittings and finally published the
p.000153: final text of the Code, which was adopted at the last session of the First Congress of Physicians of Georgia.
p.000153: The Ethics Code of Physician of Georgia is the first national code of ethics in the sphere of biomedicine. It includes
p.000153: specific provisions aiming at protecting research subjects. Particularly it says the following:
p.000153: “Patient’s interests are supreme in scientific research on human being. The research goals and its possible outcomes
p.000153: never interfere with the main mission of a physician – to serve for patient’s health and life.”
p.000153: Although much has been done in building of the legal protection of the research subjects, many problems
p.000153: are remained to be addressed. Just to mention, no sanctions are yet introduced against violation of the rights of
p.000153: research subjects and infringement of the principles reflected in existing legislation on biomedical research. Also,
p.000153: existing ethics committees need be improved and the new system of research ethics committees is to be
p.000153: implemented. The draft regulation for the new system of research ethics committees has been already
p.000153: prepared. Its legitimisation will become possible after ratification of the Law on Biomedical Research
p.000153: Involving Human Subjects.
p.000153:
p.000153: 3.4.3 Education in Bioethics
p.000153:
p.000153: Education in the field of Bioethics in Georgia has developed chiefly in two domains: on one hand, high medical
p.000153: education system at Tbilisi State Medical University; on the other hand, in the shape implementation of legislation
p.000153: related to human rights, health and biomedicine developed by Health legislation and bioethics group at National
p.000153: Institute of Health (former National Health Management Centre) and Georgian Health Law
p.000153: and Bioethics Society. Since its establishment GHLBS has been actively involved in educational programmes in the field
p.000153: of Bioethics and has been incessantly organizing various training courses aiming at rising awareness of, on one
p.000153: hand, patients and general public, and on another, medical society.
p.000153: Currently, Tbilisi states medical university offers courses in Bioethics at different levels: on undergraduate level –
p.000153: for medical students, and on postgraduate level – for residents. Both courses are obligatory and constitute integral
p.000153: part of study curriculum.
p.000153: Individuals who successfully enter residency-training program after graduation of high medical school are expected to
p.000153: take one-week obligatory program in bioethics during their residency training. The course focuses on raising
p.000153: awareness of residents about modern principles of bioethics/ medical ethics and of relevant legislation of
p.000153: Georgia and assisting them in developing skills for coping with various ethical problems/dilemmas which may
p.000153: arise during their professional medical activity. During the course the audience is introduces with the issues
p.000153: related to various ethical problems associated with development of new technologies in the field of health
...
p.000159: created (law on health care; adopted in 1997) and requirements for organizing drug trials are specified (law on drug
p.000159: and pharmaceutical activity; adopted in 1995),
p.000159: • Convention on Human Rights and Biomedicine is signed and ratified (entered into force in Georgia on 1.03.01);
p.000159: also, its additional protocol on Biomedical Research has been signed;
p.000159: • First research (institutional) ethics committees for drug trials are established;
p.000159: • Specific law on biomedical research involving human subjects has been drafted and submitted to the Government;
p.000159: • Concept on the establishment of the two-tired network of research ethics committees on the regional level has been
p.000159: drafted (central research ethics committee and regional research ethics committees);
p.000159: • National council on bioethics stresses the importance of strengthening the system of ethical review of
p.000159: research protocols and advocates for the speeding up of the process of adoption of the specific law on biomedical
p.000159: research;
p.000159: • Teaching programmes in bioethics, including research ethics have been introduced on undergraduate as
p.000159: well as postgraduate level (programmes for residents and doctoral students as well as continuing medical
p.000159: education programmes for practicing physicians) of medial education/training.
p.000159: Is to be done:
p.000159: • Stimulation and speeding up the process of ratification of the law on biomedical research involving human
p.000159: subjects;
p.000159: • Introduction of sanctions in administrative and criminal code of Georgia for the infringement of the
p.000159: principles set out in the legislation related to the protection of research subjects;
p.000159: • Enforcement of the above mentioned concept on ethics committees (order of the minister of health or inclusion of
p.000159: the main statements of the concept in the draft law on biomedical research during the discussions at the parliament);
p.000159: • Education: undergraduate, postgraduate education; education of potential members of research ethics
p.000159: committees;
p.000159: • Establishment of central and regional ethics committees;
p.000159: • Setting up quality assurance system for research ethics committees.
p.000159:
p.000159: Finally, step-by-step we have to strengthen mechanisms, which will ensure that the rights and dignity of
p.000159: human research subjects are duly protected. This will be one more brick in the wall in the process of building
p.000159: democratic society, which doesn’t allows injustice to take place among people.
p.000159:
p.000159:
p.000160: 160
p.000160:
p.000161: 161
p.000161:
p.000161: 3.4.5 Perspectives and Forms of International Cooperation
p.000161:
p.000161: Georgia is the member of all international cooperation in the field of protection human rights in
p.000161: biology and medicine. Collaboration develops through the representatives of Georgia in international
p.000161: bodies and organisations, by following the international regulations, involving in educational and training
p.000161: programmes on bioethics and research ethics and by participation in scientific and practical conferences and
p.000161: workshops organized on global and regional levels. Scientific publication and common international projects help to
p.000161: share the experience and to build the harmonized relations in the bioethics in the frame of international
p.000161: informational, legal and research space.
...
p.000171: clinical trials;
p.000171: 2) arbitration of complex aspects on ethical assessment performed by local commissions;
p.000171: 3) registration of clinical trials that are performed in the province or in the city;
p.000171: 4) counseling of members of local commissions.
p.000171: The main functions of local commissions responsible for ethical reviews are as follows:
p.000171: 1) performance of ethical assessment of all documentation on clinical trials;
p.000171:
p.000171:
p.000172: 172
p.000172:
p.000173: 173
p.000173:
p.000173: 2) performance of ethical assessment of all changes and additions to documentation on clinical trials;
p.000173: 3) conclusions on agreement or refusal for the beginning or continuation of clinical trials;
p.000173: 4) assessment of following ethical, moral and juridical norms in the process of clinical trials and after
p.000173: their end.
p.000173: The commission should include sufficient number of members that would have the necessary experience and
p.000173: qualification to be able to assess all ethical, moral and juridical aspects of planned research; besides commission
p.000173: members should be independent of researches and sponsors and should not participate in the planned
p.000173: clinical research. The commission should include at least 5 members, namely specialists that are competent
p.000173: in the area of clinical trials as well as persons who are not researches themselves, specialist in legislation,
p.000173: representatives of religious community and of non- governmental organizations; the commission should include
p.000173: males and females of different age groups.
p.000173:
p.000173: 3.5.3. Education in Bioethics
p.000173:
p.000173: During the last decades due to new approaches to moral and ethical problems in medicine and science,
p.000173: development of bioethics as a interdisciplinary field, it was necessary to revise the respective educational
p.000173: programmes at all levels.
p.000173: The science “Bioethics” as a separate science was not included in the State standard of university medical education in
p.000173: the Republic of Kazakhstan, but many aspects related to bioethics were included in other programmes (specialties). For
p.000173: example, at the Semipalatinsk State Medical Academy problems of biomedical ethics were included in the programme
p.000173: of discipline “Communicative skills” at the department of internal diseases. At the moment special training
p.000173: programme is under the process of development. At the Kazakhstan State Medical Academy (in Astana) problems of
p.000173: biomedical ethics were included in the training programme at the department of public health. Similar situation took
p.000173: place in other medical universities of the country. In December 2006 the Scientific Council of the Almaty
p.000173: Institute for Postgraduate Training has decided to organize the Department of health legislation and bioethics in
p.000173: 2007. It will allow to introduce widely into
p.000173: the practice main principles of human rights protection of persons who participate in studies or experiments.
p.000173: At present time different aspects of scientific research ethics are often included in programmes of postgraduate
p.000173: training. For example, since 2001 the Higher School of Public Health (HSPH) began to realize training programmes for
p.000173: researches of the public health system. Starting since 2002 the Higher School of Public Health became the participant
p.000173: of the international programme “Intensive training on bioethics”. Together with Bangladesh Council on Medical
...
p.000173: with participation of human beings; informed consent; confidentiality; motivation; ethics of clinical studies;
p.000173: ethics of population and demographic studies; ethical aspects of scientific research in the area of health of children
p.000173: and reproductive health; functions of ethical committees; manuals on ethical review; organization of scientific
p.000173: research in developing countries; religion and culture in ethics and other topics.
p.000173: Around 20 specialists from different research institutions of the country participated in the development of
p.000173: programmes for workshops that were organized at the Higher School of Public Health. In future the Consultative
p.000173: Committee will be responsible for the general management of the programme, its monitoring and assessment. The programme
p.000173: was translated into English and sent for revision to international consultants.
p.000173: Recently programmes on bioethics were developed at the department of pharmaceutical management of the Higher School of
p.000173: Public Health for public health managers (18 training hours) and for public health masters (45
p.000173:
p.000174: 174
p.000174:
p.000175: 175
p.000175:
p.000175: training hours). At the same time it is necessary to mention that programmes that were developed not fulfill completely
p.000175: the growing demands of education in bioethics area.
p.000175: The level of knowledge and education on legislation among general public seeking health care improved
p.000175: recently; the network of ethical committees in research institutions of the country enlarged significantly, the
p.000175: role of Kazakhstan’s scientists in international research increased including multi-centre clinical trials of
p.000175: medical drugs. That is why educational programmes in the area of bioethics should be revised and improved for
p.000175: medical students and graduate physicians, researches, nurses, members of ethical committees and other specialists.
p.000175:
p.000175: 3.5.4. The System of Ethical Review
p.000175:
p.000175: According to recent legislative acts to ensure ethical control of biomedical research in the Republic of
p.000175: Kazakhstan the Ministry of Public Health started intensive activity to organize ethical commissions at research
p.000175: institutes and in the most significant clinical institutions. Simultaneously according to initiative of the
p.000175: Association of Physicians and Pharmacists of Kazakhstan at the Almaty Institute for Postgraduate Training The National
p.000175: Public Committee on Bioethics was organized; this committee is responsible for ethical control not only in the system
p.000175: of the Ministry of Health but also in institutions of other ministries where studies and trials with participation of
p.000175: human beings are conducted. Recently this initiative became more active through the National Coordinating Council
p.000175: for Health Protection, the Government of Kazakhstan, the Parliament of the Republic of Kazakhstan, non-governmental
p.000175: organizations and international organizations.
...
p.000181: as it describes customs and moral traditions, philosophical and aesthetic views, moral principles and norms
p.000181: of behaviour. With regard to its moral significance, “Manas” may be compared to Confucian Pentateuch. Like
p.000181: Confucian ethics, “Manas” depicts a model of putting the world into good order. Much attention is given
p.000181: to the struggle against chaos, which is expressed through regulation of human relationships, i.e. by establishing norms
p.000181: of behaviour, the system of prohibitions and social stratification.
p.000181: “Manas” is called a “cultural encyclopedia” of Kyrgyz people. It ranks among outstanding monuments of world
p.000181: culture, such as “Iliad” and “Odissey”, “Mahabharata”, “Epic of Gilgamesh”, “Kalevala”, “Rigveda” and many
p.000181: others. The Turkic epic poem “Manas” differs from west European, Slavonic and other epic poems not just in its
p.000181: volume. It covers a long historical period and gives a detailed genealogy and a distinct biographical line of
p.000181: athlete Manas – the central hero of the epic poem – from the moment of his birth to his death including the description
p.000181: of main events of his life. Poems, songs and legends passed across the generations served as a teaching
p.000181: material in folk pedagogics. The unique nature of oral folklore allows people to pass their moral knowledge to
p.000181: future generations within a family and within a clan thus ensuring continuity of spiritual life and
p.000181: connection between epochs. Another equally efficient method of education was joining to folk customs and traditions.
p.000181: Epic poems embraced all sides
p.000181: Ethical views of the early Kyrgyz make up a system of values, norms and rules based on aspiration for happiness.
p.000181: Therefore, ethics of the ancient Kyrgyz may be defined as the ethics of positive eudemonism19, and their overall
p.000181: worldview as world- and life-asserting.
p.000181: Although the epic poem does not contain distinctly formulated precepts, moral lessons learned from centuries-long
p.000181: history formed a traditional system of moral values that has survived to our days:
p.000181: 1. unity and solidarity of the nation,
p.000181: 2. international accord,
p.000181: 3. national honour,
p.000181: 4. movement towards prosperity and well-being through a continuous labour and knowledge,
p.000181: 5. humanism, generosity, tolerance,
p.000181: 6. harmony with nature,
p.000181: 7. strengthening and protection of Kyrgyzstan state system.
p.000181: Ethical norms in “Manas” are based on four cardinal virtues (wisdom, patience, conscience and generosity) that are
p.000181: personified in images. They are opposed by four vices: laziness, wickedness, greed and arrogance. It is said that a
p.000181: clever person is always able by using one’s mind which is “the best of all treasures” to oppose positive qualities to
p.000181: negative ones and defeat the evil by kindness, wickedness by patience, greed by generosity. Hence, the person has to
p.000181: make every effort to improve his or her moral nature, to overcome evil elements and to change the surrounding world.
...
p.000183: Kyrgyz ethnos had been existing in form of clans. Relationships within the community had been forming during
p.000183: a long historical period. Changes, if any, occurred due to the influence of external environment forming the worldview:
p.000183: the sense of sharing needs and interests of other people, feelings of mutual aid and collectivism. Kyrgyz people
p.000183: survived in crisis situations only due to spiritual and genetic health of their ancestors. People retained and
p.000183: developed clan traditions, upbringing practices, code of ancestral honour. Clan honour for Kyrgyz people is one of
p.000183: the most essential concepts. Every Kyrgyz had his ancestors, his land and his clan. Each clan had its hierarchy
p.000183: at the head of which was the most respected clan member. Collectivism, mutual aid, empathy, respect for other
p.000183: people – those were the qualities inherent in Kyrgyz mentality.
p.000183: Cultural and historical sources reveal respect to women in nomadic tribes, however there were conflicting
p.000183: traditions with regard to this issue. It is noteworthy that women had a high social status in Kyrgyz society [6].
p.000183: Ethical ideas in works by Kyrgyz thinkers. Spiritual culture of Kyrgyz people reflected in philosophical and poetic art
p.000183: of akyns20 is characterized by the search for perfection. Problems of upbringing and education, of humanism
p.000183: and love for people have a significant place in philosophical poetry of Kyrgyz thinkers, and therefore there
p.000183: is every reason to consider
p.000183: 20 Akyn is an improvising poet and singer in the Kazakh and Kyrgyz cultures. Akyns played and important role in terms
p.000183: of expressing people’s thoughts and feelings, exposing social vices, and glorifying heroes.
p.000183:
p.000184: 184
p.000184:
p.000185: 185
p.000185:
p.000185: it as a code of moral and ethical norms on human behaviour in Kyrgyz culture. Some scientists associate
p.000185: this special attention to moral issues with an access to Chinese sources known for their interest in ethics. The
p.000185: history of development of ethical and philosophical ideas in Kyrgyz culture may be divided into three stages. The first
p.000185: stage is associated with names of late medieval Kyrgyz thinkers: Asan-Kaigy (XV c), Tolubai Synchi and Sanch- Synchi
p.000185: (XIII c) [3]. Kyrgyz people justly call them legendary thinkers, folk sages (akylmanam). We know about these
p.000185: Kyrgyz thinkers from folk legends. Only fragments of their sayings survived to our time.
p.000185: The epoch of late Middle Ages with its patriarchal and feudal system sets a number of moral tasks. Undoubtedly, moral
p.000185: in a class society was at all times an instrument for ruling people, however, in akyns’ philosophical poetry one may
p.000185: find an unbiased opinion on moral and ethical issues. They reflected on the eternal question about struggle with
p.000185: the evil and dreamt about “universal well-being”. Due to reconstruction of Asan Kaigy’s ethical ideas, we may see
...
p.000185: called people for an active struggle for the sake of Justice. In his songs he developed the idea of righteous
p.000185: retribution and blamed the oppressors.
p.000185: The heritage of legendary thinkers allows us to return to forgotten spiritual values of Kyrgyz people
p.000185: based on love, compassion, empathy, clear conscience, peaceable disposition and feeling that they are a part of the
p.000185: universe. They felt aversion to violence and rudeness. Throughout the course of ethics development, starting from
p.000185: legendary thinkers to akyns- democrats, the care for widows and orphans was the responsibility of all clan members.
p.000185: The next stage of development of ethics philosophy is represented by akyn-zamanists21 Kalygul Bai Uulu
p.000185: (1785-1855), Arstanbek Bailashuulu (1866-1917) and Moldo Kylych Sharymkanov (1866). They lived in the time
p.000185: of global changes resulting from the decay of patriarchal feudalism and the rise of capitalistic relations.
p.000185: Besides in 1876 the territory inhabited by Kyrgyz people was incorporated into the Russian Empire [9-11]. All
p.000185: those processes were reflected in akyns’ poetry. In their poems “Time of Downfall”, “Time of Poverty” and “Time of
p.000185: Sorrow” akyn-zamanists called their epoch the time of degradation and decay. Moldo Kylych, being a son of a learned
p.000185: man, received a good education. He was acquainted with works by eastern classics Firdousi, Navoi, Jami, Yasavi and
p.000185: others. He wrote about his time: “Morals and manners show the loss of people’s well-being”. In his poem “Time of
p.000185: Sorrow” he noted that moral bankruptcy, degradation of moral principles, moral apathy were frightening features of the
p.000185: time. In their attitudes zamanists were close to French philosophers of the Age of Enlightenment (J.-J. Russo, Voltaire
p.000185: et al.).
p.000185: At the same time akyn-zamanists’ poetry contained some optimism and faith in moral potential of Kyrgyz people that
p.000185: would help them to overcome all difficulties. Kalygul Bai Uulu associated with the image of a spiritual
p.000185: 21 Zamanism – philosophical teaching about frailty and an inevitable tragic end of the world
p.000185:
p.000186: 186
p.000186:
p.000187: 187
p.000187:
p.000187: leader expressing expectations of Kyrgyz people through his poetry inspires their hopes.
p.000187: Problems of justice are very essential for Kalygul. Being a judge, he proclaims a kind of ethical code comprising
p.000187: universal values and norms of human behaviour: honesty, unselfishness, justice, mutual respect.
p.000187: Criticizing the state system of their time as a form of social inequality akyns offered a moral characteristic of
p.000187: behaviour in different social strata. Akyn-democrats tended to give a realistic picture of the world. Thus
p.000187: Toktogul Saltyganov presents his ethical views through opposing the good to the evil. Jenijok taught that every man
p.000187: should strive for self-perfection from his young days [7].
...
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
p.000191: trials of pharmaceutical products involving subjects with mental disorders may only be carried out after
p.000191: obtaining a written informed consent from a legally authorized representative in accordance with applicable law.
p.000191: Protection of patients’ rights in biomedical research and other interventions in Kyrgyz Republic are
p.000191: also regulated by the following laws:
p.000191: - “On Narcotic and Psychoactive Drugs and Precursors” (No 66, 22 May 1998);
p.000191: - “On Donorship of Blood and Blood Components in Kyrgyz Republic” (No 951-XII, 3 July 1992);
p.000191: - “On Tuberculosis Prevention in Kyrgyz Republic” (No 56, 18 May 1998);
p.000191: - “On Prevention of Diseases Caused by Iodine Deficit” (No 40, 8 February 2000);
p.000191: - “On Citizens’ Medical Insurance in Kyrgyz Republic” (No 208, 28 December 2006);
p.000191: - “On HIV/AIDS Prevention in Kyrgyz Republic” (No 149, 13 August 2005);
p.000191: - “On Citizens’ Reproductive Rights” (No 5, 13 January 2000).
p.000191: Statements of civil, administrative and criminal codes set the responsibility in case of violating
p.000191: patients’ rights in medical interventions and in case of violating the legally established order of practice in
p.000191: healthcare and biomedicine.
p.000191: 3.6.3. Education in Bioethics
p.000191:
p.000191: Today Kyrgyz Republic has several institutions for a higher medical education: the Kyrgyz State Medical Academy,
p.000191: Medical Faculty of the Kyrgyz-Russian (Slavic) University, Medical Faculty at the International University of
p.000191: Kyrgyzstan and Medical Faculty at the Osh State University.
p.000191: The State Standard of Education in Kyrgyz Republic does not include bioethics as a separate subject. Nevertheless,
p.000191: bioethics has been introduced into the syllabus of the Kyrgyz State Medical Academy and is taught to
p.000191: undergraduate students. The course in bioethics consists of lectures (36
p.000191: h) and practical seminars (18 h). One of the course topics is “Ethical and Legal Control of Biomedical Research”.
p.000191: Bioethics is also taught at Chairs of Clinical Medicine and Pediatrics of the Medical Faculty at the Kyrgyz- Russian
p.000191: (Slavic) University (lectures – 19 h and seminars – 19 h). Bioethics is not taught at the postgraduate level.
p.000191: Presently, there is no state system of teaching GCP to members of ethics committees. However courses on basic and
p.000191: clinical pharmacology provide information on clinical trials and GCP principles to students at all faculties of the
p.000191: Kyrgyz State Medical Academy.
p.000191: Two staff-members from the Department of Basic and Clinical Pharmacology of the Kyrgyz State Medical
p.000191: Academy (one of them is the Chairman of Independent Ethics Committee and the other one the Chairman of the
p.000191: Pharmacological Committee) and three professionals from the Department for Providing Pharmaceutical Products and
p.000191: Medical Facilities have attended training courses in GCP conducted by WHO.
p.000191: Two members of the Independent Ethics Committee for Biomedical Research and the Chairman of the Pharmacological
p.000191: Committee have attended Module 1 and Module 2 Training Courses in the framework of FECCIS Worcshop on SIDCER
p.000191: «Recognition programme» (Tashkent, 2006).
...
p.000193: “Design, Pre-Clinical and Clinical Trials of Pharmaceutical Products” includes 5 Articles, 3 of which directly
p.000193: concern clinical trials. Article 28 emphasizes rights of the patients involved into clinical trials of pharmaceutical
p.000193: products stating that boards at authorized healthcare state institutions of Kyrgyz Republic “are guarantees for
p.000193: the patients’ rights”. Besides a set of documents has been designed in compliance with GCP international
p.000193: standards.
p.000193: All documents relating to pharmaceutical products submitted to the Pharmacological Committee (the
p.000193: institution responsible for ethical review of research protocols) are simultaneously submitted to the
p.000193: Ethics Committee for ethical review. There is a certain algorithm of conducting ethical review using standard
p.000193: operational procedures; however we lack a complete and comprehensive SOP system. According to the Statute of the
p.000193: Ethics Committee, a decision is made within 30 days after submitting the complete set of documents.
p.000193: Currently Kyrgyz Republic does not have systems of certifying ethics committees and surveying ethical review practices;
p.000193: neither has it a procedure for appealing against decisions. During last eight years The Ethics Committee has carried
p.000193: out ethical review of 23 clinical trial protocols, mostly phase 3 and 4 trials. Phase 1 clinical trials do not involve
p.000193: volunteers.
p.000193: Education and training for members of ethics committees is essential for their efficient work. Meanwhile there is no
p.000193: regular system of education for members of ethics committees; however, in the framework of cooperation in FECCIS
p.000193: members of the Ethics Committee of Kyrgyz Republic participated in WHO training programmes on the protection of
p.000193: patients’ rights and the meaning of SOPs in EC practice.
p.000193: Thus, at the present stage of sovereign Kyrgyzstan development basic legislation has been developed and the order of
p.000193: the Ethics Committee practice in compliance with international standards has been established. Now there is a
p.000193: theoretical and practical basis for a successful integration of Kyrgyz republic into the international process of
p.000193: ethical review development.
p.000193:
p.000193: 3.6.5. Perspectives and Forms of International Cooperation
p.000193:
p.000193: The independent Ethics Committee of the Kyrgyz Republic is a member of FECCIS, which gives an opportunity for
p.000193: cooperation in research ethics. The activity of EC of the Kyrgyz Republic has been presented at international
p.000193: conferences, which facilitates the exchange of information and working experience.
p.000193: In addition to participation of EC members in training courses organized by FECCIS, there is an opportunity to
p.000193: take part in training seminars on GCP conducted by WHO. Staff-members from the Chairs of Basic and
p.000193: Clinical Pharmacology of the Kyrgyz State Medical Academy and from the Department for Providing Pharmaceutical Products
...
p.000205: Pharmaceuticals and New Methods of Treatment (Order of the Ministry of Health Care and Social Security No.38 of
p.000205: 24.01.06) started its work the same year in accordance with the Law On Pharmaceutical Products and the Order of the
p.000205: Ministry of Health Care (No. 54-r par.12 of 09.07.2002 On Creation of National Ethics Commission).
p.000205: International pharmaceutical companies performing CT and interested in creation of GCP-compliant conditions were
p.000205: initiators of its creation as well. Operation of the said Committee, in fact, is a part of control and permission
p.000205: system of the Ministry of Health Care and Social Security. To obtain permit of the Ministry of Health Care for CT it is
p.000205: necessary to receive an approval of this Committee.
p.000205: An attribute of this Committee is availability of detailed standards for its work – “standard operation
p.000205: procedures”. Meeting requirements of international laws, these procedures at the same time take into
p.000205: account statements of Moldova laws and peculiarities of conduct of clinical researches in our country.
p.000205: So, the network of ethics committees targeted on ethical review of CT is currently developing smoothly.
p.000205: There is a necessary background for their development: necessity in their functioning from the side of
p.000205: researches willing to perform qualified clinical researches in accordance with international regulations and
p.000205: legal base. Experience of ethical review subject to future interpretation is being accumulated.
p.000205:
p.000205: 3.7.3. Education in Bioethics
p.000205:
p.000205: There is no doubts that training and education in bioethics for population and firstly for youth has become a
p.000205: necessity, a requirement of the time and not a fashion or somebody’s ambition. This imperative is caused
p.000205: by anthropoecological and anthropogenic crisis sweeping today the Earth as a result of natural and even
p.000205: unrestrained activities of a man and world community in general to provide human existence. In this connection
p.000205: it is necessary concentrate human powers firstly intellectual ones for safety
p.000205:
p.000206: 206
p.000206:
p.000207: 207
p.000207:
p.000207: development of modern civilization. This is the time to elaborate new approaches to human survival strategy,
p.000207: which would provide opportunities of more efficient handling of global anthropoecological crisis, exclude
p.000207: planetary omnicide that closely follows tracks of the modern world.
p.000207: Bioethics as it is well known is an efficient mechanism in securing safety development of the society. That
p.000207: means that well-established training and education of population in this practical philosophy would facilitate
p.000207: solutions for many issues related to survival of mankind. The Republic of Moldova performs a lot as to the issue:
p.000207: Firstly, for purposeful coordination of this work the Bioethics Association of the Republic of
p.000207: Moldova was created in the country in 2001 (31 of May), and the National Bioethics Centre was founded (10 of
p.000207: November 2004) uniting experts in this science and practical philosophy of all country higher educational
p.000207: institutions, other scientific institutions, for effectual organization and implementation of different
p.000207: decisions and advises in this field with the help of UNESCO together with the Department of Philosophy and Bioethics
p.000207: project called Extension of Development and Promotion of Knowledge in Bioethics in the Republic of Moldova.
p.000207: Secondly, for purposeful teaching of bioethics in students circles and primary at the biomedical,
p.000207: agronomical, veterinarian and similar departments, traditional Department of Philosophy has been reorganized
p.000207: into the Department of Philosophy and Bioethics in 1999 under the Order of the President of State University of
p.000207: Medicine and Pharmacy named after Testemitianu N.A., which undertook solving of all issues related to teaching of this
p.000207: discipline to students. They include: working out of text-books and teaching aids, dictionaries, elaboration of
p.000207: thematic plans, curriculums and workshop projects, tests, staff training, method teaching and methodological training
p.000207: of teachers of higher education institutions, colleges and lyceums of the Republic including in bioethics.
p.000207: 64-hour training course for students of our institution and 32-hour course for other universities has been worked out
p.000207: by the Department. Several text- books and teaching aids on this discipline were published in Romanian and Russian, we
p.000207: will point of the following:
p.000207: - Philosophy and Bioethics: History, personalities, paradigms.), Chisinau, 2000, 256 p.
p.000207: - Philosophy (with Bioethics course). Chisinau, 2002, 552 p.
p.000207: - Philosophy and Bioethics Dictionary. Chisinau, 2004, 441 p.
p.000207: - Elements of Bioethics. Chisinau, 2005, 176 p.
p.000207: - Bioethics: origin, dilemma, trends. Chisinau, 2005, 234 p.
p.000207: These and other training and methodological and scientific works of the Department staff allowed organization and
p.000207: holding of training not only for students but for a certain number of professors of universities and colleges of the
p.000207: country in accordance with detailed program on Bioethics through the National Bioethics Centre and Bioethics
p.000207: Association of the Republic of Moldova. More than 50 persons who would be able to give lectures on bioethics in the
p.000207: higher and secondary specialized educational institutions of our country as well as in lyceums underwent advanced
p.000207: training in science and method training related to this field at these national workshops.
p.000207: Thirdly, the Department of Philosophy and Bioethics of State University of Medicine and Pharmacy named after
...
p.000207: If we are to continue to develop our ideas related to organization of training process in bioethical knowledge in
p.000207: our country it is necessary
p.000207:
p.000208: 208
p.000208:
p.000209: 209
p.000209:
p.000209: to especially stress the work of the Department, Association and the National Bioethics Centre in
p.000209: popularization of this phenomenon among the population of the Republic and primarily among the youth.
p.000209: Introduction into Bioethics program is of special popularity among the radio and television auditoria. Over
p.000209: last 3 years the personnel of the Centre and the Department organized and held about 20 talks (radio and television) of
p.000209: 15 to 45 minutes each on basic themes of this type of practical philosophy. Such programs as Bioethics –
p.000209: The Science of Survival, Euthanasia from the Point of View of Bioethics, Cloning in the Contest of Bioethics,
p.000209: Bioethical Aspects of Artificial Human Reproduction, Experiments in Humans and Animals in Biomedical Sphere:
p.000209: Bioethical Aspects, Religion and Bioethics and other with participation of bioethics specialists, biologists,
p.000209: medics and religious theologists can be marked among them, as well as From Anthropocentrism to
p.000209: Biospherocentrism, Backgrounds of Bioethics, From Ethics to Biological Ethics, Abortion and Bioethics, Bioethical
p.000209: Education of Society – Requirement of the Human Survival Strategy, Transplantology and Bioethics, Human Genome and
p.000209: Bioethics, Biomedical and Spiritual World: Comparative Analysis, Principles and Imperatives of Bioethics,
p.000209: Paternalism and Antipaternalism in Human Activity, Informative Consent and Interpretation in Medical Practice and
p.000209: others.. Here we started to check the interest in some ideas from social bioethics, such as Senility and Bioethics,
p.000209: Terrorism and Bioethics, Homosexualism, Transsexualism and Travestism in the Contest of Bioethics, Suicide and
p.000209: Bioethics, Homeless in the Light of Bioethics, Bioethics and AIDS, People with Physical Incapability in the Light of
p.000209: Bioethics, Asceticism and Bioethical Knowledge, Sadism and Masochism in the Contest of Bioethics etc. All that promotes
p.000209: propaganda of bioethical knowledge among the population both of the cities and rural settlements, formation of skill to
p.000209: care about living and biosphere in general.
p.000209: Periodicals with regular publication of interviews, articles and, for
p.000209: example, such newspapers as Komsomolskaya Pravda, Argumenty i Fakty, Nezavisimaya Moldova, Făclia, Moldova
p.000209: Suverană, Literatura şi arta are used to the same extent, i.e. for propaganda and promotion of knowledge
p.000209: in bioethics. We will underline several of them: Philosophy (With Bioethics Course), the Svetoch newspaper, No.
p.000209: 14 of 5 April 2003,
p.000209: p.6 (in Romanian); Homo Sapiens, be a Human!, the Argumenty i Fakty newspaper, No. 21, May 2005, p.3 (in
p.000209: Russian); Bioethics, Philosophy,
...
p.000209: bioethics commissions operate in practically all patient care and preventive and scientific and biomedical
p.000209: institutions, elaborating procedures for operation and standard operation procedures based on model regulation.
p.000209: It is necessary to underline the role of bioethics committees in organization and holding of training and
p.000209: educational process starting with the National Ethics Committee under the Ministry of Health Care and Social Security
p.000209: and to basic levels of this system. First of all, we set up trainings for members of the committees at workshops, and
p.000209: then they perform the same work in their teams, i.e. promote bioethical knowledge.
p.000209: So, successful set up of bioethical training is important for the Republic of Moldova from various points of
p.000209: view, and, first of all at the point of integration of our country into European and world community. From one
p.000209: side use of experience of other countries in this process is the condition for formation of moral
p.000209: mechanisms embodiment for ensuring of secure development strategy for our region, further democratization of
p.000209: social life. From the other side, the experience of the Bioethics Association of the Republic of Moldova,
p.000209: the National Bioethics Centre on bioethics and the Department of Philosophy and Bioethics of the State University of
p.000209: Medicine and Pharmacy named after Testemitianu N.A. on set up of trainings and education of inhabitants in
p.000209: bioethical interconnections and interactions among humans, society and biosphere, i.e. in implementation of one of
p.000209: the significant principles of bioethics – the co-evolutional one.
p.000209:
p.000210: 210
p.000210:
p.000211: 211
p.000211:
p.000211: And finally, wide spread of the experience and practice of the state and public formations in training and educational
p.000211: process of bioethical knowledge will favor integration in social life of new ethical and legal approaches,
p.000211: principles and values, the help of which may not only reasonably use achievements of current scientific and
p.000211: technological progress but promote implementation of modern strategy of the world community meaning survival of
p.000211: the mankind through steady and safe development.
p.000211: These are summary results of our works during the last 10-12 years in organization of training, education and promotion
p.000211: of bioethical knowledge among people of our country, and, first of all, among the youth. The work we have performed
p.000211: undoubtedly will be a serious base for further extension and strengthening of the developed system especially in
p.000211: carrying on of bioethical education of young students, future specialists of all types.
p.000211:
p.000211: References
p.000211: 1. Bioethics: principles, rules, issues. Edited by Yudin B.G. М., 1998,
p.000211: 472 p. (in Russian)
p.000211: 2. Vekovshinina S.V., Kulinichenko V.L. Bioethics: onset and rationale (philosophy and methodological analysis).
p.000211: Kiev, 2002, 152 p. (in Russian)
p.000211: 3. Second National Congress on Bioethics. 29.09 – 2.10 2004. Kiev, 2004, 305 p. (in Russian)
p.000211: 4. Testemitsanu N.A., Popushoy Ye.P., Ioksa V.A. Famous Doctors of Moldavia. Chisinau, 1985, 231 p. (in Russian)
p.000211: 5. Tsirdya T.N., Berlinsky P.V. Philosophy (with course on bioethics). Chisinau, 2002, 553 p. (in Russian)
p.000211: 6. Development of Bioethics Ideas in the European Context. Mater. of the IV International symposium on
p.000211: bioethics. Kiev, 2006, 160 p. (in Ukrainian)
p.000211: 7. Dicţionar de Filosofie şi Bioetică. T.Ţîrdea, P.Berlinschi, A.Eşanu et al. Chişinău, 2004, 441 p. (in Rumanian)
p.000211: 8. D’Onofrio F., Giunta R. La Bioetica nel futuro dell’uomo. Napoli, 1999, 224 p.
p.000211: 9. Istoria medicinei româneşti. Red. V.Bologa et al. Bucuresti, 1972,
p.000211: 565 p.
p.000211: 10. Istoria şi Filosofia culturii. Coord. Gr. Socolov. Chişinău, 1998,
p.000211: 398 p. (in Rumanian)
p.000211: 11. Nistor Ion. Istoria Basarabiei. Chişinău, 1991. 295 p.
p.000211: (in Rumanian)
p.000211: 12. Ţîrdea T. Filosofie şi bioetică: istorie, personalităţi, paradigme. Chişinău, 2000, 215 p. (in Rumanian)
p.000211: 13. Ţîrdea T. Bioetică: origini, dileme, tendinţe. Chişinău, 2005, 234 p
p.000211: (in Rumanian)
p.000211: 14. Tirdea T. Elemente de bioetică. Chisinau, 2005, 176 p (in
p.000211: Rumanian)
p.000211:
...
p.000217: patients.
p.000217: - inclusion all researches (pharmaceutical products as well as biological active substances,
p.000217: technologies, materials, devices and items for medical use involving human subjects as a study object) into the sphere
p.000217: of activities of the ethics committee
p.000217: - maintenance of ethical environment using medical publications issuing only results of researches that passed
p.000217: ethical review by ethics committees.
p.000217: New documents devoted to ethical and legal aspects of clinical researches are elaborated annually, changes are made to
p.000217: existing documents. General provisions of international laws, in particular, ICH GCP are reflected in
p.000217: guidelines produced by the Agency for Pharmaceutical Products of the Ministry of Health Care and Social
p.000217: Security of Moldova. There is a process of regular and consistent introduction of GCP principles into the practice of
p.000217: organization and performance of clinical researches of medical agents. Up- to-date task is creation of local ethics
p.000217: committees in Moldova. Creation of such independent committees authorized with relevant powers will promote active
p.000217: participation of Moldova clinics in multi-Centreed international researches, allow controlling observance of the
p.000217: rights and safety of study subjects not only at the stage of setting up but also during the study course.
p.000217:
p.000217: 3.7.5. Perspectives and Forms of International Cooperation
p.000217:
p.000217: There are no doubts that successful education in bioethics, improvement of ethical review system for biomedical
p.000217: researches mainly depend on involvement of the country, its governmental bodies, public entities, scientific
p.000217: communities in different international events connected with provision of safe development of society,
p.000217: cooperation with other states, international organizations for improvement of research work in bioethics (to a
p.000217: large extent), in promotion and popularization of bioethical knowledge, in performance of biomedical researches
p.000217: involving human and animal subjects, etc.
p.000217: Certain experience in international cooperation related to this field is gained by the Republic of
p.000217: Moldova. First, we would like to remind about organization and holding of scientific workshops with international
p.000217: participation of many European countries on bioethical topics in our country and abroad, first of all, about a role of
p.000217: bioethization of the society to ensure safety of the modern world. During the last 11 years the same number of
p.000217: scientific conferences was held and eleven books were published with materials of speakers at these scientific
p.000217: forums (organizers: Department of Philosophy and Bioethics of State University of Medicine and Pharmacy named after
p.000217: Testemitianu N.A., the National Bioethics Centre of the Republic of Moldova).
p.000217: Since 2000 the National Ethics Committee is a member of the FEC CIS. Moldova collaborates with ethics
p.000217: committees of the CIS countries
p.000217:
p.000218: 218
p.000218:
p.000219: 219
p.000219:
...
p.000219: representatives from FECCIS (Russia, Ukraine, Moldova) and SIDCER (WHO) and EFGCP (Belgium) was held in Chicinau.
p.000219: Chairman of the National Ethics Committee of the Republic of Moldova, Professor Gikavy V.I. took part in the workshop
p.000219: of the Commission of the Council of Europe on Ethical Issues (Ljubljana, 2004). Professor M. Gavrilyuk, Deputy-director
p.000219: of the Neurology and Neurosurgery Institute of the Ministry of Health Care and Social Security is a permanent
p.000219: representative of the Republic in the Commission of the Council of Europe on ethics of biomedical researches since
p.000219: 2005.
p.000219: Secondly, the staff of the State University of Medicine and Pharmacy named after Testemitianu N.A., the State
p.000219: University of Moldova, the State Agricultural University and other, members of the National Bioethics Centre of
p.000219: the Republic of Moldova take part on a regular basis in scientific conferences organized in other countries, exchange
p.000219: with their experience, mainly, on scientific and educational publications, activity of bioethical committees,
p.000219: etc. Four workers of the Department of the Philosophy and Bioethics just for the last 3-4 years took
p.000219: part and made presentations at the 2nd National Bioethics Congress (Kiev, 2004), the same number of
p.000219: presentations was made at the 4th Bioethics Symposium (Kiev, 2006), four presentations were made at the
p.000219: International Conference on bioethical education (Romania, Keya, 2006 and Romania, Bucharest, 2006), with
p.000219: presentations at the International seminar on issues of ethical review in biomedical researches (Ukraine,
p.000219: Kiev, 2006), with presentations on issues of students bioethics education (Croatia, Split, 2006), etc.
p.000219: Thirdly, professors of philosophy, philosophy and bioethics departments of many of higher educational institutions
p.000219: of Chisinau published lately materials on bioethics in different scientific journals, other foreign
p.000219: publications, for example in Kursk (Russian Federation) – 5 articles, in Yassy (Romania) – 2 articles,
p.000219: in Arad (Romania) – 2 articles, in Galatia (Romania) – 2 articles, in Lvov (Ukraine) – 1 article, etc. Our
p.000219: colleagues from these scientific Centres publish their works in scientific publications of Chisinau (journals,
p.000219: university research works, conference materials, etc.).
p.000219: During the last years the Department of Philosophy and Bioethics of the State University of Medicine and Pharmacy named
p.000219: after Testemitianu N.A. is trying to enter different international projects related to training programs on bioethics,
p.000219: performance of ethical review of biomedical researches, staff training, etc. To this extent we are looking for
p.000219: forms of international scientific and pedagogical cooperation in bioethics with the CIS countries, and especially with
p.000219: those states where large educational experience for this subject was already gained, where large-scale research work is
p.000219: carried out.
p.000219: To improve training programs in bioethics and its lecturing in the State University of Medicine and Pharmacy named
...
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
p.000225: thousands of disabled, old people and orphans. In the 50’s of XVI century they attempted to place a part of care
p.000225: for people health, social support for sick and weak people on the state. Stoglav, a great council of Russian
p.000225: bishops held in 1551, together with tsar and boyar Duma ordered to found everywhere hospices for “leprous, aged,
p.000225: lying in boxes on the streets, carrying carts and sledges and having no place to sleep”. “Desyatina”, the tenth
p.000225: part of funds from sale of bread, cattle and from rent, was brought in to keep churches, monasteries, hospitals,
p.000225: hospices and receive odd and poor people. At the same time representatives of different social classes donated money
p.000225: for church and charity needs.
p.000225: Breakup between secular and church ideologies that began in the second half of the XVII century became wider in the
p.000225: XVIII century. Peter I activity is characterized with two mutually exclusive tendencies: strengthening
p.000225: of absolutism and europeisation of Russia. Implementing reforms for strengthening of role of the state in all
p.000225: spheres Peter I included the Orthodox church in government structure and strengthen state control on it and
p.000225: consequently on church charity. On Peter’s initiative social charity became state one. At Peter I times they took
p.000225: measures against beggary, parish as self- organized church and social unit was abolished.
p.000225: At the same time in the XVIII century higher medical education was formed in Russia. Hospital schools, medical
p.000225: department of the Moscow University, surgery academies were founded. In these circumstances the following
p.000225: feature of Russian nature revealed: to study and to alter forms and methods of organization appeared in other
p.000225: countries. For example, based on medical education system in Western Europe, in Holland particularly, in Russia it
p.000225: certainly had disadvantages but it had no breakup between interns and sergeants, between theoretical and clinical
p.000225: educations, students were trained “at patient bed”.
p.000225: Students of religious schools were studying medicine because of specific features of the Russian society
p.000225: of the XVIII century. They were raznochinets, Russian intellectuals not of gentle birth, they knew Greek and Latin.
p.000225: This fact explains such features of Russian doctors and scientists as democracy and patriotism, self-denying service to
p.000225: people. Activity of such scientists as C.G.Zabelin, D.S.Samoilovich, N.M.Maximovich-Ambodic, M.G.Shein,
p.000225: A.S.Shumlyanskiy exemplify it. Physicians of the XIX century such as M.Y.Muromov, E.O.Mukhin. N.I.Pirogov,
p.000225: A.M.Filomafitskiy, S.F.Hotovitskiy, F.I.Inozemtsev and others maintained this tradition. Their professional activity
p.000225: and civil position were based on moral ideals. They wrote works where they discuss qualities characterizing a
p.000225: doctor, ethical aspects of relations with society, patients and colleagues. In everyday activity they pointed and
p.000225: solved problems, which were beginnings of bioethics principles and rules. They used method of experiment,
p.000225: observing disease activity and experimented on animals. At that time ethical approaches to experiments were formed.
p.000225: So, A.M.Filomafitckiy (11807-1849), the first Russian scientist, who made vivisection and surgery method as the base
p.000225: of physiology, said: “... Experiment made by inexperienced hand and aimlessly should be severely punished,
...
p.000227: intelligence discussing social, political and moral problems. Its founders and leaders were famous
p.000227: physicians N.V. Sklifosovskiy, S,S, Korsakov,
p.000227: A.Y. Krasovskiy, F.F. Arisman, E.A. Osipov, G,E. Rain and others. The association held Pirogov’s congresses where
p.000227: the most urgent problems of medicine health protection such as fight against epidemics, management of medical
p.000227: care, medical organization at the front and home front and others were discussed. Congresses sent to the
p.000227: government decisions and applications and though most of them were not answered some of them were
p.000227: followed by orders. They were: decision on foundation of the Women Medical Institute (1902), manifest of corporal
p.000227: punishment abolition for all peasants in Russia and some others. Many times the Pirogov association discussed ethic
p.000227: issues such as status of physicians in Russia, problems of private practice and treatment payment, physicians’ mutual
p.000227: aid, physician right to treat without patient and his relatives’ consent and others (12).
p.000227: One more considerable page of Russian public medicine history has moral accent and is connected with struggle
p.000227: of progressive public persons for women rights and their political emancipation, the right for higher medical education
p.000227: and independent practice. Progressive university professors, scientists and writers supported these demands.
p.000227: Supporters of equal rights for women were S.P. Botkin, I.M. Sechenov, A.L. Krasovskiy, P.F. Lesgaft,
p.000227: V.L. Gruber, etc. They opened the door of their classes for first women and give them equal opportunities with men.
p.000227: Progressive media magazines and newspapers such as Medicine bulletin, Modern medicine, Saint-Petersburg
p.000227:
p.000228: 228
p.000228:
p.000229: 229
p.000229:
p.000229: Bulletin wrote about a need for the country to have women-doctors, about their role in propagation of hygiene,
p.000229: necessity of treatment of women whose shame often “results in great evil in medical practice”. Foundation of the Higher
p.000229: Women Medical Courses (1872, 1876) was the beginning of higher women medical education in our country, thus, Russia
p.000229: left behind almost all European states, besides Switzerland and the USA (the College of 1864). Courses could exist
p.000229: only on private donations. Means were collected in favor of the Courses. Zemskiy doctors sent part of their
p.000229: salary in favor of the courses. Association of mutual aid of women-doctors founded in 1890 was very useful. In 1897
p.000229: efforts of progressive society resulted in foundation of the first Russian Women Medical Institute, which was opened in
p.000229: Saint- Petersburg (now the Saint-Petersburg Medical University named after I.P. Pavlov).
p.000229: Events in medicine and health protection happened in period from 2nd half of the XIX — beginning of the XX century
p.000229: stimulated development of medical ethical ideas. Many old problems became more acute and new ones appeared, relations
p.000229: of doctor and society, doctor and patient, intercolleagueal relations in medicine were changed. Russian physicians were
p.000229: characteristic of not only speeches and declarations, talks about duty and morality but of deeds, behavior, example,
p.000229: and demonstration – quite often during dozens of years or even during their whole life - of what a doctor should be.
p.000229: Open discussion of “complicated” medical issues not only inside of medical society can be considered as
p.000229: a root of such bioethics feature as openness, transparency, necessity in public monitoring of biological
p.000229: researches.
p.000229: Development of a method of chronic experiment in animals is linked to the name of I.P.Pavlov (1849-1936). In 1876 at
...
p.000239: framework of secular ideas and values clear and conventional to people and capable of appealing to people and give them
p.000239: hope. A distinguishing feature of the Russian society is that conventional factors invariably play significant role in
p.000239: many walks of social life, adherence to traditional ideological and social values which saw little influence
p.000239: of the changing social and economic systems, political regimes as well as fresh social and ideological paradigms for
p.000239: development declared in the recent decades of the XX century. Under any state system – monarchical or collective type,
p.000239: totalitarian or liberal – an impact of a number of constants which determine a civilization portrait of Russia is
p.000239: feasibly evident. Among them a crucial role belongs to religion, first and foremost the Orthodox Christian Church which
p.000239: by masses of population is perceived not only as an institution with the main function of not just disseminating the
p.000239: ideas of Christianity but mostly as preserver of the Russian national values and traditions (by different social
p.000239: studies three fourths of believers who are almost half of the population in Russia are Orthodox Christians). The same
p.000239: can be said about the Islam – second confession in Russia in terms of adherents’ number and influence (about 19% among
p.000239: believers) (20).
p.000239: Today religious organizations prove active in most different fields: religion itself, education, health care,
p.000239: culture, charity and mercy, business and economic. Changes occurring in the society and the Church demanded for a
p.000239: comprehensive philosophy that would reflect general attitude of the Church to issues of state and the Church
p.000239: relations and concerns of the modern society on the whole.
p.000239: At the Anniversary Episcopal Assembly in 2000 the Basic Social Conception of Russian Orthodox Church was
p.000239: adopted. The conception falls into 16 sections covering most various issues related to life of a Christian believer in
p.000239: secular world. In section 11 – “Public and Individual Health” – the attitude of Orthodox Church to disease and health
p.000239: is rendered, importance of church activities in health care is stressed, necessity of society and church cooperation in
p.000239: public health care issues is emphasized. It covers such vital from religious viewpoint principles as doctor and patient
p.000239: relationship which should be based with respect to integrity, free choice and “personal dignity”. In particular it
p.000239: stresses: “We should by all means encourage a dialogue between a doctor and a patient that is
p.000239: characteristic of current medical approach. This approach is undoubtedly engrained in the Christian tradition,
p.000239: although there is a temptation to relegate it to a level of merely agreement relationship. At the same time one should
p.000239: admit that a more conventional “pattern like” model of physician and patient relationship which is fairly criticized
p.000239: for numerous attempts to justify medical power abuse may as well represent a truly fatherly attitude to patient that
...
p.000255: – P. 36 - 47.
p.000255:
p.000256: 256
p.000256:
p.000257: 257
p.000257:
p.000257: Being guided by the principles of respect for human, the ensuring of the value of person, protection of rights
p.000257: and freedoms of individual and taking into account the insufficiency of studying of biological and social
p.000257: consequences of human cloning the above-mentioned law put temporary ban on the biomedical trial on human
p.000257: cloning.
p.000257: The attention of legislators to the ethical side of biomedicine is also demonstrated by the Draft Technical Regulations
p.000257: “On requirements for the safety of medicines, the processes of their development, manufacturing, production,
p.000257: testing, storage, transportation, realization, application and utilization”.
p.000257: In contrast to current federal laws, this bill proposes the more detailed regulation of process of the clinical
p.000257: drug research ethical review. It also constitutes research subjects’ rights and guarantees of these rights
p.000257: in accordance with the most progressive international standards in this field.
p.000257: Legislation initiatives in the sphere of protection of patients’ rights40, activity directed to adaptation of
p.000257: international guidelines, as well as transformation of the positions of international declarations and conventions
p.000257: in the sphere of biomedicine into the domestic legal acts, give us the reason to expect the strengthening and
p.000257: development of the institute of ethical review in our country.
p.000257:
p.000257: 3.8.3 Education in Bioethics
p.000257:
p.000257: Issues on education of medical ethics and deontology in medical schools and colleges of the USSR were
p.000257: started to discuss in the 60’s of the XX century after the 1st All-Union Conference on issues of medical
p.000257: deontology in 1969 being a kind of triggering point for revival of talks on them. The final resolution, in particular,
p.000257: said: “The Conference would like to draw attention of the Chief Agency on Educational Facilities of the Ministry of
p.000257: Health of the USSR on necessity to implement medical deontology into education process”.
p.000257:
p.000257:
p.000257: 40 For example, Draft Law “On legal basis of bioethics and its guaranties”, “On reproductive rights of citizens”,
p.000257: “On additions to Criminal Code of the Russian Federation regarding to criminal liability for conducting
p.000257: medical trials involving human subjects without their voluntary consent” and others.
p.000257: Many medical schools developed medical oaths based on the Hippocratic Oath. In 1971 the Presidium of the Supreme Soviet
p.000257: of the USSR approved an official text of the Oath of Medical Doctor of the Soviet Union.
p.000257: In 1976 the Ministry of Health of the USSR approved interdepartmental curriculum on medical ethics (deontology)
p.000257: for higher medical and pharmaceutical educational facilities. The curriculum distributed the course along the
p.000257: entire educational process basing on that “concepts of morals and morality, development of higher feelings and medical
p.000257: ethics is an integral part of the entire educational process and should be implemented in various aspects during all
p.000257: years of training at all departments“.
...
p.000257: health care formation” (Department of History of Medicine), “Categories of medical ethics” (Department of Marx and
p.000257: Lenin Philosophy), “Modern concepts on medical and psychological aspects of an individuality” (Course on medical
p.000257: psychology), “Deontological issues in disease diagnostics” (Department of Preliminary Studies of Internal
p.000257: Diseases); 1 lecture for 3 year students: “Deontological issues of treatment” (Department of Faculty Therapy); 2
p.000257: lectures for 5 year students: “Deontological issues for work of district physician” (Department of
p.000257: Hospital Therapy) and “Legal principles of medical services for working population in the USSR”
p.000257: (Department of Forensics Medicine). The curriculum was widely discussed in mass media and majority of comments were
p.000257: that it was inefficient, did not cover many important issues, which are of tremendous value for medical practice, for
p.000257: instance, no definition of patient rights was given, it did not dwell on issues of brain death, refusal of
p.000257: extraordinary treatment for dying patients, it never mentioned the Nuremberg Code or the Declaration of Helsinki, etc.
p.000257: In 1977 and 1982 two other All-Union conferences on medical deontology were held. There were published
p.000257: multiple books on issues of medical ethics and deontology for various medical fields. It indicated that in 70-80’s
p.000257: the system of Soviet higher medical education had professors who not only fully understood a role of medical
p.000257: deontology for education
p.000257:
p.000258: 258
p.000258:
p.000259: 259
p.000259:
p.000259: and training of undergraduate doctors but also contributed considerably for development of the content of this
p.000259: subject (Evlashko Y.P., Kosarev I. I., Leschinsky L.A., Orlov A.N., Suvorova R.V., Rokitsky M.R., Shamov I. A.,
p.000259: Jarovinsky M.Ya., etc.). In 1988 two volume manual Deontology on Medicine was published edited by Petrovsky
p.000259: B.V.
p.000259: In the 80’s the educational curriculum of medical nurse colleges had some academic hours assigned to medical
p.000259: deontology – the course was called as Basics of medical psychology, ethics and deontology. In 1992 the Pledge of
p.000259: Medical Doctor of Russia came into force.
p.000259: In 1993 the Vrach (Doctor) magazine published an appeal to scientific community and heads of the Russian science from
p.000259: members of the Russian national committee on bioethics (“Bioethics in Russia: Beginning of the way”). The Appeal
p.000259: stated: “Modern medicine requires modern moral consciousness. In the whole world principles of bioethics for a
p.000259: long time are an integral part of professional life of medical workers ... Absence in our country of the said
p.000259: mechanisms of ethical control results in a range of negative consequences, hinders improvement of moral environment
p.000259: within our scientific community; it is one of the main reasons for distrust of the society to science (that, by the
p.000259: way, impacts the society readiness provide science with tangible support); it is a direct violation of
p.000259: international acts enforced in this field...” In this document the most well-known medical scientists of the
p.000259: country wrote with anxiety about those harmful consequences indicating absence of proper ethical control on
p.000259: scientific experiments. Neglect of elementary medical and ethical norms in practical health care being widely spread in
p.000259: our days looks similarly dangerous. It was noted by many speakers at the XVIII All-Russia Pirogov’s Conference of
p.000259: Medical Doctors held in Moscow in 1997. The Conference approved a new text for the Oath of Russian Medical Doctor and
p.000259: the Code of Medical Ethics presented by the National Ethics Committee – Russian Medical Association.
p.000259: In October 1994 in Geneva the 4th WHO Conference on issues of medical ethics education was held where
p.000259: participant unanimously stated that education to ethics (bioethics) issues should be mandatory rather than optional.
p.000259: The Conference participants agreed that medical ethics should become an integral part of medical education and
p.000259: that its coaching should be obligatory and continuous during the entire pre-graduate educational
p.000259: process and for post-graduate education, therefore, all medical schools were to have a department on medical ethics and
p.000259: appropriate number of trained professors.
p.000259: In 1997 under the aegis of the Ministry of Health of the Russian Federation the meeting on issues of
p.000259: medical ethics education was held where necessity of introduction of bioethics learning was acknowledged. It
p.000259: is necessary to note that the Russian Orthodox Church supported introduction of the biomedical ethics education
p.000259: into the medical education system of Russia. It is indicated with the appeal to the ministries of health care and
p.000259: vocational education of the Russian Federation approved during the VI International Christmas educational
p.000259: lectures of 1998 held by the Moscow Patriarch of the Russian Orthodox Church.
p.000259: Some of higher educational facilities of medical as well as philosophy, law and other fields as per initiative
p.000259: of those enthusiasts-professors the bioethics education process was launched as well. Since the beginning
p.000259: of the 90’s the separate course on biomedical ethics was provided in the Moscow State University named after Lomonosov
p.000259: M.V. at the Departments of philosophy and psychology, and since 1994 it was also introduced at the medical department.
p.000259: The most capacious course in regard to number of academic hours assigned was provided at the nurse department
p.000259: for the 1st year students of the Moscow Medical Academy named after Sechenov I.M. - 56 hrs (30 hrs of lectures and 26
p.000259: hrs of seminars). Actually, this subject was given at the Department of history of medicine since 1994, and as a
p.000259: separate course – since 1995. Another issue is even more important: at this department biomedical ethics was included
p.000259: into the state educational standard, i.e. it is obligatory for all 22 departments of the higher nurse education in
p.000259: Russia. Making this subject as mandatory from the point of view of educational minimum for this category of medical
p.000259: workers, naturally, required generation of appropriate curriculum (author – Professor Yarovinsky M.Ya.).
p.000259: In the Russian State Medical University since 1996 the Department of philosophy and culture sciences was called as the
p.000259: Department of philosophy and culture sciences with a course on bioethics, and there the biomedical education course (22
p.000259: academic hours: 18 hours of lectures and 4 hours of seminars) is provided since 1996 for all 4 year students of
p.000259: physician and pediatric departments.
p.000259:
p.000260: 260
p.000260:
p.000261: 261
p.000261:
p.000261: Also since 1996 the course on bioethics was provided in the St- Petersburg Pediatric Medical Academy at the
p.000261: Department of humanitarian subjects and bioethics and in the Kazan Medical University. The Department of philosophy of
p.000261: the Moscow Medical Dentistry Institute since 1997 was called the Department of philosophy and biomedical ethics, the
p.000261: course of biomedical ethics there (40 academic hours) is provided at the dentistry department for 1-year
p.000261: students, and at the physician department — for 3- year students. At the evening education department for 1-year
p.000261: students this subject was assigned with 20 academic hours. As an option biomedical ethics was suggested for
p.000261: students since 1993. In the Krasnoyarsk Medical Academy the course on professional medical ethics was provided for pre-
p.000261: graduate students (48 academic hours), and at the higher nurse education department (40 academic hours).
p.000261: The next step for establishing of this subject education was the All- Russian Educational and Methodical
p.000261: Conference Biomedical Ethics in Higher Medical Education Facilities held by the Ministry of Health of the Russian
p.000261: Federation in 1999; since 2000 bioethics became an obligatory subject in medical schools. Introduction of
p.000261: biomedical ethics into a set of humanitarian subjects of medical education is one of the evidences of real renewal of
p.000261: humanitarian training of medical students in Russia.
p.000261: Currently educational system in the Russian Federation has curriculums for general (beginning, secondary) and
p.000261: professional (secondary, higher, additional) education. Their content is determined by state educational
p.000261: standards. Standards for “secondary” and nurse vocational training do not contain bioethical issues.
p.000261: At the stage of higher vocational training bioethics become an integral part of curriculums of medical
p.000261: or pharmaceutical fields (a course of humanitarian and social and economic subjects), for such majors as Law,
p.000261: International Relations, Social Work (natural sciences part in the course Concepts of modern natural sciences),
p.000261: Biology and Bioecology (a part of general vocational subjects). As a negative sign it should be noted that
p.000261: bioethics education is not stipulated for such major as Philosophy. Existence of national and regional (school-
p.000261: related) component in state standards and the right to some extent to alter curriculum content allows for many of
p.000261: educational facilities in Russia to include bioethics into education of future agriculture workers, veterinaries,
p.000261: teachers, philosophers and other trades.
p.000261: At the same time there is no trade of bioethics in the All-Russian Classifier of Educational Trades as well
p.000261: as it is not mentioned in the List of Scientific Specialist Trades. Therefore, targeted training of specialists
p.000261: including specialists of higher qualification (masters and doctors of science) in regard to bioethics is not
p.000261: provided. However, theses or dissertations for master or doctor degree covering to some extent bioethics
p.000261: issues are defended using reference numbers of other trades such as philosophy, sociology, public health.
p.000261: Currently training of medical doctors and pharmacists is conducted in 47 universities and academies subjected to the
p.000261: Federal Agency on health care and social development as well as 25 departments and institutions of the Russian
p.000261: education ministry, 5 military medical educational facilities, 10 private higher educational facilities as well as in
p.000261: the Kyrgyz-Russian Slavic University accredited in Russia.
p.000261: Typical unified program of education in higher medical educational facilities in Russia was developed in 2001 by the
p.000261: group of Moscow scientists, and in 2003 the reference curriculum on bioethics for Pharmacy trade was published (authors
p.000261: – workers of the Moscow Medical Academy named after Sechenov I.M.), which are planned for 36 academic hours of class
p.000261: work (18 hours of lectures and 18 hours of seminars) and 18 hours of independent work in the 2nd semester. The
p.000261: curriculum stipulates learning of history and traditions of Russian ethics, theoretical basics of biomedical ethics,
p.000261: models and rules of relationships between doctor and patient, patient rights, analysis of bioethical issues of
p.000261: experimental medicine, reproductive technologies, euthanasia, transplantology and medical genetics, HIV infection,
p.000261: ethics in psychiatry, moral issues of distribution of health care resources. Working educational programs that the
p.000261: education is based upon are developed by departments implementing them.
p.000261: Currently training in bioethics at the specialized department is conducted only in one higher educational facility, the
p.000261: Russian State Medical University. Three cities (Ivanovo, Kazan, Samara) have departments on bioethics and law
p.000261: associated with other subjects (forensics medicine, history of medicine) or without it. Five educational
p.000261: facilities provide such education at the departments of philosophy, another five changed department titles to
p.000261: mention “philosophy and bioethics”. Three cities delegated this coaching to health care management department. In every
p.000261: third of medical educational facilities
p.000261:
p.000262: 262
p.000262:
p.000263: 263
p.000263:
p.000263: bioethics is learned at departments of humanitarian and social and economic type. Finally, another three higher
p.000263: educational facilities (Astrakhan Medical Academy, St-Petersburg Medical University named after Pavlov I.P. and
p.000263: Stavropol Medical Academy) formed interdepartmental teams for teaching the subject involving clinicians (clinical
p.000263: pharmacologists, psychiatrists).
p.000263: Majority of medical academies and universities has the amount of academic hours complying with the curriculum
p.000263: stipulated one – 36 hours, two – shrank it insignificantly up to 32 hours, and in one academy – to 19 hours.
p.000263: More than a half of medical educational facilities in Russia managed in their curriculum to move the classes from 1st
p.000263: year students to more trained ones up to the pre-graduates at their last year training (Volgograd, Kursk, Ryazan,
p.000263: St-Petersburg Pediatric Medical Academy).
p.000263: An important feature of the modern stage of development of biomedical education in medical education facilities is
p.000263: its close organizational and methodical association with coaching in jurisprudence and medical law. It is not by
p.000263: chance that one of the main magazines publishing articles and other materials on bioethics-related topics is
p.000263: Medical Law included into the list of magazines recommended by the Higher Attestation Commission for publication of
p.000263: results of dissertation research.
p.000263: Special departments on medical law were established in two Moscow facilities (Moscow Medical Academy named after
p.000263: Sechenov I.M. and Moscow State Medical and Dentistry University), in 11 cities the law training is
p.000263: provided in the departments, which titles mention law. In 7 cases these are departments of humanitarian and
p.000263: social and economic field: bioethics, philosophy, political sciences, economics, sociology, psychology and pedagogics;
p.000263: in 4 cases – forensics medicine.
p.000263: Four universities set up the educational process on jurisprudence at humanitarian departments
p.000263: (humanitarian sciences - 2, social and humanitarian - 2), four – at departments of forensics medicine and
p.000263: four – at departments of public health and health care. In Astrakhan they decided to involve professors of three
p.000263: departments: philosophy, public health and forensic medicine.
p.000263: Objectives of bioethics and law coaching are to identify, formulate and bring to students those norms of
p.000263: morals and law that will protect their patient and, at the same time, will not hinder innovations in medicine and,
p.000263: moreover, beneficial use of modern diagnostic and medicinal technologies. Achievement of this goal is based on complex,
p.000263: interdisciplinary approach to the educational process as it is required by the essence of bioethics.
p.000263: Bioethics as it is should be in the Centre integrating common efforts of men of law, forensic medicine specialists,
p.000263: philosophers and other representative of humanitarian departments and, naturally, clinicians and health care
p.000263: managers as well as university administration for training and education of future specialists. Some actions
p.000263: in this respect are performed (Moscow State Medical and Dentistry University, etc.). Maybe, it makes sense to
p.000263: set a task to prepare a typical reference curriculum at the federal level that could be an assistance and incentive for
p.000263: universities. We should also take into account strong and weak points of the Interdepartmental Curriculum on medical
p.000263: ethics and deontology implemented in the USSR in 70’s and 80’s of the ХХ century. That curriculum could be considered
p.000263: as a historical prerequisite for education in the field of bioethics for all Post-Soviet countries. At the
p.000263: same time, the XXI century requirements show necessity for inclusion into the training course of completely new issues.
p.000263: In particular, it seems of significant importance to include there issues on evidence-based medicine. Nowadays this
p.000263: field of medical science is unfairly considered as the outskirts of educational curriculums, while it allows giving
p.000263: grounds to clinical practice with quantitative and qualitative analysis of world research data rather than basing it on
p.000263: intuition, traditions and experience which young specialists just do not possess.
p.000263: Educational and methodical basis for bioethics currently cannot be called as perfect but despite that currently
p.000263: there are good monographs that, regretfully, are not fully available in university libraries. Such publications are:
p.000263: Biomedical Ethics//Edited by Pokrovsky V.I.Vol.1. - M., 1997 and Biomedical Ethics//Edited by Pokrovsky V.I.
p.000263: and Lopukhin Y.M. Vol.2. - M., 1999;. Bioethics: principles, rules, issues//Edited by Yudin B.G.- M., 1998; .
p.000263: Introduction for Bioethics. - M., 1998, etc.
p.000263: In 2005 a handbook for higher educational facilities fir the Pharmacy trade edited by Lopatin P.V. was published, and a
p.000263: year before – a teaching aid Medical Ethics edited by Academician of the Russian Academy of Medical Sciences,
p.000263: Professor Lopukhin Y.M. and Corresponding member of the Russian academy of Sciences, Professor Yudin B.G.
p.000263: (translated from English). In 2006 Publishing House Meditsina (Medicine) issued a handbook
p.000263:
p.000264: 264
p.000264:
p.000265: 265
p.000265:
p.000265: on medical ethics by Shamov I.A. where the author suggested introducing continuous education of the subject and
p.000265: provides a curriculum for the entire period of study.
p.000265: A handbook for students in medical schools recommended by the Education and Methodical Association of
p.000265: medical and pharmaceutical universities of Russia is handbook Medical Ethics (Bioethics) by Yarovinsky M.Ya. (M.,
p.000265: 2006). Besides, there are publications prepared directly by educational facilities, for instance, by the Samara
p.000265: State Medical University (Sergeyev V.V., Nasledkov V.N. et al. Lectures on Bioethics. Samara, 2005), as well
p.000265: as monographs and collections of articles, foreign manual, for instance, the ones approved in the Republic of Belarus.
p.000265: Some role was played by monograph Ethics of Treatment by Siluyanova I.V. (M., 2001).
p.000265: Also departments providing bioethics education start to interact. In 2005 the All-Russian Educational and Methodical
p.000265: Conference Biomedical Ethics in the higher medical educational facilities of Russia (the Russian State
p.000265: Medical University) was held which summarized experience accumulated in the field of bioethics education in various
p.000265: universities and schools.
p.000265: Motivation to study bioethics among students and specialists is quite high. Sociological polls found that more than 80%
p.000265: of students and young medical doctors realize necessity to master bioethics knowledge. And experienced doctors
p.000265: who, in their majority, never studied biomedical ethics, as it is currently understood, quite often do not
p.000265: express any determined opinion.
p.000265: Importance of specific training for doctors with more than 10-year professional experience, and they are
p.000265: the basis of the industry human resources, in regard to ethical and legal issues, is rather
p.000265: considerable. It is confirmed with the questionnaire data we obtained. “Is there a need in ethical committees in
p.000265: treatment and prevention facilities?” The answer is “No” among more than 25% (!) of MD’s vs. students. Such prevalence
p.000265: of answers is caused, naturally, not by neglecting of ethical values but with ignorance of the subject. Obviously,
p.000265: post-graduate education shall become a foremost objective.
p.000265: Nowadays, there is no practice of systematic organization of training course on bioethics issues for medical doctors
p.000265: and other specialists at the post- graduate period. The exclusion is a regular topical post-graduate education cycle
p.000265: for medical doctors and researchers Methods for Set-up and Conduct
p.000265: of Clinical Studies of Pharmaceutical Products in the Russian State Medical University. On their own Russian
p.000265: specialists can get bioethical training within the framework of programs supported by international organizations
p.000265: or universities, for instance in the school on bioethics in Vilnius at the Vilnius University and Albany
p.000265: Medical College-Graduate College of Union University Bioethics Program (Schenectady, New York).
p.000265: Improvement of doctor and researcher knowledge in regard to protection of rights of biomedical research participants is
p.000265: significantly facilitated with the conduct of training cycles on rules of Good Clinical Practice by medical
p.000265: universities (Moscow Medical Academy, Russian State Medical University) and large contract research organizations
p.000265: (Smolensk, Saint-Petersburg).
p.000265: A specific value for ethical review system setup in the country is provided by training of the ethical
p.000265: committee members. Such trainings are organized under the aegis of the Forum for Ethics Committees in CIS Countries
p.000265: as well as by initiatives of particular ethical committees.
p.000265: The Russian Federation joining to the Bologna Club (September, 2004), that is, to states participating in processes of
p.000265: reforming of European education on the basis of Bologna Declaration principles (1998), raised necessity in resolving
p.000265: of some new issues by those organizing bioethical education. It includes struggle for the place of the subject
p.000265: of bioethics in the part of curriculums that is compiled in accordance with the Bologna Declaration requirements to be
p.000265: implemented on mandatory rather than optional basis; for appropriate rate of work content and assessment in the system
p.000265: of ECTS credits; preparation of various educational and methodical materials for independent work of students
p.000265: (multimedia aids, readers, case collections, business games, tests); development of control and measurement materials
p.000265: and, naturally, targeted specialized training of professor competitive in conditions of higher educational
p.000265: mobility of their students.
p.000265: In general, one can come to a conclusion on a need for creation in the Russian Federation specialized educational
p.000265: facilities of organizational, design and methodical basis for teaching bioethics. During the last years one can
p.000265: observe a notable trend for transformation of bioethics education into specialized courses and departments. At the same
p.000265: time, it is necessary to make efforts to develop state educational standards, typical unified and working educational
p.000265: programs to comply with scientific and practical
p.000265:
p.000266: 266
p.000266:
p.000267: 267
p.000267:
p.000267: requirements, to coordinate activities of university departments on teaching issues of legal and ethical control in
p.000267: medicine.
p.000267: The main task is to be planned preparation of qualified staff of professors, which requires set up of special
p.000267: post-graduate study system, including post- graduate research and vocational training at the course of general and
p.000267: topical post-graduate education, establishment of the bioethics grade.
p.000267:
p.000267: 3.8.4. System of Ethical Review
p.000267:
p.000267: The Russian legislation in the field of ethical and legal provision for biomedical research is represented with a range
p.000267: of documents. First of all, it is the Constitution of the Russian Federation (Art.21), which states: “… no one can be
p.000267: made undergo medical, scientific or other experiments without his/her consent.” Beside, there is the Basics of the
p.000267: Legislation of the Russian Federation on Protection of Health of Citizens where Article 43 considers issues on
p.000267: application of new methods of prevention, diagnostics, treatment; medical agents, immunobiological agents and
p.000267: disinfecting agents and biomedical research conduct. However, this article is declarative to a large extent: rights
p.000267: of citizens involved in biomedical studies stipulated there do not have any mechanisms of implementation and
p.000267: enforcement, including the ones via ethical review of applications for research conduct. At the same time,
p.000267: in accordance with this document children of age below 15 can participate in studies of new medicinal agents, methods,
p.000267: etc, only in case of vital indications though in real life this statement is constantly breached that is inevitable and
p.000267: determined with realia of medical practice development and scientific progress. Article 29 of this document prohibits
p.000267: involvement into studies of those arrested or convicted though, in some cases these persons can benefit from
...
p.000279: involving specialists of appropriate trade – full professors and professors of departments working on issues of
p.000279: biomedical ethics and medical law – are ready to set up and conduct educational cycles for members of ethical
p.000279: committees, clinical researchers, medical community. Ethical committees of Russia are open for discussion of joint
p.000279: scientific research for all comers. They are ready to assist in preparation of constituent documents and basics for
p.000279: methods of practical activities, to participate in development of ethical programs in various fields.
p.000279: From the point of view of harmonization of curriculum in different countries and, first of all, Europe,
p.000279: new opportunities are provided by the Bologna process. Joining of Russia to this process (de jure since
p.000279: September 2003) did not formally mean that the country should develop curriculum of set content but the very
p.000279: spirit of Bologna process (which main essence is consolidation of resources in Europe for effective competition at the
p.000279: educational market) implies convergence. Otherwise it would be impossible to attain mutual acknowledgement of
p.000279: educational qualifications and mobility of students and professors.
p.000279:
p.000280: 280
p.000280:
p.000281: 281
p.000281:
p.000281: In regard to bioethical and legal education for the entire population Russia is in conditions bringing
p.000281: it closer to other post-Soviet states and making it different from countries of traditional democracy, since
p.000281: democratic changes emerged there in last decades only. Therefore, it seems of paramount importance to acquaint Russians
p.000281: with problems, tasks and possibilities of legal and bioethical regulation in the field of health care and biomedical
p.000281: science basing on effective experience of other countries and, especially, the ones of the so-called “near abroad”. It
p.000281: could be attained through creation of topical TV shows, round tables with specialists in various fields of biology and
p.000281: medicine, publications series of articles on pressing issues of bioethics and medical legislation, creation of Internet
p.000281: resources with this orientation. Changes of the Russian legislation that are awaited for a long time and,
p.000281: which is important, proper execution of legal and bioethical norms, without which it is impossible to secure
p.000281: respectful attitude to human rights and dignity in the sphere of bioethics, depend on general legal culture of
p.000281: people, their bioethical “maturity”.
p.000281: 3.9 REPUBLIC oF tAjIKIStAn (S.D.Achrorova)
p.000281:
p.000281: 3.9.1 Historical and Cultural Background
p.000281:
p.000281: Nowadays in Republic of Tajikistan, like all over the world, the need for biomedical research is growing steadily, as
p.000281: well as the concern for such human values as a person’s health, rights and dignity. Therefore, people of
p.000281: different professions, religions and nationalities have come together to form medical ethics committees that would
...
p.000287: process of the implementation in Tajikistan of new and more developed agricultural and industrial machinery, transport
p.000287: equipment, new methods of farming and new crops. In the period from the end of the XIX to the beginning of the XX
p.000287: century, Russian culture influenced the development of the Tajik philosophical, scientific and engineering thought.
p.000287: Ahmad Donish, Hodji Halif, Hodji Jusup, Yakubi Farang, Hairat, Somi, Sobir, Asiri, Siddiki, Aini and others advocated
p.000287: ideas of national progress and social justice and criticized medieval feudal system. Scientific centres of Moscow,
p.000287: Leningrad and other cities were helpful in rising Tajik philosophers. The study of the history of Tajik philosophy and
p.000287: teachings of ancient peoples of the Central Asia was also very important. S.Aini, A.A.Semenov, A.M.Bogoutdinov,
p.000287: Z.Sh.Radzhabov, M.Boltaev, G.A.Ashurov, M.Dinorshoev, M.Radjabov and others analyzed in their works problems of the
p.000287: unity of the national and the international in the history of Tajik culture and philosophy, revealed special
p.000287: regularities of their development, the character of interaction with other philosophical trends and unmasked
p.000287: reactionary nature of Europocentric and Asiacentric concepts. Tajik scientists carried out studies in the
p.000287: sphere of dialectical, historical materialism and philosophy of natural sciences; they analyzed laws and categories of
p.000287: materialistic dialectics, objective regularities of historical development and conscious human activity,
p.000287: problems of education, formation of socialist nations, methodology of modern science, etc. (S.Umarov, M.S.Asimov,
p.000287: S.B.Morochnik, V.I.Pripisnov, M.Gafarova, A.Tursunov, I.Sharipov, S.A.Radjabov, K.Sabirov, M.Kamilov). The works on
p.000287: scientific atheism analyzed problems of developing a scientific and materialistic worldview, causes for
p.000287: survival of religious views and ways
p.000287:
p.000288: 288
p.000288:
p.000289: 289
p.000289:
p.000289: to overcome the problem; gave a critical analysis of various religious concepts (A.Bazarov, R.Madjiev). There
p.000289: were also new studies in the field of sociology, ethics and aesthetics.
p.000289: The late eighties and early nineties were marked with complicated and contradictory events, the most significant
p.000289: of which was a disappearance of such a state as the USSR on the map of the world. Instead, about 15
p.000289: new independent states appeared, and Tajikistan among those. Thus, within a short historical interval Tajikistan
p.000289: moved from one historical period to another; the state and power structure changed, as well as its
p.000289: attributes. The former political system was destroyed, which resulted in the change of ownership patterns and social
p.000289: relations.
p.000289: The development of Tajikistan as an independent secular republic in the post-Soviet space was accompanied
p.000289: with economic, political and social instability. A significant support from the international community was
...
p.000291: planned and emergency treatment. However, often, particularly in providing emergency care, the physician, voluntarily
p.000291: or not, may be in a situation when he/she is violating a religious rule.
p.000291: When developing legislative acts referring to healthcare in Tajikistan we have followed the fundamental principles of
p.000291: the protection of human rights and dignity in biomedicine. The basic document is the Constitution of Tajikistan. The
p.000291: current Constitution is ensuring the priority of providing healthcare to the population of Tajikistan.
p.000291: The Constitution of Tajikistan proclaims citizens’ rights and freedoms and determines responsibilities of natural
p.000291: and juridical persons. One of the rights guaranteed by the Constitution is the right for health protection implying
p.000291: the following:
p.000291: - medical care and social protection;
p.000291:
p.000292: 292
p.000292:
p.000293: 293
p.000293:
p.000293: - safe environment, food products and drinking water;
p.000293: - qualified medical and sanitary care including a free choice of a physician and healthcare institution;
p.000293: - safe and healthy living and working conditions, as well as safe and healthy conditions for rest, education and
p.000293: upbringing;
p.000293: - sanitary and epidemiologic well-being in the territory where a person lives;
p.000293: - truthful and timely information about an individual’s health including existing and potential risks and the degree of
p.000293: risk;
p.000293: - participation in measures on health protection and public expertise with regard to these issues;
p.000293: - possibility to create public organizations for the purpose of facilitating health protection and protection of human
p.000293: rights;
p.000293: - legal assistance in any case of discrimination referring to health condition;
p.000293: - compensation for a caused harm;
p.000293: - making an appeal in the event of wrongful decisions or actions of healthcare professionals;
p.000293: - independent medical expertise in case of discordance with the decision of the State expertise.
p.000293: The healthcare legislation in Tajikistan includes Constitution norms, Tajikistan law “On the Protection
p.000293: of Population Health” and other national legislation acts, international regulations adopted by
p.000293: Tajikistan, international treaties and normative documents issued by state structures. All these documents state that
p.000293: the society and government are responsible to contemporaries and future generations for the health level of the
p.000293: Tajikistan population. The current legislation is regulating social relations in the sphere of healthcare covering a
...
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
p.000295: access to the service of reproductive health, at preventing HIV/ AIDS spreading and at eliminating sex discrimination
p.000295: in the field of primary and secondary education. To ensure the national demographic policy, the Government approved
p.000295: and adopted the programme “The Concept of RT State Demographic Policy for the Period 2003-2015” (2002).
p.000295: The independent Tajikistan with its scientific potential in healthcare has reached a new, international level of
p.000295: science development, and therefore it is necessary to carry out ethical review of biomedical research in compliance
p.000295: with international regulations. The controlling body is the Committee on Medical Ethics (CME) at the RT Health
p.000295: Ministry. In its activity, the CME is guided by the Constitution of Republic Tajikistan. Documents regulating the
p.000295: CME practice comply with international legal standards and RT laws. The CME forms a part of the Forum for Ethics
p.000295: Committees in the Commonwealth of Independent States. The CME is to review and monitor scientific research in medicine
p.000295: and the compliance with ethical regulations to protect right and dignity of a research subject. Presently, the RT
p.000295: Government is considering the law “On the Protection of Human Rights and Dignity in Biomedical Research”
p.000295: based on the IPA CIS model Law “On the Protection of Human Rights and Dignity in Biomedical Research in CIS”.
p.000295:
p.000295: 3.9.3 Education in Bioethics
p.000295:
p.000295: In Tajikistan biomedical ethics is considered as a interdisciplinary field of knowledge analyzing moral problems of
p.000295: human attitude to living organisms. However meanwhile we do not have either a system of organizational and legal
p.000295: support or objective conditions for a proper development of bioethics. This implies an insufficient propagation of
p.000295: scientific knowledge and juridical culture both in medical community and public at large. Another factor is scarce
p.000295: technical equipment for biomedical research, though much is being done to improve the situation.
p.000295: In the XXI century, the reform of healthcare in Tajikistan is inseparably linked with scientific studies in the fields
p.000295: where the issues of bioethics are of vital importance. In western countries, bioethics is an advanced educational
p.000295: discipline. In the last decade some CIS countries, such as Russia, Ukraine, etc. have been introducing courses on
p.000295: bioethics into the syllabus of medical, philosophical and sociological faculties.
p.000295: At the Tajikistan Medical University ethics is taught within a Course on Ethics and Deontology at the Department of
p.000295: Philosophy. Education in ethics for undergraduate medical students helps them to develop their moral and ethical
p.000295: outlook and to make an appropriate and just decision when conducting a medical research. Unfortunately today
p.000295: bioethics as a special discipline is not included into the system of education in Tajikistan.
p.000295: Introduction of a course on biomedical ethics into the course of higher educational institutions in RT is the demand of
p.000295: the times as Tajikistan has taken the path of democratic development of the juridical civil state where reforms cover
p.000295: the total sphere of education for the purpose of forming a new outlook in professional training.
p.000295:
p.000296: 296
p.000296:
p.000297: 297
p.000297:
p.000297: Humanities are essential components of professional training of a future physician as they enhance moral development
p.000297: and mutual understanding. We share the opinion that bioethics is a subject of interdisciplinary
p.000297: communication, and, with regard to medicine, it should be taught at institutes of higher medical education as moral and
p.000297: ethical knowledge used in patient- physician communication.
p.000297: Bioethics in CT is developing in several directions: education (medical, pedagogical, social, and economic);
p.000297: legislative regulation and establishment of ethics committees. Considering WHO recommendations (1994) on the
p.000297: introduction of a course on bioethics into the syllabi of medical educational institutions all over the world, and
p.000297: the necessity to work out and study moral and legal regulation and to implement into healthcare
p.000297: practice new biomedical technologies, it is essential to introduce into the practice of undergraduate and
p.000297: postgraduate education a systematic training of CT medical professionals in biomedical ethics. To achieve this
p.000297: goal, it is necessary to introduce into the State Standard of Higher Medical Education of RT the discipline “Biomedical
p.000297: Ethics” and to develop a programme of a general and special course. Already at the stage of master training and
p.000297: postgraduate studies, it is necessary to introduce a programme on ethical and legal problems of each medical specialty.
p.000297: One of the key elements here concerns ethical aspects of planning and conducting biomedical research, approbating and
p.000297: implementing new technologies. It is essential to develop a firm ethical position with regard to biomedical
p.000297: research, to introduce teaching programmes covering basic ethical principles for investigators and to
p.000297: establish a system of local ethics committees that review biomedical research.
p.000297: In the process of the formation of the Republican Committee on Medical Ethics (RCME) a seminar organized by a
p.000297: representative from J.Hopkins University (Baltimore, USA) was held in Dushanbe (2004) to train future RCME members.
p.000297: On completing the seminar, the students took exams and received certificates. In 2004 we also accomplished a
p.000297: project within the framework of a LIGP/ACTR/ACCELS Programme of the American Council for International Education and
p.000297: Culture at the Department of States.
p.000297: During the last two years from one to three professionals annually have attended courses on ethical review
p.000297: held in Almaty (Kazakhstan) at the Higher School of Public Healthcare.
p.000297: The implementation of European standards in CT and a new model of the teaching process require a cardinal change
p.000297: and structuring of all teaching programmes in compliance with the principles of the Bologna educational
p.000297: system.
p.000297:
p.000297: 3.9.4. The System of Ethical Review
p.000297:
p.000297: The current international system of a public and state control of safeguarding rights, dignity and autonomy
p.000297: of human subjects participating in biomedical research, and of compliance with universal ethical principles of
p.000297: biomedical research involving human subjects, implies the creation of independent public institutions – ethics
p.000297: committees.
p.000297: Ethics committees are analytical, consultative and monitoring units of various composition and status. They have to
p.000297: work out moral regulations for biomedical research, to carry out ethical review and give recommendations in case of
p.000297: conflicts arising in biomedical research or in medical practice. The Committee on Medical Ethics (CME) at the Health
p.000297: Ministry of Tajikistan performs these functions. To undergo ethical review, investigators should submit research
p.000297: proposals and their supporting documents to the CME secretary. Ethical review of biomedical research is carried
p.000297: out at the CME meeting in compliance with adopted regulations. The CME members may make positive, conditional (with
p.000297: clear suggestions for revision) and negative (in case of potential harm to research subjects’ rights and dignity)
p.000297: decisions on applications for the ethical review. They may monitor the compliance with ethical regulations throughout
p.000297: the research.
p.000297: Another significant aspect of the creation and development of the ethical review system is the review of
p.000297: dissertation works. There is an agreement between the Russian Federation and Tajikistan according to which
p.000297: certification and approval of candidate and doctoral dissertations is performed by the Expert Council for Medicine
p.000297: at the Higher Certifying Commission of the Ministry of Education of the Russian Federation. According to the
p.000297: Bulletin of the Higher Certifying Commission “On the Procedure of Biomedical Research Involving Human Subjects”
p.000297: (No 3, 2002), the Expert Council for Medicine emphasized that the chairpersons of dissertation councils should review
p.000297: both registered and new methods of diagnostics and treatment with regard to their compliance with
p.000297:
p.000298: 298
p.000298:
p.000299: 299
p.000299:
p.000299: international and Russian legislation on biomedical research involving human subjects.
p.000299: When planning clinical research within the framework of a dissertation work investigators should follow regulating
p.000299: documents of the health ministries of Tajikistan and the Russian Federation and obtain a written informed
p.000299: consent from research subjects or their legal representatives. The research project should be approved by the CME at
p.000299: the Health ministry of Tajikistan. Dissertation councils may only accept dissertations for review if they meet the
p.000299: abovementioned requirements.
p.000299: Though the CME at the Health Ministry of CT has been partially equipped with technical facilities, there
p.000299: are, unfortunately, a number of administrative and technical problems caused by the lack of a real financial
p.000299: support. This is the reason why the CME members cannot receive their education abroad, except participation
p.000299: in international conferences held by the FECCIS. Besides, we need funds to organize specialized seminars and courses
p.000299: for training members of regional and local ECs. There are serious financial problems concerning the publication of
p.000299: methodical materials.
p.000299: There is a pressing need to introduce a course on medical ethics into syllabi of institutes of higher medical
p.000299: education and medical colleges. Currently, a methodical manual on the principles of ethical review for
p.000299: undergraduate and post-graduate students is in active preparation.
p.000299: In 2003-2004, a group of physicians from the Republican Oncological Centre implemented a six-month educational
p.000299: project “The Initiative for the Protection of Patients’ Rights in Tajikistan”. The physicians found that,
p.000299: unfortunately, medical professionals lack knowledge on legislation referring to patient’s rights. The project’s
p.000299: objective was to conduct 20 educational seminars on ethical aspects of the patient—physician communication and
p.000299: mechanisms for safeguarding patients’ rights for physicians of healthcare institutions in Dushanbe and five other
p.000299: regions (Rudaki, Gissar, Tursun- Zade, Varzob and Vahdat). Unfortunately, medical professionals showed a low level
p.000299: of knowledge referring to patients’ rights. Thus, 50% of responding physicians in Dushanbe and about 100% of physicians
p.000299: in the regions did not have a proper knowledge on the relevant legislation. A survey revealed frequent cases of the
p.000299: violation of patients’ rights on different levels of medical and social services (50% of physicians
p.000299: mentioned healthcare institutions, 20% - institutions of social service, 30% - public authorities).
p.000299: Only 2% of respondents mentioned that patients might defend their rights via public institutions. According to the
p.000299: survey data, all physicians (100%) believe that medical secrecy implies non-disclosure of a diagnosis and that
...
p.000301: treating princes and common people who needed his help and avoided in every way accepting any gifts.
p.000301: Outstanding physicians who lived and worked in Ukraine during different periods (M.Maksimovich-Ambodic,
p.000301: D.Saimolovich, M.Pirogov, V.Obraztsov, N.Strazhesko, F.Yanovski, D.Zabolotny, A.Bogomolets and many others) not
p.000301: only followed high ethical standards and rules but also developed and extended those. They used new methods of
p.000301: diagnostics, treatment and prevention only after having studied those in research on animals and often in
p.000301: “autoexperiments”. That was their nature – to serve people unselfishly and be ready for self-sacrifice if need be.
p.000301: A bright example of this is life and work of professor F.Yanovsky (1860
p.000301: – 1928) whom citizens of Kiev justly named “the Holy Physician”. He wrote: “All people have equal rights to earthly
p.000301: goods. I cannot start living solely for myself and shut my eyes to others who might need me, and it is not because I am
p.000301: so kind but because to behave otherwise would be unfair”.
p.000301: Zemstvo (primary health care) physicians41 who had been working in Kherson and other southern provinces
p.000301: (N.S.Uvarov, A.V.Korchak-
p.000301:
p.000301: 41 Zemstvo Medicine is a special form of medical and sanitary care of the rural population in Russia in 1864-1917. The
p.000301: administrative districts were divided into physician’s areas (10- 40 and more km) with about 25,000 rural residents.
p.000301: The activities of zemstvo physicians included: rendering medical care to the rural population; infection
p.000301: control; smallpox vaccination; obstetrical care; sanitary surveillance at schools; hygienic education of the
p.000301: population and sanitary measures.
p.000301: Chepurovski, O.N.Teziakov, A.I.Smidovich et al.) tended to develop a new system of public healthcare based on
p.000301: democratic principles, equity, creative approach and with the emphasis on preventive medicine. Like V.V.Veresaev42,
p.000301: they were against an abnormal system of private medical practice that made physicians to live on those rubles and
p.000301: kopecks they received from their patients, and to live better they should wish to have more patients. In short,
p.000301: there was a conflict with ethical principles and morals – to build up one’s well-being on illnesses and sufferings of
p.000301: others.
p.000301: There were attempts to oppose those abnormal tendencies, and one of them was adoption of “The Code of Medical
p.000301: Ethics” proposed by the Society of Uman Physicians.
p.000301: In the Soviet period medical ethics used the best of what had been accumulated by preceding generations.
p.000301: All graduates from medical institutes took The Oath of the Soviet Physician that outlined main ethical principles.
p.000301: However in medicine, as in other fields, ethics principles were often marked with dogmatism which depreciated their
p.000301: role.
p.000301: At the beginning of the 1990s the process of establishing bioethics committees began in Ukraine. It was
p.000301: stimulated by the joint international projects with scientists from the USA and west European countries. In 1998 the
p.000301: National Committee on Bioethics at the National Academy of Sciences was established on UNESCO’s recommendation. In 2001
...
p.000301: preparation.
p.000301: The Commission prepared for the Supreme Soviet recommendations on ratification of Convention on Human Rights and
p.000301: Biomedicine adopted by the Council of Europe and signed by Ukraine. In cooperation with the Ministry of Justice much
p.000301: work was done on comparing our legislation with main statements of every article of the Convention. It turned
p.000301: out that the existing
p.000301:
p.000301: 42 V.V. Veresaev (1867 – 1945) – a famous physician and writer, the author of “Notes of a Doctor”
p.000301:
p.000302: 302
p.000302:
p.000303: 303
p.000303:
p.000303: Ukraine legislation for the most part correspond to the Convention, and there are but some statements to be harmonized.
p.000303: This issue was discussed at the bilateral meeting in Strasbourg (2002). After that the Commission initiated the process
p.000303: of ratification. Currently the process is in its completion stage. After the ratification the Convention of the Council
p.000303: of Europe will have the force of law.
p.000303: Today commissions and committees on bioethics are actively working at the National Academy of Sciences, Ukrainian
p.000303: Academy of Medical Sciences and all medical universities, at research institutes and other biomedical
p.000303: institutions. Presently there are about 100 bioethics committe es and commissions functioning on
p.000303: different levels. Their work is particularly active in the Crimea, Lvov, Odessa and Kharkov. The main task of
p.000303: commissions and committees on bioethics is to promote ethical principles in all spheres of their institutions’ activity
p.000303: and perform ethical review of research projects. In the institutes of higher education they have to participate in
p.000303: teaching bioethics.
p.000303: Now we are facing a new stage: each committee or commission functioning at the local level should be
p.000303: accredited by the central institution and continuously provided with all relevant information. For this purpose we need
p.000303: to develop the system of accreditation and to establish the information centre. These are the principal directions of
p.000303: our current active work.
p.000303: Over the last two years the Supreme Certifying Commission of Ukraine have been carrying out ethical review of all
p.000303: dissertations in medicine and biology.
p.000303: We have established an effective cooperation with the Division on Bioethics at the Council of Europe. Within
p.000303: this period two bilateral meetings in Strasbourg and Kiev were held with the participation of authoritative
p.000303: experts Anna Maclaren (United Kingdom) and Maria Louisa Labat (France). Preparation for the Convention ratification
p.000303: and problems relating to the use of stem cells were on the agenda. That was not only mutual exchange of
p.000303: information but also the search of adequate decisions. All participants agreed that fundamental research should go on
p.000303: the use of stem cells should go on and that too much of advertising and commercialization discredits the whole thing.
p.000303: The third bilateral meeting is to be held in the end of 2007.
p.000303: The greatest achievement, however, is that bioethics gradually enters into the life of scientific laboratories and
p.000303: institutes as well as into syllabi of medical universities. Ethical review of new research projects has become a
p.000303: routine practice.
p.000303: 3.10.2. Legal Regulations
p.000303:
...
p.000303: states the principle of freedom and equality with regard to human rights and dignity (Art. 21); non-admission of
p.000303: discrimination (Art. 24); person’s inalienable right to life (Art. 27); everyone’s right to respect of his/her dignity,
p.000303: (Art. 28). Article 28 states in particular: “No person shall be subjected to medical, scientific or other experiments
p.000303: without his or her free consent”. Article 32 states that the collection, storage, use and dissemination of confidential
p.000303: information about a person without his or her consent shall not be permitted. The Constitution declares that everyone
p.000303: has the right to health protection, medical care and medical insurance (Art. 49); and that everyone has the right to an
p.000303: environment that is safe for life and health is guaranteed the right of free access to information about the
p.000303: environmental situation, the quality of food and consumer goods (Art. 50). Thus, The Constitution secures the
p.000303: fundamental human rights with regard to biomedical research.
p.000303: Another important document is “Basic Legislation on Public Health Service in Ukraine “. This law adopted in
p.000303: 1992 is continuously revised and amended. It sets general healthcare principles and those concerning
p.000303: biomedical research, defines state and public responsibility for the health level and preservation of the Ukraine gene
p.000303: pool.
p.000303: The “Basic Legislation” contains statements on professional standards. It stipulates that only those
p.000303: who have an appropriate education and qualification meeting uniform qualification requirements may take up medical and
p.000303: pharmacological practice (Art. 74.1). All methods used for diagnostics, treatment and prevention of diseases, as
p.000303: well as pharmaceutical products should be authorized by the Ministry of Health (Art. 44.1). The Law establishes the
p.000303: mechanism of state regulation ensuring adherence to medical legislation, state standards, criteria and requirements
p.000303: relating to providing
p.000303:
p.000304: 304
p.000304:
p.000305: 305
p.000305:
p.000305: a healthy environment and conditions for sanitary-and-epidemiologic well- being (Art. 22). The regulatory mechanism set
p.000305: out in this Article concerns also norms of professional activity in healthcare, standards of medical service, medicinal
p.000305: products and technologies and rules of the State Pharmacopoeia. The Law stipulates for a possibility that the Ukrainian
p.000305: Cabinet of Ministers and other authorized institutions, including local governing bodies, may terminate the
p.000305: activity of any institution if it violates medical legislation or state requirements or, else, performs acts
p.000305: conflicting with the statute of the institution (Art. 16.5). Finally, the Law ensures an individual’s right to choose a
p.000305: physician and a healthcare institution (Art. 6d) and the right to change the physician (Art. 34.1).
p.000305: One of the cardinal bioethics principles is that of a person’s voluntary informed consent. The law obliges the
p.000305: physician to explain to the patient the state of his or her health, the goal of suggested research and treatment
p.000305: measures, a prognosis for a possible disease evolution including potential risk for person’s health and life. The
...
p.000307: Materials of Clinical Trials”.
p.000307: With all this considerable number of regulating documents, there is no legislation in the sphere of human
p.000307: genome with regard to both general and specific principles. Almost unregulated is one of the most significant bioethics
p.000307: fields - in vitro research on embryos. Article 19 of the law “On Transplantation of Organs and Other Anatomical
p.000307: Materials” stipulates that it may be possible to use fetal material for transplantation, while issues relating to
p.000307: research on embryos and creation of human embryos for research purposes are not regulated.
p.000307: One of stimulating events that should facilitate the process of legal regulation in the sphere of biomedical
p.000307: research was signing of Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the
p.000307: Application of Biology and Medicine: Convention on Human Rights and Biomedicine in March 2002. This implied
p.000307: assuming political obligations to introduce relevant norms into national legislation (signing and ratification of an
p.000307: additional Protocol on biomedical research is meanwhile a more remote perspective). Today, on the instructions of the
p.000307: Cabinet on
p.000307: the necessity to ratify the Convention efforts are underway towards the development of a relevant legal and
p.000307: normative basis. There was an attempt to adopt a complex law on human rights and biomedicine by analogy with the
p.000307: Convention but the institutions where the draft law was submitted for consideration decided that it required an
p.000307: essential revision.
p.000307:
p.000307: 3.10.3. Education in Bioethics
p.000307:
p.000307: There are 17 institutes of higher medical education of the 4th level of accreditation (undergraduate level) and 3
p.000307: institutes for postgraduate training located in 14 provinces of Ukraine.
p.000307: Starting from 1990s some bioethics problems began to appear in the course of undergraduate and postgraduate training of
p.000307: medical professionals, biologists, social workers and veterinaries, and eventually special training modules and courses
p.000307: in bioethics have been designed.
p.000307: In 2004 the Ministry of Health approved an elective course in bioethics for students of the 5th year at medical
p.000307: universities and institutes of the 4th level of accreditation. The course consists of lectures (10 academic hours),
p.000307: practical seminars (17 academic hours) and students’ individual work (54 academic hours)
p.000307: Although the elective course in bioethics was adopted as a special course for institutes of higher
p.000307: medical education, today bioethics in Ukraine is usually taught not as a separate course but as a
p.000307: fragment of compulsory courses in philosophy of science and medicine, ethics, ethics and deontology of social
p.000307: work, valeology et al. The list of topics and number of hours depend on different teachers and their views on
p.000307: bioethics and the place it has in their courses.
p.000307: Bioethics is also taught at medical institutions for postgraduate training, at universities and polytechnic institutes,
p.000307: at veterinary academies and other institutes of higher education in Kiev, Lvov, Kharkov, Odessa, Vinnitsa and other
p.000307: Ukrainian cities.
p.000307: Thus the Department of Philosophy at National Medical Academy for Postgraduate Studies named after P.L.Shupik was one
p.000307: of the first in Ukraine to introduce in 2000 a compulsory course “Bioethics as Modern Medical Ethics” (12 hours) for
p.000307: postgraduate students. Bioethics is also included into some other courses offered by the Academy: “Sociocultural,
p.000307: Ethical and
p.000307:
p.000308: 308
p.000308:
p.000309: 309
p.000309:
p.000309: Deontological Aspects of Physician’s Activity” (18 h) for clinical residents; “Philosophy of Medicine” (36 h) for
p.000309: PhD students and PhD candidates; “Organization and Performance of Ethical Review of Biomedical Research” (36 h) for
p.000309: physicians and members of ethics committees at research institutes and institutes of higher medical education in
p.000309: Ukraine.
p.000309: A considerable experience in teaching bioethics has been accumulated at National Medical University named
p.000309: after A.A.Bogomolets and at Ukrainian Medical College (Kiev). A programme on experimental studies of bioethics
p.000309: basic principles was launched in 2000 at Ukrainian Medical College at National Medical University named
p.000309: after A.A.Bogomolets and has been successfully functioning since then. Within the framework of teaching
p.000309: seminar the following activities are carried out during every academic year:
p.000309: • Individual work – analysis of actual bioethical problems and situations; assistance in the preparation of
p.000309: a computer presentation; report presentation and a follow-up discussion;
p.000309: • Regular public open lectures by leading Ukrainian and Russian scientists on actual ethical problems
p.000309: relating to biomedical technologies;
p.000309: • Visiting teaching seminars on the basis of the Institute of Experimental and Theoretical Biophysics at the Russian
p.000309: Academy of Sciences (town of Pushchino, Russia)
p.000309: In Kiev compulsory courses in bioethics are also taught at the National Technical University (Department of
p.000309: Political Sciences, Sociology and Social Work), Academy of Labour and Social Relations (Department of
p.000309: Practical Psychology and Social Work), T. Schevchenko National University (Faculties of Ethics and Aesthetics,
p.000309: Biochemistry and Science Methodology), at the National Agrarian University et al.
p.000309: In the western region of Ukraine bioethics is taught in the context of fundamental principles of
p.000309: Christian moral (Ivano-Frankovsk Medical Academy, Lvov Theological Academy, Lvov State Academy of Veterinary
p.000309: Medicine named by S.Z.Gzhitsky, Lvov State Medical University named after D. Galitsky, The Western Branch of
p.000309: Interregional Academy of Personnel Management et al.). Thus Lvov Medical University offers an elective
p.000309: course in bioethics for students in the 3rd year at every faculty. There are also seminars (16 h) for
p.000309: physicians and teaching staff held at the Department of Healthcare Organization and Management. To provide the
p.000309: teaching process with methodical materials, The Training and Methodical Centre for Bioethics was established at the
p.000309: University.
p.000309: Institutes of higher education in Kharkov became methodical centres of teaching bioethics in the Eastearn Ukraine.
p.000309: Since 2004 the Department of Valeology at the Faculty of Philosophy of Kharkov National University named after
p.000309: V.Karazin has been offering a special course “Bioethics as the Ethics of Health” (90 hours). The course
p.000309: was designed for students of the 2nd year who are trained as teachers in valeology. At all faculties of Kharkov
p.000309: Medical University bioethics is taught as an elective seminar course. Kharkov Zoo-Veterinary Academy has a
p.000309: noteworthy experience of teaching bioethics based on the use of alternative methods of studying anatomy and physiology
p.000309: of human beings and animals.
p.000309: At Vinnitsa National Medical University named after N.I. Pirogov bioethics is taught to students of the 3rd
p.000309: year (Faculty of Dentistry, 27h) and to students of the 5th year (Faculty of Pharmacology, 54 h). Both courses end with
p.000309: a test. Bioethics is also taught at institutes of higher education in Dnepropetrovsk, Zaporozhye, Lugansk, Odessa,
p.000309: Poltava, Sumy et al.
p.000309: Different public associations play an essential role in distribution of bioethical knowledge - such as
p.000309: All-Ukraine Public Organization “Ukraine Association on Bioethics”; Kiev Ecological and Cultural Centre; Kharkov
p.000309: Regional Society for Animal Protection and others. Due to their efforts a number of foreign materials were translated
p.000309: into Ukrainian language, books and manuals on teaching bioethics were written to be used in Ukrainian
p.000309: universities and institutes.
p.000309: The existing experience of teaching bioethics at Ukrainian institutes of higher education allows us to draw the
p.000309: following conclusions.
p.000309: The introduction of courses in bioethics in Ukraine, as in other post- soviet countries, is complicated by the fact
p.000309: that for a long time scientists and teachers had no opportunity to study foreign materials on the subject. The lack of
p.000309: home studies in the field of bioethics and the lack of comprehensive knowledge on theoretical, methodological,
p.000309: historical and cultural contexts of the development of bioethical discourse affects negatively the level and quality of
p.000309: teaching bioethics.
p.000309: On the other hand, in Ukraine, as in other European countries, there is a tendency of teaching bioethics as an
p.000309: applied biomedical ethics of a narrow professional character. At UNESCO seminar on problems of
p.000309:
p.000310: 310
p.000310:
p.000311: 311
p.000311:
p.000311: teaching bioethics in East European countries (Moscow, January 2005) it was mentioned that 70% of those who teach
p.000311: bioethics are physicians with a classical medical education. Thus, the majority of bioethics teachers have not studied
p.000311: ethics as an independent or philosophical discipline, which certainly affects the general tendency of education in
p.000311: bioethics and interpretation of basic bioethics problems.
p.000311: Currently there is an urgent need to teach bioethics as a special form of worldview, as an interdisciplinary science
p.000311: uniting separate fields of natural sciences and humanities. Bioethics should be considered and studied as
p.000311: global ethics (knowledge of humanity global problems and ways how to resolve those) and as a field involving
p.000311: different cultural traditions.
p.000311: Today opportunities for education in the field bioethics and Good Clinical Practice on the international level
p.000311: for specialists from Ukraine are restricted to separate training courses and seminars (including conferences,
p.000311: symposiums or congresses on bioethics and clinical research) held by public organizations, institutes of higher
p.000311: medical education, research institutes, National Academy of Sciences, National Academy of Medical Sciences and State
p.000311: Pharmacological centre of Ukraine.
p.000311: We do not have a system of education in GCP principles. The only course for training members of ethics committees
p.000311: “Organization and Performance of Ethical Review of Biomedical research” (36 h) was designed and adopted at the
p.000311: Department of Philosophy of National Academy for Postgraduate Training named after P.L.Shupik (Kiev).
p.000311: Over last 5 years several PhD dissertations in specialties “science philosophy” and “public management”
p.000311: directly related to medical and ecological ethics have been defended.
p.000311: Nowadays teaching bioethics as an academic discipline requires the combination of instrumental principles,
p.000311: approaches and standards of natural sciences with theoretical models and principles of humanities.
p.000311: Although teaching bioethics as a separate discipline has begun only 5-6 years ago, a high level of higher
p.000311: medical and humanitarian education, highly professional teachers, a sufficient number of libraries, internet
p.000311: offer a favorable opportunity for a further development of education in bioethics. Teaching bioethics as
p.000311: a compulsory discipline at medical, biological and humanitarian institutions of higher education will facilitate
p.000311: not only humanization but also algorithmization of specialists’ thought,
p.000311: democratization of professional activity, interdisciplinary integration of theoretical and practical knowledge as
p.000311: well as improving of teaching process as a whole.
p.000311:
p.000311: References
p.000311: 1 Vekovshina S.V., Kulichenko V.L. Bioethics: Origins and [Theoretical] Grounds (A Philosophical
p.000311: and Methodological Analysis) Kiev, 2002 (in Russian).
p.000311: 2 Potter W.R. Bioethics – Bridge to the Future. /Ed. Vekovshinina,
p.000311: V.L. Kulinichenko. Kiev, 2992 (Translated from English).
p.000311: 3 Ethics Committees. Establishment, structure, functions. /Ed. V.L. Kulinichenko, S.V. Vekovshinina. Kiev, 2002
p.000311: (in Ukranian & Russian)
p.000311: 4 Bioethics Anthology / Ed. Yu.Kundiev. Lvov, 2003 (in Ukranian & Russian).
p.000311: 5 Ethics Committees: the present and the future. /Ed. S.V. Vekovshinina,
p.000311: V.L. Kulinichenko. Kiev, 2004 (in Russian).
p.000311: 6 Moskalenko V.F., Popov M.V. Bioethics: philosophical, methodological, social and medical
p.000311: problems. Vinnitsa, 2005 (in Ukranian).
p.000311: 7 Egorenkov A.I. Methods of Studying Basics of Bioethics for Students of Medical and Biological Faculties.
p.000311: Manual for teachers. Kiev, 2001 (in Russian).
p.000311: 8 Egorenkov A.I. Acquiring Skills for Systems Analysis of Bioethical Problems in Teaching the Students of
p.000311: Medical and Biological Faculties. Kiev, 2003 (in Russian).
p.000311: 9 Bioethics in Medicine and Food Industry. The Necessity and Meaning of Moral Behaviour. /Ed. J. Hodges, S.
p.000311: Timchenko. Kiev, 2005 (in Russian).
p.000311:
...
p.000313: Before the 1990s the majority of research in Ukraine was conducted without any ethical control.
p.000313: In the beginning of the 1990s Ukrainian scientists started participating more actively in international scientific
p.000313: projects and clinical research, which stimulated implementation of ethical review. By that time, Ukraine had a negative
p.000313: experience when international projects could not be developed just because there was no procedure of ethical
p.000313: review. Starting from 1992 leading research institutions begin to establish local ethics committees for
p.000313: considering ethical aspects of actual international projects with the participation of Ukraine. In 1995
p.000313: the Pharmacological Centre of the Ministry of Health established Ethics Committee to harmonize the system of
p.000313: conducting clinical trials and registration of pharmaceutical products.
p.000313: In 1998 on the initiative of UNESCO the International Committee on Bioethics was established which
p.000313: followed by establishing national ethics committees in many countries. In the same year, on the proposal
p.000313: of the National Commission of Ukraine for UNESCO submitted to the National Academy of Sciences the
p.000313: Bioethics Committee was established at the Presidium of National Academy of Science of Ukraine. Leading
p.000313: academicians in the fields of biology, medicine, philosophy, as well as representatives of Ministry of
p.000313: Health, Ministry of Environmental Safety, Ministry of Education and Science, Ministry of Justice and of Academy of
p.000313: Medical Sciences and Academy of Agrarian Sciences were invited to take part in the work of the Committee.
p.000313: In 2002 Bioethics Committee at the Presidium of Academy of Medical Sciences of Ukraine was established. In cooperation
p.000313: with Ministry of Health it developed model regulations for medical ethics committees at scientific and medical
p.000313: institutions in line with modern international requirements. During these years a number of public organizations
p.000313: having a concern in bioethics have emerged, and the implementation of the system of ethical review for biomedical
p.000313: research has begun on a large scale.
p.000313: Today we have the following system of ethical review. Firstly, there are different laws and by-laws regulating
p.000313: biomedical research. The order of conducting clinical trials of pharmaceutical products and reviewing materials of
p.000313: clinical trials has been developed in compliance with the Articles 7 and 8 of the Ukrainian Law “On Pharmaceutical
p.000313: Products”43 and in line with requirements of the Directive 2001/20/EC of the European Parliament and of the
p.000313: Council EC ICH GCP44 and Declaration of Helsinki45. It was approved by the Order of the Ministry of health
p.000313: of Ukraine No 6646. The responsibility for reviewing documentation on clinical drug trials rests with the State
p.000313: Pharmacological Centre of the Ukrainian Ministry of Health.
p.000313: General principles of conducting clinical trials:
p.000313: • According to the sponsor’s choice, clinical trials are mostly conducted at specialized medical
...
p.000315: Alongside with the growing number of clinical trials there is a growth of medical institutions authorized by the
p.000315: Ukraine Ministry of Health where clinical trials may be conducted. Thus, 166 medical institutions were
p.000315: authorized in 1996, by 2001 there were over 200 institutions and today there are 400 medical institutions that may
p.000315: conduct clinical trials.
p.000315: As normally the term for the ethical review of trial related documents and decision making is no longer than 60 days,
p.000315: it is easy to imagine the heavy load of the shoulders of ethics committees/commissions members. The role and
p.000315: responsibility of ethics committees/commissions at scientific- research institutions in the sphere of medicine and
p.000315: biology grows also due to the requirement to carry out a compulsory ethical review of scientific projects
p.000315: (earlier it concerned mainly international projects). Ethical review of publications in scientific journals is
p.000315: also becoming a routine practice. In 2005 a compulsory ethical review of dissertation works in medicine,
p.000315: biology and veterinary medicine. The continuously growing amount of
p.000315: 47 www.pharma-Centre.kiev.ua/clinic/programm.doc
p.000315:
p.000316: 316
p.000316:
p.000317: 317
p.000317:
p.000317: work performed by ethics committees/commissions makes us think about the necessity of financing this work.
p.000317: New demands on the quality of ethical review require improving the work of existing local ethics committees. It
p.000317: is necessary to organize a continuing education of ethics committees members and to develop legal regulation of
p.000317: operation and interaction of committees at different levels.
p.000317:
p.000317: 3.10.5. Perspectives and Forms of International Cooperation
p.000317:
p.000317: World tendencies of bioethics development have an essential influence on its development in Ukraine. First local ethics
p.000317: committees in Ukraine were established in 1992. They were approved at the Board Meeting of the Ukrainian Ministry of
p.000317: Health, and thus became legitimate to carry out ethical review of scientific projects. This idea can be
p.000317: illustrated with two large international projects. The Institute of Pediatrics, Obstetrics and Gynecology of the
p.000317: Ukraine Academy of Medical Sciences participated in an international multicentre epidemiological study “Mother
p.000317: and Child”, and the Institute of Occupational Medicine of the Ukrainian Academy of Medical Sciences in cooperation
p.000317: with colleagues from USA conducted an ophthalmologic research in rescuers who had participated in the elimination of
p.000317: the Chernobyl accident. Both projects were carried out in cooperation with the University of Illinois and
p.000317: Columbia University (USA). Within the framework of the projects the teaching staff of universities provided a basic
p.000317: training in bioethics for Ukrainian medical specialists involved in the projects.
p.000317: Since 1998 Ukraine cooperates with different UN organizations including UNESCO that has initiated
p.000317: establishing the National Committee on Bioethics in Ukraine. In 1998 the Committee on Bioethics was established at the
...
p.000319: of ethics committees (with the support of UNESCO and other
p.000319:
p.000320: 320
p.000320:
p.000321: 321
p.000321:
p.000321: organizations). The work on the development of an efficient network of ethics committees and on the
p.000321: harmonization of international and national standards for ethical review of biomedical research will be continued.
p.000321:
p.000321: References
p.000321: 1. Programme in Bioethics. General Course for Students of Higher
p.000321: medical Institutes. - М., 2001. 40 p. (in Russian)
p.000321: 2. An Outline of the Programme in BIOETHICS for the speciality
p.000321: 040500 -Pharmacia. М., 2003. 18 p. (in Russian)
p.000321: 3. http://www.med-law.ru
p.000321: 4. Bioethics Manual. / Ed. P.V. Lopatin. М., 2005. 240 p. (in Russian)
p.000321: 5. Medical Ethics Manual. Translated from English. /Ed. Yu.M.
p.000321: Lopukhin, B.G.Yudin. М., 2004. 400 p. (in Russian)
p.000321: 6. http://www.bioethics.union.edu
p.000321: 3.11 REPUBLIC oF UzBEKIStAn (M.S. Abdullakhodjaeva)
p.000321:
p.000321: 3.11.1. Historical and Cultural Background
p.000321:
p.000321: The history of bioethics in Uzbekistan roots back to interpretations of ethical teachings in pre-Islamic tradition and
p.000321: in the Koran.
p.000321: Syncretism of the oriental philosophical tradition gave rise to a term that has no analogues in European culture –
p.000321: “adab” and “adabnoma” – a teaching describing the due behaviour of a well-brought-up person. The term combines the
p.000321: general education, the theory of ethics and norms of a polite behaviour. Both in a strictly scientific sense and by
p.000321: birth terms “ethics” and “adabnoma” are not identical; they differ in the approach to the study of ethics, in
p.000321: argumentation and in the focus of their attention (general abstract principles and/or a code of behaviour). Central
p.000321: Asian codes of behaviour “Kobusnoma” by Unsurmaol Kaykovus, the treatise “On Ethics” by Ibn Sina, “Four
p.000321: Conversations” be Arusi Samarkandi, “The Oriental Code of Decencies” by Sadyk Kashgari and many other works are
p.000321: fundamental methodological sources of Uzbek model of bioethics. Adabnoma, rather than Islam, provided a
p.000321: basis for the development of research ethics and medical practice in pre-Soviet time. Thus, distinctive features
p.000321: of national historical and cultural, philosophical and methodological sources of biomedical ethics in
p.000321: Uzbekistan are the pedagogical orientation and a pronounced didactic character. Such were traditions, norms
p.000321: and values of Zoroastrism and Islam and achievements in medicine and philosophy of the Moslem (Arabic)
p.000321: Renaissance, creative heritage of Central Asian thinkers and physicians Abu Ali Ibn Sina, Abu Abdullah
p.000321: Khorezmi, Abu Nasr Mohammed al-Farabi, Abu Raihan Beruni and other prominent figures representing Islamic
...
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
p.000325: Ibn Sina’s views on childhood are noteworthy. “Canon of Medical Science” states that child’s life and health
p.000325: should be objects of care, protection and a special regimen from the moment of conception, not just from the moment of
p.000325: birth. A newborn baby needs a wet nurse with a stable nervous system. Games are essential, as all educational
p.000325: and formative processes, starting from very early years, should proceed from games. One may not punish a child, as
p.000325: the task of a tutor and physician if to protect the child’s soul, to facilitate the development of the feeling of
p.000325: self-respect. It is particularly important to prohibit any punishment for children under age of five, i.e. at the age
p.000325: when a child does not realize the meaning of his/her actions. Abu Ali Ibn Sina believed that, irrespective of state and
p.000325: public benefits, a child should receive a good intellectual, moral and ethical education in the family and at school.
p.000325: In his works, Ali Abu Ibn Sina gave much attention to school education. Kind and well-educated teachers may only
p.000325: teach at school,
p.000325: where children are brought up and educated until the age of fourteen. A teacher should know well the subject
p.000325: he teaches; he should follow the moral principles and be an honest, loving and courageous person.
p.000325: In the system of Ibn Sina’s ethical views, a concept of mizaj implying the necessity of an entirely individual approach
p.000325: to each individual, irrespective of the person’s age of health condition and considering a unique combination of
p.000325: qualities on the individual and his/her living and working conditions.
p.000325: The knowledge of human nature and temperament is the basis of a physician’s strategy when maintaining a
p.000325: proper level of health, and, if need be, planning the therapy. A comprehensive study of the “Canon” helps us to tell a
p.000325: sanguine person from a phlegmatic one or a choleric person from a melancholy one, and to mark out characteristic
p.000325: biotypes. If we translate it into the language of modern bioethics, we can see clearly the logical construct of
p.000325: Hippocrates, Galen and Avicenna; treat not a disease but a person, and not just a person but also a biotype
p.000325: whose psychological responses are subordinate to its biological nature (mizaj), or temperament. Ages later Ivan
p.000325: Pavlov mentioned the biotypological approach used widely by Ibn Sina as a fruitful one, revealing “fundamental
p.000325: features” of human nature.
p.000325: Thus, “Canon of Medical Science” written in the times of the Oriental Renaissance, and very popular during the European
...
p.000327: provides an ideological foundation for the development of bioethical values. However, it would be incorrect
p.000327: merely to reduce Uzbekistan ethical norms to Islamic ones. Uzbekistan is a secular state, and Islam adherents form
p.000327: but one of society segments, and religious norms are but one of the components of biomedical ethics in Uzbekistan. Many
p.000327: ethical and medical rules of social life exist not only in form of religious dogmas but also as traditions, rituals and
p.000327: folklore, which helps to observe the norms across generations.
p.000327: Biomedical ethics in Uzbekistan is open to world tendencies, such as globalization and westernization that have a
p.000327: strong impact on Uzbekistan science. Achievements in the field of informed consent, reproductive behaviour,
p.000327: etc. prove the response to world tendencies. The protection of universal human values, as well as traditional values is
p.000327: a key issue of the contemporary medical ethics in Uzbekistan.
p.000327: Thus, the Uzbekistan model of biomedical ethics is at the stage of intensive development. The intensity
p.000327: of research development in this field is predetermined by ethical tendencies in Uzbekistan education and
p.000327: philosophy existing throughout the history of Uzbekistan (Zagyrtdinove
p.000327: F.B. Peculiarities of Biomedical Ethics in Uzbekistan. In: “”Bioethics in Uzbekistan – Clinical, Philosophical
p.000327: and Legal Aspects.” Tashkent, 2006, pp. pp. 122-128).
p.000327: 3.11.2. Legal Regulations
p.000327:
p.000327: The State plays a key role in safeguarding social and economic rights of its citizens, and therefore
p.000327: the State social policy should be directed at maintaining social health, which is described by three groups of
p.000327: characteristics: 1) population health (physical, mental and social); 2) intellectual potential and the level of
p.000327: professional knowledge; 3) spiritual and moral values.
p.000327: To maintain and improve population health and to raise a healthy generation, the Ministry of Public
p.000327: Health of the Republic of Uzbekistan undertakes a considerable work on reforming healthcare based on a number of
p.000327: principles and with a special attention to:
p.000327: • the observance of constitutional rights to receive a qualified medical care and
p.000327: • the principle of an equitable access to medical service.
p.000327: Issues relating to social relations in medicine are regulated by the Constitution of the Republic of
p.000327: Uzbekistan (Art. 24, 26, 40, 43; 1922) and by laws directed to the protection of citizens’ rights in medicine.
p.000327: 1. “On the State Control” (3 of July 1992; revised editions: 6 of May 1995; 15 of April 1999; 31 of August 2000);
...
p.000337:
p.000338: 338
p.000338:
p.000339: 339
p.000339:
p.000339: - to follow the physician’s prescriptions after having given consent to a medical intervention;
p.000339: - to comply with the routine of the healthcare institution;
p.000339: - to collaborate with the physician in the process of treatment;
p.000339: - to inform the physician without delay about a change in his/her health condition in the process of diagnostics and
p.000339: treatment;
p.000339: - to apply to the physician immediately if there is a suspicion of a disease or a disease posing hazard of a wide
p.000339: spreading;
p.000339: - to avoid any actions that may infringe other patients’ rights.
p.000339: It is essential to include into the draft project of the Law provisions on the physician’s rights and responsibilities
p.000339: that enhance the rapport with the patient, as both the patient and the physician become partners having reciprocal
p.000339: rights and responsibilities, and the right for one party, is the responsibility of another one.
p.000339: The Law “On Medical Practice” will facilitate the regulation of independent ethical review and safeguard the
p.000339: protection of rights and dignity of Uzbekistan citizens in biomedical trials.
p.000339: Legislative measures undertaken in Uzbekistan will be able to protect individuals, the society and humankind as a
p.000339: whole against undesirable or sometimes harmful consequences from the implementation of new biomedical
p.000339: technologies.
p.000339:
p.000339: 3.11.3. Education in Bioethics
p.000339:
p.000339: Problems of teaching bioethics arouse much discussion at all international forums on bioethics.
p.000339: According to UNESCO Ethics Education Programme (EEP), for the biennium 2004-2005 the activities in the area of ethics
p.000339: teaching have primarily focused on East and Central Europe. During 2006-2007 priority has been given to
p.000339: South-East Europe and part of the Arab region (Gulf region).
p.000339: To facilitate the development of new relations in Uzbekistan healthcare that would more adequately comply with
p.000339: current political and social conditions, all Uzbekistan institutes of higher medical institutions and
p.000339: universities (faculties of law, philosophy and biology) introduced regular courses on bioethics into the syllabi
p.000339: of undergraduate and postgraduate education.
p.000339: According to the State Standard of Education, at institutes of higher medical education bioethics is taught at two
p.000339: levels: 1st level --”Introduction to Bioethics” and 2nd level – “Biomedical ethics” for senior students (3rd year).
p.000339: In 1998, Tashkent Medical Academy (TMA) included the study of basic bioethical problems in the baccalaureate programme
p.000339: on social sciences and humanities. Since 2002 TMA is offering modules on bioethics for magistracy residents; in 2003
p.000339: the Faculty of Post-Graduate Education at the Tashkent Medical Academy included topics on bioethics into the
p.000339: programme for post-graduate education, and since 2004 bioethics is taught as an elective course.
p.000339: The Chair of Philosophy has designed a programme on bioethics and published a manual “Introduction to Bioethics”
p.000339: in Russian and Uzbek (2004). In 2005, an anonymous questionnaire on key bioethical problems was offered to medical
p.000339: students of the second year to assess the level of their training and the system of their values and general worldview
p.000339: [1].
p.000339: In the second year students study philosophical and legal aspects of bioethics. The course consists of
p.000339: lectures (10 hours) and seminars (10 hours).
p.000339: In the third year, bioethics is taught at all faculties (general medicine, dentistry, pediatrics, biomedicine, etc.).
p.000339: The course aims at raising the level of education in biomedical ethics and the professional level of future physicians.
p.000339: Their knowledge of bioethics will help them to avoid deontological and professional mistakes and to make decisions in
p.000339: difficult situations.
p.000339: The working group of the NEC in collaboration with the TMA professionals teaching bioethics has designed a
p.000339: programme on biomedical ethics for baccalaureate students. The course consists of five lectures (10 hours), 8
p.000339: seminars (17 hours) and 54 hours are given to individual work. The course ends up with a test.
p.000339: Themes vary depending on the course. The syllabus on bioethics covers the following topics: categorical issues of
p.000339: bioethics as a science (relation of the concepts “bioethics”, “biomedical ethics”, “medical ethics”, “ecological
p.000339: ethics”, “research ethics”; subject and tasks of bioethics; theory, principles and methods of biomedical ethics, etc.);
p.000339: international legislation on bioethics; history of medical ethics (including issues of spiritual development
p.000339: and
p.000339:
p.000340: 340
p.000340:
p.000341: 341
p.000341:
p.000341: education, of life and death reflected in works by scientists of different times and peoples; secular and religious
p.000341: aspects of modern biomedical ethics; specific features of biomedical ethics in Islamic countries and
p.000341: Zoroastrian medicine), etc. In addition to that, students should study the Constitution of the Republic of Uzbekistan
p.000341: (1992), as well as laws and normative documents regulating public relations in healthcare. All cardinal problems of
p.000341: theoretical and applied bioethics are considered including ethical problems in clinical trials and biomedical research
p.000341: involving human subjects and animals. Specific ethical problems associated with students’ specialization are also
p.000341: considered.
p.000341: The NEC of the Republic of Uzbekistan is carrying on an essential work on the development of a regular education in
p.000341: bioethics and on training home specialists in the field of modern bioethics.
p.000341: Since 2000, members of the NEC and of regional and local ethics committees have participated in training
p.000341: seminars on bioethics (2001 – Saint- Petersburg, Russia; 2001 – Kiev, Ukraine; 2002 – Almaty, Kazakhstan; 2003
p.000341: – Saint-Petersburg, Russia and Tashkent, Uzbekistan; 2004 – Kiev, Ukraine and Baku, Azerbaijan; 2005 – Yerevan,
p.000341: Armenia; Almaty, Kazakhstan and Tashkent, Uzbekistan; 2006 – Tashkent, Uzbekistan). Training seminars were organized by
p.000341: the Forum for Ethics in the Commonwealth of Independent States, US National Healthcare Union and American Centers for
p.000341: Disease Control and Prevention (CDCP) in collaboration with UNDP (World Bank/WHO), IPA CIS, EFGCP, UNESCO, EC
p.000341: and other international and national organizations. Training seminar on research ethics for members of NEC and local
p.000341: ECs of Uzbekistan that was held in Tashkent, Uzbekistan was conducted in the framework of SIDCER “Recognition
p.000341: Programme”. Within this seminar there were a training courses “Standard Operational Procedures” and “Human
p.000341: Subject Protection”. The training seminars covered the following issues:
p.000341: - The role of ethical review in biomedical research;
p.000341: - The role of SOPs in conducting ethical review, establishing ECs, choosing independent consultants and
p.000341: confidentiality agreement.
p.000341: The teaching programmes on ethics for EC members and programmes on GCP for postgraduate education were discussed at the
p.000341: seminars (C.Jankw, Austria) as well as Fogarty Programme (B.Yudin, Russia):
p.000341: - the procedure of establishing an EC and EC meetings;
p.000341: - legislative basis for the ethical review of biomedical research;
p.000341: - the procedure of obtaining informed consent.
p.000341: There were also training seminars for EC members from countries of Central Asia. Tashkent hosted training seminars
p.000341: “Principles of Ethics in Biomedical Research”(CDCP, 2003), “Principles of Conducting Ethical Review and
p.000341: Obtaining Informed Consent” (CDCP, 2005).
p.000341: In addition to training EC members, NEC of the Republic of Uzbekistan provides assistance in educating students and
p.000341: physicians with regard to the protection of human rights and dignity in modern medicine and biology. The
p.000341: introduction of a course on bioethics pursues the following goals: 1) to provide new knowledge; 2) to develop practical
p.000341: abilities; 3) to develop a conscious need for moral development [2].
p.000341: Recognizing the necessity of training professionals with a high level of proficiency, we shall use the following three
p.000341: variants of a course programme designed in the framework of the project “Bioethics for CIS Countries” (the head of the
p.000341: Project – B.G.Yudin):
p.000341: - Short-term course for investigators and EC members (held in Tashkent, 2005);
p.000341: - A programme for bioethics teachers;
p.000341: - A programme for training professionals with a high level of proficiency in bioethics.
p.000341: The introduction of a course on bioethics into syllabi of institutes of higher medical institutions in
p.000341: Uzbekistan meets the demands of the time and is connected with reformation processes in health care and education
p.000341: aiming at humanization and development of a new worldview in the context of the National model of training
p.000341: professionals and building a democratic and jural civil society.
p.000341:
p.000341: References
p.000341: 1. Atakhanov Sh.E., Mukhamedova Z.M. On the Necessity to Introduce the Course on Bioethics into the Higher Education.
p.000341: In: Materials of the First National Congress on Bioethics of the Republic of Uzbekistan. Tashkent, 2005, pp. 88-89 (in
p.000341: Russian).
p.000341: 2. Nazhmetdinova D.K., Mukhamedova Z.M. Problems of Bioethics in the Context of Moral Components of
p.000341: Medical Knowledge of Future Physicians. In: Materials of the First National Congress on Bioethics of the Republic of
p.000341: Uzbekistan. Tashkent, 2005, pp. 100-103 (in Russian).
p.000341:
p.000342: 342
p.000342:
p.000343: 343
p.000343:
p.000343: 3. Rustamova M.T. Ethical Education of Medical Students and its Role in the Protection of Patients’ Rights. In:
p.000343: Materials of the First National Congress on Bioethics of the Republic of Uzbekistan. Tashkent, 2005, pp. 105-106
p.000343: (in Russian).
p.000343: 4. Abdullakhodjaeva M.S., Mukhamedova Z.M., Rustamova M.T.. Avicenna and the ethics of science and
p.000343: technology today. In: Ethics of science and technology Exploration of the frontiers of science and ethics. UNESCO,
p.000343: France, 2006.
p.000343: 5. Zagrytdinova F. On Biomedical Ethical Problems. Tashkent, 2005, p. 131 (in Russian).
p.000343: 6. Mukhamedova Z.M. Introduction in Bioethics. Tashkent, 2004, p. 110 (in Russian).
p.000343: 7. Mukhamedova Z.M. Bioethics. Tashkent, 2006, p. 148.
p.000343: 8. Zagrytdinova F. Ethics: A Manual. Tashkent, 2005, p. 134.
p.000343:
p.000343: 3.11.4. The System of Ethical Review
p.000343:
p.000343: A rapid development of biology, pharmaceutical industry and new biotechnologies for diseases diagnostics,
p.000343: treatment and prevention required the review of clinical efficiency of new and generic pharmaceutical products and put
p.000343: in the forefront the necessity to protect human rights in biomedical research involving human subjects.
p.000343: The establishment of national, regional and local ECs facilitated a wide implementation of ethical review of
p.000343: biomedical research performed in Uzbekistan in compliance with international ethical principles and WHO Operational
p.000343: Guidelines for Ethics Committees that Review Biomedical Research (2000).
p.000343: The necessity to establish EC for conducting ethical review of clinical trials (CT) emerged in Uzbekistan in the
p.000343: end of the nineteenth. It was connected with involvement of Uzbekistan in international scientific projects, which
p.000343: implied conducting an ethical review in conformity with international ethical norms. Another important reason was the
p.000343: establishment of the State Registration of Pharmaceutical Products and Medical Facilities. Presently, the NEC conducts
p.000343: ethical review of CT of home and foreign pharmaceutical products and multi-centre research. From the very beginning the
p.000343: NEC has been conducted ethical review of biomedical research involving human
p.000343: subjects. The NEC controls the procedure of obtaining informed consent and other ethical aspects including the
p.000343: safety of research participants’ insurance and monitors the process of medical research to check the risks of the
p.000343: research. The NEC also controls educational programmes on bioethics in institutes of higher education, training
p.000343: seminars and conferences on bioethics and publications in medical journals and mass media. It is responsible for a
p.000343: prompt notification of authorized bodies in the case of any unexpected adverse effects that are hazardous to research
p.000343: participants or other persons associated with the research, in the event of any serious violation of ethical norms or
p.000343: in the case of the suspension/termination of a research involving human subjects that was previously approved by the
p.000343: NEC and conducted in Uzbekistan or with the participation of Uzbekistan.
p.000343: In 2000, the minister of public health approved the document Regulations for the National Ethics Committee at the
p.000343: Medical Scientific Council of the Ministry of Public Health of the Republic of Uzbekistan”. The Regulations define the
p.000343: tasks, responsibilities and rights of the Committee, as well as its structure and procedures.
p.000343: In 2003, the document was revised. It included a wider range of tasks, a more detailed description of the NEC
p.000343: organization activity, procedures, rights and responsibilities (in particular, a new clause “Responsibilities
p.000343: of Investigators and Research Directors” was added). The NEC is an independent institution created on a
p.000343: voluntary basis at the Ministry of Public Health for the protection of human rights, health and safety in biomedical
p.000343: research. Currently, the Regulations for the NEC (adopted on June 20, 2005) are in full compliance with relevant
p.000343: international principles and norms.
p.000343: In connection with the completion of establishing local ECs throughout the Republic of Uzbekistan, and to improve their
...
p.000343: the NEC at the site of the research with regard to compliance with the review procedures, obtaining informed consent
p.000343: from the research subjects, research safety (serious adverse effects, inadequate reaction) and notifying
p.000343: NEC if the
p.000343:
p.000344: 344
p.000344:
p.000345: 345
p.000345:
p.000345: research should be terminated because of complications arising in the course of the biomedical research). Local ECs
p.000345: describe the results of their activity in form of an annual report that are archived and retained at local
p.000345: ECs. Operational procedures and rules relating to documenting and archiving should ensure confidentiality of
p.000345: local ECs performance. At the same time the activity of ECs at all levels should be open to the society, which is
p.000345: stated in relevant documents. Information about ECs members, work schedule and decisions may not be confidential.
p.000345: Thus, Republic of Uzbekistan created a multilevel system for ethical review of biomedical research. In compliance with
p.000345: WHO recommendations the NEC members are leading Uzbekistan scientists with experience in various fields of medical
p.000345: and other sciences (biology, law, genetics, philosophy) and representatives of religious and public institutions,
p.000345: ombudsmen and a representative of the National Centre for Human Rights. Regional and local ECs established at regional
p.000345: centers (Samarkand, Bukhara, Andijan, Nukus) and large clinical sites at institutes of higher medical education and
p.000345: research institutes are also headed by eminent Uzbekistan scientists.
p.000345: The NEC reviews international research projects involving human subjects and makes its decisions about the
p.000345: project. The NEC of Republic Uzbekistan has been registered at American Centers for Information Disease Control
p.000345: (Atlanta) and American Centers for Disease Control and Prevention (NAMRO-3, Cairo).
p.000345: The NEC functions in conformity with Standard Operational Procedures (SOPs) designed in the process of a regular work.
p.000345: According to the NEC procedures, the documents should be reviewed within 7-30 days (expedited or regular review). Since
p.000345: the time of its establishment, the NEC has reviewed over 320 various projects including joint international
p.000345: research projects, research projects designed by Uzbekistan scientists and dissertations based on biomedical research
p.000345: involving human subjects.
p.000345: The NEC review also projects of clinical trials of pharmaceutical products, of medical equipment and other products for
p.000345: medical needs. Usually research projects meet ethical requirements, and the NEC makes positive decisions. Sometimes,
p.000345: however, there are cases when the NEC declines a project. This usually concerns clinical trials of a non-registered
p.000345: pharmaceutical product or of a new rout of a known drug administration when there is no approval by the Pharmacological
p.000345: Committee or the drug is hazardous to a patient’s
p.000345: health. Negative decisions are also made if the risk of complications or adverse effects is very high. The
...
p.000347: signed by potential trial participants.
p.000347: The NEC activity in the sphere of implementing ethical principles into medical science and healthcare enhanced the
p.000347: quality of patient—physician relationship and of medical services provided by healthcare institutions. This
p.000347: also served to reduce the number of complaints from patients.
p.000347: The NEC coordinates its activity with the Centre of Science and Technology. The latter considers applied,
p.000347: fundamental and innovation grant projects relating to biomedical research after they were approved by the NEC.
p.000347: The NEC collaborates with the Higher Certifying Commission at the Cabinet of the Republic of Uzbekistan. According
p.000347: to the petition of the NEC Medical Council “On the Necessity to Conduct Ethical Review of Dissertation
p.000347: Works Involving Patients or Volunteers as Research Subjects” (Protocol No 25, 2002) the Commission considers
p.000347: dissertation works only after the NEC permission to carry out the research (including biomedical research with animals)
p.000347: was obtained.
p.000347: The NEC participated in the organization of the First National Congress on Bioethics with international participation
p.000347: (2005) and a scientific conference “Ethical Aspects of New Biotechnologies in Biology and Medicine” (2006). It
p.000347: facilitated the publication of the Conference papers and of a book “Bioethics in Uzbekistan. Clinical, Philosophical
p.000347: and Legal Aspects” (2006).
p.000347: At the First National Congress four trends in bioethics were discussed:
p.000347: - ethical problems in science;
p.000347: - legal aspects of bioethics;
p.000347: - bioethics and education;
p.000347: - bioethics and the environment.
p.000347: A special attention was given to ethical aspects of new biotechnologies, patient-physician relationships in various
p.000347: fields of healthcare (pediatrics, neonatology, surgery, neurosurgery, emergency care, neurology, psychiatry) and
p.000347: bioethical education.
p.000347: The Congress adopted a Resolution that will facilitate the development of bioethics in Uzbekistan.
p.000347: The main tasks of the Congress were to promote legislation with regard to the protection of human rights and
p.000347: dignity in biomedical research involving human subjects; to outline the strategy for developing the activity of the NEC
p.000347: in the field of bioethics; to discuss educational programmes on bioethics for students of higher educational
p.000347: establishments.
p.000347: The Congress participants discussed and adopted the Ethical Code of Uzbekistan Physician-Investigator”
p.000347: setting out basic principles of ethical review of biomedical research involving human subjects. The
p.000347: implementation of the Ethical Code will form a basis for a legal solution of bioethical problems. This, in its turn,
p.000347: will allow us to provide medical care corresponding to the level of modern biomedical technologies and to observe
p.000347: patients’ rights in compliance with adopted international documents.
p.000347: The adopted Resolution and the Ethical Code of Uzbekistan Physician- Investigator not only mark a new stage in
p.000347: the development of the NEC activity, but also evidence the growth and prospects with regard to solving key
p.000347: problems of bioethics relating to the protection of human rights and dignity in Uzbekistan.
...
p.000349: bioethics. Members of ECs from Uzbekistan, Kyrgyzstan and Tajikistan took part in the seminar.
p.000349: The First National Congress on Bioethics adopted a Resolution that reflected basic priorities of biomedical
p.000349: ethics in Uzbekistan and set out a programme for the NEC activity relating to the development of bioethics in
p.000349: Uzbekistan. The Ethical Code of Uzbekistan Physician-Investigator regulates moral aspects of physicians’
p.000349: relationships with patients and their relatives in everyday work and in biomedical research. The Code formed a basis
p.000349: for a further development of legal regulation in the field of bioethics.
p.000349: In the framework of the FECCIS international seminar according to the SIDCER “Recognition programme “, a
p.000349: scientific conference “Ethical Aspects of New Biotechnologies in Biology and Medicine” was held
p.000349:
p.000350: 350
p.000350:
p.000351: 351
p.000351:
p.000351: (Tashkent, 2006). Scientists from Uzbekistan, Kyrgyzstan, Russia and Tajikistan presented their talks.
p.000351: The initiative to extend the NEC relations with the countries of Central Asian Region (CAR) - Kazakhstan, Kyrgyzstan,
p.000351: Tajikistan and Turkmenistan - is also very important. The cluster meeting of chairpersons and members of the CAR ECs
p.000351: held in Tashkent (2006) adopted a Resolution about establishing in the framework of the FECCIS a Bioethics Association
p.000351: for the CAR countries. The Association aims at providing a high-quality and efficient ethical review. Resolution
p.000351: emphasizes the importance of training EC members. For this purpose, we intend to create the UNESCO Chair of
p.000351: Bioethics at institutes of higher medical education for training specialists, establishing relations with
p.000351: European and other international organizations. Much attention is given to the collaboration with the countries
p.000351: of Central Asia (Iran, Afghanistan, Pakistan). Two members of the NEC of the Republic of Uzbekistan have
p.000351: been elected honorary members of the Iran Association of Bioethicists (academician the Uzbekistan Academy
p.000351: of Science, M.S.Abdullakhodjaeva and assistant professor Z.M.Mykhamedova). We plan to open the Association
p.000351: Representative Office at the NEC of the Republic of Uzbekistan. The Statute of the Association of National Ethics
p.000351: Committees has been designed.
p.000351: In the last years, the process of harmonization of ethical review standards has been in the focus of the NEC attention.
p.000351: In its work the NEC is consistent with the current tendencies of the international process of developing ethical review
p.000351: at a global scale and developing conditions for creating national systems, which is reflected in the
p.000351: NEC activity directed at collaboration with WHO, WMA, UNESCO, European Commission and other leading
p.000351: organizations in the field of bioethics.
p.000351: Much attention is given to creating school of bioethics in Uzbekistan and training new scientific and medical
p.000351: specialists in this field. The collaboration with UNESCO allows us to implement at a broader scale the
p.000351: UNESCO Ethics Education Programme. On the instructions of The Cabinet of the Republic of Uzbekistan,
p.000351: programmes on bioethics for Masters of Medicine and doctoral students of institutes of higher medical education
p.000351: are under preparation. The NEC members take part in designing the programmes in a close collaboration with the UNESCO
p.000351: Ethics Education Programme.
p.000351: Chapter 4. tHE PERSPECtIVES FoR GLoBAL IntERnAtIonAL HARMonIzAtIon
p.000351: tHE EtHICAL REVIEW oF BIoMEDICAL RESEARCH In CIS CoUntRIES
p.000351: (o.I.Kubar, G.L.Mikirtichian)
p.000351:
p.000351: Review of materials presented by the Republic of Armenia, the Republic of Azerbaijan, the Republic of Belarus,
p.000351: Georgia, the Republic of Kazakhstan, the Kyrgyz Republic, the Republic of Moldova, the Russian Federation, the
p.000351: Republic of Tajikistan, the Ukraine and the Republic of Uzbekistan on issue of historical and cultural
p.000351: basics of development of ethical self-consciousness and its practical implementation in medicine; dynamic
p.000351: process of law generation in the field of protection of human rights in medicine and biology;
p.000351: establishing of bioethics as educational subject and introduction of an ethical component into the state system of
p.000351: control of biomedical studies, is a unique resource to analyze perspectives and potential forms of cooperation with
p.000351: both each of 11 mentioned and the Commonwealth of Independent States as a whole in the global development of research
p.000351: ethics and bioethics.
p.000351: Grounding on profound historical experience of highly moral attitude to medical trade and treatment, the region
p.000351: countries contributed significantly into formation of modern universal concept of protection of human rights and
p.000351: dignity in medicine and biology. Such conclusion is a direct result of analysis of cultural and historical unity
p.000351: of nations and states of the CIS region and only confirms a concept of humanitarian unity of the humanity
p.000351: development.
p.000351: The field of regulatory and legislative control has a situation of harmonic interaction of the region countries with
p.000351: the world society. A legal scale of the Commonwealth states presented as a basic regulation allows seeing explicit
p.000351: desire to correspond to international standards in legislation development and direct introduction of international
p.000351: standards as an instrument for legal regulation in the field of biomedical studies and ethical examination. In this
p.000351: respect the fact of mutual interests of parties seems to be symbolical. The CIS countries become members of
p.000351: international organizations and structures at various levels that directly impacts establishing of universal standards
p.000351: for protection of human rights and their legalization. The Commonwealth states
p.000351:
p.000352: 352
p.000352:
p.000353: 353
p.000353:
p.000353: within the framework of IPA CIS are full fledged international members for all significant world events
p.000353: in the sphere of social and humanitarian development of society, and by themselves they form a wonderful example
p.000353: of collective law development in the form of model laws providing reference points for national law and
p.000353: order. Determining value of model law development in health care, science and education aimed for improvement of the
p.000353: bioethical component is demonstrated during presentation of both general trends of construction of an
p.000353: ethical examination system in the region and when national specific features are described. Attractiveness of the
p.000353: region countries for biomedical research and mutual responsibility of both international organizations and
p.000353: parliaments and governments of the Commonwealth countries for provision of adequate, complying to universal
p.000353: standards, regulatory framework for human rights protection are also a serious incentive. This sphere has
p.000353: multiple in their forms components of collaboration: counseling, joint law development, adaptation and
p.000353: ratification, international system of legal responsibility for their breaching and interstate appeal options.
p.000353: In the field of development of bioethical education and training for members of ethical committees there
p.000353: is well established system of interregional cooperation. Significant contribution is made by creation of national
p.000353: UNESCO commissions in the region countries with common policy aimed on the following priorities:
p.000353: - access to information and intellectual exchange;
p.000353: - development of educational programs and approaches;
p.000353: - strengthening capacities of national agencies working on ethical issues;
p.000353: - implementation of ethical norms aimed on protection of human rights in the sphere of biomedicine;
p.000353: - improvement of information awareness and training in the sphere of bioethics;
p.000353: - distribution of knowledge on bioethics among professional and public groups including via mass media;
p.000353: - counseling and education to bioethics issues among social sphere facilities;
p.000353: - extension of availability of information about regulatory documents, human rights and procedures of their protection;
p.000353: - development of training programs on ethics and their integration into educational process.
p.000353: It is noteworthy that cooperation in this sphere becomes both bilateral and multilateral. Advantage of the region
p.000353: in this sphere is preservation of communication on one language and traditional mutual penetration of
p.000353: cultures and standards becoming a root system of information bases, educational materials and educational
p.000353: testing.
p.000353: Especially advantageous situation for cooperation is created in the sphere of development and
p.000353: establishment of the system of ethical examination. Simultaneous start of development of this field and
p.000353: unique support of the global community through establishment of the Forum for Ethics Committees in the CIS and
p.000353: inclusion of this region as a single constituent of the global WHO Project SIDCER provided permanent
...
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p.000029: at the end of the 1980’s. After the USSR break-up bioethics in the region developed in different conditions but, at
p.000029: that, there were present both stable cultural peculiarity and links among the region countries. The most important
p.000029: instrument influencing rates and pattern of the bioethics development is creation of special national facilities
p.000029: that having different structure and functions in some cases are entitled to adopt and implement mandatory decisions
p.000029: in the field of bioethics. Besides, all CIS countries have more or less main and similar resources for dynamic
p.000029: development of
p.000029: bioethics, and among them – teaching bioethics as a subject (mandatory or optional) in medical colleges and
p.000029: universities as well as at departments of philosophy in some of state universities; definite (though, in
p.000029: general, far from being sufficient) interest to ethical issues from the side of those working on legislation in the
p.000029: field of science and health care; development of corporate ethics and national associations on ethics;
p.000029: stimulating influence of research ethics; wider public interest to the bioethics issues being discussed in mass media.
p.000029: Besides factors of general social and economic development influencing peculiarity and unity of the situation in
p.000029: this sphere, global impact was provided by common cultural and educational environment based on both
p.000029: advanced humanistic traditions of medicine and on capabilities for interaction and mutual influence of
p.000029: different cultures in the given territorial and historical space. Such specifics exist despite considerable cultural
p.000029: and religious differences between populations of European and Central-Asian countries of CIS. In particular, it
p.000029: is necessary to mention influence of religious traditions in the Commonwealth countries on forming of bioethics
p.000029: models currently acting there as well as models of research ethics. Likeness in perception of moral and cultural values
p.000029: is built on the fact that among population of the CIS countries (mostly it is related to the Russian population) one
p.000029: can meet representatives of virtually all ethnical, religious and cultural groups existing in the region in general. It
p.000029: means that multiplicity that can be observed within the CIS countries to some extent repeats multiplicity of population
p.000029: of separate countries that is especially characteristic for scientific and medical creative environment formed during
p.000029: many years.
p.000029: It is really hard to overestimate a role, which is played by the factor of involvement of all Commonwealth
...
p.000031: more than 150 publications. Regretfully, among six CIS countries being current members of the Council of Europe such
p.000031: basic document as the Convention on Human Rights and Biomedicine are currently signed only by three – Georgia, Moldova,
p.000031: Ukraine; and it is only Georgia that actually ratified it. At the same time, acknowledgement of high authority of the
p.000031: Convention in this or that form is generally common for virtually entire bioethical community in all CIS countries.
p.000031: The international enactments mentioned above became a basis for legal regulation of biomedical research and
p.000031: their ethical review in all CIS countries (detailed analysis of legal participation of a particular country in any of
p.000031: international documents – recommendation influence, ratification, adaptation to national legislation, etc. –
p.000031: is presented in our book in corresponding chapter for each specific state). A crucial issue emphasizing profound
p.000031: importance of international documents regulating this sphere is a fact of priority of international law
p.000031: approved by all Commonwealth countries. International cooperation in the field of bioethics is implemented also
p.000031: through formation of regional programs and Centres of bioethics and research ethics with involvement of
p.000031: international organizations being leaders in this field. A convincing example of such cooperation is a setup of
p.000031: national committees of bioethics with UNESCO support in some of the Commonwealth countries and planned scientific and
p.000031: educational activities of the UNESCO office in Moscow and some other countries in the region
p.000031: being held in context of national, social and cultural, historical and political traditions and utilization of the
p.000031: world experience in the field of bioethics.
p.000031: In 2001 animportant bioethical resource, the Forumfor Ethics Committees in the CIS (FECCIS), was established in the
p.000031: region. The FECCIS is one of five regional forums created within the framework of the WHO project, the Strategic
p.000031: Initiative for Developing Capacity in Ethical Review (SIDCER). Sharing main priorities of the WHO SIDCER project on
p.000031: protection of the rights and dignity of research subjects in all countries in the world basing on respect to cultural,
p.000031: religious and national differences the FECCIS seeks the main task of facilitating development of bioethics in the
p.000031: region of the CIS countries, paying specific attention to ethics of biomedical research involving human
p.000031: subjects. During all its years of existence (2001–2007) the Forum activities were directed on development of regulatory
p.000031: and methodical basis on research ethics; development and implementation of education programs for members of
...
p.000081: redoubling of the review and decisions;
p.000081: • ethical review conducted only at the level of the national EC (in some CIS countries) hampers the analysis of a
p.000081: specific character of a particular research centre and limits opportunities of a dynamic monitoring of ongoing
p.000081: research;
p.000081: • we cannot exclude cases of administrative and economic dependence of local EC on interests of research centres as
p.000081: they are highly motivated to conduct a research;
p.000081: • usually there is no legal system of appeal with regard to the EC decisions;
p.000081: • the lack of detailed regulations concerning EC financing;
p.000081: • the lack of state inspection of the EC activity;
p.000081: • the lack of demand for ethical review on the part of research subjects;
p.000081: • the lack of a regular state system for training EC members.
p.000081: The mentioned problems determine the leading trends in the development of the system of the EC performance and
p.000081: structure in the CIS countries:
p.000081: • to develop legislation ensuring the EC independent performance;
p.000081: • to separate power (responsibilities and rights) in the performance of EC on different levels (national, regional,
p.000081: local);
p.000081: • to create the system of EC interaction inside the country and on the international level;
p.000081: • to develop the demand for ethical review in all research subjects;
p.000081: • to eliminate informational vacuum with regard to issues of the protection of human rights and dignity in
p.000081: biomedical research;
p.000081: • to create an educational and informational programme on bioethics for medical professionals and other persons
p.000081: associated with the research;
p.000081:
p.000082: 82
p.000082:
p.000083: 83
p.000083:
p.000083: • to develop a special system for training EC members;
p.000083: • to introduce the practice of the state inspection and independent audit of EC performance;
p.000083: • to develop legal regulations for the EC economic activity.
p.000083: The analysis of the current state from the viewpoint of the principle of obtaining research subjects’ informed
p.000083: consent shows that a principal achievement of the CIS countries is a legal regulation of this procedure.
p.000083: Among issues requiring a further development we should mention first the need to work out guidelines and norms for
p.000083: interpreting separate statements in legislative acts, terms of their application and their harmonization with norms of
p.000083: international law in the field of bioethics. There is a particularly urgent need to create bioethics information
p.000083: field with potentials for a differential education of various population groups aiming at raising the
p.000083: level of public knowledge about human rights and moral responsibility in biomedical research.
p.000083: In the history of establishing a system of ethical review and ethics committees in the region the
p.000083: performance of the mentioned Forum for Ethics Committees in the Commonwealth of Independent States takes a
p.000083: special place as a public movement aiming at fulfilling this task in the region via creating a possibility for the
p.000083: access to the world experience in the development of ethical concept of biomedical research considering national
p.000083: cultural and moral values.
p.000083: The FECCIS was established on 21 of March 2001 according to the Resolution of the Conference for representatives of
p.000083: ethics committees and others authorized bodies from the CIS countries held in Saint-Petersburg, Russia. The FECCIS is
p.000083: one of the five regional forums, established in the framework of the WHO/SIDCER project.
p.000083: Sharing the basic priorities of the SIDCER project referring to the protection of human rights and dignity in
p.000083: biomedical research all over the world with respect to cultural, historical, religious and social differences, the
p.000083: FECCIS has defined as its the main objective to support the development of bioethics in the region with an emphasis on
p.000083: ethics of biomedical research involving human subjects.
p.000083: Over the period 2001-2006, the FECCIS activity has been directed to developing legislative and normative
p.000083: system in the field of research ethics, working out and implementing educational programmes for the EC
p.000083: members, developing informational space and a dialogue with all interested parties participating in the review of
p.000083: biomedical research.
p.000083: With regard to the legislative initiative, FECCIS, as mentioned above, has been concentrating its efforts on
p.000083: working out a legislative basis for protecting human rights in biomedical research through collaboration with the
p.000083: Permanent Commission on Social Policy and Human Rights of the Inter– Parliamentary Assembly of the Confederation of
p.000083: the Independent States. This collaboration resulted in the development of the IPA CIS model Law ‘On the Protection
p.000083: of Human Rights and Dignity in Biomedical Research in the CIS’ adopted in 2005 (see Chapters 1.2 and 2.2). In
p.000083: collaboration with the Permanent Commission on Science and Education of the IPA CIS the FECCIS worked out Model
p.000083: recommendations “ On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS “.
p.000083: An important direction of the FECCIS activity is the development of mechanisms, fundamentals and conditions for an
p.000083: internal monitoring and independent surveying, and evaluating the EC performance, to ensure a due quality of ethical
p.000083: review.
p.000083: This direction of the FECCIS activity includes working out the Collection of model Standard Operational
p.000083: Procedures. Independent and competent representatives of the CIS countries and experts from all over the world took
p.000083: part in this work. Consultations, discussions and analysis of the main statements on the establishment,
...
p.000083: The integrity of the model SOPs is achieved through the use of universal terminology, commonly accepted norms of
p.000083: bioethics reflected in documents that have been used and a consistent description of the EC operation at
p.000083: different stages and in different situations of ethical review of biomedical research.
p.000083: The Collection of model SOPs prepared at the FECCIS Secretariat is to become an available practical
p.000083: manual on working out SOPs as a universal instrument for achieving professionalism, openness, pluralism and
p.000083: independence of the EC practices and for ensuring a common methodological space for the CIS countries and the world
p.000083: community, which will facilitate the protection of rights and dignity of individuals and communities in
p.000083:
p.000084: 84
p.000084:
p.000085: 85
p.000085:
p.000085: biomedical research. The process of SOP implementation was accompanied with a thorough consideration for specific
p.000085: features and the potential of their practical applications. The Collection of model SOPs was presented and
p.000085: discussed at the FECCIS Workshops in St.-Petersburg, Russia (2003); Kiev, Ukraine (2004, 2006); Minsk, Republic Belarus
p.000085: (2005). Two editions of the Collection of model SOPs were published in 2004 and 2005. The development and
p.000085: publication of the Collection of model SOPs stimulates writing national manuals and methodical standards for ECs
p.000085: functioning on different levels. Publication of methodical guidelines in Ukraine (2006, in Ukrainian) is one of the
p.000085: examples.
p.000085: The other priority in the FECCIS activity is the design and development of educational programmes for training EC
p.000085: members that could be integrated into national programmes of professional education of cardinal problems of bioethics.
p.000085: The programmes can also be helpful in formation of a database on practical teaching materials referring to biomedical
p.000085: research ethics.
p.000085: To form the database, national programmes on bioethics adopted in the CIS countries have been displayed in the FECCIS
p.000085: website. New programmes have been developed by a FECCIS working group headed by professor
p.000085: B.G. Yudin in the framework of the Fogarty grant. Representatives of five CIS countries have attended the course
p.000085: “E-Education in Research Ethics: Central and Eastern Europe” organized by Albany Medical College (USA) in partnership
p.000085: with the Department of Medical History and Ethics of Vilnius University (Lithuania) and sponsored by the Fogarty
p.000085: International Centre.
p.000085: A special attention has been paid to a direct participation in organizing and conducting training seminars for the EC
p.000085: members in the framework of the SIDCER “Recognition Programme”. The Project objective is to promote the highest ethical
p.000085: and scientific standards of conducting ethical review of biomedical research. The Project includes the procedure
p.000085: of the EC self- evaluation, preparation for a follow-up survey and the survey that results in granting the
p.000085: “Recognition” status if the EC meets the standards of ethical review. The EC members are trained according
p.000085: programmes including lectures and seminars in working groups. Programmes offer the following Modules: “Human Subject
p.000085: Protection”, “Standard Operational Procedures” and “Inspection and Survey of the Ethics Committee”. This
p.000085: Project is actually the first stage of implementing the system of the EC accreditation, certification and survey in
p.000085: the CIS countries.
p.000085: Organization of 17 international seminars and conferences in 8 of 11 CIS countries has been very important with regard
p.000085: to the formation of the common informational field. Conference and seminars have been held in cooperation with
p.000085: different national and international structures. Conference materials have been published in Russian, English and
p.000085: national languages of the CIS countries.
p.000085: The conferences and seminars aimed at exchanging information and discussing topical issues of the development
p.000085: of regulation and educational standards relating to the protection of research participants’ rights, to the development
p.000085: of national systems of ethical review and to the creation of a harmonized legislation and methodology referring to
p.000085: biomedical research ethics both in the CIS region and in the global international space.
p.000085: Due to the development of these main initiatives, the following has been achieved and accomplished:
p.000085: • information exchange in the field of bioethics in the CIS region;
p.000085: • the analysis of issues relating to bioethical education in the region;
p.000085: • an open access to and discussion of international documents and guidelines on bioethics and research
p.000085: ethics (translation into national languages);
p.000085: • implementation of SOPs into the process of ethical review;
p.000085: • stimulation of efforts directed towards the development of national systems of ethical review in compliance
p.000085: with the GCP standards and international guidelines;
p.000085: • assistance in the organization of the EC members education and training in the region;
p.000085: • the EC preparation for the survey and evaluation of their performance;
p.000085: • raising the EC authority and their role in the development of international standards concerning the
...
p.000105: - Law on Children’s Rights (19.05.1998)
p.000105: - Law on Transplantation of Human Organs and Tissues (28.10.1999)
p.000105: - Law on Immunoprophylaxis of Infectious Diseases (14.04.2000)
p.000105: - Law on Tuberculosis Control in Azerbaijan (05.02.2000)
p.000105: - Law on Psychiatric Care (12.06.2001)
p.000105: - Law on Narcological Service and Control (29.06.2001)
p.000105: - Law on Nutrition of Newborns and Infants (17.06.2003)
p.000105: - Law on the State Care for Patients with Diabetes (23.12.2003)
p.000105: - Law on Iodination of Sodium Chloride for the Mass Prevention of Iodine Deficiency.
p.000105: - Law on Donorship of Blood, Blood Components and Blood Donor Service (03.05.2005)
p.000105: - Law on State Care for Patients with Hereditary Diseases Such as Hemophilia and Thalassemia (03.05.2005).
p.000105:
p.000106: 106
p.000106:
p.000107: 107
p.000107:
p.000107: 3.2.3. Education in Bioethics
p.000107:
p.000107: When considering problems of education we precede from the fact that bioethics, in relation to medicine, is
p.000107: nowadays a developing academic discipline with its inherent strict standards. We should start teaching
p.000107: bioethics in the period when students pass on from theoretical subjects to practical activity.
p.000107: In accordance with recommendations of the World Health Organization to introduce courses on medical ethics into the
p.000107: syllabus of medical schools everywhere in the world, an educational programme on bioethics was developed in
p.000107: Azerbaijan in the 1990s. The programme emphasizes the universal character of principles and rules of bioethics
p.000107: and covers all basic problems of bioethics with due consideration for the international experience and national
p.000107: traditions. The method of teaching aims at enabling medical professionals to acquire ethical skills in
p.000107: physician-patient relationships, professional decision-making and conducting scientific research.
p.000107: Education in bioethics at Azerbaijan Medical University (8,000 students) began in 2000. Considering an
p.000107: interdisciplinary character of the programme, issues of biomedical ethics are normally introduced into the
p.000107: teaching process of all faculties, especially, clinical ones.
p.000107: In 2000 an international conference “Methods of Teaching Medical Ethics” was held in Baku. On that occasion
p.000107: numerous methodical materials were prepared: methodical plans, textbooks, brochures and glossaries of
p.000107: bioethical terminology. The materials have been very helpful in training specialists with an experience in
p.000107: research and applied ethics who have received appropriate certificates.
p.000107: To improve the quality of teaching bioethics and to increase educational level of medical students, the initiative
p.000107: group of Azerbaijan Medical University including the academician of the Russian Academy of Medical Sciences and the
p.000107: National Academy of Sciences professor A.A.Namazova, professor G.A.Aliev, assistant professor Z.G.Guseinova,
p.000107: candidate of medical sciences T.G.Tagi-Zade developed a teaching and methodical programme “Introduction of
p.000107: Teaching Materials on Biomedical Ethics Into the Syllabus of Higher Educational Institutes”. For that purpose the group
p.000107: has made up the following materials: the first Azerbaijan manual on medical ethics «Tiabaiat etikasy», a number of
p.000107: methodical recommendations and
p.000107: such texts as “Ethical Principles in Medicine”, “Euthanasia: Bioethical Aspects”, “Deontology in Medicine” et
p.000107: al.
p.000107: Alongside with the abovementioned, sociological surveys in medical community and public at large were conducted in
p.000107: Azerbaijan with the aim to assess the level of awareness and knowledge about legal aspects of bioethical issues. The
p.000107: surveys are helpful in outlining ways of further activity in the field of education and scientific research.
p.000107: With the assistance of Azerbaijan Ministry of Health and international organizations, especially the Forum for
p.000107: Ethics Committees in the Commonwealth of Independent States, the initiative group develops standard operational
p.000107: procedures and protocols for ethics committees and proposals on adaptation and implementation of international
p.000107: standards for biomedicine in Azerbaijan.
p.000107:
p.000107: References
p.000107: 1. Ethical Problems in Azerbaijan. In: Materials of Regional Swiss Conference on Medical Ethics. Tbilisi,
p.000107: Georgia, 1999 (in Russian).
p.000107: 2. Implementation of Teaching Materials on Medical Ethics into the Syllabus of the Medical University. In:
...
p.000127: problems of human life and death, to form an understanding of the necessity to follow principles and rules of
p.000127: biomedical ethics in professional activity, to combine reason and feelings, intuition and logic, emotions and
p.000127: intellectual efforts. To achieve this goal, we have to define the problems we choose for bioethical education. From a
p.000127: variety of topics arising due to the development of biology, medicine and practical healthcare we chose
p.000127: most essential problems consistent with the principles of a system and holistic approach. Besides, to analyze
p.000127: ethical situations, we need to select from the whole volume of special knowledge sections that are most
p.000127: ethics-orientated and provide ethical and humanitarian comments by ethicists.
p.000127: At the same time, we are searching for interdisciplinary approaches to bring moral and ethical norms in conformity with
p.000127: the current medical and biological reality.
p.000127: An important achievement of the BSMU is that already at the stage of pre- clinical training medical students
p.000127: participate in resolving ethical problems relating to using dead human bodies in the teaching process and experiments
p.000127: on animals [14, 20]. In the course on human anatomy students are informed about legal, ethical and religious aspects of
p.000127: using a dead body of separate organs for an educational or scientific purpose. Learning ethical norms of handling
p.000127: anatomic preparations facilitates the development of the most essential humanistic quality – respect for a human
p.000127: being. Humane attitude to animals involved in experiments is very important for the development of compassion and
p.000127: empathy. Implementation of teaching aids alternative to experiments (computer programmes of experiments on virtual
p.000127: animals, video-films, CDs, three-dimensional models, etc.) allowed to exclude or minimize experiments on
p.000127: animals. As the result, students see that ethical principles are not merely postulated but implemented in practice.
p.000127: Medical students acquire bioethical knowledge out of class as well. Students of BSMU participate actively in
p.000127: the hospice movement. During several years they have been taking part in the BACCUP Programme at the Cardiff
p.000127: Medical University working as volunteers together with British medical students in summer holidays.
p.000127: Problems of bioethics, medical deontology and clinical ethics in medical practice can be successfully resolved only if
p.000127: medical professionals know the
p.000127: current legislation referring to healthcare. Therefore it is necessary, firstly, to regulate norms of medical activity
p.000127: according to new conditions in practical healthcare, and, secondly, to provide legal knowledge to medical specialists.
p.000127: Sociological surveys carried out in Belarus showed that, unfortunately, medical students, as a rule, do
p.000127: not have systematic knowledge in either deontology or medical ethics, or in medical and common law.
...
p.000129: – introducing courses on bioethics into syllabi and teaching programmes for retraining specialists with higher and
p.000129: secondary special education in medicine and pharmacy;
p.000129: - teaching bioethics within a programme for training teaching staff of high qualification (postgraduates, doctoral
p.000129: students);
p.000129: – raising professional level of professionals who organize and carry out clinical trials so that they could be admitted
p.000129: to this activity.
p.000129: However, we do not have a separate course on bioethics at the graduate and post-graduate levels. We also lack a State
p.000129: system of teaching GCP and a systematic training for EC members. Training courses in ethical review of clinical drug
p.000129: trials are held at the Republican Centre of Expertise and Trials in Healthcare. The course is very short (2-4 hours).
p.000129: There are no dissertation boards, and no dissertation on bioethics has been defended, as the Higher Certifying
p.000129: Commission does not have this discipline on the list of specialties. The first dissertation on bioethics as a basis of
p.000129: the physician’s professional culture is planned in the section of “Culturology”. Therefore, currently the question of
p.000129: introducing differentiated specialized courses on bioethics for different categories of postgraduate audience is under
p.000129: consideration.
p.000129: We also use some other opportunities to raise graduates’ and postgraduates’ professional level in
p.000129: bioethics, particularly, international grants received on one’s personal initiative. Thus V.K.Kevra participated in
p.000129: an Educational Project at the Lithuanian National Committee on Bioethics;
p.000129: O.P.Aizberg attended the Seminar on Bioethical Problems in Narcology organized by the “AWEF—AIDS: East-West”
p.000129: Foundation (Kiev, 2006).
p.000129: The third level – providing bioethical knowledge for the population
p.000129: – is the most “deserted” field of work. A low level of public awareness affecting the public opinion and
p.000129: decision making with regard to vitally important issues – from informed consent to adoption of laws – requires
p.000129: taking immediate measures to change the situation.
p.000129: Here we have high hopes for the Project “Education in Bioethics and Promotion of Bioethical Knowledge in Belarus”
p.000129: approved and supported by the Division of the Social Sciences and Humanities of the UNESCO Moscow Office.
p.000129: Within the next few years, the Project will help us to resolve the mentioned problems.
p.000129: The Project includes:
p.000129: • the development of teaching programmes in bioethics for ECs members considering their qualification and
p.000129: the content of EC work;
p.000129: • the development of guidelines for the system of raising the expertise level for EC members, organization of
p.000129: seminars on international documents relating to bioethics (UNESCO, WHO, Council of Europe, etc.);
p.000129: • the development of methodological basis and a long-term programme for raising the level of public awareness in
p.000129: bioethics.
p.000129: We hope that due to the use of necessary facilities, resources and ways of implementing the Project we shall be able to
...
p.000131: Pharmaceutical Products (2006); the Order No 254 of the Health Ministry of Belarus “On Approval of Guidelines for
p.000131: Clinical Trials of Pharmaceutical Products” (1999); Methodical Recommendations on Establishing ECs and their
p.000131: Operation (2000); Guidelines on Accreditation of Healthcare Institutions and Certification of Specialists
p.000131: Conducting Clinical Trials of Pharmaceutical Products, Medical Equipment and other Medical Goods (2004). The control of
p.000131: the process rests with the Republican Centre of Expertise and Trials in Healthcare authorized hereto by the Health
p.000131: Ministry of Belarus.
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: * This section has been written with the assistance of G.G. Voronov and G.V. Godovalnikov (Republican Centre of
p.000131: Expertise and Trials in Healthcare)
p.000131:
p.000132: 132
p.000132:
p.000133: 133
p.000133:
p.000133: In Belarus a gradual implementation of the procedure for a compulsory ethical review of clinical trials performed by
p.000133: ECs began in 1999 when the Order No 254 of the Health Ministry of Belarus was issued. The Order No 161 on 14 of May
p.000133: 1999 stimulated the process of accrediting healthcare institutions and certifying specialists conducting
p.000133: clinical trials. According to this Order, to gain the right to conduct clinical trials, an Ethics Committee should be
p.000133: established at accredited institutions in compliance with Methodical Recommendations. There also should be specialists
p.000133: with the knowledge in good clinical practice.
p.000133: Since 2000 the Republican Centre of Expertise and Trials has been organizing educational seminars on international
p.000133: regulations for carrying out clinical trials in compliance with GCP. During 7 years over 700 physicians and
p.000133: pharmacists, conducting clinical trials and participating in the EC activity, attended the seminar. This helped
p.000133: to create optimum conditions for the development
p.000133: of the network of local ECs, which formed the basis for implementing ethical review
p.000133: procedures into the practice of biomedical research.
p.000133: Due to the mentioned measures, currently, apart from the NCBE, 51 local ECs at healthcare institutions
p.000133: accredited to conduct clinical trials are functioning in Belarus. Among those there are, in particular,
p.000133: 11 regional and
p.000133: 20 city hospitals, 3 out-patient clinics, 9 Republican science-and-
p.000133: practical Centres; 3 scientific-and-research institutes. In 1998 the National Coordinating Safety Centre was
p.000133: established at the Institute of Genetics and Cytology of the National Academy of Sciences; in 2000 BSMU established an
p.000133: EC, and the International State Ecological University named after A.D. Sakharov established an EC in 2003. ECs at
p.000133: healthcare institutions work on implementing ethical review into the design of dissertation research that would precede
p.000133: the approval of the dissertation theme by the Scientific Council.
p.000133: While one of the main NCBE tasks is to facilitate public control ensuring the observance of ethical norms and
p.000133: regulations in pre-clinical and clinical trials, local ECs at healthcare institutions are implementing in practice the
p.000133: system of administrative and State control ensuring the protection trial subjects’ rights and interests.
...
p.000137: of a system for public and State control, which ensures the protection of human rights and interests in the Republic.
p.000137: Today we have different types of committees for bioethics (ethical committees, commissions on ethics, associations,
p.000137: etc.) functioning at different regulatory levels (national, regional, local). Committees belonging to
p.000137: each of these types have their goals and functions and find a common ground in solving ethical dilemmas arising
p.000137: in different fields of research and healthcare. The creation of the National Committee for
p.000137: Bioethics (NCBE) and its efficient functioning in compliance with the Project Proposal “Establishing the
p.000137: National Committee for Bioethics and Providing Bioethical Education to Specialists in Republic of Belarus” (in
p.000137: the framework of the Programme of Social Sciences and Humanities, UNESCO Moscow Office) aims to provide a competent
p.000137: ethical review of scientific research in healthcare, to organize forums for discussing problems of bioethics on a
p.000137: national level, and to have an impact on the development of legislation policy in the field of bioethics.
p.000137: The NCBE has been established as an advisory body to exercise public control of compliance with ethical norms and
p.000137: regulations in experiments on animals and research involving human subjects in order to safeguard human rights and
p.000137: freedoms when applying to them modern scientific achievements, and in educational, treatment-and-preventive and
p.000137: other activities. The Statement on the National Committee for Bioethics has been approved by the Order of the Health
p.000137: Ministry of Republic Belarus. The Statement sets out a wide range of the NCBE functions with regard to:
p.000137: - providing healthcare, monitoring clinical trials and registration of new pharmaceutical products and medical
p.000137: technologies;
p.000137: - disease treatment and prevention and scientific-research activity;
p.000137: - providing bioethical education to professionals and public at large;
p.000137: - legislative initiatives concerning healthcare and biomedical research;
p.000137: - resolving social and legal problems in nature-conservative activities [20].
p.000137: The NCBE is independent in its appraisals, opinions and decisions. It has the status of an advisory
p.000137: body, and does not make legal decisions but actively cooperates with legislative and executive bodies and
p.000137: with public organizations. In autumn 2006 the NCBE members T.V. Mishatkina and Ya.S. Yaskevich took part in the
p.000137: meeting of the Round Table at the National Assembly of Republic Belarus, where the Law Project “On the
p.000137: Transplantation of Human Organs and Tissues” was discussed [25,26]. The Law was adopted in March 2007.
p.000137: Thus, the NCBE should facilitate:
p.000137: - the development of a democratic mechanism for the discussion and analysis of difficult moral problems
p.000137: relating to the achievements in biomedical science and technology;
p.000137:
p.000138: 138
p.000138:
p.000139: 139
p.000139:
...
p.000139: scientific and teaching-and-methodical work are presented at international conferences. In particular,
p.000139: professionals from Belarus participated in the International Scientific Conference on Humanities in the
p.000139: Contemporary World (Saint-Petersburg, 2002) [10] in the International Scientific and Practical Seminar on Bioethics in
p.000139: the framework of the programme of Fogarty International Centre (Bulgaria, 2003) and in regular international seminars
p.000139: and symposia held in Kiev Materials prepared by Belarusian scientists in the framework of international cooperation are
p.000139: published in Russian and Ukrainian scientific journals and in volumes of conference proceedings [27-29].
p.000139: Participation of Belarus professionals in the FECCIS and, particularly, in meetings and symposia of the FECCIS in
p.000139: St.-Petersburg, Baku, Yerevan and Kiev is very essential for the development of bioethical thought and
p.000139: bioethics in Belarus. Seminars organized in the framework of the FECCIS and reports by leading specialists and experts
p.000139: of the international level are certainly very helpful for a more profound understanding of bioethical problems
p.000139: and dilemmas and facilitate education of persons concerned.
p.000139: During the last years, specialists in bioethics from Belarus have been taking part in activities undertaken by UNESCO,
p.000139: particularly, in meetings of regional experts in bioethics (January 2005, Moscow; March 2005, Minsk; September 2005,
p.000139: Vilnius). On the request of UNESCO, T.V.Mishatkina, an expert in ethics from Belarus, designed and submitted to
p.000139: the UNESCO Headquarters 11 educational programmes on the fundamentals of education in ethics and bioethics.
p.000139: Today the international cooperation in implementing bioethical principles and developing ethical review of
p.000139: biomedical research goes along three directions supported by UNESCO:
p.000139: – theoretical development of a conceptual model of bioethics;
p.000139: – practical work on the organization of the National Committee and on the development of local ECs activity;
p.000139: – providing bioethical education to professionals and general public in accordance with the Project Proposal
p.000139: within the Programme for Social Sciences and Humanities(UNESCO Moscow Office) “Bioethics Education in Republic of
p.000139: Belarus”.
p.000139: Cooperation in developing the theory of the ethics of biomedical research. A joint project “Social,
p.000139: Philosophical and Ethical Problems of Genomic Research and Clinical Medicine” is carried out in
p.000139: cooperation with the Institute of Philosophy of the Russian Academy of Sciences. The theme of the Project has been
p.000139: approved by the Belarusian Republican Fund of Fundamental Research at the National Academy of Science of Belarus and
...
p.000143:
p.000143: Another objective is to develop and introduce into practice teaching programmes, methods and approaches
p.000143: ensuring the acknowledgement and understanding of principal bioethical problems in medical community and in public at
p.000143: large.
p.000143: Main ways of cooperation here are the design and subsequent use of modules of teaching programmes on biomedical ethics
p.000143: for a differentiated ethical education in different social communities.
p.000143: One of the last events demonstrating the cooperation in bioethical education was a Scientific-and-Practical
p.000143: Seminar “Humanization in the Education of Specialists in Medicine and Biology” held by young scientists of the
p.000143: Belarus Academy of Post-Graduate Education. The Seminar was supported by the Health Ministry of Republic
p.000143: Belarus, the National Committee on Bioethics and the Belarusian Republican Fund of Fundamental Research at the National
p.000143: Academy of Science of Belarus. Experts from UNESCO, InterNICHE (United Kingdom) and Centre for Protection Animals’
p.000143: Rights “Vita” (Russia) participated in the Seminar. The main objectives of the seminar were the
p.000143: discussions relating to the observance of principles of bioethics in scientific and educational activity,
p.000143: and, in particular, the use of laboratory animals in science and education and the application of new alternative
p.000143: technologies in education and in scientific experiments [39-42].
p.000143: International cooperation on establishing the National Committee on Bioethics in Belarus. The starting
p.000143: point in establishing the National Committee on Bioethics in Belarus was an International Seminar “The
p.000143: National Committee on Bioethics of Belarus Republic and the Activity of Local (Regional) Committees on
p.000143: Bioethics: the Experience of the East and Central Europe”. The seminar aimed at providing knowledge on ECs operation
p.000143: and the procedure of ethical review of biomedical research in the context of European experience. The
p.000143: Seminar was supported by the UNESCO Moscow Office and the Belarusian Commission for UNESCO. Other partners in
p.000143: organization and holding the Seminar were the FECCIS, GCP Alliance – Europe, the Health Ministry of Republic of
p.000143: Belarus, the Centre for Expertise and Trials in Healthcare, Belarus State Medical University, the State
p.000143: Economical University of Belarus (Institute of Education in Social Sciences and Humanities), the
p.000143: Belarus Academy of Post-Graduate Education, International State Ecological University named after A.D. Sakharov.
...
p.000147: 29. Mosse I.B. Modification of radiation-induced bystander effect with melanin. Abstracts of the 52th annual
p.000147: meeting of the Radiation research society (Denver, Colorado, USA, – November 16-19, 2005). (in English).
p.000147: 3.4. GEoRGIA
p.000147: (G.Kiknadze, G.Dgaviashvily, t.Kurtanidze)
p.000147:
p.000147: Like many other developing countries, Georgia experiences considerable difficulties. One may suggest that it is not
p.000147: time to speak about research ethics when you hear everyday, that fundamental rights of citizens, including right to
p.000147: life, are violated (e.g. in terms of regional conflicts). However, it is never too early or too late to speak about the
p.000147: rights and freedoms of individuals, particularly in the field of health and biomedical research as far as various
p.000147: biomedical researches are being carried out currently in those countries. So, we have to do something to ensure the
p.000147: safety of people in this sphere.
p.000147: Georgia has made considerable step forward in establishing legal framework for human rights protection in
p.000147: the field of health care and biomedicine, including specific legislation on protection of research subjects.
p.000147: Georgia has signed and ratified all major documents of the Council of Europe in this sphere and endorsed various
p.000147: international texts. Moreover, national legislation has been brought in harmony with internationally accepted
p.000147: standards of human rights protection. These steps have been followed by educational activities to raise awareness of
p.000147: the society.
p.000147: However, there is a lot of work to be done to effectively implement aforementioned legislation, particularly in the
p.000147: field of biomedical research. The most topical issue for Georgia now is the development of effective system
p.000147: of ethical review of research projects. Although, certain type of system is operating, it needs
p.000147: improvement in terms of accessibility and quality.
p.000147:
p.000147: 3.4.1 Historical and Cultural Background
p.000147:
p.000147: Georgia is situated on the border of Europe and Asia. It occupies the Central and Western parts of the Caucasus. The
p.000147: Western part of the country is washed by the Black Sea. The Northern boundaries of Georgia run along the Great
p.000147: Caucasian Range. Citizens of Georgian nationality comprise about 70% of the whole population. Other nationalities
p.000147: are Russians, Osetians, Abkhazians, Azerbaijanis, Armenians, Greeks.
p.000147: Georgia is a newly independent Republic (It restored its independence in April 1991). At the same time it has
p.000147: a long history of Statehood.
p.000147:
p.000148: 148
p.000148:
p.000149: 149
p.000149:
p.000149: Georgian slave-owning kingdoms Kolkheti and Iberia emerged in the 6th- 4th centuries BC. The unification of
p.000149: Georgia in the form of the united kingdom started in XI century. In 1801 Georgia lost its independence as a
p.000149: result of the expansive policy of Russian Empire. In 1918 independence of Georgia was re-announced (Republic of
p.000149: Georgia), which lasted only up to 1921, when intervention of Russia resulted in incorporation of Georgia in the Soviet
p.000149: Union.
...
p.000153: are remained to be addressed. Just to mention, no sanctions are yet introduced against violation of the rights of
p.000153: research subjects and infringement of the principles reflected in existing legislation on biomedical research. Also,
p.000153: existing ethics committees need be improved and the new system of research ethics committees is to be
p.000153: implemented. The draft regulation for the new system of research ethics committees has been already
p.000153: prepared. Its legitimisation will become possible after ratification of the Law on Biomedical Research
p.000153: Involving Human Subjects.
p.000153:
p.000153: 3.4.3 Education in Bioethics
p.000153:
p.000153: Education in the field of Bioethics in Georgia has developed chiefly in two domains: on one hand, high medical
p.000153: education system at Tbilisi State Medical University; on the other hand, in the shape implementation of legislation
p.000153: related to human rights, health and biomedicine developed by Health legislation and bioethics group at National
p.000153: Institute of Health (former National Health Management Centre) and Georgian Health Law
p.000153: and Bioethics Society. Since its establishment GHLBS has been actively involved in educational programmes in the field
p.000153: of Bioethics and has been incessantly organizing various training courses aiming at rising awareness of, on one
p.000153: hand, patients and general public, and on another, medical society.
p.000153: Currently, Tbilisi states medical university offers courses in Bioethics at different levels: on undergraduate level –
p.000153: for medical students, and on postgraduate level – for residents. Both courses are obligatory and constitute integral
p.000153: part of study curriculum.
p.000153: Individuals who successfully enter residency-training program after graduation of high medical school are expected to
p.000153: take one-week obligatory program in bioethics during their residency training. The course focuses on raising
p.000153: awareness of residents about modern principles of bioethics/ medical ethics and of relevant legislation of
p.000153: Georgia and assisting them in developing skills for coping with various ethical problems/dilemmas which may
p.000153: arise during their professional medical activity. During the course the audience is introduces with the issues
p.000153: related to various ethical problems associated with development of new technologies in the field of health
p.000153: care/biomedicine: the role of ethics and law in health care; individual rights of patients, Georgian legislation
p.000153: on individual rights of patients; informed consent; competency and decision making capacity; specific groups
...
p.000159: the main statements of the concept in the draft law on biomedical research during the discussions at the parliament);
p.000159: • Education: undergraduate, postgraduate education; education of potential members of research ethics
p.000159: committees;
p.000159: • Establishment of central and regional ethics committees;
p.000159: • Setting up quality assurance system for research ethics committees.
p.000159:
p.000159: Finally, step-by-step we have to strengthen mechanisms, which will ensure that the rights and dignity of
p.000159: human research subjects are duly protected. This will be one more brick in the wall in the process of building
p.000159: democratic society, which doesn’t allows injustice to take place among people.
p.000159:
p.000159:
p.000160: 160
p.000160:
p.000161: 161
p.000161:
p.000161: 3.4.5 Perspectives and Forms of International Cooperation
p.000161:
p.000161: Georgia is the member of all international cooperation in the field of protection human rights in
p.000161: biology and medicine. Collaboration develops through the representatives of Georgia in international
p.000161: bodies and organisations, by following the international regulations, involving in educational and training
p.000161: programmes on bioethics and research ethics and by participation in scientific and practical conferences and
p.000161: workshops organized on global and regional levels. Scientific publication and common international projects help to
p.000161: share the experience and to build the harmonized relations in the bioethics in the frame of international
p.000161: informational, legal and research space.
p.000161: 3.5. REPUBLIC oF KAzAKHStAn
p.000161: (А.B.Sadykova, B.Е.Sarymsakova)
p.000161:
p.000161: 3.5.1. Historical and Cultural Background
p.000161:
p.000161: Kazakhstan is a country with very rich historical and cultural past time. Being geographically located in the Centre of
p.000161: Eurasia Kazakhstan was on the crossroad of ancient world civilizations, on the cross of transportation arteries,
p.000161: social and economic, cultural and ideological relations between East and West, South and North, between
p.000161: Europe and Asia, between the largest states of Eurasian continent. At different phases of the history states with
p.000161: original cultural history were organized and developed at the territory of Kazakhstan; the modern Kazakhstan is
p.000161: the inheritor of this cultural history. In the middle of XV century Kazakhs united in the unique khanate but after
p.000161: the death of khan Tauke and invasions of Djungars the country disintegrated and was divided into 3 “zhuzes”
p.000161: (sub-countries) each of which was practically independent of others. The khan of Jounger Zhuz applied to Russia for
...
p.000171: 1) performance of ethical assessment of all documentation on clinical trials;
p.000171:
p.000171:
p.000172: 172
p.000172:
p.000173: 173
p.000173:
p.000173: 2) performance of ethical assessment of all changes and additions to documentation on clinical trials;
p.000173: 3) conclusions on agreement or refusal for the beginning or continuation of clinical trials;
p.000173: 4) assessment of following ethical, moral and juridical norms in the process of clinical trials and after
p.000173: their end.
p.000173: The commission should include sufficient number of members that would have the necessary experience and
p.000173: qualification to be able to assess all ethical, moral and juridical aspects of planned research; besides commission
p.000173: members should be independent of researches and sponsors and should not participate in the planned
p.000173: clinical research. The commission should include at least 5 members, namely specialists that are competent
p.000173: in the area of clinical trials as well as persons who are not researches themselves, specialist in legislation,
p.000173: representatives of religious community and of non- governmental organizations; the commission should include
p.000173: males and females of different age groups.
p.000173:
p.000173: 3.5.3. Education in Bioethics
p.000173:
p.000173: During the last decades due to new approaches to moral and ethical problems in medicine and science,
p.000173: development of bioethics as a interdisciplinary field, it was necessary to revise the respective educational
p.000173: programmes at all levels.
p.000173: The science “Bioethics” as a separate science was not included in the State standard of university medical education in
p.000173: the Republic of Kazakhstan, but many aspects related to bioethics were included in other programmes (specialties). For
p.000173: example, at the Semipalatinsk State Medical Academy problems of biomedical ethics were included in the programme
p.000173: of discipline “Communicative skills” at the department of internal diseases. At the moment special training
p.000173: programme is under the process of development. At the Kazakhstan State Medical Academy (in Astana) problems of
p.000173: biomedical ethics were included in the training programme at the department of public health. Similar situation took
p.000173: place in other medical universities of the country. In December 2006 the Scientific Council of the Almaty
p.000173: Institute for Postgraduate Training has decided to organize the Department of health legislation and bioethics in
p.000173: 2007. It will allow to introduce widely into
p.000173: the practice main principles of human rights protection of persons who participate in studies or experiments.
p.000173: At present time different aspects of scientific research ethics are often included in programmes of postgraduate
p.000173: training. For example, since 2001 the Higher School of Public Health (HSPH) began to realize training programmes for
p.000173: researches of the public health system. Starting since 2002 the Higher School of Public Health became the participant
p.000173: of the international programme “Intensive training on bioethics”. Together with Bangladesh Council on Medical
p.000173: Research with financial and technical support from the International Educational Reward in Bioethics and Carrier
p.000173: Development of the Fogarty International Centre (FIC) and National Institutes of Health (NIH), USA, several workshops
p.000173: were conducted in Almaty for physicians of Kazakhstan.
p.000173: The programme of these workshops had the following main goals:
p.000173: 1. The development of complete training plan/programme for the workshop on bioethics;
p.000173: 2. Training of young researches of different scientific specialties in the area of bioethics of scientific research.
p.000173: Many important topics were discussed during these workshops including: historical perspectives of ethics
p.000173: of scientific research in public health area; international declarations and manuals on scientific research
p.000173: with participation of human beings; informed consent; confidentiality; motivation; ethics of clinical studies;
p.000173: ethics of population and demographic studies; ethical aspects of scientific research in the area of health of children
p.000173: and reproductive health; functions of ethical committees; manuals on ethical review; organization of scientific
p.000173: research in developing countries; religion and culture in ethics and other topics.
p.000173: Around 20 specialists from different research institutions of the country participated in the development of
p.000173: programmes for workshops that were organized at the Higher School of Public Health. In future the Consultative
p.000173: Committee will be responsible for the general management of the programme, its monitoring and assessment. The programme
p.000173: was translated into English and sent for revision to international consultants.
p.000173: Recently programmes on bioethics were developed at the department of pharmaceutical management of the Higher School of
p.000173: Public Health for public health managers (18 training hours) and for public health masters (45
p.000173:
p.000174: 174
p.000174:
p.000175: 175
p.000175:
p.000175: training hours). At the same time it is necessary to mention that programmes that were developed not fulfill completely
p.000175: the growing demands of education in bioethics area.
p.000175: The level of knowledge and education on legislation among general public seeking health care improved
p.000175: recently; the network of ethical committees in research institutions of the country enlarged significantly, the
p.000175: role of Kazakhstan’s scientists in international research increased including multi-centre clinical trials of
p.000175: medical drugs. That is why educational programmes in the area of bioethics should be revised and improved for
p.000175: medical students and graduate physicians, researches, nurses, members of ethical committees and other specialists.
p.000175:
p.000175: 3.5.4. The System of Ethical Review
p.000175:
p.000175: According to recent legislative acts to ensure ethical control of biomedical research in the Republic of
p.000175: Kazakhstan the Ministry of Public Health started intensive activity to organize ethical commissions at research
p.000175: institutes and in the most significant clinical institutions. Simultaneously according to initiative of the
p.000175: Association of Physicians and Pharmacists of Kazakhstan at the Almaty Institute for Postgraduate Training The National
p.000175: Public Committee on Bioethics was organized; this committee is responsible for ethical control not only in the system
p.000175: of the Ministry of Health but also in institutions of other ministries where studies and trials with participation of
p.000175: human beings are conducted. Recently this initiative became more active through the National Coordinating Council
p.000175: for Health Protection, the Government of Kazakhstan, the Parliament of the Republic of Kazakhstan, non-governmental
p.000175: organizations and international organizations.
p.000175: To create favorable conditions for the development of similar structures in other ministries and agencies the
p.000175: Commission on Bioethics determined principal targets for the near time:
p.000175: - coordination of the activity of ethical committees in the country;
p.000175: - development of unified approaches to requirements and mechanisms of ethical review process;
p.000175: - counseling help to other ethical structures and implementation of different models;
p.000175: - help in training of experts;
...
p.000199: was made in a short period of time.
p.000199: First bioethical ideas entered our Republic in the end of the 80’s of the last century, as the ex-USSR though. However,
p.000199: they found true response in the scientific circles in the beginning of the 90’s. Comparing to western countries
p.000199: establishment of bioethics in the Republic of Moldova happened rather late - in the first part of the last decade of
p.000199: the XX century. This is the first stage of bioethics development in the local, national territory. Bioethical problems
p.000199: of this stage were however at the background due to large-scale social shock happened during that time: collapse of the
p.000199: USSR, declaration of the Republic’s independency, Transdniestria conflict, etc. Notwithstanding abovementioned small
p.000199: group of scientists examined consistently possibilities for bioethics development in our country.
p.000199: The second stage includes the period from 1995 trough 1999. It is necessary to stress that in such a
p.000199: contingency the Department Philosophy (since 1999 – Department of Philosophy and Bioethics) of the State University of
p.000199: Medicine and Pharmacy named after Testemitsanu N.F. became the core or the Centre for establishment and development of
p.000199: bioethics in the Republic of Moldova. Academician Theodor Tsidrya, chief of the Department of Philosophy, was
p.000199: the initiator for distribution of bioethics ideas in Moldova. He created efficient grounds for introduction of
p.000199: bioethics into different fields of operation especially in scientific and educational spheres, first alone, then
p.000199: together with the staff of the Department. Lectures of the famous Italian expert in philosophy - Pietro Cavasin – in
p.000199: the past director of one of the Italian bioethics institutes - became a stimulus. Taking into consideration his
p.000199: activity in promotion of bioethical knowledge in the Republic of Moldova in 2001, the University conferred him with
p.000199: Doctor Honoris Causa title.
p.000199: Professor and teacher’s group of the Department became a prime scientific, teaching and methodological and
p.000199: practical Centre of bioethics development in the Republic of Moldova. We need to stress great support of the
p.000199: National Commission for UNESCO Affairs in organization of the National Bioethics Centre in the Republic of Moldova on
p.000199: 10 of November 2004, and holding of different events. Mission of the Centre includes first of all the following: 1)
p.000199: harmonization and coordination of joint actions in this field between the Department, Bioethics Association and
p.000199: National Commission for UNESCO Affairs in the Republic of Moldova and the Ministry of Health
p.000199:
p.000200: 200
p.000200:
p.000201: 201
p.000201:
p.000201: Care and Social Security; 2) consolidation of all competent bodies at the national level to organize different events
p.000201: and implementations; 3) effectual promotion of bioethical knowledge; 4) facilitation of implementation of
p.000201: research results into different activities’ areas; 5) coordination of various activities in the bioethics at the
p.000201: national level.
p.000201: Since 2005 expansion of different activities connected with further establishing of bioethical ideas in our
p.000201: country is noticed: increase of academic hours in subject block for bioethics for students, doctoral
...
p.000205: necessity, a requirement of the time and not a fashion or somebody’s ambition. This imperative is caused
p.000205: by anthropoecological and anthropogenic crisis sweeping today the Earth as a result of natural and even
p.000205: unrestrained activities of a man and world community in general to provide human existence. In this connection
p.000205: it is necessary concentrate human powers firstly intellectual ones for safety
p.000205:
p.000206: 206
p.000206:
p.000207: 207
p.000207:
p.000207: development of modern civilization. This is the time to elaborate new approaches to human survival strategy,
p.000207: which would provide opportunities of more efficient handling of global anthropoecological crisis, exclude
p.000207: planetary omnicide that closely follows tracks of the modern world.
p.000207: Bioethics as it is well known is an efficient mechanism in securing safety development of the society. That
p.000207: means that well-established training and education of population in this practical philosophy would facilitate
p.000207: solutions for many issues related to survival of mankind. The Republic of Moldova performs a lot as to the issue:
p.000207: Firstly, for purposeful coordination of this work the Bioethics Association of the Republic of
p.000207: Moldova was created in the country in 2001 (31 of May), and the National Bioethics Centre was founded (10 of
p.000207: November 2004) uniting experts in this science and practical philosophy of all country higher educational
p.000207: institutions, other scientific institutions, for effectual organization and implementation of different
p.000207: decisions and advises in this field with the help of UNESCO together with the Department of Philosophy and Bioethics
p.000207: project called Extension of Development and Promotion of Knowledge in Bioethics in the Republic of Moldova.
p.000207: Secondly, for purposeful teaching of bioethics in students circles and primary at the biomedical,
p.000207: agronomical, veterinarian and similar departments, traditional Department of Philosophy has been reorganized
p.000207: into the Department of Philosophy and Bioethics in 1999 under the Order of the President of State University of
p.000207: Medicine and Pharmacy named after Testemitianu N.A., which undertook solving of all issues related to teaching of this
p.000207: discipline to students. They include: working out of text-books and teaching aids, dictionaries, elaboration of
p.000207: thematic plans, curriculums and workshop projects, tests, staff training, method teaching and methodological training
p.000207: of teachers of higher education institutions, colleges and lyceums of the Republic including in bioethics.
p.000207: 64-hour training course for students of our institution and 32-hour course for other universities has been worked out
p.000207: by the Department. Several text- books and teaching aids on this discipline were published in Romanian and Russian, we
p.000207: will point of the following:
p.000207: - Philosophy and Bioethics: History, personalities, paradigms.), Chisinau, 2000, 256 p.
p.000207: - Philosophy (with Bioethics course). Chisinau, 2002, 552 p.
p.000207: - Philosophy and Bioethics Dictionary. Chisinau, 2004, 441 p.
p.000207: - Elements of Bioethics. Chisinau, 2005, 176 p.
p.000207: - Bioethics: origin, dilemma, trends. Chisinau, 2005, 234 p.
p.000207: These and other training and methodological and scientific works of the Department staff allowed organization and
p.000207: holding of training not only for students but for a certain number of professors of universities and colleges of the
p.000207: country in accordance with detailed program on Bioethics through the National Bioethics Centre and Bioethics
p.000207: Association of the Republic of Moldova. More than 50 persons who would be able to give lectures on bioethics in the
p.000207: higher and secondary specialized educational institutions of our country as well as in lyceums underwent advanced
p.000207: training in science and method training related to this field at these national workshops.
p.000207: Thirdly, the Department of Philosophy and Bioethics of State University of Medicine and Pharmacy named after
p.000207: Testemitianu N.A., the National Bioethics Centre carries out permanent research work in bioethical knowledge
p.000207: considering bioethics in the widest definition of this term (as per V.P. Rotter). Since 1995 until 2006 the
p.000207: Department has organized and held eleven international scientific workshops on topic Bioethics, Philosophy and
p.000207: Medicine in Human Survival Strategy. Scientists and practitioners from many world countries (the Ukraine, the Russian
p.000207: Federation, Bulgaria, Romania, Canada, the USA, the Republic of Moldova, etc.) and other specialties (philosophers,
p.000207: medics, biologists, ecologists, engineers, economists, agronomists etc.) participate in such workshops
p.000207: contributing to bioethical development in close connection with biomedicine, philosophy, ecology, economy, technique,
p.000207: other fields of knowledge. This promoted development of researches in ethics of life not only in the Department of
p.000207: Philosophy and Bioethics of State University of Medicine and Pharmacy named after Testemitianu N.A. but in other higher
p.000207: educational institutions of the country.
p.000207: Since 2002 the Department offers post-gradual studies (daily and distant training), doctor of science (distant) and
p.000207: master (daily) training in bioethical sphere where graduates of philosophic, medical, theological, agricultural and
p.000207: other department study. After graduation and successful defense of works they are conferred the degree of doctor or
p.000207: doctor habilitate of philosophic science (majoring in bioethics) and master on bioethics, respectively.
p.000207: If we are to continue to develop our ideas related to organization of training process in bioethical knowledge in
p.000207: our country it is necessary
p.000207:
p.000208: 208
p.000208:
p.000209: 209
p.000209:
p.000209: to especially stress the work of the Department, Association and the National Bioethics Centre in
p.000209: popularization of this phenomenon among the population of the Republic and primarily among the youth.
p.000209: Introduction into Bioethics program is of special popularity among the radio and television auditoria. Over
p.000209: last 3 years the personnel of the Centre and the Department organized and held about 20 talks (radio and television) of
p.000209: 15 to 45 minutes each on basic themes of this type of practical philosophy. Such programs as Bioethics –
p.000209: The Science of Survival, Euthanasia from the Point of View of Bioethics, Cloning in the Contest of Bioethics,
p.000209: Bioethical Aspects of Artificial Human Reproduction, Experiments in Humans and Animals in Biomedical Sphere:
p.000209: Bioethical Aspects, Religion and Bioethics and other with participation of bioethics specialists, biologists,
...
p.000209: 14 of 5 April 2003,
p.000209: p.6 (in Romanian); Homo Sapiens, be a Human!, the Argumenty i Fakty newspaper, No. 21, May 2005, p.3 (in
p.000209: Russian); Bioethics, Philosophy,
p.000209: Economics and Medicine in the Strategy of Humane Safety Ensuring, the Literatura i Iskusstvo weekly, No. 11, 17 of
p.000209: March 2005, p.2; Philosophy and Bioethics, the Literatura i Iskusstvo weekly, No. 35, 1 of September 2005, p.7; And
p.000209: Philosophers May Safe the Mankind, the Svetoch newspaper on 19 of February 2000, p.6, etc.
p.000209: Traditions of extensive participation of the community in formation of moral principles of social life are rather
p.000209: strong in our country as in other CIS countries. As it was said before, the first public officially
p.000209: registered organization in 2001 undertaking responsibility to promote ideas of bioethics in the
p.000209: Republic was Bioethics Association, united philosophers, medics, lawyers, theologists, biologists, scientists,
p.000209: students and other public representatives. All bioethics commissions created in local hospitals, scientific
p.000209: institutions and others are the result of the activity of the Association and the National Bioethics Centre. Today,
p.000209: bioethics commissions operate in practically all patient care and preventive and scientific and biomedical
p.000209: institutions, elaborating procedures for operation and standard operation procedures based on model regulation.
p.000209: It is necessary to underline the role of bioethics committees in organization and holding of training and
p.000209: educational process starting with the National Ethics Committee under the Ministry of Health Care and Social Security
p.000209: and to basic levels of this system. First of all, we set up trainings for members of the committees at workshops, and
p.000209: then they perform the same work in their teams, i.e. promote bioethical knowledge.
p.000209: So, successful set up of bioethical training is important for the Republic of Moldova from various points of
p.000209: view, and, first of all at the point of integration of our country into European and world community. From one
p.000209: side use of experience of other countries in this process is the condition for formation of moral
p.000209: mechanisms embodiment for ensuring of secure development strategy for our region, further democratization of
p.000209: social life. From the other side, the experience of the Bioethics Association of the Republic of Moldova,
p.000209: the National Bioethics Centre on bioethics and the Department of Philosophy and Bioethics of the State University of
p.000209: Medicine and Pharmacy named after Testemitianu N.A. on set up of trainings and education of inhabitants in
p.000209: bioethical interconnections and interactions among humans, society and biosphere, i.e. in implementation of one of
p.000209: the significant principles of bioethics – the co-evolutional one.
p.000209:
p.000210: 210
p.000210:
p.000211: 211
p.000211:
p.000211: And finally, wide spread of the experience and practice of the state and public formations in training and educational
p.000211: process of bioethical knowledge will favor integration in social life of new ethical and legal approaches,
p.000211: principles and values, the help of which may not only reasonably use achievements of current scientific and
p.000211: technological progress but promote implementation of modern strategy of the world community meaning survival of
p.000211: the mankind through steady and safe development.
p.000211: These are summary results of our works during the last 10-12 years in organization of training, education and promotion
p.000211: of bioethical knowledge among people of our country, and, first of all, among the youth. The work we have performed
p.000211: undoubtedly will be a serious base for further extension and strengthening of the developed system especially in
p.000211: carrying on of bioethical education of young students, future specialists of all types.
p.000211:
p.000211: References
p.000211: 1. Bioethics: principles, rules, issues. Edited by Yudin B.G. М., 1998,
p.000211: 472 p. (in Russian)
p.000211: 2. Vekovshinina S.V., Kulinichenko V.L. Bioethics: onset and rationale (philosophy and methodological analysis).
p.000211: Kiev, 2002, 152 p. (in Russian)
p.000211: 3. Second National Congress on Bioethics. 29.09 – 2.10 2004. Kiev, 2004, 305 p. (in Russian)
p.000211: 4. Testemitsanu N.A., Popushoy Ye.P., Ioksa V.A. Famous Doctors of Moldavia. Chisinau, 1985, 231 p. (in Russian)
...
p.000217: b) Amendments are required to produce a positive decision;
p.000217: c) Negative decision;
p.000217: d) Cancellation of any previously made decision.
p.000217: During a clinical research an investigator must inform the Ethics Committee on necessity to introduce certain
p.000217: amendments and alterations to the clinical study protocol and to the information provided to study subjects, as well on
p.000217: occurrence of severe and/or unexpected adverse events and side effects and on any new data on possible impact of the
p.000217: tested article on humans. Based on results of review of materials provided by the investigator, the Ethics Committee
p.000217: makes decision on possible introduction of these or those alterations and amendments, continuation of clinical research
p.000217: or its separate stages, on measures which must be taken to ensure safety and protection of study subject rights.
p.000217: The Ministry of Health Care and Social Security and authorized agencies pay great attention to settlement of such
p.000217: complicated and diverse ethical and legal issues arising during clinical researches. We are trying to observe the
p.000217: following main principles in operation of the committee involved in ethical issues of the CT:
p.000217: - unified methodological approach based on GCP guidelines;
p.000217: - striving to independence of decisions to promote protection of study subject rights.
p.000217: - special attention is paid to patient informed consent
p.000217: - assistance to educational programs for members of the ethics committees, for doctors- researchers,
p.000217: patients.
p.000217: - inclusion all researches (pharmaceutical products as well as biological active substances,
p.000217: technologies, materials, devices and items for medical use involving human subjects as a study object) into the sphere
p.000217: of activities of the ethics committee
p.000217: - maintenance of ethical environment using medical publications issuing only results of researches that passed
p.000217: ethical review by ethics committees.
p.000217: New documents devoted to ethical and legal aspects of clinical researches are elaborated annually, changes are made to
p.000217: existing documents. General provisions of international laws, in particular, ICH GCP are reflected in
p.000217: guidelines produced by the Agency for Pharmaceutical Products of the Ministry of Health Care and Social
p.000217: Security of Moldova. There is a process of regular and consistent introduction of GCP principles into the practice of
p.000217: organization and performance of clinical researches of medical agents. Up- to-date task is creation of local ethics
p.000217: committees in Moldova. Creation of such independent committees authorized with relevant powers will promote active
p.000217: participation of Moldova clinics in multi-Centreed international researches, allow controlling observance of the
p.000217: rights and safety of study subjects not only at the stage of setting up but also during the study course.
p.000217:
p.000217: 3.7.5. Perspectives and Forms of International Cooperation
p.000217:
...
p.000219: Kiev, Ukraine, 2001; Almaty, the Republic of Kazakhstan, 2002; , Kiev, Ukraine, 2004; Saint-Petersburg, Russia,
p.000219: 2003; Baku, the Republic of Azerbaijan, 2004; Saint-Petersburg, Russia, 2004; Minsk, Belarus, 2005; Almaty,
p.000219: the Republic of Kazakhstan, 2005; Tashkent, the Republic of Uzbekistan, 2005; Yerevan, the Republic of Armenia,
p.000219: 2005.
p.000219: In 2006 the workshop on “Human Rights Protection &. Standard Operation Procedures” with participation the
p.000219: representatives from FECCIS (Russia, Ukraine, Moldova) and SIDCER (WHO) and EFGCP (Belgium) was held in Chicinau.
p.000219: Chairman of the National Ethics Committee of the Republic of Moldova, Professor Gikavy V.I. took part in the workshop
p.000219: of the Commission of the Council of Europe on Ethical Issues (Ljubljana, 2004). Professor M. Gavrilyuk, Deputy-director
p.000219: of the Neurology and Neurosurgery Institute of the Ministry of Health Care and Social Security is a permanent
p.000219: representative of the Republic in the Commission of the Council of Europe on ethics of biomedical researches since
p.000219: 2005.
p.000219: Secondly, the staff of the State University of Medicine and Pharmacy named after Testemitianu N.A., the State
p.000219: University of Moldova, the State Agricultural University and other, members of the National Bioethics Centre of
p.000219: the Republic of Moldova take part on a regular basis in scientific conferences organized in other countries, exchange
p.000219: with their experience, mainly, on scientific and educational publications, activity of bioethical committees,
p.000219: etc. Four workers of the Department of the Philosophy and Bioethics just for the last 3-4 years took
p.000219: part and made presentations at the 2nd National Bioethics Congress (Kiev, 2004), the same number of
p.000219: presentations was made at the 4th Bioethics Symposium (Kiev, 2006), four presentations were made at the
p.000219: International Conference on bioethical education (Romania, Keya, 2006 and Romania, Bucharest, 2006), with
p.000219: presentations at the International seminar on issues of ethical review in biomedical researches (Ukraine,
p.000219: Kiev, 2006), with presentations on issues of students bioethics education (Croatia, Split, 2006), etc.
p.000219: Thirdly, professors of philosophy, philosophy and bioethics departments of many of higher educational institutions
p.000219: of Chisinau published lately materials on bioethics in different scientific journals, other foreign
p.000219: publications, for example in Kursk (Russian Federation) – 5 articles, in Yassy (Romania) – 2 articles,
p.000219: in Arad (Romania) – 2 articles, in Galatia (Romania) – 2 articles, in Lvov (Ukraine) – 1 article, etc. Our
p.000219: colleagues from these scientific Centres publish their works in scientific publications of Chisinau (journals,
p.000219: university research works, conference materials, etc.).
p.000219: During the last years the Department of Philosophy and Bioethics of the State University of Medicine and Pharmacy named
p.000219: after Testemitianu N.A. is trying to enter different international projects related to training programs on bioethics,
p.000219: performance of ethical review of biomedical researches, staff training, etc. To this extent we are looking for
p.000219: forms of international scientific and pedagogical cooperation in bioethics with the CIS countries, and especially with
p.000219: those states where large educational experience for this subject was already gained, where large-scale research work is
p.000219: carried out.
p.000219: To improve training programs in bioethics and its lecturing in the State University of Medicine and Pharmacy named
p.000219: after Testemitianu N.A., a famous Italian specialist in these spheres of practical philosophy, Pietro
p.000219: Cavasin, give lectures to students and doctor candidates for 5 years in the State University of Moldova. There was
p.000219: constant exchange of both scientific and educational literature here.
p.000219: Since 2004 we expanded relationship with foreign colleagues as to training of high-qualified specialists, i.e.
p.000219: through post-graduate and master studies in bioethics. Anna Marin, post-graduate of the Department prepares
p.000219: dissertation in bioethics under guidance of two specialists now: Doctor of Philosophy Raymond Massé – Laval University
p.000219: (Canada) and professors of our Department. Two professors of the Department gained master degree majoring in
p.000219: bioethics in French in Bucharest, and one more staff member got training in the University of Angers
p.000219: (France). All expenses on implementation of these projects were covered by the French-speaking Agency for the Republic
p.000219: of Moldova.
p.000219: We consider for the future (as a suggestion) as useful and, more important, as necessary development and publication of
p.000219: a text-book for the University students under the title The Fundamentals of Bioethics by scientists of the CIS
p.000219: countries. It could be started now without any long-term delay, let’s say, from January 2007 under general scientific
p.000219: and methodological guidance of heads of departments where this subject is a part of a curriculum of a higher
p.000219: educational facility, where it is taught, where teaching aids were published, and
p.000219:
p.000220: 220
p.000220:
p.000221: 221
p.000221:
p.000221: some experience in this sphere was gained. At least, our Department as well as plenty of other groups from other
p.000221: countries are ready to participate in such project. It would be rational and useful to organize regular educational and
p.000221: methodical workshops for professors lecturing bioethics in scientific Centres of different CIS countries (Kiev, Moscow,
p.000221: Chisinau, Baku, Yerevan, etc.)
p.000221: We also consider as useful the initiative of Moscow colleagues with participation of other CIS countries on
p.000221: development of a training course in bioethics for highest qualification specialists with duration of 320 academic hours
p.000221: (it is possible to reduce the time if to consider that information sciences and foreign languages were already taught
p.000221: to young university professors of higher educational facilities). This is the beginning of the large work and we hope
p.000221: to see it finished in the nearest future as a good example of cooperation among the CIS countries.
p.000221: 3.8 RUSSIAn FEDERAtIon (G.L.Mikirtichian, A.F.nikitina, A.S.Sozinov,
p.000221: M.E.Guryleva, E.A.Malysheva)
p.000221:
p.000221: 3.8.1 Historical and Cultural Background
p.000221:
p.000221: During the period of its existence Russian medicine has accumulated the great volume of ethic knowledge both in
p.000221: theoretical research and in practice. Founding and development of medical ethics as predecessor of bioethics in Russia
p.000221: was determined by social and economical factors, historical, cultural and national features, religious and moral
p.000221: traditions of the peoples living over the country.
p.000221: Chapter 5 From the beginning Russia was multinational state with multinational neighbors. This
p.000221: multinationality influenced the foundation of Russian culture. Geographical position of the state at the junction of
p.000221: Europe and Asia resulted in ambivalence of people nature and state organization as European as Asian and gave birth to
p.000221: a philosophical concept of eurasianism, that was founded by one of the most universal Russian thinkers
p.000221: abroad N.S.Trubetskoy (1890-1938). D.L.Lihachev believed that universality and belonging to East and West were
p.000221: the most characteristic features of the Russian culture (14). Junction of East and West civilizations, crossing of
p.000221: two pole streams of culture, which pushed off each other and could not be joined but co-existed, have determined such
...
p.000257: testing, storage, transportation, realization, application and utilization”.
p.000257: In contrast to current federal laws, this bill proposes the more detailed regulation of process of the clinical
p.000257: drug research ethical review. It also constitutes research subjects’ rights and guarantees of these rights
p.000257: in accordance with the most progressive international standards in this field.
p.000257: Legislation initiatives in the sphere of protection of patients’ rights40, activity directed to adaptation of
p.000257: international guidelines, as well as transformation of the positions of international declarations and conventions
p.000257: in the sphere of biomedicine into the domestic legal acts, give us the reason to expect the strengthening and
p.000257: development of the institute of ethical review in our country.
p.000257:
p.000257: 3.8.3 Education in Bioethics
p.000257:
p.000257: Issues on education of medical ethics and deontology in medical schools and colleges of the USSR were
p.000257: started to discuss in the 60’s of the XX century after the 1st All-Union Conference on issues of medical
p.000257: deontology in 1969 being a kind of triggering point for revival of talks on them. The final resolution, in particular,
p.000257: said: “The Conference would like to draw attention of the Chief Agency on Educational Facilities of the Ministry of
p.000257: Health of the USSR on necessity to implement medical deontology into education process”.
p.000257:
p.000257:
p.000257: 40 For example, Draft Law “On legal basis of bioethics and its guaranties”, “On reproductive rights of citizens”,
p.000257: “On additions to Criminal Code of the Russian Federation regarding to criminal liability for conducting
p.000257: medical trials involving human subjects without their voluntary consent” and others.
p.000257: Many medical schools developed medical oaths based on the Hippocratic Oath. In 1971 the Presidium of the Supreme Soviet
p.000257: of the USSR approved an official text of the Oath of Medical Doctor of the Soviet Union.
p.000257: In 1976 the Ministry of Health of the USSR approved interdepartmental curriculum on medical ethics (deontology)
p.000257: for higher medical and pharmaceutical educational facilities. The curriculum distributed the course along the
p.000257: entire educational process basing on that “concepts of morals and morality, development of higher feelings and medical
p.000257: ethics is an integral part of the entire educational process and should be implemented in various aspects during all
p.000257: years of training at all departments“.
p.000257: The curriculum stipulated one lecture for the 1 year students: “Medical ethics and medical
p.000257: deontology, their role for formation of a medical doctor and pharmacist” (Introduction for the subject);
p.000257: 5 lectures for the 2 year students: “Soviet health care as qualitatively new system“ (Department of
p.000257: Social Hygiene and Health Care Management), “Main peculiarities of deontology development at different stages of
p.000257: health care formation” (Department of History of Medicine), “Categories of medical ethics” (Department of Marx and
p.000257: Lenin Philosophy), “Modern concepts on medical and psychological aspects of an individuality” (Course on medical
p.000257: psychology), “Deontological issues in disease diagnostics” (Department of Preliminary Studies of Internal
p.000257: Diseases); 1 lecture for 3 year students: “Deontological issues of treatment” (Department of Faculty Therapy); 2
p.000257: lectures for 5 year students: “Deontological issues for work of district physician” (Department of
p.000257: Hospital Therapy) and “Legal principles of medical services for working population in the USSR”
p.000257: (Department of Forensics Medicine). The curriculum was widely discussed in mass media and majority of comments were
p.000257: that it was inefficient, did not cover many important issues, which are of tremendous value for medical practice, for
p.000257: instance, no definition of patient rights was given, it did not dwell on issues of brain death, refusal of
p.000257: extraordinary treatment for dying patients, it never mentioned the Nuremberg Code or the Declaration of Helsinki, etc.
p.000257: In 1977 and 1982 two other All-Union conferences on medical deontology were held. There were published
p.000257: multiple books on issues of medical ethics and deontology for various medical fields. It indicated that in 70-80’s
p.000257: the system of Soviet higher medical education had professors who not only fully understood a role of medical
p.000257: deontology for education
p.000257:
p.000258: 258
p.000258:
p.000259: 259
p.000259:
p.000259: and training of undergraduate doctors but also contributed considerably for development of the content of this
p.000259: subject (Evlashko Y.P., Kosarev I. I., Leschinsky L.A., Orlov A.N., Suvorova R.V., Rokitsky M.R., Shamov I. A.,
p.000259: Jarovinsky M.Ya., etc.). In 1988 two volume manual Deontology on Medicine was published edited by Petrovsky
p.000259: B.V.
p.000259: In the 80’s the educational curriculum of medical nurse colleges had some academic hours assigned to medical
p.000259: deontology – the course was called as Basics of medical psychology, ethics and deontology. In 1992 the Pledge of
p.000259: Medical Doctor of Russia came into force.
p.000259: In 1993 the Vrach (Doctor) magazine published an appeal to scientific community and heads of the Russian science from
p.000259: members of the Russian national committee on bioethics (“Bioethics in Russia: Beginning of the way”). The Appeal
p.000259: stated: “Modern medicine requires modern moral consciousness. In the whole world principles of bioethics for a
p.000259: long time are an integral part of professional life of medical workers ... Absence in our country of the said
p.000259: mechanisms of ethical control results in a range of negative consequences, hinders improvement of moral environment
p.000259: within our scientific community; it is one of the main reasons for distrust of the society to science (that, by the
p.000259: way, impacts the society readiness provide science with tangible support); it is a direct violation of
p.000259: international acts enforced in this field...” In this document the most well-known medical scientists of the
p.000259: country wrote with anxiety about those harmful consequences indicating absence of proper ethical control on
p.000259: scientific experiments. Neglect of elementary medical and ethical norms in practical health care being widely spread in
p.000259: our days looks similarly dangerous. It was noted by many speakers at the XVIII All-Russia Pirogov’s Conference of
p.000259: Medical Doctors held in Moscow in 1997. The Conference approved a new text for the Oath of Russian Medical Doctor and
p.000259: the Code of Medical Ethics presented by the National Ethics Committee – Russian Medical Association.
p.000259: In October 1994 in Geneva the 4th WHO Conference on issues of medical ethics education was held where
p.000259: participant unanimously stated that education to ethics (bioethics) issues should be mandatory rather than optional.
p.000259: The Conference participants agreed that medical ethics should become an integral part of medical education and
p.000259: that its coaching should be obligatory and continuous during the entire pre-graduate educational
p.000259: process and for post-graduate education, therefore, all medical schools were to have a department on medical ethics and
p.000259: appropriate number of trained professors.
p.000259: In 1997 under the aegis of the Ministry of Health of the Russian Federation the meeting on issues of
p.000259: medical ethics education was held where necessity of introduction of bioethics learning was acknowledged. It
p.000259: is necessary to note that the Russian Orthodox Church supported introduction of the biomedical ethics education
p.000259: into the medical education system of Russia. It is indicated with the appeal to the ministries of health care and
p.000259: vocational education of the Russian Federation approved during the VI International Christmas educational
p.000259: lectures of 1998 held by the Moscow Patriarch of the Russian Orthodox Church.
p.000259: Some of higher educational facilities of medical as well as philosophy, law and other fields as per initiative
p.000259: of those enthusiasts-professors the bioethics education process was launched as well. Since the beginning
p.000259: of the 90’s the separate course on biomedical ethics was provided in the Moscow State University named after Lomonosov
p.000259: M.V. at the Departments of philosophy and psychology, and since 1994 it was also introduced at the medical department.
p.000259: The most capacious course in regard to number of academic hours assigned was provided at the nurse department
p.000259: for the 1st year students of the Moscow Medical Academy named after Sechenov I.M. - 56 hrs (30 hrs of lectures and 26
p.000259: hrs of seminars). Actually, this subject was given at the Department of history of medicine since 1994, and as a
p.000259: separate course – since 1995. Another issue is even more important: at this department biomedical ethics was included
p.000259: into the state educational standard, i.e. it is obligatory for all 22 departments of the higher nurse education in
p.000259: Russia. Making this subject as mandatory from the point of view of educational minimum for this category of medical
p.000259: workers, naturally, required generation of appropriate curriculum (author – Professor Yarovinsky M.Ya.).
p.000259: In the Russian State Medical University since 1996 the Department of philosophy and culture sciences was called as the
p.000259: Department of philosophy and culture sciences with a course on bioethics, and there the biomedical education course (22
p.000259: academic hours: 18 hours of lectures and 4 hours of seminars) is provided since 1996 for all 4 year students of
p.000259: physician and pediatric departments.
p.000259:
p.000260: 260
p.000260:
p.000261: 261
p.000261:
p.000261: Also since 1996 the course on bioethics was provided in the St- Petersburg Pediatric Medical Academy at the
p.000261: Department of humanitarian subjects and bioethics and in the Kazan Medical University. The Department of philosophy of
p.000261: the Moscow Medical Dentistry Institute since 1997 was called the Department of philosophy and biomedical ethics, the
p.000261: course of biomedical ethics there (40 academic hours) is provided at the dentistry department for 1-year
p.000261: students, and at the physician department — for 3- year students. At the evening education department for 1-year
p.000261: students this subject was assigned with 20 academic hours. As an option biomedical ethics was suggested for
p.000261: students since 1993. In the Krasnoyarsk Medical Academy the course on professional medical ethics was provided for pre-
p.000261: graduate students (48 academic hours), and at the higher nurse education department (40 academic hours).
p.000261: The next step for establishing of this subject education was the All- Russian Educational and Methodical
p.000261: Conference Biomedical Ethics in Higher Medical Education Facilities held by the Ministry of Health of the Russian
p.000261: Federation in 1999; since 2000 bioethics became an obligatory subject in medical schools. Introduction of
p.000261: biomedical ethics into a set of humanitarian subjects of medical education is one of the evidences of real renewal of
p.000261: humanitarian training of medical students in Russia.
p.000261: Currently educational system in the Russian Federation has curriculums for general (beginning, secondary) and
p.000261: professional (secondary, higher, additional) education. Their content is determined by state educational
p.000261: standards. Standards for “secondary” and nurse vocational training do not contain bioethical issues.
p.000261: At the stage of higher vocational training bioethics become an integral part of curriculums of medical
p.000261: or pharmaceutical fields (a course of humanitarian and social and economic subjects), for such majors as Law,
p.000261: International Relations, Social Work (natural sciences part in the course Concepts of modern natural sciences),
p.000261: Biology and Bioecology (a part of general vocational subjects). As a negative sign it should be noted that
p.000261: bioethics education is not stipulated for such major as Philosophy. Existence of national and regional (school-
p.000261: related) component in state standards and the right to some extent to alter curriculum content allows for many of
p.000261: educational facilities in Russia to include bioethics into education of future agriculture workers, veterinaries,
p.000261: teachers, philosophers and other trades.
p.000261: At the same time there is no trade of bioethics in the All-Russian Classifier of Educational Trades as well
p.000261: as it is not mentioned in the List of Scientific Specialist Trades. Therefore, targeted training of specialists
p.000261: including specialists of higher qualification (masters and doctors of science) in regard to bioethics is not
p.000261: provided. However, theses or dissertations for master or doctor degree covering to some extent bioethics
p.000261: issues are defended using reference numbers of other trades such as philosophy, sociology, public health.
p.000261: Currently training of medical doctors and pharmacists is conducted in 47 universities and academies subjected to the
p.000261: Federal Agency on health care and social development as well as 25 departments and institutions of the Russian
p.000261: education ministry, 5 military medical educational facilities, 10 private higher educational facilities as well as in
p.000261: the Kyrgyz-Russian Slavic University accredited in Russia.
p.000261: Typical unified program of education in higher medical educational facilities in Russia was developed in 2001 by the
p.000261: group of Moscow scientists, and in 2003 the reference curriculum on bioethics for Pharmacy trade was published (authors
p.000261: – workers of the Moscow Medical Academy named after Sechenov I.M.), which are planned for 36 academic hours of class
p.000261: work (18 hours of lectures and 18 hours of seminars) and 18 hours of independent work in the 2nd semester. The
p.000261: curriculum stipulates learning of history and traditions of Russian ethics, theoretical basics of biomedical ethics,
p.000261: models and rules of relationships between doctor and patient, patient rights, analysis of bioethical issues of
p.000261: experimental medicine, reproductive technologies, euthanasia, transplantology and medical genetics, HIV infection,
p.000261: ethics in psychiatry, moral issues of distribution of health care resources. Working educational programs that the
p.000261: education is based upon are developed by departments implementing them.
p.000261: Currently training in bioethics at the specialized department is conducted only in one higher educational facility, the
p.000261: Russian State Medical University. Three cities (Ivanovo, Kazan, Samara) have departments on bioethics and law
p.000261: associated with other subjects (forensics medicine, history of medicine) or without it. Five educational
p.000261: facilities provide such education at the departments of philosophy, another five changed department titles to
p.000261: mention “philosophy and bioethics”. Three cities delegated this coaching to health care management department. In every
p.000261: third of medical educational facilities
p.000261:
p.000262: 262
p.000262:
p.000263: 263
p.000263:
p.000263: bioethics is learned at departments of humanitarian and social and economic type. Finally, another three higher
p.000263: educational facilities (Astrakhan Medical Academy, St-Petersburg Medical University named after Pavlov I.P. and
p.000263: Stavropol Medical Academy) formed interdepartmental teams for teaching the subject involving clinicians (clinical
p.000263: pharmacologists, psychiatrists).
p.000263: Majority of medical academies and universities has the amount of academic hours complying with the curriculum
p.000263: stipulated one – 36 hours, two – shrank it insignificantly up to 32 hours, and in one academy – to 19 hours.
p.000263: More than a half of medical educational facilities in Russia managed in their curriculum to move the classes from 1st
p.000263: year students to more trained ones up to the pre-graduates at their last year training (Volgograd, Kursk, Ryazan,
p.000263: St-Petersburg Pediatric Medical Academy).
p.000263: An important feature of the modern stage of development of biomedical education in medical education facilities is
p.000263: its close organizational and methodical association with coaching in jurisprudence and medical law. It is not by
p.000263: chance that one of the main magazines publishing articles and other materials on bioethics-related topics is
p.000263: Medical Law included into the list of magazines recommended by the Higher Attestation Commission for publication of
p.000263: results of dissertation research.
p.000263: Special departments on medical law were established in two Moscow facilities (Moscow Medical Academy named after
p.000263: Sechenov I.M. and Moscow State Medical and Dentistry University), in 11 cities the law training is
p.000263: provided in the departments, which titles mention law. In 7 cases these are departments of humanitarian and
p.000263: social and economic field: bioethics, philosophy, political sciences, economics, sociology, psychology and pedagogics;
p.000263: in 4 cases – forensics medicine.
p.000263: Four universities set up the educational process on jurisprudence at humanitarian departments
p.000263: (humanitarian sciences - 2, social and humanitarian - 2), four – at departments of forensics medicine and
p.000263: four – at departments of public health and health care. In Astrakhan they decided to involve professors of three
p.000263: departments: philosophy, public health and forensic medicine.
p.000263: Objectives of bioethics and law coaching are to identify, formulate and bring to students those norms of
p.000263: morals and law that will protect their patient and, at the same time, will not hinder innovations in medicine and,
p.000263: moreover, beneficial use of modern diagnostic and medicinal technologies. Achievement of this goal is based on complex,
p.000263: interdisciplinary approach to the educational process as it is required by the essence of bioethics.
p.000263: Bioethics as it is should be in the Centre integrating common efforts of men of law, forensic medicine specialists,
p.000263: philosophers and other representative of humanitarian departments and, naturally, clinicians and health care
p.000263: managers as well as university administration for training and education of future specialists. Some actions
p.000263: in this respect are performed (Moscow State Medical and Dentistry University, etc.). Maybe, it makes sense to
p.000263: set a task to prepare a typical reference curriculum at the federal level that could be an assistance and incentive for
p.000263: universities. We should also take into account strong and weak points of the Interdepartmental Curriculum on medical
p.000263: ethics and deontology implemented in the USSR in 70’s and 80’s of the ХХ century. That curriculum could be considered
p.000263: as a historical prerequisite for education in the field of bioethics for all Post-Soviet countries. At the
p.000263: same time, the XXI century requirements show necessity for inclusion into the training course of completely new issues.
p.000263: In particular, it seems of significant importance to include there issues on evidence-based medicine. Nowadays this
p.000263: field of medical science is unfairly considered as the outskirts of educational curriculums, while it allows giving
p.000263: grounds to clinical practice with quantitative and qualitative analysis of world research data rather than basing it on
p.000263: intuition, traditions and experience which young specialists just do not possess.
p.000263: Educational and methodical basis for bioethics currently cannot be called as perfect but despite that currently
p.000263: there are good monographs that, regretfully, are not fully available in university libraries. Such publications are:
p.000263: Biomedical Ethics//Edited by Pokrovsky V.I.Vol.1. - M., 1997 and Biomedical Ethics//Edited by Pokrovsky V.I.
p.000263: and Lopukhin Y.M. Vol.2. - M., 1999;. Bioethics: principles, rules, issues//Edited by Yudin B.G.- M., 1998; .
p.000263: Introduction for Bioethics. - M., 1998, etc.
p.000263: In 2005 a handbook for higher educational facilities fir the Pharmacy trade edited by Lopatin P.V. was published, and a
p.000263: year before – a teaching aid Medical Ethics edited by Academician of the Russian Academy of Medical Sciences,
p.000263: Professor Lopukhin Y.M. and Corresponding member of the Russian academy of Sciences, Professor Yudin B.G.
p.000263: (translated from English). In 2006 Publishing House Meditsina (Medicine) issued a handbook
p.000263:
p.000264: 264
p.000264:
p.000265: 265
p.000265:
p.000265: on medical ethics by Shamov I.A. where the author suggested introducing continuous education of the subject and
p.000265: provides a curriculum for the entire period of study.
p.000265: A handbook for students in medical schools recommended by the Education and Methodical Association of
p.000265: medical and pharmaceutical universities of Russia is handbook Medical Ethics (Bioethics) by Yarovinsky M.Ya. (M.,
p.000265: 2006). Besides, there are publications prepared directly by educational facilities, for instance, by the Samara
p.000265: State Medical University (Sergeyev V.V., Nasledkov V.N. et al. Lectures on Bioethics. Samara, 2005), as well
p.000265: as monographs and collections of articles, foreign manual, for instance, the ones approved in the Republic of Belarus.
p.000265: Some role was played by monograph Ethics of Treatment by Siluyanova I.V. (M., 2001).
p.000265: Also departments providing bioethics education start to interact. In 2005 the All-Russian Educational and Methodical
p.000265: Conference Biomedical Ethics in the higher medical educational facilities of Russia (the Russian State
p.000265: Medical University) was held which summarized experience accumulated in the field of bioethics education in various
p.000265: universities and schools.
p.000265: Motivation to study bioethics among students and specialists is quite high. Sociological polls found that more than 80%
p.000265: of students and young medical doctors realize necessity to master bioethics knowledge. And experienced doctors
p.000265: who, in their majority, never studied biomedical ethics, as it is currently understood, quite often do not
p.000265: express any determined opinion.
p.000265: Importance of specific training for doctors with more than 10-year professional experience, and they are
p.000265: the basis of the industry human resources, in regard to ethical and legal issues, is rather
p.000265: considerable. It is confirmed with the questionnaire data we obtained. “Is there a need in ethical committees in
p.000265: treatment and prevention facilities?” The answer is “No” among more than 25% (!) of MD’s vs. students. Such prevalence
p.000265: of answers is caused, naturally, not by neglecting of ethical values but with ignorance of the subject. Obviously,
p.000265: post-graduate education shall become a foremost objective.
p.000265: Nowadays, there is no practice of systematic organization of training course on bioethics issues for medical doctors
...
p.000265: Improvement of doctor and researcher knowledge in regard to protection of rights of biomedical research participants is
p.000265: significantly facilitated with the conduct of training cycles on rules of Good Clinical Practice by medical
p.000265: universities (Moscow Medical Academy, Russian State Medical University) and large contract research organizations
p.000265: (Smolensk, Saint-Petersburg).
p.000265: A specific value for ethical review system setup in the country is provided by training of the ethical
p.000265: committee members. Such trainings are organized under the aegis of the Forum for Ethics Committees in CIS Countries
p.000265: as well as by initiatives of particular ethical committees.
p.000265: The Russian Federation joining to the Bologna Club (September, 2004), that is, to states participating in processes of
p.000265: reforming of European education on the basis of Bologna Declaration principles (1998), raised necessity in resolving
p.000265: of some new issues by those organizing bioethical education. It includes struggle for the place of the subject
p.000265: of bioethics in the part of curriculums that is compiled in accordance with the Bologna Declaration requirements to be
p.000265: implemented on mandatory rather than optional basis; for appropriate rate of work content and assessment in the system
p.000265: of ECTS credits; preparation of various educational and methodical materials for independent work of students
p.000265: (multimedia aids, readers, case collections, business games, tests); development of control and measurement materials
p.000265: and, naturally, targeted specialized training of professor competitive in conditions of higher educational
p.000265: mobility of their students.
p.000265: In general, one can come to a conclusion on a need for creation in the Russian Federation specialized educational
p.000265: facilities of organizational, design and methodical basis for teaching bioethics. During the last years one can
p.000265: observe a notable trend for transformation of bioethics education into specialized courses and departments. At the same
p.000265: time, it is necessary to make efforts to develop state educational standards, typical unified and working educational
p.000265: programs to comply with scientific and practical
p.000265:
p.000266: 266
p.000266:
p.000267: 267
p.000267:
p.000267: requirements, to coordinate activities of university departments on teaching issues of legal and ethical control in
p.000267: medicine.
p.000267: The main task is to be planned preparation of qualified staff of professors, which requires set up of special
p.000267: post-graduate study system, including post- graduate research and vocational training at the course of general and
p.000267: topical post-graduate education, establishment of the bioethics grade.
p.000267:
p.000267: 3.8.4. System of Ethical Review
p.000267:
p.000267: The Russian legislation in the field of ethical and legal provision for biomedical research is represented with a range
p.000267: of documents. First of all, it is the Constitution of the Russian Federation (Art.21), which states: “… no one can be
p.000267: made undergo medical, scientific or other experiments without his/her consent.” Beside, there is the Basics of the
p.000267: Legislation of the Russian Federation on Protection of Health of Citizens where Article 43 considers issues on
p.000267: application of new methods of prevention, diagnostics, treatment; medical agents, immunobiological agents and
p.000267: disinfecting agents and biomedical research conduct. However, this article is declarative to a large extent: rights
p.000267: of citizens involved in biomedical studies stipulated there do not have any mechanisms of implementation and
p.000267: enforcement, including the ones via ethical review of applications for research conduct. At the same time,
...
p.000275: Every year in Russia each hundred biomedical research is rejected, decision on other 7% of protocols is
p.000275: postponed until the study organizers correct serious planning defects, 31% of CT requires changes of the materials for
p.000275: CT of medicinal agents (in most of cases it is necessary to rework text in the patient information and informed consent
p.000275: note), which are not fatal, and only about 61% do not give rise to doubts on their ethical features and are approved by
p.000275: ethical review (from the speech of Academician of the Russian Academy of Medical Sciences, Professor Komarov F.I.
p.000275: Principles and Results of Work of the Ethics Committee at the Federal Agency on Control over Quality of
p.000275: Pharmaceutical Products, 2006), similar data were presented
p.000275:
p.000276: 276
p.000276:
p.000277: 277
p.000277:
p.000277: with LEC of the Russian State Medical University and Republican EC of the Republic of Tatarstan. Such principled
p.000277: approach is a notable barrier non-admitting researches with high probability for making harm to the
p.000277: biomedical research potential subjects.
p.000277:
p.000277: 3.8.5. Perspectives and Forms of International Cooperation
p.000277:
p.000277: Perspectives for cooperation in the field of ethical review are related to creation of common ethical and legal
p.000277: environment in the countries of the Commonwealth of Independent States, Europe and the world. There are
p.000277: three main areas of activities in cooperation with foreign partners are especially important for Russia:
p.000277: legislation harmonization, joint research and educational activities.
p.000277: In regard to legislation unification quite significant event was adoption in 2005 of the National Standard of the
p.000277: Russian Federation GOST R 52379- 2005 “Good Clinical Practice” (approved by the Order of the Federal Agency on
p.000277: technical regulations and metrology of September 27, 2005, No.232). This document completely implemented GCP, which is
p.000277: an international ethical and scientific standard of design and conduct of research involving human subjects as well as
p.000277: a standard of documentary registration and presentation of results of such studies, into the Russian legislation. It
p.000277: was identical to the Guidelines for Good Clinical Practice of the International Conference on Harmonization of
p.000277: Technical Requirements for Registration Pharmaceuticals for Human Use, which, in turn, was developed with consideration
p.000277: of acting requirements of good clinical practice of the European Union, the USA and Japan, as well as
p.000277: Australia, Canada and WHO. Compliance with this document makes possible to our country to adhere to united
p.000277: rules with countries of the European Union, the USA and Japan, that should facilitate mutual recognition of
p.000277: clinical study results with authorized agencies in these countries and become a basis to extend conduct of
p.000277: multicentre studies, eliminate practice of duplicating medical and biological studies in different regions of the world
p.000277: allowing to Russia to become full-fledged participant in process of international studies and, eventually, to
p.000277: result in mutual acknowledgement of pharmaceuticals approval.
...
p.000277: independently – from their legal representatives), ethical research support at all stages until project completion.
p.000277: Special situation of biomedical research conduct are specially controlled by ethical committees when study subjects are
p.000277: related to vulnerable population categories (due to their age, intellectual, mental, or social immaturity or
p.000277: vulnerability) or when studies stipulate obtaining information on genetic code of the study subject.
p.000277: Ethical committees of the CIS countries reached common understanding on necessity of ethical review, they
p.000277: approved common basics for their activities, and the next stage is building up the ethical control
p.000277: vertical system and making this process transparent both within the country and the Commonwealth that is possible
p.000277: through implementation of Acknowledgement program initiated by WHO and suggested for implementation in the post- Soviet
p.000277: countries by FECCIS. This program stipulated ethical committee certification that was a guarantee for
p.000277: compliance to highest quality standards of ethical review and development of a system of effective control
p.000277: over research activities in the country for the world community. Russia started preparation of ethical committees for
p.000277: participation in this procedure.
p.000277:
p.000278: 278
p.000278:
p.000279: 279
p.000279:
p.000279: Realization of significance of ethical review of biomedical studies facilitates attraction of grants from
p.000279: various funds and organizations to this field: these are foreign educational grants offered at the territory of Russia,
p.000279: for instance, by the Fogarty Fund, U.S. Civilian Research and Development Foundation (CRDF), or support for research
p.000279: projects in particular entities of the Russian Federation (for instance, a grant of the Academy of Sciences of the
p.000279: Republic of Tatarstan). They all facilitate wide spread of bioethical knowledge, realization of necessity for conduct
p.000279: of civilized ethical review of research projects in the sphere of medicine and provision of population safety during
p.000279: their conduct. In perspective, it will make possible for Russia to become a fully-functional participant in
p.000279: international biomedical researches and, eventually, result in closer cooperation of various countries in this sphere,
p.000279: strengthening of mutual trust, and at the next stage – mutual acknowledgement of approval for medicinal agents,
p.000279: new methods of treatment, products for medical use.
p.000279: There is the UNESCO Moscow Office (www.unesco.ru), which objectives are cooperation with Russia and
p.000279: post-Soviet countries in various educational and scientific programs including the ones on bioethics. Its
p.000279: activity Social and Humanitarian Sciences for promotion of knowledge, development of norms and establishment of
p.000279: intellectual cooperation in order to assist to social transformations includes cluster on Ethics of Science and
p.000279: Technology with emphasis on bioethics. The UNESCO Office facilitates development of institutions in the field
p.000279: of protection of human rights and dignity due to advances of biomedical researches. And starting from 2002 as to an
p.000279: initiative and with support of this organization there were conducted educational workshops, conferences for experience
p.000279: and knowledge exchange on bioethics issues – for instance, the International meeting of experts for development of
p.000279: cooperation in the sphere of ethics and bioethics in Minsk, 2005, for CIS and Baltic state, Promotion of
p.000279: knowledge in bioethics, Moldova, 2005; Social justice in health care: justice and human rights, Moscow,
p.000279: 2005.
p.000279: Current international scientific cooperation allows presenting scientific research results at conferences, meetings,
p.000279: and other scientific forums with bioethical orientation. At the same time, possibilities for joint organization of
p.000279: research conduct in this important field are still utilized insufficiently. It seems to be advisable to use
p.000279: financial support of international funds
p.000279: for transcultural studies, to set-up a specialized magazine to publish their results, to conduct on a regular
p.000279: basis specific scientific meetings within CIS that will provide opportunities for experience exchange,
p.000279: analysis of complex cases, collisions, and, possibly, for search for consensus in case of discrepancies and
p.000279: disagreements within CIS. Possibly, it makes sense to establish the Centre on Bioethics coordinating researches
p.000279: in this field, training specialists, promoting bioethics ideas and principles among various population groups. Also it
p.000279: appears to be of similar importance to introduce a separate trade, bioethics, within the list approved by the Higher
p.000279: Attestation Commission that will facilitate activation of research with participation of specialists of highest
p.000279: qualification.
p.000279: It is still of importance to provide methodical assistance to some of the CIS states for development of the ethical
p.000279: review system there, for helping them in developing positive public attitude in regard to necessity of such structures
p.000279: within the state, for training specialists able of conducting ethical review of biomedical researches. Ethical
p.000279: committees that have been created quite recently were yet unable to find their place in the society; they make just
p.000279: their first steps and require assistance. For that those ethical committees actually working in Russia through
p.000279: involving specialists of appropriate trade – full professors and professors of departments working on issues of
p.000279: biomedical ethics and medical law – are ready to set up and conduct educational cycles for members of ethical
p.000279: committees, clinical researchers, medical community. Ethical committees of Russia are open for discussion of joint
p.000279: scientific research for all comers. They are ready to assist in preparation of constituent documents and basics for
p.000279: methods of practical activities, to participate in development of ethical programs in various fields.
p.000279: From the point of view of harmonization of curriculum in different countries and, first of all, Europe,
p.000279: new opportunities are provided by the Bologna process. Joining of Russia to this process (de jure since
p.000279: September 2003) did not formally mean that the country should develop curriculum of set content but the very
p.000279: spirit of Bologna process (which main essence is consolidation of resources in Europe for effective competition at the
p.000279: educational market) implies convergence. Otherwise it would be impossible to attain mutual acknowledgement of
p.000279: educational qualifications and mobility of students and professors.
p.000279:
p.000280: 280
p.000280:
p.000281: 281
p.000281:
p.000281: In regard to bioethical and legal education for the entire population Russia is in conditions bringing
p.000281: it closer to other post-Soviet states and making it different from countries of traditional democracy, since
p.000281: democratic changes emerged there in last decades only. Therefore, it seems of paramount importance to acquaint Russians
p.000281: with problems, tasks and possibilities of legal and bioethical regulation in the field of health care and biomedical
p.000281: science basing on effective experience of other countries and, especially, the ones of the so-called “near abroad”. It
p.000281: could be attained through creation of topical TV shows, round tables with specialists in various fields of biology and
p.000281: medicine, publications series of articles on pressing issues of bioethics and medical legislation, creation of Internet
p.000281: resources with this orientation. Changes of the Russian legislation that are awaited for a long time and,
p.000281: which is important, proper execution of legal and bioethical norms, without which it is impossible to secure
p.000281: respectful attitude to human rights and dignity in the sphere of bioethics, depend on general legal culture of
p.000281: people, their bioethical “maturity”.
p.000281: 3.9 REPUBLIC oF tAjIKIStAn (S.D.Achrorova)
p.000281:
p.000281: 3.9.1 Historical and Cultural Background
p.000281:
p.000281: Nowadays in Republic of Tajikistan, like all over the world, the need for biomedical research is growing steadily, as
...
p.000295: Committees in the Commonwealth of Independent States. The CME is to review and monitor scientific research in medicine
p.000295: and the compliance with ethical regulations to protect right and dignity of a research subject. Presently, the RT
p.000295: Government is considering the law “On the Protection of Human Rights and Dignity in Biomedical Research”
p.000295: based on the IPA CIS model Law “On the Protection of Human Rights and Dignity in Biomedical Research in CIS”.
p.000295:
p.000295: 3.9.3 Education in Bioethics
p.000295:
p.000295: In Tajikistan biomedical ethics is considered as a interdisciplinary field of knowledge analyzing moral problems of
p.000295: human attitude to living organisms. However meanwhile we do not have either a system of organizational and legal
p.000295: support or objective conditions for a proper development of bioethics. This implies an insufficient propagation of
p.000295: scientific knowledge and juridical culture both in medical community and public at large. Another factor is scarce
p.000295: technical equipment for biomedical research, though much is being done to improve the situation.
p.000295: In the XXI century, the reform of healthcare in Tajikistan is inseparably linked with scientific studies in the fields
p.000295: where the issues of bioethics are of vital importance. In western countries, bioethics is an advanced educational
p.000295: discipline. In the last decade some CIS countries, such as Russia, Ukraine, etc. have been introducing courses on
p.000295: bioethics into the syllabus of medical, philosophical and sociological faculties.
p.000295: At the Tajikistan Medical University ethics is taught within a Course on Ethics and Deontology at the Department of
p.000295: Philosophy. Education in ethics for undergraduate medical students helps them to develop their moral and ethical
p.000295: outlook and to make an appropriate and just decision when conducting a medical research. Unfortunately today
p.000295: bioethics as a special discipline is not included into the system of education in Tajikistan.
p.000295: Introduction of a course on biomedical ethics into the course of higher educational institutions in RT is the demand of
p.000295: the times as Tajikistan has taken the path of democratic development of the juridical civil state where reforms cover
p.000295: the total sphere of education for the purpose of forming a new outlook in professional training.
p.000295:
p.000296: 296
p.000296:
p.000297: 297
p.000297:
p.000297: Humanities are essential components of professional training of a future physician as they enhance moral development
p.000297: and mutual understanding. We share the opinion that bioethics is a subject of interdisciplinary
p.000297: communication, and, with regard to medicine, it should be taught at institutes of higher medical education as moral and
p.000297: ethical knowledge used in patient- physician communication.
p.000297: Bioethics in CT is developing in several directions: education (medical, pedagogical, social, and economic);
p.000297: legislative regulation and establishment of ethics committees. Considering WHO recommendations (1994) on the
p.000297: introduction of a course on bioethics into the syllabi of medical educational institutions all over the world, and
p.000297: the necessity to work out and study moral and legal regulation and to implement into healthcare
p.000297: practice new biomedical technologies, it is essential to introduce into the practice of undergraduate and
p.000297: postgraduate education a systematic training of CT medical professionals in biomedical ethics. To achieve this
p.000297: goal, it is necessary to introduce into the State Standard of Higher Medical Education of RT the discipline “Biomedical
p.000297: Ethics” and to develop a programme of a general and special course. Already at the stage of master training and
p.000297: postgraduate studies, it is necessary to introduce a programme on ethical and legal problems of each medical specialty.
p.000297: One of the key elements here concerns ethical aspects of planning and conducting biomedical research, approbating and
p.000297: implementing new technologies. It is essential to develop a firm ethical position with regard to biomedical
p.000297: research, to introduce teaching programmes covering basic ethical principles for investigators and to
p.000297: establish a system of local ethics committees that review biomedical research.
p.000297: In the process of the formation of the Republican Committee on Medical Ethics (RCME) a seminar organized by a
p.000297: representative from J.Hopkins University (Baltimore, USA) was held in Dushanbe (2004) to train future RCME members.
p.000297: On completing the seminar, the students took exams and received certificates. In 2004 we also accomplished a
p.000297: project within the framework of a LIGP/ACTR/ACCELS Programme of the American Council for International Education and
p.000297: Culture at the Department of States.
p.000297: During the last two years from one to three professionals annually have attended courses on ethical review
p.000297: held in Almaty (Kazakhstan) at the Higher School of Public Healthcare.
p.000297: The implementation of European standards in CT and a new model of the teaching process require a cardinal change
p.000297: and structuring of all teaching programmes in compliance with the principles of the Bologna educational
p.000297: system.
p.000297:
p.000297: 3.9.4. The System of Ethical Review
p.000297:
p.000297: The current international system of a public and state control of safeguarding rights, dignity and autonomy
p.000297: of human subjects participating in biomedical research, and of compliance with universal ethical principles of
p.000297: biomedical research involving human subjects, implies the creation of independent public institutions – ethics
p.000297: committees.
p.000297: Ethics committees are analytical, consultative and monitoring units of various composition and status. They have to
p.000297: work out moral regulations for biomedical research, to carry out ethical review and give recommendations in case of
p.000297: conflicts arising in biomedical research or in medical practice. The Committee on Medical Ethics (CME) at the Health
p.000297: Ministry of Tajikistan performs these functions. To undergo ethical review, investigators should submit research
p.000297: proposals and their supporting documents to the CME secretary. Ethical review of biomedical research is carried
p.000297: out at the CME meeting in compliance with adopted regulations. The CME members may make positive, conditional (with
p.000297: clear suggestions for revision) and negative (in case of potential harm to research subjects’ rights and dignity)
p.000297: decisions on applications for the ethical review. They may monitor the compliance with ethical regulations throughout
p.000297: the research.
p.000297: Another significant aspect of the creation and development of the ethical review system is the review of
...
p.000299: documents of the health ministries of Tajikistan and the Russian Federation and obtain a written informed
p.000299: consent from research subjects or their legal representatives. The research project should be approved by the CME at
p.000299: the Health ministry of Tajikistan. Dissertation councils may only accept dissertations for review if they meet the
p.000299: abovementioned requirements.
p.000299: Though the CME at the Health Ministry of CT has been partially equipped with technical facilities, there
p.000299: are, unfortunately, a number of administrative and technical problems caused by the lack of a real financial
p.000299: support. This is the reason why the CME members cannot receive their education abroad, except participation
p.000299: in international conferences held by the FECCIS. Besides, we need funds to organize specialized seminars and courses
p.000299: for training members of regional and local ECs. There are serious financial problems concerning the publication of
p.000299: methodical materials.
p.000299: There is a pressing need to introduce a course on medical ethics into syllabi of institutes of higher medical
p.000299: education and medical colleges. Currently, a methodical manual on the principles of ethical review for
p.000299: undergraduate and post-graduate students is in active preparation.
p.000299: In 2003-2004, a group of physicians from the Republican Oncological Centre implemented a six-month educational
p.000299: project “The Initiative for the Protection of Patients’ Rights in Tajikistan”. The physicians found that,
p.000299: unfortunately, medical professionals lack knowledge on legislation referring to patient’s rights. The project’s
p.000299: objective was to conduct 20 educational seminars on ethical aspects of the patient—physician communication and
p.000299: mechanisms for safeguarding patients’ rights for physicians of healthcare institutions in Dushanbe and five other
p.000299: regions (Rudaki, Gissar, Tursun- Zade, Varzob and Vahdat). Unfortunately, medical professionals showed a low level
p.000299: of knowledge referring to patients’ rights. Thus, 50% of responding physicians in Dushanbe and about 100% of physicians
p.000299: in the regions did not have a proper knowledge on the relevant legislation. A survey revealed frequent cases of the
p.000299: violation of patients’ rights on different levels of medical and social services (50% of physicians
p.000299: mentioned healthcare institutions, 20% - institutions of social service, 30% - public authorities).
p.000299: Only 2% of respondents mentioned that patients might defend their rights via public institutions. According to the
p.000299: survey data, all physicians (100%) believe that medical secrecy implies non-disclosure of a diagnosis and that
p.000299: information on a patient’s health should be concealed from him/her, which conflicts with the Declaration of
p.000299: Patients’ Rights. However the majority of respondents gave correct answers to questions about the
p.000299: physician’s responsibility for a patient’s health if the patient refuses to follow medical prescriptions or regimen. As
p.000299: to legitimization of euthanasia in Tajikistan, 95% of respondents gave negative answers. The survey results show that
p.000299: the development of a mechanism for safeguarding patient’ rights should be in the centre of all healthcare reforms in
p.000299: Tajikistan. To develop the ethical review system, it is necessary to raise the level of professional ethical knowledge
...
p.000317: The practice of ethical review and an ethical follow-up procedure for research projects conducted in cooperation with
p.000317: the USA shows itself in the implementation of joint projects. The development of this practice ensures a high quality
p.000317: of ethical review of international projects which later is extended
p.000317:
p.000318: 318
p.000318:
p.000319: 319
p.000319:
p.000319: to the national level. Thus in 2005 the Ethics Committee of the Occupational Medicine at the Ukraine Academy of Medical
p.000319: Sciences was registered at the Office for Human Research Protection at the USA Government and received the Federalwide
p.000319: Assurance FWA00007871. Several local committees in Ukraine also have international registration numbers.
p.000319: Since November 1995 when Ukraine became a permanent member of the Council of Europe, a Ukraine representative has been
p.000319: working actively at the Steering Committee on Bioethics in Strasbourg (France). In the framework of this activity
p.000319: Ukraine participated in the development of international documents including the revised text of the “Convention
p.000319: of Human Rights and Biomedicine” (Oviedo, 1997). In 2004 the representative of Ukraine was elected to the Board of the
p.000319: Steering Committee on Bioethics as a Committee Reporter on the activity of Ethics Committees at medical research
p.000319: institutions. Two seminars on topical ethical problems in transplantology and cell therapy were held in Ukraine with
p.000319: the assistance and participation of CE experts. The representative of Ukraine takes part as a reporter in the
p.000319: educational project of the CE on implementation of CE documents on bioethics in the countries of the former Soviet
p.000319: Union. Currently, in the framework of the Steering Committee on Bioethics at the CE, Ukraine participates in the
p.000319: development of guidelines for a fetus and embryo protection and in the design of a protocol relating to genetic
p.000319: testing.
p.000319: International Seminar “Development of the Recommendations on Application of Standard Operational Procedures
p.000319: for Ethical Review of Biomedical Research” was held in the framework of the Second National Congress on Bioethics
p.000319: (Kiev, 2004) organized in cooperation with FECCIS and UNESCO. Experts and participants from CIS, Baltic States, the USA
p.000319: and Japan attended the Seminar.
p.000319: The main objective of the seminar was to discuss ways and methods of implementing Standard Operational Procedures
p.000319: into the practice of ethical evaluation of biomedical research in the countries of the former Soviet Union
p.000319: and neighbouring Baltic countries and countries of Eastern Europe. High ethical standards and requirements outlined in
p.000319: this document should be implemented into the practice of local ethics committees. At the same time we should consider
p.000319: specific local features of a particular region. Therefore we have to focus our attention on issues of interaction
p.000319: between regional, national and local ethics committees. Another important problem
...
p.000325: positive qualities – mercy, respect for human dignity, readiness to self-sacrifice in a patient’s interests,
p.000325: etc.
p.000325: When analyzing Ibn Sina’s ethical precepts we should note that those were in line with Hippocrates’s teaching. Ibn Sina
p.000325: wrote: “The physician should read Hippocrates’s precepts so as to be able to show honesty and frankness when treating
p.000325: patients. He should keep his clothes clean, be neat and perfumed. When he visits a patient he should be amiable, and
p.000325: cheerful, and witty so that he could cheer the ill person, because support offered by the physician multiplies the
p.000325: strength of natural warmth”. He was tireless in calling upon physicians to develop their general and special knowledge,
p.000325: to exchange professional experience and travel. In those times, travels served to extend scientific contacts. In the
p.000325: Middle Ages, there were many charlatan “healers” and even physicians deceiving their patients. Reasons for that Ibn
p.000325: Sina saw in a poor medical training, as physicians were not taught to see in each person his/her unique world of
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
p.000325: Ibn Sina’s views on childhood are noteworthy. “Canon of Medical Science” states that child’s life and health
p.000325: should be objects of care, protection and a special regimen from the moment of conception, not just from the moment of
p.000325: birth. A newborn baby needs a wet nurse with a stable nervous system. Games are essential, as all educational
p.000325: and formative processes, starting from very early years, should proceed from games. One may not punish a child, as
p.000325: the task of a tutor and physician if to protect the child’s soul, to facilitate the development of the feeling of
p.000325: self-respect. It is particularly important to prohibit any punishment for children under age of five, i.e. at the age
p.000325: when a child does not realize the meaning of his/her actions. Abu Ali Ibn Sina believed that, irrespective of state and
p.000325: public benefits, a child should receive a good intellectual, moral and ethical education in the family and at school.
p.000325: In his works, Ali Abu Ibn Sina gave much attention to school education. Kind and well-educated teachers may only
p.000325: teach at school,
p.000325: where children are brought up and educated until the age of fourteen. A teacher should know well the subject
p.000325: he teaches; he should follow the moral principles and be an honest, loving and courageous person.
...
p.000329: law, provisions of the law “On Protection of Consumers’ Rights” are applied.
p.000329: It is noteworthy that in the events of a damage to a patient’s life and health the guilty part (medical professionals)
p.000329: are liable to criminal prosecution or to disciplinary or financial sanctions as prescribed by Articles 989 and 1022 of
p.000329: the Civil Code of the Republic of Uzbekistan. According to the Articles mentioned, the person who has suffered undue
p.000329: harm and/or moral damage
p.000329:
p.000330: 330
p.000330:
p.000331: 331
p.000331:
p.000331: resulting from an intervention is entitled to fair financial compensation estimated according to the
p.000331: conditions and procedures prescribed by law.
p.000331: Currently, there are but single instances of suits brought by patients or their relatives against medical institutions.
p.000331: Uzbekistan has little experience in considering such complaints at court, because citizens are not properly informed
p.000331: about their rights. The lack of knowledge in this field negatively affects physician-patient relationships and the
p.000331: treatment efficiency. It is physicians’ professional duty to know patients’ and physicians’ rights and
p.000331: responsibilities. Incidentally, while the patient may be ignorant of his rights and responsibilities relating to
p.000331: medical care, the physician usually has this knowledge but intentionally conceals it from the patient,
p.000331: which is a disadvantage to both the patient and the physician.
p.000331: To involve medical professionals in educational activity aiming at informing patients about their rights, as
p.000331: well as physicians’ rights is one of urgent tasks for the healthcare system of Uzbekistan. .
p.000331: Ethical norms considering special features in relationship with patients from various age and social groups should have
p.000331: a significant place in the system regulating medical activity, particularly the rule of confidentiality relating to
p.000331: information obtained from the patient. This rule applies to adults (capable), minors (incapable or partially
p.000331: capable) and to persons with restricted capabilities who need a constant care.
p.000331: Ethical principles are essential in providing medical care to patients with sexually transmitted diseases. A
p.000331: more tolerant attitude of the society and law-enforcement bodies to patients from risk groups (sex workers,
p.000331: truckers, etc.) requires the development of legislation and social tolerance via public institutions (mahalline
p.000331: committees).
p.000331: The law of the Republic of Uzbekistan “On the Protection of Citizen’s Health” contains a number of articles concerning
p.000331: ethical issues. Thus, Article 46 sets out main principles safeguarding patents’ rights. The law of the
p.000331: Republic of Uzbekistan “On Pharmaceutical Products and Pharmaceutical Activity” (1997) also protects patients’
p.000331: rights in biomedical research. It defines the State authorities and competence of the Ministry of Public Health of
...
p.000343: treatment and prevention required the review of clinical efficiency of new and generic pharmaceutical products and put
p.000343: in the forefront the necessity to protect human rights in biomedical research involving human subjects.
p.000343: The establishment of national, regional and local ECs facilitated a wide implementation of ethical review of
p.000343: biomedical research performed in Uzbekistan in compliance with international ethical principles and WHO Operational
p.000343: Guidelines for Ethics Committees that Review Biomedical Research (2000).
p.000343: The necessity to establish EC for conducting ethical review of clinical trials (CT) emerged in Uzbekistan in the
p.000343: end of the nineteenth. It was connected with involvement of Uzbekistan in international scientific projects, which
p.000343: implied conducting an ethical review in conformity with international ethical norms. Another important reason was the
p.000343: establishment of the State Registration of Pharmaceutical Products and Medical Facilities. Presently, the NEC conducts
p.000343: ethical review of CT of home and foreign pharmaceutical products and multi-centre research. From the very beginning the
p.000343: NEC has been conducted ethical review of biomedical research involving human
p.000343: subjects. The NEC controls the procedure of obtaining informed consent and other ethical aspects including the
p.000343: safety of research participants’ insurance and monitors the process of medical research to check the risks of the
p.000343: research. The NEC also controls educational programmes on bioethics in institutes of higher education, training
p.000343: seminars and conferences on bioethics and publications in medical journals and mass media. It is responsible for a
p.000343: prompt notification of authorized bodies in the case of any unexpected adverse effects that are hazardous to research
p.000343: participants or other persons associated with the research, in the event of any serious violation of ethical norms or
p.000343: in the case of the suspension/termination of a research involving human subjects that was previously approved by the
p.000343: NEC and conducted in Uzbekistan or with the participation of Uzbekistan.
p.000343: In 2000, the minister of public health approved the document Regulations for the National Ethics Committee at the
p.000343: Medical Scientific Council of the Ministry of Public Health of the Republic of Uzbekistan”. The Regulations define the
p.000343: tasks, responsibilities and rights of the Committee, as well as its structure and procedures.
p.000343: In 2003, the document was revised. It included a wider range of tasks, a more detailed description of the NEC
p.000343: organization activity, procedures, rights and responsibilities (in particular, a new clause “Responsibilities
p.000343: of Investigators and Research Directors” was added). The NEC is an independent institution created on a
p.000343: voluntary basis at the Ministry of Public Health for the protection of human rights, health and safety in biomedical
p.000343: research. Currently, the Regulations for the NEC (adopted on June 20, 2005) are in full compliance with relevant
p.000343: international principles and norms.
...
p.000347: was obtained.
p.000347: The NEC participated in the organization of the First National Congress on Bioethics with international participation
p.000347: (2005) and a scientific conference “Ethical Aspects of New Biotechnologies in Biology and Medicine” (2006). It
p.000347: facilitated the publication of the Conference papers and of a book “Bioethics in Uzbekistan. Clinical, Philosophical
p.000347: and Legal Aspects” (2006).
p.000347: At the First National Congress four trends in bioethics were discussed:
p.000347: - ethical problems in science;
p.000347: - legal aspects of bioethics;
p.000347: - bioethics and education;
p.000347: - bioethics and the environment.
p.000347: A special attention was given to ethical aspects of new biotechnologies, patient-physician relationships in various
p.000347: fields of healthcare (pediatrics, neonatology, surgery, neurosurgery, emergency care, neurology, psychiatry) and
p.000347: bioethical education.
p.000347: The Congress adopted a Resolution that will facilitate the development of bioethics in Uzbekistan.
p.000347: The main tasks of the Congress were to promote legislation with regard to the protection of human rights and
p.000347: dignity in biomedical research involving human subjects; to outline the strategy for developing the activity of the NEC
p.000347: in the field of bioethics; to discuss educational programmes on bioethics for students of higher educational
p.000347: establishments.
p.000347: The Congress participants discussed and adopted the Ethical Code of Uzbekistan Physician-Investigator”
p.000347: setting out basic principles of ethical review of biomedical research involving human subjects. The
p.000347: implementation of the Ethical Code will form a basis for a legal solution of bioethical problems. This, in its turn,
p.000347: will allow us to provide medical care corresponding to the level of modern biomedical technologies and to observe
p.000347: patients’ rights in compliance with adopted international documents.
p.000347: The adopted Resolution and the Ethical Code of Uzbekistan Physician- Investigator not only mark a new stage in
p.000347: the development of the NEC activity, but also evidence the growth and prospects with regard to solving key
p.000347: problems of bioethics relating to the protection of human rights and dignity in Uzbekistan.
p.000347: To summarize, we should emphasize that a social, cultural, historical and scientific level ensures a harmonious
p.000347: integration of the Republic of Uzbekistan into the process of developing research ethics and establishing system of
p.000347: ethical review.
p.000347:
p.000347: 3.11.5. Perspectives and Forms of International Cooperation
p.000347:
p.000347: According to the UNESCO strategy for 2002-2007, the NEC of Uzbekistan facilitates the promotion of
p.000347: ethical principles and norms as guiding lines for scientific and technological development and social reforms
p.000347: through international, regional and global cooperation. The UNESCO Executive Committee instituted the Avicenna
...
p.000351: UNESCO Ethics Education Programme. On the instructions of The Cabinet of the Republic of Uzbekistan,
p.000351: programmes on bioethics for Masters of Medicine and doctoral students of institutes of higher medical education
p.000351: are under preparation. The NEC members take part in designing the programmes in a close collaboration with the UNESCO
p.000351: Ethics Education Programme.
p.000351: Chapter 4. tHE PERSPECtIVES FoR GLoBAL IntERnAtIonAL HARMonIzAtIon
p.000351: tHE EtHICAL REVIEW oF BIoMEDICAL RESEARCH In CIS CoUntRIES
p.000351: (o.I.Kubar, G.L.Mikirtichian)
p.000351:
p.000351: Review of materials presented by the Republic of Armenia, the Republic of Azerbaijan, the Republic of Belarus,
p.000351: Georgia, the Republic of Kazakhstan, the Kyrgyz Republic, the Republic of Moldova, the Russian Federation, the
p.000351: Republic of Tajikistan, the Ukraine and the Republic of Uzbekistan on issue of historical and cultural
p.000351: basics of development of ethical self-consciousness and its practical implementation in medicine; dynamic
p.000351: process of law generation in the field of protection of human rights in medicine and biology;
p.000351: establishing of bioethics as educational subject and introduction of an ethical component into the state system of
p.000351: control of biomedical studies, is a unique resource to analyze perspectives and potential forms of cooperation with
p.000351: both each of 11 mentioned and the Commonwealth of Independent States as a whole in the global development of research
p.000351: ethics and bioethics.
p.000351: Grounding on profound historical experience of highly moral attitude to medical trade and treatment, the region
p.000351: countries contributed significantly into formation of modern universal concept of protection of human rights and
p.000351: dignity in medicine and biology. Such conclusion is a direct result of analysis of cultural and historical unity
p.000351: of nations and states of the CIS region and only confirms a concept of humanitarian unity of the humanity
p.000351: development.
p.000351: The field of regulatory and legislative control has a situation of harmonic interaction of the region countries with
p.000351: the world society. A legal scale of the Commonwealth states presented as a basic regulation allows seeing explicit
p.000351: desire to correspond to international standards in legislation development and direct introduction of international
p.000351: standards as an instrument for legal regulation in the field of biomedical studies and ethical examination. In this
p.000351: respect the fact of mutual interests of parties seems to be symbolical. The CIS countries become members of
p.000351: international organizations and structures at various levels that directly impacts establishing of universal standards
p.000351: for protection of human rights and their legalization. The Commonwealth states
...
p.000353: of collective law development in the form of model laws providing reference points for national law and
p.000353: order. Determining value of model law development in health care, science and education aimed for improvement of the
p.000353: bioethical component is demonstrated during presentation of both general trends of construction of an
p.000353: ethical examination system in the region and when national specific features are described. Attractiveness of the
p.000353: region countries for biomedical research and mutual responsibility of both international organizations and
p.000353: parliaments and governments of the Commonwealth countries for provision of adequate, complying to universal
p.000353: standards, regulatory framework for human rights protection are also a serious incentive. This sphere has
p.000353: multiple in their forms components of collaboration: counseling, joint law development, adaptation and
p.000353: ratification, international system of legal responsibility for their breaching and interstate appeal options.
p.000353: In the field of development of bioethical education and training for members of ethical committees there
p.000353: is well established system of interregional cooperation. Significant contribution is made by creation of national
p.000353: UNESCO commissions in the region countries with common policy aimed on the following priorities:
p.000353: - access to information and intellectual exchange;
p.000353: - development of educational programs and approaches;
p.000353: - strengthening capacities of national agencies working on ethical issues;
p.000353: - implementation of ethical norms aimed on protection of human rights in the sphere of biomedicine;
p.000353: - improvement of information awareness and training in the sphere of bioethics;
p.000353: - distribution of knowledge on bioethics among professional and public groups including via mass media;
p.000353: - counseling and education to bioethics issues among social sphere facilities;
p.000353: - extension of availability of information about regulatory documents, human rights and procedures of their protection;
p.000353: - development of training programs on ethics and their integration into educational process.
p.000353: It is noteworthy that cooperation in this sphere becomes both bilateral and multilateral. Advantage of the region
p.000353: in this sphere is preservation of communication on one language and traditional mutual penetration of
p.000353: cultures and standards becoming a root system of information bases, educational materials and educational
p.000353: testing.
p.000353: Especially advantageous situation for cooperation is created in the sphere of development and
p.000353: establishment of the system of ethical examination. Simultaneous start of development of this field and
p.000353: unique support of the global community through establishment of the Forum for Ethics Committees in the CIS and
p.000353: inclusion of this region as a single constituent of the global WHO Project SIDCER provided permanent
p.000353: international dialogue on key issues of research ethics with international agencies leading in this sphere –
p.000353: such as WHO, the European Commission, the Council of Europe, UNESCO, the European Forum for Good Clinical Practice,
p.000353: the World Medical Association as well as authoritative national agencies: DHHS, USA and Ethics Committees of
p.000353: countries of all Continents. Such dialogue became a basis for experience exchange and real integration of ethical
p.000353: examination systems of the CIS countries into global discussion and research process.
p.000353: Integrity and value of cooperation with international organization is also presented with equal access for
p.000353: the CIS countries to discussion and development of international documents and guidelines on ethics of
p.000353: biomedical studies such as the Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000,
...
p.000355: equal access to scientific achievements through support of maximal, as much as possible free flow and
p.000355: exchange of knowledge and mutual benefiting from such exchange; protection of interests of existing and future
p.000355: human generations that the current publication is dedicated to.
p.000355:
p.000356: 356
p.000356:
p.000357: 357
p.000357:
p.000357: ABBREVIAtIon
p.000357:
p.000357:
p.000357: BMR – Biomedical Research
p.000357: CIoMS – Council for International Organizations of Medical Science
p.000357: CIS – Commonwealth of Independent States
p.000357: Ct – Clinical Trials
p.000357: EC/ECs – Ethics Committee/Ethics Committees EFGCP – European Forum for Good Clinical Practice FECCIS – Forum for Ethics
p.000357: Committees in the CIS GCP – Good Clinical Practice
p.000357: GLP Good Laboratory Practice
p.000357: GMP – Good Manufacture Practice
p.000357: ICH – International Conference on Harmonization of Technical Requirements for the Registration of
p.000357: Pharmaceuticals for Human Use IPA CIS – Inter-Parliamentary Assembly of the Commonwealth of Independent States
p.000357: SIDCER – Strategic Initiative for Developing Capacity in Ethical Review
p.000357: SoP – Standard Operating Procedures
p.000357: tDR – Special Programme for Research and Training in Tropical Diseases)
p.000357: UnESCo – United National Educational, Scientific and Cultural Organization
p.000357: WHo – World Health Organization
p.000357: WMA – World Medical Association
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357: The authors of the Book wish to express their gratitude to their colleagues from the Forum for Ethics
p.000357: Committee in Commonwealth of Independent States; experts and specialists from all other national, regional
p.000357: and international organizations who contributed in the process of establishment and development ethical review system
p.000357: in the Commonwealth of Independent States, which became the background of this Book.
p.000357:
p.000357: It is the special pleasure to thank the UNESCO Office in Moscow, Saint-Petersburg Pasteur Institute and the
p.000357: Inter-Parliamentary Assembly of the Commonwealth of Independent States for their constant support and fruitful
p.000357: cooperation during the process of the preparation of this BookWe also thank the following organizations for their
p.000357: financial support that enabled us to have this Book printed and presented.
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000358: 358
p.000358:
p.000359: 359
p.000359:
p.000359: StemXCells Bank of Kazan State Medical University, Republic of Tatarstan, Russia
p.000359:
p.000359:
p.000359:
p.000359:
p.000359:
p.000359:
p.000359: Ethics Committee of Health Care Ministry, Republic of Tatarstan, Russia
p.000359:
p.000359:
p.000359: Republican Centre of Expertise and Trials in Healthcare, Republic of Belarus
p.000359:
p.000359:
p.000359:
p.000359:
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p.000035: 12 For instance, in the Republic of Armenia – the Law of the Republic of Armenia On Reproductive Health
p.000035: and Reproductive Rights of Person, 12 of September 2002, in the Republic of Belarus – the Law of the
p.000035: Republic of Belarus On Safety of Gene Engineering Activities, 9 of January 2006, in the Republic of Kazakhstan – the
p.000035: Law of the Republic of Kazakhstan, 16 of July , 2004, N 565-2 On Reproductive Rights of Citizens and Guarantees of
p.000035: Implementation Thereof, in the Kyrgyz Republic – the Law of the Kyrgyz Republic, 20 of December 1999, On Reproductive
p.000035: Rights of Citizens, in the Russian Federation – the Order of the Ministry of Health of the Russian Federation. 26 of
p.000035: February 2003, N 67 On Utilization of Assisting Reproductive Technologies (ART) for Treatment of Female and Male
p.000035: Infertility, the Federal Law, 5 of July 1996, N 86-FZ On State Regulation in the Field of Gene-Engineering Activities,
p.000035: the Order of the Ministry of Health of the Russian Federation, 30 of December 1993, N 316 On Further Development of the
p.000035: Medical and Genetic Service of the Ministry of Health of the Russian Federation, in the Republic of Tajikistan – the
p.000035: Law of the Republic of Tajikistan, 2 of December 2002, No.72 On Reproductive Health and Reproductive Rights, the Order
p.000035: of the Ministry of Health of the Republic of Tajikistan No.974, 1 of October 1985, On Measures for Further Development
p.000035: of Medical and Genetic Assistance to the Population, in the Ukraine – the Joint Order of the Ministry of Health Care
p.000035: and Academy of Medical
p.000035: adopted laws prohibiting human cloning. At the same time, a range of actual issues related to specifics of genetic
p.000035: studies, experiments on embryos and utilization of embryo and fetal tissues for medical purposes, of psychological and
p.000035: sociological studies still require legal solutions.
p.000035: In general, one should note that among all other types of biomedical testing at the CIS space only clinical studies of
p.000035: medicinal substances underwent more consistent legal regulation13. All countries have special laws regulating public
p.000035: relations appearing due to development, production, manufacture, preclinical and clinical studies and other
p.000035: actions in the sphere of medicinal agents. Besides, the Commonwealth countries usually have a whole set of regulatory
p.000035: and legal acts including branch ones – at the level of ministries of health care – establishing detailed order for
p.000035: conduct of preclinical and clinical studies of medicinal agents. In some countries these documents are, in fact,
p.000035: internationally acknowledged standards of Good Clinical Practice adopted for a particular region. Along with
p.000035: establishing of ethical and legal principles for the biomedical study conduct the national GCP requirements create
p.000035: grounds for development and functioning of a system of ethical committees in these countries. In some of the
p.000035: countries there are adopted enactments regulating activities and status of such committees14. However, in total at the
p.000035: CIS space there is no uniformity in regard to building up of the ethics committee system that is related to both
p.000035: absence of basic solutions for some issues in regard to legal nature of these facilities and to differences in the
p.000035: system of administrative management in health care and scientific activities. At the same time, some common features
...
p.000051: Emergence of the biotechnological industry in the USA as a new institution for not only applied science, but also for
p.000051: fundamental research at the 70’s of the XX century was provoked with several factors including: a) considerably grown
p.000051: abilities to “recombine”, “produce” and simply “manipulate” DNA and all other molecules; b) transformation of
p.000051: the administrative environment which should encourage rapid transition of research to applied problems such as changes
p.000051: in the patent law that not just supported but forced to commercialize inventions in both industrial and academic
p.000051: sectors; c) and in the limit case – fusion of state- funded scientific research with venture capital interested
p.000051: in investments
p.000051: for development of extended base of molecular and biological studies” (P.Rabinov. Making PCR: a story of
p.000051: biotechnology. Univ.of Chicago Press. 1996. p. 19). Commercialization made possible consolidation of resources
p.000051: necessary for breakthrough in biotechnologies that occurred at the end of XX – beginning of the XXI centuries. It has
p.000051: also resulted in reconstruction of self-identity of science and scientists we observe these days changing
p.000051: self-comprehension of science and creating new identity of “a businessman scientist”.
p.000051: Another important consequence of commercialization was changes of patenting practices. In 1980 the US Supreme Court
p.000051: decided that creation of new forms of life is subjected to the Federal Patent Law. It made possible, after some time,
p.000051: to start patenting of not only artificially developed organisms or laboratory animals, but also patenting of human
p.000051: genes, DNA sequences, embryo stem cells, etc. Pragmatic interest for investment protection has changed
p.000051: the world perception. In the form of a patent it provided fundamental scientific knowledge with a form
p.000051: of merchandise. From the point of view of philosophy it means radical fusion of cultural and natural horizons, ideas
p.000051: of discovery and invention. Science commercialization in the sphere of biotechnologies created a new market, a new type
p.000051: of goods, new property rights, boosting synchronous similar processes in other branches of biomedicine. And at
p.000051: that, not only living organisms or elements of human body (genes and cells) become objects of commercial utilization
p.000051: but genomes of entire nations. For instance, in 2000 in Iceland one private biotechnological company, DeCode Genetics
p.000051: “purchased” an exclusive right for commercial use of genome materials and data of the Iceland population for 12 years.
p.000051: Along with structural changes of scientific activities its main checkpoints are altered as well.
p.000051:
p.000051: Constructing a Human
p.000051: One of the main vectors that can be used to characterize direction in development of science and technologies in
p.000051: the last decade is its steady approaching to a man, his needs, aspirations, desires. As a result we can see, if
p.000051: one can say so, tighter “enveloping” of a man, his immersion into the world projected and equipped for him by
p.000051: science and technologies. Naturally, the case is not limited with only “servicing” for a man – science
p.000051:
p.000052: 52
p.000052:
p.000053: 53
p.000053:
...
p.000151: clinical phase when human beings are involved in the research programme. It requires that ethics committee to be
p.000151: created at the institution where the trial is to be carried out. Interestingly, this law specifically mentions
p.000151: recommendations set out in WMA Declaration of Helsinki to be the basis for conducting clinical trials on human beings.
p.000151: As already mentioned the most specific law on the protection of the research subjects will be the Law on
p.000151: Biomedical Research involving Human Subjects, which is being submitted to the Government this year. The aim of the
p.000151: draft law is protection of the rights, health and life of a research subject of biomedical research and provision of
p.000151: safety and respect for dignity during the research. The draft law concerns any type of research aiming at obtaining
p.000151: information and broadening knowledge in the sphere of biomedicine, which serves the interests of human health
p.000151: protection and implies:
p.000151: • Physical intervention on human being;
p.000151: • Research on biological materials which initially were taken and stored with other purpose;
p.000151: • Intervention which doesn’t imply physical intervention on human being but can pose danger to mental health or
p.000151: psychological condition of human being;
p.000151: • Research on foetus and/or embryo in vivo (The Law does not apply to research on embryos in vitro.
p.000151: The draft Law on Biomedical Research involving Human Subjects is based on the following core principles:
p.000151: • Primacy of the human being;
p.000151: • Autonomy of research subjects: information, informed consent, confidentiality and privacy;
p.000151: • Scientific quality;
p.000151: • Minimizing risks and keeping adequate risk-benefit ratio;
p.000151: • Safety;
p.000151: • Protection of vulnerable groups;
p.000151: • Multidisciplinary review of ethical acceptability of research protocol and its approval by an ethics committee.
p.000151:
p.000152: 152
p.000152:
p.000153: 153
p.000153:
p.000153: Side by side with legislation certain impact on the ethical conduct of health care providers as researchers has ethical
p.000153: regulations, which could be considered as soft legal instruments. In April 2003 the Congress of Georgian Physicians
p.000153: endorsed the Ethics Code of Physician of Georgia. The code was developed by Georgian Health Law and Bioethics Society
p.000153: (GHLBS) and the Health Legislation and Bioethics Department of the National Institute of Health. The first version of
p.000153: the Code was discussed by the participants of the Congress and was submitted to further considerations to the National
p.000153: Council on Bioethics. The letter considered the document during its three different sittings and finally published the
...
p.000291: individual’s convictions. One of the factors that might limit the physician’s freedom in decision-making is the
p.000291: religious and cultural milieu that formed an individual’s consciousness. Without the knowledge of cultural details, a
p.000291: competent design of biomedical research in Tajikistan – a Moslem country and an officially secular State – is not
p.000291: possible. Besides, there are strong believers practicing Islam and observing all religious holidays. Thus, many
p.000291: people keep the strict fast during the Ramadan. In this period people suffering from severe diseases, refuse taking
p.000291: medicines both per os and by injection, which is harmful to their health. Thus, for example, patients who have had
p.000291: operations for glaucoma refuse courses of conservative supportive therapy or keep the fast, which weakens visual
p.000291: functions. Quite often during the Ramadan people
p.000291: get to the surgery department of the emergency station with pancreonecrosis after having a rich and fat meal (pilaw) in
p.000291: the night after fasting during the day. In some cases this situation has a lethal outcome. Islamic traditions dictate a
p.000291: respectful attitude to the human body even after a person’s death and therefore relatives of the deceased do not
p.000291: consent to the post-mortem examination and removal of organs for transplantation. According to Moslem religion, the
p.000291: soul of the embryo appears in the first week of the fourth month of pregnancy, and the law prohibits abortion after
p.000291: this term. Besides, Tajikistan population is not disposed to contraception measures or abortion, and therefore Tajik
p.000291: families are commonly having many children. When carrying out preventive health examination of strong believers, it is
p.000291: important to divide them into separate streams according to sex.
p.000291: Artificial fertilization in Tajikistan is permitted. It is desirable to use sperm of the woman’s husband provided that
p.000291: his consent has been obtained. There are no strict religious restrictions with regard to transplantation and removal
p.000291: donor organs. Sharia laws state that medical professionals should struggle for a patient’s life to the last moment and
p.000291: totally reject euthanasia. These and other similar examples emphasize the necessity to consider cultural
p.000291: aspects with regard to providing medical care and conducting biomedical research in Tajikistan.
p.000291: Biomedical research if conducted without considering cultural and religious aspects may have negative
p.000291: consequences. The physician should follow certain rules not to harm religious feelings. This is essential both in
...
p.000305: The law “On Pharmaceutical Products” states the necessity to obtain a written consent from a potential subject of a
p.000305: clinical trial or from his or her legal representative (Art. 8). This additional measure is connected with the danger
p.000305: of abuse and infringement of human rights.
p.000305: The right to information is closely related to the concept of informed consent. Recognition of this right is
p.000305: particularly essential for former soviet republics with their traditional paternalistic approach to physician-patient
p.000305: relationship. The transition to the concept of cooperation signifies the respect for the patient’s will, for his or her
p.000305: dignity and free choice. This is especially important for the sphere of biomedical research involving human subjects.
p.000305: The general rule is fixed in Ukrainian legislation – in Basic Legislation and in special laws. However,
p.000305: Basic Legislation says nothing about the confidentiality of private information, and corresponding
p.000305: statements can
p.000305:
p.000306: 306
p.000306:
p.000307: 307
p.000307:
p.000307: be found only in the Ukrainian laws “On Prevention of AIDS Disease and Social Protection of Population” (Art. 8) and
p.000307: “On Providing Psychiatric Care” where only the patient or his/her legal representative have the right to private
p.000307: information.
p.000307: The Ukrainian law “On Prohibition of Reproductive Human Cloning” is restricted to the sphere defined in the law title
p.000307: and does not regulate in any way embryo cloning “for therapeutic purposes”. It only prohibits importing cloned human
p.000307: embryos into Ukraine and exporting them from the country.
p.000307: Apart from abovementioned laws, there are many other legislative acts regulating, one way or another, issues relating
p.000307: to biomedical experiments. These are Ukrainian laws “On Scientific and Scientific/Technical Expertise”, “On Ensuring
p.000307: Sanitary and Epidemiologic Well-Being of the Population”, “On Healthcare”, “On Protection of People from
p.000307: Ionizing Radiation”, “On Measures against Tuberculosis”, “On Implantation of Pace-makers”, “On the Animal World” and
p.000307: “On Veterinary Medicine” and a number of other laws and Decrees of the Ukrainian Cabinet of Ministers,
p.000307: President’s Decrees and orders of the Ministry of Health. Noteworthy is the order of the Ukrainian Ministry of Health
p.000307: No 66 on February 2006 “On Rules of Conducting Clinical Trials of Pharmaceutical Products and Reviewing
p.000307: Materials of Clinical Trials”.
p.000307: With all this considerable number of regulating documents, there is no legislation in the sphere of human
p.000307: genome with regard to both general and specific principles. Almost unregulated is one of the most significant bioethics
p.000307: fields - in vitro research on embryos. Article 19 of the law “On Transplantation of Organs and Other Anatomical
p.000307: Materials” stipulates that it may be possible to use fetal material for transplantation, while issues relating to
p.000307: research on embryos and creation of human embryos for research purposes are not regulated.
p.000307: One of stimulating events that should facilitate the process of legal regulation in the sphere of biomedical
...
p.000319: Sciences was registered at the Office for Human Research Protection at the USA Government and received the Federalwide
p.000319: Assurance FWA00007871. Several local committees in Ukraine also have international registration numbers.
p.000319: Since November 1995 when Ukraine became a permanent member of the Council of Europe, a Ukraine representative has been
p.000319: working actively at the Steering Committee on Bioethics in Strasbourg (France). In the framework of this activity
p.000319: Ukraine participated in the development of international documents including the revised text of the “Convention
p.000319: of Human Rights and Biomedicine” (Oviedo, 1997). In 2004 the representative of Ukraine was elected to the Board of the
p.000319: Steering Committee on Bioethics as a Committee Reporter on the activity of Ethics Committees at medical research
p.000319: institutions. Two seminars on topical ethical problems in transplantology and cell therapy were held in Ukraine with
p.000319: the assistance and participation of CE experts. The representative of Ukraine takes part as a reporter in the
p.000319: educational project of the CE on implementation of CE documents on bioethics in the countries of the former Soviet
p.000319: Union. Currently, in the framework of the Steering Committee on Bioethics at the CE, Ukraine participates in the
p.000319: development of guidelines for a fetus and embryo protection and in the design of a protocol relating to genetic
p.000319: testing.
p.000319: International Seminar “Development of the Recommendations on Application of Standard Operational Procedures
p.000319: for Ethical Review of Biomedical Research” was held in the framework of the Second National Congress on Bioethics
p.000319: (Kiev, 2004) organized in cooperation with FECCIS and UNESCO. Experts and participants from CIS, Baltic States, the USA
p.000319: and Japan attended the Seminar.
p.000319: The main objective of the seminar was to discuss ways and methods of implementing Standard Operational Procedures
p.000319: into the practice of ethical evaluation of biomedical research in the countries of the former Soviet Union
p.000319: and neighbouring Baltic countries and countries of Eastern Europe. High ethical standards and requirements outlined in
p.000319: this document should be implemented into the practice of local ethics committees. At the same time we should consider
p.000319: specific local features of a particular region. Therefore we have to focus our attention on issues of interaction
p.000319: between regional, national and local ethics committees. Another important problem
p.000319: is raising the qualification level of members of the ethics committees that review biomedical research. The seminar
p.000319: facilitated a further harmonization of international ethical standards with regard to regional conditions. It had both
p.000319: scientific and practical significance for the countries of the region.
...
Social / gender
Searching for indicator gender:
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p.000033: Art. 13, Constitution of Azerbaijan; Art. 2, Constitution of Belarus, Art. 3, Constitution of the Ukraine, Art. 2,
p.000033: Constitution of Russia; P.1, Art. 36, Constitution of Moldova, etc.). Free development of a person is
p.000033: protected by law and independent court. Person dignity is acknowledged as a special value to be protected by the state
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
p.000033: state becomes a guarantor for protection of personal rights and freedoms. Other directions of the state
p.000033: policy in social sphere are also extremely important for provision of human rights in the area of health care and
p.000033: biomedical research.
p.000033: 9 The Constitution of Kyrgyz Republic also mentions psychological tests in this list (Art.18 of the Constitution of
p.000033: Kyrgyz Republic). Since there is almost no special legal regulations within the regions of the CIS countries for such
p.000033: sphere of biomedical research as psychological studies this fact has a special value. Such constitutional statement can
p.000033: become a basis for independent regulation of the given type of experiments.
p.000033: 10 Art. 16 and Art. 24 of the Constitutions of Kyrgyz Republic and the Republic of Moldova, respectively.
p.000033: The right for protection of health and its state support are legally fixed in all Commonwealth countries (Art. 34 of
p.000033: the Constitution of the Republic of Armenia, Art. 41 of the Constitution of the Republic of Azerbaijan, Art. 45 of the
...
Social / international student
Searching for indicator international student:
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p.000095: associated with the application of modern technologies.
p.000095: The Manual has the following distinctive features:
p.000095: 1. It contains views and ideas of medieval Armenian thinkers, philosophers and physicians relating to
p.000095: the problems of life and death, good and evil, etc. In particular, it presents views of David Anhaght whose 1500th
p.000095: anniversary was celebrated by UNESCO in 1980 in Saloniki (Greece) and Yerevan.
p.000095: 2. It should be noted that the Manual presents results of sociological research on some issues conducted among
p.000095: the University students and
p.000095: teaching staff. The research was initiated by the Centre for the Study of Public Opinion on Bioethics
p.000095: Problems at the Chair of Social Sciences. It allowed the authors to enrich the theoretical material with the
p.000095: results of sociological studies.
p.000095: 3. The Supplement includes main legislative acts adopted not only by the international community but also by the
p.000095: National Assembly of Republic of Armenia.
p.000095: 4. The Supplement also contains different tests and questionnaires for the self-analysis, so that students could test
p.000095: to what extent they are morally and physiologically ready to follow rules and requirements of modern
p.000095: bioethics. Besides, there are Case Studies arousing lively discussions. Prof.
p.000095: A. Karmy from Israel kindly sent these Case Studies to us.
p.000095: In spite of all difficulties in teaching bioethics, we have a noteworthy experience of student’s work. Within the
p.000095: framework of international student conferences, the Medical University organized round table
p.000095: discussions. In 2001 and 2003 two international student conferences on the fundamental principles and norms of
p.000095: bioethics were held. The majority of both foreign and Armenian students for the first time began to learn
p.000095: elements of bioethics. For a more comprehensive study of such topics as patient—physician relationship, the
p.000095: culture of physician’s speech and professional communication, compulsory hospitalization, etc., we give several
p.000095: lectures in Yerevan theatres instead of University lecture halls. These theatres show specially and only
p.000095: for our students, such plays as “Psychosis” and “The Street-Car Named Desire” (Sandukian Academic Theatre),
p.000095: “The Dentist from the East” (Akop Paronian Theatre of Musical Comedy) and “Physiology of Family” (Malian Theatre). Each
p.000095: performance is followed by a vivid discussion with actors and directors, and after that students write their essays
p.000095: on a suggested topic. In addition to theatre performances, students are invited to watch relevant films
p.000095: (documentaries and feature films).
p.000095: Together with the Institute of Philosophy, Sociology and Law of the Academy of Science of Republic of Armenia
p.000095: our Chair is writing a brochure “Albert Schweizer: A Great Humanist”. We also prepare for publication the glossary on
p.000095: bioethics in Armenian language. We give a special attention to practical aspects of teaching bioethics. Thus we began
p.000095: to design special training programmes on bioethics for students of medical institutes in Armenia.
p.000095:
p.000096: 96
p.000096:
p.000097: 97
p.000097:
...
Social / parents
Searching for indicator parent:
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p.000013: days and still-borns per every 1000 of births. The causes of these deaths are respiratory states typical for the
p.000013: prenatal period, cases of the fetal asphyxia and asphyxia at birth.
p.000013: In many respects, a high death rate registered in the majority of the CIS countries over a long period can be
p.000013: explained, by the population ageing and by the decrease of the quality of life and health. At the same time, the number
p.000013: of births per 1000 population in the countries of the European Union is less (at the average 11,1) than in Azerbaijan
p.000013: (24,2), Kyrgyzstan (26,1), Tajikistan and Turkmenistan (33,1). However, in spite of the high population ageing rate,
p.000013: the number of deaths in the EU countries is lower (10,1) than in the CIS countries (12,6), which in it’s turn, may be
p.000013: explained by the level of preventive measures and healthcare in general, and by the social-economic situation in the
p.000013: CIS countries.
p.000013:
p.000013: 6 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000013: 2005, p. 62“.
p.000013:
p.000014: 14
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: The natural increase of the population is the main source for advanced reproduction of labor resources at a certain
p.000015: territory. According to the data shown above, in the CIS countries two types of reproduction prevail that may by
p.000015: characterized as simple and reductive. If the simple population reproduction requires the numeral equality
p.000015: of the parent and children generation, the current level of survival rate (including the average life
p.000015: expectancy) requires 250-260 births per each 100 families. The birth rate corresponding to such a level is
p.000015: registered only in some CIS countries, such as Azerbaijan, Kyrgyzstan and Tajikistan. The functions of fertility
p.000015: and survival, as exogenous characteristics of the population reproduction, form its endogenous characteristics, i.e.
p.000015: age structure of population and also the measure of the population growth (net coefficient of population reproduction)
p.000015: and, hence, the actual level of the natality. The Russian Federation shows a tendency to a reductive
p.000015: reproduction of the population; however, in some years the increase due to the migration has compensated the natural
p.000015: decrease of the population, which is not so typical for Moldova, Belarus and Ukraine. Therefore, the total population
p.000015: size has not reduced. During the last five years the natural decrease of the population in the Russian
p.000015: Federation has prevailed over the increase due to the migration, which has decreased after 1994, and the total number
p.000015: of citizens began to decrease steadily.
p.000015: The population structure and the morbidity level characterize the general social-demographic situation in the
p.000015: CIS countries.
p.000015: Diseases of blood circulation system that are typical causes of death in elder people, take the leading role
p.000015: among the main causes of death. In 2003, the male mortality by this cause was 41% of deaths in Kyrgyzstan, 45% in
p.000015: Kazakhstan, 48-49% in Russia and Moldova, 50% and more in Azerbaijan, Armenia, Belarus and Ukraine. Female
...
p.000117: Safety of Genetic Engineering” (2005), the Draft Law “On transplantation of Human Organs and Tissues”, orders and
p.000117: instructions of the Belarus Health Ministry of are in compliance with the main principles of bioethics set out by WHO.
p.000117: The central law determining the State policy in the sphere of citizens’ health protection, legal, economical and
p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armed forces, prisoners and persons under arrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
p.000119: • Equal rights of patients and physicians to respect for their human dignity (Art. 14);
p.000119: • Mutual trust and mutual responsibility of the patient and the physician, patient is an active participant of the
p.000119: treatment process (Art. 16);
p.000119: • Compulsory consent from the patient for a medical intervention, except for cases provided by law (Art.
p.000119: 21);
...
Searching for indicator parents:
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p.000077: “seller” was a minor, imbecile, or a person in a state of artificial excitation, and where the “buyer” was a
p.000077: person who acted through psychological compulsion, deception, seduction, promise of profit or suggestion by authority.
p.000077: On the whole, the analysis of legal and ethical principles referring to biomedical research existing in the tsarist
p.000077: Russia in the beginning of the XX century shows that humanistic concepts of a voluntary and conscious choice made by
p.000077: the research subject and confidentiality have been combined with a responsible and merciful attitude on the part of a
p.000077: physician-investigator, and reinforced with accepted moral and ethical norms and legislative acts in force.
p.000077: Turning to a more recent period in national history, the following stages of Soviet law development illustrate how the
p.000077: issues in ethical and legal regulation of medical and biological research were interpreted in the USSR.
p.000077: In the law of the Russian Soviet Federal Socialistic Republic (RSFSR) on 1 of December 1924 “On the Professional
p.000077: Activity and Rights of Health Professionals” the need to obtain the patient’s consent, in particular when surgery is
p.000077: being planned, was declared. It was also stated that “with respect to those under 16 years of age or mentally disabled,
p.000077: the consent of their parents or care-givers”, i.e., their legal representatives, was necessary. Similar laws were
p.000077: adopted in the other Republics of the USSR. One should specifically underline that neither the law on 1 of December
p.000077: 1924, nor the decrees of the Soviet Ministries of Health until 1936, clarified how the patient’s consent was to be
p.000077: documented, and how it was necessary to regulate the conditions of medical research involving human subjects.
p.000077: In 1936 the legal regulation of the scientific and ethical aspects of the medical experiment was addressed in the
p.000077: Statutes “On the conduct of study of new medicines and medical methods associated with the risk for life and health of
p.000077: patients” adopted by the Scientific Medical Council of the People’s Commissariat of Health Care of the RSFSR
p.000077: (Resolution of the Bureau of the Scientific Medical Council, 23 of April 1936. In: Book of Resolutions
p.000077: - Peoples Commissariat of Health Care of the RSFSR. Scientific Medical Council. No 1-4, pp. 37-38).
p.000077: The events that encouraged the authorities to develop this document were described in detail in an article by
p.000077: professor I.Ya. Bychkov, where the author emphasized that in medicine “in order to assess the value of
p.000077: invention it is always necessary to study it in humans; and considering the fact that the medicine or device is new, it
p.000077: is always associated with some risk, can cause health problems or even endanger the life of the person who is the
p.000077: subject of the trial of a new method or a new medicine”(Bychkov I.Ya. On the question of legal regulation of medical
...
p.000117: The central law determining the State policy in the sphere of citizens’ health protection, legal, economical and
p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armed forces, prisoners and persons under arrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
p.000119: • Equal rights of patients and physicians to respect for their human dignity (Art. 14);
p.000119: • Mutual trust and mutual responsibility of the patient and the physician, patient is an active participant of the
p.000119: treatment process (Art. 16);
p.000119: • Compulsory consent from the patient for a medical intervention, except for cases provided by law (Art.
p.000119: 21);
p.000119: • Compulsory written consent from a patient, his/her close relatives or legal representatives for removal
p.000119: organs or tissues for diagnostic or therapeutic purposes; removal of organs and tissues for other purposes may not
...
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan”.
p.000167: In 2006 according the law “On changes and additions to some legislative documents on public health of the Republic of
p.000167: Kazakhstan” the article 20 was supplemented with the following paragraphs:
p.000167: «it is prohibited to perform clinical trials and(or) testing of pharmaceutical substances or medical drugs with
p.000167: participation of:
p.000167:
p.000167:
p.000168: 168
p.000168:
p.000169: 169
p.000169:
p.000169: - persons before coming to age with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treatment of children diseases or when the goal of clinical trial is to collect data on the optimal dosage of this
p.000169: medical drug supposed for usage in children and adolescents. In the last case clinical studies of any medical drug in
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
p.000169: The article 43 of the Law of the Republic of Kazakhstan “On the System of Public Health” published on 4th
p.000169: June 2003 contains the juridical definition of scientific medical expertise; in this article it is indicated that
p.000169: objects of scientific medical expertise are as follows:
p.000169: - drafts of programmes of basic and applied scientific research;
p.000169: - republican targeted scientific medical programmes;
...
p.000189: healthcare state institutions of Kyrgyz Republic and at healthcare institutions carry out an expert evaluation with
p.000189: regard to ethical criteria, consider moral and ethical problems arising in the course of clinical trials of
p.000189: pharmaceutical products and ensure the protection of patient’s rights.
p.000189: This Law contains important provisions concerning human rights in clinical trials of pharmaceutical
p.000189: products. In particular, it says that a patient gives his or her written consent to participate in a clinical
p.000189: trial of a pharmaceutical product and has the right to withdraw his or her consent at any stage of the research. Before
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
p.000189: out in such vulnerable patients as children without parents; military personnel; prisoners and persons under
p.000189: investigation in detention Centres; pregnant women (except for cases when clinical trials are designed specially
p.000189: for pregnant women and when the
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000191: 191
p.000191:
p.000191: necessary information can only be obtained in a clinical trial provided that the trail is not hazardous to a woman or
p.000191: to a fetus).
p.000191: Besides, the Law sets certain restrictions relating to clinical trials involving children. Thus the trials are
p.000191: only permitted if the investigational pharmaceutical product is specially indicated for use in children or to obtain
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
...
p.000249: article correspond in a whole with the discussed provisions of the Fundamental principles of Legislation. The
p.000249: noteworthy point is the more detailed description of information which should be given to subject, namely: 1)
p.000249: information on pharmaceutical products and nature of clinical trials of this drugs; 2) information on anticipated
p.000249: efficiency, the drug safety, and the degree of risks for the patient; 3) information on measures in the case of
p.000249: unforeseeable effects of pharmaceutical product on his health;
p.000249: 4) information on the terms of patient’s health insurance.
p.000249: The provision of the Law concerning the necessity of health insurance as well as insurance of civil liability of
p.000249: persons who carry out the study (items 3, 9 of the article 40, items 2 of the article 38) ensures an important
p.000249: additional guarantee of protection of subjects’ interests.
p.000249: At the same time, we cannot but mention an excessively “soft” approach to the question of terminating a clinical trial
p.000249: in the case of events that may be hazardous to the patient’s health. The Law states only that clinical trials may be
p.000249: terminated, while it should state that clinical trials must be terminated.
p.000249: Aiming at safeguarding the rights and interests of vulnerable contingents the Law forbids or
p.000249: limits their participation in clinical trials of medicines. Particularly clinical trials involving minors who
p.000249: don’t have parents, soldiers, persons under any form of detention or imprisonment is absolutely forbidden. The Law also
p.000249: sets up the limitation for the cases of clinical studies involving minors who have parents – such studies may be
p.000249: conducted only if pharmaceutical product is proposed for treatment of child diseases or if the aim of clinical trial is
p.000249: the getting the information about the best dosing of drug for therapy of minors. In latter situation the clinical trial
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000095: During the last two years the Chair of Social Sciences did its best in providing students with necessary teaching
p.000095: materials. Most of them were received from the Russian Federation, Belarus and Israel. However, as the new generation
p.000095: of students does not know either Russian or English language well enough, there is an urgent need for teaching
p.000095: materials on bioethics in Armenian language. The Department of Social Sciences has developed a brief course on
p.000095: bioethics in Armenian language. The course aims at:
p.000095: - providing students with some fundamental knowledge on the essence and principal problems of bioethics so that
p.000095: they would be capable to comprehend problems of life and death, health and life;
p.000095: - acquainting future physicians with moral aspects of topical problems of modern medicine and biomedical research
p.000095: associated with the application of modern technologies.
p.000095: The Manual has the following distinctive features:
p.000095: 1. It contains views and ideas of medieval Armenian thinkers, philosophers and physicians relating to
p.000095: the problems of life and death, good and evil, etc. In particular, it presents views of David Anhaght whose 1500th
p.000095: anniversary was celebrated by UNESCO in 1980 in Saloniki (Greece) and Yerevan.
p.000095: 2. It should be noted that the Manual presents results of sociological research on some issues conducted among
p.000095: the University students and
p.000095: teaching staff. The research was initiated by the Centre for the Study of Public Opinion on Bioethics
p.000095: Problems at the Chair of Social Sciences. It allowed the authors to enrich the theoretical material with the
p.000095: results of sociological studies.
p.000095: 3. The Supplement includes main legislative acts adopted not only by the international community but also by the
p.000095: National Assembly of Republic of Armenia.
p.000095: 4. The Supplement also contains different tests and questionnaires for the self-analysis, so that students could test
p.000095: to what extent they are morally and physiologically ready to follow rules and requirements of modern
p.000095: bioethics. Besides, there are Case Studies arousing lively discussions. Prof.
p.000095: A. Karmy from Israel kindly sent these Case Studies to us.
p.000095: In spite of all difficulties in teaching bioethics, we have a noteworthy experience of student’s work. Within the
p.000095: framework of international student conferences, the Medical University organized round table
p.000095: discussions. In 2001 and 2003 two international student conferences on the fundamental principles and norms of
p.000095: bioethics were held. The majority of both foreign and Armenian students for the first time began to learn
p.000095: elements of bioethics. For a more comprehensive study of such topics as patient—physician relationship, the
p.000095: culture of physician’s speech and professional communication, compulsory hospitalization, etc., we give several
p.000095: lectures in Yerevan theatres instead of University lecture halls. These theatres show specially and only
p.000095: for our students, such plays as “Psychosis” and “The Street-Car Named Desire” (Sandukian Academic Theatre),
...
p.000123: the Health Ministry of Belarus, the European Parliament, The Embassy of United Kingdom in Belarus,
p.000123: and World Association for the Protection of Animals, the international symposium “Ethical Problems of Using
p.000123: Animals in Teaching and Scientific Research” was held in Belarus. The Symposium stimulated the study of the problems of
p.000123: humanizing medical education. Members of the teaching staff and students from Belarus, Russia, United Kingdom and
p.000123: Sweden took part in the Symposium [14,16,18,19].
p.000123: • In 1999 recommendations “Teaching Basics of Medical Ethics and Deontology in the Course on Human Anatomy” (Denisov
p.000123: S.D., Yaroshevich S.P.) were published, as well as other works relating to ethical norms of handling
p.000123: anatomic preparations [3,15,17].
p.000123: • In 2000 Minsk hosted the international scientific-and-practical conference “Biomedical Ethics: Problems and
p.000123: Perspectives”; a volume of conference proceedings was published [9].
p.000123: • In 2000 one of the first text-books in CIS countries “Biomedical Ethics” (220 p.) for students studying
p.000123: medicine and biology approved by the Ministry of Education of Belarus was published [12]. The text-book includes a
p.000123: supplement in which leading scientists and physicians of Belarus of different age and specialties give their
p.000123: professional opinion on ethical problems.
p.000123: • In 2001 the International State Ecological University named after A.D.Sakharov introduced a course “Basics of
p.000123: Biomedical Ethics” (20 h) into the syllabus for students studying medicine and biology. Since 2003
p.000123:
p.000123: * Data by N.E. Luigas and C.D. Denisov
p.000123:
p.000124: 124
p.000124:
p.000125: 125
p.000125:
p.000125: the course in biomedical ethics (36 h) is taught at the Belarus State Medical University (BSMU) and other
p.000125: institutes of higher medical education. Teaching programmes “Basics of Biomedical Ethics” for undergraduate
p.000125: students and “Topical Problems of Biomedical Ethics” for medical post- graduates have been designed.
p.000125: • A programme in biomedical ethics has been developed for the system of raising the professional level of medical
p.000125: practitioners and teaching staff of medical institutes (18—36 h). Academy for Post-Graduate Education of Republic
p.000125: Belarus offers a course “Biomedical Ethics in Psychiatry” (for teaching professionals, clinical psychiatrists
p.000125: and investigators – 24 h).
p.000125: • In the framework of Russia—Belarus scientific-and-practical conferences on the problem of
p.000125: developing professional knowledge in bioethics (Kirov, 2003; Minsk, 2004) problems of teaching bioethics to
...
p.000129: – raising professional level of professionals who organize and carry out clinical trials so that they could be admitted
p.000129: to this activity.
p.000129: However, we do not have a separate course on bioethics at the graduate and post-graduate levels. We also lack a State
p.000129: system of teaching GCP and a systematic training for EC members. Training courses in ethical review of clinical drug
p.000129: trials are held at the Republican Centre of Expertise and Trials in Healthcare. The course is very short (2-4 hours).
p.000129: There are no dissertation boards, and no dissertation on bioethics has been defended, as the Higher Certifying
p.000129: Commission does not have this discipline on the list of specialties. The first dissertation on bioethics as a basis of
p.000129: the physician’s professional culture is planned in the section of “Culturology”. Therefore, currently the question of
p.000129: introducing differentiated specialized courses on bioethics for different categories of postgraduate audience is under
p.000129: consideration.
p.000129: We also use some other opportunities to raise graduates’ and postgraduates’ professional level in
p.000129: bioethics, particularly, international grants received on one’s personal initiative. Thus V.K.Kevra participated in
p.000129: an Educational Project at the Lithuanian National Committee on Bioethics;
p.000129: O.P.Aizberg attended the Seminar on Bioethical Problems in Narcology organized by the “AWEF—AIDS: East-West”
p.000129: Foundation (Kiev, 2006).
p.000129: The third level – providing bioethical knowledge for the population
p.000129: – is the most “deserted” field of work. A low level of public awareness affecting the public opinion and
p.000129: decision making with regard to vitally important issues – from informed consent to adoption of laws – requires
p.000129: taking immediate measures to change the situation.
p.000129: Here we have high hopes for the Project “Education in Bioethics and Promotion of Bioethical Knowledge in Belarus”
p.000129: approved and supported by the Division of the Social Sciences and Humanities of the UNESCO Moscow Office.
p.000129: Within the next few years, the Project will help us to resolve the mentioned problems.
p.000129: The Project includes:
p.000129: • the development of teaching programmes in bioethics for ECs members considering their qualification and
p.000129: the content of EC work;
p.000129: • the development of guidelines for the system of raising the expertise level for EC members, organization of
p.000129: seminars on international documents relating to bioethics (UNESCO, WHO, Council of Europe, etc.);
p.000129: • the development of methodological basis and a long-term programme for raising the level of public awareness in
p.000129: bioethics.
p.000129: We hope that due to the use of necessary facilities, resources and ways of implementing the Project we shall be able to
p.000129: create a harmonious, logical and comprehensive theoretical model of biomedical ethics and a system programme
p.000129: of continuing education.
p.000129: Today in Belarus a number of highly qualified specialists are involved in theoretical work and in teaching
p.000129: bioethics. In the framework of the UNESCO Project, a list of experts in bioethics and bioethical education from
...
p.000183: of akyns20 is characterized by the search for perfection. Problems of upbringing and education, of humanism
p.000183: and love for people have a significant place in philosophical poetry of Kyrgyz thinkers, and therefore there
p.000183: is every reason to consider
p.000183: 20 Akyn is an improvising poet and singer in the Kazakh and Kyrgyz cultures. Akyns played and important role in terms
p.000183: of expressing people’s thoughts and feelings, exposing social vices, and glorifying heroes.
p.000183:
p.000184: 184
p.000184:
p.000185: 185
p.000185:
p.000185: it as a code of moral and ethical norms on human behaviour in Kyrgyz culture. Some scientists associate
p.000185: this special attention to moral issues with an access to Chinese sources known for their interest in ethics. The
p.000185: history of development of ethical and philosophical ideas in Kyrgyz culture may be divided into three stages. The first
p.000185: stage is associated with names of late medieval Kyrgyz thinkers: Asan-Kaigy (XV c), Tolubai Synchi and Sanch- Synchi
p.000185: (XIII c) [3]. Kyrgyz people justly call them legendary thinkers, folk sages (akylmanam). We know about these
p.000185: Kyrgyz thinkers from folk legends. Only fragments of their sayings survived to our time.
p.000185: The epoch of late Middle Ages with its patriarchal and feudal system sets a number of moral tasks. Undoubtedly, moral
p.000185: in a class society was at all times an instrument for ruling people, however, in akyns’ philosophical poetry one may
p.000185: find an unbiased opinion on moral and ethical issues. They reflected on the eternal question about struggle with
p.000185: the evil and dreamt about “universal well-being”. Due to reconstruction of Asan Kaigy’s ethical ideas, we may see
p.000185: that empathy, compassion, sympathy for others are the main principles of his moral.
p.000185: Considering the time when the sage lived and worked, it would be appropriate to note that the call for
p.000185: compassion and love for all living beings related mostly to the oppressed people, disunited by internecine
p.000185: feud, and the compassion might be interpreted as a protest against the existing system of inequality. Therefore Asan
p.000185: Kaigy saw his task in cultivating love and compassion not only for human beings but also for everything alive.
p.000185: Actually, Asan Kaigy proclaimed a categorical imperative “treat others as you would like to be treated, if you were
p.000185: them” and gave everyone the right to be understood. Only if a person follows this rule, he will rid his soul of evil
p.000185: and find harmony. Asan Kaigy was telling people that they should love and respect others and thus to contribute to
p.000185: their happiness [4].
p.000185: Tolubai Synchi also focused his attention on analyzing relationships between people and cultivating
p.000185: magnanimity that, in his view, was a combination of such virtues as nobleness, generosity, justice in compassion,
p.000185: love and respect for people. For him greed is the worst vice: “A generous man is a good man; a greedy man is a
p.000185: good-for-nothing man” [12]. Like Asan Kaigy, Tolubai-Synchi was also searching after ways to happiness. His maxims
p.000185: based on opposing the good and the evil, kind and wicked acts have
...
p.000215: - sufficient scientific experience confirmed by documents and publications;
p.000215: - correspondence to high ethical standards;
p.000215: - availability of sufficient time for performance of the clinical research under the protocol;
p.000215: - availability of necessary means and facilities for performance of planned research.
p.000215: 3. Concordance of a study research site to the study goals and objectives:
p.000215: - ability to enroll subject cohorts within scheduled study time;
p.000215: - provision of clinic with necessary personnel: diagnostic and patient care equipment, communication facilities,
p.000215: computer equipment;
p.000215: - ability to provide emergency medical care in case of adverse events and side effects.
p.000215: 4. Procedure for attraction of possible study subjects (advertising, announcements, etc.), evaluation of
p.000215: correspondence of provided information to ethical norms.
p.000215: 5. Patient insurance procedure and payment of remuneration.
p.000215: 6. Content of research information provided to the patient.
p.000215: 7. Procedure for obtaining of the patient written consent for participation in the research;
p.000215:
p.000216: 216
p.000216:
p.000217: 217
p.000217:
p.000217: Only members of the ethics committee independent from sponsor and researcher take part in decision-making
p.000217: process as to certain clinical research.
p.000217: Decision of the ethics committee is given in accordance with one of the following variants:
p.000217: a) Permission to perform of a clinical research (approved opinion);
p.000217: b) Amendments are required to produce a positive decision;
p.000217: c) Negative decision;
p.000217: d) Cancellation of any previously made decision.
p.000217: During a clinical research an investigator must inform the Ethics Committee on necessity to introduce certain
p.000217: amendments and alterations to the clinical study protocol and to the information provided to study subjects, as well on
p.000217: occurrence of severe and/or unexpected adverse events and side effects and on any new data on possible impact of the
p.000217: tested article on humans. Based on results of review of materials provided by the investigator, the Ethics Committee
p.000217: makes decision on possible introduction of these or those alterations and amendments, continuation of clinical research
p.000217: or its separate stages, on measures which must be taken to ensure safety and protection of study subject rights.
p.000217: The Ministry of Health Care and Social Security and authorized agencies pay great attention to settlement of such
p.000217: complicated and diverse ethical and legal issues arising during clinical researches. We are trying to observe the
p.000217: following main principles in operation of the committee involved in ethical issues of the CT:
p.000217: - unified methodological approach based on GCP guidelines;
p.000217: - striving to independence of decisions to promote protection of study subject rights.
p.000217: - special attention is paid to patient informed consent
...
p.000225: especially if sufferings of an animal after blood operation are lengthened without any need, but experiments made
p.000225: by hands of a skillful and loyal observer are necessary for science and saving
p.000225:
p.000226: 226
p.000226:
p.000227: 227
p.000227:
p.000227: of mankind...” (11). D.S.Samoylovich (1744-1805), founder of the Russian epidemiology, self-tested plague infection
p.000227: and its course. There were negative examples. In the middle of the XIX century in Moscow foundling hospital they
p.000227: were searching for substitute of breast milk for children, and among others Libihovskiy beef broth was studied. As a
p.000227: result many children fell ill and so it was concluded to be harmful (8).
p.000227: One of the first who began to defend rights of prisoners on health and medical help was F.P.Gaaz (1780-1853). In his
p.000227: everyday practice he defended and implemented the slogan “hurry up to make good”, displaying humane attitude to most
p.000227: miserable people such as exiles, convicts, he supported them morally and gave medical and social help, took care about
p.000227: their children. He both worked with selfless devotion and attracted unselfish assistants being of different classes and
p.000227: generations.
p.000227: Moral position of N.I.Pirogov (1810-1881) displays principle of honesty in Russia. He paid special attention to medical
p.000227: mistakes. In contrast with existing in medical society opinion he believed that every honest man should be able to
p.000227: admit and proclaim his mistakes to warn against them not well- informed people (24). Many Russian physicians became his
p.000227: followers and were able to admit and analyze their mistakes. They were A.Y.Krasovskiy, C.P.Kolomina, F.I.Sinitsin and
p.000227: others.
p.000227: An issue of patient consent for surgery was discussed by physicians in the past. N.I.Pirogov remembered in the Old
p.000227: Doctor Dairy, that an inspector of medical institutions I.Rule required from doctors in the hospital not to do any
p.000227: surgery without patient agreement.
p.000227: The time since the end of the XVIII century till beginning of the XIX century one can state as a
p.000227: birth of public medicine. First medical papers, medical societies, public hospitals and chemist’s shops,
p.000227: charity organizations were founded in Russia. One of the forms of public movement was movement of narodniks, which in
p.000227: the 60-70’s of the XIX century became mass ideology of intelligence not of gentle birth trying to be spokesman of
p.000227: peasants. At the call of members of organization Narodnaya Volya (People’s Will) Russian teachers and doctors went
p.000227: willingly “close to the people” and went to work in the depth of Russia (13).
p.000227: Conditions existing in Russia after abolition of serfdom such as quick development of capitalism and
p.000227: industrial and urban growth changed medicine very much. In the second half of the XIX century medicine became
p.000227: scientific and based on experimental methods. Medicine was differenced and integrated. Owing to scientific and
p.000227: technical progress many discoveries were made in biology and medicine, they changed conceptions of etiology and
...
p.000229: vivisection as shocking and useless misused in the sake of science” of January 17, 1904, the commission
p.000229: consisting of professors P.M. Albitskiy, I.P. Pavlov and N.P. Kravkov was founded in the Medical Military
p.000229: Academy. This commission
p.000229: presented its conclusions on this letter. Conclusions showed disagreements with accusations, the statements of the
p.000229: letter were named anti-scientific and sanctimonious. Nevertheless this case forced to think about humanity of
p.000229: experiments in animals and improvements of conditions of their keeping.
p.000229: At the same time legitimacy of trials with human subjects is under discussion in the society. In connection
p.000229: with achievements in microbiology doctors by way of self-experimenting researched contagiousness of infectious diseases
p.000229: even the highly harmful ones. Self-experimentations carried out by physicians have never been disapproved of; they were
p.000229: rather perceived as acts of heroism and admired. There were a great number of such examples. In 70-s of the XIX century
p.000229: O.O. Motchutkovskiy, a physician from Odessa, several times made self injections with blood samples from patients
p.000229: infected with epidemic typhus and got severely diseased. After injecting themselves with blood samples from patients
p.000229: infected with relapsing fever, G. N. Mikh and N.I. Mechnikov also suffered through severe illnesses. N.F. Gamaleja,
p.000229: N.I. Metchnikov, D.K. Zabolotnyi, M. Pettnkofer took pure culture of cholera vibrio. Such examples can be
p.000229: continued.
p.000229: In relation to experiments with other human subjects many researchers were guided by the respectful opinion of
p.000229: S.P. Botkin (1832-1889): “It is evident that trials with human subjects are permitted only in extraordinary cases
p.000229: when we can be sure of their harmlessness otherwise we resort to experiments with animals, conditions for
p.000229: our observations being significantly simplified”.
p.000229: In early XX century a book by V.V. Veresaev “Doctor’s notes” produced great social aftersound. It can be
p.000229: regarded as social and cultural assessment of many problems in medical ethics which are of concern even today in the
p.000229: rise of the XXI century. It contained sharp criticism towards a common practice of that time to neglect patients’
p.000229: rights and needs including subjects of biomedical research. V.V. Veresaev (1867-1945) provides ample evidence of
p.000229: cruel experiments with human subjects and puts under question the researchers’ reports that these trials were performed
p.000229: with those people’s consent. V.V. Veresaev was courageous to disclose and put under public scrutiny the secrets of
p.000229: medical community. Thoroughly, providing great number of examples he showed the destitute position of an average
p.000229: practicing doctor, his vulnerability. And at the same time he stressed the high requirements that the
p.000229: community imposed over a physician (5, 6).
p.000229:
p.000230: 230
p.000230:
p.000231: 231
p.000231:
p.000231: V.A. Manassein (1841-1901), a noted general practitioner, editor of “The Doctor” magazine, a person who won a
...
p.000243: bk.: Bioethics: principles, regulations, problems. М., 1998, p. 93–110.
p.000243: 6. Ivanjushkin A.J. History of medical ethics and biomedical experiments in human and animal parties.
p.000243: In bk.: Introduction to bioethics. М., 1998, p. 95-133.
p.000243: 7. Cirill, metropolite. On «Basic social conception of Russian Orthodox Church». Anniversary Episcopal Assembly RCOC.
p.000243: StPb, 2000, p. 133-149.
p.000243: 8. Klementovskiy А.I. On application of Libikhov meat extract (broth) for a child at the breast. Moscow medical
p.000243: newspaper, 1859, №34, p. 269- 272; №35, p. 278-280; №36, p. 285-287.
p.000243: 9. Kljutchevskiy V.О. Selected Works. М., 1987, v.1, p.1, p. 78-79.
p.000243: 10. Korotkikh R.V. Legal and ethical issues of health care in Russia in period of reforms. In bk.: Biomedical
p.000243: ethics (edited by. V.I.Pokrovskiy). М., 1997, p. 47-58.
p.000243: 11. Koshtojantz Kh.S. Study on history of physiology in Russia.
p.000243: М., 1946, p. 111.
p.000243: 12. Kubar О.I. Ethical and legal issues of research in human parties: in history of Russia XX century. Human, 2001, №3.
p.000243: 13. Levit М.М. Establishing public medicine in Russia. М.: 1974,
p.000243: 231 p.
p.000243: 14. Likhatchev D.S. Russian culture. М.: Art, 2000, 438 p.
p.000243: 15. Ljubargskiy G.J. Human, 2004, №3, p. 186.
p.000243: 16. Maksimov Е.D. Study of historical development and current situation in public charity in Russia.
p.000243: In bk.: Public and personal care in Russia. StP, 1907, p. 4.
p.000243: 17. Mikirtitchan G.L., Filimonov S.V. Opinion of doctors and patients on problems of information and obtaining informed
p.000243: consent form. In bk.: Actual problems of diagnostics, treatment and disease prevention, issue. 3. StP, 2004, p.
p.000243: 291-302.
p.000243: 18. Mikirtitchan G.L., Filimonov S.V. Results of social study attitudes among doctors and patients to some
p.000243: genetic methods. International conference of CIS countries Forum for Ethics Committee. Yerevan, 2005, p. 52-56.
p.000243: 19. Mirskiy М.B. Medicine in Russia XVI - XIX cc. М., 1996, p.
p.000243: 301- 309.
p.000243: 20. Mtchedlov М.P. Are young citizens of Russia religious? Human, 2005, №6, p. 111-118.
p.000243: 21. Nikolay Ivanovitch Pirogov and his heritage. Pirogov’s conferences.
p.000243: B/м. B/g. 253 p.
p.000243: 22. Petrov V., Sedova N. Bioethics in practice. М., 2002, p. 60-89.
p.000243: 23. Petukhov V.V. The proper and the real in moral mentality of Russian
p.000243: citizens. Human, 2006, №3, p. 148-149.
p.000243: 24. Pirogov N.I. Selected works. М., v.2, p. 286.
p.000243: 25. Savina E.А., Degtjarenko L.J. Life psychology in Russian sayings and proverbs. Human, 2001, №5, p.186-192.
p.000243: 26. Anniversary Episcopal Assembly RCOC August, 13-16, 2000.
p.000243: Digest of abstracts and documents. Chapters Х-ХII. SPb, 2000, p. 192-200.
p.000243:
p.000244: 244
p.000244:
p.000245: 245
p.000245:
p.000245: 27. Judin B.G. National specific of establishing bioethics in Russia. In
p.000245: bk.: Philosophy of biomedical research. М., 2004, p. 71-90.
...
p.000265: 2006). Besides, there are publications prepared directly by educational facilities, for instance, by the Samara
p.000265: State Medical University (Sergeyev V.V., Nasledkov V.N. et al. Lectures on Bioethics. Samara, 2005), as well
p.000265: as monographs and collections of articles, foreign manual, for instance, the ones approved in the Republic of Belarus.
p.000265: Some role was played by monograph Ethics of Treatment by Siluyanova I.V. (M., 2001).
p.000265: Also departments providing bioethics education start to interact. In 2005 the All-Russian Educational and Methodical
p.000265: Conference Biomedical Ethics in the higher medical educational facilities of Russia (the Russian State
p.000265: Medical University) was held which summarized experience accumulated in the field of bioethics education in various
p.000265: universities and schools.
p.000265: Motivation to study bioethics among students and specialists is quite high. Sociological polls found that more than 80%
p.000265: of students and young medical doctors realize necessity to master bioethics knowledge. And experienced doctors
p.000265: who, in their majority, never studied biomedical ethics, as it is currently understood, quite often do not
p.000265: express any determined opinion.
p.000265: Importance of specific training for doctors with more than 10-year professional experience, and they are
p.000265: the basis of the industry human resources, in regard to ethical and legal issues, is rather
p.000265: considerable. It is confirmed with the questionnaire data we obtained. “Is there a need in ethical committees in
p.000265: treatment and prevention facilities?” The answer is “No” among more than 25% (!) of MD’s vs. students. Such prevalence
p.000265: of answers is caused, naturally, not by neglecting of ethical values but with ignorance of the subject. Obviously,
p.000265: post-graduate education shall become a foremost objective.
p.000265: Nowadays, there is no practice of systematic organization of training course on bioethics issues for medical doctors
p.000265: and other specialists at the post- graduate period. The exclusion is a regular topical post-graduate education cycle
p.000265: for medical doctors and researchers Methods for Set-up and Conduct
p.000265: of Clinical Studies of Pharmaceutical Products in the Russian State Medical University. On their own Russian
p.000265: specialists can get bioethical training within the framework of programs supported by international organizations
p.000265: or universities, for instance in the school on bioethics in Vilnius at the Vilnius University and Albany
p.000265: Medical College-Graduate College of Union University Bioethics Program (Schenectady, New York).
p.000265: Improvement of doctor and researcher knowledge in regard to protection of rights of biomedical research participants is
...
p.000295: discipline. In the last decade some CIS countries, such as Russia, Ukraine, etc. have been introducing courses on
p.000295: bioethics into the syllabus of medical, philosophical and sociological faculties.
p.000295: At the Tajikistan Medical University ethics is taught within a Course on Ethics and Deontology at the Department of
p.000295: Philosophy. Education in ethics for undergraduate medical students helps them to develop their moral and ethical
p.000295: outlook and to make an appropriate and just decision when conducting a medical research. Unfortunately today
p.000295: bioethics as a special discipline is not included into the system of education in Tajikistan.
p.000295: Introduction of a course on biomedical ethics into the course of higher educational institutions in RT is the demand of
p.000295: the times as Tajikistan has taken the path of democratic development of the juridical civil state where reforms cover
p.000295: the total sphere of education for the purpose of forming a new outlook in professional training.
p.000295:
p.000296: 296
p.000296:
p.000297: 297
p.000297:
p.000297: Humanities are essential components of professional training of a future physician as they enhance moral development
p.000297: and mutual understanding. We share the opinion that bioethics is a subject of interdisciplinary
p.000297: communication, and, with regard to medicine, it should be taught at institutes of higher medical education as moral and
p.000297: ethical knowledge used in patient- physician communication.
p.000297: Bioethics in CT is developing in several directions: education (medical, pedagogical, social, and economic);
p.000297: legislative regulation and establishment of ethics committees. Considering WHO recommendations (1994) on the
p.000297: introduction of a course on bioethics into the syllabi of medical educational institutions all over the world, and
p.000297: the necessity to work out and study moral and legal regulation and to implement into healthcare
p.000297: practice new biomedical technologies, it is essential to introduce into the practice of undergraduate and
p.000297: postgraduate education a systematic training of CT medical professionals in biomedical ethics. To achieve this
p.000297: goal, it is necessary to introduce into the State Standard of Higher Medical Education of RT the discipline “Biomedical
p.000297: Ethics” and to develop a programme of a general and special course. Already at the stage of master training and
p.000297: postgraduate studies, it is necessary to introduce a programme on ethical and legal problems of each medical specialty.
...
p.000305: application, in the patient’s best interests, of new and scientifically justified medicinal products or methods not yet
p.000305: authorized for general use (Art. 44.2). The rule concerns also blood transfusion (46) and biomedical research
p.000305: involving human subjects provided that the research is scientifically justified and the potential benefit overweighs
p.000305: risks of harmful consequences for the research subjects’ health or life. Information on biomedical research
p.000305: should be open to public on condition that personal data are confidential. The rule of informed consent relates also
p.000305: to organ transplantation performed according to the order prescribed by the law if the use of other life-sustaining
p.000305: methods does not yield desired results, and the harm for a donor’s health is less than that threatening the recipient
p.000305: (Art. 47).
p.000305: The rule of voluntary informed consent is present in practically all special normative acts relating to medical
p.000305: interventions, use of pharmaceutical products and biomedical research.
p.000305: Article 43 of the “Basic Legislation on Public Health Service in Ukraine”, states that in case of minors
p.000305: under 15 or adults who according to
p.000305: law do not have capacity to consent any intervention may be possible only with the authorization of his or her legal
p.000305: representative. At the same time, an essential item about the opinion of the minor that, according to Convention on
p.000305: Human Rights and Biomedicine, should be taken into consideration as an increasingly determining factor in proportion to
p.000305: his or her age and degree of maturity (Convention, Art. 6) is not included into Ukrainian legislation. Neither is the
p.000305: item that adults who according to law do not have capacity to consent shall as far as possible take part in the
p.000305: decision-making procedure. However, there is a similar rule about informed consent to the application of new methods or
p.000305: pharmaceutical products concerning minors from 15 to 18 years of age and individuals with a limited capacity to consent
p.000305: (Art. 44.2 of Basic Legislation).
p.000305: The right to withdraw consent is not clearly stated either in the law or in the majority of other special
p.000305: laws but the Ukrainian law “On Pharmaceutical Products” (Art. 8). According to this law, a volunteer or the person’s
p.000305: legal representative can freely withdraw his or her consent to participate in clinical trials.
p.000305: There is no regulation relating to medical interventions for the benefit of the health of the person concerned
...
p.000349: Nearly all NEC members gave their presentations at scientific symposia and conferences on bioethics held in the CIS and
p.000349: other countries. In 2005, the NEC held the First National Congress on Bioethics in Tashkent. Television, all leading
p.000349: newspapers and scientific journals broadly covered issues of biomedical ethics discussed at the Congress.
p.000349: The idea to combine scientific progress and ethics brought together about 200 medical scientists and members
p.000349: of teaching staff, investigators, physicians, biologists, experts in law, philosophers, theologists, journalists,
p.000349: deputies of the Legislative Chamber of Uzbekistan Parliament, representatives of various public organizations,
p.000349: delegates from different Uzbekistan cities, as well as from Kazakhstan, Kyrgyzstan, Tajikistan, Ukraine, Russia,
p.000349: Belgium, South Africa, Philippines, Singapore and other countries.
p.000349: The Congress participants discussed key issues of bioethics relating to the protection of human rights and dignity of
p.000349: biomedical research subjects in connection with the use of achievements in biology and medicine.
p.000349: The Congress participants made many interesting presentations. The Minister of Healthcare of Uzbekistan, prof.
p.000349: F.G.Nazirov spoke about ethical aspects of using new technologies in medicine; Doctor of Philosophy, professor Moshin
p.000349: Ebrahim from the Islamic University of South African Republic shared his opinion on the rights of a fetus; scientists
p.000349: from Philippines, Ukraine and Russia touched upon ethical problems concerning the use of embryonic and stromal human
p.000349: stem cells in treating various diseases. The Chairperson of the FECCIS, prof. O.I.Kubar from St.-Petersburg and Dr.U.
p.000349: Sharapov gave a talk
p.000349: on ethical aspects of clinical trials concerning HIV/AIDS; physicians from the Republican Specialized Surgery Centre at
p.000349: the Ministry of Public Health of Uzbekistan spoke about bioethical aspects of organ and tissue transplantation, and
p.000349: specialists from the Scientific Centre for Emergency Medical Care presented talks on similar problems in
p.000349: emergency medicine.
p.000349: J.N.Franco from Singapore and a group of physicians from Belgium spoke about problems of patient—physician relationship
p.000349: in the conditions of a rapid development of new biotechnologies and about truth-telling with regard to
p.000349: patients with terminal diseases. M.Baimukhamedov gave a talk on ethical aspects of the protection of patients’ rights
p.000349: in TV-medical consultations. The Congress participants discussed problems of ecological ethics and the use of
p.000349: genetically modified products and their effect on integral health (presentations by academician T.I.Iskanderov
p.000349: from Uzbekistan, Z.Nasyrova and Z.Akhrorova - scientists from Kazakhstan and Tajikistan). The Head of the WHO
...
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p.000001: of Armenia, Republic of Azerbaijan, Republic of Belarus, Georgia, Republic of Kazakhstan, Kyrgyz Republic,
p.000001: Republic of Moldova, Russian Federation, Republic of tajikistan, Ukraine and Republic of Uzbekistan. Separate
p.000001: chapters are given to the discussion of social, historical, cultural, philosophical and legal issues of ethical review
p.000001: of biomedical research. they also offer an analysis of specific problems with regard to national, state and regional
p.000001: situation and outline ways of integrating CIS countries into the process of global discussion on
p.000001: comprehending the humanitarian and scientific mission of the research. the book raises issues concerning
p.000001: fundamental interests of states, governments and other authorized institutions of CIS, interests of leading
p.000001: international structures and institutions in the relevant sphere and addressed to broad sections of the public involved
p.000001: into the process of ethical review of biomedical research.
p.000001:
p.000001: this book is the result of a collective work of the members of the Forum for Ethics Committees in the Commonwealth of
p.000001: Independent States (FECCIS) functioning in the framework of the Project “Strategic Initiative for Developing Capacity
p.000001: in Ethical Review” (SIDCER/tDR/WHo). the authors of this edition are leading specialists in ethics, philosophy,
p.000001: medicine, biology, jurisprudence, social and economical science recognized in their countries and at the international
p.000001: level.
p.000001:
p.000001: the authors are responsible for the choice and the presentation of the facts contained in this publication and for the
p.000001: opinions expressed therein, which are not necessarily those of UnESCo and do not commit the organization.
p.000001:
p.000001: Editor-in-chief
p.000001: and Project Director: Prof. Olga KUBAR
p.000001:
p.000001: Editorial Board: Prof. Galina Mikirtichian
p.000001: and Assistant Prof. Anastasiya Nikitina
p.000001: Reviewer: Prof. Nadezda Golik, Saint-Petersburg State University
p.000001:
p.000001: Editor: Nikolay Chaika, PhD
p.000001: Translation: Olga Ochkur & Dr.Valery Zvonarev
p.000001:
p.000001: Design: Maria Krasnova
p.000001: Page Print: Oksana Achmitzanova
p.000001: ContEntS
p.000001: INTRODUCTION (O.I.Kubar, H. ten Have) 7
p.000001: Chapter 1 - General tendencies of the social policy and human rights in medicine in the CIS countries.
p.000009: 9
p.000009: 1.1. Social and Demographic Factors (E.Yu.Vladimirova). 9
p.000009: 1.2. Ethical and Legal Issues in the Field of Biology and Medicine (O.I.Kubar, B.G.Yudin, A.E.Nikitina,
p.000009: E.Yu.Vladimirova). 27
p.000009: Chapter 2 - Current Status and Perspective of the CIS’ Region Participation in the International
p.000009: Biomedical Research 46
p.000009: 2.1. Philosophical Aspects of the Biomedical Research (P.D.Tishchenko, B.G.Yudin).
p.000046: 46
p.000046: 2.2. Characteristic of the Biomedical Research in the Region (O.I.Kubar, E.A.Malysheva).
p.000063: 63
...
p.000029: deficiency of capabilities for maintaining direct contacts with members of international bioethical community,
p.000029: in particular, due to limited knowledge of foreign languages for professional use and insufficient acquaintance with
p.000029: basic foreign publications.
p.000029: At the same time, within the community of the CIS countries there is a unique opportunity for international
p.000029: communication since not only majority of citizens but also specialists use a single instrument for communication, the
p.000029: Russian language. Development of bioethics in the CIS countries started about 20 years ago; one of the strongest
p.000029: impulses emerged after the first contacts of Soviet philosophers and medical researchers with their foreign colleagues
p.000029: at the end of the 1980’s. After the USSR break-up bioethics in the region developed in different conditions but, at
p.000029: that, there were present both stable cultural peculiarity and links among the region countries. The most important
p.000029: instrument influencing rates and pattern of the bioethics development is creation of special national facilities
p.000029: that having different structure and functions in some cases are entitled to adopt and implement mandatory decisions
p.000029: in the field of bioethics. Besides, all CIS countries have more or less main and similar resources for dynamic
p.000029: development of
p.000029: bioethics, and among them – teaching bioethics as a subject (mandatory or optional) in medical colleges and
p.000029: universities as well as at departments of philosophy in some of state universities; definite (though, in
p.000029: general, far from being sufficient) interest to ethical issues from the side of those working on legislation in the
p.000029: field of science and health care; development of corporate ethics and national associations on ethics;
p.000029: stimulating influence of research ethics; wider public interest to the bioethics issues being discussed in mass media.
p.000029: Besides factors of general social and economic development influencing peculiarity and unity of the situation in
p.000029: this sphere, global impact was provided by common cultural and educational environment based on both
p.000029: advanced humanistic traditions of medicine and on capabilities for interaction and mutual influence of
p.000029: different cultures in the given territorial and historical space. Such specifics exist despite considerable cultural
p.000029: and religious differences between populations of European and Central-Asian countries of CIS. In particular, it
p.000029: is necessary to mention influence of religious traditions in the Commonwealth countries on forming of bioethics
...
p.000043: interaction with world bioethical community and ready for rational collaboration in the region directed to development
p.000043: of optimal conditions for reaching ethical comfort in medicine and in research
p.000043: via building up of the society’s ethical self-consciousness, legal sense and attaining of a new type of relationships
p.000043: among individuals, social groups and states based on social partnership and dialogue in regard to the most crucial
p.000043: issues of ethical content.
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: References to international documents mentioned in the text are provided in the chapter for the member states.
p.000043: Texts of the model laws of IPA CIS are available at the web site: www.iacis.ru/html, the text of the model
p.000043: law of IPA CIS On Protection of Human Rights and Dignity in Biomedical Researches in the CIS and the text of
p.000043: the model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS can be also
p.000043: found at the following web sites: www. feccis.net and www.pasteur-nii.spb.ru
p.000043:
p.000044: 44
p.000044:
p.000045: 45
p.000045:
p.000045: Chapter 2. CURREnt StAtUS AnD PERSPECtIVE oF tHE CIS’ REGIon PARtICIPAtIon
p.000045: In tHE IntERnAtIonAL BIoMEDICAL RESEARCH
p.000045:
p.000045: 2.1 Philosophical Aspects of the Biomedical Research (P.D.tishchenko, B.G.Yudin)
p.000045:
p.000045:
p.000045: Philosophy of modern biomedical research (BMR) is a limitless topic with multiplicity of versatile aspects. Here we
p.000045: would like to dwell on those of them that are to some extent are related to issues of ethical examination
p.000045:
p.000045: Specific Position of Science in the Modern Culture
p.000045: Understanding of trends of development of the modern biomedical research is impossible without taking
p.000045: into account on-going general civilization transformations of our days. First of all, let’s take a look at the
p.000045: most general context of the issue.
p.000045: In this respect it is necessary to remind about a central role that science have played and still plays in the modern
p.000045: culture. As to exact expression by E. Husserl: “When at the beginning of the New Age religious belief began
p.000045: to degenerate more and more into lifeless convention, intellectual humanity stood in a new great faith –
p.000045: faith into autonomous philosophy and science. Scientific judgments were to highlight and guide entire human culture
p.000045: providing it with new autonomous form.” (Husserl E. Cartesian Meditations, p.14). If to take into account that
p.000045: ideology of new European education to a large extent is a gradual process of mastering the system of scientific
p.000045: knowledge, then without exaggeration one can say that the modern man (unlike a person in the Christian culture) is
p.000045: created “in the image and likeness of a scientist”.
p.000045: The leading position of science is retained and considerably strengthened gaining qualitatively new forms. Along
p.000045: with that, in the modern cultural situation science becomes more tolerant to other forms of cognition
p.000045: and comprehending of the reality. Ideas, concepts and practices that several decades ago were considered
p.000045: as superstitions are rehabilitated and gain status of fully-developed modern doctrines. In the whole world
p.000045: one can
p.000045: observe revival of archaic (shamanism, cabala and other esoteric practices) and creation of new non-scientific
p.000045: (and often anti-scientific) ideologies. Appear new bridges for cooperation between science and traditional religions
p.000045: appear.
p.000045: Another process is ongoing along with this paradoxical one. Science is still a mainstream for resolution of human
p.000045: problems, protection of a man against unfavorable natural impacts (for instance, diseases). But the mightier is
p.000045: scientific control over the nature, the clearer hazards are – that is, risks, related to development of science and
...
p.000051: the administrative environment which should encourage rapid transition of research to applied problems such as changes
p.000051: in the patent law that not just supported but forced to commercialize inventions in both industrial and academic
p.000051: sectors; c) and in the limit case – fusion of state- funded scientific research with venture capital interested
p.000051: in investments
p.000051: for development of extended base of molecular and biological studies” (P.Rabinov. Making PCR: a story of
p.000051: biotechnology. Univ.of Chicago Press. 1996. p. 19). Commercialization made possible consolidation of resources
p.000051: necessary for breakthrough in biotechnologies that occurred at the end of XX – beginning of the XXI centuries. It has
p.000051: also resulted in reconstruction of self-identity of science and scientists we observe these days changing
p.000051: self-comprehension of science and creating new identity of “a businessman scientist”.
p.000051: Another important consequence of commercialization was changes of patenting practices. In 1980 the US Supreme Court
p.000051: decided that creation of new forms of life is subjected to the Federal Patent Law. It made possible, after some time,
p.000051: to start patenting of not only artificially developed organisms or laboratory animals, but also patenting of human
p.000051: genes, DNA sequences, embryo stem cells, etc. Pragmatic interest for investment protection has changed
p.000051: the world perception. In the form of a patent it provided fundamental scientific knowledge with a form
p.000051: of merchandise. From the point of view of philosophy it means radical fusion of cultural and natural horizons, ideas
p.000051: of discovery and invention. Science commercialization in the sphere of biotechnologies created a new market, a new type
p.000051: of goods, new property rights, boosting synchronous similar processes in other branches of biomedicine. And at
p.000051: that, not only living organisms or elements of human body (genes and cells) become objects of commercial utilization
p.000051: but genomes of entire nations. For instance, in 2000 in Iceland one private biotechnological company, DeCode Genetics
p.000051: “purchased” an exclusive right for commercial use of genome materials and data of the Iceland population for 12 years.
p.000051: Along with structural changes of scientific activities its main checkpoints are altered as well.
p.000051:
p.000051: Constructing a Human
p.000051: One of the main vectors that can be used to characterize direction in development of science and technologies in
p.000051: the last decade is its steady approaching to a man, his needs, aspirations, desires. As a result we can see, if
p.000051: one can say so, tighter “enveloping” of a man, his immersion into the world projected and equipped for him by
p.000051: science and technologies. Naturally, the case is not limited with only “servicing” for a man – science
p.000051:
p.000052: 52
p.000052:
p.000053: 53
p.000053:
p.000053: and technologies approach him not only from outside, but, seemingly, from inside, in a sense making him their creation,
p.000053: projecting not only for him but also projecting himself. Literally speaking, it is done in some modern genetic,
p.000053: embryologic and other biomedical research, for instance, related to cloning16. As a result initially in the USA
...
p.000053: ambitious objectives as overcoming cancer and cardiovascular diseases by preliminary set time points. And though these
p.000053: disorders were not completely eliminated successes achieved in this respect especially in regard to
p.000053: cardiovascular diseases appeared to be highly impressive. And as people as per their own knowledge of life felt those
p.000053: effects caused with these newest technologies, their demands and desired addressed to science and technology became
p.000053: more and more versatile and insistent. Thus, growing practical effectiveness of science and technology in those
p.000053: fields that are the closest to daily needs and interests of a common person started to act as a strong driver orienting
p.000053: and boosting development of science and technologies.
p.000053: Along with these changes in priorities of scientific and technological policy similar re-orientation takes place
p.000053: also in business that gained considerable success in re-targeting research interests on creation of what can be
p.000053: attractive for mass consumer. And it is characteristic that those branches of industry that had the closest links with
p.000053: medicine – pharmaceutical industry, medical device manufacture, biotechnological manufacture – were among the most
p.000053: successful. Thus, people become users of knowledge, technologies
p.000053:
p.000053: 16 See with this regard, e.g., Y.Habermas. Future of Human Nature. On the Way to Liberal Eugenics. M., 2002;
p.000053: F.Fukuyama. Out Post-human Future: Consequences of Biotech Revolution. M., 2004; Yudin B.G. About a Man,
p.000053: His Nature and Future. “Issues of Philosophy” (Voprosi Filosofii), 2004, V.2; L. Kass. Non-ageing Bodies,
p.000053: Happy Souls… “A Man” (Chelovek), 2003, V.6.
p.000053: and products developed due to biomedical researches and on corresponding production facilities to a larger extent.
p.000053: Here one terminological explanation is necessary. Generally speaking, any innovation, being a part of not only
p.000053: manufacturing process but also of our way of life and social practices, can be considered as a kind of
p.000053: “object” (even in case of symbolic understanding of this term in regard to, for instance, our social life). However,
p.000053: object-Centreed understanding quite often turns to be too narrow since this novelty is not only a particular object,
p.000053: but also particular practices of its use, operating, etc. Both from human and social points of view this is the matter
p.000053: which is the most significant, since consequences for a man and society usually beget not the object itself but the
p.000053: ways how we interact with them, results of these interactions and, finally, those changes in us that are caused with
p.000053: these interactions. In other words, in real life we deal not with objects and things per se but technologies.
p.000053: It is interesting to compare a pattern of development of biotechnologies with what happened in the same years in the
p.000053: field of informatics and computer technologies. In this respect, the crucial point was creation of a personal computer
p.000053: that swiftly extruded bulky and hard to operate computers of the past. And there we can again see the similar trend –
p.000053: modern technologies approach a man closer and closer changing radically his lifestyle and how and what he sees in the
p.000053: world and how he interacts with the world.
p.000053: In this respect it is worth to turn your attention to the following. In the beginning and middle of the previous
...
p.000089: period of establishing scientific basics of medicine, Armenian classical medicine had a beneficial impact from
p.000089: antique science. The influence of antique philosophers and physicians (Plato, Aristotle, Empedocles,
p.000089: Hippocrates and Galen) on the development of Armenian classical medicine was particularly strong. Due to the active
p.000089: translation from Greek language, during the period of the V- VII centuries texts of antique scientists had been
p.000089: translated into Armenian. Those texts inspired medieval Armenian physicians and naturalists, e.g. Grigor
p.000089: Magistros (X-XI c.), Mekhitar Heratsi (XII c.), Amirdovlat Amasiatsi (XV c.) et al.
p.000089: It is noteworthy that great Armenian philosophers (David the Invincible, Anania Shirakatsi et al.) placed high
p.000089: emphasis on the problems of good and evil, suffering and compassion, life and death. They considered those issues
p.000089: in light of Christian morals. Today Armenian Apostolic Church is continuing this tradition. Suffice it to say,
p.000089: that the Ararat Eparchy with its rich experience in propagating ideas of bioethics is planning to establish a Church
p.000089: Public Council for Medical Ethics. Armenian Apostolic Church takes a rather strict position on some problems of
p.000089: bioethics: it prohibits human cloning and cloning of human organs, euthanasia, artificial fertilization and abortion,
p.000089: which is considered as infringement of human life.
p.000089: In this context the views of David Anhaght (the Invincible) formulated in his works (“Definition of Philosophy”,
p.000089: “Commentary on Aristotle’s Analytics” and “Commentary on Porphyry’s Introduction”) are of much interest.
p.000089: David Anhaght took problems of medical ethics very much to heart. His ideas on the value of human life are of
p.000089: particular importance. In his book “Definition of Medicine” he mentioned views of the Stoics who tended to justify
p.000089: suicide under certain conditions: starvation, loss of close relatives, natural cataclysms, violation of human dignity,
p.000089: terminal illness and senile marasmus. Two last cases are directly related to medicine. The Stoics wrote: “A man who
p.000089: kills himself to rid himself of pain in his ill and wretched body, commits the righteous act. Thus, a philosopher
p.000089: who was half-paralyzed appealed to the emperor Julian: Half of my body is dead; the other half is still alive. Have
p.000089: pity on the half-alive philosopher and order either to heal or to kill me. Likewise, it would be right for a man who
p.000089: had reached old age to kill himself when he is delirious, confused and utters meaningless phrases”.
p.000089: David Anhaght did not share Stoic views on permissibility of suicides under conditions mentioned: “In this regard
p.000089: we say that no one should kill oneself – neither those who have the right to do this, nor those who don’t… Trials,
p.000089: whenever or wherever they happen, come to us not in order that we should kill ourselves, but so that we tried our soul.
p.000089: Like a good helmsman is tested not in still water, but in the stormy sea, the lofty soul goes to meet a trial”.
...
p.000091: In his treatise “The Usefulness of Medicine” Amirdovlat Amasiatsi, an outstanding Armenian physician (XV c.) writes:
p.000091: “The physician should be reasonable and have the sense of duty; he should be tolerant and ready to give advice. In no
p.000091: circumstance should he be a drunkard nor should he be greedy and mercenary-minded. He should love the poor and be
p.000091: merciful, faithful and god-fearing. If he does not understand the essence of the disease he should
p.000091: prescribe no drug in order not to stain his reputation. If the physician is ignorant it would be better not to call him
p.000091: to see a patient, and, in general, he should not be regarded as a physician.” These words showing an ideal image of the
p.000091: physician-humanist and his moral code are still essential for modern medicine that synthesized imperishable moral
p.000091: values set forth in medical systems of the East and the West.
p.000091: Today, each of the presented problems gives rise to many new questions. At the present stage of bioethics development
p.000091: we are more able to formulate the questions than to offer a comprehensive solution, and therefore most of them remain
p.000091: open.
p.000091: References
p.000091: 1. Amirdovlat Amasiatsi. The Good of Medicine. Yerevan, 1940, p. 9 (in Armenian).
p.000091: 2. Arevshatyan S.S. Early Armenian Translations and Their Cultural and Historical Significance. // Journal of
p.000091: History and Philology of Academy of Sciences of Armenian S.S.R. 1973, No 1, p. 23-37 (in Armenian).
p.000091: 3. Vardanyan S.A. Medical and Biological Views of David the Invincible. / Philosophy of David the
p.000091: Invincible. Moscow, 1984, pp. 83-93 (in Russian).
p.000091: 4. David Anhaght. Works. Moscow, 1980, pp. 84, 77, 71, 49, 72, 44, 75,
p.000091: 61, 63, 65 (in Russian).
p.000091: 5. Oganesyan L.A. The History of Armenian Medicine. Yerevan, 1946, Vol. 1, pp. 85-127, 141-143 (in Russian).
p.000091: 6. Vardanyan Stella. History de la medicine en Armenia. Paris, 1999. pp. 43-52.
p.000091: 7. Vardanyan S. Medicine and Philosophy in Early and Medieval Armenia. In: Collection of Scientific Works.
p.000091: Yerevan, 2005, pp. 644-647 (in Russian).
p.000091: 8. Informed Consent. UNESCO Chair in Bioethics, Editor: Prof. Amnon Carmi. – Israel, 2003.
p.000091: 9. Davtyan S.A. The Problem of Implementing New Approaches in the Process of Teaching Traditional Ethics and Bioethics.
p.000091: In: The Process of Implementing New Teaching and Scientific Technologies. Yerevan, 2003, pp. 40-42 (in Armenian).
p.000091: 10. Davtyan S. The traditions, customs, culture, and mentality of the nation and problem of Eutanasia in Armenia.
p.000091: Eilat, Israel, 2002, p. 10.
p.000091:
p.000091: 3.1.2 Legal Regulations
p.000091:
p.000091: Biomedical research and, particularly, a clinical trial is a complicated process requiring not only heavy financial and
p.000091: intellectual costs, but also a competent approach to research planning in order to obtain eventually a safe and
p.000091: effective pharmaceutical product or method.
p.000091: The development and study of new pharmaceutical products is impossible without research involving
p.000091: human subjects, and here we face two main problems. On the one hand, we have to obtain reliable data on
p.000091:
p.000092: 92
p.000092:
p.000093: 93
p.000093:
p.000093: the efficiency and safety of any new drug or method, while; on the other hand we must not expose human subjects
p.000093: participating in the research to an excessive risk.
...
p.000095: bioethics. Besides, there are Case Studies arousing lively discussions. Prof.
p.000095: A. Karmy from Israel kindly sent these Case Studies to us.
p.000095: In spite of all difficulties in teaching bioethics, we have a noteworthy experience of student’s work. Within the
p.000095: framework of international student conferences, the Medical University organized round table
p.000095: discussions. In 2001 and 2003 two international student conferences on the fundamental principles and norms of
p.000095: bioethics were held. The majority of both foreign and Armenian students for the first time began to learn
p.000095: elements of bioethics. For a more comprehensive study of such topics as patient—physician relationship, the
p.000095: culture of physician’s speech and professional communication, compulsory hospitalization, etc., we give several
p.000095: lectures in Yerevan theatres instead of University lecture halls. These theatres show specially and only
p.000095: for our students, such plays as “Psychosis” and “The Street-Car Named Desire” (Sandukian Academic Theatre),
p.000095: “The Dentist from the East” (Akop Paronian Theatre of Musical Comedy) and “Physiology of Family” (Malian Theatre). Each
p.000095: performance is followed by a vivid discussion with actors and directors, and after that students write their essays
p.000095: on a suggested topic. In addition to theatre performances, students are invited to watch relevant films
p.000095: (documentaries and feature films).
p.000095: Together with the Institute of Philosophy, Sociology and Law of the Academy of Science of Republic of Armenia
p.000095: our Chair is writing a brochure “Albert Schweizer: A Great Humanist”. We also prepare for publication the glossary on
p.000095: bioethics in Armenian language. We give a special attention to practical aspects of teaching bioethics. Thus we began
p.000095: to design special training programmes on bioethics for students of medical institutes in Armenia.
p.000095:
p.000096: 96
p.000096:
p.000097: 97
p.000097:
p.000097: TV programmes on cloning, euthanasia and other problems with participation of associate professor S.Davtyan
p.000097: evoked a wide public response. If we manage to resolve the problem of sponsorship in the nearest future, we shall
p.000097: be able to give a series of TV programmes on topical issues of bioethics. This would facilitate a more active
p.000097: propagation of bioethical knowledge in various strata of Armenian society. UNESCO Office in Yerevan may
p.000097: participate in financing of the projects.
p.000097: Despite all this work a considerable part of Armenian medical community are skeptical about bioethics.
p.000097: Some physicians and University professors believe that teaching bioethics is something needless, to put it mildly.
p.000097: Apart from implicit forms of discrediting teaching of bioethics, there are cases when lecturers openly tell students
p.000097: that there is no need to study bioethics, which, actually, creates the atmosphere of dislike and distrust for the
p.000097: discipline, and puts a psychological barrier between students and the teaching staff.
p.000097: Another problem is a shortage of young teachers who might lecture in English, Russian and Armenian and the
p.000097: absence of a system for training specialists on bioethics.
...
p.000101: efforts of FECCIS and international experts.
p.000101: As to education in bioethics, the representatives from Republic of Armenia participated in the
p.000101: International Course on Research Ethics for Countries of Central and Eastern Europe at Albany Medical College
p.000101: (USA) and Vilnius University (Lithuania). The course received support from Fogarty Foundation. There are perspectives
p.000101: for participation of other representatives from Armenia in this Course.
p.000101:
p.000102: 102
p.000102:
p.000103: 103
p.000103:
p.000103: 3.2. REPUBLIC oF AzERBAIjAn
p.000103: (А.А.Namazova, Z.G.Guseinova, T.G.Tagi-Zade)
p.000103:
p.000103: 3.2.1 Historical and Cultural Background
p.000103:
p.000103: Rich historical and cultural heritage reflected in works by progressive thinkers of the past and contemporary
p.000103: scientists, multinational and multiconfessional population of the republic are the factors contributing to the
p.000103: development of bioethics in Azerbaijan. Tolerance and respect for other national cultures and human dignity, esteem for
p.000103: elderly people, principles of mercy, concern and care for dying people, i.e. traditions that have been forming over
p.000103: centuries-long history, play a significant part in this process.
p.000103: Azerbaijan people, as many other peoples of Eastern countries find evidence of physicians’ search and
p.000103: reflection on philosophy and ethics in ancient medical manuscripts. The ancient world knew the name of a
p.000103: legendary physician Logman. In Azerbaijan secrets of medical knowledge and prescriptions for treatment and prevention
p.000103: of different diseases were passed across the generations in the name of Logman. Not long ago two Logman’s precepts
p.000103: were found. The first precept is about the noble mission of the physician: “Everything in the Earth is the
p.000103: fruit of human kindness/ And where the doctor is, there is always air of kindness”. The second one warns against
p.000103: excessive eating and drinking alcohol, i.e. advocates the culture of hygiene: “Do not thou fill thyself with vine/ Be
p.000103: moderate in eating pilaw and bread/ Or otherwise the world in which we live/ Will turn into a cattle-shed”.
p.000103: Fundamental principles of the physician’s ethical behaviour were set forth in an ancient monument of Azerbaijan
p.000103: literature – a folk epic poem “Dede Korkud”. There we find many pieces of useful advice on how to stay healthy and
p.000103: about significance of moral purity and health.
p.000103: Prominent thinkers, poets and scientists of ancient land of Azerbaijan, such as Bahmanyar Ibn Mirzaban, Nizami
p.000103: Gyandjavi, Hatib Tabrizi, Mahmud Shabustari, Omar Osmanogli, Seid Yahya Bakuvi, Nahchivani, Hagani, Fizuli,
p.000103: Vagif, and many others described in their works a hard unselfish and dedicated work of ancient physicians and fruitful
p.000103: results of their job [6]. They all contributed into the development of medical ethics in Azerbaijan.
p.000103: In the XI century the first madrasah schools were established in Azerbaijan where theology and medicine
...
p.000137: Transplantation of Human Organs and Tissues” was discussed [25,26]. The Law was adopted in March 2007.
p.000137: Thus, the NCBE should facilitate:
p.000137: - the development of a democratic mechanism for the discussion and analysis of difficult moral problems
p.000137: relating to the achievements in biomedical science and technology;
p.000137:
p.000138: 138
p.000138:
p.000139: 139
p.000139:
p.000139: - public control ensuring the protection of human rights according to criteria of biomedical ethics;
p.000139: - the development of proposals relating to the legal regulation in biomedicine;
p.000139: - EC establishing, regulation and coordination of their activity at different levels; education of the EC
p.000139: members;
p.000139: - raising the level of a continuing bioethical education in professional medical community (from undergraduate to
p.000139: postgraduate education);
p.000139: - creating the opportunity for international cooperation in bioethics;
p.000139: - promoting a healthy life-style and informing the population about achievements and current problems in
p.000139: bioethics.
p.000139:
p.000139: 3.3.5. Perspectives and Forms of International Cooperation
p.000139:
p.000139: Republic of Belarus has developed an effective partnership with the leading international organizations such
p.000139: as UNESCO and Forum for Ethics Committees in the Commonwealth of Independent States, as well as bilateral cooperation
p.000139: with The Institute of Philosophy of the Russian Academy of Sciences, the Ukraine State Medical University named after
p.000139: Bogomolets, the Ukrainian Association on Bioethics, Higher Medical School of Hanover, the Committee for Ethics in
p.000139: Science of the Warsaw University, the National Committee for Bioethics of Lithuania, the Lithuanian Association
p.000139: of Psychiatrists, the Fogarty International Centre and National Institute of Health (USA), etc. Results of
p.000139: scientific and teaching-and-methodical work are presented at international conferences. In particular,
p.000139: professionals from Belarus participated in the International Scientific Conference on Humanities in the
p.000139: Contemporary World (Saint-Petersburg, 2002) [10] in the International Scientific and Practical Seminar on Bioethics in
p.000139: the framework of the programme of Fogarty International Centre (Bulgaria, 2003) and in regular international seminars
p.000139: and symposia held in Kiev Materials prepared by Belarusian scientists in the framework of international cooperation are
p.000139: published in Russian and Ukrainian scientific journals and in volumes of conference proceedings [27-29].
p.000139: Participation of Belarus professionals in the FECCIS and, particularly, in meetings and symposia of the FECCIS in
p.000139: St.-Petersburg, Baku, Yerevan and Kiev is very essential for the development of bioethical thought and
p.000139: bioethics in Belarus. Seminars organized in the framework of the FECCIS and reports by leading specialists and experts
p.000139: of the international level are certainly very helpful for a more profound understanding of bioethical problems
p.000139: and dilemmas and facilitate education of persons concerned.
p.000139: During the last years, specialists in bioethics from Belarus have been taking part in activities undertaken by UNESCO,
p.000139: particularly, in meetings of regional experts in bioethics (January 2005, Moscow; March 2005, Minsk; September 2005,
p.000139: Vilnius). On the request of UNESCO, T.V.Mishatkina, an expert in ethics from Belarus, designed and submitted to
p.000139: the UNESCO Headquarters 11 educational programmes on the fundamentals of education in ethics and bioethics.
p.000139: Today the international cooperation in implementing bioethical principles and developing ethical review of
p.000139: biomedical research goes along three directions supported by UNESCO:
p.000139: – theoretical development of a conceptual model of bioethics;
p.000139: – practical work on the organization of the National Committee and on the development of local ECs activity;
p.000139: – providing bioethical education to professionals and general public in accordance with the Project Proposal
p.000139: within the Programme for Social Sciences and Humanities(UNESCO Moscow Office) “Bioethics Education in Republic of
p.000139: Belarus”.
p.000139: Cooperation in developing the theory of the ethics of biomedical research. A joint project “Social,
p.000139: Philosophical and Ethical Problems of Genomic Research and Clinical Medicine” is carried out in
p.000139: cooperation with the Institute of Philosophy of the Russian Academy of Sciences. The theme of the Project has been
p.000139: approved by the Belarusian Republican Fund of Fundamental Research at the National Academy of Science of Belarus and
p.000139: Russian Foundation for the Humanities (Project Directors: B.G. Yudin and T.V. Mishatkina; the term of the Project – two
p.000139: years).
p.000139:
p.000139: Project objectives:
p.000139: 1. on the basis of the interdisciplinary approach to make an inventory, description and analysis of social,
p.000139: philosophical and ethical problems in genomics, modern biotechnologies and clinical medicine;
p.000139: 2. to trace global and national tendencies of principles of bioethical regulation in research and medical practices;
p.000139:
p.000140: 140
p.000140:
p.000141: 141
p.000141:
p.000141: 3. to work out recommendations on methodology and procedures of humanitarian review in the above-mentioned
p.000141: fields;
p.000141: 4. to specify the conceptual model of biomedical ethics. To achieve the goals, we have to solve the following tasks:
p.000141: - theoretical and methodological analysis of interdisciplinary approaches and finding mechanisms for
p.000141: interaction between humanities and natural sciences;
p.000141: - definition of the methodological status of fundamental ethical problems referring to achievements in
p.000141: genomics, development of new biotechnologies and situations in modern biomedicine;
p.000141: - content structure determination, inventory, classification and interpretation of main elements of
p.000141: bioethical knowledge; investigation of its structure, functions, principles and specific nature of moral values;
p.000141: development of a conceptual model of bioethical ethics;
...
p.000179: independence and became the centre of attraction for other ethnic groups. The final stage of ethnogenesis related
p.000179: Kyrgyz people to Oirot (Kalmats), Naiman and other peoples of Central Asia.
p.000179: Starting from the XIII century Kyrgyz people had to fight wars of independence from different invaders. In
p.000179: the second half of the XV century Kyrgyz tribes joined in an independent khanate that embraced a major part of Kyrgyz
p.000179: people. The Great Silk Road was very important for Kyrgyzstan. The town of Osh – the main city in the south of the
p.000179: present-day Kyrgyzstan
p.000179: – due to its favorable geographic location was a transit town in the Fergana line of the Great Silk Road.
p.000179: In 1863 the North Kyrgyzstan and in 1876 the South Kyrgyzstan were incorporated into the Russian Empire. After the
p.000179: Great October Revolution Kyrgyz people, as other peoples of former tsarist Russia entered the Soviet Republic
p.000179: In 1918 Kyrgyzstan formed a part of Turkistan Autonomous Soviet Socialist Republic. In 1924 the Kara-Kyrgyz
p.000179: Autonomous Region within the Russian SFSR was established. In 1926 it was transformed into the Kyrgyz Autonomous
p.000179: Republic, and in 1936 – into the Kyrgyz Republic. On 31 of August 1999, Kyrgyzstan declared its independence.
p.000179: We know that myths and legends form the base of every culture. Nomadic life-style and the loss of written
p.000179: language of early Kyrgyz people
p.000179:
p.000180: 180
p.000180:
p.000181: 181
p.000181:
p.000181: stimulated the rise of a special philosophy that revealed itself in poetic folklore. It has accumulated the
p.000181: basic problems of human existence, mental and philosophic activity and spirituality.
p.000181: To reconstruct spiritual life of the Kyrgyz ancestors, we should mention an epic poem “Manas” that depicted
p.000181: historical events and ethnographic details, different aspects of the Kyrgyz life, worldview and national outlook
p.000181: from the III century BC (the Hunnu period) and to the beginning of the XX century. As a concentrated representation
p.000181: of folk philosophy, “Manas” is both the result of creative thinking across generations and the evidence of ancient
p.000181: Kyrgyz civilization. In fact, “Manas” is a moral code of the nomads and still a source of morals and humanism,
p.000181: as it describes customs and moral traditions, philosophical and aesthetic views, moral principles and norms
p.000181: of behaviour. With regard to its moral significance, “Manas” may be compared to Confucian Pentateuch. Like
p.000181: Confucian ethics, “Manas” depicts a model of putting the world into good order. Much attention is given
p.000181: to the struggle against chaos, which is expressed through regulation of human relationships, i.e. by establishing norms
p.000181: of behaviour, the system of prohibitions and social stratification.
p.000181: “Manas” is called a “cultural encyclopedia” of Kyrgyz people. It ranks among outstanding monuments of world
p.000181: culture, such as “Iliad” and “Odissey”, “Mahabharata”, “Epic of Gilgamesh”, “Kalevala”, “Rigveda” and many
p.000181: others. The Turkic epic poem “Manas” differs from west European, Slavonic and other epic poems not just in its
p.000181: volume. It covers a long historical period and gives a detailed genealogy and a distinct biographical line of
p.000181: athlete Manas – the central hero of the epic poem – from the moment of his birth to his death including the description
p.000181: of main events of his life. Poems, songs and legends passed across the generations served as a teaching
p.000181: material in folk pedagogics. The unique nature of oral folklore allows people to pass their moral knowledge to
...
p.000185: magnanimity that, in his view, was a combination of such virtues as nobleness, generosity, justice in compassion,
p.000185: love and respect for people. For him greed is the worst vice: “A generous man is a good man; a greedy man is a
p.000185: good-for-nothing man” [12]. Like Asan Kaigy, Tolubai-Synchi was also searching after ways to happiness. His maxims
p.000185: based on opposing the good and the evil, kind and wicked acts have
p.000185: the form of edifications. Like Asan Kaigy he tried to avoid blaming actively the existing state system.
p.000185: Another humanist-philosopher was Sanchi-Synchi. Unlike Asan-Kaigy and Tolubai-Synchi, he mostly valued the active
p.000185: elements of human nature: strong will, strength of mind, persistency in the struggle against the evil. Sanchi-Synchi
p.000185: called people for an active struggle for the sake of Justice. In his songs he developed the idea of righteous
p.000185: retribution and blamed the oppressors.
p.000185: The heritage of legendary thinkers allows us to return to forgotten spiritual values of Kyrgyz people
p.000185: based on love, compassion, empathy, clear conscience, peaceable disposition and feeling that they are a part of the
p.000185: universe. They felt aversion to violence and rudeness. Throughout the course of ethics development, starting from
p.000185: legendary thinkers to akyns- democrats, the care for widows and orphans was the responsibility of all clan members.
p.000185: The next stage of development of ethics philosophy is represented by akyn-zamanists21 Kalygul Bai Uulu
p.000185: (1785-1855), Arstanbek Bailashuulu (1866-1917) and Moldo Kylych Sharymkanov (1866). They lived in the time
p.000185: of global changes resulting from the decay of patriarchal feudalism and the rise of capitalistic relations.
p.000185: Besides in 1876 the territory inhabited by Kyrgyz people was incorporated into the Russian Empire [9-11]. All
p.000185: those processes were reflected in akyns’ poetry. In their poems “Time of Downfall”, “Time of Poverty” and “Time of
p.000185: Sorrow” akyn-zamanists called their epoch the time of degradation and decay. Moldo Kylych, being a son of a learned
p.000185: man, received a good education. He was acquainted with works by eastern classics Firdousi, Navoi, Jami, Yasavi and
p.000185: others. He wrote about his time: “Morals and manners show the loss of people’s well-being”. In his poem “Time of
p.000185: Sorrow” he noted that moral bankruptcy, degradation of moral principles, moral apathy were frightening features of the
p.000185: time. In their attitudes zamanists were close to French philosophers of the Age of Enlightenment (J.-J. Russo, Voltaire
p.000185: et al.).
p.000185: At the same time akyn-zamanists’ poetry contained some optimism and faith in moral potential of Kyrgyz people that
p.000185: would help them to overcome all difficulties. Kalygul Bai Uulu associated with the image of a spiritual
p.000185: 21 Zamanism – philosophical teaching about frailty and an inevitable tragic end of the world
p.000185:
p.000186: 186
p.000186:
p.000187: 187
p.000187:
p.000187: leader expressing expectations of Kyrgyz people through his poetry inspires their hopes.
...
p.000187: that in their time was at a deadlock and could not find way out of it; thoughts about the future of Kyrgyz people. They
p.000187: understood well a close connection between the destiny of their people and the integrity of ethno- cultural space.
p.000187: Today we may rightly say that zamanism is a special king of creative work of poetry initially establishing in set
p.000187: verbal formulae a system of moral and ethical priorities of nomadic peoples. Zamanists lived in the epoch of
p.000187: disintegration of traditional Kyrgyz community, and therefore efforts were required to form an integrated Kyrgyz
p.000187: nation. They realized the hardship of that mission and used for that purpose moral norms and rules of behaviour that
p.000187: did not lose their significance to our days.
p.000187: The next stage in ethics development is associated with names of akyn- democrats Toktogul Satylganov (1864-1993),
p.000187: Togolok Moldo (1860-1942), Jenijok (1860-1918), Varna Alykulov (1884-1949). In contrast to their predecessors,
p.000187: they actively expressed ethical views of oppressed sections of Kyrgyz population.
p.000187:
p.000187: References
p.000187: 1. Abramzon S.M. Kyrgyz People and their Ethno-Genetic, Historical and Cultural Contacts. Leningrad, 1971, p. 152 (in
p.000187: Russian)
p.000187: 2. Akmoldoeva Sh. B. Spiritual World of the Early Kyrgyz (Analyzing Epos). “Manas” and Concepts of Geneva
p.000187: Conventions. Bishkek, 1999, p. 211 (in Russian)
p.000187: 3. Amanaliev A. From the History of Kyrgyz Philosophy. Frunze, 1863 (in Russian).
p.000187: 4. Asan-Kaigy. In: Anthology of Kyrgyz Portry. Bishkek, 1999 (in Kyrgyz)
p.000187: 5. Valikhanov Ch. Collected Works. Vol. 1-5. Alma-Ata, 1961-1972 (in Russian)
p.000187: 6. Kurmanjan the Mountain Queen and Her Time. Bishkek, 2002 (in Russian)
p.000187: 7. Jenijok. Poetic Works. Frunze, 1982 (in Kyrgyz)
p.000187: 8. Jusup Balasagyn “The Beneficial Knowledge”. Frunze, 1988, p. 339 (in Russian)
p.000187: 9. Kalygul Bai Uulu In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 10. Moldo Kylych. Time of Sorrow. Manuscript No 56, Library of the Kyrgyz Academy of Sciences (in Kyrgyz)
p.000187: 11. Moldo Kylych Shamyrkan Uulu. Time of Sorrow. In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 12. Tolubai-Synchi. Ibid.
p.000187: 13. http://www.peoples.ru/art/literatur...age/balasaguny.
p.000187:
p.000187: 3.6.2. Legal Regulations
p.000187:
p.000187: In Kyrgyz Republic biomedical research and protection of human rights in this sphere is regulated by a number of
p.000187: national legal acts, and first of all by Constitution.
p.000187: According to the principal Law, residents of the Kyrgyz republic have the right to health protection, free health
p.000187: care provision by a network of state healthcare institutions. The Constitution guarantees rights to healthy
p.000187: environment and to indemnification for harm caused to health or property due to actions in the sphere of nature
p.000187: management.
p.000187: Article 18 of the Constitution states that no medical, biological, and psychological experiments on human subjects
...
p.000199: this respect his everyday activity was a bright example.
p.000199: Any event in nature and especially in the society is known to have strictly defined grounds, knowledge of which allow
p.000199: researchers analyzing them deeply and widely, determine their (fundamentals) role in formation and development of this
p.000199: phenomenon, to evaluate significance of the latter in formation of social conscience at the level of country, region
p.000199: and even mankind in general. Such fact as biomedical researches is not an exception in this sense.
p.000199: Cultural and historical grounds of biomedical researches in the Republic of Moldova may be examined from several
p.000199: aspects.
p.000199: Firstly, cultural traditions of our country initially suppose existence of stable moral system, reality of
p.000199: which allows rather accurate control of different actions including science. Public mentality is strived to
p.000199: carry out true moral appraisal. Such situation dominates both in public social consciousness and in
p.000199: traditions, folk and literary works.
p.000199: Social and cultural life of Moldova is defined to a large extent by demographic situation. Density of
p.000199: population equal to 127 people per 1 square km is high comparing to other regions of the southeastern Europe. In
p.000199: addition the distance between settlements is small. Hence there appears singularity of information process.
p.000199: Moldova to strengthen its economy and independence besides critical times kept original scientific traditions
p.000199: practically in all fields of knowledge. Medicine, pharmacy, biology, ecology, philosophy and science of culture
p.000199: exhibited considerable development.
p.000199: Efficient ways for establishing of bioethics were found in Moldova. As a result, significant progress as to this field
p.000199: was made in a short period of time.
p.000199: First bioethical ideas entered our Republic in the end of the 80’s of the last century, as the ex-USSR though. However,
p.000199: they found true response in the scientific circles in the beginning of the 90’s. Comparing to western countries
p.000199: establishment of bioethics in the Republic of Moldova happened rather late - in the first part of the last decade of
p.000199: the XX century. This is the first stage of bioethics development in the local, national territory. Bioethical problems
p.000199: of this stage were however at the background due to large-scale social shock happened during that time: collapse of the
p.000199: USSR, declaration of the Republic’s independency, Transdniestria conflict, etc. Notwithstanding abovementioned small
p.000199: group of scientists examined consistently possibilities for bioethics development in our country.
p.000199: The second stage includes the period from 1995 trough 1999. It is necessary to stress that in such a
p.000199: contingency the Department Philosophy (since 1999 – Department of Philosophy and Bioethics) of the State University of
p.000199: Medicine and Pharmacy named after Testemitsanu N.F. became the core or the Centre for establishment and development of
p.000199: bioethics in the Republic of Moldova. Academician Theodor Tsidrya, chief of the Department of Philosophy, was
p.000199: the initiator for distribution of bioethics ideas in Moldova. He created efficient grounds for introduction of
p.000199: bioethics into different fields of operation especially in scientific and educational spheres, first alone, then
p.000199: together with the staff of the Department. Lectures of the famous Italian expert in philosophy - Pietro Cavasin – in
p.000199: the past director of one of the Italian bioethics institutes - became a stimulus. Taking into consideration his
p.000199: activity in promotion of bioethical knowledge in the Republic of Moldova in 2001, the University conferred him with
p.000199: Doctor Honoris Causa title.
p.000199: Professor and teacher’s group of the Department became a prime scientific, teaching and methodological and
p.000199: practical Centre of bioethics development in the Republic of Moldova. We need to stress great support of the
p.000199: National Commission for UNESCO Affairs in organization of the National Bioethics Centre in the Republic of Moldova on
p.000199: 10 of November 2004, and holding of different events. Mission of the Centre includes first of all the following: 1)
p.000199: harmonization and coordination of joint actions in this field between the Department, Bioethics Association and
p.000199: National Commission for UNESCO Affairs in the Republic of Moldova and the Ministry of Health
p.000199:
p.000200: 200
p.000200:
p.000201: 201
p.000201:
p.000201: Care and Social Security; 2) consolidation of all competent bodies at the national level to organize different events
p.000201: and implementations; 3) effectual promotion of bioethical knowledge; 4) facilitation of implementation of
p.000201: research results into different activities’ areas; 5) coordination of various activities in the bioethics at the
p.000201: national level.
p.000201: Since 2005 expansion of different activities connected with further establishing of bioethical ideas in our
p.000201: country is noticed: increase of academic hours in subject block for bioethics for students, doctoral
p.000201: candidates, applicants and residents, introduction of bioethical training for medical and nursery medical personnel of
...
p.000205: There is a necessary background for their development: necessity in their functioning from the side of
p.000205: researches willing to perform qualified clinical researches in accordance with international regulations and
p.000205: legal base. Experience of ethical review subject to future interpretation is being accumulated.
p.000205:
p.000205: 3.7.3. Education in Bioethics
p.000205:
p.000205: There is no doubts that training and education in bioethics for population and firstly for youth has become a
p.000205: necessity, a requirement of the time and not a fashion or somebody’s ambition. This imperative is caused
p.000205: by anthropoecological and anthropogenic crisis sweeping today the Earth as a result of natural and even
p.000205: unrestrained activities of a man and world community in general to provide human existence. In this connection
p.000205: it is necessary concentrate human powers firstly intellectual ones for safety
p.000205:
p.000206: 206
p.000206:
p.000207: 207
p.000207:
p.000207: development of modern civilization. This is the time to elaborate new approaches to human survival strategy,
p.000207: which would provide opportunities of more efficient handling of global anthropoecological crisis, exclude
p.000207: planetary omnicide that closely follows tracks of the modern world.
p.000207: Bioethics as it is well known is an efficient mechanism in securing safety development of the society. That
p.000207: means that well-established training and education of population in this practical philosophy would facilitate
p.000207: solutions for many issues related to survival of mankind. The Republic of Moldova performs a lot as to the issue:
p.000207: Firstly, for purposeful coordination of this work the Bioethics Association of the Republic of
p.000207: Moldova was created in the country in 2001 (31 of May), and the National Bioethics Centre was founded (10 of
p.000207: November 2004) uniting experts in this science and practical philosophy of all country higher educational
p.000207: institutions, other scientific institutions, for effectual organization and implementation of different
p.000207: decisions and advises in this field with the help of UNESCO together with the Department of Philosophy and Bioethics
p.000207: project called Extension of Development and Promotion of Knowledge in Bioethics in the Republic of Moldova.
p.000207: Secondly, for purposeful teaching of bioethics in students circles and primary at the biomedical,
p.000207: agronomical, veterinarian and similar departments, traditional Department of Philosophy has been reorganized
p.000207: into the Department of Philosophy and Bioethics in 1999 under the Order of the President of State University of
p.000207: Medicine and Pharmacy named after Testemitianu N.A., which undertook solving of all issues related to teaching of this
p.000207: discipline to students. They include: working out of text-books and teaching aids, dictionaries, elaboration of
p.000207: thematic plans, curriculums and workshop projects, tests, staff training, method teaching and methodological training
p.000207: of teachers of higher education institutions, colleges and lyceums of the Republic including in bioethics.
p.000207: 64-hour training course for students of our institution and 32-hour course for other universities has been worked out
p.000207: by the Department. Several text- books and teaching aids on this discipline were published in Romanian and Russian, we
p.000207: will point of the following:
p.000207: - Philosophy and Bioethics: History, personalities, paradigms.), Chisinau, 2000, 256 p.
p.000207: - Philosophy (with Bioethics course). Chisinau, 2002, 552 p.
p.000207: - Philosophy and Bioethics Dictionary. Chisinau, 2004, 441 p.
p.000207: - Elements of Bioethics. Chisinau, 2005, 176 p.
p.000207: - Bioethics: origin, dilemma, trends. Chisinau, 2005, 234 p.
p.000207: These and other training and methodological and scientific works of the Department staff allowed organization and
p.000207: holding of training not only for students but for a certain number of professors of universities and colleges of the
p.000207: country in accordance with detailed program on Bioethics through the National Bioethics Centre and Bioethics
p.000207: Association of the Republic of Moldova. More than 50 persons who would be able to give lectures on bioethics in the
p.000207: higher and secondary specialized educational institutions of our country as well as in lyceums underwent advanced
p.000207: training in science and method training related to this field at these national workshops.
p.000207: Thirdly, the Department of Philosophy and Bioethics of State University of Medicine and Pharmacy named after
p.000207: Testemitianu N.A., the National Bioethics Centre carries out permanent research work in bioethical knowledge
p.000207: considering bioethics in the widest definition of this term (as per V.P. Rotter). Since 1995 until 2006 the
p.000207: Department has organized and held eleven international scientific workshops on topic Bioethics, Philosophy and
p.000207: Medicine in Human Survival Strategy. Scientists and practitioners from many world countries (the Ukraine, the Russian
p.000207: Federation, Bulgaria, Romania, Canada, the USA, the Republic of Moldova, etc.) and other specialties (philosophers,
p.000207: medics, biologists, ecologists, engineers, economists, agronomists etc.) participate in such workshops
p.000207: contributing to bioethical development in close connection with biomedicine, philosophy, ecology, economy, technique,
p.000207: other fields of knowledge. This promoted development of researches in ethics of life not only in the Department of
p.000207: Philosophy and Bioethics of State University of Medicine and Pharmacy named after Testemitianu N.A. but in other higher
p.000207: educational institutions of the country.
p.000207: Since 2002 the Department offers post-gradual studies (daily and distant training), doctor of science (distant) and
p.000207: master (daily) training in bioethical sphere where graduates of philosophic, medical, theological, agricultural and
p.000207: other department study. After graduation and successful defense of works they are conferred the degree of doctor or
p.000207: doctor habilitate of philosophic science (majoring in bioethics) and master on bioethics, respectively.
p.000207: If we are to continue to develop our ideas related to organization of training process in bioethical knowledge in
p.000207: our country it is necessary
p.000207:
p.000208: 208
p.000208:
p.000209: 209
p.000209:
p.000209: to especially stress the work of the Department, Association and the National Bioethics Centre in
p.000209: popularization of this phenomenon among the population of the Republic and primarily among the youth.
p.000209: Introduction into Bioethics program is of special popularity among the radio and television auditoria. Over
p.000209: last 3 years the personnel of the Centre and the Department organized and held about 20 talks (radio and television) of
p.000209: 15 to 45 minutes each on basic themes of this type of practical philosophy. Such programs as Bioethics –
p.000209: The Science of Survival, Euthanasia from the Point of View of Bioethics, Cloning in the Contest of Bioethics,
p.000209: Bioethical Aspects of Artificial Human Reproduction, Experiments in Humans and Animals in Biomedical Sphere:
p.000209: Bioethical Aspects, Religion and Bioethics and other with participation of bioethics specialists, biologists,
p.000209: medics and religious theologists can be marked among them, as well as From Anthropocentrism to
p.000209: Biospherocentrism, Backgrounds of Bioethics, From Ethics to Biological Ethics, Abortion and Bioethics, Bioethical
p.000209: Education of Society – Requirement of the Human Survival Strategy, Transplantology and Bioethics, Human Genome and
p.000209: Bioethics, Biomedical and Spiritual World: Comparative Analysis, Principles and Imperatives of Bioethics,
p.000209: Paternalism and Antipaternalism in Human Activity, Informative Consent and Interpretation in Medical Practice and
p.000209: others.. Here we started to check the interest in some ideas from social bioethics, such as Senility and Bioethics,
p.000209: Terrorism and Bioethics, Homosexualism, Transsexualism and Travestism in the Contest of Bioethics, Suicide and
p.000209: Bioethics, Homeless in the Light of Bioethics, Bioethics and AIDS, People with Physical Incapability in the Light of
p.000209: Bioethics, Asceticism and Bioethical Knowledge, Sadism and Masochism in the Contest of Bioethics etc. All that promotes
p.000209: propaganda of bioethical knowledge among the population both of the cities and rural settlements, formation of skill to
p.000209: care about living and biosphere in general.
p.000209: Periodicals with regular publication of interviews, articles and, for
p.000209: example, such newspapers as Komsomolskaya Pravda, Argumenty i Fakty, Nezavisimaya Moldova, Făclia, Moldova
p.000209: Suverană, Literatura şi arta are used to the same extent, i.e. for propaganda and promotion of knowledge
p.000209: in bioethics. We will underline several of them: Philosophy (With Bioethics Course), the Svetoch newspaper, No.
p.000209: 14 of 5 April 2003,
p.000209: p.6 (in Romanian); Homo Sapiens, be a Human!, the Argumenty i Fakty newspaper, No. 21, May 2005, p.3 (in
p.000209: Russian); Bioethics, Philosophy,
p.000209: Economics and Medicine in the Strategy of Humane Safety Ensuring, the Literatura i Iskusstvo weekly, No. 11, 17 of
p.000209: March 2005, p.2; Philosophy and Bioethics, the Literatura i Iskusstvo weekly, No. 35, 1 of September 2005, p.7; And
p.000209: Philosophers May Safe the Mankind, the Svetoch newspaper on 19 of February 2000, p.6, etc.
p.000209: Traditions of extensive participation of the community in formation of moral principles of social life are rather
p.000209: strong in our country as in other CIS countries. As it was said before, the first public officially
p.000209: registered organization in 2001 undertaking responsibility to promote ideas of bioethics in the
p.000209: Republic was Bioethics Association, united philosophers, medics, lawyers, theologists, biologists, scientists,
p.000209: students and other public representatives. All bioethics commissions created in local hospitals, scientific
p.000209: institutions and others are the result of the activity of the Association and the National Bioethics Centre. Today,
p.000209: bioethics commissions operate in practically all patient care and preventive and scientific and biomedical
p.000209: institutions, elaborating procedures for operation and standard operation procedures based on model regulation.
p.000209: It is necessary to underline the role of bioethics committees in organization and holding of training and
p.000209: educational process starting with the National Ethics Committee under the Ministry of Health Care and Social Security
p.000209: and to basic levels of this system. First of all, we set up trainings for members of the committees at workshops, and
p.000209: then they perform the same work in their teams, i.e. promote bioethical knowledge.
p.000209: So, successful set up of bioethical training is important for the Republic of Moldova from various points of
p.000209: view, and, first of all at the point of integration of our country into European and world community. From one
p.000209: side use of experience of other countries in this process is the condition for formation of moral
p.000209: mechanisms embodiment for ensuring of secure development strategy for our region, further democratization of
p.000209: social life. From the other side, the experience of the Bioethics Association of the Republic of Moldova,
p.000209: the National Bioethics Centre on bioethics and the Department of Philosophy and Bioethics of the State University of
p.000209: Medicine and Pharmacy named after Testemitianu N.A. on set up of trainings and education of inhabitants in
p.000209: bioethical interconnections and interactions among humans, society and biosphere, i.e. in implementation of one of
p.000209: the significant principles of bioethics – the co-evolutional one.
p.000209:
p.000210: 210
p.000210:
p.000211: 211
p.000211:
p.000211: And finally, wide spread of the experience and practice of the state and public formations in training and educational
p.000211: process of bioethical knowledge will favor integration in social life of new ethical and legal approaches,
p.000211: principles and values, the help of which may not only reasonably use achievements of current scientific and
p.000211: technological progress but promote implementation of modern strategy of the world community meaning survival of
p.000211: the mankind through steady and safe development.
p.000211: These are summary results of our works during the last 10-12 years in organization of training, education and promotion
p.000211: of bioethical knowledge among people of our country, and, first of all, among the youth. The work we have performed
p.000211: undoubtedly will be a serious base for further extension and strengthening of the developed system especially in
p.000211: carrying on of bioethical education of young students, future specialists of all types.
p.000211:
p.000211: References
p.000211: 1. Bioethics: principles, rules, issues. Edited by Yudin B.G. М., 1998,
p.000211: 472 p. (in Russian)
p.000211: 2. Vekovshinina S.V., Kulinichenko V.L. Bioethics: onset and rationale (philosophy and methodological analysis).
p.000211: Kiev, 2002, 152 p. (in Russian)
p.000211: 3. Second National Congress on Bioethics. 29.09 – 2.10 2004. Kiev, 2004, 305 p. (in Russian)
p.000211: 4. Testemitsanu N.A., Popushoy Ye.P., Ioksa V.A. Famous Doctors of Moldavia. Chisinau, 1985, 231 p. (in Russian)
p.000211: 5. Tsirdya T.N., Berlinsky P.V. Philosophy (with course on bioethics). Chisinau, 2002, 553 p. (in Russian)
p.000211: 6. Development of Bioethics Ideas in the European Context. Mater. of the IV International symposium on
p.000211: bioethics. Kiev, 2006, 160 p. (in Ukrainian)
p.000211: 7. Dicţionar de Filosofie şi Bioetică. T.Ţîrdea, P.Berlinschi, A.Eşanu et al. Chişinău, 2004, 441 p. (in Rumanian)
p.000211: 8. D’Onofrio F., Giunta R. La Bioetica nel futuro dell’uomo. Napoli, 1999, 224 p.
p.000211: 9. Istoria medicinei româneşti. Red. V.Bologa et al. Bucuresti, 1972,
p.000211: 565 p.
p.000211: 10. Istoria şi Filosofia culturii. Coord. Gr. Socolov. Chişinău, 1998,
p.000211: 398 p. (in Rumanian)
p.000211: 11. Nistor Ion. Istoria Basarabiei. Chişinău, 1991. 295 p.
p.000211: (in Rumanian)
p.000211: 12. Ţîrdea T. Filosofie şi bioetică: istorie, personalităţi, paradigme. Chişinău, 2000, 215 p. (in Rumanian)
p.000211: 13. Ţîrdea T. Bioetică: origini, dileme, tendinţe. Chişinău, 2005, 234 p
p.000211: (in Rumanian)
p.000211: 14. Tirdea T. Elemente de bioetică. Chisinau, 2005, 176 p (in
p.000211: Rumanian)
p.000211:
p.000211: 3.7.4. The System of Ethical Review
p.000211:
p.000211: So called independent ethical committees are created to ensure the rights and safety of subjects of clinical
p.000211: research.
p.000211: Pursuant to the definition applied in Europe (Good Clinical Practice for Trials on Medicinal Products in
p.000211: European Community, III/3976/88/- EN, July 1991), ethical committees are independent bodies consisting of
p.000211: professional medics or persons of non-medical specialties being responsible for ensuring of rights and health
...
p.000217: committees in Moldova. Creation of such independent committees authorized with relevant powers will promote active
p.000217: participation of Moldova clinics in multi-Centreed international researches, allow controlling observance of the
p.000217: rights and safety of study subjects not only at the stage of setting up but also during the study course.
p.000217:
p.000217: 3.7.5. Perspectives and Forms of International Cooperation
p.000217:
p.000217: There are no doubts that successful education in bioethics, improvement of ethical review system for biomedical
p.000217: researches mainly depend on involvement of the country, its governmental bodies, public entities, scientific
p.000217: communities in different international events connected with provision of safe development of society,
p.000217: cooperation with other states, international organizations for improvement of research work in bioethics (to a
p.000217: large extent), in promotion and popularization of bioethical knowledge, in performance of biomedical researches
p.000217: involving human and animal subjects, etc.
p.000217: Certain experience in international cooperation related to this field is gained by the Republic of
p.000217: Moldova. First, we would like to remind about organization and holding of scientific workshops with international
p.000217: participation of many European countries on bioethical topics in our country and abroad, first of all, about a role of
p.000217: bioethization of the society to ensure safety of the modern world. During the last 11 years the same number of
p.000217: scientific conferences was held and eleven books were published with materials of speakers at these scientific
p.000217: forums (organizers: Department of Philosophy and Bioethics of State University of Medicine and Pharmacy named after
p.000217: Testemitianu N.A., the National Bioethics Centre of the Republic of Moldova).
p.000217: Since 2000 the National Ethics Committee is a member of the FEC CIS. Moldova collaborates with ethics
p.000217: committees of the CIS countries
p.000217:
p.000218: 218
p.000218:
p.000219: 219
p.000219:
p.000219: through this Forum. As to international cooperation and as a member of the Forum, representatives of our committee were
p.000219: participants of the majority of conducted conferences and workshops of the FECCIS: Saint-Petersburg, Russia, 2001;
p.000219: Kiev, Ukraine, 2001; Almaty, the Republic of Kazakhstan, 2002; , Kiev, Ukraine, 2004; Saint-Petersburg, Russia,
p.000219: 2003; Baku, the Republic of Azerbaijan, 2004; Saint-Petersburg, Russia, 2004; Minsk, Belarus, 2005; Almaty,
p.000219: the Republic of Kazakhstan, 2005; Tashkent, the Republic of Uzbekistan, 2005; Yerevan, the Republic of Armenia,
p.000219: 2005.
p.000219: In 2006 the workshop on “Human Rights Protection &. Standard Operation Procedures” with participation the
p.000219: representatives from FECCIS (Russia, Ukraine, Moldova) and SIDCER (WHO) and EFGCP (Belgium) was held in Chicinau.
p.000219: Chairman of the National Ethics Committee of the Republic of Moldova, Professor Gikavy V.I. took part in the workshop
p.000219: of the Commission of the Council of Europe on Ethical Issues (Ljubljana, 2004). Professor M. Gavrilyuk, Deputy-director
p.000219: of the Neurology and Neurosurgery Institute of the Ministry of Health Care and Social Security is a permanent
p.000219: representative of the Republic in the Commission of the Council of Europe on ethics of biomedical researches since
p.000219: 2005.
p.000219: Secondly, the staff of the State University of Medicine and Pharmacy named after Testemitianu N.A., the State
p.000219: University of Moldova, the State Agricultural University and other, members of the National Bioethics Centre of
p.000219: the Republic of Moldova take part on a regular basis in scientific conferences organized in other countries, exchange
p.000219: with their experience, mainly, on scientific and educational publications, activity of bioethical committees,
p.000219: etc. Four workers of the Department of the Philosophy and Bioethics just for the last 3-4 years took
p.000219: part and made presentations at the 2nd National Bioethics Congress (Kiev, 2004), the same number of
p.000219: presentations was made at the 4th Bioethics Symposium (Kiev, 2006), four presentations were made at the
p.000219: International Conference on bioethical education (Romania, Keya, 2006 and Romania, Bucharest, 2006), with
p.000219: presentations at the International seminar on issues of ethical review in biomedical researches (Ukraine,
p.000219: Kiev, 2006), with presentations on issues of students bioethics education (Croatia, Split, 2006), etc.
p.000219: Thirdly, professors of philosophy, philosophy and bioethics departments of many of higher educational institutions
p.000219: of Chisinau published lately materials on bioethics in different scientific journals, other foreign
p.000219: publications, for example in Kursk (Russian Federation) – 5 articles, in Yassy (Romania) – 2 articles,
p.000219: in Arad (Romania) – 2 articles, in Galatia (Romania) – 2 articles, in Lvov (Ukraine) – 1 article, etc. Our
p.000219: colleagues from these scientific Centres publish their works in scientific publications of Chisinau (journals,
p.000219: university research works, conference materials, etc.).
p.000219: During the last years the Department of Philosophy and Bioethics of the State University of Medicine and Pharmacy named
p.000219: after Testemitianu N.A. is trying to enter different international projects related to training programs on bioethics,
p.000219: performance of ethical review of biomedical researches, staff training, etc. To this extent we are looking for
p.000219: forms of international scientific and pedagogical cooperation in bioethics with the CIS countries, and especially with
p.000219: those states where large educational experience for this subject was already gained, where large-scale research work is
p.000219: carried out.
p.000219: To improve training programs in bioethics and its lecturing in the State University of Medicine and Pharmacy named
p.000219: after Testemitianu N.A., a famous Italian specialist in these spheres of practical philosophy, Pietro
p.000219: Cavasin, give lectures to students and doctor candidates for 5 years in the State University of Moldova. There was
p.000219: constant exchange of both scientific and educational literature here.
p.000219: Since 2004 we expanded relationship with foreign colleagues as to training of high-qualified specialists, i.e.
p.000219: through post-graduate and master studies in bioethics. Anna Marin, post-graduate of the Department prepares
p.000219: dissertation in bioethics under guidance of two specialists now: Doctor of Philosophy Raymond Massé – Laval University
p.000219: (Canada) and professors of our Department. Two professors of the Department gained master degree majoring in
p.000219: bioethics in French in Bucharest, and one more staff member got training in the University of Angers
p.000219: (France). All expenses on implementation of these projects were covered by the French-speaking Agency for the Republic
p.000219: of Moldova.
p.000219: We consider for the future (as a suggestion) as useful and, more important, as necessary development and publication of
p.000219: a text-book for the University students under the title The Fundamentals of Bioethics by scientists of the CIS
p.000219: countries. It could be started now without any long-term delay, let’s say, from January 2007 under general scientific
p.000219: and methodological guidance of heads of departments where this subject is a part of a curriculum of a higher
p.000219: educational facility, where it is taught, where teaching aids were published, and
p.000219:
p.000220: 220
p.000220:
p.000221: 221
p.000221:
p.000221: some experience in this sphere was gained. At least, our Department as well as plenty of other groups from other
p.000221: countries are ready to participate in such project. It would be rational and useful to organize regular educational and
p.000221: methodical workshops for professors lecturing bioethics in scientific Centres of different CIS countries (Kiev, Moscow,
p.000221: Chisinau, Baku, Yerevan, etc.)
p.000221: We also consider as useful the initiative of Moscow colleagues with participation of other CIS countries on
p.000221: development of a training course in bioethics for highest qualification specialists with duration of 320 academic hours
...
p.000223: personality is central, important as daily bread, and it is not high but everyday, though in Russia the word
p.000223: “personality” is in one row with the high notions and its meanings are not everyday.
p.000223: Speaking about language as means of communication one should note one more feature which is important for
p.000223: doctor-patient relations. The Russian language in contrast with the Romance and German languages is synthetic, not
p.000223: analytical, i.e. it may be axiomatizated hardly but is able to express emotions and feelings (22,27).
p.000223: Folk proverbs are very important feature of ethnos awareness and national mentality. They accumulate important
p.000223: conclusions and observations about nature and society laws. Many of them assert group priority over
p.000223: personality, collective things priority over individual, necessity to obey any group law. Man strength is in his group
p.000223: membership, whilst his personnel responsibility is vogue (25).
p.000223: Russians were characterized to have many interethnic contacts with people of different origin, cultural
p.000223: traditions and language that influenced undoubtedly the general Slavic culture foundation. Connections with
p.000223: Byzantine, a godmother and keeper of ancient civilization where Orthodoxy became a state religion, were the most
p.000223: fruitful for the Old Russian culture. Together with adoption of Christianity a Byzantine philosophy related to the
p.000223: Plato’s Hellenism, which gave it anthropological and historiosophy orientation, had penetrated to
p.000223: Russia. Anthropocentrism of Russian philosophical researches became one of characteristic principles of Russian
p.000223: philosophy. From Nil Sorskiy to A.N.Radischev, from Radischev to Soloviev and Berdiaev a Russian thought has been
p.000223: always attracted by cognition of mystery of person, his death and immortality (3). The Russian philosophy created
p.000223: “philosophy of life” long before birth of western European existentialism and pragmatism. Peculiarity
p.000223: of the Russian philosophy is in the fact that the Russian thought has always been (and will be forever) connected with
p.000223: its religion element and grounding and inspiration of freedom valued at any time by Russian minds had never died inside
p.000223: of church awareness. First of all everywhere dominance of morality evidences that. We can see it in works of nearly all
p.000223: Russian thinkers even those who had no works devoted to moral problems.
p.000223: Adoption of Christianity determined evaluation of Russian spirituality in subsequent periods. Founding on traditions of
p.000223: eastern orthodoxy, ideas of spirituality, shame and conscience, love to neighbor were brought in Old Russia, a
p.000223: spiritual foundation of charity as everyday piety was formed. Alms as early form of personnel charity was spread among
p.000223: all social classes, it was not only simple execution of commandment of love to a neighbor, but a true need. It was
p.000223: personnel charity that created the foundation necessary for helping the poor at the following times. It was forming
p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
...
p.000239: many walks of social life, adherence to traditional ideological and social values which saw little influence
p.000239: of the changing social and economic systems, political regimes as well as fresh social and ideological paradigms for
p.000239: development declared in the recent decades of the XX century. Under any state system – monarchical or collective type,
p.000239: totalitarian or liberal – an impact of a number of constants which determine a civilization portrait of Russia is
p.000239: feasibly evident. Among them a crucial role belongs to religion, first and foremost the Orthodox Christian Church which
p.000239: by masses of population is perceived not only as an institution with the main function of not just disseminating the
p.000239: ideas of Christianity but mostly as preserver of the Russian national values and traditions (by different social
p.000239: studies three fourths of believers who are almost half of the population in Russia are Orthodox Christians). The same
p.000239: can be said about the Islam – second confession in Russia in terms of adherents’ number and influence (about 19% among
p.000239: believers) (20).
p.000239: Today religious organizations prove active in most different fields: religion itself, education, health care,
p.000239: culture, charity and mercy, business and economic. Changes occurring in the society and the Church demanded for a
p.000239: comprehensive philosophy that would reflect general attitude of the Church to issues of state and the Church
p.000239: relations and concerns of the modern society on the whole.
p.000239: At the Anniversary Episcopal Assembly in 2000 the Basic Social Conception of Russian Orthodox Church was
p.000239: adopted. The conception falls into 16 sections covering most various issues related to life of a Christian believer in
p.000239: secular world. In section 11 – “Public and Individual Health” – the attitude of Orthodox Church to disease and health
p.000239: is rendered, importance of church activities in health care is stressed, necessity of society and church cooperation in
p.000239: public health care issues is emphasized. It covers such vital from religious viewpoint principles as doctor and patient
p.000239: relationship which should be based with respect to integrity, free choice and “personal dignity”. In particular it
p.000239: stresses: “We should by all means encourage a dialogue between a doctor and a patient that is
p.000239: characteristic of current medical approach. This approach is undoubtedly engrained in the Christian tradition,
p.000239: although there is a temptation to relegate it to a level of merely agreement relationship. At the same time one should
p.000239: admit that a more conventional “pattern like” model of physician and patient relationship which is fairly criticized
p.000239: for numerous attempts to justify medical power abuse may as well represent a truly fatherly attitude to patient that
p.000239: depend on doctor’s morality. Not giving preference to any of the health care organization models the Church
p.000239: considers that this service should work efficiently at its maximum and must be available to all members of society
...
p.000241: like, collegial philosophies, support of the current government and antagonism to liberal western ideas
p.000241: prevail. A common trend among all young interviewees, disregarding distinctions in their philosophic and
p.000241: religious ideas, towards moral and spiritual values is demonstrated, for instance, the way they reacted to the
p.000241: concept of ‘morality’ (positive 87.9% among believers and 81.8% among non-believers, negative 12.1% and 18.2%
p.000241: respectively), ‘justice’(positive 96.6% and 94.3%, negative 3.4%
p.000241: and 5.7%), ‘faith’ (positive 97.1% and 85.9%, negative 2.9% and 14.1%),
p.000241: ‘prayer’ (positive 92.3% and 56.3%, negative 7.7% and 43.8%). A particular part of young believers and
p.000241: non-believers advocates the idea of paternal mode of relations, sticks to the idea of conventional patriarchal
p.000241: views in family pattern, supporting filial piety within the family, male dominance in family relations (believers 28%,
p.000241: non-believers 21.9%).
p.000241: For the Russian medicine and health care a paternal model of doctor and patient relations is a typical one. Genesis of
p.000241: these relations can not be seen apart either from economic and cultural development of Russia on the whole or from the
p.000241: ethical staples of medical activity in Russia. Orthodox theological ideas and Russian religious philosophy to a
p.000241: significant extent reinforced the paternal model of doctor and patient relations, promoting ideas of humbling,
p.000241: non-resistance, and respect to universal hierarchy.
p.000241: Developments in medical science and biotechnology increased the power and responsibility of a medical doctor in
p.000241: terms of understanding what life and death and use harm mean. A simultaneous turn of mind in social ideas and mentality
p.000241: of people brought about by a wide spread liberal ideas gave a great impetus to new attitudes based on ideas of personal
p.000241: rights and freedom. All this entailed a necessity to seek for such grounds in doctor and patient
p.000241: communication as recognizing patients’ autonomy, their right for identity and decision making. Process of shifting
p.000241: towards non-paternal model in our country is not a smooth one.
p.000241: One can judge about the steadiness of paternal model by numerous interviews among doctors and patients
p.000241: carried out in recent years. The results of medical and social study in the St-Petersburg Pediatric Academy in 2002-
p.000241: 2004, viewpoints of doctors and citizens on the staple issues of medical ethics (bioethics) depending on
p.000241: their status revealed that currently only few doctors as well as their patients are prepared to apply an
p.000241: antipaternal relationship model in practice (17, 18). Big number of doctors sticks to paternal positions
p.000241: in communication with patients. This situation is also seen as psychologically favorable by many patients who
p.000241: lack desire to take decisions for their own health issues either partly or completely, they are happy to shift this
...
p.000241:
p.000242: 242
p.000242:
p.000243: 243
p.000243:
p.000243: Russia the principles of identity typical of the West are still underdeveloped. The basis of human rights theory is yet
p.000243: being established. Majority of Russian citizens as social studies show, reject the imposed ‘alien’
p.000243: communication schemes, for instance, the Western view over various issues of personal and social life not out of
p.000243: reasonable arguments or some ideological efforts but out of their inconsistency with customary ideas and values.
p.000243: This gives grounds for discussion and implementation of the bioethical staple principles and provisions in
p.000243: countries with various ethnic, culture and religious traditions, creates challenges because of peculiarities
p.000243: and inconsistencies between the Russian and western ethical systems in health care and medicine. In this respect it is
p.000243: reasonable to draw guidelines and interpret specific regulations and acts and their provisions taking into
p.000243: account two main aspects: culture and ethnical traditions of given states and their compliance with the common norms of
p.000243: international laws in the field of bioethics.
p.000243:
p.000243: References
p.000243: 1. Berdiaev N.A. Destiny of Russia: Selected Works. M., Kharkov: EKSMO Press Folio, 1998, 736 p. (herein and
p.000243: hereinafter in Russian)
p.000243: 2. Dmitrieva T.B., Polozgiy B.S. Psychological Health of Russian
p.000243: Citizens. Human, 2002, №6, p. 21-31.
p.000243: 3. Zamalaev. А.F. Lectures on history of Russian philosophy: XI –
p.000243: early XX cc. StP., 1994.
p.000243: 4. Zenkovskiy V.V. History of Russian philosophy. L., Eko, 1991, p. I,
p.000243: p. II, p. b.
p.000243: 5. Ivanjushkin A.J. Medical ethics in Russia (XIX - early XX cc.). In
p.000243: bk.: Bioethics: principles, regulations, problems. М., 1998, p. 93–110.
p.000243: 6. Ivanjushkin A.J. History of medical ethics and biomedical experiments in human and animal parties.
p.000243: In bk.: Introduction to bioethics. М., 1998, p. 95-133.
p.000243: 7. Cirill, metropolite. On «Basic social conception of Russian Orthodox Church». Anniversary Episcopal Assembly RCOC.
p.000243: StPb, 2000, p. 133-149.
p.000243: 8. Klementovskiy А.I. On application of Libikhov meat extract (broth) for a child at the breast. Moscow medical
p.000243: newspaper, 1859, №34, p. 269- 272; №35, p. 278-280; №36, p. 285-287.
p.000243: 9. Kljutchevskiy V.О. Selected Works. М., 1987, v.1, p.1, p. 78-79.
p.000243: 10. Korotkikh R.V. Legal and ethical issues of health care in Russia in period of reforms. In bk.: Biomedical
p.000243: ethics (edited by. V.I.Pokrovskiy). М., 1997, p. 47-58.
p.000243: 11. Koshtojantz Kh.S. Study on history of physiology in Russia.
p.000243: М., 1946, p. 111.
p.000243: 12. Kubar О.I. Ethical and legal issues of research in human parties: in history of Russia XX century. Human, 2001, №3.
p.000243: 13. Levit М.М. Establishing public medicine in Russia. М.: 1974,
p.000243: 231 p.
p.000243: 14. Likhatchev D.S. Russian culture. М.: Art, 2000, 438 p.
p.000243: 15. Ljubargskiy G.J. Human, 2004, №3, p. 186.
p.000243: 16. Maksimov Е.D. Study of historical development and current situation in public charity in Russia.
p.000243: In bk.: Public and personal care in Russia. StP, 1907, p. 4.
p.000243: 17. Mikirtitchan G.L., Filimonov S.V. Opinion of doctors and patients on problems of information and obtaining informed
p.000243: consent form. In bk.: Actual problems of diagnostics, treatment and disease prevention, issue. 3. StP, 2004, p.
p.000243: 291-302.
p.000243: 18. Mikirtitchan G.L., Filimonov S.V. Results of social study attitudes among doctors and patients to some
p.000243: genetic methods. International conference of CIS countries Forum for Ethics Committee. Yerevan, 2005, p. 52-56.
p.000243: 19. Mirskiy М.B. Medicine in Russia XVI - XIX cc. М., 1996, p.
p.000243: 301- 309.
p.000243: 20. Mtchedlov М.P. Are young citizens of Russia religious? Human, 2005, №6, p. 111-118.
p.000243: 21. Nikolay Ivanovitch Pirogov and his heritage. Pirogov’s conferences.
p.000243: B/м. B/g. 253 p.
p.000243: 22. Petrov V., Sedova N. Bioethics in practice. М., 2002, p. 60-89.
p.000243: 23. Petukhov V.V. The proper and the real in moral mentality of Russian
p.000243: citizens. Human, 2006, №3, p. 148-149.
p.000243: 24. Pirogov N.I. Selected works. М., v.2, p. 286.
p.000243: 25. Savina E.А., Degtjarenko L.J. Life psychology in Russian sayings and proverbs. Human, 2001, №5, p.186-192.
p.000243: 26. Anniversary Episcopal Assembly RCOC August, 13-16, 2000.
p.000243: Digest of abstracts and documents. Chapters Х-ХII. SPb, 2000, p. 192-200.
p.000243:
p.000244: 244
p.000244:
p.000245: 245
p.000245:
p.000245: 27. Judin B.G. National specific of establishing bioethics in Russia. In
p.000245: bk.: Philosophy of biomedical research. М., 2004, p. 71-90.
p.000245: 28. Jarovinskiy М.J. Lectures on medical ethics (bioethics). М., 2004,
p.000245: 528 p.
p.000245:
p.000245: 3.8.2 Legal Regulations
p.000245:
p.000245: The ethical review of biomedical research involving human subjects is the important component in rights, interests and
p.000245: dignity of human subjects and in the same time is the necessary condition for further development of medical science
p.000245: and technology.
p.000245: The basis for legal regulation of biomedical research and its ethical evaluation is laid by a complex of
p.000245: international acts both of legal and ethical character.
p.000245: First of all we could mention Nuremberg Code (1947), the Declaration of Helsinki (1964, with all further
p.000245: revisions) – the documents which in many points determined the Russian policy on regulation of biomedicine and
p.000245: healthcare sphere22.
p.000245: The serious stimulus for Russian domestic legislative activity and for biomedical practice is also produced by other
p.000245: documents of recommending character, which are devoted to general and specific questions of biomedical research. Here
p.000245: are some examples of such documents: International Ethical Guidelines for Biomedical Research Involving Human
p.000245: Subjects (1982, 1993, 2002), International Guidelines for Ethical Review of Epidemiological Studies (CIOMS, 1991), ICH
p.000245: GCP (1996), Operational Guidelines for Ethics Committees that Review Biomedical Research (2000) and others23.
p.000245:
...
p.000257: Many medical schools developed medical oaths based on the Hippocratic Oath. In 1971 the Presidium of the Supreme Soviet
p.000257: of the USSR approved an official text of the Oath of Medical Doctor of the Soviet Union.
p.000257: In 1976 the Ministry of Health of the USSR approved interdepartmental curriculum on medical ethics (deontology)
p.000257: for higher medical and pharmaceutical educational facilities. The curriculum distributed the course along the
p.000257: entire educational process basing on that “concepts of morals and morality, development of higher feelings and medical
p.000257: ethics is an integral part of the entire educational process and should be implemented in various aspects during all
p.000257: years of training at all departments“.
p.000257: The curriculum stipulated one lecture for the 1 year students: “Medical ethics and medical
p.000257: deontology, their role for formation of a medical doctor and pharmacist” (Introduction for the subject);
p.000257: 5 lectures for the 2 year students: “Soviet health care as qualitatively new system“ (Department of
p.000257: Social Hygiene and Health Care Management), “Main peculiarities of deontology development at different stages of
p.000257: health care formation” (Department of History of Medicine), “Categories of medical ethics” (Department of Marx and
p.000257: Lenin Philosophy), “Modern concepts on medical and psychological aspects of an individuality” (Course on medical
p.000257: psychology), “Deontological issues in disease diagnostics” (Department of Preliminary Studies of Internal
p.000257: Diseases); 1 lecture for 3 year students: “Deontological issues of treatment” (Department of Faculty Therapy); 2
p.000257: lectures for 5 year students: “Deontological issues for work of district physician” (Department of
p.000257: Hospital Therapy) and “Legal principles of medical services for working population in the USSR”
p.000257: (Department of Forensics Medicine). The curriculum was widely discussed in mass media and majority of comments were
p.000257: that it was inefficient, did not cover many important issues, which are of tremendous value for medical practice, for
p.000257: instance, no definition of patient rights was given, it did not dwell on issues of brain death, refusal of
p.000257: extraordinary treatment for dying patients, it never mentioned the Nuremberg Code or the Declaration of Helsinki, etc.
p.000257: In 1977 and 1982 two other All-Union conferences on medical deontology were held. There were published
p.000257: multiple books on issues of medical ethics and deontology for various medical fields. It indicated that in 70-80’s
p.000257: the system of Soviet higher medical education had professors who not only fully understood a role of medical
p.000257: deontology for education
p.000257:
p.000258: 258
p.000258:
p.000259: 259
p.000259:
...
p.000259: that its coaching should be obligatory and continuous during the entire pre-graduate educational
p.000259: process and for post-graduate education, therefore, all medical schools were to have a department on medical ethics and
p.000259: appropriate number of trained professors.
p.000259: In 1997 under the aegis of the Ministry of Health of the Russian Federation the meeting on issues of
p.000259: medical ethics education was held where necessity of introduction of bioethics learning was acknowledged. It
p.000259: is necessary to note that the Russian Orthodox Church supported introduction of the biomedical ethics education
p.000259: into the medical education system of Russia. It is indicated with the appeal to the ministries of health care and
p.000259: vocational education of the Russian Federation approved during the VI International Christmas educational
p.000259: lectures of 1998 held by the Moscow Patriarch of the Russian Orthodox Church.
p.000259: Some of higher educational facilities of medical as well as philosophy, law and other fields as per initiative
p.000259: of those enthusiasts-professors the bioethics education process was launched as well. Since the beginning
p.000259: of the 90’s the separate course on biomedical ethics was provided in the Moscow State University named after Lomonosov
p.000259: M.V. at the Departments of philosophy and psychology, and since 1994 it was also introduced at the medical department.
p.000259: The most capacious course in regard to number of academic hours assigned was provided at the nurse department
p.000259: for the 1st year students of the Moscow Medical Academy named after Sechenov I.M. - 56 hrs (30 hrs of lectures and 26
p.000259: hrs of seminars). Actually, this subject was given at the Department of history of medicine since 1994, and as a
p.000259: separate course – since 1995. Another issue is even more important: at this department biomedical ethics was included
p.000259: into the state educational standard, i.e. it is obligatory for all 22 departments of the higher nurse education in
p.000259: Russia. Making this subject as mandatory from the point of view of educational minimum for this category of medical
p.000259: workers, naturally, required generation of appropriate curriculum (author – Professor Yarovinsky M.Ya.).
p.000259: In the Russian State Medical University since 1996 the Department of philosophy and culture sciences was called as the
p.000259: Department of philosophy and culture sciences with a course on bioethics, and there the biomedical education course (22
p.000259: academic hours: 18 hours of lectures and 4 hours of seminars) is provided since 1996 for all 4 year students of
p.000259: physician and pediatric departments.
p.000259:
p.000260: 260
p.000260:
p.000261: 261
p.000261:
p.000261: Also since 1996 the course on bioethics was provided in the St- Petersburg Pediatric Medical Academy at the
p.000261: Department of humanitarian subjects and bioethics and in the Kazan Medical University. The Department of philosophy of
p.000261: the Moscow Medical Dentistry Institute since 1997 was called the Department of philosophy and biomedical ethics, the
p.000261: course of biomedical ethics there (40 academic hours) is provided at the dentistry department for 1-year
p.000261: students, and at the physician department — for 3- year students. At the evening education department for 1-year
p.000261: students this subject was assigned with 20 academic hours. As an option biomedical ethics was suggested for
p.000261: students since 1993. In the Krasnoyarsk Medical Academy the course on professional medical ethics was provided for pre-
p.000261: graduate students (48 academic hours), and at the higher nurse education department (40 academic hours).
p.000261: The next step for establishing of this subject education was the All- Russian Educational and Methodical
p.000261: Conference Biomedical Ethics in Higher Medical Education Facilities held by the Ministry of Health of the Russian
p.000261: Federation in 1999; since 2000 bioethics became an obligatory subject in medical schools. Introduction of
p.000261: biomedical ethics into a set of humanitarian subjects of medical education is one of the evidences of real renewal of
p.000261: humanitarian training of medical students in Russia.
p.000261: Currently educational system in the Russian Federation has curriculums for general (beginning, secondary) and
p.000261: professional (secondary, higher, additional) education. Their content is determined by state educational
p.000261: standards. Standards for “secondary” and nurse vocational training do not contain bioethical issues.
p.000261: At the stage of higher vocational training bioethics become an integral part of curriculums of medical
p.000261: or pharmaceutical fields (a course of humanitarian and social and economic subjects), for such majors as Law,
p.000261: International Relations, Social Work (natural sciences part in the course Concepts of modern natural sciences),
p.000261: Biology and Bioecology (a part of general vocational subjects). As a negative sign it should be noted that
p.000261: bioethics education is not stipulated for such major as Philosophy. Existence of national and regional (school-
p.000261: related) component in state standards and the right to some extent to alter curriculum content allows for many of
p.000261: educational facilities in Russia to include bioethics into education of future agriculture workers, veterinaries,
p.000261: teachers, philosophers and other trades.
p.000261: At the same time there is no trade of bioethics in the All-Russian Classifier of Educational Trades as well
p.000261: as it is not mentioned in the List of Scientific Specialist Trades. Therefore, targeted training of specialists
p.000261: including specialists of higher qualification (masters and doctors of science) in regard to bioethics is not
p.000261: provided. However, theses or dissertations for master or doctor degree covering to some extent bioethics
p.000261: issues are defended using reference numbers of other trades such as philosophy, sociology, public health.
p.000261: Currently training of medical doctors and pharmacists is conducted in 47 universities and academies subjected to the
p.000261: Federal Agency on health care and social development as well as 25 departments and institutions of the Russian
p.000261: education ministry, 5 military medical educational facilities, 10 private higher educational facilities as well as in
p.000261: the Kyrgyz-Russian Slavic University accredited in Russia.
p.000261: Typical unified program of education in higher medical educational facilities in Russia was developed in 2001 by the
p.000261: group of Moscow scientists, and in 2003 the reference curriculum on bioethics for Pharmacy trade was published (authors
p.000261: – workers of the Moscow Medical Academy named after Sechenov I.M.), which are planned for 36 academic hours of class
p.000261: work (18 hours of lectures and 18 hours of seminars) and 18 hours of independent work in the 2nd semester. The
p.000261: curriculum stipulates learning of history and traditions of Russian ethics, theoretical basics of biomedical ethics,
p.000261: models and rules of relationships between doctor and patient, patient rights, analysis of bioethical issues of
p.000261: experimental medicine, reproductive technologies, euthanasia, transplantology and medical genetics, HIV infection,
p.000261: ethics in psychiatry, moral issues of distribution of health care resources. Working educational programs that the
p.000261: education is based upon are developed by departments implementing them.
p.000261: Currently training in bioethics at the specialized department is conducted only in one higher educational facility, the
p.000261: Russian State Medical University. Three cities (Ivanovo, Kazan, Samara) have departments on bioethics and law
p.000261: associated with other subjects (forensics medicine, history of medicine) or without it. Five educational
p.000261: facilities provide such education at the departments of philosophy, another five changed department titles to
p.000261: mention “philosophy and bioethics”. Three cities delegated this coaching to health care management department. In every
p.000261: third of medical educational facilities
p.000261:
p.000262: 262
p.000262:
p.000263: 263
p.000263:
p.000263: bioethics is learned at departments of humanitarian and social and economic type. Finally, another three higher
p.000263: educational facilities (Astrakhan Medical Academy, St-Petersburg Medical University named after Pavlov I.P. and
p.000263: Stavropol Medical Academy) formed interdepartmental teams for teaching the subject involving clinicians (clinical
p.000263: pharmacologists, psychiatrists).
p.000263: Majority of medical academies and universities has the amount of academic hours complying with the curriculum
p.000263: stipulated one – 36 hours, two – shrank it insignificantly up to 32 hours, and in one academy – to 19 hours.
p.000263: More than a half of medical educational facilities in Russia managed in their curriculum to move the classes from 1st
p.000263: year students to more trained ones up to the pre-graduates at their last year training (Volgograd, Kursk, Ryazan,
p.000263: St-Petersburg Pediatric Medical Academy).
p.000263: An important feature of the modern stage of development of biomedical education in medical education facilities is
p.000263: its close organizational and methodical association with coaching in jurisprudence and medical law. It is not by
p.000263: chance that one of the main magazines publishing articles and other materials on bioethics-related topics is
p.000263: Medical Law included into the list of magazines recommended by the Higher Attestation Commission for publication of
p.000263: results of dissertation research.
p.000263: Special departments on medical law were established in two Moscow facilities (Moscow Medical Academy named after
p.000263: Sechenov I.M. and Moscow State Medical and Dentistry University), in 11 cities the law training is
p.000263: provided in the departments, which titles mention law. In 7 cases these are departments of humanitarian and
p.000263: social and economic field: bioethics, philosophy, political sciences, economics, sociology, psychology and pedagogics;
p.000263: in 4 cases – forensics medicine.
p.000263: Four universities set up the educational process on jurisprudence at humanitarian departments
p.000263: (humanitarian sciences - 2, social and humanitarian - 2), four – at departments of forensics medicine and
p.000263: four – at departments of public health and health care. In Astrakhan they decided to involve professors of three
p.000263: departments: philosophy, public health and forensic medicine.
p.000263: Objectives of bioethics and law coaching are to identify, formulate and bring to students those norms of
p.000263: morals and law that will protect their patient and, at the same time, will not hinder innovations in medicine and,
p.000263: moreover, beneficial use of modern diagnostic and medicinal technologies. Achievement of this goal is based on complex,
p.000263: interdisciplinary approach to the educational process as it is required by the essence of bioethics.
p.000263: Bioethics as it is should be in the Centre integrating common efforts of men of law, forensic medicine specialists,
p.000263: philosophers and other representative of humanitarian departments and, naturally, clinicians and health care
p.000263: managers as well as university administration for training and education of future specialists. Some actions
p.000263: in this respect are performed (Moscow State Medical and Dentistry University, etc.). Maybe, it makes sense to
p.000263: set a task to prepare a typical reference curriculum at the federal level that could be an assistance and incentive for
p.000263: universities. We should also take into account strong and weak points of the Interdepartmental Curriculum on medical
p.000263: ethics and deontology implemented in the USSR in 70’s and 80’s of the ХХ century. That curriculum could be considered
p.000263: as a historical prerequisite for education in the field of bioethics for all Post-Soviet countries. At the
...
p.000281: Russian Empire and were industrialized. In 1925 the Tajik Autonomous Soviet Socialist Republic was created as a
p.000281: part of Uzbekistan Republic, but in 1929 the Tajik Soviet Socialist Republic was made a separate constituent
p.000281: republic with the city of Dushanbe as its capital. In 1991 the Soviet Union collapsed, and Tajikistan declared
p.000281: its independence.
p.000281: Tajikistan is a mountainous landlocked country in Central Asia. Afghanistan borders to the south,
p.000281: Uzbekistan to the west, Kyrgyzstan to the North, and China to the east. The total area of Tajikistan Republic is
p.000281: 143.1 thousands of square km, and it has a population of 7,163,506 citizens. Tajikistan consists of 4 administrative
p.000281: divisions: 2 provinces (Sughd in the north and Khatlon in the south), 1 autonomous province (Gorno-Badakhshan
p.000281: - Pamir), and disrtricts of republican subordination around Dushanbe.
p.000281: Tajikistan is an agrarian-industrial country and has a considerable potential. Lengthy wars caused
p.000281: devastations and human losses, which resulted in a dramatic economic recession. However, during the last peaceful
p.000281: years the economics and living standard have notably increased.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000283: 283
p.000283:
p.000283: The Tajik people have a rich and ancient culture. Since antiquity to the period of feudalism moral and
p.000283: ethical issues took an important place in religious and philosophical outlook. Until the IX century it had
p.000283: been developing in the context of Iranian philosophy, and later, since the 9th to the XV century in the
p.000283: context of Arabic philosophy. Due to the ethnic, language, social and political commonality in antiquity and the early
p.000283: Middle Ages particularly close relations were between East-Iranian (ancestors of the Tajiks) and West-Iranian
p.000283: (ancestors of the Persians) people. The Tajik- Persian philosophical thought had also a connection with Indian and
p.000283: Greek philosophy. However the closest links connected the Tajik culture and spiritual and philosophic outlook
p.000283: with cultures of Turkic peoples of Central Asia and Azerbaijan. There was a mutual enrichment of cultures, spiritual
p.000283: values and scientific achievements.
p.000283: Religious and philosophical ideas of Tajik ancestors roots back to an ancient monument of spiritual
p.000283: culture “Avesta” the holy canon of Zoroastrism (Mazdeism) containing not only religious dogmas but also
p.000283: ideas on cosmogony, philosophy, morals and law. The characteristic feature of Zoroastrianism is dualism, i.e. the view
p.000283: that two fundamental concepts exist, such as good and evil, and the struggle between these is the pivot and content of
p.000283: the universe. Zoroastrianism formulated a ternary ideal of the righteous man (“good thoughts”, “good words” and
p.000283: “good deeds”) opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked words” and “wicked deeds”). The
p.000283: Zoroastrian idea about infinite time as an initial substance gave rise to zervanism – a teaching in the framework of
p.000283: which a materialistic trend developed that denied the creation, and god as the creator of the universe, and
p.000283: affirmed the belief in the eternity of the world. In the end of the slave-owning system and in the beginning of
p.000283: feudalism, Manichaeism (Mani, 215-276) and Mazdakism (Mazdak, the end of the V - the beginning of the VI century)
p.000283: became very influential. Those philosophical trends assimilated the Zoroastrian ideal about the struggle
p.000283: between the good and the evil. The social doctrine of Mazdakism proclaimed ideas of justice and equality.
p.000283: The earliest written evidence that peoples of Central Asia had a good knowledge of mathematics and astronomy is
p.000283: “Avesta” containing data on the movement of celestial bodies, the system of time count and some mathematical rules.
p.000283: In that period, early states in Central Asia achieved a high
p.000283: level of material production and culture: crafts, agriculture, architecture and art. That was the time when many
...
p.000283: science. That was the time when astronomical observatories, “Houses of Wisdom” and libraries were built.
p.000283: Scientists from Central Asia translated and commented the scientific heritage of ancient Greece and India and
p.000283: wrote original works on mathematics, astronomy, mineralogy, applied mechanics, physics, chemistry and medicine.
p.000283: Mohammed ibn Musa al-Khorezmi, Abdul Marvazi, Usman Balhi al-Fergani (IX c.), Abul-Vefa al-Buzjani, Abulmahmud Hudjani
p.000283: (X c.) and many others made an essential contribution to science. In the XI-XIV centuries Khorezm, Bukhara,
p.000283: Merv, Gazna and other towns, and later, in the XV century, Samarkand with the Ulugbek’s observatory,
p.000283: were outstanding scientific centres. The names of Biruni (X-XI c.), Omar Khayyam (XI-XII c.), al-Djurjani
p.000283: (XII c.), Naseeruddin Tusi, Shamsiddine Samarkandi, Djamaleddine Bukhoroi, Alishakh Buhoroi (XIIc.), Mohammed
p.000283: Samarkandi, Ansori (XIV c.) and others are associated with medieval towns. The leading scientists of the
p.000283: Samarkand scientific school were Kazi-zade ar-Rumi, Djemshid al-Kashi
p.000283: (XIV-XV c.), Ali Kushchi (XV c.), Abu Ali Ibn Sina and others.
p.000283: Ethics as a scientific trend had a significant place in works of prominent oriental thinkers, and Ali Ibn Sina
p.000283: (Abu Ali al-Husain ibn Sina-e Balkhi (Latinized Avicenna) one of them; a philosopher, musician, poet, physician,
p.000283: the follower of Aristotle, he was a scientist of encyclopaedic knowledge and one of the greatest minds of the Middle
p.000283: Ages. Roger Bacon was certainly right when he wrote that Ibn Sina was “the greatest teacher of philosophy after
p.000283: Aristotle”. The Tajik by birth, he was born in the suburb of Bukhara
p.000283:
p.000284: 284
p.000284:
p.000285: 285
p.000285:
p.000285: (Afshon) in 980, lived in different cities of the Central Asia and Iran, served various rulers as a court
p.000285: physician and vizier, and died in 1037 near Hamadan.
p.000285: Abu Ali Ibn Sina wrote in the Arabic and Tajik languages. He left a rich scientific heritage – about 300 works, and
p.000285: among those “Book of Healing”, “Book of Knowledge”, “Book of Directions and Remarks”, “Book of Salvation” and
p.000285: “Canon of Medical Science”. The latter had been considered as one of the fundamental medical guidelines during
p.000285: five centuries. He was the author of works on philosophy (e.g. commentaries on Aristotle’s “Poetics”), wrote lyrical
p.000285: poetry, and some poems have survived to out time. Ibn Sina’s “Book of Healing” was the highest achievement of the
p.000285: medieval philosophy, particularly, as it tried to reconcile rationalistic thinking and religion. A great
p.000285: number of his works were translated into Latin in the second half of the XII century.
p.000285: “Book of Healing” in 18 volumes included “Logic”, “Poetics”, “Rhetoric”, “Physics” (in eight
p.000285: chapters; the sixth chapter was entitled “On the Soul”) and “Metaphysics”. Dominique Gundisalvi from
p.000285: Toledo completed the latter in 1180.
p.000285: Following Aristotle, Abu Ali Ibn Sina classified knowledge into theoretical and practical trends, and
p.000285: attributed ethics, economics and politics to the practical area. He considered problems of essence and existence in the
p.000285: light of Neoplatonism.
p.000285: The starting point of Aristotle’s ethical teaching was the theory that social life of human beings is realized
p.000285: in actions and in their interaction. Already in the first paragraph of “Great Ethics” Aristotle wrote that to act in
p.000285: social life, one should have certain ethical qualities and be a worthy man. To be a worthy man means to have virtues.
p.000285: Therefore, the one who intends to act in social and political life should be a virtuous man. Substance and form cannot
p.000285: exist independently, they are interconnected. In the so called “dispute of universalia”– one of the fundamental
p.000285: problems in medieval scholasticism – Abu Ali Ibn Sina followed Aristotle’s theory of interrelation of substance and
p.000285: form and believed that universalia exist both in things and in human mind. The latter elicits universalia from
p.000285: things, and even ante things (ante res) and after things (post res). Ibn Sina did not doubt that the world is
p.000285: intelligible and stressed the importance of logic considering it as an introduction to every science. With regard to
p.000285: psychology, Ibn Sina also
p.000285: followed Aristotle and distinguished the vegetable, animal and rational soul. He gave a special attention to
p.000285: the human soul and did not deny its immortality, not in the direct, but in the philosophical sense, i.e. he
p.000285: did not believe in metempsychosis. Neoplatonic ideas of Aristotle are present also in those philosophical views of Abu
p.000285: Ali Ibn Sina that contain elements of Sufism. Aristotle’s philosophy developed by Abu Ali Ibn Sina and his followers
p.000285: (including Omar Khayyam) was very popular in the orient. The teaching of Ibn Sina contained some materialistic elements
p.000285: (the idea of the eternal material world, sensualist elements in the theory of cognition, etc.). Ibn Sina’s talent shows
p.000285: itself most fully in the analysis of Neoplatonism philosophy. His works “Book of Healing” and “Book of Salvation” are
p.000285: still considered encyclopaedias of Muslim Neoplatonism. Another work by Ibn Sina “The Justice” that has not survived to
p.000285: our days presented an analysis and comparison of views of Alexandria and Baghdad schools of Neoplatonism. In “The
p.000285: Justice” Abu Ali Ibn Sina is an arbitrator between the two quite famous medieval philosophical schools. His book
p.000285: “Oriental Wisdom”, probably, also offered an analysis of works by oriental philosophers who commented on
p.000285: Neoplatonism considering views of Alexandria scientists. “Book of Directions” that was, by legend, Ibn Sina’s last
p.000285: work shows the author’s Sufi views. A number of works consider the problem of free will. Abu Ibn Sina associated
p.000285: free will with active, practical intellect, which stressed a purely ethical, not psychological, nature of his
p.000285: theory. A.K.Zakuev rightly noted that Ibn Sina’s teaching covers problems of regulating human behaviour, moral
p.000285: judgments, and of ethical compliance of human behaviour with commonly recognized moral principles and with an
p.000285: individual’s own views derived from those principles for regulating his/her behaviour of his/
p.000285: her own volition.
p.000285: Some works by Ibn Sina show us his adherence to certain aspects of Sufism and mystical symbolism. Famous for its
p.000285: encyclopaedic character, his philosophy served for reconciliation of religious views and rationalistic sciences, which
p.000285: alone would suffice to consider him an original philosopher. Avicenna had a noticeable influence on views of
p.000285: Thomas d’Aquin and Albert the Great – the two prominent medieval philosophers. Agiographic texts abound in
p.000285: evidences on remarkable abilities of Hadji Naseeruddin Obaidullah Ahmar from Maverannahr (1404-1490), a religious
p.000285: figure, who worked miracles to protect order, justice and the oppressed. His actions
p.000285:
p.000286: 286
p.000286:
p.000287: 287
p.000287:
p.000287: showed his mercy to the oppressed and sternness towards oppressors and their accomplices who forgot the moral norms of
p.000287: Sharia. His style of behaviour demonstrated norms of righteousness, good deeds and ethical conduct.
p.000287: Abu Ali Ibn Sina was very popular among European scholastics (especially in the XIII c.). In the Middle
p.000287: Ages separate chapters from Avicenna’s “Book of Healing”, such as “Logic”, “On the Soul” and
p.000287: “Metaphysics” were translated into Latin, and Christian philosophers all over Europe considered themselves
p.000287: either followers of admirers of Abu Ali Ibn Sina.
p.000287: Ethical views of another great Tajik scientist, thinker and political figure of the XIII century Naseeruddin
p.000287: Tusi on the essence and norms of morals we find in his work “Ahloki Nosiri” composed of two parts: “On the fundamentals
p.000287: of morals” and “Doctrine of the purpose”. For him ethics as a science of behaviour is an essence of not only innate but
p.000287: also of acquired qualities, and being a product of social relations it may change according to social events. The
p.000287: author describes factors causing ethical changes.
p.000287: Ar-Razi proceeded from the materialistic tradition of Democritus who recognized natural regularities of nature
p.000287: and society and affirmed the cognoscibility of the world. Advanced ideas of Biruni who opposed the
p.000287: natural-science approach to the religious worldview were widespread. During the IX-XIV century, kalam, a scholastic
p.000287: philosophy of Islam that emerged in the VIII century, gained popularity and was opposing progressive views of Ibn Sina
p.000287: and his followers. Kalam defenders (Gazalii Fahruddin Rosi) advocated the idea of the Creation and believed that the
p.000287: world depends on the divine will. In the XI century, the teachings of Ismailism (a philosophical doctrine of Ismailism
p.000287: based on Neoplatonic and Aristotle’s views) became very influential (Nasir Hisrov). In their teaching on the
p.000287: harmony of the universe the Ismailis likened the constitution of the universe (“macrocosm”) to the constitution of
p.000287: human body (“microcosm”).
p.000287: Continuous internal wars in khanates of the Central Asia over XVI-XIX centuries resulted in the decline of productive
p.000287: forces, and living conditions of working masses changed for the worse. During that period, reactionary clergy was
p.000287: extremely influential, and repressed any scientific thought. The main attention was given to Muslim theology and
p.000287: ethics. The influence of the Sufi doctrine and literature with biographies of Sufi sheikhs and moral regulations of
p.000287: various Sufi Orders was particularly strong. Progressive
p.000287: tendencies and anti-feudal views were expressed in works by Tajik poets and thinkers, such as Binoi (1453-1512), Vasifi
p.000287: (1485-1551), Hiloli (executed in 1529), Saiido Nasafi (died in 1707 or in 1711), Bedil (1644-1721) and others. Their
p.000287: works reflected interests of working people and their protest against a feudal exploitation.
p.000287: Starting from the second half of the XIX century, the Russian Empire had a favourable influence on the development of
p.000287: philosophical and socio- political thought of the Tajik and other peoples of the Central Asia. Under the influence of
p.000287: Russian culture, democratic and enlightening views paved the way to Marxist-Leninist ideology. The involvement in the
p.000287: sphere of economic and scientific interests of Russia, despite an imperial policy of tsarism, facilitated the
p.000287: process of the implementation in Tajikistan of new and more developed agricultural and industrial machinery, transport
p.000287: equipment, new methods of farming and new crops. In the period from the end of the XIX to the beginning of the XX
p.000287: century, Russian culture influenced the development of the Tajik philosophical, scientific and engineering thought.
p.000287: Ahmad Donish, Hodji Halif, Hodji Jusup, Yakubi Farang, Hairat, Somi, Sobir, Asiri, Siddiki, Aini and others advocated
p.000287: ideas of national progress and social justice and criticized medieval feudal system. Scientific centres of Moscow,
p.000287: Leningrad and other cities were helpful in rising Tajik philosophers. The study of the history of Tajik philosophy and
p.000287: teachings of ancient peoples of the Central Asia was also very important. S.Aini, A.A.Semenov, A.M.Bogoutdinov,
p.000287: Z.Sh.Radzhabov, M.Boltaev, G.A.Ashurov, M.Dinorshoev, M.Radjabov and others analyzed in their works problems of the
p.000287: unity of the national and the international in the history of Tajik culture and philosophy, revealed special
p.000287: regularities of their development, the character of interaction with other philosophical trends and unmasked
p.000287: reactionary nature of Europocentric and Asiacentric concepts. Tajik scientists carried out studies in the
p.000287: sphere of dialectical, historical materialism and philosophy of natural sciences; they analyzed laws and categories of
p.000287: materialistic dialectics, objective regularities of historical development and conscious human activity,
p.000287: problems of education, formation of socialist nations, methodology of modern science, etc. (S.Umarov, M.S.Asimov,
p.000287: S.B.Morochnik, V.I.Pripisnov, M.Gafarova, A.Tursunov, I.Sharipov, S.A.Radjabov, K.Sabirov, M.Kamilov). The works on
p.000287: scientific atheism analyzed problems of developing a scientific and materialistic worldview, causes for
p.000287: survival of religious views and ways
p.000287:
p.000288: 288
p.000288:
p.000289: 289
p.000289:
p.000289: to overcome the problem; gave a critical analysis of various religious concepts (A.Bazarov, R.Madjiev). There
p.000289: were also new studies in the field of sociology, ethics and aesthetics.
p.000289: The late eighties and early nineties were marked with complicated and contradictory events, the most significant
p.000289: of which was a disappearance of such a state as the USSR on the map of the world. Instead, about 15
p.000289: new independent states appeared, and Tajikistan among those. Thus, within a short historical interval Tajikistan
p.000289: moved from one historical period to another; the state and power structure changed, as well as its
p.000289: attributes. The former political system was destroyed, which resulted in the change of ownership patterns and social
p.000289: relations.
...
p.000295: based on the IPA CIS model Law “On the Protection of Human Rights and Dignity in Biomedical Research in CIS”.
p.000295:
p.000295: 3.9.3 Education in Bioethics
p.000295:
p.000295: In Tajikistan biomedical ethics is considered as a interdisciplinary field of knowledge analyzing moral problems of
p.000295: human attitude to living organisms. However meanwhile we do not have either a system of organizational and legal
p.000295: support or objective conditions for a proper development of bioethics. This implies an insufficient propagation of
p.000295: scientific knowledge and juridical culture both in medical community and public at large. Another factor is scarce
p.000295: technical equipment for biomedical research, though much is being done to improve the situation.
p.000295: In the XXI century, the reform of healthcare in Tajikistan is inseparably linked with scientific studies in the fields
p.000295: where the issues of bioethics are of vital importance. In western countries, bioethics is an advanced educational
p.000295: discipline. In the last decade some CIS countries, such as Russia, Ukraine, etc. have been introducing courses on
p.000295: bioethics into the syllabus of medical, philosophical and sociological faculties.
p.000295: At the Tajikistan Medical University ethics is taught within a Course on Ethics and Deontology at the Department of
p.000295: Philosophy. Education in ethics for undergraduate medical students helps them to develop their moral and ethical
p.000295: outlook and to make an appropriate and just decision when conducting a medical research. Unfortunately today
p.000295: bioethics as a special discipline is not included into the system of education in Tajikistan.
p.000295: Introduction of a course on biomedical ethics into the course of higher educational institutions in RT is the demand of
p.000295: the times as Tajikistan has taken the path of democratic development of the juridical civil state where reforms cover
p.000295: the total sphere of education for the purpose of forming a new outlook in professional training.
p.000295:
p.000296: 296
p.000296:
p.000297: 297
p.000297:
p.000297: Humanities are essential components of professional training of a future physician as they enhance moral development
p.000297: and mutual understanding. We share the opinion that bioethics is a subject of interdisciplinary
p.000297: communication, and, with regard to medicine, it should be taught at institutes of higher medical education as moral and
p.000297: ethical knowledge used in patient- physician communication.
p.000297: Bioethics in CT is developing in several directions: education (medical, pedagogical, social, and economic);
...
p.000307: Cabinet on
p.000307: the necessity to ratify the Convention efforts are underway towards the development of a relevant legal and
p.000307: normative basis. There was an attempt to adopt a complex law on human rights and biomedicine by analogy with the
p.000307: Convention but the institutions where the draft law was submitted for consideration decided that it required an
p.000307: essential revision.
p.000307:
p.000307: 3.10.3. Education in Bioethics
p.000307:
p.000307: There are 17 institutes of higher medical education of the 4th level of accreditation (undergraduate level) and 3
p.000307: institutes for postgraduate training located in 14 provinces of Ukraine.
p.000307: Starting from 1990s some bioethics problems began to appear in the course of undergraduate and postgraduate training of
p.000307: medical professionals, biologists, social workers and veterinaries, and eventually special training modules and courses
p.000307: in bioethics have been designed.
p.000307: In 2004 the Ministry of Health approved an elective course in bioethics for students of the 5th year at medical
p.000307: universities and institutes of the 4th level of accreditation. The course consists of lectures (10 academic hours),
p.000307: practical seminars (17 academic hours) and students’ individual work (54 academic hours)
p.000307: Although the elective course in bioethics was adopted as a special course for institutes of higher
p.000307: medical education, today bioethics in Ukraine is usually taught not as a separate course but as a
p.000307: fragment of compulsory courses in philosophy of science and medicine, ethics, ethics and deontology of social
p.000307: work, valeology et al. The list of topics and number of hours depend on different teachers and their views on
p.000307: bioethics and the place it has in their courses.
p.000307: Bioethics is also taught at medical institutions for postgraduate training, at universities and polytechnic institutes,
p.000307: at veterinary academies and other institutes of higher education in Kiev, Lvov, Kharkov, Odessa, Vinnitsa and other
p.000307: Ukrainian cities.
p.000307: Thus the Department of Philosophy at National Medical Academy for Postgraduate Studies named after P.L.Shupik was one
p.000307: of the first in Ukraine to introduce in 2000 a compulsory course “Bioethics as Modern Medical Ethics” (12 hours) for
p.000307: postgraduate students. Bioethics is also included into some other courses offered by the Academy: “Sociocultural,
p.000307: Ethical and
p.000307:
p.000308: 308
p.000308:
p.000309: 309
p.000309:
p.000309: Deontological Aspects of Physician’s Activity” (18 h) for clinical residents; “Philosophy of Medicine” (36 h) for
p.000309: PhD students and PhD candidates; “Organization and Performance of Ethical Review of Biomedical Research” (36 h) for
p.000309: physicians and members of ethics committees at research institutes and institutes of higher medical education in
p.000309: Ukraine.
p.000309: A considerable experience in teaching bioethics has been accumulated at National Medical University named
p.000309: after A.A.Bogomolets and at Ukrainian Medical College (Kiev). A programme on experimental studies of bioethics
p.000309: basic principles was launched in 2000 at Ukrainian Medical College at National Medical University named
p.000309: after A.A.Bogomolets and has been successfully functioning since then. Within the framework of teaching
p.000309: seminar the following activities are carried out during every academic year:
p.000309: • Individual work – analysis of actual bioethical problems and situations; assistance in the preparation of
p.000309: a computer presentation; report presentation and a follow-up discussion;
p.000309: • Regular public open lectures by leading Ukrainian and Russian scientists on actual ethical problems
p.000309: relating to biomedical technologies;
p.000309: • Visiting teaching seminars on the basis of the Institute of Experimental and Theoretical Biophysics at the Russian
p.000309: Academy of Sciences (town of Pushchino, Russia)
p.000309: In Kiev compulsory courses in bioethics are also taught at the National Technical University (Department of
p.000309: Political Sciences, Sociology and Social Work), Academy of Labour and Social Relations (Department of
p.000309: Practical Psychology and Social Work), T. Schevchenko National University (Faculties of Ethics and Aesthetics,
p.000309: Biochemistry and Science Methodology), at the National Agrarian University et al.
p.000309: In the western region of Ukraine bioethics is taught in the context of fundamental principles of
p.000309: Christian moral (Ivano-Frankovsk Medical Academy, Lvov Theological Academy, Lvov State Academy of Veterinary
p.000309: Medicine named by S.Z.Gzhitsky, Lvov State Medical University named after D. Galitsky, The Western Branch of
p.000309: Interregional Academy of Personnel Management et al.). Thus Lvov Medical University offers an elective
p.000309: course in bioethics for students in the 3rd year at every faculty. There are also seminars (16 h) for
p.000309: physicians and teaching staff held at the Department of Healthcare Organization and Management. To provide the
p.000309: teaching process with methodical materials, The Training and Methodical Centre for Bioethics was established at the
p.000309: University.
p.000309: Institutes of higher education in Kharkov became methodical centres of teaching bioethics in the Eastearn Ukraine.
p.000309: Since 2004 the Department of Valeology at the Faculty of Philosophy of Kharkov National University named after
p.000309: V.Karazin has been offering a special course “Bioethics as the Ethics of Health” (90 hours). The course
p.000309: was designed for students of the 2nd year who are trained as teachers in valeology. At all faculties of Kharkov
p.000309: Medical University bioethics is taught as an elective seminar course. Kharkov Zoo-Veterinary Academy has a
p.000309: noteworthy experience of teaching bioethics based on the use of alternative methods of studying anatomy and physiology
p.000309: of human beings and animals.
p.000309: At Vinnitsa National Medical University named after N.I. Pirogov bioethics is taught to students of the 3rd
p.000309: year (Faculty of Dentistry, 27h) and to students of the 5th year (Faculty of Pharmacology, 54 h). Both courses end with
p.000309: a test. Bioethics is also taught at institutes of higher education in Dnepropetrovsk, Zaporozhye, Lugansk, Odessa,
p.000309: Poltava, Sumy et al.
p.000309: Different public associations play an essential role in distribution of bioethical knowledge - such as
p.000309: All-Ukraine Public Organization “Ukraine Association on Bioethics”; Kiev Ecological and Cultural Centre; Kharkov
p.000309: Regional Society for Animal Protection and others. Due to their efforts a number of foreign materials were translated
p.000309: into Ukrainian language, books and manuals on teaching bioethics were written to be used in Ukrainian
p.000309: universities and institutes.
...
p.000311: bioethics and interpretation of basic bioethics problems.
p.000311: Currently there is an urgent need to teach bioethics as a special form of worldview, as an interdisciplinary science
p.000311: uniting separate fields of natural sciences and humanities. Bioethics should be considered and studied as
p.000311: global ethics (knowledge of humanity global problems and ways how to resolve those) and as a field involving
p.000311: different cultural traditions.
p.000311: Today opportunities for education in the field bioethics and Good Clinical Practice on the international level
p.000311: for specialists from Ukraine are restricted to separate training courses and seminars (including conferences,
p.000311: symposiums or congresses on bioethics and clinical research) held by public organizations, institutes of higher
p.000311: medical education, research institutes, National Academy of Sciences, National Academy of Medical Sciences and State
p.000311: Pharmacological centre of Ukraine.
p.000311: We do not have a system of education in GCP principles. The only course for training members of ethics committees
p.000311: “Organization and Performance of Ethical Review of Biomedical research” (36 h) was designed and adopted at the
p.000311: Department of Philosophy of National Academy for Postgraduate Training named after P.L.Shupik (Kiev).
p.000311: Over last 5 years several PhD dissertations in specialties “science philosophy” and “public management”
p.000311: directly related to medical and ecological ethics have been defended.
p.000311: Nowadays teaching bioethics as an academic discipline requires the combination of instrumental principles,
p.000311: approaches and standards of natural sciences with theoretical models and principles of humanities.
p.000311: Although teaching bioethics as a separate discipline has begun only 5-6 years ago, a high level of higher
p.000311: medical and humanitarian education, highly professional teachers, a sufficient number of libraries, internet
p.000311: offer a favorable opportunity for a further development of education in bioethics. Teaching bioethics as
p.000311: a compulsory discipline at medical, biological and humanitarian institutions of higher education will facilitate
p.000311: not only humanization but also algorithmization of specialists’ thought,
p.000311: democratization of professional activity, interdisciplinary integration of theoretical and practical knowledge as
p.000311: well as improving of teaching process as a whole.
p.000311:
p.000311: References
p.000311: 1 Vekovshina S.V., Kulichenko V.L. Bioethics: Origins and [Theoretical] Grounds (A Philosophical
p.000311: and Methodological Analysis) Kiev, 2002 (in Russian).
p.000311: 2 Potter W.R. Bioethics – Bridge to the Future. /Ed. Vekovshinina,
p.000311: V.L. Kulinichenko. Kiev, 2992 (Translated from English).
p.000311: 3 Ethics Committees. Establishment, structure, functions. /Ed. V.L. Kulinichenko, S.V. Vekovshinina. Kiev, 2002
...
p.000313: also trials of new medical equipment and other medical facilities, methods of surgical intervention, epidemiological
p.000313: studies, research in genetics and psychology and others.
p.000313: Before the 1990s the majority of research in Ukraine was conducted without any ethical control.
p.000313: In the beginning of the 1990s Ukrainian scientists started participating more actively in international scientific
p.000313: projects and clinical research, which stimulated implementation of ethical review. By that time, Ukraine had a negative
p.000313: experience when international projects could not be developed just because there was no procedure of ethical
p.000313: review. Starting from 1992 leading research institutions begin to establish local ethics committees for
p.000313: considering ethical aspects of actual international projects with the participation of Ukraine. In 1995
p.000313: the Pharmacological Centre of the Ministry of Health established Ethics Committee to harmonize the system of
p.000313: conducting clinical trials and registration of pharmaceutical products.
p.000313: In 1998 on the initiative of UNESCO the International Committee on Bioethics was established which
p.000313: followed by establishing national ethics committees in many countries. In the same year, on the proposal
p.000313: of the National Commission of Ukraine for UNESCO submitted to the National Academy of Sciences the
p.000313: Bioethics Committee was established at the Presidium of National Academy of Science of Ukraine. Leading
p.000313: academicians in the fields of biology, medicine, philosophy, as well as representatives of Ministry of
p.000313: Health, Ministry of Environmental Safety, Ministry of Education and Science, Ministry of Justice and of Academy of
p.000313: Medical Sciences and Academy of Agrarian Sciences were invited to take part in the work of the Committee.
p.000313: In 2002 Bioethics Committee at the Presidium of Academy of Medical Sciences of Ukraine was established. In cooperation
p.000313: with Ministry of Health it developed model regulations for medical ethics committees at scientific and medical
p.000313: institutions in line with modern international requirements. During these years a number of public organizations
p.000313: having a concern in bioethics have emerged, and the implementation of the system of ethical review for biomedical
p.000313: research has begun on a large scale.
p.000313: Today we have the following system of ethical review. Firstly, there are different laws and by-laws regulating
p.000313: biomedical research. The order of conducting clinical trials of pharmaceutical products and reviewing materials of
p.000313: clinical trials has been developed in compliance with the Articles 7 and 8 of the Ukrainian Law “On Pharmaceutical
p.000313: Products”43 and in line with requirements of the Directive 2001/20/EC of the European Parliament and of the
p.000313: Council EC ICH GCP44 and Declaration of Helsinki45. It was approved by the Order of the Ministry of health
p.000313: of Ukraine No 6646. The responsibility for reviewing documentation on clinical drug trials rests with the State
p.000313: Pharmacological Centre of the Ukrainian Ministry of Health.
p.000313: General principles of conducting clinical trials:
...
p.000321: “adab” and “adabnoma” – a teaching describing the due behaviour of a well-brought-up person. The term combines the
p.000321: general education, the theory of ethics and norms of a polite behaviour. Both in a strictly scientific sense and by
p.000321: birth terms “ethics” and “adabnoma” are not identical; they differ in the approach to the study of ethics, in
p.000321: argumentation and in the focus of their attention (general abstract principles and/or a code of behaviour). Central
p.000321: Asian codes of behaviour “Kobusnoma” by Unsurmaol Kaykovus, the treatise “On Ethics” by Ibn Sina, “Four
p.000321: Conversations” be Arusi Samarkandi, “The Oriental Code of Decencies” by Sadyk Kashgari and many other works are
p.000321: fundamental methodological sources of Uzbek model of bioethics. Adabnoma, rather than Islam, provided a
p.000321: basis for the development of research ethics and medical practice in pre-Soviet time. Thus, distinctive features
p.000321: of national historical and cultural, philosophical and methodological sources of biomedical ethics in
p.000321: Uzbekistan are the pedagogical orientation and a pronounced didactic character. Such were traditions, norms
p.000321: and values of Zoroastrism and Islam and achievements in medicine and philosophy of the Moslem (Arabic)
p.000321: Renaissance, creative heritage of Central Asian thinkers and physicians Abu Ali Ibn Sina, Abu Abdullah
p.000321: Khorezmi, Abu Nasr Mohammed al-Farabi, Abu Raihan Beruni and other prominent figures representing Islamic
p.000321: philosophical and religious thought (Al Kindi, Abu Hamida Gazali, Ibn Rushda, Abu Bakra Ar-Razi). However,
p.000321: nowadays syncretism of oriental philosophy reveals itself in the fact that modern Uzbek philosophers and physicians do
p.000321: not make a clear distinction between secular and religious argumentation. Sacred texts have traditionally been a source
p.000321: of philosophical thought for Uzbek investigators. Western scientists usually state their positions. The Western
p.000321: bio[medical] ethics distinguishes between biomedical ethics based on religious teachings and secular biomedical ethics
p.000321:
p.000322: 322
p.000322:
p.000323: 323
p.000323:
p.000323: that uses ethical argumentation as such. Sacred texts offer a comprehensive collection of thoughts, and one may find in
p.000323: them confirmation from “above” of nearly any statement.
p.000323: Moslem teaching has developed special canons of the attitude to patients and disabled persons that, to a large
p.000323: extent, formed the basis for patient-physician relationship. First of all, Al Bukhari’s khadises remind Moslems
p.000323: that the Prophet suffered severely, and therefore, who, if not Him, knows better what it means to be ill and suffer
p.000323: (Abu Abdullah Muhammad ibn Ismoil al-Bukhoriy. Khadis. Al-jomi’ ac-cokhikh 4. Ishornali tiuplam. Tashkent, Komuslar
p.000323: bosh takhririiati, 1992. B. 3 – in Uzbek). Everything that befalls human beings is of God’s will. To visit the sick,
p.000323: even infants, is a duty of each Moslem. It is a tradition not to ask about the disease or name the disease aloud; one
...
p.000323: illness, the physician’s duty is to relieve his/her suffering with various analgesics and to render moral support
p.000323: in the face of impending death, so that the patient would leave this world as a sensible person who
p.000323: completed all his/her earthy tasks, bid farewell to his/her relatives and repented before the Almighty Allah.
p.000323: Abu Ali Ibn Sina (980-1037) expressed his attitude to euthanasia in his “Biography” wrote that a
p.000323: seriously ill person consciously “broke the regimen for the last time”, which hastened his death. Here
p.000323: we have to mention his views on medical and ethical problems of dying and natural death. These views expand the scope
p.000323: of modern bioethics, which allows us to retransmit from the past entire strata of knowledge about the physician’s duty
p.000323: and search of new ways for applying ethics when it is necessary to care for a dying patient, to form behaviour
p.000323: standards in seriously ill patients, to safeguard their rights for a good death and to maintain their faith in
p.000323: spiritual and moral immortality of human soul.
p.000323: In the light of the aforesaid, Ibn Sina’s treatise “Illumination” that is not widely known among researches is of a
p.000323: particular interest. The treatise adds to concepts of natural death presented in “Canon”. In modern terms, the treatise
p.000323: suggests that the philosophy of death ensues logically from a moral comprehension of life. Ibn Sina offers a systemic
p.000323: substantiation of the natural death from the viewpoint of the right to a good death and in the light of the theory that
p.000323: death means “the return” to an origin. This idea was developed in many works, particularly in works by Ilya Mechnikov
p.000323: (1845- 1916) who attempted to explain the concept of “the instinct of natural death” from the viewpoint of biology and
p.000323: psychophysiology.
p.000323: With regard to ethical principles, “Canon of medical Science” is a literary source containing elements of
p.000323: bioethics. It differs from its antiquity analogues in the attempt to characterize medicine not only as a system of
p.000323: medical and biological knowledge, but also as a canon of spiritual and ethical basis of the entire medical science
p.000323: (“Avicenna and the ethics of science and technology today”. Division of Science and Technology Ethics, UNESCO, France,
p.000323: 2006, p. 1-16). There were many reasons why “Canon” excited much interest in different historical periods including the
p.000323: European Renaissance. However, there are no doubts that in “Canon of Medical Science” a human being for the first time
p.000323: becomes not merely a subject of an anatomical or physiological research but a person. It is noteworthy that the “Canon”
p.000323: is really permeated with humanistic ideas. It has a powerful spiritual and moral potential for the development of
p.000323: medical science the subject of which is not just a human being but also his/her life style with all the variety of
p.000323: cultural,
p.000323:
p.000324: 324
p.000324:
p.000325: 325
p.000325:
...
p.000325: he teaches; he should follow the moral principles and be an honest, loving and courageous person.
p.000325: In the system of Ibn Sina’s ethical views, a concept of mizaj implying the necessity of an entirely individual approach
p.000325: to each individual, irrespective of the person’s age of health condition and considering a unique combination of
p.000325: qualities on the individual and his/her living and working conditions.
p.000325: The knowledge of human nature and temperament is the basis of a physician’s strategy when maintaining a
p.000325: proper level of health, and, if need be, planning the therapy. A comprehensive study of the “Canon” helps us to tell a
p.000325: sanguine person from a phlegmatic one or a choleric person from a melancholy one, and to mark out characteristic
p.000325: biotypes. If we translate it into the language of modern bioethics, we can see clearly the logical construct of
p.000325: Hippocrates, Galen and Avicenna; treat not a disease but a person, and not just a person but also a biotype
p.000325: whose psychological responses are subordinate to its biological nature (mizaj), or temperament. Ages later Ivan
p.000325: Pavlov mentioned the biotypological approach used widely by Ibn Sina as a fruitful one, revealing “fundamental
p.000325: features” of human nature.
p.000325: Thus, “Canon of Medical Science” written in the times of the Oriental Renaissance, and very popular during the European
p.000325: Renaissance, nowadays, if profoundly studied, can contribute essentially to the theory of bioethics, and humanize
p.000325: modern medicine and healthcare. Fundamental ethical ideas of “Canon of Medical Science” uniting medicine and a worthy
p.000325: life in the philosophy of health are still topical nowadays. Moreover, it outruns, in many respects, our
p.000325: ideas on medical ethics. Indeed, Ibn Sina’s attempts to link problems of medicine with the mode of life and to create
p.000325: conditions for maintaining spiritual harmony throughout a person’s life are particularly significant nowadays.
p.000325: According Ibn Sina’s precepts, the physician should do not only his/her professional duties but also his/her moral duty
p.000325: (Kasymov
p.000325: A.I. Ethical Views of Abu Ali Ibn Sina (Avicenna). In: “Bioethics in Uzbekistan – Clinical, Philosophical
p.000325: and Legal Aspects.” Tashkent, 2006, pp. 57-62).
p.000325: In 2003, the Islamic Republic of Iran and UNESCO instituted the Avicenna prize for the development of modern
p.000325: bioethics in science. The role of Avicenna in the development of current bioethical views runs all through the book
p.000325: “Avicenna and the Ethics of Science Technology Today” published
p.000325:
p.000326: 326
p.000326:
p.000327: 327
p.000327:
p.000327: by UNESCO in 2006. Avicenna’s life and works invite us to think about the ethics of science. (“Avicenna and the Ethics
p.000327: of Science and Technology Today”. UNESCO, France, 2006, pp.1-18).
p.000327: The Moslem etiquette of attitude to the patient has been and is certainly influencing the content of professional
p.000327: ethics of Uzbekistan physicians. However, a transformation of the socio-economic development model that
p.000327: began after Uzbekistan had declared its independence in 1991, and, as a consequence, commercialization of
...
p.000327: provides an ideological foundation for the development of bioethical values. However, it would be incorrect
p.000327: merely to reduce Uzbekistan ethical norms to Islamic ones. Uzbekistan is a secular state, and Islam adherents form
p.000327: but one of society segments, and religious norms are but one of the components of biomedical ethics in Uzbekistan. Many
p.000327: ethical and medical rules of social life exist not only in form of religious dogmas but also as traditions, rituals and
p.000327: folklore, which helps to observe the norms across generations.
p.000327: Biomedical ethics in Uzbekistan is open to world tendencies, such as globalization and westernization that have a
p.000327: strong impact on Uzbekistan science. Achievements in the field of informed consent, reproductive behaviour,
p.000327: etc. prove the response to world tendencies. The protection of universal human values, as well as traditional values is
p.000327: a key issue of the contemporary medical ethics in Uzbekistan.
p.000327: Thus, the Uzbekistan model of biomedical ethics is at the stage of intensive development. The intensity
p.000327: of research development in this field is predetermined by ethical tendencies in Uzbekistan education and
p.000327: philosophy existing throughout the history of Uzbekistan (Zagyrtdinove
p.000327: F.B. Peculiarities of Biomedical Ethics in Uzbekistan. In: “”Bioethics in Uzbekistan – Clinical, Philosophical
p.000327: and Legal Aspects.” Tashkent, 2006, pp. pp. 122-128).
p.000327: 3.11.2. Legal Regulations
p.000327:
p.000327: The State plays a key role in safeguarding social and economic rights of its citizens, and therefore
p.000327: the State social policy should be directed at maintaining social health, which is described by three groups of
p.000327: characteristics: 1) population health (physical, mental and social); 2) intellectual potential and the level of
p.000327: professional knowledge; 3) spiritual and moral values.
p.000327: To maintain and improve population health and to raise a healthy generation, the Ministry of Public
p.000327: Health of the Republic of Uzbekistan undertakes a considerable work on reforming healthcare based on a number of
p.000327: principles and with a special attention to:
p.000327: • the observance of constitutional rights to receive a qualified medical care and
p.000327: • the principle of an equitable access to medical service.
p.000327: Issues relating to social relations in medicine are regulated by the Constitution of the Republic of
p.000327: Uzbekistan (Art. 24, 26, 40, 43; 1922) and by laws directed to the protection of citizens’ rights in medicine.
p.000327: 1. “On the State Control” (3 of July 1992; revised editions: 6 of May 1995; 15 of April 1999; 31 of August 2000);
p.000327: 2. “On the Protection of Consumers’ Rights” (26 of April 1996; revised edition: 5 of April 2002);
...
p.000339: rights and responsibilities, and the right for one party, is the responsibility of another one.
p.000339: The Law “On Medical Practice” will facilitate the regulation of independent ethical review and safeguard the
p.000339: protection of rights and dignity of Uzbekistan citizens in biomedical trials.
p.000339: Legislative measures undertaken in Uzbekistan will be able to protect individuals, the society and humankind as a
p.000339: whole against undesirable or sometimes harmful consequences from the implementation of new biomedical
p.000339: technologies.
p.000339:
p.000339: 3.11.3. Education in Bioethics
p.000339:
p.000339: Problems of teaching bioethics arouse much discussion at all international forums on bioethics.
p.000339: According to UNESCO Ethics Education Programme (EEP), for the biennium 2004-2005 the activities in the area of ethics
p.000339: teaching have primarily focused on East and Central Europe. During 2006-2007 priority has been given to
p.000339: South-East Europe and part of the Arab region (Gulf region).
p.000339: To facilitate the development of new relations in Uzbekistan healthcare that would more adequately comply with
p.000339: current political and social conditions, all Uzbekistan institutes of higher medical institutions and
p.000339: universities (faculties of law, philosophy and biology) introduced regular courses on bioethics into the syllabi
p.000339: of undergraduate and postgraduate education.
p.000339: According to the State Standard of Education, at institutes of higher medical education bioethics is taught at two
p.000339: levels: 1st level --”Introduction to Bioethics” and 2nd level – “Biomedical ethics” for senior students (3rd year).
p.000339: In 1998, Tashkent Medical Academy (TMA) included the study of basic bioethical problems in the baccalaureate programme
p.000339: on social sciences and humanities. Since 2002 TMA is offering modules on bioethics for magistracy residents; in 2003
p.000339: the Faculty of Post-Graduate Education at the Tashkent Medical Academy included topics on bioethics into the
p.000339: programme for post-graduate education, and since 2004 bioethics is taught as an elective course.
p.000339: The Chair of Philosophy has designed a programme on bioethics and published a manual “Introduction to Bioethics”
p.000339: in Russian and Uzbek (2004). In 2005, an anonymous questionnaire on key bioethical problems was offered to medical
p.000339: students of the second year to assess the level of their training and the system of their values and general worldview
p.000339: [1].
p.000339: In the second year students study philosophical and legal aspects of bioethics. The course consists of
p.000339: lectures (10 hours) and seminars (10 hours).
p.000339: In the third year, bioethics is taught at all faculties (general medicine, dentistry, pediatrics, biomedicine, etc.).
p.000339: The course aims at raising the level of education in biomedical ethics and the professional level of future physicians.
p.000339: Their knowledge of bioethics will help them to avoid deontological and professional mistakes and to make decisions in
p.000339: difficult situations.
p.000339: The working group of the NEC in collaboration with the TMA professionals teaching bioethics has designed a
p.000339: programme on biomedical ethics for baccalaureate students. The course consists of five lectures (10 hours), 8
p.000339: seminars (17 hours) and 54 hours are given to individual work. The course ends up with a test.
p.000339: Themes vary depending on the course. The syllabus on bioethics covers the following topics: categorical issues of
p.000339: bioethics as a science (relation of the concepts “bioethics”, “biomedical ethics”, “medical ethics”, “ecological
...
p.000343: activity, a new and more comprehensive version of the Regulations for local ECs was discussed and adopted at
p.000343: the First National Congress on Bioethics with international participation. The Regulations state that local ECs
p.000343: are created under the aegis of the NEC at patient care institutions and research institutes in form of a public unit
p.000343: that is not registered as a juridical person. Local ECs are responsible for monitoring biomedical research approved by
p.000343: the NEC at the site of the research with regard to compliance with the review procedures, obtaining informed consent
p.000343: from the research subjects, research safety (serious adverse effects, inadequate reaction) and notifying
p.000343: NEC if the
p.000343:
p.000344: 344
p.000344:
p.000345: 345
p.000345:
p.000345: research should be terminated because of complications arising in the course of the biomedical research). Local ECs
p.000345: describe the results of their activity in form of an annual report that are archived and retained at local
p.000345: ECs. Operational procedures and rules relating to documenting and archiving should ensure confidentiality of
p.000345: local ECs performance. At the same time the activity of ECs at all levels should be open to the society, which is
p.000345: stated in relevant documents. Information about ECs members, work schedule and decisions may not be confidential.
p.000345: Thus, Republic of Uzbekistan created a multilevel system for ethical review of biomedical research. In compliance with
p.000345: WHO recommendations the NEC members are leading Uzbekistan scientists with experience in various fields of medical
p.000345: and other sciences (biology, law, genetics, philosophy) and representatives of religious and public institutions,
p.000345: ombudsmen and a representative of the National Centre for Human Rights. Regional and local ECs established at regional
p.000345: centers (Samarkand, Bukhara, Andijan, Nukus) and large clinical sites at institutes of higher medical education and
p.000345: research institutes are also headed by eminent Uzbekistan scientists.
p.000345: The NEC reviews international research projects involving human subjects and makes its decisions about the
p.000345: project. The NEC of Republic Uzbekistan has been registered at American Centers for Information Disease Control
p.000345: (Atlanta) and American Centers for Disease Control and Prevention (NAMRO-3, Cairo).
p.000345: The NEC functions in conformity with Standard Operational Procedures (SOPs) designed in the process of a regular work.
p.000345: According to the NEC procedures, the documents should be reviewed within 7-30 days (expedited or regular review). Since
p.000345: the time of its establishment, the NEC has reviewed over 320 various projects including joint international
p.000345: research projects, research projects designed by Uzbekistan scientists and dissertations based on biomedical research
p.000345: involving human subjects.
p.000345: The NEC review also projects of clinical trials of pharmaceutical products, of medical equipment and other products for
p.000345: medical needs. Usually research projects meet ethical requirements, and the NEC makes positive decisions. Sometimes,
p.000345: however, there are cases when the NEC declines a project. This usually concerns clinical trials of a non-registered
...
p.000349: Teheran (October 2006). The NEC members made an essential contribution to the development of normative and
p.000349: methodical recommendations of the IPA CIS, the model law, and to the volume of SOPs.
p.000349: Nearly all NEC members gave their presentations at scientific symposia and conferences on bioethics held in the CIS and
p.000349: other countries. In 2005, the NEC held the First National Congress on Bioethics in Tashkent. Television, all leading
p.000349: newspapers and scientific journals broadly covered issues of biomedical ethics discussed at the Congress.
p.000349: The idea to combine scientific progress and ethics brought together about 200 medical scientists and members
p.000349: of teaching staff, investigators, physicians, biologists, experts in law, philosophers, theologists, journalists,
p.000349: deputies of the Legislative Chamber of Uzbekistan Parliament, representatives of various public organizations,
p.000349: delegates from different Uzbekistan cities, as well as from Kazakhstan, Kyrgyzstan, Tajikistan, Ukraine, Russia,
p.000349: Belgium, South Africa, Philippines, Singapore and other countries.
p.000349: The Congress participants discussed key issues of bioethics relating to the protection of human rights and dignity of
p.000349: biomedical research subjects in connection with the use of achievements in biology and medicine.
p.000349: The Congress participants made many interesting presentations. The Minister of Healthcare of Uzbekistan, prof.
p.000349: F.G.Nazirov spoke about ethical aspects of using new technologies in medicine; Doctor of Philosophy, professor Moshin
p.000349: Ebrahim from the Islamic University of South African Republic shared his opinion on the rights of a fetus; scientists
p.000349: from Philippines, Ukraine and Russia touched upon ethical problems concerning the use of embryonic and stromal human
p.000349: stem cells in treating various diseases. The Chairperson of the FECCIS, prof. O.I.Kubar from St.-Petersburg and Dr.U.
p.000349: Sharapov gave a talk
p.000349: on ethical aspects of clinical trials concerning HIV/AIDS; physicians from the Republican Specialized Surgery Centre at
p.000349: the Ministry of Public Health of Uzbekistan spoke about bioethical aspects of organ and tissue transplantation, and
p.000349: specialists from the Scientific Centre for Emergency Medical Care presented talks on similar problems in
p.000349: emergency medicine.
p.000349: J.N.Franco from Singapore and a group of physicians from Belgium spoke about problems of patient—physician relationship
p.000349: in the conditions of a rapid development of new biotechnologies and about truth-telling with regard to
p.000349: patients with terminal diseases. M.Baimukhamedov gave a talk on ethical aspects of the protection of patients’ rights
p.000349: in TV-medical consultations. The Congress participants discussed problems of ecological ethics and the use of
...
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p.000021: and retain conditions for a narrow reproduction.
p.000021: When considering the situation we should note that the most dramatic aggravation was observed in the areas of the
p.000021: income per person, poverty, demography and social unity, which is essential for understanding social- economic
p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
p.000021: into the international system of biomedical research both from a viewpoint of interested researchers and potential
p.000021: participants.
p.000021: In the period of transition to the market economics all the CIS countries had to face such problems as considerable
p.000021: inequity in the income distribution, stratification of the society by income and increasing poverty. In 2004, the ratio
p.000021: of the total income of 10% of the most and 10% of the least well-to- do population was 3-5 times in Azerbaijan, Belarus
p.000021: and Ukraine; 11 times in Kazakhstan, Kyrgyzstan, Moldova, Russia and Tajikistan; 21 times in Armenia.
p.000021: In recent years (2005-2007), in the majority of the CIS countries some smoothing of the society stratification by
p.000021: income and the decrease of the population quota with the income beyond the cost of living (poverty line) was observed.
p.000021: Some processes were observed in the CIS countries that were not typical before. Thus, the number of the “poor” children
p.000021: usually was growing much faster than the number of poor persons in every other age group because of the rapid spread of
p.000021: the unemployment and increasing number of persons in a low-paid job, alongside with a disproportional indexation of the
p.000021: family allowances. The level of food consumption by children has considerably decreased. Presently, the change
p.000021: in the nutrition structure is expressed by transition to food products that are less expensive and richer in
p.000021: calories. There is a lack of food products that are necessary for the normal growth and development of the organism.
p.000021: Besides, a decrease in food consumption and the worsening of the sanitary situation, hygiene and living conditions have
p.000021: caused the increase of the number of diseases (tuberculosis, rachitis) traditionally associated with poverty.
p.000021: Specific features of the demographic situation and, indirectly, the amount of labor resources depend also on
p.000021: the age groups prevailing in the total population size, which, in its turn, implies special approaches to the
p.000021: healthcare structure development in the CIS countries. The increase of
p.000021:
p.000022: 22
p.000022:
p.000023: 23
p.000023:
p.000023: the elder population and the decrease of the share of children in the total population are typical for the majority of
p.000023: the CIS countries.
...
p.000027: context this term is used with different, narrower meaning – deontology in this case implies a teaching on professional
p.000027: duties of medical workers in regard to their patients.
p.000027:
p.000028: 28
p.000028:
p.000029: 29
p.000029:
p.000029: included into curriculum of medical schools. At that, however, it was not distinguished as a separate subject – it was
p.000029: to be taught by those professors having classes on their medical fields. Therefore, within the study course there was
p.000029: simply no time to highlight medical deontology issues.
p.000029: A very important factor determining particularities and complexity of relationship development during a research
p.000029: process was characteristic for the entire medical community in the USSR paternalistic attitude among doctors
p.000029: and patients, peculiar standoff of health care professions (no public discussion on problems and errors, corporate
p.000029: spirit of medical workers) and strict vertical pattern of administration resulting in dependence of actions and making
p.000029: decisions.
p.000029: The common features being found at appearance and development of bioethics in the region are worth of specific
p.000029: attention. For a long time the region countries were out of global international dialogue on bioethics issues,
p.000029: therefore, they despite of their particular experience and specific approach to ethical issues in health care
p.000029: were not represented in the international bioethical society at a long run. Such isolation brought forth
p.000029: several considerable consequences: relatively poor development of major bioethical potential in the CIS countries and
p.000029: deficiency of capabilities for maintaining direct contacts with members of international bioethical community,
p.000029: in particular, due to limited knowledge of foreign languages for professional use and insufficient acquaintance with
p.000029: basic foreign publications.
p.000029: At the same time, within the community of the CIS countries there is a unique opportunity for international
p.000029: communication since not only majority of citizens but also specialists use a single instrument for communication, the
p.000029: Russian language. Development of bioethics in the CIS countries started about 20 years ago; one of the strongest
p.000029: impulses emerged after the first contacts of Soviet philosophers and medical researchers with their foreign colleagues
p.000029: at the end of the 1980’s. After the USSR break-up bioethics in the region developed in different conditions but, at
p.000029: that, there were present both stable cultural peculiarity and links among the region countries. The most important
p.000029: instrument influencing rates and pattern of the bioethics development is creation of special national facilities
p.000029: that having different structure and functions in some cases are entitled to adopt and implement mandatory decisions
p.000029: in the field of bioethics. Besides, all CIS countries have more or less main and similar resources for dynamic
p.000029: development of
p.000029: bioethics, and among them – teaching bioethics as a subject (mandatory or optional) in medical colleges and
...
p.000091: knowledge deserves a severe punishment, up to death penalty”.
p.000091: This discussion started many ages ago is still topical nowadays. Neither lawsuits against physicians who
p.000091: support euthanasia thus violating one of the fundamental principles in The Hippocratic Oath (“To please no one will I
p.000091: prescribe a deadly drug nor give advice which may cause his death”), nor protests of public at large advocating
p.000091: traditional views do not guarantee that those who stick to more radical opinions will not triumph in the near future
p.000091: (alas!).
p.000091: Philosophical moral principles of the Hellenistic world had a great influence on the moral code of
p.000091: medieval Armenian medicine along with the highest values of the Christian ethics. The physician who violated The
p.000091: Hippocratic Oath and gave his patient “a deadly drug” was not merely reproached for that but treated as a
p.000091: criminal guilty of an innocent person’s death with all the corresponding consequences, as stated in the chapter “On
p.000091: Physicians Prescribing Deadly Drugs” in “The Book of Chrii”.
p.000091: In his treatise “The Usefulness of Medicine” Amirdovlat Amasiatsi, an outstanding Armenian physician (XV c.) writes:
p.000091: “The physician should be reasonable and have the sense of duty; he should be tolerant and ready to give advice. In no
p.000091: circumstance should he be a drunkard nor should he be greedy and mercenary-minded. He should love the poor and be
p.000091: merciful, faithful and god-fearing. If he does not understand the essence of the disease he should
p.000091: prescribe no drug in order not to stain his reputation. If the physician is ignorant it would be better not to call him
p.000091: to see a patient, and, in general, he should not be regarded as a physician.” These words showing an ideal image of the
p.000091: physician-humanist and his moral code are still essential for modern medicine that synthesized imperishable moral
p.000091: values set forth in medical systems of the East and the West.
p.000091: Today, each of the presented problems gives rise to many new questions. At the present stage of bioethics development
p.000091: we are more able to formulate the questions than to offer a comprehensive solution, and therefore most of them remain
p.000091: open.
p.000091: References
p.000091: 1. Amirdovlat Amasiatsi. The Good of Medicine. Yerevan, 1940, p. 9 (in Armenian).
p.000091: 2. Arevshatyan S.S. Early Armenian Translations and Their Cultural and Historical Significance. // Journal of
p.000091: History and Philology of Academy of Sciences of Armenian S.S.R. 1973, No 1, p. 23-37 (in Armenian).
p.000091: 3. Vardanyan S.A. Medical and Biological Views of David the Invincible. / Philosophy of David the
p.000091: Invincible. Moscow, 1984, pp. 83-93 (in Russian).
p.000091: 4. David Anhaght. Works. Moscow, 1980, pp. 84, 77, 71, 49, 72, 44, 75,
p.000091: 61, 63, 65 (in Russian).
p.000091: 5. Oganesyan L.A. The History of Armenian Medicine. Yerevan, 1946, Vol. 1, pp. 85-127, 141-143 (in Russian).
p.000091: 6. Vardanyan Stella. History de la medicine en Armenia. Paris, 1999. pp. 43-52.
...
p.000099: - informed consent form signed by the trial participant,
p.000099: - investigator’s brochure,
p.000099: - written information and promotion materials for potential trial participants
p.000099: - documents confirming investigator’s qualification.
p.000099: When reviewing the protocol of the clinical trial the following should be considered:
p.000099: - scientific justification of the trial goals and objectives;
p.000099: - data of pre-clinical studies;
p.000099: - results of previous clinical trials;
p.000099: - risk/benefit balance of the suggested treatment;
p.000099: - the justification of the treatment plan (dosages, duration of the treatment);
p.000099: - ethics of control choice (placebo, reference drug, no treatment);
p.000099: - criteria of recruitment of the trial participants (inclusion/exclusion criteria);
p.000099: - procedures of informing trial participants;
p.000099: - materials presented to the trial participant;
p.000099: - procedures of obtaining written informed consent to participate in the trial.
p.000099: In its activity Ethics Committee follows three main principles: scientific justification, risk/benefit balance,
p.000099: informed consent.
p.000099: Scientific justification. No scientific research can be considered ethical unless it has a comprehensive scientific
p.000099: justification. A poor justification may, at best, result in the loss of participants’ time, and, at worst, it may bring
p.000099: about an unwarranted risk. Ethics Committee has the right to reject the planned research if it repeats a similar
p.000099: research, and yields no new results.
p.000099: Risk/benefit balance. The main ethical requirement for clinical trials of new drugs is to gain benefit with the
p.000099: minimum risk for the patient. It is necessary to monitor clinical trials, and register all complications, not only
p.000099: physical but such as discomfort, invasion of participant’s privacy, etc. In many cases risks are unavoidable, but it
p.000099: must be minimum and under control.
p.000099: Informed consent. The main method of protecting the individual involved in the clinical trial is his/her
p.000099: informed consent and its approval by Ethics Committee.
p.000099: The procedure of obtaining informed consent is evaluated with regard to the following requirements:
p.000099: - the potential clinical trial participant must be provided with comprehensive information on the
p.000099: goals, methods, nature of the clinical trial and its expected results, as well as on recommended and alternative
p.000099: treatment and patients’ rights and measures for their protection; information should be given in a clear and
...
p.000223: Russia. Anthropocentrism of Russian philosophical researches became one of characteristic principles of Russian
p.000223: philosophy. From Nil Sorskiy to A.N.Radischev, from Radischev to Soloviev and Berdiaev a Russian thought has been
p.000223: always attracted by cognition of mystery of person, his death and immortality (3). The Russian philosophy created
p.000223: “philosophy of life” long before birth of western European existentialism and pragmatism. Peculiarity
p.000223: of the Russian philosophy is in the fact that the Russian thought has always been (and will be forever) connected with
p.000223: its religion element and grounding and inspiration of freedom valued at any time by Russian minds had never died inside
p.000223: of church awareness. First of all everywhere dominance of morality evidences that. We can see it in works of nearly all
p.000223: Russian thinkers even those who had no works devoted to moral problems.
p.000223: Adoption of Christianity determined evaluation of Russian spirituality in subsequent periods. Founding on traditions of
p.000223: eastern orthodoxy, ideas of spirituality, shame and conscience, love to neighbor were brought in Old Russia, a
p.000223: spiritual foundation of charity as everyday piety was formed. Alms as early form of personnel charity was spread among
p.000223: all social classes, it was not only simple execution of commandment of love to a neighbor, but a true need. It was
p.000223: personnel charity that created the foundation necessary for helping the poor at the following times. It was forming
p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
p.000225: people social life organization on the basis of common views (19).
p.000225: Under church influence and with its participation care for people in need for medical and social help
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
p.000225: thousands of disabled, old people and orphans. In the 50’s of XVI century they attempted to place a part of care
p.000225: for people health, social support for sick and weak people on the state. Stoglav, a great council of Russian
p.000225: bishops held in 1551, together with tsar and boyar Duma ordered to found everywhere hospices for “leprous, aged,
p.000225: lying in boxes on the streets, carrying carts and sledges and having no place to sleep”. “Desyatina”, the tenth
p.000225: part of funds from sale of bread, cattle and from rent, was brought in to keep churches, monasteries, hospitals,
p.000225: hospices and receive odd and poor people. At the same time representatives of different social classes donated money
p.000225: for church and charity needs.
p.000225: Breakup between secular and church ideologies that began in the second half of the XVII century became wider in the
p.000225: XVIII century. Peter I activity is characterized with two mutually exclusive tendencies: strengthening
p.000225: of absolutism and europeisation of Russia. Implementing reforms for strengthening of role of the state in all
p.000225: spheres Peter I included the Orthodox church in government structure and strengthen state control on it and
p.000225: consequently on church charity. On Peter’s initiative social charity became state one. At Peter I times they took
p.000225: measures against beggary, parish as self- organized church and social unit was abolished.
p.000225: At the same time in the XVIII century higher medical education was formed in Russia. Hospital schools, medical
p.000225: department of the Moscow University, surgery academies were founded. In these circumstances the following
p.000225: feature of Russian nature revealed: to study and to alter forms and methods of organization appeared in other
p.000225: countries. For example, based on medical education system in Western Europe, in Holland particularly, in Russia it
p.000225: certainly had disadvantages but it had no breakup between interns and sergeants, between theoretical and clinical
p.000225: educations, students were trained “at patient bed”.
p.000225: Students of religious schools were studying medicine because of specific features of the Russian society
...
p.000289: new independent states appeared, and Tajikistan among those. Thus, within a short historical interval Tajikistan
p.000289: moved from one historical period to another; the state and power structure changed, as well as its
p.000289: attributes. The former political system was destroyed, which resulted in the change of ownership patterns and social
p.000289: relations.
p.000289: The development of Tajikistan as an independent secular republic in the post-Soviet space was accompanied
p.000289: with economic, political and social instability. A significant support from the international community was
p.000289: directed to the needs associated with the civil was (1992-1995) and its consequences. Emergency measures of
p.000289: providing medicines, vaccines, bandaging material taken by the international community made an essential contribution
p.000289: into the solution of healthcare problems. At the same time, there was a need in more thorough structural changes that
p.000289: would help to overcome existing problems and facilitate the development of safe mechanisms for providing
p.000289: healthcare and safeguarding patients’ rights.
p.000289: As current biomedical researches are carried out at a large scale and at many Centres, they affect interests of many
p.000289: people and many countries. New problems emerge, because “rich” countries carry over their biomedical research to other,
p.000289: “poorer” countries, and use the results of the research at home, as, “poor” countries cannot afford to use the research
p.000289: findings for economic reasons. To eliminate this injustice, the medical community took certain measures. The WMA
p.000289: Declaration of Helsinki and the additional Protocol to the CE Convention on Human Rights and Biomedicine require
p.000289: that in the countries where a biomedical research is planned the permission should be sought from state structures, and
p.000289: interests of people who live there and who are potential research subjects should be considered.
p.000289: The involvement of Republic of Tajikistan, as an independent state, in international research projects
p.000289: requiring ethical review to ensure the compliance with international regulations triggered the process of
p.000289: establishing in Tajikistan the Committee on Medical Ethics and developing the system
p.000289: of State registration of pharmaceutical products, medical facilities and other medical goods.
p.000289: For a further development of medical ethical review of scientific-research projects, the Ministry of Health established
p.000289: the Republican Committee on Medical Ethics at the Department of the Management of Medical Personnel and Science (Order
p.000289: No 250; 4 of June 2004). The first research project that had to undergo ethical review to ensure the compliance
p.000289: with documents setting international rules in ethics was a joint Tajik-American research on AIDS and hepatitis C in
p.000289: drug addicts.
p.000289:
...
p.000323:
p.000324: 324
p.000324:
p.000325: 325
p.000325:
p.000325: legal, religious and other features. According to Ibn Sina, it is essential to humanize the process of bringing up
p.000325: healthy people and to find the ways for maintaining and developing spiritual harmony throughout a person’s life.
p.000325: Ethical views of Ibn Sina are still topical nowadays. He saw a physician as a patient’s friend, tutor and helper.
p.000325: To fulfill this noble mission, the physician, apart from professional knowledge and experience, should have many
p.000325: positive qualities – mercy, respect for human dignity, readiness to self-sacrifice in a patient’s interests,
p.000325: etc.
p.000325: When analyzing Ibn Sina’s ethical precepts we should note that those were in line with Hippocrates’s teaching. Ibn Sina
p.000325: wrote: “The physician should read Hippocrates’s precepts so as to be able to show honesty and frankness when treating
p.000325: patients. He should keep his clothes clean, be neat and perfumed. When he visits a patient he should be amiable, and
p.000325: cheerful, and witty so that he could cheer the ill person, because support offered by the physician multiplies the
p.000325: strength of natural warmth”. He was tireless in calling upon physicians to develop their general and special knowledge,
p.000325: to exchange professional experience and travel. In those times, travels served to extend scientific contacts. In the
p.000325: Middle Ages, there were many charlatan “healers” and even physicians deceiving their patients. Reasons for that Ibn
p.000325: Sina saw in a poor medical training, as physicians were not taught to see in each person his/her unique world of
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
p.000325: Ibn Sina’s views on childhood are noteworthy. “Canon of Medical Science” states that child’s life and health
p.000325: should be objects of care, protection and a special regimen from the moment of conception, not just from the moment of
p.000325: birth. A newborn baby needs a wet nurse with a stable nervous system. Games are essential, as all educational
p.000325: and formative processes, starting from very early years, should proceed from games. One may not punish a child, as
p.000325: the task of a tutor and physician if to protect the child’s soul, to facilitate the development of the feeling of
p.000325: self-respect. It is particularly important to prohibit any punishment for children under age of five, i.e. at the age
p.000325: when a child does not realize the meaning of his/her actions. Abu Ali Ibn Sina believed that, irrespective of state and
...
p.000333: are practicing Islam and other religions. The clause on the liberty of conscience in the Constitution of the
p.000333: Republic of Uzbekistan reflects the respect for the feelings of believers in our country, and therefore specific
p.000333: features of religious thinking are to be considered in
p.000333:
p.000334: 334
p.000334:
p.000335: 335
p.000335:
p.000335: adopting the Code of the Republic of Uzbekistan on Bioethical Problems (Mukhamedova Z.M. Islamic Bioethics in
p.000335: Historical Context. In: “Materials of the First National Congress on Bioethics”, Tashkent, 2005, pp. 98-100).
p.000335: It is necessary to note that nowadays there is a number of ethical codes interpreting teachings of the Koran and Sunnah
p.000335: with regard to complicated medical and biological problems. Thus, there are the Islamic Code of Medical
p.000335: Ethics48 and Islamic Bioethics49 correlating their statements with the Islam teachings: the Koran, Shariat and
p.000335: Hasid.50 These Codes are used in Kuwait, Egypt, Saudi Arabia, Iran, Pakistan and in other countries with Moslem
p.000335: communities (Canada, USA et al.). These documents pave the way to the development of ethical and religious regulations
p.000335: for biomedicine in Uzbekistan.
p.000335: Despite measures taken in our country, there remain problems relating to the protection of human rights in healthcare.
p.000335: Monitoring surveys carried out by the Ombudsman of the Republic of Uzbekistan showed that citizens apply to different
p.000335: state structures not only because of a poor material and technical basis of healthcare institutions or lack of
p.000335: pharmaceuticals, but also because the violation of patients’ rights to information about their diseases and
p.000335: methods of their treatment. The majority of patients, particularly in rural areas, do not have any knowledge on
p.000335: their rights, as healthcare institutions have not established procedures for providing relevant information. Mostly,
p.000335: patients are informed of their responsibilities and regulations the patient has to observe at a healthcare institution.
p.000335: Violation patients’ rights frequently result also from a low level of legal knowledge in medical professionals. The
p.000335: analysis of complaints submitted
p.000335: 48 The Islamic code of medical ethics. World Med J 1982, Kuwait Document, Islamic Code of Medical Ethics,
p.000335: International Organization of Islamic Medicine, 1981, Proposed Medical Research Projects, edited by: Abdul Jawad M. As
p.000335: Sawai, Commission on Scientific Signs of Qur,an and Sunnah, 1992.
p.000335: 49 Abdallah S. Daar, A.Binsumeit Al Khitamy. Bioethics for clinicians: 21. Islamic bioethics CMAJ 2001; 164(1):60-3
p.000335: 50 Hathout H. Why an Islamic perspective? In: El-Gindy AR, editor. Health policy, ethics and human values:
p.000335: Islamic perspective. Kuwait: Islamic Organization of Medical Sciences; 1995. p. 81- 5.;Hamdani DH. Canadian
p.000335: Muslims on the eve of the twenty-first century. J Muslim Minority Affairs 1999; 19(2):197-209.
p.000335: to various state structures with regard to violation of citizens’ rights in healthcare show that conditions
...
Searching for indicator poverty:
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p.000011: reproduction of population is not achieved,
p.000011: i.e. the total fertility rate (see below) is equal to or less than 2.1. These countries are Armenia,
p.000011: Belarus, Georgia, Moldova, Russia and Ukraine
p.000011: Belarus, Georgia, Russia and Ukraine are noted for the ratio of persons over 65 to the so called economically
p.000011: productive persons (at the age of 15-64), and Kyrgyz Republic, Tajikistan, Turkmenistan and Uzbekistan,
p.000011: where the age-dependency ratio is 2-3 times higher than in Belarus, Russia and Ukraine, stand out for that of children
p.000011: under 15.
p.000011: The greatest reduction of the able-bodied population in comparison with 1989 is observed in Georgia (by 20% for males
p.000011: and by 18% for females) and Ukraine (by 3,8% for males and by 4,9% for females). A significant increase of the
p.000011: able-bodied citizens (by 26-47%) is registered in Azerbaijan, Kyrgyzstan, Uzbekistan, Tajikistan and Turkmenistan
p.000011: The increase in the number of young people has a favorable effect on the increase of the total population, and the
p.000011: growing number of early marriages implies a perspective of a sooner birth of the first children and the increase of the
p.000011: total fertility rate.
p.000011: During last four years in the majority of the CIS countries no decrease of the fertility rate was registered. On
p.000011: the contrary, in 2003-2004 it has slightly increased. This process can be related to some stabilization
p.000011: in
p.000011:
p.000011: 2 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 23.
p.000011: social and economic situation in the CIS countries, as well as to the fact that people, born in the middle of 1980-s
p.000011: when the birth rate in Soviet Union was relatively high reached the fertility age.3
p.000011: At the beginning of 2005, the population size in the CIS countries was 279 million people (according to the Statistic
p.000011: Committee). In comparison with the beginning of 1991, the population has reduced by 2.7 million people or
p.000011: 1.0%.4
p.000011: By the type of demographic processes in the 90-s the CIS countries were divided into two groups. In the
p.000011: first group including Ukraine, Belarus, Russia, Kazakhstan, Moldova, Georgia and Armenia the population has
p.000011: been decreasing from year to year. The second group includes Azerbaijan and Republics of Central Asia where the
p.000011: population and the demographic potential kept on increasing. At the same time, as it was mentioned above, depopulation
p.000011: processes in Belarus, Russia and Ukraine are increasing, which means that the death rate exceeds the birth rate. This
p.000011: results in the increasing polarization of the two groups of CIS countries by the demographic potential, and hence
p.000011: creates, in prospect, additional preconditions for its redistribution between countries through migration processes.
p.000011: (Table 2).
p.000011: During last years in the majority of the CIS countries, the reduction of the fertility rate was not registered. On the
p.000011: contrary, in 2003-2004 it has somewhat increased. In Azerbaijan and Kazakhstan the increase is noticed in all age
p.000011: groups, in Belarus and Ukraine – at the age of 30 and older. At the same time, the highest fertility rate is still
p.000011: registered in women at the age of 20-24 (89-95 newborns per 1000 women of fertile age in Belarus, Georgia, Moldova,
p.000011: Russia and Ukraine, over 120 newborns – in Armenia, Azerbaijan and Kyrgyzstan, 143 – in Kazakhstan).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 3 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 26.
p.000011: 4 In the previous decade – in the 1980s – the population in former Soviet Republics, except for Baltic States,
p.000011: increased by 22.6 mln of people (8.7%).
p.000011:
p.000012: 12
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: The increase of the age-specific rates results in the increase of the total birth rate (the total birth rate is the sum
p.000013: of the age-specific fertility rates in the age range of 15-49 years; it shows the average number of children born by
p.000013: one women in her life if for every age the fertility rate remained the same as it was in the year for which the
p.000013: age-specific rates were calculated). The most significant increase of the fertility rate was in Kazakhstan where the
p.000013: total fertility rate in 2004 was 2,21 versus 2,03 in 2003. According to the recent data, the average value of this
p.000013: index in the CIS countries is 1,9 of births per one woman. The half of the population of the CIS lives in the countries
p.000013: where the simple reproduction of the population is not reached, i.e. this rate is below 2,1 (1,38 in Armenia (2004),
p.000013: 1,20 in Belarus (2004), 1,40 in Georgia (2003),
p.000013: 1,22 in Moldova (2003), 1,34 in Russia (2004), 1,20 in Ukraine (2003)).6 The problem of saving life and health
...
p.000013: infant mortality in all CIS countries in recent years, its level remains very high. The infant mortality rate in the
p.000013: CIS countries is much higher than that in the developed countries where its value is 3-5 deaths during the first year
p.000013: per 1000 newborns. (Table 3).
p.000013: About a half of dying infants falls to the share of the babies of the first year of life, nearly 70% of which die in
p.000013: the first week. The prenatal mortality rate in the CIS countries is fluctuating from 6 to 16 deaths at the age of 0-6
p.000013: days and still-borns per every 1000 of births. The causes of these deaths are respiratory states typical for the
p.000013: prenatal period, cases of the fetal asphyxia and asphyxia at birth.
p.000013: In many respects, a high death rate registered in the majority of the CIS countries over a long period can be
p.000013: explained, by the population ageing and by the decrease of the quality of life and health. At the same time, the number
p.000013: of births per 1000 population in the countries of the European Union is less (at the average 11,1) than in Azerbaijan
p.000013: (24,2), Kyrgyzstan (26,1), Tajikistan and Turkmenistan (33,1). However, in spite of the high population ageing rate,
p.000013: the number of deaths in the EU countries is lower (10,1) than in the CIS countries (12,6), which in it’s turn, may be
p.000013: explained by the level of preventive measures and healthcare in general, and by the social-economic situation in the
p.000013: CIS countries.
p.000013:
p.000013: 6 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000013: 2005, p. 62“.
p.000013:
p.000014: 14
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: The natural increase of the population is the main source for advanced reproduction of labor resources at a certain
p.000015: territory. According to the data shown above, in the CIS countries two types of reproduction prevail that may by
p.000015: characterized as simple and reductive. If the simple population reproduction requires the numeral equality
p.000015: of the parent and children generation, the current level of survival rate (including the average life
p.000015: expectancy) requires 250-260 births per each 100 families. The birth rate corresponding to such a level is
p.000015: registered only in some CIS countries, such as Azerbaijan, Kyrgyzstan and Tajikistan. The functions of fertility
p.000015: and survival, as exogenous characteristics of the population reproduction, form its endogenous characteristics, i.e.
p.000015: age structure of population and also the measure of the population growth (net coefficient of population reproduction)
p.000015: and, hence, the actual level of the natality. The Russian Federation shows a tendency to a reductive
p.000015: reproduction of the population; however, in some years the increase due to the migration has compensated the natural
p.000015: decrease of the population, which is not so typical for Moldova, Belarus and Ukraine. Therefore, the total population
...
p.000021: As we know, the population reproduction depends mostly on two factors: firstly – on the ratio of marriages and
p.000021: divorces; secondly – on the ratio between males and females at the fertile age. As to the first factor, in
p.000021: the conditions of the increasing youth unemployment, rapidly growing prices housing costs and uncertain prospects, the
p.000021: nuptial ratio has decreased in all nine countries from 4% (Azerbaijan) to 34% (Russian Federation). The decrease of the
p.000021: nuptial ratio for persons in the second marriage in all countries was even sharper. An average decrease of this index
p.000021: was 28%; only in Ukraine the increase of the nuptial ratio was registered, but in 1993 the fertility in this country
p.000021: has decreased dramatically (by 20%), and hence the hopes associated with the nuptial ratio were not justified. In
p.000021: contrast to the number of marriages the number of the divorces was growing. The second factor is also unfavorable. The
p.000021: female population exceeds male population, and this ratio becomes worse with every new age group.
p.000021: Thus, the marriage/divorce ratio, as well as male/female ratio determines negative tendencies in demographic
p.000021: situation in the CIS countries. The mentioned ratios have a negative impact on the generation renewal,
p.000021: and retain conditions for a narrow reproduction.
p.000021: When considering the situation we should note that the most dramatic aggravation was observed in the areas of the
p.000021: income per person, poverty, demography and social unity, which is essential for understanding social- economic
p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
p.000021: into the international system of biomedical research both from a viewpoint of interested researchers and potential
p.000021: participants.
p.000021: In the period of transition to the market economics all the CIS countries had to face such problems as considerable
p.000021: inequity in the income distribution, stratification of the society by income and increasing poverty. In 2004, the ratio
p.000021: of the total income of 10% of the most and 10% of the least well-to- do population was 3-5 times in Azerbaijan, Belarus
p.000021: and Ukraine; 11 times in Kazakhstan, Kyrgyzstan, Moldova, Russia and Tajikistan; 21 times in Armenia.
p.000021: In recent years (2005-2007), in the majority of the CIS countries some smoothing of the society stratification by
p.000021: income and the decrease of the population quota with the income beyond the cost of living (poverty line) was observed.
p.000021: Some processes were observed in the CIS countries that were not typical before. Thus, the number of the “poor” children
p.000021: usually was growing much faster than the number of poor persons in every other age group because of the rapid spread of
p.000021: the unemployment and increasing number of persons in a low-paid job, alongside with a disproportional indexation of the
p.000021: family allowances. The level of food consumption by children has considerably decreased. Presently, the change
p.000021: in the nutrition structure is expressed by transition to food products that are less expensive and richer in
p.000021: calories. There is a lack of food products that are necessary for the normal growth and development of the organism.
p.000021: Besides, a decrease in food consumption and the worsening of the sanitary situation, hygiene and living conditions have
p.000021: caused the increase of the number of diseases (tuberculosis, rachitis) traditionally associated with poverty.
p.000021: Specific features of the demographic situation and, indirectly, the amount of labor resources depend also on
p.000021: the age groups prevailing in the total population size, which, in its turn, implies special approaches to the
p.000021: healthcare structure development in the CIS countries. The increase of
p.000021:
p.000022: 22
p.000022:
p.000023: 23
p.000023:
p.000023: the elder population and the decrease of the share of children in the total population are typical for the majority of
p.000023: the CIS countries.
p.000023: In fact, during the period from 1989 to 2004 in all the CIS countries the part of population under working age
p.000023: decreased. This especially concerns the age group under four. The part of working population did not decrease due to
p.000023: the generation born in the period from the late 70s to the mid-80s (time interval characterized as a period of the
p.000023: highest fertility rate). At the same time, on the average, the part of the population over working age has increased,
p.000023: which, as shown above, alongside with the decrease of fertility and, consequently, the decrease of the population under
p.000023: the working age, can lead to the population ageing and the decrease of the population initiative and economic activity.
p.000023: The number of children under 16 in the CIS countries is nearly 80 millions. Compared with 1989, the
...
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
p.000023: To summarize the analysis of the demographic situation, it is necessary to note that with regard to self-preservation
p.000023: the following public processes are crucial:
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
p.000023: mortality in able-bodied population, “rejuvenation” of some diseases, spread of alcoholism and drug addiction;
p.000023: - the change in consumption of genetically habitual food products, decrease in food calorie content for the
p.000023: considerable part of the society;
p.000023: - reduced access to social services in conditions of a large-scale commercialization, which negatively
p.000023: affects the quality of human resources, intellectual, scientific and physical potential of the country;
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000025: 25
p.000025:
p.000025: - the decreasing number of medical institutions; a level of the population morbidity and mortality still remains
p.000025: high; the number of handicapped people is increasing;
p.000025: - stratification of the society by income, when 10% of the most well- to-do population have incomes more than 10 times
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
p.000025: efficiency of social assistance programs by weight of amounts received by families beyond the poverty line in total
p.000025: amounts of social support).
p.000025: 1.2 Ethical and Legal Issues
p.000025: in the Field of Biology and Medicine (o.I.Kubar, B.G.Yudin, A.E.nikitina, E.Yu.Vladimirova)
p.000025:
p.000025: Characterizing trends of legal and ethical control in the sphere of practical health care and biomedical
p.000025: research in the CIS member states it is necessary to emphasize a multilevel system of factors determining common
p.000025: pattern of directions, characteristics, features and mechanisms of national and international, retrospective and
p.000025: perspective influence. A rationale for forming of the given community is geographical closeness, unity of political
p.000025: history of the pre-Soviet and Soviet periods, contingency and interpenetration of cultures and traditions, forming
p.000025: extreme ethnical, cultural and religious multiplicity making countries in the region different.
p.000025: By itself such multiplicity leads, in particular, to the following - the set of actual ethical norms being a basis for
p.000025: medical care in the region countries is a historical foundation and a clear reflection of tolerance concepts both to
p.000025: cultural differences as they are and to their particular carriers. Moreover, in this case we can talk not just about
p.000025: tolerance but also about respectful relationship to differences of that kind.
p.000025: One more factor, which should be taken into account when explaining closeness of ethical and legal basis of health
p.000025: care, is that other countries in the region inherited legal base that was established in the Soviet period of their
...
p.000185: Another humanist-philosopher was Sanchi-Synchi. Unlike Asan-Kaigy and Tolubai-Synchi, he mostly valued the active
p.000185: elements of human nature: strong will, strength of mind, persistency in the struggle against the evil. Sanchi-Synchi
p.000185: called people for an active struggle for the sake of Justice. In his songs he developed the idea of righteous
p.000185: retribution and blamed the oppressors.
p.000185: The heritage of legendary thinkers allows us to return to forgotten spiritual values of Kyrgyz people
p.000185: based on love, compassion, empathy, clear conscience, peaceable disposition and feeling that they are a part of the
p.000185: universe. They felt aversion to violence and rudeness. Throughout the course of ethics development, starting from
p.000185: legendary thinkers to akyns- democrats, the care for widows and orphans was the responsibility of all clan members.
p.000185: The next stage of development of ethics philosophy is represented by akyn-zamanists21 Kalygul Bai Uulu
p.000185: (1785-1855), Arstanbek Bailashuulu (1866-1917) and Moldo Kylych Sharymkanov (1866). They lived in the time
p.000185: of global changes resulting from the decay of patriarchal feudalism and the rise of capitalistic relations.
p.000185: Besides in 1876 the territory inhabited by Kyrgyz people was incorporated into the Russian Empire [9-11]. All
p.000185: those processes were reflected in akyns’ poetry. In their poems “Time of Downfall”, “Time of Poverty” and “Time of
p.000185: Sorrow” akyn-zamanists called their epoch the time of degradation and decay. Moldo Kylych, being a son of a learned
p.000185: man, received a good education. He was acquainted with works by eastern classics Firdousi, Navoi, Jami, Yasavi and
p.000185: others. He wrote about his time: “Morals and manners show the loss of people’s well-being”. In his poem “Time of
p.000185: Sorrow” he noted that moral bankruptcy, degradation of moral principles, moral apathy were frightening features of the
p.000185: time. In their attitudes zamanists were close to French philosophers of the Age of Enlightenment (J.-J. Russo, Voltaire
p.000185: et al.).
p.000185: At the same time akyn-zamanists’ poetry contained some optimism and faith in moral potential of Kyrgyz people that
p.000185: would help them to overcome all difficulties. Kalygul Bai Uulu associated with the image of a spiritual
p.000185: 21 Zamanism – philosophical teaching about frailty and an inevitable tragic end of the world
p.000185:
p.000186: 186
p.000186:
p.000187: 187
p.000187:
p.000187: leader expressing expectations of Kyrgyz people through his poetry inspires their hopes.
p.000187: Problems of justice are very essential for Kalygul. Being a judge, he proclaims a kind of ethical code comprising
p.000187: universal values and norms of human behaviour: honesty, unselfishness, justice, mutual respect.
p.000187: Criticizing the state system of their time as a form of social inequality akyns offered a moral characteristic of
p.000187: behaviour in different social strata. Akyn-democrats tended to give a realistic picture of the world. Thus
...
p.000293:
p.000294: 294
p.000294:
p.000295: 295
p.000295:
p.000295: - Decree of the RT Government “On the Approval of the Concept of Healthcare Reformation in Republic of Tajikistan”
p.000295: (No 94; 4 of March 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Prevention and Control of
p.000295: HIV/AIDS/STD in Republic of Tajikistan in the Period to 2007” (No 475; 27 of November 2002)
p.000295: - Decree of the RT Government “On the RT Strategy for Preventing the Menace of AIDS Spreading for the Period of
p.000295: 2002-2005” (No 389; 1 of October 2002)
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
p.000295: access to the service of reproductive health, at preventing HIV/ AIDS spreading and at eliminating sex discrimination
p.000295: in the field of primary and secondary education. To ensure the national demographic policy, the Government approved
p.000295: and adopted the programme “The Concept of RT State Demographic Policy for the Period 2003-2015” (2002).
p.000295: The independent Tajikistan with its scientific potential in healthcare has reached a new, international level of
p.000295: science development, and therefore it is necessary to carry out ethical review of biomedical research in compliance
p.000295: with international regulations. The controlling body is the Committee on Medical Ethics (CME) at the RT Health
p.000295: Ministry. In its activity, the CME is guided by the Constitution of Republic Tajikistan. Documents regulating the
p.000295: CME practice comply with international legal standards and RT laws. The CME forms a part of the Forum for Ethics
p.000295: Committees in the Commonwealth of Independent States. The CME is to review and monitor scientific research in medicine
...
Searching for indicator low-income:
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p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
p.000271: alterations of the drug introduction routes, its doses, and significant changes in number of the CT subjects. An ethics
p.000271: committee can approve amendments to the clinical study conduct only if presented changes do not lead to worsening of
p.000271: conditions for subjects.
p.000271: After the application review an ethics committee can make one of the following decisions: to approve study
...
Searching for indicator social status:
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p.000183: A peculiar feature of “The Beneficial Knowledge” is that the author allows the reader to himself to gain an
p.000183: understanding of sense of life, of virtues and vices. Jusup Balasagyn argues that everyone should know and observe
p.000183: moral norms and rules of behaviour. “The Beneficial Knowledge” is a peculiar moral code of its time. Over a long time
p.000183: Kyrgyz ethnos had been existing in form of clans. Relationships within the community had been forming during
p.000183: a long historical period. Changes, if any, occurred due to the influence of external environment forming the worldview:
p.000183: the sense of sharing needs and interests of other people, feelings of mutual aid and collectivism. Kyrgyz people
p.000183: survived in crisis situations only due to spiritual and genetic health of their ancestors. People retained and
p.000183: developed clan traditions, upbringing practices, code of ancestral honour. Clan honour for Kyrgyz people is one of
p.000183: the most essential concepts. Every Kyrgyz had his ancestors, his land and his clan. Each clan had its hierarchy
p.000183: at the head of which was the most respected clan member. Collectivism, mutual aid, empathy, respect for other
p.000183: people – those were the qualities inherent in Kyrgyz mentality.
p.000183: Cultural and historical sources reveal respect to women in nomadic tribes, however there were conflicting
p.000183: traditions with regard to this issue. It is noteworthy that women had a high social status in Kyrgyz society [6].
p.000183: Ethical ideas in works by Kyrgyz thinkers. Spiritual culture of Kyrgyz people reflected in philosophical and poetic art
p.000183: of akyns20 is characterized by the search for perfection. Problems of upbringing and education, of humanism
p.000183: and love for people have a significant place in philosophical poetry of Kyrgyz thinkers, and therefore there
p.000183: is every reason to consider
p.000183: 20 Akyn is an improvising poet and singer in the Kazakh and Kyrgyz cultures. Akyns played and important role in terms
p.000183: of expressing people’s thoughts and feelings, exposing social vices, and glorifying heroes.
p.000183:
p.000184: 184
p.000184:
p.000185: 185
p.000185:
p.000185: it as a code of moral and ethical norms on human behaviour in Kyrgyz culture. Some scientists associate
p.000185: this special attention to moral issues with an access to Chinese sources known for their interest in ethics. The
p.000185: history of development of ethical and philosophical ideas in Kyrgyz culture may be divided into three stages. The first
p.000185: stage is associated with names of late medieval Kyrgyz thinkers: Asan-Kaigy (XV c), Tolubai Synchi and Sanch- Synchi
p.000185: (XIII c) [3]. Kyrgyz people justly call them legendary thinkers, folk sages (akylmanam). We know about these
p.000185: Kyrgyz thinkers from folk legends. Only fragments of their sayings survived to our time.
p.000185: The epoch of late Middle Ages with its patriarchal and feudal system sets a number of moral tasks. Undoubtedly, moral
p.000185: in a class society was at all times an instrument for ruling people, however, in akyns’ philosophical poetry one may
...
p.000239: relations and concerns of the modern society on the whole.
p.000239: At the Anniversary Episcopal Assembly in 2000 the Basic Social Conception of Russian Orthodox Church was
p.000239: adopted. The conception falls into 16 sections covering most various issues related to life of a Christian believer in
p.000239: secular world. In section 11 – “Public and Individual Health” – the attitude of Orthodox Church to disease and health
p.000239: is rendered, importance of church activities in health care is stressed, necessity of society and church cooperation in
p.000239: public health care issues is emphasized. It covers such vital from religious viewpoint principles as doctor and patient
p.000239: relationship which should be based with respect to integrity, free choice and “personal dignity”. In particular it
p.000239: stresses: “We should by all means encourage a dialogue between a doctor and a patient that is
p.000239: characteristic of current medical approach. This approach is undoubtedly engrained in the Christian tradition,
p.000239: although there is a temptation to relegate it to a level of merely agreement relationship. At the same time one should
p.000239: admit that a more conventional “pattern like” model of physician and patient relationship which is fairly criticized
p.000239: for numerous attempts to justify medical power abuse may as well represent a truly fatherly attitude to patient that
p.000239: depend on doctor’s morality. Not giving preference to any of the health care organization models the Church
p.000239: considers that this service should work efficiently at its maximum and must be available to all members of society
p.000239: disregarding their financial and social status even with limited medical resources distributed. For such distribution
p.000239: to be fair the aspect of “vital requirements” should prevail over the aspect of “market relations”. The doctor should
p.000239: not see the degree of their responsibility for medical service in relation with financial reward and its amount only by
p.000239: this turning his profession into pure profit making. At the same time decent payment for medical professionals is seen
p.000239: as an essential task for the society and the state (26).
p.000239: Section 12 “Bioethical Issues” shows the official position of RCOC
p.000239: on a range of aspects which currently are concerning in the society and are brought about by blooming development of
p.000239: biomedical technology in late the
p.000239:
p.000240: 240
p.000240:
p.000241: 241
p.000241:
p.000241: XX century. These completely new challenges are once again comprehended and reinterpreted in the context of ideas of
p.000241: human life and personal dignity which are entrenched in the “Divine afflation”. It shows attitude of the
p.000241: Church to abortion, new reproductive methods, medical genetic methods of diagnostics, tissue and organ
p.000241: transplantation, reanimation and help to the parting, sexual issues. Moreover some sections of the social
p.000241: conception are devoted to the questions of marriage and family, psychological health, problems of drug and alcohol
p.000241: addiction, health care and the ecological environment (7).
p.000241: The current trend is towards younger age among religious groups of society. A study by VCIOM showed that 58% of young
...
Economic / Food Insecurity
Searching for indicator hungry:
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p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
p.000225: people social life organization on the basis of common views (19).
p.000225: Under church influence and with its participation care for people in need for medical and social help
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
p.000225: thousands of disabled, old people and orphans. In the 50’s of XVI century they attempted to place a part of care
p.000225: for people health, social support for sick and weak people on the state. Stoglav, a great council of Russian
p.000225: bishops held in 1551, together with tsar and boyar Duma ordered to found everywhere hospices for “leprous, aged,
p.000225: lying in boxes on the streets, carrying carts and sledges and having no place to sleep”. “Desyatina”, the tenth
p.000225: part of funds from sale of bread, cattle and from rent, was brought in to keep churches, monasteries, hospitals,
p.000225: hospices and receive odd and poor people. At the same time representatives of different social classes donated money
p.000225: for church and charity needs.
...
General/Other / Dependent
Searching for indicator dependent:
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p.000035: the Kyrgyz Republic On Protection of Population Health of the Kyrgyz Republic (09.01.2005), the Law of the
p.000035: Republic of Moldova On Rights and Responsibility of Patient (27.10.2005), Basics of the Law of the Russian Federation
p.000035: On Protection of Citizen Health (22.07.1993), the Law of the Republic of Tajikistan On Protection of Population Health
p.000035: (15.05.1997), Basics of the Law of the Ukraine On Health Care (1992), the Law of the Republic of Uzbekistan On
p.000035: Protection of Citizen Health (29.08.1996). Legislation specifically related to protection of especially vulnerable
p.000035: groups of patients and subjects is of particular importance for regulation of biomedical activities including valuation
p.000035: of biomedical research. Virtually all countries adopted separate laws on psychiatric assistance to population,
p.000035: counteraction to HIV infection, donorship, transplantation, protection of children rights. These enactments reflect
p.000035: specificity of institutions of informed consent and patient confidentiality in some situations of biomedical int
p.000035: rventions as well as stipulate additional guarantees of rights of dependent groups of patients/ subjects. In many CIS
p.000035: countries laws and by-laws regulate various issues in the area of auxiliary methods of reproduction and genetic
p.000035: assistance to the population12. Two countries (the Russian Federation and the Ukraine)
p.000035: 12 For instance, in the Republic of Armenia – the Law of the Republic of Armenia On Reproductive Health
p.000035: and Reproductive Rights of Person, 12 of September 2002, in the Republic of Belarus – the Law of the
p.000035: Republic of Belarus On Safety of Gene Engineering Activities, 9 of January 2006, in the Republic of Kazakhstan – the
p.000035: Law of the Republic of Kazakhstan, 16 of July , 2004, N 565-2 On Reproductive Rights of Citizens and Guarantees of
p.000035: Implementation Thereof, in the Kyrgyz Republic – the Law of the Kyrgyz Republic, 20 of December 1999, On Reproductive
p.000035: Rights of Citizens, in the Russian Federation – the Order of the Ministry of Health of the Russian Federation. 26 of
p.000035: February 2003, N 67 On Utilization of Assisting Reproductive Technologies (ART) for Treatment of Female and Male
p.000035: Infertility, the Federal Law, 5 of July 1996, N 86-FZ On State Regulation in the Field of Gene-Engineering Activities,
p.000035: the Order of the Ministry of Health of the Russian Federation, 30 of December 1993, N 316 On Further Development of the
p.000035: Medical and Genetic Service of the Ministry of Health of the Russian Federation, in the Republic of Tajikistan – the
p.000035: Law of the Republic of Tajikistan, 2 of December 2002, No.72 On Reproductive Health and Reproductive Rights, the Order
p.000035: of the Ministry of Health of the Republic of Tajikistan No.974, 1 of October 1985, On Measures for Further Development
p.000035: of Medical and Genetic Assistance to the Population, in the Ukraine – the Joint Order of the Ministry of Health Care
p.000035: and Academy of Medical
...
p.000057: say that the circuit of technoscience we described is unstable. But, alas, neither cybernetics not the theory of
p.000057: systems can forecast future course of events.
p.000057:
p.000057: Industry of Biomedical Research
p.000057: Thus, scientific research to larger and larger scale is focused on cognition, on one hand, of various ways of
p.000057: influencing a man and, on the other, capacities of a man. Multiple experiments, where a man participates as a subject
p.000057: can be considered as the most characteristic expression of both. Each such experiment, generally speaking, is
p.000057: designed to extend our knowledge of properties of various agents, devices, methods of influencing a man, etc. At that,
p.000057: necessity for its conduct can be determined with needs of development of some particular section of biology, or
p.000057: medicine, or another field of knowledge. If, however, one attempts to imagine integral totality of such experiments
p.000057: (taken irrespective of subject specificity of each of them), than it turns out that it provides us with some knowledge
p.000057: about a man. We can claim: the more science pretends to serve interests and benefit of man, the more significant role
p.000057: there should be played with experiments involving human subjects.
p.000057: Several decades ago H.Jonas discussing issues of experiments involving a man, said perspicuously about a need to
p.000057: limit somehow “exorbitant appetite of the industry of scientific research”. Also he turned attention to the
p.000057: following - “now the scientific society will have to struggle with the strongest temptation – to switch to
p.000057: regular, daily experimenting with the most available human material: dependent ones due to various
p.000057: reasons, ignorant and suggestible disabled” (H.Jonas. Philosophical reflections on experiments with human
p.000057: subjects. In: Experimentation with human subjects, ed. by P.Freund, George Braziller Inc., 1970, p. 529).
p.000057: At the same time Jonas – and this was, generally, the commonly accepted point of view – could claim that
p.000057: experiments with human subjects
p.000057:
p.000058: 58
p.000058:
p.000059: 59
p.000059:
p.000059: “we consider as extraordinary but not normal ways to serve to public good” (the same, p. 526). But
p.000059: those days no one disputed of the crucial principles of the Nuremberg Code: each of such experiments due to
p.000059: risks it is associated with can be justified only with paramount necessity. In other words, it is acceptable only when
p.000059: there is not other way to gain knowledge being extremely important for the society and science.
p.000059: During the past decades an industry of scientific research or, being more specific, biomedical research
p.000059: involving human subjects became full- scaled reality. At that, biomedical researches by themselves are more and more
p.000059: often considered not only from the point of view of risks, but also from the point of view of benefits that they can
p.000059: bring to a subject. Usually, a therapeutic effect of a developed novel medicinal agent or a new method of treatment is
p.000059: considered as such benefit.
p.000059: And the issue on which of these two interpretations of biomedical research is more acceptable is worth
p.000059: of specific discussion that we have no possibility to talk over herein. It is important for us to stress that
...
p.000253: efficient participation of society in the protection of clinical research subjects’ rights and health.
p.000253: In its work the committee is guided by the basic international principles of conducting the clinical trials and by the
p.000253: current legislation of the Russian Federation.
p.000253: The basic tasks of committee are the following:
p.000253: - carrying out the qualitative ethical and legal review of the materials of clinical research for the purpose of
p.000253: subjects protection from the possible negative consequences resulting from the application of medicines.
p.000253: - adjustment of scientific validity of clinical research, expected effectiveness and safety of the
p.000253: tested medicines.
p.000253: - preparation of resolutions on the expediency of conducting the clinical research.
p.000253: The structure of the committee is formed on the interdisciplinary basis by the Federal Service for supervision in the
p.000253: sphere of public health and
p.000253:
p.000253: 36 At present moment this body is represented by the Federal Service for supervision in the sphere of public health
p.000253: and social development of the Ministry of Public Health and social development of Russian Federation.
p.000253: 37 The order of the Ministry of Public Health and social development of Russian Federation on 2 of August 2004, N 57
p.000253: “On ethics committee”//Healthcare. N1, 2005.
p.000253: social development and is approved by the Ministry of Public Health and social development of the Russian Federation.
p.000253: The committee may include persons who are not directly dependent on the researchers and sponsor. The members of the
p.000253: committee should have the proper qualification and experience of ethics review of scientific, medical and ethical
p.000253: aspects of different studies. The committee may include the representatives of the public (lawyers,
p.000253: journalists, priests, etc.).
p.000253: Among documents which are important for development of the system of ethical review in Russia we should also point out
p.000253: the mentioned “Rules of Clinical Practice in the Russian Federation” (Rules of Clinical Practice) and the national
p.000253: standard “Good Clinical Practice. GOST- R 52379-2005 “ (National standard).
p.000253: Today the Rules of Clinical Practice have limited application caused by essential reorganization of the system of
p.000253: control and assessment of effectiveness and safety of products, processes and services, including those in medical
p.000253: sphere.
p.000253: The National standard that entered into force in April, 2006 is more meaningful document in this sphere.
p.000253: This act is the element of the system of technical regulation and develops the provisions of the Federal Law “On
p.000253: Technical Regulation”, which establishes the requirements for products, manufacturing, exploitation, storage,
p.000253: transportation, realization and utilization, service delivery, etc.
p.000253: The national standard is the Russian version of ICH GCP and by its status is recommending document. It establishes the
p.000253: ethical and scientific standard of the quality of planning and conducting research involving human subjects as well as
p.000253: the standard of recording and registering the study results.
p.000253: These standards may be applied not only to the studies of medicines, but also to “other clinical experiments, which can
...
General/Other / Developing Country
Searching for indicator underdeveloped:
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p.000241: lack desire to take decisions for their own health issues either partly or completely, they are happy to shift this
p.000241: responsibility to doctors.
p.000241: The study reveals that attitude of many doctors and patients to current biotechnology is not yet coined; there is no
p.000241: solid ethical basis. Opinions of church-going interviewees differs drastically from that of non-believers’ and to
p.000241: greater extent meets the provisions of religious and medical ethics. At the same time among church-going doctors great
p.000241: number of interviewees proved not prepared to solving current ethical tasks and either refused to answer questions of
p.000241: the interview or found them too challenging.
p.000241: Russia has not yet determined the answer to the question of referring itself to a civilization – Western or Eastern. In
p.000241: the early 1990’s the strategy was linked to the opportunity for Russia to be integrated into the Western community, and
p.000241: it was first of all seen through attitude to values and interests. Integrity of values in Russia and in the West is
p.000241: retained today in recognition of such values as freedom, justice, material well-being and other. However, our country
p.000241: yet has not seen them implemented fully. Establishing value system in the field of medicine which represent perhaps the
p.000241: most conventional block in the general system of values is still under way. In the mentality of citizens of
p.000241:
p.000242: 242
p.000242:
p.000243: 243
p.000243:
p.000243: Russia the principles of identity typical of the West are still underdeveloped. The basis of human rights theory is yet
p.000243: being established. Majority of Russian citizens as social studies show, reject the imposed ‘alien’
p.000243: communication schemes, for instance, the Western view over various issues of personal and social life not out of
p.000243: reasonable arguments or some ideological efforts but out of their inconsistency with customary ideas and values.
p.000243: This gives grounds for discussion and implementation of the bioethical staple principles and provisions in
p.000243: countries with various ethnic, culture and religious traditions, creates challenges because of peculiarities
p.000243: and inconsistencies between the Russian and western ethical systems in health care and medicine. In this respect it is
p.000243: reasonable to draw guidelines and interpret specific regulations and acts and their provisions taking into
p.000243: account two main aspects: culture and ethnical traditions of given states and their compliance with the common norms of
p.000243: international laws in the field of bioethics.
p.000243:
p.000243: References
p.000243: 1. Berdiaev N.A. Destiny of Russia: Selected Works. M., Kharkov: EKSMO Press Folio, 1998, 736 p. (herein and
p.000243: hereinafter in Russian)
p.000243: 2. Dmitrieva T.B., Polozgiy B.S. Psychological Health of Russian
p.000243: Citizens. Human, 2002, №6, p. 21-31.
p.000243: 3. Zamalaev. А.F. Lectures on history of Russian philosophy: XI –
p.000243: early XX cc. StP., 1994.
p.000243: 4. Zenkovskiy V.V. History of Russian philosophy. L., Eko, 1991, p. I,
p.000243: p. II, p. b.
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.000031: review of biomedical research that, certainly, facilitated harmonization of both regional and global
p.000031: international approaches to establishment of ethical standards in biology and medicine. Besides, notable value for
p.000031: adaptation and improvement of universal ethical principles has the representation of some of the CIS countries in
p.000031: several international entities, for instance, such highly respected agency as the Council of Europe, in particular, in
p.000031: the structure of the Steering Committee on Bioethics (CDBI) responsible for development of multiple documents, mainly,
p.000031: the legal ones, on protection of rights and dignity of human subjects in research and medical care.
p.000031: Consolidation of efforts and mutually enriching knowledge exchange take place also at the stage of regional or
p.000031: bilateral cooperation with international facilities and leading world specialists in the field of ethics through
p.000031: trainings, joint researches and discussions.
p.000031: Another priority component with considerable contribution in forming
p.000031: of ethical and legal unity in medical care is trends and mechanisms based on
p.000031: realia of regional cooperation of the CIS member states.
p.000031: Due to international and regional legal collaboration the constitutional regulation of a legal status of a
p.000031: person in the Commonwealth countries is adjusted to international standards creating legal opportunities
p.000031: for implementing such important ethical principles of biomedical research as
p.000031:
p.000032: 32
p.000032:
p.000033: 33
p.000033:
p.000033: respect to autonomy and individual dignity of a patient/subject as well as a principle of justice.
p.000033: Majority of constitutions of the CIS countries proclaim a person as a basic value (Art. 4, Constitution of Armenia;
p.000033: Art. 13, Constitution of Azerbaijan; Art. 2, Constitution of Belarus, Art. 3, Constitution of the Ukraine, Art. 2,
p.000033: Constitution of Russia; P.1, Art. 36, Constitution of Moldova, etc.). Free development of a person is
p.000033: protected by law and independent court. Person dignity is acknowledged as a special value to be protected by the state
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
...
p.000065: process and its unification within CIS identifying unity of views on a range of factors determining modern realia of
p.000065: development of the CIS countries.
p.000065: First of all, one should note that strengthening of health of the population as one of the main priorities
p.000065: for formation of a social state is included into a concept of legal basics and mechanisms for the social state
p.000065: implementation in the Commonwealth countries. Mechanism of state social and technical standard as norms and regulations
p.000065: providing implementation of constitution-guaranteed social rights of citizens and being, at the same time, checkpoints
p.000065: for implementation of social and economical policy of a social state is determined as the most important element of
p.000065: social policy. Value of this statement for the state regulation in any sphere of human activities is extremely high,
p.000065: and in regard to biomedical studies at the state legislative level it introduced an order for regulation on the basis
p.000065: of state standards, which established as highly important the standards for good preclinical, clinical and
p.000065: manufacture practices identical to international standards of GLP, GCP and GMP.
p.000065:
p.000066: 66
p.000066:
p.000067: 67
p.000067:
p.000067: Returning to statements of the aforementioned (1.2) model Law of IPA CIS On Protection of Human Rights and Dignity in
p.000067: Biomedical Researches in the CIS, it is necessary to indicate that even the text preamble of the law
p.000067: states that “the present law introduces state guarantees for protection of human rights, dignity, autonomy and
p.000067: integrity when conducting biomedical studies” and it is based on statements of the Constitution and a set of universal
p.000067: principles proclaimed by fundamental international documents.
p.000067: The sphere of action of the present law is spread on state citizens participating in biomedical research
p.000067: and is applied in regard to all facilities and persons being related to conduct of biomedical research at the territory
p.000067: of the state as well as it stipulates that foreign citizens and persons with absent nationality being present at
p.000067: the territory of the state in case of participation in a biomedical study can enjoy all rights established with
p.000067: the given law equally to citizens of this state. Such statement is quite significant in regard to situation in the
p.000067: CIS region due to openness of borders and notable migration processes.
p.000067: In regard to harmonization both within CIS and at the international level it is important that the law
p.000067: unifies terminology in compliance with GCP-approved definitions creating attitude for mutual understanding and
p.000067: development of a united information field of biomedical research. Some articles of the law stipulate the state
p.000067: policy standard and rights of participants of biomedical studies. Separate chapters are dedicated to study safety and
p.000067: an ethical review system, a format of an informed consent and compliance with confidentiality requirements, therefore,
p.000067: corresponding to the core of all international enactments in the sphere of biomedical research. There is a separate
p.000067: chapter on special situations of the biomedical study conduct including articles regarding biomedical
...
p.000075: gland without doing any harm to the animal, and that because with respect to the thyroid animals and human beings are
p.000075: similar, these conclusions are probably applicable to humans as well; and indeed, when the tumors of thyroids are
p.000075: removed, it can be enough to preserve a very small portion of it so that the person can continue living without
p.000075: experiencing troubles related to the absence of the thyroid gland. I am also aware how a shortage of thyroid gland
p.000075: affects the human.
p.000075:
p.000076: 76
p.000076:
p.000077: 77
p.000077:
p.000077: Then I was told that although I will have analgesic medicine injected under the skin for pain relief, I will
p.000077: possibly feel some pain during the surgery and afterwards. And finally, it was explained to me, that in the case
p.000077: of successful operation or especially if the wound suppurates I will have a scar for life on my neck about 7.5-10 cm
p.000077: long. And, despite all the facts mentioned above, I agree to the surgery, and whatever happens, I will never have any
p.000077: claims either against the doctors who will perform the surgery, or the patient who will receive my thyroid gland. I am
p.000077: signing this paper in the presence of doctors B.V.Dmitriev, E.K.Vinakurova, M.P.Alexeev and the nurse
p.000077: E.V.Shevchenko (signature); we witnessed the reading and signing of this paper and hereby certify that E.P. is an adult
p.000077: and mentally capacitated person (signatures of doctors and nurse)”.
p.000077: This document dated 1917, contains all elements of current ethical concept relating to biomedical
p.000077: research: confidentiality, respect for a person’s autonomy, information about all risks associated with the
p.000077: research, freedom of a voluntary choice, verification of the research subject’s social and mental maturity.
p.000077: All statements in Dmitriev’s article base on a legal concept of a famous lawyer A.F.Kony who testified to the
p.000077: absence of criminal deed in the case of the sale of organs for treatment purposes in accordance with the contract
p.000077: between the donor (seller) and recipient (buyer). At the same time he noted that “under these circumstances the
p.000077: only ethical issue that might arise concerned the permissibility of such a deal in a situation where the
p.000077: “seller” was a minor, imbecile, or a person in a state of artificial excitation, and where the “buyer” was a
p.000077: person who acted through psychological compulsion, deception, seduction, promise of profit or suggestion by authority.
p.000077: On the whole, the analysis of legal and ethical principles referring to biomedical research existing in the tsarist
p.000077: Russia in the beginning of the XX century shows that humanistic concepts of a voluntary and conscious choice made by
p.000077: the research subject and confidentiality have been combined with a responsible and merciful attitude on the part of a
p.000077: physician-investigator, and reinforced with accepted moral and ethical norms and legislative acts in force.
p.000077: Turning to a more recent period in national history, the following stages of Soviet law development illustrate how the
p.000077: issues in ethical and legal regulation of medical and biological research were interpreted in the USSR.
...
p.000085: • the EC preparation for the survey and evaluation of their performance;
p.000085: • raising the EC authority and their role in the development of international standards concerning the
p.000085: protection of research subjects’ rights;
p.000085: • assistance in the development of national Forums for Ethics Committees in the CIS countries;
p.000085: • the evaluation of the current legislation referring to the protection of human rights in biomedical research and
p.000085: medical practice in the region;
p.000085: • the performance as a regional centre for cooperation in the field of ethical review development;
p.000085:
p.000086: 86
p.000086:
p.000087: 87
p.000087:
p.000087: • assistance in the practical application of the SOPs for ethical review in the region in compliance with
p.000087: Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO, 2002);
p.000087: • coordination of the CIS countries in the sphere of bioethical issues and ethical review of biomedical research in
p.000087: the region.
p.000087: Summarizing the above said we should recognize that the history of the development of the system for ethical review of
p.000087: biomedical research in the CIS countries is a dialectic process of ethical and legal development of the national
p.000087: consciousness and legislation directed towards protecting rights, dignity and autonomy of an individual as a
p.000087: biomedical research subject, and providing moral and ethical guarantees to the society that biomedical research is
p.000087: conducted in a strict conformity with universal ethical standards.
p.000087: Chapter 3. EtHICAL REVIEW SYStEM FoR BIoMEDICAL RESEARCH
p.000087: In tHE CIS CoUntRIES
p.000087:
p.000087: 3.1 REPUBLIC oF ARMEnIA (G.D.Aslanyan, S.A.Davtyan)
p.000087:
p.000087: 3.1.1 Historical and Cultural Background
p.000087:
p.000087: Like any new field of knowledge related to the rise or appearance in the foreground of some new realities in the life
p.000087: of our society, bioethics needs to be considered first of all from the historical, cultural and religious perspective.
p.000087: Republic of Armenia is rich in objects of unsurpassed art. There are over 4000 monuments of architecture at the
p.000087: territory of today’s Armenia. “Armenian history, – wrote Valery Briusov, a Russian poet, – is as noteworthy as the
p.000087: history of the most famous peoples of the world, including Egyptians and peoples of today’s Europe, who made their
p.000087: unique contributions into the world culture”.
p.000087: “If asked in what place of the world one is likely to find the greatest number of wonders, I would name Armenia first
p.000087: of all. Here, in this tiny
p.000087: corner of the world, you can see monuments and meet people which can become treasure and pride for the world” (Rockwell
p.000087: Kent).
p.000087: Although much of cultural and artistic wealth of Medieval Armenia, including manuscripts, had been destroyed over ages
p.000087: by different invaders, around 24 thousands of manuscripts have survived to our time, and about half of them is
...
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armed forces, prisoners and persons under arrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
p.000119: • Equal rights of patients and physicians to respect for their human dignity (Art. 14);
p.000119: • Mutual trust and mutual responsibility of the patient and the physician, patient is an active participant of the
p.000119: treatment process (Art. 16);
p.000119: • Compulsory consent from the patient for a medical intervention, except for cases provided by law (Art.
p.000119: 21);
p.000119: • Compulsory written consent from a patient, his/her close relatives or legal representatives for removal
p.000119: organs or tissues for diagnostic or therapeutic purposes; removal of organs and tissues for other purposes may not
p.000119: be carried out (Art. 23);
p.000119: • Confidentiality of patients’ personal data obtained in the patient— physician relationship; it is not permitted to
p.000119: disclose the patient’s personal information even after the patient’s death (Art. 24).
p.000119: An analysis and classification of fundamental statements of the Law of Republic Belarus on Healthcare and the Code of
...
p.000119: Priority of a person’s interests implies that interests and well-being of an individual should prevail over scientific
p.000119: and public interests:
p.000119: - “In his/her scientific and research activity the physician should be guided by the priority of the
p.000119: patient’s benefit over scientific interests; clinical trials and research may only be carried out in compliance with
p.000119: the rules established by law and with the patient’s consent” (Art. 36 CME).
p.000119: Principle of tolerance implies that all citizens, with no exception, are guaranteed that the individual’s integrity,
p.000119: principal rights and freedoms shall be respected:
p.000119: - “The main goal of physician’s professional activity is to save an individual’s life and health…
p.000119: regardless of the patient’s sex, age, nationality, social and financial status, political convictions and religion”
p.000119: (Art. 2, CME);
p.000119: - “Physician shall in every possible way contribute into protection of population health and to
p.000119: struggle against any forms of cruelty and disparagement” (Art. 5 CME).
p.000119: Equal rights and cooperation in physician-patient relationship as a cardinal principle of modern deontology
p.000119: implies the following:
p.000119: - “Physician and patient have equal rights to respect for their human dignity and may protect it according to
p.000119: current legislation” (Art. 14 CME).
p.000119: Principle of physician’s and patient’s autonomy following from the above statement reveals itself in recognizing the
p.000119: autonomy of the physician:
p.000119:
p.000120: 120
p.000120:
p.000121: 121
p.000121:
p.000121: - “Physician shall bear responsibility for all his/her professional decisions and has the right to reject
p.000121: any attempts of pressure from colleagues, patients and other persons if their requests contradict ethical
p.000121: principles, professional duty and law.” (Art. 11 CME).
p.000121: Secondly, the principle of autonomy implies the patient’s autonomy:
p.000121: - “Patient is an active participant of the treatment process” (Art. 16 CME).
p.000121: - “Patient has the right to choose the physician. In case of a disagreement with the physician the
p.000121: patient may apply to the head of the institution, to the commission on medical ethics and to other governing
p.000121: institutions or public associations involved in protection of patients’ rights” (Art. 17 CME).
p.000121: - “Organ and tissue removal for diagnostic or therapeutic purposes from a patient may only be carried out with a
p.000121: written consent from a patient obtained in an order established by law, or, in conditions provided for under
p.000121: legislative acts of Belarus, with the consent from the patient’s close relatives or his/her legal representatives.
p.000121: Organ and tissue removal for any other purposes is not permitted” (Art. 23 CME).
p.000121: - “Autopsy examination may only be carried out with the consent from the relatives of the deceased person
p.000121: with the exception of the events provided for under legislation of Belarus” (Art. 27 CME).
p.000121: “Exceptionally, in the patient’s interests, it is permitted to use a scientifically justified method or a
p.000121: medicinal product designed for a disease prevention, diagnostics, treatment, rehabilitation or prosthesis that has not
p.000121: yet been authorized in accordance with established procedure. Written informed consent should be obtained from the
p.000121: patient.” (Law on Healthcare, Art. 26).
...
p.000149: Vakhtang VI (XVII-XVIII cc) deserves major attention. Chronologically this period coincides with the epoch of
p.000149: creation of the basis for the modern law and state in Western Europe. Drafting of King Vakhtang’s Law Book can be
p.000149: considered to be an attempt to get closer to the cultural world, at which Georgia aspired during its whole history. In
p.000149: some regions of Georgia the code of Vakhtang’s Laws was in force up to the second half of the XIX century.
p.000149: An attempt to build a modern independent state in 1918-1921 was not successful due to the expansion of Russia. As a
p.000149: result Georgia became the part of the communistic space for the next 70 years. Thus, formation of the civil
p.000149: society in Georgia started within the borders of another country (Soviet Union), making Georgia unable to develop
p.000149: its own legislation independently.
p.000149: During aforementioned 70 years legislative activity in Georgia was restricted to the slight alteration or, at
p.000149: best, adaptation of the frame laws, provided by the central authorities (Moscow). As well as in other republics of the
p.000149: Soviet Union there was no tradition of training the legal professionals for the health care system in Georgia. Before
p.000149: re-establishment of Georgia’s sovereignty, the Law on Health Care, adopted in 1972 by Soviet Government, was in force.
p.000149: This document showed significant negligence of individual rights of patients. Almost none of the basic principles of
p.000149: ensuring patients’
p.000149: autonomy and self-determination (except the right to keep personal data confidentially) were even declared.
p.000149: The creation of national legislation is an essential condition for building the national and democratic state and a
p.000149: civil society. Adoption of Georgian Constitution (24 of August 1995) and Georgian Civil Code (26 of June 1997) is
p.000149: definitely significant step toward establishment of national state.
p.000149:
p.000149: 3.4.2 Legal Regulations
p.000149:
p.000149: Legislation of Georgia related to health, biomedicine and human rights comprise laws which regulate
p.000149: various aspects of medicine/health care: rights of patients and research subjects (including vulnerable groups; such
p.000149: as minors, persons with mental disorders, patients with HIV/AIDS etc.), duties and responsibilities of health
p.000149: care professionals, human organ transplantation, assisted reproductive technologies etc.
p.000149: From the above-mentioned laws the Law of Georgia on Health Care (adopted by the Parliament of Georgia in 1997)
p.000149: is considered to be the framework law, which determines the priorities and sets out fundamental principles of the
p.000149: health care legislation of Georgia. It covers full range of problems related to health, including issues related to
p.000149: protection of research subjects.
p.000149: In general, there are three major documents serving the legal basis for biomedical research involving human subjects.
p.000149: These legal texts are:
p.000149: • Convention on Human Rights and Biomedicine (Signed by Georgia in May 2000; Ratified by the Parliament in September
...
p.000151: created at the institution where the trial is to be carried out. Interestingly, this law specifically mentions
p.000151: recommendations set out in WMA Declaration of Helsinki to be the basis for conducting clinical trials on human beings.
p.000151: As already mentioned the most specific law on the protection of the research subjects will be the Law on
p.000151: Biomedical Research involving Human Subjects, which is being submitted to the Government this year. The aim of the
p.000151: draft law is protection of the rights, health and life of a research subject of biomedical research and provision of
p.000151: safety and respect for dignity during the research. The draft law concerns any type of research aiming at obtaining
p.000151: information and broadening knowledge in the sphere of biomedicine, which serves the interests of human health
p.000151: protection and implies:
p.000151: • Physical intervention on human being;
p.000151: • Research on biological materials which initially were taken and stored with other purpose;
p.000151: • Intervention which doesn’t imply physical intervention on human being but can pose danger to mental health or
p.000151: psychological condition of human being;
p.000151: • Research on foetus and/or embryo in vivo (The Law does not apply to research on embryos in vitro.
p.000151: The draft Law on Biomedical Research involving Human Subjects is based on the following core principles:
p.000151: • Primacy of the human being;
p.000151: • Autonomy of research subjects: information, informed consent, confidentiality and privacy;
p.000151: • Scientific quality;
p.000151: • Minimizing risks and keeping adequate risk-benefit ratio;
p.000151: • Safety;
p.000151: • Protection of vulnerable groups;
p.000151: • Multidisciplinary review of ethical acceptability of research protocol and its approval by an ethics committee.
p.000151:
p.000152: 152
p.000152:
p.000153: 153
p.000153:
p.000153: Side by side with legislation certain impact on the ethical conduct of health care providers as researchers has ethical
p.000153: regulations, which could be considered as soft legal instruments. In April 2003 the Congress of Georgian Physicians
p.000153: endorsed the Ethics Code of Physician of Georgia. The code was developed by Georgian Health Law and Bioethics Society
p.000153: (GHLBS) and the Health Legislation and Bioethics Department of the National Institute of Health. The first version of
p.000153: the Code was discussed by the participants of the Congress and was submitted to further considerations to the National
p.000153: Council on Bioethics. The letter considered the document during its three different sittings and finally published the
p.000153: final text of the Code, which was adopted at the last session of the First Congress of Physicians of Georgia.
p.000153: The Ethics Code of Physician of Georgia is the first national code of ethics in the sphere of biomedicine. It includes
...
p.000161: 3.5. REPUBLIC oF KAzAKHStAn
p.000161: (А.B.Sadykova, B.Е.Sarymsakova)
p.000161:
p.000161: 3.5.1. Historical and Cultural Background
p.000161:
p.000161: Kazakhstan is a country with very rich historical and cultural past time. Being geographically located in the Centre of
p.000161: Eurasia Kazakhstan was on the crossroad of ancient world civilizations, on the cross of transportation arteries,
p.000161: social and economic, cultural and ideological relations between East and West, South and North, between
p.000161: Europe and Asia, between the largest states of Eurasian continent. At different phases of the history states with
p.000161: original cultural history were organized and developed at the territory of Kazakhstan; the modern Kazakhstan is
p.000161: the inheritor of this cultural history. In the middle of XV century Kazakhs united in the unique khanate but after
p.000161: the death of khan Tauke and invasions of Djungars the country disintegrated and was divided into 3 “zhuzes”
p.000161: (sub-countries) each of which was practically independent of others. The khan of Jounger Zhuz applied to Russia for
p.000161: protection – so since that time the incorporation of Kazakh territories started.
p.000161: In 1866 all Kazakh territories were under the political power of Russia but some part of Older Zhuz and Middle Zhuz was
p.000161: incorporated into the Czinn Empire.
p.000161: In 1917 «Alash-Ordy» declared its autonomy.
p.000161: In 1920 Kirgyz Autonomic Republic was organized as a part of the Russian Federation.
p.000161: In 1925 the republic received the name of Kazakh Autonomic Republic with the capital in Almaty and in 1936 it was
p.000161: transformed into Kazakhskaya Soviet Socialist Republic.
p.000161: In 1956 some part of republican territory was adjoined to Omskaya province and Altaysky krai.
p.000161: On 16th of December 1991 Kazakhstan became independent republic. The official name of the country is the
p.000161: “Republic of Kazakhstan” (RK). Astana is the capital of the country, Almaty – the biggest city of the country. The
p.000161: territory of Kazakhstan is equal to 2,717,300 sq. km.
p.000161: The population size of the country (data of 2006) is equal to 15.3 million citizens. Around 53% of the population is
p.000161: urban citizens. There are over
p.000161:
p.000162: 162
p.000162:
p.000163: 163
p.000163:
p.000163: 120 nationalities in Kazakhstan, among them Kazakhs – 58.9%, Russians
p.000163: – 25.9%, Ukranians - 15,2%, and Uzbeks, Germans, Tatars, Uygurs and representatives of other nationalities.
p.000163: Medicine as a part of population culture is the result of practical and scientific selection of methods for the
p.000163: treatment of different diseases. It is well known that even ancient healers used infusions, decoctions, blood-
p.000163: lettings and other traditional methods of treatment (1).
p.000163: Multiple archeological findings on the territory of Kazakhstan proves the existence of drug therapy, surgery,
p.000163: neurosurgery. For example, the scull with marks of trepanation was found in Karagandinskaya province and the origin of
p.000163: this scull was dated by V-IV centuries B.C. Mortars for preparation of medical drugs from the same epoch were
...
p.000221: Russian ethnos originated and evaluated on great Russian plains that determined particular life style and view on
p.000221: external world, so-called “Russian soul breadth”. Social surroundings, relationships and labor system
p.000221:
p.000222: 222
p.000222:
p.000223: 223
p.000223:
p.000223: had the great influence on formation of the Russian national character. Humanity, placability and openness
p.000223: of our ancestors soul were formed under the influence of their main activities such as arable farming, cattle
p.000223: breeding and workmanship, and of community social order, which had been lasting longer then at other peoples. Among
p.000223: values of community it should be mentioned justice, power of “world”, thrifty housekeeping, knowing of folk wisdom,
p.000223: bogatyr (a Russian hero) strength, etc. Having given voluntary his destiny over to the community, man condemned himself
p.000223: to be tolerant and obedient. The community, by means of which the Russian people were able to keep their ethnos
p.000223: independent in spite of numerous invasions, had also the high value. For the sake of the community a Russian was ready
p.000223: to suffer, tolerate and sacrifice almost everything. Nevertheless, historical facts demonstrated examples of “Slavic
p.000223: freedom” from Cossacks, drinking- bouts, revelries, disorder, “fantastically fast life” to rebel and revolutions.
p.000223: The Russian culture is well known to exist inasmuch as Russian (and Old Russian) words meaning cultural
p.000223: contents exist. Contemporary analysis of the word “personality” (autonomy of “personality” is one of the
p.000223: principles of bioethics) in Russian and European languages showed that word “personality” is rather young
p.000223: for the Russian language, it was absent in the Old Russian language and in the modern Russian it handed its
p.000223: meaning to word “person” (15). As regards the notion “individuality” it has been adopted slowly and hardly in modern
p.000223: word usage. This fact differs Russia from Western Europe where individuality became the main value of the Modern time.
p.000223: The idea of person, personality itself began to form here in XIII century. And today in Western Europe the notion of
p.000223: personality is central, important as daily bread, and it is not high but everyday, though in Russia the word
p.000223: “personality” is in one row with the high notions and its meanings are not everyday.
p.000223: Speaking about language as means of communication one should note one more feature which is important for
p.000223: doctor-patient relations. The Russian language in contrast with the Romance and German languages is synthetic, not
p.000223: analytical, i.e. it may be axiomatizated hardly but is able to express emotions and feelings (22,27).
p.000223: Folk proverbs are very important feature of ethnos awareness and national mentality. They accumulate important
p.000223: conclusions and observations about nature and society laws. Many of them assert group priority over
p.000223: personality, collective things priority over individual, necessity to obey any group law. Man strength is in his group
...
p.000241: non-believers advocates the idea of paternal mode of relations, sticks to the idea of conventional patriarchal
p.000241: views in family pattern, supporting filial piety within the family, male dominance in family relations (believers 28%,
p.000241: non-believers 21.9%).
p.000241: For the Russian medicine and health care a paternal model of doctor and patient relations is a typical one. Genesis of
p.000241: these relations can not be seen apart either from economic and cultural development of Russia on the whole or from the
p.000241: ethical staples of medical activity in Russia. Orthodox theological ideas and Russian religious philosophy to a
p.000241: significant extent reinforced the paternal model of doctor and patient relations, promoting ideas of humbling,
p.000241: non-resistance, and respect to universal hierarchy.
p.000241: Developments in medical science and biotechnology increased the power and responsibility of a medical doctor in
p.000241: terms of understanding what life and death and use harm mean. A simultaneous turn of mind in social ideas and mentality
p.000241: of people brought about by a wide spread liberal ideas gave a great impetus to new attitudes based on ideas of personal
p.000241: rights and freedom. All this entailed a necessity to seek for such grounds in doctor and patient
p.000241: communication as recognizing patients’ autonomy, their right for identity and decision making. Process of shifting
p.000241: towards non-paternal model in our country is not a smooth one.
p.000241: One can judge about the steadiness of paternal model by numerous interviews among doctors and patients
p.000241: carried out in recent years. The results of medical and social study in the St-Petersburg Pediatric Academy in 2002-
p.000241: 2004, viewpoints of doctors and citizens on the staple issues of medical ethics (bioethics) depending on
p.000241: their status revealed that currently only few doctors as well as their patients are prepared to apply an
p.000241: antipaternal relationship model in practice (17, 18). Big number of doctors sticks to paternal positions
p.000241: in communication with patients. This situation is also seen as psychologically favorable by many patients who
p.000241: lack desire to take decisions for their own health issues either partly or completely, they are happy to shift this
p.000241: responsibility to doctors.
p.000241: The study reveals that attitude of many doctors and patients to current biotechnology is not yet coined; there is no
p.000241: solid ethical basis. Opinions of church-going interviewees differs drastically from that of non-believers’ and to
p.000241: greater extent meets the provisions of religious and medical ethics. At the same time among church-going doctors great
p.000241: number of interviewees proved not prepared to solving current ethical tasks and either refused to answer questions of
p.000241: the interview or found them too challenging.
p.000241: Russia has not yet determined the answer to the question of referring itself to a civilization – Western or Eastern. In
...
p.000277: Russian Federation GOST R 52379- 2005 “Good Clinical Practice” (approved by the Order of the Federal Agency on
p.000277: technical regulations and metrology of September 27, 2005, No.232). This document completely implemented GCP, which is
p.000277: an international ethical and scientific standard of design and conduct of research involving human subjects as well as
p.000277: a standard of documentary registration and presentation of results of such studies, into the Russian legislation. It
p.000277: was identical to the Guidelines for Good Clinical Practice of the International Conference on Harmonization of
p.000277: Technical Requirements for Registration Pharmaceuticals for Human Use, which, in turn, was developed with consideration
p.000277: of acting requirements of good clinical practice of the European Union, the USA and Japan, as well as
p.000277: Australia, Canada and WHO. Compliance with this document makes possible to our country to adhere to united
p.000277: rules with countries of the European Union, the USA and Japan, that should facilitate mutual recognition of
p.000277: clinical study results with authorized agencies in these countries and become a basis to extend conduct of
p.000277: multicentre studies, eliminate practice of duplicating medical and biological studies in different regions of the world
p.000277: allowing to Russia to become full-fledged participant in process of international studies and, eventually, to
p.000277: result in mutual acknowledgement of pharmaceuticals approval.
p.000277: To secure state guarantees for protection of personal rights, dignity, autonomy and integrity conducting biomedical
p.000277: research in the CIS member
p.000277: states in 2005 there was issuesd a model Law On Protection of Human Rights and Dignity in Biomedical Researches in the
p.000277: CIS, which corresponded to all principles of biomedical ethics and medical law, interstate agreements in the field of
p.000277: biomedical research ethics. This document allows attaining common understanding of protection of human rights
p.000277: and fundamental freedoms in the sphere of biology and medicine application, to unite efforts of scientists
p.000277: and politicians from all CIS countries in the common legal and ethical environment for biomedical researches
p.000277: that covers all types of impacting a man, including studies on embryos in vivo. Along with that, the law
p.000277: enforcement is secured via creation of interstate and national systems of ethical review that is
p.000277: designed in accordance with ideology of the WHO program SIDCER and initiated by the Forum for Ethics Committees in
p.000277: the CIS.
p.000277: Currently we came to understanding that all biomedical projects held in the CIS countries shall undergo independent
p.000277: ethical review at the national level; there were established ethics committees forming a mechanism for provision of
p.000277: ethical review quality and research project safety through control at all stages of informed consent
...
p.000297: implementing new technologies. It is essential to develop a firm ethical position with regard to biomedical
p.000297: research, to introduce teaching programmes covering basic ethical principles for investigators and to
p.000297: establish a system of local ethics committees that review biomedical research.
p.000297: In the process of the formation of the Republican Committee on Medical Ethics (RCME) a seminar organized by a
p.000297: representative from J.Hopkins University (Baltimore, USA) was held in Dushanbe (2004) to train future RCME members.
p.000297: On completing the seminar, the students took exams and received certificates. In 2004 we also accomplished a
p.000297: project within the framework of a LIGP/ACTR/ACCELS Programme of the American Council for International Education and
p.000297: Culture at the Department of States.
p.000297: During the last two years from one to three professionals annually have attended courses on ethical review
p.000297: held in Almaty (Kazakhstan) at the Higher School of Public Healthcare.
p.000297: The implementation of European standards in CT and a new model of the teaching process require a cardinal change
p.000297: and structuring of all teaching programmes in compliance with the principles of the Bologna educational
p.000297: system.
p.000297:
p.000297: 3.9.4. The System of Ethical Review
p.000297:
p.000297: The current international system of a public and state control of safeguarding rights, dignity and autonomy
p.000297: of human subjects participating in biomedical research, and of compliance with universal ethical principles of
p.000297: biomedical research involving human subjects, implies the creation of independent public institutions – ethics
p.000297: committees.
p.000297: Ethics committees are analytical, consultative and monitoring units of various composition and status. They have to
p.000297: work out moral regulations for biomedical research, to carry out ethical review and give recommendations in case of
p.000297: conflicts arising in biomedical research or in medical practice. The Committee on Medical Ethics (CME) at the Health
p.000297: Ministry of Tajikistan performs these functions. To undergo ethical review, investigators should submit research
p.000297: proposals and their supporting documents to the CME secretary. Ethical review of biomedical research is carried
p.000297: out at the CME meeting in compliance with adopted regulations. The CME members may make positive, conditional (with
p.000297: clear suggestions for revision) and negative (in case of potential harm to research subjects’ rights and dignity)
p.000297: decisions on applications for the ethical review. They may monitor the compliance with ethical regulations throughout
p.000297: the research.
p.000297: Another significant aspect of the creation and development of the ethical review system is the review of
p.000297: dissertation works. There is an agreement between the Russian Federation and Tajikistan according to which
p.000297: certification and approval of candidate and doctoral dissertations is performed by the Expert Council for Medicine
...
p.000335: causing violation of citizens’ rights in this sphere are determined by a number of factors, such as:
p.000335: 1. imperfection of legislation referring to medical practice;
p.000335: 2. a low level of implementing normative and legal documents regulating the practice of healthcare system;
p.000335: 3. an inadequate level of citizens’ awareness of their rights and responsibilities in medicine.
p.000335: All abovementioned problems are the object of bioethics – a new field of knowledge rapidly developing all over the
p.000335: world for working out ways and methods for resolving problem situations in healthcare and in the sphere of new
p.000335: medical technologies. To improve the situation, the Republic of Uzbekistan worked out a draft law on medical
p.000335: practice.
p.000335: When designing the law attention has been paid to the following issues:
p.000335: 1. Modern medicine is a high-tech field; a rapid development of new biotechnologies, new treatment methods is
p.000335: continuously expanding ways of medical intervention in human body. Therefore, an individual needs new mechanisms of
p.000335: protection in the sphere of medicine, because a person’s health, life and dignity depend on them.
p.000335: 2. Issues concerning an appropriate quality of medical assistance, its availability, social justice, equality and
p.000335: non-discrimination in healthcare are also essential.
p.000335: 3. It is necessary to create a model of patient—physician relationship that would imply cooperation and dialogue
p.000335: between two parties equal in rights based on the respect for a person’s autonomy.
p.000335: 4. A patient has certain rights the violation of which entails not only moral but also judicial responsibility.
p.000335: Appropriate sanctions should be applied to a physician in the event of a damage done to a patient that resulted from
p.000335: unqualified and careless actions.
p.000335: 5. In setting out principles of medical practice, we have to think not only about an individual’s rights and freedoms
p.000335: but also about his/her dignity and integrity. The concept of human integrity covers an individual’s genetic structures,
p.000335: intellect and psyche. Any medical intervention is only possible with a voluntary and informed consent obtained from a
p.000335: person.
p.000335: 6. A necessary condition for a medical intervention is a patient’s voluntary and informed consent. A
p.000335: voluntary consent implies that it has been
p.000335:
p.000336: 336
p.000336:
p.000337: 337
p.000337:
p.000337: obtained without deception, concealing information or pressure. Consent is informed when it is given by a person who
p.000337: has been informed, in a plain and understandable language, about the purpose and nature of the suggested intervention,
p.000337: its possible risks and alternative treatment methods.
p.000337: 7. It is necessary to define in national legislation the status of embryos at different stages of their
p.000337: development. The lack of legal regulation here opens up opportunities for their commercial use or for a groundless
p.000337: accusation of physicians studying embryos. We need laws on human reproduction, human genetic structures,
...
General/Other / Manipulable
Searching for indicator manipulate:
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p.000051: that, in turn, uses scientific achievements.
p.000051: This is the background for realization that so-called applied science deals with those problems that are
p.000051: determined with the very development of technologies, and, along with that, such “servicing” science becomes
p.000051: determinative both as to quantitative and financial or other supplies, and as to social recognition. As we already
p.000051: noted a regulator for scientific activity becomes not obtaining knowledge pretending to be the truth to some extent but
p.000051: gaining an effect that can be implemented into a technology in demand. One should say that also social expectations
p.000051: regarded to science today shows clear domination of demands for new effective technologies but not for explanation of
p.000051: the world. Such transformations of relationships among science, technology and society, particularly, real move
p.000051: of science from avant-garde to auxiliary roles are launched in the realm of natural sciences,
p.000051: but then spread to social and humanitarian sciences.
p.000051: Thus, both the society and the state including all authorities responsible for formation of policies in regard to
p.000051: science are more inclined to perceive both research activities and the very science as a machine capable of
p.000051: generating new technologies.
p.000051:
p.000051: Science on the Market
p.000051: Commercialization of science is another very peculiar feature in development of biomedical technologies.
p.000051: Emergence of the biotechnological industry in the USA as a new institution for not only applied science, but also for
p.000051: fundamental research at the 70’s of the XX century was provoked with several factors including: a) considerably grown
p.000051: abilities to “recombine”, “produce” and simply “manipulate” DNA and all other molecules; b) transformation of
p.000051: the administrative environment which should encourage rapid transition of research to applied problems such as changes
p.000051: in the patent law that not just supported but forced to commercialize inventions in both industrial and academic
p.000051: sectors; c) and in the limit case – fusion of state- funded scientific research with venture capital interested
p.000051: in investments
p.000051: for development of extended base of molecular and biological studies” (P.Rabinov. Making PCR: a story of
p.000051: biotechnology. Univ.of Chicago Press. 1996. p. 19). Commercialization made possible consolidation of resources
p.000051: necessary for breakthrough in biotechnologies that occurred at the end of XX – beginning of the XXI centuries. It has
p.000051: also resulted in reconstruction of self-identity of science and scientists we observe these days changing
p.000051: self-comprehension of science and creating new identity of “a businessman scientist”.
p.000051: Another important consequence of commercialization was changes of patenting practices. In 1980 the US Supreme Court
p.000051: decided that creation of new forms of life is subjected to the Federal Patent Law. It made possible, after some time,
p.000051: to start patenting of not only artificially developed organisms or laboratory animals, but also patenting of human
p.000051: genes, DNA sequences, embryo stem cells, etc. Pragmatic interest for investment protection has changed
p.000051: the world perception. In the form of a patent it provided fundamental scientific knowledge with a form
...
p.000055: sources.” (J.Spanberger et al. The knowledge-based society: measuring sustainability of the information society.
p.000055: Futura, 2002). Or it could be said as follows: the term “mass media” in this sense is related to all social and
p.000055: humanitarian technologies which are substantially important, necessary for functioning of the circuit.
p.000055: For instance, a special sphere of activity within the circuit is to bring to a consumer not only information about a
p.000055: newly developed technology but the technology itself. Let’s say, as per some estimation, when producing new medicinal
p.000055: agent its development (i.e., the laboratory) takes about one tenth of all financial expenditures, and all other costs
p.000055: are incurred for promotion of a drug up to the stage of a marketed product. Naturally, an activity for new technology
p.000055: promotion is also built upon technological basis, and at that at these stages the main role is played by social and
p.000055: humanitarian technologies. It indicates once again that development of some product – in this case, a medicinal agent –
p.000055: within the framework of technoscience is nothing else but a
p.000055:
p.000056: 56
p.000056:
p.000057: 57
p.000057:
p.000057: part of technological process and, thus, technoscience deals, first of all, not with objects as they are but with
p.000057: extensive circuits including, beside these objects, also joint, coordinated activity of various people and social
p.000057: structures.
p.000057: It does not matter how effective is advertising but one should not demonize it and consider as omnipotent. A
p.000057: consumer, generally speaking, is far from always being a puppet that is easy to manipulate. He has his own and not only
p.000057: dictated externally needs and preferences. Effectiveness of functioning of the technoscience circuit is, to a large
p.000057: extent, secured with built in mechanisms of identification of consumer interests and expectations. Due to use of
p.000057: social and humanitarian technologies these interests and expectations, in their turn, are brought to notice of
p.000057: the business and laboratory and become factors determining strategy of technology development.
p.000057: Further, it is necessary to mention another network where information circulates in the circuit. In this case we
p.000057: mean not mass but specialized information about desire of a businessman to invest in development of
p.000057: specific technologies, on one hand, and about technological possibilities and perspectives of this or that laboratory,
p.000057: on the other. In many cases but not always the laboratory is a constituent of a business company. If there are no such
p.000057: tight connections, then information mediator is required.
p.000057: Thus, in general, the technoscientific circuit includes four elements related with one another with direct
p.000057: and reverse informational, financial and commodity flows. It should be stressed that reverse connections within
p.000057: this circuit are positive: a signal coming from one element to another does not weaken as it happens in case of
p.000057: negative feedback but, contrariwise, strengthens. Thus, it provides unprecedented dynamism for functioning of the
p.000057: circuit.
p.000057: In practice, it looks approximately like the following: the laboratory purposefully works to meet demands of
p.000057: customers that it is aware of due to work of mass media; customers are ready to bear expenses for products meeting
...
General/Other / Natural Hazards
Searching for indicator hazard:
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p.000053: for possibilities of using
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000055: 55
p.000055:
p.000055: them in biomedicine; also it is peculiar that, first of all, in this very aspect of their development appears within
p.000055: the sphere of ethical analysis.
p.000055: Thus, scientific and technological progress is more and more oriented on interests and needs of an individual who is a
p.000055: main consumer of what is provided by the progress. New technologies turn to be such commodities oriented on mass
p.000055: consumption; without this large-scale involvement it would be impossible to provide effectiveness of a
p.000055: laboratory. In turn, interests and needs of consumers become strong drivers determining, to a large extent,
p.000055: directions and urging rates of the scientific and technical progress. As a result, there is a two-way connection
p.000055: between the laboratory producing new technologies and individuals being their consumers. The laboratory and mass
p.000055: individual consumer, in other words, are included into a single circuit.
p.000055: However, such closing of science to needs of a man does not come on its own – everything has the price. One of the most
p.000055: serious constituents of this payment is more and more acute necessity to study specifically what are actually human
p.000055: needs and requirements and how exactly to meet them. And it means that a man becomes more and more an object
p.000055: for various scientific researches. And to the extent, at which strength of scientific cognition is focused
p.000055: on him, with which newer, finer and more effective means of influencing on him are developed, elements of risk and
p.000055: hazard he is exposed to are growing inevitably. Therefore, a task of protecting a man, in whose direct interests
p.000055: science and technique is advancing, is actualized from negative consequences of this very project.
p.000055: The next constituent of the circuit described herein is business, enterprise capital. It funds the laboratory,
p.000055: thus, providing opportunities for development of new technologies. In turn, the mass consumer paying for technological
p.000055: novelties allows business not only to reimburse for incurred expenditures but also to gain profit, which often is again
p.000055: invested into the laboratory and development of other new technologies. It is important to stress stable type of
p.000055: connections among three discussed elements – business is involved into this circuit not every once in a while but
p.000055: becomes an integral part of permanently acting and steadily growing circuit. In society based on knowledge investments
p.000055: into the laboratory are the most promising ones.
p.000055: Science and Mass Media
p.000055: As a link for all said elements there is one more, this is mass media that has a range of functions within this
p.000055: circuit.
p.000055: First of all, they bring to potential customers information on appearance of technological innovations at the
p.000055: market. But the mass media function in this circuit is far from being limited with dispassionate informing. On the
p.000055: contrary, quite often they form demand for these or those technological products – in this respect it is sufficient to
p.000055: remind about how sophisticated, obtrusive and even aggressive advertising can be. We can note here that
p.000055: advertising of a hydro power station or, for instance, a walking excavator would be senseless – advertising is
...
p.000337: cause harm against potential benefit of the research.
p.000337: Biomedical research or a clinical trial may only be carried out after the person concerned has given free
p.000337: and informed consent to it based on information provided by the investigator.
p.000337: Physician-investigator should safeguard the patient’s right to withdraw his/her consent to participate in a research at
p.000337: any time and for any reason.
p.000337: This draft project of the law has been submitted to the Legislative Chamber of Uzbekistan Parliament; it
p.000337: has been discussed, and will be adopted in 2007.
p.000337: Alongside the patients’ rights, the Law “On Medical Practice” implies patients’ responsibilities. Thus, Article 47
p.000337: states that the patient should
p.000337: - to show tact and respect towards medical professionals;
p.000337: - to give comprehensive information necessary for the diagnostics and treatment of a disease;
p.000337:
p.000338: 338
p.000338:
p.000339: 339
p.000339:
p.000339: - to follow the physician’s prescriptions after having given consent to a medical intervention;
p.000339: - to comply with the routine of the healthcare institution;
p.000339: - to collaborate with the physician in the process of treatment;
p.000339: - to inform the physician without delay about a change in his/her health condition in the process of diagnostics and
p.000339: treatment;
p.000339: - to apply to the physician immediately if there is a suspicion of a disease or a disease posing hazard of a wide
p.000339: spreading;
p.000339: - to avoid any actions that may infringe other patients’ rights.
p.000339: It is essential to include into the draft project of the Law provisions on the physician’s rights and responsibilities
p.000339: that enhance the rapport with the patient, as both the patient and the physician become partners having reciprocal
p.000339: rights and responsibilities, and the right for one party, is the responsibility of another one.
p.000339: The Law “On Medical Practice” will facilitate the regulation of independent ethical review and safeguard the
p.000339: protection of rights and dignity of Uzbekistan citizens in biomedical trials.
p.000339: Legislative measures undertaken in Uzbekistan will be able to protect individuals, the society and humankind as a
p.000339: whole against undesirable or sometimes harmful consequences from the implementation of new biomedical
p.000339: technologies.
p.000339:
p.000339: 3.11.3. Education in Bioethics
p.000339:
p.000339: Problems of teaching bioethics arouse much discussion at all international forums on bioethics.
p.000339: According to UNESCO Ethics Education Programme (EEP), for the biennium 2004-2005 the activities in the area of ethics
p.000339: teaching have primarily focused on East and Central Europe. During 2006-2007 priority has been given to
p.000339: South-East Europe and part of the Arab region (Gulf region).
...
General/Other / Other Country
Searching for indicator another country:
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p.000149: result of the expansive policy of Russian Empire. In 1918 independence of Georgia was re-announced (Republic of
p.000149: Georgia), which lasted only up to 1921, when intervention of Russia resulted in incorporation of Georgia in the Soviet
p.000149: Union.
p.000149: Georgia has little experience in building the civil society. However, it has definitively moves towards the
p.000149: integration with the Western World and harmonisation with the western law. The legislative basis apparently is one
p.000149: of the most important points in the process of establishing common anthropocentric values and viewpoint of the civil,
p.000149: open society.
p.000149: The history of the Georgian state and law dates back to ancient times. Due to the historical misfortunes Georgia never
p.000149: participated in the process of great codifications. In this connection legislative activity of the King
p.000149: Vakhtang VI (XVII-XVIII cc) deserves major attention. Chronologically this period coincides with the epoch of
p.000149: creation of the basis for the modern law and state in Western Europe. Drafting of King Vakhtang’s Law Book can be
p.000149: considered to be an attempt to get closer to the cultural world, at which Georgia aspired during its whole history. In
p.000149: some regions of Georgia the code of Vakhtang’s Laws was in force up to the second half of the XIX century.
p.000149: An attempt to build a modern independent state in 1918-1921 was not successful due to the expansion of Russia. As a
p.000149: result Georgia became the part of the communistic space for the next 70 years. Thus, formation of the civil
p.000149: society in Georgia started within the borders of another country (Soviet Union), making Georgia unable to develop
p.000149: its own legislation independently.
p.000149: During aforementioned 70 years legislative activity in Georgia was restricted to the slight alteration or, at
p.000149: best, adaptation of the frame laws, provided by the central authorities (Moscow). As well as in other republics of the
p.000149: Soviet Union there was no tradition of training the legal professionals for the health care system in Georgia. Before
p.000149: re-establishment of Georgia’s sovereignty, the Law on Health Care, adopted in 1972 by Soviet Government, was in force.
p.000149: This document showed significant negligence of individual rights of patients. Almost none of the basic principles of
p.000149: ensuring patients’
p.000149: autonomy and self-determination (except the right to keep personal data confidentially) were even declared.
p.000149: The creation of national legislation is an essential condition for building the national and democratic state and a
p.000149: civil society. Adoption of Georgian Constitution (24 of August 1995) and Georgian Civil Code (26 of June 1997) is
p.000149: definitely significant step toward establishment of national state.
p.000149:
p.000149: 3.4.2 Legal Regulations
p.000149:
p.000149: Legislation of Georgia related to health, biomedicine and human rights comprise laws which regulate
p.000149: various aspects of medicine/health care: rights of patients and research subjects (including vulnerable groups; such
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000067: principles proclaimed by fundamental international documents.
p.000067: The sphere of action of the present law is spread on state citizens participating in biomedical research
p.000067: and is applied in regard to all facilities and persons being related to conduct of biomedical research at the territory
p.000067: of the state as well as it stipulates that foreign citizens and persons with absent nationality being present at
p.000067: the territory of the state in case of participation in a biomedical study can enjoy all rights established with
p.000067: the given law equally to citizens of this state. Such statement is quite significant in regard to situation in the
p.000067: CIS region due to openness of borders and notable migration processes.
p.000067: In regard to harmonization both within CIS and at the international level it is important that the law
p.000067: unifies terminology in compliance with GCP-approved definitions creating attitude for mutual understanding and
p.000067: development of a united information field of biomedical research. Some articles of the law stipulate the state
p.000067: policy standard and rights of participants of biomedical studies. Separate chapters are dedicated to study safety and
p.000067: an ethical review system, a format of an informed consent and compliance with confidentiality requirements, therefore,
p.000067: corresponding to the core of all international enactments in the sphere of biomedical research. There is a separate
p.000067: chapter on special situations of the biomedical study conduct including articles regarding biomedical
p.000067: research involving vulnerable persons, research in emergency clinical situations, epidemiological and social
p.000067: studies. In general, force of the law covers all types of biomedical research involving human subjects including the
p.000067: ones with embryos in vivo, but excluding research on embryos in vitro. Liability for breaching the law is also
p.000067: stipulated.
p.000067: Beside regulatory model regulation there is a functioning union for executive authorities of the
p.000067: Commonwealth countries as the Council on Cooperation in the Field of Health Care mentioned above which
p.000067: has the interstate commission on standardization, registration and control of quality
p.000067: of medicinal agents, products for medical use and medical equipment in the CIS member states.
p.000067: By the order of the Council on Cooperation in the Field of Health Care the CIS Executive Committee prepared and
p.000067: submitted final information of regulatory and legal documents in the field of sanitary and epidemiological regulations
p.000067: and provision of sanitary and epidemiological well-being of population in the CIS member states as well as
p.000067: concerning agreements and decisions on provision of coordinated actions of the CIS member states in the field of
p.000067: standardization, registration and quality control of medicinal agents, products for medical use and medical
p.000067: equipment.
p.000067: Acknowledging logic of closeness of conditions and problems of biomedical study conduct in the CIS region
p.000067: the coordinated harmonized actions include not only authorized state agencies but also public entities (for
p.000067: instance, the FECCIS) and professional associations of manufacturers of medicinal agents and pharmaceutical companies
...
p.000215: - documents confirming all decisions (including negative ones) previously made by the ethics committees
p.000215: (local or otherwise) in respect to this research;
p.000215: - documents confirming absence of interest of the research group members in the result of the research.
p.000215: During discussion of the clinical research materials the following issues shall be considered:
p.000215: 1. Concordance of the provided protocol to the goals and objectives of the research, possibility to obtain well based
p.000215: result at lowest risk level for the study subjects, appropriateness of possible risk and inconvenience for the subjects
p.000215: or other persons.
p.000215: 2. Aptitude of a researcher as to conduct of suggested clinical research, such as:
p.000215: - high professional qualification;
p.000215: - sufficient work experience in the relevant field of medicine;
p.000215: - sufficient scientific experience confirmed by documents and publications;
p.000215: - correspondence to high ethical standards;
p.000215: - availability of sufficient time for performance of the clinical research under the protocol;
p.000215: - availability of necessary means and facilities for performance of planned research.
p.000215: 3. Concordance of a study research site to the study goals and objectives:
p.000215: - ability to enroll subject cohorts within scheduled study time;
p.000215: - provision of clinic with necessary personnel: diagnostic and patient care equipment, communication facilities,
p.000215: computer equipment;
p.000215: - ability to provide emergency medical care in case of adverse events and side effects.
p.000215: 4. Procedure for attraction of possible study subjects (advertising, announcements, etc.), evaluation of
p.000215: correspondence of provided information to ethical norms.
p.000215: 5. Patient insurance procedure and payment of remuneration.
p.000215: 6. Content of research information provided to the patient.
p.000215: 7. Procedure for obtaining of the patient written consent for participation in the research;
p.000215:
p.000216: 216
p.000216:
p.000217: 217
p.000217:
p.000217: Only members of the ethics committee independent from sponsor and researcher take part in decision-making
p.000217: process as to certain clinical research.
p.000217: Decision of the ethics committee is given in accordance with one of the following variants:
p.000217: a) Permission to perform of a clinical research (approved opinion);
p.000217: b) Amendments are required to produce a positive decision;
p.000217: c) Negative decision;
p.000217: d) Cancellation of any previously made decision.
p.000217: During a clinical research an investigator must inform the Ethics Committee on necessity to introduce certain
p.000217: amendments and alterations to the clinical study protocol and to the information provided to study subjects, as well on
p.000217: occurrence of severe and/or unexpected adverse events and side effects and on any new data on possible impact of the
p.000217: tested article on humans. Based on results of review of materials provided by the investigator, the Ethics Committee
...
p.000287: scientific atheism analyzed problems of developing a scientific and materialistic worldview, causes for
p.000287: survival of religious views and ways
p.000287:
p.000288: 288
p.000288:
p.000289: 289
p.000289:
p.000289: to overcome the problem; gave a critical analysis of various religious concepts (A.Bazarov, R.Madjiev). There
p.000289: were also new studies in the field of sociology, ethics and aesthetics.
p.000289: The late eighties and early nineties were marked with complicated and contradictory events, the most significant
p.000289: of which was a disappearance of such a state as the USSR on the map of the world. Instead, about 15
p.000289: new independent states appeared, and Tajikistan among those. Thus, within a short historical interval Tajikistan
p.000289: moved from one historical period to another; the state and power structure changed, as well as its
p.000289: attributes. The former political system was destroyed, which resulted in the change of ownership patterns and social
p.000289: relations.
p.000289: The development of Tajikistan as an independent secular republic in the post-Soviet space was accompanied
p.000289: with economic, political and social instability. A significant support from the international community was
p.000289: directed to the needs associated with the civil was (1992-1995) and its consequences. Emergency measures of
p.000289: providing medicines, vaccines, bandaging material taken by the international community made an essential contribution
p.000289: into the solution of healthcare problems. At the same time, there was a need in more thorough structural changes that
p.000289: would help to overcome existing problems and facilitate the development of safe mechanisms for providing
p.000289: healthcare and safeguarding patients’ rights.
p.000289: As current biomedical researches are carried out at a large scale and at many Centres, they affect interests of many
p.000289: people and many countries. New problems emerge, because “rich” countries carry over their biomedical research to other,
p.000289: “poorer” countries, and use the results of the research at home, as, “poor” countries cannot afford to use the research
p.000289: findings for economic reasons. To eliminate this injustice, the medical community took certain measures. The WMA
p.000289: Declaration of Helsinki and the additional Protocol to the CE Convention on Human Rights and Biomedicine require
p.000289: that in the countries where a biomedical research is planned the permission should be sought from state structures, and
p.000289: interests of people who live there and who are potential research subjects should be considered.
p.000289: The involvement of Republic of Tajikistan, as an independent state, in international research projects
p.000289: requiring ethical review to ensure the compliance with international regulations triggered the process of
p.000289: establishing in Tajikistan the Committee on Medical Ethics and developing the system
...
p.000291: Precursors”, “The Concept of Healthcare Reformation in Republic of Tajikistan” (2002). These documents are
p.000291: focused on the international practice; implementation of new, more efficient organization approaches,
p.000291: improving the quality and availability of medical and sanitary care and a further development of international
p.000291: cooperation.
p.000291: In the context of democratization processes in Tajikistan, when conducting a biomedical research we have to proceed
p.000291: from the principle of the respect for a person’s freedom and, hence, from the principle of the respect for an
p.000291: individual’s convictions. One of the factors that might limit the physician’s freedom in decision-making is the
p.000291: religious and cultural milieu that formed an individual’s consciousness. Without the knowledge of cultural details, a
p.000291: competent design of biomedical research in Tajikistan – a Moslem country and an officially secular State – is not
p.000291: possible. Besides, there are strong believers practicing Islam and observing all religious holidays. Thus, many
p.000291: people keep the strict fast during the Ramadan. In this period people suffering from severe diseases, refuse taking
p.000291: medicines both per os and by injection, which is harmful to their health. Thus, for example, patients who have had
p.000291: operations for glaucoma refuse courses of conservative supportive therapy or keep the fast, which weakens visual
p.000291: functions. Quite often during the Ramadan people
p.000291: get to the surgery department of the emergency station with pancreonecrosis after having a rich and fat meal (pilaw) in
p.000291: the night after fasting during the day. In some cases this situation has a lethal outcome. Islamic traditions dictate a
p.000291: respectful attitude to the human body even after a person’s death and therefore relatives of the deceased do not
p.000291: consent to the post-mortem examination and removal of organs for transplantation. According to Moslem religion, the
p.000291: soul of the embryo appears in the first week of the fourth month of pregnancy, and the law prohibits abortion after
p.000291: this term. Besides, Tajikistan population is not disposed to contraception measures or abortion, and therefore Tajik
p.000291: families are commonly having many children. When carrying out preventive health examination of strong believers, it is
p.000291: important to divide them into separate streams according to sex.
p.000291: Artificial fertilization in Tajikistan is permitted. It is desirable to use sperm of the woman’s husband provided that
p.000291: his consent has been obtained. There are no strict religious restrictions with regard to transplantation and removal
p.000291: donor organs. Sharia laws state that medical professionals should struggle for a patient’s life to the last moment and
p.000291: totally reject euthanasia. These and other similar examples emphasize the necessity to consider cultural
p.000291: aspects with regard to providing medical care and conducting biomedical research in Tajikistan.
p.000291: Biomedical research if conducted without considering cultural and religious aspects may have negative
p.000291: consequences. The physician should follow certain rules not to harm religious feelings. This is essential both in
p.000291: planned and emergency treatment. However, often, particularly in providing emergency care, the physician, voluntarily
p.000291: or not, may be in a situation when he/she is violating a religious rule.
p.000291: When developing legislative acts referring to healthcare in Tajikistan we have followed the fundamental principles of
p.000291: the protection of human rights and dignity in biomedicine. The basic document is the Constitution of Tajikistan. The
p.000291: current Constitution is ensuring the priority of providing healthcare to the population of Tajikistan.
p.000291: The Constitution of Tajikistan proclaims citizens’ rights and freedoms and determines responsibilities of natural
p.000291: and juridical persons. One of the rights guaranteed by the Constitution is the right for health protection implying
p.000291: the following:
p.000291: - medical care and social protection;
p.000291:
p.000292: 292
p.000292:
p.000293: 293
p.000293:
p.000293: - safe environment, food products and drinking water;
p.000293: - qualified medical and sanitary care including a free choice of a physician and healthcare institution;
p.000293: - safe and healthy living and working conditions, as well as safe and healthy conditions for rest, education and
p.000293: upbringing;
p.000293: - sanitary and epidemiologic well-being in the territory where a person lives;
p.000293: - truthful and timely information about an individual’s health including existing and potential risks and the degree of
p.000293: risk;
...
p.000305: Human Rights and Biomedicine, should be taken into consideration as an increasingly determining factor in proportion to
p.000305: his or her age and degree of maturity (Convention, Art. 6) is not included into Ukrainian legislation. Neither is the
p.000305: item that adults who according to law do not have capacity to consent shall as far as possible take part in the
p.000305: decision-making procedure. However, there is a similar rule about informed consent to the application of new methods or
p.000305: pharmaceutical products concerning minors from 15 to 18 years of age and individuals with a limited capacity to consent
p.000305: (Art. 44.2 of Basic Legislation).
p.000305: The right to withdraw consent is not clearly stated either in the law or in the majority of other special
p.000305: laws but the Ukrainian law “On Pharmaceutical Products” (Art. 8). According to this law, a volunteer or the person’s
p.000305: legal representative can freely withdraw his or her consent to participate in clinical trials.
p.000305: There is no regulation relating to medical interventions for the benefit of the health of the person concerned
p.000305: in emergency situations when the appropriate informed consent cannot be obtained. For this case we need a legal
p.000305: norm stating that the previously expressed wishes relating to a medical intervention by a patient who is not, at the
p.000305: time of the intervention, in a condition to express his or her wishes should be taken into account.
p.000305: The law “On Pharmaceutical Products” states the necessity to obtain a written consent from a potential subject of a
p.000305: clinical trial or from his or her legal representative (Art. 8). This additional measure is connected with the danger
p.000305: of abuse and infringement of human rights.
p.000305: The right to information is closely related to the concept of informed consent. Recognition of this right is
p.000305: particularly essential for former soviet republics with their traditional paternalistic approach to physician-patient
p.000305: relationship. The transition to the concept of cooperation signifies the respect for the patient’s will, for his or her
p.000305: dignity and free choice. This is especially important for the sphere of biomedical research involving human subjects.
p.000305: The general rule is fixed in Ukrainian legislation – in Basic Legislation and in special laws. However,
p.000305: Basic Legislation says nothing about the confidentiality of private information, and corresponding
p.000305: statements can
p.000305:
p.000306: 306
p.000306:
p.000307: 307
p.000307:
p.000307: be found only in the Ukrainian laws “On Prevention of AIDS Disease and Social Protection of Population” (Art. 8) and
...
p.000347: also served to reduce the number of complaints from patients.
p.000347: The NEC coordinates its activity with the Centre of Science and Technology. The latter considers applied,
p.000347: fundamental and innovation grant projects relating to biomedical research after they were approved by the NEC.
p.000347: The NEC collaborates with the Higher Certifying Commission at the Cabinet of the Republic of Uzbekistan. According
p.000347: to the petition of the NEC Medical Council “On the Necessity to Conduct Ethical Review of Dissertation
p.000347: Works Involving Patients or Volunteers as Research Subjects” (Protocol No 25, 2002) the Commission considers
p.000347: dissertation works only after the NEC permission to carry out the research (including biomedical research with animals)
p.000347: was obtained.
p.000347: The NEC participated in the organization of the First National Congress on Bioethics with international participation
p.000347: (2005) and a scientific conference “Ethical Aspects of New Biotechnologies in Biology and Medicine” (2006). It
p.000347: facilitated the publication of the Conference papers and of a book “Bioethics in Uzbekistan. Clinical, Philosophical
p.000347: and Legal Aspects” (2006).
p.000347: At the First National Congress four trends in bioethics were discussed:
p.000347: - ethical problems in science;
p.000347: - legal aspects of bioethics;
p.000347: - bioethics and education;
p.000347: - bioethics and the environment.
p.000347: A special attention was given to ethical aspects of new biotechnologies, patient-physician relationships in various
p.000347: fields of healthcare (pediatrics, neonatology, surgery, neurosurgery, emergency care, neurology, psychiatry) and
p.000347: bioethical education.
p.000347: The Congress adopted a Resolution that will facilitate the development of bioethics in Uzbekistan.
p.000347: The main tasks of the Congress were to promote legislation with regard to the protection of human rights and
p.000347: dignity in biomedical research involving human subjects; to outline the strategy for developing the activity of the NEC
p.000347: in the field of bioethics; to discuss educational programmes on bioethics for students of higher educational
p.000347: establishments.
p.000347: The Congress participants discussed and adopted the Ethical Code of Uzbekistan Physician-Investigator”
p.000347: setting out basic principles of ethical review of biomedical research involving human subjects. The
p.000347: implementation of the Ethical Code will form a basis for a legal solution of bioethical problems. This, in its turn,
p.000347: will allow us to provide medical care corresponding to the level of modern biomedical technologies and to observe
p.000347: patients’ rights in compliance with adopted international documents.
p.000347: The adopted Resolution and the Ethical Code of Uzbekistan Physician- Investigator not only mark a new stage in
p.000347: the development of the NEC activity, but also evidence the growth and prospects with regard to solving key
p.000347: problems of bioethics relating to the protection of human rights and dignity in Uzbekistan.
...
p.000349: deputies of the Legislative Chamber of Uzbekistan Parliament, representatives of various public organizations,
p.000349: delegates from different Uzbekistan cities, as well as from Kazakhstan, Kyrgyzstan, Tajikistan, Ukraine, Russia,
p.000349: Belgium, South Africa, Philippines, Singapore and other countries.
p.000349: The Congress participants discussed key issues of bioethics relating to the protection of human rights and dignity of
p.000349: biomedical research subjects in connection with the use of achievements in biology and medicine.
p.000349: The Congress participants made many interesting presentations. The Minister of Healthcare of Uzbekistan, prof.
p.000349: F.G.Nazirov spoke about ethical aspects of using new technologies in medicine; Doctor of Philosophy, professor Moshin
p.000349: Ebrahim from the Islamic University of South African Republic shared his opinion on the rights of a fetus; scientists
p.000349: from Philippines, Ukraine and Russia touched upon ethical problems concerning the use of embryonic and stromal human
p.000349: stem cells in treating various diseases. The Chairperson of the FECCIS, prof. O.I.Kubar from St.-Petersburg and Dr.U.
p.000349: Sharapov gave a talk
p.000349: on ethical aspects of clinical trials concerning HIV/AIDS; physicians from the Republican Specialized Surgery Centre at
p.000349: the Ministry of Public Health of Uzbekistan spoke about bioethical aspects of organ and tissue transplantation, and
p.000349: specialists from the Scientific Centre for Emergency Medical Care presented talks on similar problems in
p.000349: emergency medicine.
p.000349: J.N.Franco from Singapore and a group of physicians from Belgium spoke about problems of patient—physician relationship
p.000349: in the conditions of a rapid development of new biotechnologies and about truth-telling with regard to
p.000349: patients with terminal diseases. M.Baimukhamedov gave a talk on ethical aspects of the protection of patients’ rights
p.000349: in TV-medical consultations. The Congress participants discussed problems of ecological ethics and the use of
p.000349: genetically modified products and their effect on integral health (presentations by academician T.I.Iskanderov
p.000349: from Uzbekistan, Z.Nasyrova and Z.Akhrorova - scientists from Kazakhstan and Tajikistan). The Head of the WHO
p.000349: Office in Uzbekistan Dr. Arun Nanda, prof.
p.000349: E.I.Musabaev (Uzbekistan), physicians from Russia, The Tashkent Medical Academy and Samarkand Scientific Center
p.000349: presented talks on legal aspects of bioethics.
p.000349: The Chairperson of the NEC and of the Medical Council of the Ministry of Public Health, academician
p.000349: M.S.Abdullakhodjaeva spoke about ethics in science, and professors from the Tashkent Medical Academy
p.000349: Sh.E.Atakhanov, M.T.Rustamova and others discussed issues on teaching ethics to medical students.
p.000349: In the framework of the Congress a training seminar was held for considering fundamental problems of
p.000349: bioethics. Members of ECs from Uzbekistan, Kyrgyzstan and Tajikistan took part in the seminar.
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000029: World Medical
p.000029:
p.000030: 30
p.000030:
p.000031: 31
p.000031:
p.000031: Association (WMA) of 1964 with amendments, International Ethical Guidelines for Biomedical Research Involving
p.000031: Human Subjects developed by CIOMS and WHO in 1982 and amended in 1993 and 2000, International Guidelines for Ethical
p.000031: Review of Epidemiological Studies, CIOMS, 1991, Guidelines for Good Clinical Practice (ICH GCP), 1996;
p.000031: Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000) with additional document
p.000031: of 2002, Convention for the Protection of Human Rights and Dignity with Regard to the Application of
p.000031: Biology and Medicine: Convention of Human Rights and Biomedicine (Council of Europe, 1997) and adopted in addition
p.000031: thereof Additional Protocols including the Protocol on Biomedical Research, Universal Declaration on Bioethics and
p.000031: Human Rights (UNESCO, 2005), Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), International
p.000031: Declaration on Human Genetic Data (UNESCO, 2003) and a number of other documents which current total list includes
p.000031: more than 150 publications. Regretfully, among six CIS countries being current members of the Council of Europe such
p.000031: basic document as the Convention on Human Rights and Biomedicine are currently signed only by three – Georgia, Moldova,
p.000031: Ukraine; and it is only Georgia that actually ratified it. At the same time, acknowledgement of high authority of the
p.000031: Convention in this or that form is generally common for virtually entire bioethical community in all CIS countries.
p.000031: The international enactments mentioned above became a basis for legal regulation of biomedical research and
p.000031: their ethical review in all CIS countries (detailed analysis of legal participation of a particular country in any of
p.000031: international documents – recommendation influence, ratification, adaptation to national legislation, etc. –
p.000031: is presented in our book in corresponding chapter for each specific state). A crucial issue emphasizing profound
p.000031: importance of international documents regulating this sphere is a fact of priority of international law
p.000031: approved by all Commonwealth countries. International cooperation in the field of bioethics is implemented also
p.000031: through formation of regional programs and Centres of bioethics and research ethics with involvement of
p.000031: international organizations being leaders in this field. A convincing example of such cooperation is a setup of
p.000031: national committees of bioethics with UNESCO support in some of the Commonwealth countries and planned scientific and
p.000031: educational activities of the UNESCO office in Moscow and some other countries in the region
p.000031: being held in context of national, social and cultural, historical and political traditions and utilization of the
p.000031: world experience in the field of bioethics.
...
p.000037: state activities aimed on development of conditions for execution of these rights and freedoms as well as readiness of
p.000037: society for their conscious perception and compliance are required.
p.000037: This process takes prolonged gradual movement on development of a complex mechanism for protection of
p.000037: human rights and constitutes of legal, administrative, economic and humanitarian means. Such objective is
p.000037: implemented in the most consistent fashion by the Inter-Parliamentary Assembly of the Commonwealth of Independent
p.000037: States, which as one of the main objectives takes development of mechanisms for interstate regulation of respect for
p.000037: human rights in the region. IPA CIS as an agency for inter- parliamentary cooperation accumulates information on
p.000037: political, economic, social and cultural, ecological, demographic and other constituents of life of the Commonwealth
p.000037: countries that provides effectiveness, timeliness and demand for produced recommendations on harmonization and
p.000037: convergence of legislation of the CIS countries. Activity of IPA CIS in this respect is versatile and includes a range
p.000037: of spheres and areas determined with specifics and competence of permanent commissions such as commission on social
p.000037: policy and human rights, on legal issues, on science and education, on foreign policy issues, on defense
p.000037: and security, etc. In 1998 the Council of IPA CIS as the higher leading authority of the Assembly approved the
p.000037: declaration that emphasized solidarity of national parliaments with ideology
p.000037:
p.000038: 38
p.000038:
p.000039: 39
p.000039:
p.000039: of the Universal Declaration of Human Rights and stressed that since the moment of its proclamation the field of human
p.000039: rights exhibited considerable progress in general and that efforts in the field of human rights undertaken within CIS
p.000039: are also directed on provision of common respect for them, facilitation of strengthening of atmosphere of
p.000039: friendship and trust, effective implementation of multi-party agreements where a special place is given to the CIS
p.000039: Convention on Human Rights and Fundamental Freedoms adopted in Minsk in 1995.
p.000039: Criminal, penal procedure and penal enforcement model codes adopted by IPA CIS being a basis for development of similar
p.000039: codes in some of the Commonwealth countries should be considered as norms of general type establishing crucial
p.000039: requirements to an order of legal act execution in regard to main freedoms and rights of citizens in the Commonwealth
p.000039: countries. Statements of the given model codes were also reflected in initiation and creation of many legislator
p.000039: enactments in the CIS countries in the field of criminal law and criminal procedures. The model civil code adopted by
p.000039: IPA CIS has special values for establishing of new conditions for administration and management in all spheres of
p.000039: activities and its main statements were to some extent practically embodied in civil legislation of all CIS countries.
...
p.000039: to cases of
p.000039: biomedical studies and ethical review is assigned to the following model laws: On Sanitary and Epidemic
p.000039: Well-being of the Population, On Prevention of Spread of Diseases with Social Significance, the Concept on Formation of
p.000039: Legal Basics and Mechanisms for Implementation of Social State in the CIS Countries, the Charter of Social Rights and
p.000039: Guarantees for Citizens of Independent States (adopted by IPA CIS, 29.10.1994). Also many projects of model acts
p.000039: included into perspective plan of model law development are also important for formation of state policies of the CIS
p.000039: countries in the field of health care and biomedicine such as the following: On Social Protection of Handicapped, On
p.000039: Folk Medicine, Recommendations on National Legislations Adjustment of the CIS Member States in the Sphere of Social
p.000039: Protection and Medical Service for Liquidation Participants of the Disaster Consequences at the Chernobyl NPS, On
p.000039: Counteracting HIV/AIDS in the CIS Member States, Medical Code of the CIS Member States, On Preventing
p.000039: Distribution of Forged and Low-quality Drugs, On Natural Medical Resources, Medicinal- sanitary Areas and Resorts, and
p.000039: many others.
p.000039: Activity of IPA CIS also facilitates development of regional legal cooperation in the field of health care and
p.000039: social protection of the population at the level of heads of states and governments. As per initiatives of this
p.000039: authority the member states executed the following basic agreements:
p.000039: - Agreement on Cooperation in the Field of Protection of Population Health (Minsk, 26 of June 1992),
p.000039: - Agreement on Medical Services for Military Personnel and Their Family Members, Workers and Servants of
p.000039: Frontier Troops (Minsk, 26 of June, 1992),
p.000039: - Agreement on Provision for Population of Medicinal Drugs, Vaccines and Other Immunobiological Agents, Goods for
p.000039: Medicinal Use and Medical Equipment Manufactured at the Territory of the CIS Member States (Ashkhabat, 24 of
p.000039: December 1993),
p.000039: - Agreement on Social Security and Health Protection of Citizens Exposed to Ionizing Radiation as a Result of
p.000039: Chernobyl and Other Radiation Catastrophes and Accidents as well as Nuclear Testing (Moscow, 9 of September
p.000039: 1994),
p.000039: - Agreement on Cooperation for Resolution of Issues of Disability and Disabled (Moscow, 12 of April 1996),
p.000039:
p.000040: 40
p.000040:
p.000041: 41
p.000041:
p.000041: - Agreement on Provision of Medical Care to Citizens of the CIS Member States (Moscow, 27 of March 1997),
p.000041: - Convention on Transfer of Persons with Mental Disorders for Compulsory Treatment (Moscow, 28 of March 1997),
p.000041: - Agreement on Cooperation for Resolution of Issues of HIV Infection (Moscow, 25 of November 1998),
...
p.000041: person at the field of biomedicine but also for improvement of internal legislation in order to make it to
p.000041: reflect statements of the present model law and to be able to guarantee to everybody without exclusions
p.000041: respect for personal integrity, fundamental rights and freedoms that every person possesses.
p.000041: The Forum for Ethics Committees in the CIS admitting its responsibility for achieving the most rapid and rational
p.000041: utilization of the given law statement confirmed readiness of the Forum members from various CIS
p.000041: countries to facilitate the process of integration and operative application of the model law in biomedicine as well as
p.000041: its further regulatory improvement in accordance with local cultural, historical and social peculiarities and
p.000041: the guarantee for retaining of the law spirit determined with commonly acknowledged human rights and
p.000041: freedoms.
p.000041: The implementation process assumes execution of the following consequent actions: studying contingency of
p.000041: national legislation in the given field with the model law statements; making legislative national
p.000041: statements compliant with the model law ones; incorporation of the model law statements into national legislation;
p.000041: further development of the model law statements in accordance with national conditions and progress in the
p.000041: field of biomedicine and ethics and development of mechanisms for adherence and compliance with the given
p.000041: model law statements. Reaching the said goals is possible only in conditions of authority and professional
p.000041:
p.000042: 42
p.000042:
p.000043: 43
p.000043:
p.000043: integrity of cooperation of all stakeholders and it assumes wide and open discussions involving various social layers
p.000043: and international entities. The latter will facilitate formation of demand from the side of citizens of the CIS
p.000043: countries and international community for the fastest inclusion of the model law statements into professional,
p.000043: regulatory and general humanitarian spheres of life in the region countries. Certainly, this process, beside
p.000043: knowledge and confidence, will require signs of respect, acknowledgement, tolerance and mutual understanding in order
p.000043: to bring forth comprehensive dialogue with various social layers having final goal of reaching social and individual
p.000043: ethical legal sense in the space of the CIS member states and their full-grown inclusion in the global
p.000043: international regulatory framework on adherence and preservation of human rights and freedoms. It is gratifying to
p.000043: claim that value of the given model law for the international community was time and again demonstrated at its
p.000043: development by representatives of such international organizations as WHO, the Council of Europe, the European
p.000043: Commission, the European Forum for Good Clinical Practice, UNESCO, the World Medical Association, etc. Need for the
p.000043: model law implementation into national legislation of the CIS countries and readiness of corresponding structures for
p.000043: provision of enforcement of these statements was exhibited with universal response of leading specialists in the field
p.000043: of medicine, biology, ethics, legislation and sociology desiring to participate in promotion of the given regulatory
...
p.000061: selected within the aspect of the given publication.
p.000061:
p.000062: 62
p.000062:
p.000063: 63
p.000063:
p.000063: To retain integrity of perception of materials herein as when defining common elements of ethical and legal trends in
p.000063: the sphere of biology and medicine there will be used similar parameters of chronological and logical consideration due
p.000063: to priority of their influence.
p.000063: Thus, from the point of view of historical community based on common ideological and social and economic
p.000063: inheritance of the countries in the region we should distinguish a set of important elements determining both
p.000063: closeness of positions in the region in regard to international participation in biomedical research and their
p.000063: specificity. First of all, one should note that the USSR had a regulated state system of organizing,
p.000063: examination, registration of medical use products that included regulatory and methodical requirements and standards
p.000063: for study conduct. From administrative point of view the system was purely “vertical” assuming a whole set for
p.000063: management, approval and setup only at the All-Soviet level excluding possibility for independent approving
p.000063: and executive structures to conduct biomedical research in individual republics of the former Soviet
p.000063: Union. Regulations determining this order were clearly determined and strictly controlled. Studies could be
p.000063: conducted only at clinical sites of the Pharmacological Committee being a central approving authority, and a
p.000063: list of the clinical sites was centrally approved. The clinical site list included only research medical facilities
p.000063: with corresponding staff and technical capacities. Representatives of developing entities were prohibited from
p.000063: contacting directly with facilities and performers of clinical studies. Representatives of sponsoring entities
p.000063: including accredited foreign pharmaceutical companies had contacts only at the level of central approving authorities.
p.000063: From research methodical point of view the system for setup and conduct of biomedical studies had clear pharmacological
p.000063: bias. Existing methodical guidelines and regulations on biomedical research conduct were developed for particular
p.000063: pharmacological groups of medicinal agents and took into account all specifics of their biological and
p.000063: pharmacological action. Such documents were produced with participation of only leading specialists in the
p.000063: corresponding field of pharmacology, biology and medicine. Then these documents were strictly examined at the level of
p.000063: specialized commissions (also distinguished as per a principle of pharmacological orientation of candidate
p.000063: agents) and later were to be discussed and approved at the international level (within the system for
p.000063: international cooperation defined
p.000063: by borders of the former socialist camp). At this level specialized, specialized profile approach for consideration and
p.000063: approval of documents was strictly followed.
p.000063: Such specialization could be tracked at all stages of biomedical research from examination of application
p.000063: documents at the level of specialized commissions to study conduct in specialized sites only. Even the list of
...
p.000077: claims either against the doctors who will perform the surgery, or the patient who will receive my thyroid gland. I am
p.000077: signing this paper in the presence of doctors B.V.Dmitriev, E.K.Vinakurova, M.P.Alexeev and the nurse
p.000077: E.V.Shevchenko (signature); we witnessed the reading and signing of this paper and hereby certify that E.P. is an adult
p.000077: and mentally capacitated person (signatures of doctors and nurse)”.
p.000077: This document dated 1917, contains all elements of current ethical concept relating to biomedical
p.000077: research: confidentiality, respect for a person’s autonomy, information about all risks associated with the
p.000077: research, freedom of a voluntary choice, verification of the research subject’s social and mental maturity.
p.000077: All statements in Dmitriev’s article base on a legal concept of a famous lawyer A.F.Kony who testified to the
p.000077: absence of criminal deed in the case of the sale of organs for treatment purposes in accordance with the contract
p.000077: between the donor (seller) and recipient (buyer). At the same time he noted that “under these circumstances the
p.000077: only ethical issue that might arise concerned the permissibility of such a deal in a situation where the
p.000077: “seller” was a minor, imbecile, or a person in a state of artificial excitation, and where the “buyer” was a
p.000077: person who acted through psychological compulsion, deception, seduction, promise of profit or suggestion by authority.
p.000077: On the whole, the analysis of legal and ethical principles referring to biomedical research existing in the tsarist
p.000077: Russia in the beginning of the XX century shows that humanistic concepts of a voluntary and conscious choice made by
p.000077: the research subject and confidentiality have been combined with a responsible and merciful attitude on the part of a
p.000077: physician-investigator, and reinforced with accepted moral and ethical norms and legislative acts in force.
p.000077: Turning to a more recent period in national history, the following stages of Soviet law development illustrate how the
p.000077: issues in ethical and legal regulation of medical and biological research were interpreted in the USSR.
p.000077: In the law of the Russian Soviet Federal Socialistic Republic (RSFSR) on 1 of December 1924 “On the Professional
p.000077: Activity and Rights of Health Professionals” the need to obtain the patient’s consent, in particular when surgery is
p.000077: being planned, was declared. It was also stated that “with respect to those under 16 years of age or mentally disabled,
p.000077: the consent of their parents or care-givers”, i.e., their legal representatives, was necessary. Similar laws were
p.000077: adopted in the other Republics of the USSR. One should specifically underline that neither the law on 1 of December
p.000077: 1924, nor the decrees of the Soviet Ministries of Health until 1936, clarified how the patient’s consent was to be
...
p.000085: The conferences and seminars aimed at exchanging information and discussing topical issues of the development
p.000085: of regulation and educational standards relating to the protection of research participants’ rights, to the development
p.000085: of national systems of ethical review and to the creation of a harmonized legislation and methodology referring to
p.000085: biomedical research ethics both in the CIS region and in the global international space.
p.000085: Due to the development of these main initiatives, the following has been achieved and accomplished:
p.000085: • information exchange in the field of bioethics in the CIS region;
p.000085: • the analysis of issues relating to bioethical education in the region;
p.000085: • an open access to and discussion of international documents and guidelines on bioethics and research
p.000085: ethics (translation into national languages);
p.000085: • implementation of SOPs into the process of ethical review;
p.000085: • stimulation of efforts directed towards the development of national systems of ethical review in compliance
p.000085: with the GCP standards and international guidelines;
p.000085: • assistance in the organization of the EC members education and training in the region;
p.000085: • the EC preparation for the survey and evaluation of their performance;
p.000085: • raising the EC authority and their role in the development of international standards concerning the
p.000085: protection of research subjects’ rights;
p.000085: • assistance in the development of national Forums for Ethics Committees in the CIS countries;
p.000085: • the evaluation of the current legislation referring to the protection of human rights in biomedical research and
p.000085: medical practice in the region;
p.000085: • the performance as a regional centre for cooperation in the field of ethical review development;
p.000085:
p.000086: 86
p.000086:
p.000087: 87
p.000087:
p.000087: • assistance in the practical application of the SOPs for ethical review in the region in compliance with
p.000087: Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO, 2002);
p.000087: • coordination of the CIS countries in the sphere of bioethical issues and ethical review of biomedical research in
p.000087: the region.
p.000087: Summarizing the above said we should recognize that the history of the development of the system for ethical review of
p.000087: biomedical research in the CIS countries is a dialectic process of ethical and legal development of the national
p.000087: consciousness and legislation directed towards protecting rights, dignity and autonomy of an individual as a
p.000087: biomedical research subject, and providing moral and ethical guarantees to the society that biomedical research is
p.000087: conducted in a strict conformity with universal ethical standards.
p.000087: Chapter 3. EtHICAL REVIEW SYStEM FoR BIoMEDICAL RESEARCH
p.000087: In tHE CIS CoUntRIES
p.000087:
...
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
p.000169: The article 43 of the Law of the Republic of Kazakhstan “On the System of Public Health” published on 4th
p.000169: June 2003 contains the juridical definition of scientific medical expertise; in this article it is indicated that
p.000169: objects of scientific medical expertise are as follows:
p.000169: - drafts of programmes of basic and applied scientific research;
p.000169: - republican targeted scientific medical programmes;
p.000169: - results of completed scientific medical programmes and projects;
p.000169: - scientific research that were nominated for the state awards of the Republic of Kazakhstan;
p.000169: - results of scientific medical programmes that are supposed to be implemented into public health practice.
p.000169: The order of scientific medical expertise is determined by the national authority in public health area.
p.000169: The article 42 “Expertise of medical drug” of the same Law says that the expertise of medical drug represents a study
p.000169: or a trial of medical drug
p.000169: for its safety, efficacy and quality and that physical, chemical and biological tests as well as clinical trials should
p.000169: be used for this process; besides all documentation for this medical drug should be assessed thoroughly; the order of
p.000169: all these tests and trials is determined by the national authority in public health area. Paragraphs 2 and 3 of the
p.000169: article 42 clarify that “assessment of safety, efficacy and quality of medical drugs should be performed by expert
p.000169: commissions via expertise of medical drug according to specification and other documents in the order determined by the
p.000169: national authority in public health area”. The expertise should be performed by institutions and persons that did not
p.000169: participate in the process of development and production of this specific medical drug.
p.000169: In 2005 two official documents were approved by the orders of the Ministry of Health №3493 and №3494 on 15th
p.000169: of March 2005: “On approval of instructions on clinical trials and studies and (or) tests of pharmaceutical substances
p.000169: and medical drugs in Kazakhstan” and №3489 on 14th of March “On approval of instructions on monitoring of adverse
p.000169: reactions produced by medical drugs”. These instructions were developed in accordance to international
p.000169: standards GLP and GCP.
p.000169: Mentioned legislative and regulatory documents formulated the unified requirements to planning, implementation,
p.000169: documentation and control of clinical trials in the Republic of Kazakhstan. They ensure the protection of
p.000169: rights, safety and health of persons participating in trials as well as reliability and good quality of data
p.000169: collected during such trials. The right for supervision of clinical trials was delegated to the National Centre for
p.000169: expertise of medical drugs, medical devices and medical equipment of the Ministry of Public Health of Kazakhstan.
p.000169: The important rule that was introduced in obligatory conditions for clinical trials was the necessity to obtain the
p.000169: inform consent of each participant of studies/experiments; this consent should be provided in the written form.
...
p.000267: in accordance with this document children of age below 15 can participate in studies of new medicinal agents, methods,
p.000267: etc, only in case of vital indications though in real life this statement is constantly breached that is inevitable and
p.000267: determined with realia of medical practice development and scientific progress. Article 29 of this document prohibits
p.000267: involvement into studies of those arrested or convicted though, in some cases these persons can benefit from
p.000267: their participation in clinical biomedical research. In this respect the Russian legislation differs from
p.000267: European norms that allow in case of specific and clearly defined conditions to hold studies with involvement of
p.000267: those categories of citizens. Another document regulating possibility for conduct of biomedical studies in the Russian
p.000267: Federation is the Law on Psychiatric Care where Article 5 proclaims the right of a person with mental disorder to
p.000267: consent or to refuse of participation in such studies though necessity for such action is not stipulated. The Law on
p.000267: Pharmaceutical Products analyzes quite profoundly those norms regulating research on new
p.000267: medicinal agents but, regretfully, it covers only one though rather important sphere of biomedical research – studies
p.000267: of pharmaceuticals. This law as it is shown by the text is written basing on an assumption that each study is premised
p.000267: with an examination held by an ethical committee but either status, or authority, or order of creation, or composition
p.000267: of ethical committees are not stipulated by the Law; there only guidelines that “the ethical committee acts at the
p.000267: federal executive authority which competence covers state control and surveillance in the sphere of pharmaceuticals”
p.000267: (Art. 37). There is also no such mechanism for creation and activities of such organization in any other Russian legal
p.000267: document. The National standard of the Russian Federation GOST R52379-2005 “Good Clinical Practice” adopted in 2006
p.000267: defines the term “Independent Ethical Committee” as an independent group (review council or committee acting at
p.000267: the facility, regional or international level) consisting of medical workers as well as persons not related to medical
p.000267: trade that provides protection of rights, safety and well-being of study subjects and for the society it is a guarantor
p.000267: for such protection, in particular, through review, adoption/approval of study protocol, investigator
p.000267: personalities, study sites as well as materials and methods to be used for obtaining and documenting informed consent
p.000267: from the study subjects. EC should function in compliance with the principles of good clinical practice“.
p.000267: Thus, basing on analysis of existing legislation one can conclude that the biomedical research ethical review in the
p.000267: Russian Federation is conducted by ethical committees acting in health care or research facilities including the ones
p.000267: of the Ministry of Health Care of the Russian Federation, Russian Academy of Medical Sciences, medical
p.000267: associations, research medical Centres, hospitals. In majority of cases such activity is borne by local ethical
p.000267: committees.
p.000267: First ethical committees in Russia were created not more than 10 years ago. Initially such committees were created at
...
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p.000029: can meet representatives of virtually all ethnical, religious and cultural groups existing in the region in general. It
p.000029: means that multiplicity that can be observed within the CIS countries to some extent repeats multiplicity of population
p.000029: of separate countries that is especially characteristic for scientific and medical creative environment formed during
p.000029: many years.
p.000029: It is really hard to overestimate a role, which is played by the factor of involvement of all Commonwealth
p.000029: countries in the process of global international interaction, for creation of single approaches to collaboration
p.000029: in ethical and legal sphere. It is related both to incorporation by the new independent states into their legal systems
p.000029: of a set of international ethical and legal acts which they joined to during existence of a single country, the USSR,
p.000029: and to modern involvement of the CIS countries into international legal and informational environment. It appears to be
p.000029: of tremendous importance that officially each of the countries declared adherence to all major norms and principles
p.000029: stipulated by such international and legal documents as the Nuremberg Code of 1947, the Declaration of Helsinki of the
p.000029: World Medical
p.000029:
p.000030: 30
p.000030:
p.000031: 31
p.000031:
p.000031: Association (WMA) of 1964 with amendments, International Ethical Guidelines for Biomedical Research Involving
p.000031: Human Subjects developed by CIOMS and WHO in 1982 and amended in 1993 and 2000, International Guidelines for Ethical
p.000031: Review of Epidemiological Studies, CIOMS, 1991, Guidelines for Good Clinical Practice (ICH GCP), 1996;
p.000031: Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000) with additional document
p.000031: of 2002, Convention for the Protection of Human Rights and Dignity with Regard to the Application of
p.000031: Biology and Medicine: Convention of Human Rights and Biomedicine (Council of Europe, 1997) and adopted in addition
p.000031: thereof Additional Protocols including the Protocol on Biomedical Research, Universal Declaration on Bioethics and
p.000031: Human Rights (UNESCO, 2005), Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), International
p.000031: Declaration on Human Genetic Data (UNESCO, 2003) and a number of other documents which current total list includes
p.000031: more than 150 publications. Regretfully, among six CIS countries being current members of the Council of Europe such
p.000031: basic document as the Convention on Human Rights and Biomedicine are currently signed only by three – Georgia, Moldova,
p.000031: Ukraine; and it is only Georgia that actually ratified it. At the same time, acknowledgement of high authority of the
p.000031: Convention in this or that form is generally common for virtually entire bioethical community in all CIS countries.
p.000031: The international enactments mentioned above became a basis for legal regulation of biomedical research and
p.000031: their ethical review in all CIS countries (detailed analysis of legal participation of a particular country in any of
p.000031: international documents – recommendation influence, ratification, adaptation to national legislation, etc. –
...
p.000072: 72
p.000072:
p.000073: 73
p.000073:
p.000073: of Helsinki is certainly the most important. It was adopted by World Medical Association in 1964, and has been
p.000073: continuously revised and updated.
p.000073: Recognizing the key role of the Nuremberg Code and the Helsinki Declaration with regard to ethical
p.000073: regulation of biomedical research, we should mention also some important documents that set up a kind of
p.000073: a base for those, and a number of documents facilitating the development and interpretation of the
p.000073: general principles set out in the Declaration of Helsinki and its actualization in connection with new
p.000073: conditions caused by the progress in biology and biomedicine in the last decades of the XX and in the beginning of the
p.000073: XXI century.
p.000073: The current concept of ethical regulation of biomedical research, asserting that an individual, and the
p.000073: society as a whole, has the right to benefit from scientific achievements and must be safeguarded against any
p.000073: risk or damage, developed only by the middle of the XX century. However, international community has also
p.000073: recognized some documents written in the end of the XIX and in the beginning of the XX century. Among
p.000073: the XIXcentury documents there Ethical Codes by Thomas Percival (Great Britain, 1803); William Beaumont (USA,
p.000073: 1833) и Claude Bernand (France, 1865).
p.000073: Dr. S. Fluss, the Scientific Councilor at the Council for International Organizations of Medical Sciences (CIOMS), in
p.000073: his historical analysis of materials relating to the ethics of medical research involving human subjects developed in
p.000073: the XX century, before the Declaration of Helsinki, mentions about 15 documents adopted in Germany (1900, 1931), USSR
p.000073: (1936, 1949),
p.000073: Netherlands (1955), Great Britain (1962-63) and Sweden (1963).
p.000073: Among significant international documents adopted in the period before the Declaration of Helsinki, we should mention
p.000073: the International Code of Medical Ethics (WMA, London, 1949). It states: “the physician shall act in the patient’s best
p.000073: interest when providing medical care that is to improve the patient’s physical and mental health”. Declaration of
p.000073: Geneva Adopted by the 2nd General Assembly of the World Medical Association (Geneva, Switzerland, September 1948)
p.000073: defined the physician’s duty: “The health of my patient will be my first consideration”.
p.000073: These canons of the physician’s behaviour entered the Preamble of the Declaration of Helsinki, which proves the
p.000073: significance of the abovementioned documents.
p.000073: Below is the chronology list of main documents aiming at developing ethical principles of biomedical research:
p.000073: • International Covenant on Civil and Political Rights adopted by the General Assembly of United Nations (UN, 1996)
p.000073: to enforce the “Universal Declaration of Human Rights” (General Assembly of United Nations, 1948);
p.000073: • International Ethical Guidelines for Biomedical research Involving Human Subjects (CIOMS in collaboration with
p.000073: WHO, Geneva, 1982);
p.000073: • International Guidelines for Ethical Review of Epidemiological Studies, СIOMS (Geneva, 1991);
p.000073: • Declaration on the Human Genome Project. Adopted by the 44th World Medical Assembly (Marbella, Spain, September
p.000073: 1992);
p.000073: • International Ethical Guidelines for Biomedical research Involving Human Subjects (СIОМS, Geneva, 1993 – an
p.000073: updated version of Guidelines adopted in 1982);
p.000073: • Declaration on the Promotion of Patients’ Rights in Europe (World Health Organization, WHO Regional Office
p.000073: for Europe, Amsterdam, 1994);
p.000073: • Convention for the Protection of Human Rights and Dignity with Regard to the Application of Biology and Medicine:
p.000073: Convention of Human Rights and Biomedicine (Council of Europe, Strasbourg, 1996 and its Additional Protocols);
p.000073: • Guidelines for Good Clinical Practice (GCP) developed by the International Conference on Harmonization
p.000073: of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) (Brussels, Washington,
p.000073: Tokyo, 1996);
p.000073: • Guidelines and Recommendations for European Ethics Committees
p.000073: (European Forum for Good Clinical Practice (EF GCP), Brussels, 1997);
p.000073: • The Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997);
p.000073: • Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000)
p.000073: • Universal Declaration on Bioethics and Human Rights (UNESCO, 2005)
p.000073: • and a number of other documents.
p.000073:
p.000074: 74
p.000074:
p.000075: 75
p.000075:
...
p.000079: of criminal liability for committing “crimes against Humankind”. (Decree of Presidium of the Supreme Council of the
p.000079: USSR on 19 of April 1943. Art. 1). There is an important historical document that reflected moral and legal
p.000079: understanding of experiments on live human beings – the protocols of a legal action conducted by the Military Tribunal
p.000079: of the USSR in Khabarovsk in 1949. It concerned the case of former Japanese military men accused of the development and
p.000079: use of biological weapons (“Indictment on the case of the former Japanese military men”; a supplement to Novoe Vremia
p.000079: (New Time) Journal, No 1, 1 of January 1950). The importance of the Conclusion adopted by the Tribunal in Khabarovsk is
p.000079: comparable with the importance of the Nuremberg Trials and the Code adopted there. In both cases the moral aspects of
p.000079: decisions concerned not only the individuals guilсссty of the crimes, but also the governmental policy and
p.000079: ideology which made these crimes possible.
p.000079: In the context of this Chapter the above documents are mentioned for the following purposes:
p.000079: • to eliminate informational vacuum existing in relation to the ethics of biomedical research in the former Soviet
p.000079: Union;
p.000079: • to clarify the reason of including the abovementioned documents into the international list on important documents
p.000079: of “pre-Helsinki” era to the CIOMS list;
p.000079: • to illustrate mutually enriching and complementary values of studying fundamentals of moral and cultural
p.000079: heritage;
p.000079:
p.000080: 80
p.000080:
p.000081: 81
p.000081:
p.000081: • to define the basis for a timely and harmonious assimilation of international universal norms of
p.000081: biomedical research ethics by the CIS countries.
p.000081: Summarizing the data on the ethical component of biomedical research at the time of the Soviet Union
p.000081: disintegration and formation of new independent states in the end of the nineteenths of the last century, we have
p.000081: to state that there existed efficient moral and ethical norms of medical practice and the governmental system
p.000081: regulating biomedical research. Although there were separate cases of establishing ethics committees at
p.000081: medical centres taking part in international studies, those were but of a “decorative” or “declarative” character, as
p.000081: they were established to meet the requirements of foreign pharmaceutical companies and did not have a legal status.
p.000081: The actual process of entering into the international system of ethical review began for the CIS countries also in the
p.000081: nineteenths of the last century. The rhythm and procedure for different CIS countries depended on their
p.000081: involvement in international biomedical research. As to the documents and international regulations that formed
p.000081: the basis for the development of national legislation, they were quite comparable. Materials presented for this
...
p.000243: Digest of abstracts and documents. Chapters Х-ХII. SPb, 2000, p. 192-200.
p.000243:
p.000244: 244
p.000244:
p.000245: 245
p.000245:
p.000245: 27. Judin B.G. National specific of establishing bioethics in Russia. In
p.000245: bk.: Philosophy of biomedical research. М., 2004, p. 71-90.
p.000245: 28. Jarovinskiy М.J. Lectures on medical ethics (bioethics). М., 2004,
p.000245: 528 p.
p.000245:
p.000245: 3.8.2 Legal Regulations
p.000245:
p.000245: The ethical review of biomedical research involving human subjects is the important component in rights, interests and
p.000245: dignity of human subjects and in the same time is the necessary condition for further development of medical science
p.000245: and technology.
p.000245: The basis for legal regulation of biomedical research and its ethical evaluation is laid by a complex of
p.000245: international acts both of legal and ethical character.
p.000245: First of all we could mention Nuremberg Code (1947), the Declaration of Helsinki (1964, with all further
p.000245: revisions) – the documents which in many points determined the Russian policy on regulation of biomedicine and
p.000245: healthcare sphere22.
p.000245: The serious stimulus for Russian domestic legislative activity and for biomedical practice is also produced by other
p.000245: documents of recommending character, which are devoted to general and specific questions of biomedical research. Here
p.000245: are some examples of such documents: International Ethical Guidelines for Biomedical Research Involving Human
p.000245: Subjects (1982, 1993, 2002), International Guidelines for Ethical Review of Epidemiological Studies (CIOMS, 1991), ICH
p.000245: GCP (1996), Operational Guidelines for Ethics Committees that Review Biomedical Research (2000) and others23.
p.000245:
p.000245: 22 “Nurnberg code” (The sentence of Nurnberg Tribunal)//Medical doctor.1993. N7, Helsinki Declaration (WMA)
p.000245: 1964//Collection of official documents of Association of medical doctors of Russia: medical associations,
p.000245: medical ethics and general medical problems/Ed. V.Uranov. M.:PAIMS.1995.
p.000245: 23 International Ethical Guidelines for Biomedical Research Involving Human Subjects (1982, 1993,
p.000245: 2002)//World Health Organization, Geneva, 1993, International Guidelines for Ethical Review of Epidemiological Studies
p.000245: (CIOMS, 1991)///CIOMS- Geneva. – 1993, ICH Harmonized Tripartite Guideline for GCP
p.000245: //http://www.ich.org/LOB/media/MEDIA482.pdf, Operational guidelines for ethics committees that review biomedical
p.000245: research http://www. who.int/tdr/publications/publications/ethics.htm.
p.000245: The intention to accede to Convention for the Protection of Human Rights and Dignity with regard to the
p.000245: Application of Biology and Medicine (Council of Europe (1997)24 which is the fundamental document for
p.000245: biomedical research and which imposes legal obligations for countries-parties was expressed by the Russian Federation
p.000245: in 1998 in the Order of Ministry of Health of the Russian Federation N 248 “On organizing of biomedical ethics
p.000245: committee of Ministry of Health of the Russian Federation” of 30 December 199825. However, this intention is still not
p.000245: realized. That is why the Convention, as well as the Additional Protocols to this Convention, particularly
p.000245: the Additional Protocol concerning Biomedical Research are still the only recommendations for the Russian
p.000245: Federation, although the recommendations of great importance26.
p.000245: Many other international acts of universal and regional character concerning special situations in the
p.000245: sphere of biomedical investigations; medical practice and its ethical expertise play a guiding role in biomedical
p.000245: study legal regulation in Russia27.
p.000245: Evaluating the system of Russian legal documents in the sphere of biomedical research we may conclude that
...
p.000333: Mankind (10 of November 1975).
p.000333: In its activity the National Ethics Committee (NEC) of the Republic of Uzbekistan at the Ministry of Public Health of
p.000333: Uzbekistan uses also other international documents, such as
p.000333: 1. Final Act of the International Conference on Healthcare (New-York, 22 July 1946)
p.000333: 2. The Nuremberg Code (1947)
p.000333: 3. Universal Declaration on Human Rights 1948
p.000333: 4. Declaration of Helsinki (WHO, 1964, 2002)
p.000333: 5. European Agreement on Providing Medical Assistance to Persons Temporarily Residing in Other [Member] (Geneva, 17
p.000333: of October 1980)
p.000333: 6. Convention on Biological (Rio de Janeiro, 5 of June 1992)
p.000333: 7. Budapest Summit Decisions. Human Dimension (Budapest, 1994)
p.000333: 8. Agreement on Collaboration in Public Health Protection (Minsk, 26 of June 1992)
p.000333: 9. The Charter of Social Rights and Guarantees to the Citizens of Independent States (approved by the
p.000333: Inter-parliamentary Assembly of the Commonwealth of Independent States, 29 of October 1994)
p.000333: 10. Convention on Human Rights and Biomedicine (Council of Europe, 1996)
p.000333: 11. Note for Guidance on Good Clinical Practice (ICH, 1996)
p.000333: 12. WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
p.000333: 13. Model Law of IPA CIS “On the Protection of Human Rights and Dignity in Biomedical Research in the CIS” (2005)
p.000333: 14. International Ethical guidelines for Biomedical research Involving Human Subjects (WHO/CIOMS, 13 of June 1993/2003)
p.000333: 15. Report of the International Bioethics Committee on the Possibility of Elaborating a Universal Instrument on
p.000333: Bioethics (13 of June 2003)
p.000333: 16. UNESCO Programme on Bioethics: Priorities and Perspectives (17 of October 1999)
p.000333: 17. Implementation of the Universal Declaration on the Human. Genome and Human Rights (17 of November
p.000333: 1999)
p.000333: A number of national laws of the Republic of Uzbekistan relating to the implementation of international agreements in
p.000333: healthcare imply a possibility of a joint regulation by the national Uzbekistan legislation and international norms.
p.000333: Article 1 of the Law “on the Protection of Citizen’s Health” (No 265-I; 29 of August 1996) states that “if
p.000333: an international agreement sets out rules others than those in the national legislation, norms of the international
p.000333: agreement are applied”.
p.000333: Substantiation of certain approaches to resolving bioethics problems is nowadays in the centre of political,
p.000333: philosophical and religious investigations that are to offer guiding lines in our rapidly changing world. Thus, the
p.000333: necessity to consider existing religious moral norms and cultural traditions in making decisions on key bioethical
p.000333: problems was discussed at the International Congress of Bioethics (Teheran, 2005). For the independent the
p.000333: Republic of Uzbekistan this issue is particularly topical. Despite the secular character of Uzbekistan, many residents
...
p.000353: inclusion of this region as a single constituent of the global WHO Project SIDCER provided permanent
p.000353: international dialogue on key issues of research ethics with international agencies leading in this sphere –
p.000353: such as WHO, the European Commission, the Council of Europe, UNESCO, the European Forum for Good Clinical Practice,
p.000353: the World Medical Association as well as authoritative national agencies: DHHS, USA and Ethics Committees of
p.000353: countries of all Continents. Such dialogue became a basis for experience exchange and real integration of ethical
p.000353: examination systems of the CIS countries into global discussion and research process.
p.000353: Integrity and value of cooperation with international organization is also presented with equal access for
p.000353: the CIS countries to discussion and development of international documents and guidelines on ethics of
p.000353: biomedical studies such as the Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000,
p.000353: 2002); work on new edition of the Declaration of Helsinki, documents of the Council of Europe, new version of the
p.000353: International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS), the Universal
p.000353: Declaration on the Human Genome and Human Rights, the International Declaration on Human Genetic Data, the
p.000353: Declaration on Common Bioethics Standards (UNESCO), guidelines on bioethics, legal and social consequences of genetic
p.000353: testing (the European Commission) and other universal documents and guidelines in which development members of
p.000353: the FECCIS participated.
p.000353: In general, cooperation within the framework of the FECCIS is developed with the purpose to facilitate
p.000353: creation of systems of good ethical
p.000353:
p.000354: 354
p.000354:
p.000355: 355
p.000355:
p.000355: practice and development of ethical responsibility in researchers, sponsors, authorized regulatory agencies and the
p.000355: society as a whole. This process in combination with advancements of science and social and legal trends
p.000355: facilitates appearance of constitutional society and state regulation in the CIS region. Inclusion of the CIS countries
p.000355: in the process of establishment of good practices of ethical review at international scale is focused on
p.000355: understanding of necessity of reaching independence, competence, openness and responsibility in the field of human
p.000355: rights protection when conducting biomedical studies. Development of cooperation facilitates free discussion among
p.000355: colleagues, exchange with experience, problems and successes, formation of collective recognition of ethics role
p.000355: in research and individual ethical thought of all participants of biomedical process.
p.000355: In conclusion of this chapter we consider as our priority tight to express our assurance that the given work will
...
p.000355: strategy for compliance with international ethical standards;
p.000355: • general trends and specificity of development of ethical review to form priority directions for cooperation
p.000355: at the regional and global scale;
p.000355: • information concerning experience of regional cooperation within the framework of the FECCIS;
p.000355: • approach to harmonization of norms and standards of ethical review of biomedical research in the region and at the
p.000355: global scale.
p.000355: Objective and open knowledge of wide-scaled layer of national and regional realia of ethics of biomedical
p.000355: studies in the Commonwealth countries unveils a whole range of opportunities for all stakeholders in
p.000355: regard to search for ways to further collaboration in this sphere basing on adherence to universal values and ethical
p.000355: principles.
p.000355: In general, contribution to the world society harmonizing standards is based upon respect to human
p.000355: dignity, right and freedoms; recognition of achievements of scientific and technical progress; facilitation of
p.000355: equal access to scientific achievements through support of maximal, as much as possible free flow and
p.000355: exchange of knowledge and mutual benefiting from such exchange; protection of interests of existing and future
p.000355: human generations that the current publication is dedicated to.
p.000355:
p.000356: 356
p.000356:
p.000357: 357
p.000357:
p.000357: ABBREVIAtIon
p.000357:
p.000357:
p.000357: BMR – Biomedical Research
p.000357: CIoMS – Council for International Organizations of Medical Science
p.000357: CIS – Commonwealth of Independent States
p.000357: Ct – Clinical Trials
p.000357: EC/ECs – Ethics Committee/Ethics Committees EFGCP – European Forum for Good Clinical Practice FECCIS – Forum for Ethics
p.000357: Committees in the CIS GCP – Good Clinical Practice
p.000357: GLP Good Laboratory Practice
p.000357: GMP – Good Manufacture Practice
p.000357: ICH – International Conference on Harmonization of Technical Requirements for the Registration of
p.000357: Pharmaceuticals for Human Use IPA CIS – Inter-Parliamentary Assembly of the Commonwealth of Independent States
p.000357: SIDCER – Strategic Initiative for Developing Capacity in Ethical Review
p.000357: SoP – Standard Operating Procedures
p.000357: tDR – Special Programme for Research and Training in Tropical Diseases)
p.000357: UnESCo – United National Educational, Scientific and Cultural Organization
p.000357: WHo – World Health Organization
p.000357: WMA – World Medical Association
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357:
p.000357: The authors of the Book wish to express their gratitude to their colleagues from the Forum for Ethics
p.000357: Committee in Commonwealth of Independent States; experts and specialists from all other national, regional
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
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p.000029: models currently acting there as well as models of research ethics. Likeness in perception of moral and cultural values
p.000029: is built on the fact that among population of the CIS countries (mostly it is related to the Russian population) one
p.000029: can meet representatives of virtually all ethnical, religious and cultural groups existing in the region in general. It
p.000029: means that multiplicity that can be observed within the CIS countries to some extent repeats multiplicity of population
p.000029: of separate countries that is especially characteristic for scientific and medical creative environment formed during
p.000029: many years.
p.000029: It is really hard to overestimate a role, which is played by the factor of involvement of all Commonwealth
p.000029: countries in the process of global international interaction, for creation of single approaches to collaboration
p.000029: in ethical and legal sphere. It is related both to incorporation by the new independent states into their legal systems
p.000029: of a set of international ethical and legal acts which they joined to during existence of a single country, the USSR,
p.000029: and to modern involvement of the CIS countries into international legal and informational environment. It appears to be
p.000029: of tremendous importance that officially each of the countries declared adherence to all major norms and principles
p.000029: stipulated by such international and legal documents as the Nuremberg Code of 1947, the Declaration of Helsinki of the
p.000029: World Medical
p.000029:
p.000030: 30
p.000030:
p.000031: 31
p.000031:
p.000031: Association (WMA) of 1964 with amendments, International Ethical Guidelines for Biomedical Research Involving
p.000031: Human Subjects developed by CIOMS and WHO in 1982 and amended in 1993 and 2000, International Guidelines for Ethical
p.000031: Review of Epidemiological Studies, CIOMS, 1991, Guidelines for Good Clinical Practice (ICH GCP), 1996;
p.000031: Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000) with additional document
p.000031: of 2002, Convention for the Protection of Human Rights and Dignity with Regard to the Application of
p.000031: Biology and Medicine: Convention of Human Rights and Biomedicine (Council of Europe, 1997) and adopted in addition
p.000031: thereof Additional Protocols including the Protocol on Biomedical Research, Universal Declaration on Bioethics and
p.000031: Human Rights (UNESCO, 2005), Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), International
p.000031: Declaration on Human Genetic Data (UNESCO, 2003) and a number of other documents which current total list includes
p.000031: more than 150 publications. Regretfully, among six CIS countries being current members of the Council of Europe such
p.000031: basic document as the Convention on Human Rights and Biomedicine are currently signed only by three – Georgia, Moldova,
p.000031: Ukraine; and it is only Georgia that actually ratified it. At the same time, acknowledgement of high authority of the
...
p.000071: state law of the Nazi regime arouse opposite emotions, and the very word “experiment” with regard to a human being has
p.000071: a dismal echo.
p.000071: However, the development of biomedical research is based not only on those polar, in terms of ethics, examples.
p.000071: International standards of implementation into the medical practice of new therapeutic, diagnostic and preventive
p.000071: pharmaceuticals and methods, as well as their scientific and moral resonance are reflected in historical stages of
p.000071: setting out legal concepts of bioethics.
p.000071: Currently, the list of international recommendations, declarations, codes, resolutions and other documents relating to
p.000071: bioethics is very extensive, and in the last decades it has a tendency to increase.
p.000071: One of the most important events in the history of bioethics in the XX century was the Nuremberg Code adopted by
p.000071: the International Military Tribunal in 1947. When commenting on this historical document, the world press emphasized
p.000071: that the accusatory sentence of the Nuremberg Trial “speaks on behalf of insulted human conscience”. The
p.000071: Nuremberg Code was the first document based on the “judgment of the victorious truth”, which declared the
p.000071: cardinal ethical principles with regard to an individual and stimulated the growth of public awareness and peoples’
p.000071: responsibility.
p.000071: Among international documents in which the ethical principles in medicine and their actual application were
p.000071: further developed, the Declaration
p.000071:
p.000072: 72
p.000072:
p.000073: 73
p.000073:
p.000073: of Helsinki is certainly the most important. It was adopted by World Medical Association in 1964, and has been
p.000073: continuously revised and updated.
p.000073: Recognizing the key role of the Nuremberg Code and the Helsinki Declaration with regard to ethical
p.000073: regulation of biomedical research, we should mention also some important documents that set up a kind of
p.000073: a base for those, and a number of documents facilitating the development and interpretation of the
p.000073: general principles set out in the Declaration of Helsinki and its actualization in connection with new
p.000073: conditions caused by the progress in biology and biomedicine in the last decades of the XX and in the beginning of the
p.000073: XXI century.
p.000073: The current concept of ethical regulation of biomedical research, asserting that an individual, and the
p.000073: society as a whole, has the right to benefit from scientific achievements and must be safeguarded against any
p.000073: risk or damage, developed only by the middle of the XX century. However, international community has also
p.000073: recognized some documents written in the end of the XIX and in the beginning of the XX century. Among
p.000073: the XIXcentury documents there Ethical Codes by Thomas Percival (Great Britain, 1803); William Beaumont (USA,
p.000073: 1833) и Claude Bernand (France, 1865).
p.000073: Dr. S. Fluss, the Scientific Councilor at the Council for International Organizations of Medical Sciences (CIOMS), in
p.000073: his historical analysis of materials relating to the ethics of medical research involving human subjects developed in
p.000073: the XX century, before the Declaration of Helsinki, mentions about 15 documents adopted in Germany (1900, 1931), USSR
p.000073: (1936, 1949),
p.000073: Netherlands (1955), Great Britain (1962-63) and Sweden (1963).
p.000073: Among significant international documents adopted in the period before the Declaration of Helsinki, we should mention
p.000073: the International Code of Medical Ethics (WMA, London, 1949). It states: “the physician shall act in the patient’s best
p.000073: interest when providing medical care that is to improve the patient’s physical and mental health”. Declaration of
p.000073: Geneva Adopted by the 2nd General Assembly of the World Medical Association (Geneva, Switzerland, September 1948)
p.000073: defined the physician’s duty: “The health of my patient will be my first consideration”.
p.000073: These canons of the physician’s behaviour entered the Preamble of the Declaration of Helsinki, which proves the
p.000073: significance of the abovementioned documents.
p.000073: Below is the chronology list of main documents aiming at developing ethical principles of biomedical research:
p.000073: • International Covenant on Civil and Political Rights adopted by the General Assembly of United Nations (UN, 1996)
p.000073: to enforce the “Universal Declaration of Human Rights” (General Assembly of United Nations, 1948);
p.000073: • International Ethical Guidelines for Biomedical research Involving Human Subjects (CIOMS in collaboration with
p.000073: WHO, Geneva, 1982);
p.000073: • International Guidelines for Ethical Review of Epidemiological Studies, СIOMS (Geneva, 1991);
p.000073: • Declaration on the Human Genome Project. Adopted by the 44th World Medical Assembly (Marbella, Spain, September
p.000073: 1992);
p.000073: • International Ethical Guidelines for Biomedical research Involving Human Subjects (СIОМS, Geneva, 1993 – an
p.000073: updated version of Guidelines adopted in 1982);
p.000073: • Declaration on the Promotion of Patients’ Rights in Europe (World Health Organization, WHO Regional Office
p.000073: for Europe, Amsterdam, 1994);
p.000073: • Convention for the Protection of Human Rights and Dignity with Regard to the Application of Biology and Medicine:
p.000073: Convention of Human Rights and Biomedicine (Council of Europe, Strasbourg, 1996 and its Additional Protocols);
p.000073: • Guidelines for Good Clinical Practice (GCP) developed by the International Conference on Harmonization
p.000073: of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) (Brussels, Washington,
...
p.000079: complicated by the absence of official rules regulating the conditions of medical experimentation”. In
p.000079: order to eliminate this legal vacuum, in 1936 the Scientific Medical Council of the People’s Commissariat of Health
p.000079: Care of the RSFSR established a special commission responsible for development of rules concerning trials of new
p.000079: medical methods and medicines in humans.
p.000079: It is especially interesting to compare the principles declared in the statute “On the conditions of
p.000079: conducting the research of new medicines and medical methods which can endanger the health and life of patients” with
p.000079: the principles stated by modem international instruments regulating the conduct of medical research. According to the
p.000079: Statute, trials of new medicines in human beings are permissible when the following conditions are observed: “when it
p.000079: is conducted by a physician working in the medical institution, upon notification and under responsibility of the
p.000079: medical person-in-charge of the institution, with the purpose of alleviating the patient’s suffering, and
p.000079: when the research subject has given his consent to participate (in a case where the patient, due to her
p.000079: condition, is unable to give her consent, or her consent will not have legal force, the physician must ask the legal
p.000079: representative’s consent prior to enrollment of the patient)” - this term of the Statute corresponds to the ethical
p.000079: principles formulated in articles 15, 20, 22
p.000079: and 24 of the Declaration of Helsinki;
p.000079: “when it is conducted after preliminary animal experimentation which is necessary and possible based on modern
p.000079: scientific data” - this term corresponds with article 11 of the Declaration of Helsinki;
p.000079: “any use of new medicines and methods defined in the present Statute should be documented in detail by the physician.
p.000079: The doctors in-charge of the institutions where the research is being conducted must report the results of the
p.000079: research”.
p.000079: As a whole, the Statute of 1936 was the first legal act of the Soviet health care system, which regulated the rules and
p.000079: conditions of the conduct of biomedical research, and defined the responsibility for observation of such
p.000079: regulations. As to its contents, the Statute illustrates a number of cardinal principles regulating the modem
p.000079: practice of biomedical research. However, the Statute did not declare the need to establish ethics committees, nor
p.000079: emphasize the need for independent ethical review, and the decisions on
p.000079: both professional and ethical aspects of the review were still the responsibility of the institutional organizations.
p.000079: On the whole, the significance of all these documents (considering their content and the time when they
p.000079: had been adopted) consists in the fact that the requirements concerning scientific justification and
p.000079: preliminary experiments on animals, research participants’ informed and conscious consent, high qualification of a
p.000079: physician-investigator and his responsibility in relation to research subjects fully coincide with modern norms of
p.000079: research ethics. The other important and positive aspect with regard to the analyzed documents is that the
p.000079: motivation to create those and their content has a protective legal character.
p.000079: At the same time, it should be noted that the Soviet legislation had a legal mechanism for the attribution
p.000079: of criminal liability for committing “crimes against Humankind”. (Decree of Presidium of the Supreme Council of the
p.000079: USSR on 19 of April 1943. Art. 1). There is an important historical document that reflected moral and legal
p.000079: understanding of experiments on live human beings – the protocols of a legal action conducted by the Military Tribunal
p.000079: of the USSR in Khabarovsk in 1949. It concerned the case of former Japanese military men accused of the development and
p.000079: use of biological weapons (“Indictment on the case of the former Japanese military men”; a supplement to Novoe Vremia
p.000079: (New Time) Journal, No 1, 1 of January 1950). The importance of the Conclusion adopted by the Tribunal in Khabarovsk is
p.000079: comparable with the importance of the Nuremberg Trials and the Code adopted there. In both cases the moral aspects of
p.000079: decisions concerned not only the individuals guilсссty of the crimes, but also the governmental policy and
p.000079: ideology which made these crimes possible.
p.000079: In the context of this Chapter the above documents are mentioned for the following purposes:
p.000079: • to eliminate informational vacuum existing in relation to the ethics of biomedical research in the former Soviet
p.000079: Union;
p.000079: • to clarify the reason of including the abovementioned documents into the international list on important documents
p.000079: of “pre-Helsinki” era to the CIOMS list;
p.000079: • to illustrate mutually enriching and complementary values of studying fundamentals of moral and cultural
p.000079: heritage;
p.000079:
p.000080: 80
p.000080:
p.000081: 81
p.000081:
p.000081: • to define the basis for a timely and harmonious assimilation of international universal norms of
p.000081: biomedical research ethics by the CIS countries.
p.000081: Summarizing the data on the ethical component of biomedical research at the time of the Soviet Union
p.000081: disintegration and formation of new independent states in the end of the nineteenths of the last century, we have
p.000081: to state that there existed efficient moral and ethical norms of medical practice and the governmental system
p.000081: regulating biomedical research. Although there were separate cases of establishing ethics committees at
p.000081: medical centres taking part in international studies, those were but of a “decorative” or “declarative” character, as
p.000081: they were established to meet the requirements of foreign pharmaceutical companies and did not have a legal status.
p.000081: The actual process of entering into the international system of ethical review began for the CIS countries also in the
p.000081: nineteenths of the last century. The rhythm and procedure for different CIS countries depended on their
p.000081: involvement in international biomedical research. As to the documents and international regulations that formed
...
p.000117: local ethics committees. Scientists, governing structures and public organizations put their efforts in creating
p.000117: the basis for establishing in Belarus the National Committee for Bioethics similar to those existing in many countries.
p.000117: The Committee can rightly represent Belarus on the international level and take initiatives in the protection of
p.000117: human rights in biomedicine, coordinate
p.000117: activity of local ECs and develop main concepts of professional and public education. The National Committee for
p.000117: Bioethics (NCBE) at the Health Ministry of Belarus was established in 2005 with the support of the National
p.000117: Commission of Belarus for UNESCO.
p.000117: At the same time there are still organizational and legislative problems in the development of bioethics in Belarus.
p.000117: This concerns an under-developed system of legal regulation of bioethics, a low level of ethical knowledge and legal
p.000117: culture in the medical community and in the population, and a high level of bureaucracy and conservatism in
p.000117: institutions that are to make decisions. Thus during a year, due to delays and impediments of the law, the question of
p.000117: the legal status of NCBE established on the instructions of Council of Ministers (26.07.2005) could not be
p.000117: decided, which certainly hampered NCBE activity.
p.000117:
p.000117: 3.3.2 Legal Regulations
p.000117:
p.000117: Like in the healthcare as a whole, in establishing local ECs and the NCBE
p.000117: Belarusfollowsinternationallegalandethicaldocuments. Thesedocumentsare: The Nuremberg Code (1947); Declaration of
p.000117: Helsinki (1964, with subsequent amendments); ICH GCP (1996); WHO Operational Guidelines for Ethics Committees
p.000117: That Review Medical Research (2002); UNESCO documents “The Declaration on the Principles of Tolerance”
p.000117: (1995); “The Universal Declaration on the Human Genome and Human Rights” (1997); UNESCO Guide No 1 “Establishing
p.000117: Bioethics Committees” (2005); UNESCO Guide No 2 “Bioethics Committees at Work: Procedures and Policies” (2005).
p.000117: The National Strategy of Steady Development and the Concept of Healthcare Development in Belarus (1995) are
p.000117: the basis for adopting legal acts and national programmes and determine particular measures and resources for ethical
p.000117: and legal control of biomedical research. Laws of Belarus “On Healthcare” (1999 with subsequent amendments), “On the
p.000117: Safety of Genetic Engineering” (2005), the Draft Law “On transplantation of Human Organs and Tissues”, orders and
p.000117: instructions of the Belarus Health Ministry of are in compliance with the main principles of bioethics set out by WHO.
p.000117: The central law determining the State policy in the sphere of citizens’ health protection, legal, economical and
p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
...
p.000151: • research protocol should be reviewed by independent body and ethics committee;
p.000151: • risks and benefits of the research should be assessed; risk associated with the research should not be
p.000151: disproportional to the expected benefits;
p.000151: • research subject should be fully informed about the details of the research (objectives, methods, potential
p.000151: benefits, risks, alternatives etc.);
p.000151: • research should not be started without informed consent of the research subject;
p.000151: • research subject has the right to refuse to participate in the research or withdraw from the research at any
p.000151: time despite already given written informed consent.
p.000151: The law also outlines general principles for the protection of incapable persons and minorities in the context of
p.000151: biomedical research.
p.000151: The law on Drug and Pharmaceutical Activity sets out the rules for organizing drug trials including trials in
p.000151: clinical phase when human beings are involved in the research programme. It requires that ethics committee to be
p.000151: created at the institution where the trial is to be carried out. Interestingly, this law specifically mentions
p.000151: recommendations set out in WMA Declaration of Helsinki to be the basis for conducting clinical trials on human beings.
p.000151: As already mentioned the most specific law on the protection of the research subjects will be the Law on
p.000151: Biomedical Research involving Human Subjects, which is being submitted to the Government this year. The aim of the
p.000151: draft law is protection of the rights, health and life of a research subject of biomedical research and provision of
p.000151: safety and respect for dignity during the research. The draft law concerns any type of research aiming at obtaining
p.000151: information and broadening knowledge in the sphere of biomedicine, which serves the interests of human health
p.000151: protection and implies:
p.000151: • Physical intervention on human being;
p.000151: • Research on biological materials which initially were taken and stored with other purpose;
p.000151: • Intervention which doesn’t imply physical intervention on human being but can pose danger to mental health or
p.000151: psychological condition of human being;
p.000151: • Research on foetus and/or embryo in vivo (The Law does not apply to research on embryos in vitro.
p.000151: The draft Law on Biomedical Research involving Human Subjects is based on the following core principles:
p.000151: • Primacy of the human being;
p.000151: • Autonomy of research subjects: information, informed consent, confidentiality and privacy;
p.000151: • Scientific quality;
...
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
p.000189: necessary for an authorized healthcare state institutions of Kyrgyz Republic to make a decision about a clinical trial
p.000189: of a pharmaceutical product. The list includes an approval by the ethics committee of an authorized
p.000189: healthcare state institution of Kyrgyz Republic. Article 27 states that the ethics committee of an authorized
p.000189: healthcare state
p.000189: institution of Kyrgyz Republic participates in the design of a clinical trial programme.
p.000189: According to this Article, clinical trial results are referred only to the authorized healthcare state institution of
p.000189: Kyrgyz Republic. It is forbidden to provide any information about the process and results of a clinical trial of a
p.000189: pharmaceutical to a research sponsor without the permission from an authorized healthcare state institution of Kyrgyz
p.000189: Republic.
p.000189: Article 28 of the Law states the procedure of establishing ethics board: “Ethics Boards are composed of
p.000189: medical professionals, lawyers and persons representing public organizations. The Statute of the Ethics Board and
p.000189: membership requirements are adopted by an authorized healthcare state institution of Kyrgyz Republic in
p.000189: compliance with the principles of Declaration of Helsinki”. According to the Law, ethics board at an authorized
p.000189: healthcare state institutions of Kyrgyz Republic and at healthcare institutions carry out an expert evaluation with
p.000189: regard to ethical criteria, consider moral and ethical problems arising in the course of clinical trials of
p.000189: pharmaceutical products and ensure the protection of patient’s rights.
p.000189: This Law contains important provisions concerning human rights in clinical trials of pharmaceutical
p.000189: products. In particular, it says that a patient gives his or her written consent to participate in a clinical
p.000189: trial of a pharmaceutical product and has the right to withdraw his or her consent at any stage of the research. Before
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
...
p.000243: 301- 309.
p.000243: 20. Mtchedlov М.P. Are young citizens of Russia religious? Human, 2005, №6, p. 111-118.
p.000243: 21. Nikolay Ivanovitch Pirogov and his heritage. Pirogov’s conferences.
p.000243: B/м. B/g. 253 p.
p.000243: 22. Petrov V., Sedova N. Bioethics in practice. М., 2002, p. 60-89.
p.000243: 23. Petukhov V.V. The proper and the real in moral mentality of Russian
p.000243: citizens. Human, 2006, №3, p. 148-149.
p.000243: 24. Pirogov N.I. Selected works. М., v.2, p. 286.
p.000243: 25. Savina E.А., Degtjarenko L.J. Life psychology in Russian sayings and proverbs. Human, 2001, №5, p.186-192.
p.000243: 26. Anniversary Episcopal Assembly RCOC August, 13-16, 2000.
p.000243: Digest of abstracts and documents. Chapters Х-ХII. SPb, 2000, p. 192-200.
p.000243:
p.000244: 244
p.000244:
p.000245: 245
p.000245:
p.000245: 27. Judin B.G. National specific of establishing bioethics in Russia. In
p.000245: bk.: Philosophy of biomedical research. М., 2004, p. 71-90.
p.000245: 28. Jarovinskiy М.J. Lectures on medical ethics (bioethics). М., 2004,
p.000245: 528 p.
p.000245:
p.000245: 3.8.2 Legal Regulations
p.000245:
p.000245: The ethical review of biomedical research involving human subjects is the important component in rights, interests and
p.000245: dignity of human subjects and in the same time is the necessary condition for further development of medical science
p.000245: and technology.
p.000245: The basis for legal regulation of biomedical research and its ethical evaluation is laid by a complex of
p.000245: international acts both of legal and ethical character.
p.000245: First of all we could mention Nuremberg Code (1947), the Declaration of Helsinki (1964, with all further
p.000245: revisions) – the documents which in many points determined the Russian policy on regulation of biomedicine and
p.000245: healthcare sphere22.
p.000245: The serious stimulus for Russian domestic legislative activity and for biomedical practice is also produced by other
p.000245: documents of recommending character, which are devoted to general and specific questions of biomedical research. Here
p.000245: are some examples of such documents: International Ethical Guidelines for Biomedical Research Involving Human
p.000245: Subjects (1982, 1993, 2002), International Guidelines for Ethical Review of Epidemiological Studies (CIOMS, 1991), ICH
p.000245: GCP (1996), Operational Guidelines for Ethics Committees that Review Biomedical Research (2000) and others23.
p.000245:
p.000245: 22 “Nurnberg code” (The sentence of Nurnberg Tribunal)//Medical doctor.1993. N7, Helsinki Declaration (WMA)
p.000245: 1964//Collection of official documents of Association of medical doctors of Russia: medical associations,
p.000245: medical ethics and general medical problems/Ed. V.Uranov. M.:PAIMS.1995.
p.000245: 23 International Ethical Guidelines for Biomedical Research Involving Human Subjects (1982, 1993,
p.000245: 2002)//World Health Organization, Geneva, 1993, International Guidelines for Ethical Review of Epidemiological Studies
p.000245: (CIOMS, 1991)///CIOMS- Geneva. – 1993, ICH Harmonized Tripartite Guideline for GCP
p.000245: //http://www.ich.org/LOB/media/MEDIA482.pdf, Operational guidelines for ethics committees that review biomedical
p.000245: research http://www. who.int/tdr/publications/publications/ethics.htm.
p.000245: The intention to accede to Convention for the Protection of Human Rights and Dignity with regard to the
p.000245: Application of Biology and Medicine (Council of Europe (1997)24 which is the fundamental document for
p.000245: biomedical research and which imposes legal obligations for countries-parties was expressed by the Russian Federation
p.000245: in 1998 in the Order of Ministry of Health of the Russian Federation N 248 “On organizing of biomedical ethics
p.000245: committee of Ministry of Health of the Russian Federation” of 30 December 199825. However, this intention is still not
p.000245: realized. That is why the Convention, as well as the Additional Protocols to this Convention, particularly
...
p.000253: Among documents which are important for development of the system of ethical review in Russia we should also point out
p.000253: the mentioned “Rules of Clinical Practice in the Russian Federation” (Rules of Clinical Practice) and the national
p.000253: standard “Good Clinical Practice. GOST- R 52379-2005 “ (National standard).
p.000253: Today the Rules of Clinical Practice have limited application caused by essential reorganization of the system of
p.000253: control and assessment of effectiveness and safety of products, processes and services, including those in medical
p.000253: sphere.
p.000253: The National standard that entered into force in April, 2006 is more meaningful document in this sphere.
p.000253: This act is the element of the system of technical regulation and develops the provisions of the Federal Law “On
p.000253: Technical Regulation”, which establishes the requirements for products, manufacturing, exploitation, storage,
p.000253: transportation, realization and utilization, service delivery, etc.
p.000253: The national standard is the Russian version of ICH GCP and by its status is recommending document. It establishes the
p.000253: ethical and scientific standard of the quality of planning and conducting research involving human subjects as well as
p.000253: the standard of recording and registering the study results.
p.000253: These standards may be applied not only to the studies of medicines, but also to “other clinical experiments, which can
p.000253: affect the safety and well- being of a subject”.
p.000253: The observation of the rules of the national standard is the guarantee of the validity of research results, safety of
p.000253: subjects and protection of their rights and health in accordance with the basic principles of Helsinki Declaration.
p.000253: Ignoring this standard actually means that the results of clinical research cannot be accepted as the evidence of drug
p.000253: effectiveness and safety. This fact serves as the stimulus of an effective compliance with the requirements of the
p.000253: present document.
p.000253:
p.000254: 254
p.000254:
p.000255: 255
p.000255:
p.000255: While analyzing the national standard, which in general is identical to ICH GCP, we should note two basic
p.000255: moments, which make it extremely important for development and functioning of the system of biomedical
p.000255: research ethical review in Russia.
p.000255: First, this document contains the definitions of all internationally accepted terms in sphere of clinical
p.000255: practice, including the definition of ethics committee.
p.000255: In accordance with item 1.29 of the national standard, the expert council of the organization/independent ethics
p.000255: committee is the independent body, which consists of medical professionals and persons, who are not engaged in
p.000255: medical sphere. This body provides protection of research subjects’ rights, safety and well-being and serves as
p.000255: guarantee of this protection, in particular via examination, approving of the study protocol, candidacy of researchers,
p.000255: research Centres, as well as materials and methods, which are used for obtaining and documentation of the
p.000255: informed consent of research subject.
...
p.000257: The curriculum stipulated one lecture for the 1 year students: “Medical ethics and medical
p.000257: deontology, their role for formation of a medical doctor and pharmacist” (Introduction for the subject);
p.000257: 5 lectures for the 2 year students: “Soviet health care as qualitatively new system“ (Department of
p.000257: Social Hygiene and Health Care Management), “Main peculiarities of deontology development at different stages of
p.000257: health care formation” (Department of History of Medicine), “Categories of medical ethics” (Department of Marx and
p.000257: Lenin Philosophy), “Modern concepts on medical and psychological aspects of an individuality” (Course on medical
p.000257: psychology), “Deontological issues in disease diagnostics” (Department of Preliminary Studies of Internal
p.000257: Diseases); 1 lecture for 3 year students: “Deontological issues of treatment” (Department of Faculty Therapy); 2
p.000257: lectures for 5 year students: “Deontological issues for work of district physician” (Department of
p.000257: Hospital Therapy) and “Legal principles of medical services for working population in the USSR”
p.000257: (Department of Forensics Medicine). The curriculum was widely discussed in mass media and majority of comments were
p.000257: that it was inefficient, did not cover many important issues, which are of tremendous value for medical practice, for
p.000257: instance, no definition of patient rights was given, it did not dwell on issues of brain death, refusal of
p.000257: extraordinary treatment for dying patients, it never mentioned the Nuremberg Code or the Declaration of Helsinki, etc.
p.000257: In 1977 and 1982 two other All-Union conferences on medical deontology were held. There were published
p.000257: multiple books on issues of medical ethics and deontology for various medical fields. It indicated that in 70-80’s
p.000257: the system of Soviet higher medical education had professors who not only fully understood a role of medical
p.000257: deontology for education
p.000257:
p.000258: 258
p.000258:
p.000259: 259
p.000259:
p.000259: and training of undergraduate doctors but also contributed considerably for development of the content of this
p.000259: subject (Evlashko Y.P., Kosarev I. I., Leschinsky L.A., Orlov A.N., Suvorova R.V., Rokitsky M.R., Shamov I. A.,
p.000259: Jarovinsky M.Ya., etc.). In 1988 two volume manual Deontology on Medicine was published edited by Petrovsky
p.000259: B.V.
p.000259: In the 80’s the educational curriculum of medical nurse colleges had some academic hours assigned to medical
p.000259: deontology – the course was called as Basics of medical psychology, ethics and deontology. In 1992 the Pledge of
p.000259: Medical Doctor of Russia came into force.
p.000259: In 1993 the Vrach (Doctor) magazine published an appeal to scientific community and heads of the Russian science from
p.000259: members of the Russian national committee on bioethics (“Bioethics in Russia: Beginning of the way”). The Appeal
p.000259: stated: “Modern medicine requires modern moral consciousness. In the whole world principles of bioethics for a
...
p.000289: attributes. The former political system was destroyed, which resulted in the change of ownership patterns and social
p.000289: relations.
p.000289: The development of Tajikistan as an independent secular republic in the post-Soviet space was accompanied
p.000289: with economic, political and social instability. A significant support from the international community was
p.000289: directed to the needs associated with the civil was (1992-1995) and its consequences. Emergency measures of
p.000289: providing medicines, vaccines, bandaging material taken by the international community made an essential contribution
p.000289: into the solution of healthcare problems. At the same time, there was a need in more thorough structural changes that
p.000289: would help to overcome existing problems and facilitate the development of safe mechanisms for providing
p.000289: healthcare and safeguarding patients’ rights.
p.000289: As current biomedical researches are carried out at a large scale and at many Centres, they affect interests of many
p.000289: people and many countries. New problems emerge, because “rich” countries carry over their biomedical research to other,
p.000289: “poorer” countries, and use the results of the research at home, as, “poor” countries cannot afford to use the research
p.000289: findings for economic reasons. To eliminate this injustice, the medical community took certain measures. The WMA
p.000289: Declaration of Helsinki and the additional Protocol to the CE Convention on Human Rights and Biomedicine require
p.000289: that in the countries where a biomedical research is planned the permission should be sought from state structures, and
p.000289: interests of people who live there and who are potential research subjects should be considered.
p.000289: The involvement of Republic of Tajikistan, as an independent state, in international research projects
p.000289: requiring ethical review to ensure the compliance with international regulations triggered the process of
p.000289: establishing in Tajikistan the Committee on Medical Ethics and developing the system
p.000289: of State registration of pharmaceutical products, medical facilities and other medical goods.
p.000289: For a further development of medical ethical review of scientific-research projects, the Ministry of Health established
p.000289: the Republican Committee on Medical Ethics at the Department of the Management of Medical Personnel and Science (Order
p.000289: No 250; 4 of June 2004). The first research project that had to undergo ethical review to ensure the compliance
p.000289: with documents setting international rules in ethics was a joint Tajik-American research on AIDS and hepatitis C in
p.000289: drug addicts.
p.000289:
p.000289: 3.9.2. Legal Regulations
p.000289:
p.000289: One of fundamental human rights is the right for life and health protection. Health is a natural, absolute
...
p.000313: with Ministry of Health it developed model regulations for medical ethics committees at scientific and medical
p.000313: institutions in line with modern international requirements. During these years a number of public organizations
p.000313: having a concern in bioethics have emerged, and the implementation of the system of ethical review for biomedical
p.000313: research has begun on a large scale.
p.000313: Today we have the following system of ethical review. Firstly, there are different laws and by-laws regulating
p.000313: biomedical research. The order of conducting clinical trials of pharmaceutical products and reviewing materials of
p.000313: clinical trials has been developed in compliance with the Articles 7 and 8 of the Ukrainian Law “On Pharmaceutical
p.000313: Products”43 and in line with requirements of the Directive 2001/20/EC of the European Parliament and of the
p.000313: Council EC ICH GCP44 and Declaration of Helsinki45. It was approved by the Order of the Ministry of health
p.000313: of Ukraine No 6646. The responsibility for reviewing documentation on clinical drug trials rests with the State
p.000313: Pharmacological Centre of the Ukrainian Ministry of Health.
p.000313: General principles of conducting clinical trials:
p.000313: • According to the sponsor’s choice, clinical trials are mostly conducted at specialized medical
p.000313: institutions the list of which is submitted by the Centre in accordance with established procedure and approved by the
p.000313: Ministry of Health.
p.000313: • All clinical trials are conducted in compliance with ethical principles set by Helsinki Declaration, and on the
p.000313: condition that the basic requirements relating to the protection of research subjects (patients or healthy volunteers)
p.000313: are observed. Clinical trials may only be conducted if the expected benefit justifies the risk.
p.000313: • All clinical trials are conducted only after a compulsory review of trial protocol by ethics committees
p.000313: established to protect trial subjects’ rights, safety and well-being, and to guarantee the protection for the society.
p.000313: • Planning, conducting and reporting at all phases of clinical trials, including studies of bioavailability and
p.000313: bioequivalence, should meet GCP requirements adopted by the Ukrainian Ministry of Health.
p.000313: • Trial management, data handling, documentation and an assessment of results obtained in a trial should comply with
p.000313: requirements set in standard operational procedures.
p.000313: • Registration, processing and archiving of information obtained in a trial should ensure an accurate presentation,
p.000313: interpretation and verification
p.000313:
p.000313: 43 http://www.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=123/96-вр
p.000313: 44 europa.eu/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf
p.000313: 45 http://www.wma.net/e/policy/b3.htm
p.000313: 46 http://www.pharma-Centre.kiev.ua/files/2006/Nakaz_66_d.doc
p.000313:
p.000314: 314
p.000314:
p.000315: 315
p.000315:
p.000315: of the data. Main trial related documents are archived and retained at the site of the trial and at the sponsor’s for
...
p.000331: Public Participation with Regard to Protection of Consumers’ Rights” (No 404, 2002) and “On Implementation of Measures
p.000331: for Improving the Procedure of Importing Consumer Goods” (No 427, 2002). The procedure for conducting clinical
p.000331: trials is specified in Guidelines on Conducting Clinical Trials and Determining Clinical Sites approved by the Ministry
p.000331: of Public Health of the Republic of Uzbekistan in 2001. The Guidelines are based on WHO Guidelines for Good Clinical
p.000331: Practice. When conducting CT, the Pharmacological Committee of the Central Department for Controlling the
p.000331: Quality of Pharmaceuticals and Medical Equipment an the Ministry of Public Health of the Republic of Uzbekistan is
p.000331: following this document.
p.000331: The Guidelines reflect the following aspects:
p.000331: - informing patients about CT;
p.000331: - obtaining written informed consent from patients;
p.000331: - independent ethical review;
p.000331: - insurance;
p.000331: - operational standard procedures.
p.000331: A number of other documents (decrees of the President of Republic Uzbekistan, decrees of the Cabinet of the
p.000331: Republic of Uzbekistan, orders and guidelines of the Ministry of Public Health) have been adopted for a further
p.000331: healthcare development (reforming the system of medical service, creating necessary material and technical conditions
p.000331: for providing healthcare at state and private medical institutions, etc.).
p.000331:
p.000332: 332
p.000332:
p.000333: 333
p.000333:
p.000333: Uzbekistan adopted basic international documents in the field of bioethics, such as
p.000333: 1. Declaration of Helsinki
p.000333: 2. Universal Declaration on Human Rights (1948)
p.000333: 3. The Universal Declaration on the Human Genome and Human Rights (1997)
p.000333: 4. Monaco Declaration (18 of July 2001),
p.000333: 5. International Declaration on Human Genetic Data (adopted by UNESCO General Assembly; 16 of Octobe, 2003
p.000333: 6. Universal Declaration on Bioethics and Human Rights (UNESCO, 2005)
p.000333: 7. United Nations Declaration on Human Cloning (8 of March 2005)
p.000333: 8. ECOSOS Resolution “Genetic privacy and non-discrimination” (21 of July 2004)
p.000333: 9. Resolutions of ECOSOS Commission for Human Rights:
p.000333: - Human Rights and Bioethics (25 of April 2003);
p.000333: - Principles of biomedical ethics with regard to the role of medical professionals, particularly
p.000333: physicians, in the protection of prisoners or persons under arrest against tortures and other cruel, inhuman or
p.000333: disgracing attitude and punishment (18 of December 1982);
p.000333: - Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of
p.000333: Mankind (10 of November 1975).
p.000333: In its activity the National Ethics Committee (NEC) of the Republic of Uzbekistan at the Ministry of Public Health of
p.000333: Uzbekistan uses also other international documents, such as
p.000333: 1. Final Act of the International Conference on Healthcare (New-York, 22 July 1946)
p.000333: 2. The Nuremberg Code (1947)
p.000333: 3. Universal Declaration on Human Rights 1948
p.000333: 4. Declaration of Helsinki (WHO, 1964, 2002)
p.000333: 5. European Agreement on Providing Medical Assistance to Persons Temporarily Residing in Other [Member] (Geneva, 17
p.000333: of October 1980)
p.000333: 6. Convention on Biological (Rio de Janeiro, 5 of June 1992)
p.000333: 7. Budapest Summit Decisions. Human Dimension (Budapest, 1994)
p.000333: 8. Agreement on Collaboration in Public Health Protection (Minsk, 26 of June 1992)
p.000333: 9. The Charter of Social Rights and Guarantees to the Citizens of Independent States (approved by the
p.000333: Inter-parliamentary Assembly of the Commonwealth of Independent States, 29 of October 1994)
p.000333: 10. Convention on Human Rights and Biomedicine (Council of Europe, 1996)
p.000333: 11. Note for Guidance on Good Clinical Practice (ICH, 1996)
p.000333: 12. WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
p.000333: 13. Model Law of IPA CIS “On the Protection of Human Rights and Dignity in Biomedical Research in the CIS” (2005)
p.000333: 14. International Ethical guidelines for Biomedical research Involving Human Subjects (WHO/CIOMS, 13 of June 1993/2003)
p.000333: 15. Report of the International Bioethics Committee on the Possibility of Elaborating a Universal Instrument on
p.000333: Bioethics (13 of June 2003)
p.000333: 16. UNESCO Programme on Bioethics: Priorities and Perspectives (17 of October 1999)
p.000333: 17. Implementation of the Universal Declaration on the Human. Genome and Human Rights (17 of November
p.000333: 1999)
p.000333: A number of national laws of the Republic of Uzbekistan relating to the implementation of international agreements in
...
p.000353: establishment of the system of ethical examination. Simultaneous start of development of this field and
p.000353: unique support of the global community through establishment of the Forum for Ethics Committees in the CIS and
p.000353: inclusion of this region as a single constituent of the global WHO Project SIDCER provided permanent
p.000353: international dialogue on key issues of research ethics with international agencies leading in this sphere –
p.000353: such as WHO, the European Commission, the Council of Europe, UNESCO, the European Forum for Good Clinical Practice,
p.000353: the World Medical Association as well as authoritative national agencies: DHHS, USA and Ethics Committees of
p.000353: countries of all Continents. Such dialogue became a basis for experience exchange and real integration of ethical
p.000353: examination systems of the CIS countries into global discussion and research process.
p.000353: Integrity and value of cooperation with international organization is also presented with equal access for
p.000353: the CIS countries to discussion and development of international documents and guidelines on ethics of
p.000353: biomedical studies such as the Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000,
p.000353: 2002); work on new edition of the Declaration of Helsinki, documents of the Council of Europe, new version of the
p.000353: International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS), the Universal
p.000353: Declaration on the Human Genome and Human Rights, the International Declaration on Human Genetic Data, the
p.000353: Declaration on Common Bioethics Standards (UNESCO), guidelines on bioethics, legal and social consequences of genetic
p.000353: testing (the European Commission) and other universal documents and guidelines in which development members of
p.000353: the FECCIS participated.
p.000353: In general, cooperation within the framework of the FECCIS is developed with the purpose to facilitate
p.000353: creation of systems of good ethical
p.000353:
p.000354: 354
p.000354:
p.000355: 355
p.000355:
p.000355: practice and development of ethical responsibility in researchers, sponsors, authorized regulatory agencies and the
p.000355: society as a whole. This process in combination with advancements of science and social and legal trends
p.000355: facilitates appearance of constitutional society and state regulation in the CIS region. Inclusion of the CIS countries
p.000355: in the process of establishment of good practices of ethical review at international scale is focused on
p.000355: understanding of necessity of reaching independence, competence, openness and responsibility in the field of human
p.000355: rights protection when conducting biomedical studies. Development of cooperation facilitates free discussion among
p.000355: colleagues, exchange with experience, problems and successes, formation of collective recognition of ethics role
...
General/Other / oviedo
Searching for indicator oviedo:
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p.000317: of Central and East Europe. The main fields of cooperation are training in bioethics, ethics in the practice of
p.000317: scientific research and the development of the structure of ethics committees and organizations so as to improve the
p.000317: practice of ethical review.
p.000317: The practice of ethical review and an ethical follow-up procedure for research projects conducted in cooperation with
p.000317: the USA shows itself in the implementation of joint projects. The development of this practice ensures a high quality
p.000317: of ethical review of international projects which later is extended
p.000317:
p.000318: 318
p.000318:
p.000319: 319
p.000319:
p.000319: to the national level. Thus in 2005 the Ethics Committee of the Occupational Medicine at the Ukraine Academy of Medical
p.000319: Sciences was registered at the Office for Human Research Protection at the USA Government and received the Federalwide
p.000319: Assurance FWA00007871. Several local committees in Ukraine also have international registration numbers.
p.000319: Since November 1995 when Ukraine became a permanent member of the Council of Europe, a Ukraine representative has been
p.000319: working actively at the Steering Committee on Bioethics in Strasbourg (France). In the framework of this activity
p.000319: Ukraine participated in the development of international documents including the revised text of the “Convention
p.000319: of Human Rights and Biomedicine” (Oviedo, 1997). In 2004 the representative of Ukraine was elected to the Board of the
p.000319: Steering Committee on Bioethics as a Committee Reporter on the activity of Ethics Committees at medical research
p.000319: institutions. Two seminars on topical ethical problems in transplantology and cell therapy were held in Ukraine with
p.000319: the assistance and participation of CE experts. The representative of Ukraine takes part as a reporter in the
p.000319: educational project of the CE on implementation of CE documents on bioethics in the countries of the former Soviet
p.000319: Union. Currently, in the framework of the Steering Committee on Bioethics at the CE, Ukraine participates in the
p.000319: development of guidelines for a fetus and embryo protection and in the design of a protocol relating to genetic
p.000319: testing.
p.000319: International Seminar “Development of the Recommendations on Application of Standard Operational Procedures
p.000319: for Ethical Review of Biomedical Research” was held in the framework of the Second National Congress on Bioethics
p.000319: (Kiev, 2004) organized in cooperation with FECCIS and UNESCO. Experts and participants from CIS, Baltic States, the USA
p.000319: and Japan attended the Seminar.
p.000319: The main objective of the seminar was to discuss ways and methods of implementing Standard Operational Procedures
p.000319: into the practice of ethical evaluation of biomedical research in the countries of the former Soviet Union
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000099: Presently, Ethics Committee of Armenian Health Ministry has 12 members who are independent experts
p.000099: and represent different social communities: physicians of different specialties, clinical pharmacologists, lawyers,
p.000099: nurses, representatives of culture, etc.
p.000099: Ethics Committee of Health Ministry of Republic of Armenia has the following responsibilities:
p.000099: - ethical review of clinical trials;
p.000099: - control of the trial process through a regular monitoring;
p.000099: - review of research protocol amendments;
p.000099: - protection of confidentiality.
p.000099: For a thorough and complete ethical review of clinical trials in Armenia the following documents are required:
p.000099: - research protocol,
p.000099: - informed consent form signed by the trial participant,
p.000099: - investigator’s brochure,
p.000099: - written information and promotion materials for potential trial participants
p.000099: - documents confirming investigator’s qualification.
p.000099: When reviewing the protocol of the clinical trial the following should be considered:
p.000099: - scientific justification of the trial goals and objectives;
p.000099: - data of pre-clinical studies;
p.000099: - results of previous clinical trials;
p.000099: - risk/benefit balance of the suggested treatment;
p.000099: - the justification of the treatment plan (dosages, duration of the treatment);
p.000099: - ethics of control choice (placebo, reference drug, no treatment);
p.000099: - criteria of recruitment of the trial participants (inclusion/exclusion criteria);
p.000099: - procedures of informing trial participants;
p.000099: - materials presented to the trial participant;
p.000099: - procedures of obtaining written informed consent to participate in the trial.
p.000099: In its activity Ethics Committee follows three main principles: scientific justification, risk/benefit balance,
p.000099: informed consent.
p.000099: Scientific justification. No scientific research can be considered ethical unless it has a comprehensive scientific
p.000099: justification. A poor justification may, at best, result in the loss of participants’ time, and, at worst, it may bring
p.000099: about an unwarranted risk. Ethics Committee has the right to reject the planned research if it repeats a similar
p.000099: research, and yields no new results.
p.000099: Risk/benefit balance. The main ethical requirement for clinical trials of new drugs is to gain benefit with the
p.000099: minimum risk for the patient. It is necessary to monitor clinical trials, and register all complications, not only
p.000099: physical but such as discomfort, invasion of participant’s privacy, etc. In many cases risks are unavoidable, but it
p.000099: must be minimum and under control.
...
p.000269: Objectives of the ethical review prior to the study onset are to minimize risks for clinical study subjects if it is
p.000269: well justified, to provide fair selection of them, to provide control over complete and adequate informing the patients
p.000269: and obtaining the informed consent, confidentiality terms, protection for vulnerable population groups.
p.000269: When examining the clinical study protocol, specialists consider possibility of reaching study objectives with
p.000269: involvement of less amount of subjects, assess inclusion and exclusion criteria, early exclusion criteria from
p.000269: participating in the clinical study, conditions of the study termination, objective control methods, expected
p.000269: adverse events and inconveniences for patients.
p.000269: Reviewing the Investigator Brochure there are examined data on efficacy and safety, pharmacological, pharmaceutical and
p.000269: toxicological properties of the tested medical agent as well as data on results of previously conducted preclinical and
p.000269: clinical studies.
p.000269: Requirements for information on the study provided to a candidate subject are very strict. It must
p.000269: correspond to a level of understanding of those to be involved in the study, to be easy to read and not to
p.000269: contain many medical terms. This document must describe the following: study purpose and objectives; description of the
p.000269: tested medicinal article; concomitant treatment permitted or prohibited in the given the trial’s subjects. probability
p.000269: of random assignment in one of the study groups (including the control that might be treated with placebo. Explanations
p.000269: for all terms and concepts, for instance, placebo, is obligatory!); objectively expected benefit for the patient as
p.000269: well as inconveniences and objectively expected risks for both patients/healthy volunteers and a fetus or infants; all
p.000269: study procedures (especially accurately
p.000269:
p.000270: 270
p.000270:
p.000271: 271
p.000271:
p.000271: there shall be highlighted issues on all invasive procedures planned during the study); obligations of the
p.000271: subject-participant; compensation and/or treatment the subject might expect in case the damage is incurred to his/her
p.000271: health during the study. The information note for the patient must contain a declaration that his/her participation
p.000271: in the study is voluntary and that he/she can in any moment of time refuse of participation in the study or to
p.000271: discontinue it without any sanctions or his/her rights infringement; there shall be clearly identified a list
p.000271: of persons that will be granted with direct access to information in the primary medical documentation (investigators,
p.000271: auditors, regulatory authorities, ethical committee members), and provided assurance that data identifying
p.000271: personality of the study subject will be kept secret and its disclosure is possible only within the limits
p.000271: stipulated with corresponding laws and/or by-laws. For instance, in case of public representation and
p.000271: publication of the study results anonymity of its subjects (confidentiality of information about them) is
p.000271: guaranteed. The patient information note must indicate investigator obligations in case of appearance of new data
...
p.000345: clinical trials are present at the NEC meetings.
p.000345: In the period from 1992 to 2005 inclusive, the Pharmacological Committee reviewed 910 clinical trials of
p.000345: pharmaceutical products (312 of those were from domestic and 598 from foreign manufacturers) belonging to various
p.000345: pharmaco-logical groups. Starting from 2001 the number of clinical trials has increased, which is mainly
p.000345: connected with new requirements relating to the registration of pharmaceutical products. It is noteworthy,
p.000345: that starting from 2001 all clinical trials have been conducted according to uniform guidelines complying
p.000345: with GCP for both domestic and foreign manufacturers. Clinical trials have been carried out at more than 60 medical
p.000345: institutions authorized by the Ministry of Public Health. During that period, 25 pharmaceutical products from both
p.000345: domestic and foreign manufacturers have been declined because of their low efficiency and/or expressed adverse effects.
p.000345: The first experience in actual application of ethical principles strictly according to GCP was gained in multicentre
p.000345: trials organized by large foreign pharmaceutical firms.
p.000345: To safeguard the protection of CT subjects, all documents relating to preclinical trials of toxicity and
p.000345: pharmaceutical activity of both new and generic pharmaceutical products should be most thoroughly studied
p.000345: and analyzed. Preclinical trials are conducted according to “Guidelines on
p.000345:
p.000346: 346
p.000346:
p.000347: 347
p.000347:
p.000347: Preclinical Trials of Pharmaceutical Products Safety” stating that placebo is used only to study pharmaceutical
p.000347: products for adjuvant therapy in patients with a mild or medium degree of a disease. Besides, there are
p.000347: special conditions for research participants from vulnerable groups.
p.000347: In 2001 paragraphs referring to CT ethics were included into the “Guidelines for Conducting Clinical Trials
p.000347: of Pharmaceutical Products and Expertise of Trial Materials”. Now, apart from the research Protocol and individual
p.000347: registration form, documentation submitted by the applicant to the NEC should include written informed consent forms
p.000347: signed by potential trial participants.
p.000347: The NEC activity in the sphere of implementing ethical principles into medical science and healthcare enhanced the
p.000347: quality of patient—physician relationship and of medical services provided by healthcare institutions. This
p.000347: also served to reduce the number of complaints from patients.
p.000347: The NEC coordinates its activity with the Centre of Science and Technology. The latter considers applied,
p.000347: fundamental and innovation grant projects relating to biomedical research after they were approved by the NEC.
p.000347: The NEC collaborates with the Higher Certifying Commission at the Cabinet of the Republic of Uzbekistan. According
p.000347: to the petition of the NEC Medical Council “On the Necessity to Conduct Ethical Review of Dissertation
p.000347: Works Involving Patients or Volunteers as Research Subjects” (Protocol No 25, 2002) the Commission considers
...
Orphaned Trigger Words
p.000001:
p.000001: this book is the result of a collective work of the members of the Forum for Ethics Committees in the Commonwealth of
p.000001: Independent States (FECCIS) functioning in the framework of the Project “Strategic Initiative for Developing Capacity
p.000001: in Ethical Review” (SIDCER/tDR/WHo). the authors of this edition are leading specialists in ethics, philosophy,
p.000001: medicine, biology, jurisprudence, social and economical science recognized in their countries and at the international
p.000001: level.
p.000001:
p.000001: the authors are responsible for the choice and the presentation of the facts contained in this publication and for the
p.000001: opinions expressed therein, which are not necessarily those of UnESCo and do not commit the organization.
p.000001:
p.000001: Editor-in-chief
p.000001: and Project Director: Prof. Olga KUBAR
p.000001:
p.000001: Editorial Board: Prof. Galina Mikirtichian
p.000001: and Assistant Prof. Anastasiya Nikitina
p.000001: Reviewer: Prof. Nadezda Golik, Saint-Petersburg State University
p.000001:
p.000001: Editor: Nikolay Chaika, PhD
p.000001: Translation: Olga Ochkur & Dr.Valery Zvonarev
p.000001:
p.000001: Design: Maria Krasnova
p.000001: Page Print: Oksana Achmitzanova
p.000001: ContEntS
p.000001: INTRODUCTION (O.I.Kubar, H. ten Have) 7
p.000001: Chapter 1 - General tendencies of the social policy and human rights in medicine in the CIS countries.
p.000009: 9
p.000009: 1.1. Social and Demographic Factors (E.Yu.Vladimirova). 9
p.000009: 1.2. Ethical and Legal Issues in the Field of Biology and Medicine (O.I.Kubar, B.G.Yudin, A.E.Nikitina,
p.000009: E.Yu.Vladimirova). 27
p.000009: Chapter 2 - Current Status and Perspective of the CIS’ Region Participation in the International
p.000009: Biomedical Research 46
p.000009: 2.1. Philosophical Aspects of the Biomedical Research (P.D.Tishchenko, B.G.Yudin).
p.000046: 46
p.000046: 2.2. Characteristic of the Biomedical Research in the Region (O.I.Kubar, E.A.Malysheva).
p.000063: 63
p.000063: 2.3. Establishment of the Ethical Review System & Ethics Committees in the Region (O.I.Kubar, A.G.Asatryan).
p.000071: 71
p.000071: Chapter 3 - Ethical Review System for Biomedical Research in the CIS Countries
p.000089: 89
p.000089: 3.1. Republic of Armenia (G.D.Aslanyan, S.A.Davtyan). 89
p.000089: 3.1.1. Historical and Cultural Background 89
p.000089: 3.1.2. Legal Regulations. 93
p.000089: 3.1.3. Education in Bioethics. 95
p.000089: 3.1.4. The System of Ethical Review 100
p.000089: 3.1.5. Perspectives and Forms of International Cooperation. 103
p.000089: 3.2. Republic of Azerbaijan (A.A.Namazova, Z.G.Guseinova,
p.000089:
p.000089: ISBN 978-5-98240-033-8
p.000089: © All rights are reserved by UNESCO
p.000089: © Design. Phoenix, Ltd.
p.000089: T.G.Tagi-Zade). 104
p.000089: 3.2.1. Historical and Cultural Background 104
p.000002: 2
p.000002:
p.000003: 3
p.000003:
p.000003: 3.2.2. Legal Regulations. 107
p.000003: 3.2.3. Education in Bioethics. 108
p.000003: 3.2.4. The System of Ethical Review 110
p.000003: 3.2.5. Perspectives and Forms of International Cooperation. 112
p.000003: 3.3. Republic of Belarus (T.V.Mishatkina, Ya.S.Yaskevich). 114
p.000003: 3.3.1. Historical and Cultural Background 114
p.000003: 3.3.2. Legal Regulations. 119
p.000003: 3.3.3. Education in Bioethics. 125
p.000003: 3.3.4. The System of Ethical Review 132
p.000003: 3.3.5. Perspectives and Forms of International Cooperation. 140
p.000003: 3.4. Georgia (G.Kiknadze, G.Dgaviashvily, T.Kurtanidze) 149
p.000003: 3.4.1. Historical and Cultural Background 149
p.000003: 3.4.2. Legal Regulations. 151
p.000003: 3.4.3. Education in Bioethics. 154
p.000003: 3.4.4. The System of Ethical Review 156
p.000003: 3.4.5. Perspectives and Forms of International Cooperation. 162
p.000003: 3.5. Republic of Kazakhstan (A.B.Sadykova, B.E.Sarymsakova). 163
p.000003: 3.5.1. Historical and Cultural Background. 163
p.000003: 3.5.2. Legal Regulations. 166
p.000003: 3.5.3. Education in Bioethics. 174
p.000003: 3.5.4. The System of Ethical Review 176
p.000003: 3.5.5. Perspectives and Forms of International Cooperation. 177
p.000003: 3.6. Kyrgyz Republic (A.Z.Zurdinov, U.M.Tilekeeva, B.A.Alisherov).
p.000180: 180
p.000180: 3.6.1. Historical and Cultural Background 180
p.000180: 3.6.2. Legal Regulations. 189
p.000180: 3.6.3. Education in Bioethics. 193
p.000180: 3.6.4. The System of Ethical Review 194
p.000180: 3.6.5. Perspectives and Forms of International Cooperation. 195
p.000180: 3.7. Republic of Moldova (V. I.Gikavyi, I.N.Pogonea,
p.000180: T.N.Tirdea, V.I.Ojovanu). 196
p.000180: 3.7.1. Historical and Cultural Background 196
p.000180: 3.7.2. Legal Regulations. 203
p.000180: 3.7.3. Education in Bioethics. 207
p.000180: 3.7.4. The System of Ethical Review 213
p.000180: 3.7.5. Perspectives and Forms of International Cooperation 219
p.000180: 3.8. Russian Federation (G.L.Mikirtichian, A.F.Nikitina, A.S.Sozinov, M.E.Guryleva, E.A.Malysheva)
p.000223: 223
p.000223: 3.8.1. Historical and Cultural Background 223
p.000223: 3.8.2. Legal Regulations. 246
p.000223: 3.8.3. Education in Bioethics. 258
p.000223: 3.8.4. The System of Ethical Review 268
p.000223: 3.8.5. Perspectives and Forms of International Cooperation. 278
p.000223: 3.9. Republic of Tajikistan (S.D.Achrorova) 283
p.000223: 3.9.1. Historical and Cultural Background 283
p.000223: 3.9.2. Legal Regulations. 291
p.000223: 3.9.3. Education in Bioethics. 297
p.000223: 3.9.4. The System of Ethical Review 299
p.000223: 3.9.5. Perspectives and Forms of International Cooperation. 301
p.000223: 3.10. Ukraine (Yu.I.Kundiev, N.A.Chaschin,
p.000223: A.N.Chaschin, S.V.Pustovit, P.N.Vitte) 302
p.000223: 3.10.1. Historical and Cultural Background 302
p.000223: 3.10.2. Legal Regulations. 305
p.000223: 3.10.3. Education in Bioethics. 309
p.000223: 3.10.4. The System of Ethical Review 313
p.000223: 3.10.5. Perspectives and Forms of International Cooperation. 318
p.000223: 3.11. Republic of Uzbekistan (M.S.Abdullakhodjaeva). 323
p.000223: 3.11.1. Historical and Cultural Background 323
p.000004: 4
p.000004:
p.000005: 5
p.000005:
p.000005: 3.11.2. Legal Regulations. 329
p.000005: 3.11.3. Education in Bioethics. 340
p.000005: 3.11.4. The System of Ethical Review 344
p.000005: 3.11.5. Perspectives and Forms of International Cooperation. 349
p.000005: Chapter 4 - The Perspectives for Global International Harmonization the Ethical Review of Biomedical Research in CIS
p.000005: Countries (O.I.Kubar, G.L.Mikirtichian)
p.000353: 353
p.000353: IntRoDUCtIon (olga Kubar, Henk ten Have)
p.000353:
p.000353: The current scientific and technological evolution in the field of biomedicine is characterized by the
p.000353: growing importance of the role of universal ethical values relating to the protection of human rights
p.000353: and dignity. This tendency becomes particularly essential in the course of deep social and cultural changes that have
p.000353: been happening during the last decades in the post-Soviet space. The development and implementation of the new
p.000353: countries’ national policies in the field of ethics and bioethics by bringing up initiatives and consolidating
p.000353: activities in lawmaking, education, creation of the system for the ethical review and international cooperation is
p.000353: presently one of the topical issues. Thus the process of forming the Commonwealth of Independent States (CIS), as a new
p.000353: concept of multilateral cooperation that has united eleven member countries (Republic of Armenia, Republic of
p.000353: Azerbaijan, Republic of Belarus, Georgia, Republic of Kazakhstan, Kyrgyz Republic, Republic of Moldova, Russian
p.000353: Federation, Republic of Tajikistan, Ukraine and Republic of Uzbekistan), gave rise to a unique experience of a dynamic
p.000353: legislative, administrative and informational development in the sphere of ethical regulation in biomedicine.
p.000353: The actual necessity to analyze and systematize factors and conditions influencing the development of ethical
p.000353: review in CIS countries with the view of understanding perspectives and potentials of their interaction in the
p.000353: global aspect of research ethics stimulated the Forum for Ethics Committees in the CIS (FECCIS) to initiate the project
p.000353: of writing this book. The project was presented within the framework of regional expert consultations on the
p.000353: development of cooperation in the field of ethics and bioethics in CIS and Baltic States organized by the UNESCO Moscow
p.000353: Office. The Division of Science and Technology Ethics within the Social and Human Sciences Sector at UNESCO
p.000353: Headquarters supported the project.
p.000353: The structure of the book is intended to present a socio-demographic characteristic of the CIS countries and their
p.000353: current situation, as well as the perspectives of their involvement in the international system of biomedical research
p.000353: as the basis of setting out ethical and legal tendencies in biomedicine. Chapters presenting the analysis of the
p.000353: development of ethical review system
p.000353:
p.000353:
p.000006: 6
p.000006:
p.000007: 7
p.000007:
p.000007: in CIS member countries describe all the variety of historical and cultural tendencies and specific national
p.000007: experiences in this sphere.
p.000007: Authors have used the results of the interaction between the CIS countries in the framework of FECCIS and the
p.000007: Permanent Commission on Social Policy and Human Rights of the Inter-Parliamentary Assembly of the Commonwealth of
p.000007: Independent States (IPA CIS). Elements of UNESCO and WHO programmes that outline general frames and set out
p.000007: fundamental principles and conditions for international cooperation in working out and implementation of national
p.000007: policies in bioethics formed the conceptual basis of the book.
p.000007: We do hope that the materials presented in this book make a comprehensive and realistic picture
p.000007: of the current conditions and perspectives of ethical review development in the CIS countries and will facilitate free
p.000007: exchange of knowledge in this field for the mutual benefit. By providing information on the CIS region potential for
p.000007: cooperation and education in the sphere of bioethics and biomedical research ethics, the project makes an important
p.000007: intellectual and informational contribution into UNESCO Global Ethics Observatory.
p.000007: Chapter 1. GEnERAL tEnDEnCIES
p.000007: oF tHE SoCIAL PoLICY AnD HUMAn RIGtHS In MEDICInE In tHE CIS CoUntRIES
p.000007:
p.000007: 1.1 Social and Demographic Factors (E.Yu.Vladimirova)
p.000007:
p.000007: To develop a system for the ethical review of biomedical research, we have to consider the current social and economic
p.000007: situation in the Commonwealth of Independent Countries. A state can ensure reproduction of population and a high level
p.000007: of a living standard for its residents if it does not participate in regulation of the current demographic situation
p.000007: and labour market.
p.000007: The demographic situation in the CIS countries has both common and specific features. Common features
p.000007: result from a long-term socio- economic crisis of the 1990s, discrepancy between introduced reforms and
p.000007: social policy, a dramatic decline in living standards at various social levels, and aggravation of ecological
p.000007: conditions. Specific features in each State are determined by different styles of life in the CIS countries due to
p.000007: their historical, religious, cultural and ethnic development. All these factors resulted in a general fertility rate
p.000007: decrease, mortality growth and a fall of the health quality index. These processes affect negatively the demographic,
p.000007: labour and migration potential of the CIS countries.
p.000007: The last decade of the XX century was characterized by an essential aggravation of the demographic situation that could
p.000007: be defined as a crisis. High mortality rates had practically no precedents in the Eurasian peacetime history. The
p.000007: “excess mortality” in the period since 1989 was much higher than the mortality rate in the period of Great Depression
p.000007: in the North America (1929-1933). Besides, recent changes of mortality rate, marriage ability and fertility shifts have
p.000007: been no less sharp than those generally typical of the wartime. The increase of the mortality rate due to
p.000007: cardiovascular diseases, suicides, homicide, alcoholism et al. results from a drastic increase of the social stress,
p.000007: the typical feature of which is a painful response to new and unanticipated situations.
p.000007: The main causes of stress are impoverishment, unemployment, migration, divorces and family disruption,
p.000007: the death of relatives, the loss of hope and security, the fear of the future, the growth of criminal offence rate,
p.000007: conflicts at work and in the family. “The crisis of social adaptation” is
p.000007:
p.000008: 8
p.000008:
p.000009: 9
p.000009:
p.000009: aggravated by the collapse of political, social and economic structures and the change of moral values that had been
p.000009: guiding peoples’ life for decades. Thus, the collapse of a customary life style led to social hardships in addition to
p.000009: those relating to the difficult situation and socio-psychological stress. These social complications include a
p.000009: rapid deterioration of the healthcare system, degradation of the quality and narrowing of the range of
p.000009: public services, vague administrative legislation, drastic increase in crime, and social chaos. It is obvious
p.000009: that we should apply efforts to the reformation of the “sick” economics and weak social sphere. However, to
p.000009: raise the population’s quality of life and to maintain the level of labour resources for generations participating in
p.000009: the economic life, we need to retain the major achievements of the past in education, childcare, preventive and
p.000009: sanatorium- and-spa medicine.
p.000009: At present, the demographic crisis in the majority of the CIS countries still poses a threat to the social
p.000009: stability and to the whole process of reformation; however, there is a certain stabilization of the situation.
p.000009: Let us consider changes in resident population of the CIS countries and Turkmenistan in the period from 1991 to 2006.
p.000009: (Table 1).
p.000009: The presented data show the increase of population in Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan,
p.000009: Turkmenistan and Uzbekistan considering the change in the tendencies of population reproduction.
p.000009: The population in the CIS member-countries is about 5% of world population. The population density in
p.000009: the CIS countries varies from 6- 9 persons per sq. km in Kazakhstan, Russia and Turkmenistan to 126-129 persons in
p.000009: Armenia and Moldova. Thus, the average population density in the CIS countries is 13 persons per sq. km. For
p.000009: comparison: the population in the European Union (EU) makes 7% of world population, while the average density of
p.000009: population in the EU is 114 persons per sq. km. Over 66% of Belarus, Armenia, Ukraine, and 73% of Russia population are
p.000009: city residents. In the territory of the CIS there are 24 cities with the population over 1 million.
p.000009: Since 1990, the fertility rate in all the CIS countries has been decreasing. Moreover, in Ukraine (since 1991), in
p.000009: Russia (since 1992) and in Belarus (since 1993) a natural decrease of population was registered. Thus in Russia the
p.000009: number of deaths in 1993 exceeded the number of births by 800,000. That was the lowest fertility rate (9.4 of
p.000009: births per 1000 of population) among all the CIS countries.
p.000009:
p.000010: 10
p.000010:
p.000011: 11
p.000011:
p.000011: We should note that 1993 was one of the most hard years in the demography in the CIS countries, as the
p.000011: fertility rate decreased in all CIS countries (except Tajikistan). In comparison with 1986, when the highest fertility
p.000011: rate in the USSR for the last 50 years was registered, the fertility rate in 1993 in the CIS countries decreased by 33%
p.000011: (and by 8% in comparison with 1992, which is much enough in terms of annual oscillations) and was 13.5
p.000011: births per 1000 of population. The number of deaths in 1993 in the CIS countries was 3.6 million, and increased, in
p.000011: comparison with 1992, by 429,000. The general mortality rate increased by 14% and was 12.6 deaths per 1000 of
p.000011: population2.
p.000011: The growing share of elder people and a decreasing weight of children in the total population are typical for the
p.000011: majority of the CIS countries. This is connected with worldwide tendencies to population ageing and a drop in birth
p.000011: rate, as well as with the crisis at the end of the 20th century. In six of the CIS countries even the simple
p.000011: reproduction of population is not achieved,
p.000011: i.e. the total fertility rate (see below) is equal to or less than 2.1. These countries are Armenia,
p.000011: Belarus, Georgia, Moldova, Russia and Ukraine
p.000011: Belarus, Georgia, Russia and Ukraine are noted for the ratio of persons over 65 to the so called economically
p.000011: productive persons (at the age of 15-64), and Kyrgyz Republic, Tajikistan, Turkmenistan and Uzbekistan,
p.000011: where the age-dependency ratio is 2-3 times higher than in Belarus, Russia and Ukraine, stand out for that of children
p.000011: under 15.
p.000011: The greatest reduction of the able-bodied population in comparison with 1989 is observed in Georgia (by 20% for males
p.000011: and by 18% for females) and Ukraine (by 3,8% for males and by 4,9% for females). A significant increase of the
p.000011: able-bodied citizens (by 26-47%) is registered in Azerbaijan, Kyrgyzstan, Uzbekistan, Tajikistan and Turkmenistan
p.000011: The increase in the number of young people has a favorable effect on the increase of the total population, and the
p.000011: growing number of early marriages implies a perspective of a sooner birth of the first children and the increase of the
p.000011: total fertility rate.
p.000011: During last four years in the majority of the CIS countries no decrease of the fertility rate was registered. On
p.000011: the contrary, in 2003-2004 it has slightly increased. This process can be related to some stabilization
p.000011: in
p.000011:
p.000011: 2 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 23.
p.000011: social and economic situation in the CIS countries, as well as to the fact that people, born in the middle of 1980-s
p.000011: when the birth rate in Soviet Union was relatively high reached the fertility age.3
p.000011: At the beginning of 2005, the population size in the CIS countries was 279 million people (according to the Statistic
p.000011: Committee). In comparison with the beginning of 1991, the population has reduced by 2.7 million people or
p.000011: 1.0%.4
p.000011: By the type of demographic processes in the 90-s the CIS countries were divided into two groups. In the
p.000011: first group including Ukraine, Belarus, Russia, Kazakhstan, Moldova, Georgia and Armenia the population has
p.000011: been decreasing from year to year. The second group includes Azerbaijan and Republics of Central Asia where the
p.000011: population and the demographic potential kept on increasing. At the same time, as it was mentioned above, depopulation
p.000011: processes in Belarus, Russia and Ukraine are increasing, which means that the death rate exceeds the birth rate. This
p.000011: results in the increasing polarization of the two groups of CIS countries by the demographic potential, and hence
p.000011: creates, in prospect, additional preconditions for its redistribution between countries through migration processes.
p.000011: (Table 2).
p.000011: During last years in the majority of the CIS countries, the reduction of the fertility rate was not registered. On the
p.000011: contrary, in 2003-2004 it has somewhat increased. In Azerbaijan and Kazakhstan the increase is noticed in all age
p.000011: groups, in Belarus and Ukraine – at the age of 30 and older. At the same time, the highest fertility rate is still
p.000011: registered in women at the age of 20-24 (89-95 newborns per 1000 women of fertile age in Belarus, Georgia, Moldova,
p.000011: Russia and Ukraine, over 120 newborns – in Armenia, Azerbaijan and Kyrgyzstan, 143 – in Kazakhstan).
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 3 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000011: 2005, p. 26.
p.000011: 4 In the previous decade – in the 1980s – the population in former Soviet Republics, except for Baltic States,
p.000011: increased by 22.6 mln of people (8.7%).
p.000011:
p.000012: 12
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: The increase of the age-specific rates results in the increase of the total birth rate (the total birth rate is the sum
p.000013: of the age-specific fertility rates in the age range of 15-49 years; it shows the average number of children born by
p.000013: one women in her life if for every age the fertility rate remained the same as it was in the year for which the
p.000013: age-specific rates were calculated). The most significant increase of the fertility rate was in Kazakhstan where the
p.000013: total fertility rate in 2004 was 2,21 versus 2,03 in 2003. According to the recent data, the average value of this
p.000013: index in the CIS countries is 1,9 of births per one woman. The half of the population of the CIS lives in the countries
p.000013: where the simple reproduction of the population is not reached, i.e. this rate is below 2,1 (1,38 in Armenia (2004),
p.000013: 1,20 in Belarus (2004), 1,40 in Georgia (2003),
p.000013: 1,22 in Moldova (2003), 1,34 in Russia (2004), 1,20 in Ukraine (2003)).6 The problem of saving life and health
p.000013: of newborns is particularly
p.000013: important especially considering the long period of fertility decrease. In spite of a marked reduction of the
p.000013: infant mortality in all CIS countries in recent years, its level remains very high. The infant mortality rate in the
p.000013: CIS countries is much higher than that in the developed countries where its value is 3-5 deaths during the first year
p.000013: per 1000 newborns. (Table 3).
p.000013: About a half of dying infants falls to the share of the babies of the first year of life, nearly 70% of which die in
p.000013: the first week. The prenatal mortality rate in the CIS countries is fluctuating from 6 to 16 deaths at the age of 0-6
p.000013: days and still-borns per every 1000 of births. The causes of these deaths are respiratory states typical for the
p.000013: prenatal period, cases of the fetal asphyxia and asphyxia at birth.
p.000013: In many respects, a high death rate registered in the majority of the CIS countries over a long period can be
p.000013: explained, by the population ageing and by the decrease of the quality of life and health. At the same time, the number
p.000013: of births per 1000 population in the countries of the European Union is less (at the average 11,1) than in Azerbaijan
p.000013: (24,2), Kyrgyzstan (26,1), Tajikistan and Turkmenistan (33,1). However, in spite of the high population ageing rate,
p.000013: the number of deaths in the EU countries is lower (10,1) than in the CIS countries (12,6), which in it’s turn, may be
p.000013: explained by the level of preventive measures and healthcare in general, and by the social-economic situation in the
p.000013: CIS countries.
p.000013:
p.000013: 6 “Poverty, Children and Social Policy: The Way to a Brighter Future”. UNICEF. Regional Monitoring Report. Florence,
p.000013: 2005, p. 62“.
p.000013:
p.000014: 14
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: The natural increase of the population is the main source for advanced reproduction of labor resources at a certain
p.000015: territory. According to the data shown above, in the CIS countries two types of reproduction prevail that may by
p.000015: characterized as simple and reductive. If the simple population reproduction requires the numeral equality
p.000015: of the parent and children generation, the current level of survival rate (including the average life
p.000015: expectancy) requires 250-260 births per each 100 families. The birth rate corresponding to such a level is
p.000015: registered only in some CIS countries, such as Azerbaijan, Kyrgyzstan and Tajikistan. The functions of fertility
p.000015: and survival, as exogenous characteristics of the population reproduction, form its endogenous characteristics, i.e.
p.000015: age structure of population and also the measure of the population growth (net coefficient of population reproduction)
p.000015: and, hence, the actual level of the natality. The Russian Federation shows a tendency to a reductive
p.000015: reproduction of the population; however, in some years the increase due to the migration has compensated the natural
p.000015: decrease of the population, which is not so typical for Moldova, Belarus and Ukraine. Therefore, the total population
p.000015: size has not reduced. During the last five years the natural decrease of the population in the Russian
p.000015: Federation has prevailed over the increase due to the migration, which has decreased after 1994, and the total number
p.000015: of citizens began to decrease steadily.
p.000015: The population structure and the morbidity level characterize the general social-demographic situation in the
p.000015: CIS countries.
p.000015: Diseases of blood circulation system that are typical causes of death in elder people, take the leading role
p.000015: among the main causes of death. In 2003, the male mortality by this cause was 41% of deaths in Kyrgyzstan, 45% in
p.000015: Kazakhstan, 48-49% in Russia and Moldova, 50% and more in Azerbaijan, Armenia, Belarus and Ukraine. Female
p.000015: mortality from these diseases is somewhat higher – 55-61% of female deaths (in Ukraine – 72%). (pic. 1 and 2).
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000017: 17
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.006000: 6000
p.006000:
p.005000: 5000
p.005000:
p.004000: 4000
p.004000:
p.003000: 3000
p.003000:
p.002000: 2000
p.002000:
p.001000: 1000
p.001000:
p.000000: 0
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.001000: 1000
p.001000:
p.000800: 800
p.000800:
p.000600: 600
p.000600:
p.000400: 400
p.000400:
p.000200: 200
p.000200:
p.000000: 0
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000: Picture 1. Diseases of blood circulation system (per 100 000 of
p.000000: population)
p.000000: Malignant tumors (respiratory organs diseases – in Kyrgyzstan) are in the second place among female death causes.
p.000000: Malignant tumors as a death cause in men are in the second place in Azerbaijan (88 deaths per 100000 of
p.000000: population in 2003) and Armenia (160). The male mortality rate from suicides and other external causes in
p.000000: other countries is higher than the mortality rate from cancer. In 2004 this index in Belarus was 281 deaths from
p.000000: external causes10 per 100000 of population, which is slightly higher than the mortality rate from the
p.000000: malignant tumors (240); in Kazakhstan – 232 (142), in Kyrgyzstan – 110
p.000000: (64), in Moldova – 162 (158), in Russia – 390 (236), in Ukraine – 258
p.000000: (236). (Table 4).
p.000000: In Belarus, Kazakhstan and Russia the mortality rate for males from external causes is 4-5 times higher than that from
p.000000: diseases of respiratory and digestion organs. Nearly 40% of deaths by these causes falls to the share of working
p.000000: citizens.
p.000000: On the average, in recent 15 years (in comparison to 1989) the male mortality rate at the age of 15-64 has
p.000000: increased: in Belarus – by 41%, in Kazakhstan – by 46%, in Russia – by 70%, in Ukraine – by 46%. In Kyrgyzstan and
p.000000: Moldova the mortality rate of males at the age of 35-64 has been increased by 20% and 25% respectively.
p.000000: The female mortality rate in women of working age is somewhat lower than that for men, but the scale
p.000000: of its increase is the same. Thus in the indicated period the mortality rate for females in the age
p.000000: 15-64 has increased in Kazakhstan by 32%, in Russia – by 62%, in Belarus and Kyrgyzstan (for the age of 30-64) – by 30%
p.000000: and 14% respectively, and in Ukraine (for the age of 20-64) – by 42%.
p.000000:
p.000000:
p.000000: 2000. 2004 (Georgia – 2003).
p.000000:
p.000000:
p.000000:
p.000000:
p.000000: Picture 2. Mortality from diseases of blood circulation system (per 100 000 of population)
p.000000: The most comprehensive index of the population health and of the labor resources is the life expectancy.
p.000000: Since the beginning of the transition period, it has decreased in the majority of the countries. (Table 5).
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000000:
p.000018: 18
p.000018:
p.000019: 19
p.000019:
p.000019:
p.000019: Mortality by main groups of death causes in 2004
p.000019: Table 4
p.000019: Table 5
p.000019: Life expectancy in people of certain age1) in several CIS countries
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: 1) 2003.
p.000019: 2) 2000.
p.000019: 3) From neoplasm. 4) 1995.
p.000019: 5) 2001.
p.000019:
p.000019:
p.000019:
p.000019: 1) Life expectancy is the average number of additional years a person could expect to live if current mortality trends
p.000019: were to continue for the rest of that person’s life.
p.000019:
p.000020: 20
p.000020:
p.000021: 21
p.000021:
p.000021: The significant increase of the total mortality rate and the decrease of the life expectancy at birth, as shown above,
p.000021: affected different age and sex groups with different intensity. First, the increase of mortality concerned males more
p.000021: than females. This growing disparity resulted in the increase of the number of incomplete families and widows,
p.000021: aggravation of the existing disbalance (as will be shown below) in the sex structure, reduction of
p.000021: nuptiality and population reproduction potential, and in a growing difference of the lifespan between the sexes. In
p.000021: spite of substantiated expectations, the high mortality rate in the period of transition at the early nineteenth did
p.000021: not affect seriously those population groups that usually are considered as particularly vulnerable due to biological
p.000021: or social causes, namely children and elder people. Perhaps the most remarkable feature of this recent population
p.000021: health crisis became a significant increase of the mortality rate for age groups of gainfully employed population. The
p.000021: most drastic relative growth of the mortality rate for adult males was registered in the group of “blooming age” i.e.
p.000021: at the age of 35-49, which is most typical for Russia. As to females, the mortality changes had unequal intensity, and
p.000021: the increase of mortality here was less marked, but it affected exactly the “blooming” age group from 35 to 49 years.
p.000021: As we know, the population reproduction depends mostly on two factors: firstly – on the ratio of marriages and
p.000021: divorces; secondly – on the ratio between males and females at the fertile age. As to the first factor, in
p.000021: the conditions of the increasing youth unemployment, rapidly growing prices housing costs and uncertain prospects, the
p.000021: nuptial ratio has decreased in all nine countries from 4% (Azerbaijan) to 34% (Russian Federation). The decrease of the
p.000021: nuptial ratio for persons in the second marriage in all countries was even sharper. An average decrease of this index
p.000021: was 28%; only in Ukraine the increase of the nuptial ratio was registered, but in 1993 the fertility in this country
p.000021: has decreased dramatically (by 20%), and hence the hopes associated with the nuptial ratio were not justified. In
p.000021: contrast to the number of marriages the number of the divorces was growing. The second factor is also unfavorable. The
p.000021: female population exceeds male population, and this ratio becomes worse with every new age group.
p.000021: Thus, the marriage/divorce ratio, as well as male/female ratio determines negative tendencies in demographic
p.000021: situation in the CIS countries. The mentioned ratios have a negative impact on the generation renewal,
p.000021: and retain conditions for a narrow reproduction.
p.000021: When considering the situation we should note that the most dramatic aggravation was observed in the areas of the
p.000021: income per person, poverty, demography and social unity, which is essential for understanding social- economic
p.000021: conditions of the healthcare system development, and the motivation of the CIS countries for integrating
p.000021: into the international system of biomedical research both from a viewpoint of interested researchers and potential
p.000021: participants.
p.000021: In the period of transition to the market economics all the CIS countries had to face such problems as considerable
p.000021: inequity in the income distribution, stratification of the society by income and increasing poverty. In 2004, the ratio
p.000021: of the total income of 10% of the most and 10% of the least well-to- do population was 3-5 times in Azerbaijan, Belarus
p.000021: and Ukraine; 11 times in Kazakhstan, Kyrgyzstan, Moldova, Russia and Tajikistan; 21 times in Armenia.
p.000021: In recent years (2005-2007), in the majority of the CIS countries some smoothing of the society stratification by
p.000021: income and the decrease of the population quota with the income beyond the cost of living (poverty line) was observed.
p.000021: Some processes were observed in the CIS countries that were not typical before. Thus, the number of the “poor” children
p.000021: usually was growing much faster than the number of poor persons in every other age group because of the rapid spread of
p.000021: the unemployment and increasing number of persons in a low-paid job, alongside with a disproportional indexation of the
p.000021: family allowances. The level of food consumption by children has considerably decreased. Presently, the change
p.000021: in the nutrition structure is expressed by transition to food products that are less expensive and richer in
p.000021: calories. There is a lack of food products that are necessary for the normal growth and development of the organism.
p.000021: Besides, a decrease in food consumption and the worsening of the sanitary situation, hygiene and living conditions have
p.000021: caused the increase of the number of diseases (tuberculosis, rachitis) traditionally associated with poverty.
p.000021: Specific features of the demographic situation and, indirectly, the amount of labor resources depend also on
p.000021: the age groups prevailing in the total population size, which, in its turn, implies special approaches to the
p.000021: healthcare structure development in the CIS countries. The increase of
p.000021:
p.000022: 22
p.000022:
p.000023: 23
p.000023:
p.000023: the elder population and the decrease of the share of children in the total population are typical for the majority of
p.000023: the CIS countries.
p.000023: In fact, during the period from 1989 to 2004 in all the CIS countries the part of population under working age
p.000023: decreased. This especially concerns the age group under four. The part of working population did not decrease due to
p.000023: the generation born in the period from the late 70s to the mid-80s (time interval characterized as a period of the
p.000023: highest fertility rate). At the same time, on the average, the part of the population over working age has increased,
p.000023: which, as shown above, alongside with the decrease of fertility and, consequently, the decrease of the population under
p.000023: the working age, can lead to the population ageing and the decrease of the population initiative and economic activity.
p.000023: The number of children under 16 in the CIS countries is nearly 80 millions. Compared with 1989, the
p.000023: part of children under 16 in the total population size of the CIS countries decreased by 11%. The youngest is
p.000023: the population of Azerbaijan and Armenia where children make 35 and 29% of the population. In the countries of
p.000023: Central Asia, due to a relatively high fertility, children make on the average 39-45% of the total population. If we
p.000023: consider the demographic situation in the Russian Federation, particularly with regard to children, it should be noted
p.000023: that during the 90-s the number of births was by 60 millions less than in the 80-s. In recent decade, the children’s
p.000023: morbidity has increased dramatically. The most disturbing is the fact of the mental health worsening, since in recent
p.000023: ten years the rate of mental diseases in children doubled, that of moronity increased in 1.5 times and imbecility in
p.000023: 1.6 times. We have to recognize the growing number of disabled children; in the CIS countries there are about 1.5
p.000023: million disabled children. Undoubtedly, this situation requires urgent measures aiming to provide preventive care to
p.000023: future mothers and to ensure a compulsory free medical care. Unfortunately, statistic data show the opposite. During
p.000023: the last five years, the CIS countries have a tendency of reducing the number of hospital beds for children. This is
p.000023: typical for the majority of the CIS countries, but the most complicated situation is observed in Kazakhstan,
p.000023: Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Besides, the number of doctors and other medical
p.000023: professionals is decreasing. Non-involvement in any social associations and the lack of meaningful occupation for
p.000023: children are also contributing to the growth of teenagers belonging to a “risk-group”.
p.000023: The spread of drug addiction, drug abuse and alcoholism among children is becoming a serious problem. In
p.000023: recent 10 years the morbidity level due to these causes has became 10, and in several regions even 14, times higher.
p.000023: Consequently, there is a serious threat of HIV in teenagers. In the CIS countries nearly 150 000 children are drug
p.000023: addicts. Every five years the amount of drug addicts in the “youngest” group is increasing by 100%. The children
p.000023: morbidity with venereal diseases is also connected with the above-mentioned phenomena. According to the data provided
p.000023: by Russian physicians, the syphilis morbidity rate in the group of 15-17 year females exceeded the level of 1990 by a
p.000023: factor of 68.
p.000023: To sum up, we may state that the beginning of the period of reforms, accompanied by a drastic fertility decrease and a
p.000023: dramatic mortality increase, civil wars and interregional armed conflicts was marked with a significant fall of the
p.000023: population size in all CIS countries. Today, due to the strengthening of the national state system in the independent
p.000023: states and stabilization of their economic situation, the CIS countries may be divided into two main groups. The first
p.000023: group includes countries in which the fertility rate indicates the possibility for the simple reproduction of the
p.000023: population, and where in the case of an essential improvement of the economic situation the extended reproduction may
p.000023: be expected (Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan). In the countries of the second
p.000023: group the process of the natural population loss takes place due to the various reasons (Armenia, Belarus, Georgia,
p.000023: Moldova, Russia, Ukraine).
p.000023: To summarize the analysis of the demographic situation, it is necessary to note that with regard to self-preservation
p.000023: the following public processes are crucial:
p.000023: - depopulation of the nation through the decrease of the average lifespan, increasing total mortality and
p.000023: mortality in able-bodied population, “rejuvenation” of some diseases, spread of alcoholism and drug addiction;
p.000023: - the change in consumption of genetically habitual food products, decrease in food calorie content for the
p.000023: considerable part of the society;
p.000023: - reduced access to social services in conditions of a large-scale commercialization, which negatively
p.000023: affects the quality of human resources, intellectual, scientific and physical potential of the country;
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000025: 25
p.000025:
p.000025: - the decreasing number of medical institutions; a level of the population morbidity and mortality still remains
p.000025: high; the number of handicapped people is increasing;
p.000025: - stratification of the society by income, when 10% of the most well- to-do population have incomes more than 10 times
p.000025: higher than 10% of the least successful people;
p.000025: - increasing severity of indigence and poverty, both absolute and relative. There is a formation of a stratum
p.000025: of the “nouveau paupers” among economically active able-body population, which, in its turn, leads to a
p.000025: noticeable decrease of the motivation for efficient work;
p.000025: - situation with unemployment and physical survival of the unemployed is getting more and more complicated, and
p.000025: the period of long-term unemployment is increasing;
p.000025: - low efficiency of target social assistance; (International Labour Organisation – ILO, evaluates the
p.000025: efficiency of social assistance programs by weight of amounts received by families beyond the poverty line in total
p.000025: amounts of social support).
p.000025: 1.2 Ethical and Legal Issues
p.000025: in the Field of Biology and Medicine (o.I.Kubar, B.G.Yudin, A.E.nikitina, E.Yu.Vladimirova)
p.000025:
p.000025: Characterizing trends of legal and ethical control in the sphere of practical health care and biomedical
p.000025: research in the CIS member states it is necessary to emphasize a multilevel system of factors determining common
p.000025: pattern of directions, characteristics, features and mechanisms of national and international, retrospective and
p.000025: perspective influence. A rationale for forming of the given community is geographical closeness, unity of political
p.000025: history of the pre-Soviet and Soviet periods, contingency and interpenetration of cultures and traditions, forming
p.000025: extreme ethnical, cultural and religious multiplicity making countries in the region different.
p.000025: By itself such multiplicity leads, in particular, to the following - the set of actual ethical norms being a basis for
p.000025: medical care in the region countries is a historical foundation and a clear reflection of tolerance concepts both to
p.000025: cultural differences as they are and to their particular carriers. Moreover, in this case we can talk not just about
p.000025: tolerance but also about respectful relationship to differences of that kind.
p.000025: One more factor, which should be taken into account when explaining closeness of ethical and legal basis of health
p.000025: care, is that other countries in the region inherited legal base that was established in the Soviet period of their
p.000025: history. It should be noted that the legal system existing in the USSR in the field of medicine and health care,
p.000025: first, was of declarative nature, and, second, paid insufficient attention to issues of protection of rights and
p.000025: dignity of both patients and participants of biomedical research.
p.000025: Therefore, after the USSR breakup and appearance of new independent states they faced tasks of development of new legal
p.000025: framework in the field of practical and experimental biomedicine. All CIS countries in different forms proclaimed such
p.000025: basic norms of state development as adherence to principles of a social state, which policy is directed for creation of
p.000025: conditions providing dignified life and free development of a man, acknowledgement of a person, his rights and freedoms
p.000025: as top values, while compliance with and protection of human and citizen rights and freedoms is a state obligation. In
p.000025: accordance with these principles reflecting statements of both the Universal Declaration
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000027: 27
p.000027:
p.000027: of Human Rights adopted by UN in 1948 and other international documents in this field, the legal framework of the CIS
p.000027: countries started to be formed. Certainly, today far from all provisions and principles are actually
p.000027: implemented into the practice of health care and biomedical research; the same should be noted about more specific
p.000027: enactments being directly related to the given sphere. They are more of being a kind of beacons that one
p.000027: should focus on either developing legal and ethical norms and on their daily
p.000027: implementation than as an actual measurement of achievements.
p.000027: Thus, determining approaches to analysis of trends and tendencies in building up a system for legal and ethical
p.000027: regulation in the sphere of practical health care and biomedical researches in the CIS countries the following most
p.000027: important factors shall be distinguished:
p.000027: 1. Historical community based on socio-cultural and economic inheritance being present among the
p.000027: Commonwealth countries;
p.000027: 2. Global international interaction;
p.000027: 3. Realia of regional cooperation among the member states.
p.000027: Among elements defining starting positions of new concept development for ethical and legal regulation in the
p.000027: CIS countries as carriers of the historical community, first of all, it is necessary to note a common health care
...
p.000029: simply no time to highlight medical deontology issues.
p.000029: A very important factor determining particularities and complexity of relationship development during a research
p.000029: process was characteristic for the entire medical community in the USSR paternalistic attitude among doctors
p.000029: and patients, peculiar standoff of health care professions (no public discussion on problems and errors, corporate
p.000029: spirit of medical workers) and strict vertical pattern of administration resulting in dependence of actions and making
p.000029: decisions.
p.000029: The common features being found at appearance and development of bioethics in the region are worth of specific
p.000029: attention. For a long time the region countries were out of global international dialogue on bioethics issues,
p.000029: therefore, they despite of their particular experience and specific approach to ethical issues in health care
p.000029: were not represented in the international bioethical society at a long run. Such isolation brought forth
p.000029: several considerable consequences: relatively poor development of major bioethical potential in the CIS countries and
p.000029: deficiency of capabilities for maintaining direct contacts with members of international bioethical community,
p.000029: in particular, due to limited knowledge of foreign languages for professional use and insufficient acquaintance with
p.000029: basic foreign publications.
p.000029: At the same time, within the community of the CIS countries there is a unique opportunity for international
p.000029: communication since not only majority of citizens but also specialists use a single instrument for communication, the
p.000029: Russian language. Development of bioethics in the CIS countries started about 20 years ago; one of the strongest
p.000029: impulses emerged after the first contacts of Soviet philosophers and medical researchers with their foreign colleagues
p.000029: at the end of the 1980’s. After the USSR break-up bioethics in the region developed in different conditions but, at
p.000029: that, there were present both stable cultural peculiarity and links among the region countries. The most important
p.000029: instrument influencing rates and pattern of the bioethics development is creation of special national facilities
p.000029: that having different structure and functions in some cases are entitled to adopt and implement mandatory decisions
p.000029: in the field of bioethics. Besides, all CIS countries have more or less main and similar resources for dynamic
p.000029: development of
p.000029: bioethics, and among them – teaching bioethics as a subject (mandatory or optional) in medical colleges and
p.000029: universities as well as at departments of philosophy in some of state universities; definite (though, in
p.000029: general, far from being sufficient) interest to ethical issues from the side of those working on legislation in the
p.000029: field of science and health care; development of corporate ethics and national associations on ethics;
p.000029: stimulating influence of research ethics; wider public interest to the bioethics issues being discussed in mass media.
p.000029: Besides factors of general social and economic development influencing peculiarity and unity of the situation in
p.000029: this sphere, global impact was provided by common cultural and educational environment based on both
p.000029: advanced humanistic traditions of medicine and on capabilities for interaction and mutual influence of
p.000029: different cultures in the given territorial and historical space. Such specifics exist despite considerable cultural
p.000029: and religious differences between populations of European and Central-Asian countries of CIS. In particular, it
p.000029: is necessary to mention influence of religious traditions in the Commonwealth countries on forming of bioethics
p.000029: models currently acting there as well as models of research ethics. Likeness in perception of moral and cultural values
p.000029: is built on the fact that among population of the CIS countries (mostly it is related to the Russian population) one
p.000029: can meet representatives of virtually all ethnical, religious and cultural groups existing in the region in general. It
p.000029: means that multiplicity that can be observed within the CIS countries to some extent repeats multiplicity of population
p.000029: of separate countries that is especially characteristic for scientific and medical creative environment formed during
p.000029: many years.
p.000029: It is really hard to overestimate a role, which is played by the factor of involvement of all Commonwealth
p.000029: countries in the process of global international interaction, for creation of single approaches to collaboration
p.000029: in ethical and legal sphere. It is related both to incorporation by the new independent states into their legal systems
p.000029: of a set of international ethical and legal acts which they joined to during existence of a single country, the USSR,
p.000029: and to modern involvement of the CIS countries into international legal and informational environment. It appears to be
p.000029: of tremendous importance that officially each of the countries declared adherence to all major norms and principles
p.000029: stipulated by such international and legal documents as the Nuremberg Code of 1947, the Declaration of Helsinki of the
p.000029: World Medical
p.000029:
p.000030: 30
p.000030:
p.000031: 31
p.000031:
p.000031: Association (WMA) of 1964 with amendments, International Ethical Guidelines for Biomedical Research Involving
p.000031: Human Subjects developed by CIOMS and WHO in 1982 and amended in 1993 and 2000, International Guidelines for Ethical
p.000031: Review of Epidemiological Studies, CIOMS, 1991, Guidelines for Good Clinical Practice (ICH GCP), 1996;
p.000031: Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO, 2000) with additional document
p.000031: of 2002, Convention for the Protection of Human Rights and Dignity with Regard to the Application of
p.000031: Biology and Medicine: Convention of Human Rights and Biomedicine (Council of Europe, 1997) and adopted in addition
p.000031: thereof Additional Protocols including the Protocol on Biomedical Research, Universal Declaration on Bioethics and
p.000031: Human Rights (UNESCO, 2005), Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), International
p.000031: Declaration on Human Genetic Data (UNESCO, 2003) and a number of other documents which current total list includes
p.000031: more than 150 publications. Regretfully, among six CIS countries being current members of the Council of Europe such
p.000031: basic document as the Convention on Human Rights and Biomedicine are currently signed only by three – Georgia, Moldova,
p.000031: Ukraine; and it is only Georgia that actually ratified it. At the same time, acknowledgement of high authority of the
p.000031: Convention in this or that form is generally common for virtually entire bioethical community in all CIS countries.
p.000031: The international enactments mentioned above became a basis for legal regulation of biomedical research and
p.000031: their ethical review in all CIS countries (detailed analysis of legal participation of a particular country in any of
p.000031: international documents – recommendation influence, ratification, adaptation to national legislation, etc. –
p.000031: is presented in our book in corresponding chapter for each specific state). A crucial issue emphasizing profound
p.000031: importance of international documents regulating this sphere is a fact of priority of international law
p.000031: approved by all Commonwealth countries. International cooperation in the field of bioethics is implemented also
p.000031: through formation of regional programs and Centres of bioethics and research ethics with involvement of
p.000031: international organizations being leaders in this field. A convincing example of such cooperation is a setup of
p.000031: national committees of bioethics with UNESCO support in some of the Commonwealth countries and planned scientific and
p.000031: educational activities of the UNESCO office in Moscow and some other countries in the region
p.000031: being held in context of national, social and cultural, historical and political traditions and utilization of the
p.000031: world experience in the field of bioethics.
p.000031: In 2001 animportant bioethical resource, the Forumfor Ethics Committees in the CIS (FECCIS), was established in the
p.000031: region. The FECCIS is one of five regional forums created within the framework of the WHO project, the Strategic
p.000031: Initiative for Developing Capacity in Ethical Review (SIDCER). Sharing main priorities of the WHO SIDCER project on
p.000031: protection of the rights and dignity of research subjects in all countries in the world basing on respect to cultural,
p.000031: religious and national differences the FECCIS seeks the main task of facilitating development of bioethics in the
p.000031: region of the CIS countries, paying specific attention to ethics of biomedical research involving human
p.000031: subjects. During all its years of existence (2001–2007) the Forum activities were directed on development of regulatory
p.000031: and methodical basis on research ethics; development and implementation of education programs for members of
p.000031: ethical committees; development of information space and extensive dialogue with various parties involved in ethical
p.000031: review of biomedical research that, certainly, facilitated harmonization of both regional and global
p.000031: international approaches to establishment of ethical standards in biology and medicine. Besides, notable value for
p.000031: adaptation and improvement of universal ethical principles has the representation of some of the CIS countries in
p.000031: several international entities, for instance, such highly respected agency as the Council of Europe, in particular, in
p.000031: the structure of the Steering Committee on Bioethics (CDBI) responsible for development of multiple documents, mainly,
p.000031: the legal ones, on protection of rights and dignity of human subjects in research and medical care.
p.000031: Consolidation of efforts and mutually enriching knowledge exchange take place also at the stage of regional or
p.000031: bilateral cooperation with international facilities and leading world specialists in the field of ethics through
p.000031: trainings, joint researches and discussions.
p.000031: Another priority component with considerable contribution in forming
p.000031: of ethical and legal unity in medical care is trends and mechanisms based on
p.000031: realia of regional cooperation of the CIS member states.
p.000031: Due to international and regional legal collaboration the constitutional regulation of a legal status of a
p.000031: person in the Commonwealth countries is adjusted to international standards creating legal opportunities
p.000031: for implementing such important ethical principles of biomedical research as
p.000031:
p.000032: 32
p.000032:
p.000033: 33
p.000033:
p.000033: respect to autonomy and individual dignity of a patient/subject as well as a principle of justice.
p.000033: Majority of constitutions of the CIS countries proclaim a person as a basic value (Art. 4, Constitution of Armenia;
p.000033: Art. 13, Constitution of Azerbaijan; Art. 2, Constitution of Belarus, Art. 3, Constitution of the Ukraine, Art. 2,
p.000033: Constitution of Russia; P.1, Art. 36, Constitution of Moldova, etc.). Free development of a person is
p.000033: protected by law and independent court. Person dignity is acknowledged as a special value to be protected by the state
p.000033: in all Commonwealth countries. All constitutions of the CIS countries contain prohibition for medical, scientific
p.000033: or other experiments involving human subjects without their voluntary consent9. Guarantees of respect for personal
p.000033: autonomy are provided in the Commonwealth countries with constitutional statements declaring the right for everyone on
p.000033: personal security (in some countries physical and moral constituents of the security are indicated10), the right on
p.000033: personal and family secrets, the right for everyone for confidentiality of correspondence, phone communications, mail,
p.000033: telegraph messages and information transmitted via other communication means (these rights can be limited only as
p.000033: stipulated by law, usually, for prevention of crimes or finding out truth during criminal investigations or as a
p.000033: punishment for committed crimes). It is prohibited to collect, store, use and distribute information about
p.000033: individual life without such person’s consent. Statements presented in constitutions of all CIS countries
p.000033: guaranteeing equality of all persons
p.000033: – independently of gender, race, nationality, language, origin, property and position, place of residence,
p.000033: denomination, political and religious beliefs, assignment to public unions as well as other circumstances – are of
p.000033: tremendous value for acknowledgement and compliance with the principle of justice in biomedical research. At that, the
p.000033: state becomes a guarantor for protection of personal rights and freedoms. Other directions of the state
p.000033: policy in social sphere are also extremely important for provision of human rights in the area of health care and
p.000033: biomedical research.
p.000033: 9 The Constitution of Kyrgyz Republic also mentions psychological tests in this list (Art.18 of the Constitution of
p.000033: Kyrgyz Republic). Since there is almost no special legal regulations within the regions of the CIS countries for such
p.000033: sphere of biomedical research as psychological studies this fact has a special value. Such constitutional statement can
p.000033: become a basis for independent regulation of the given type of experiments.
p.000033: 10 Art. 16 and Art. 24 of the Constitutions of Kyrgyz Republic and the Republic of Moldova, respectively.
p.000033: The right for protection of health and its state support are legally fixed in all Commonwealth countries (Art. 34 of
p.000033: the Constitution of the Republic of Armenia, Art. 41 of the Constitution of the Republic of Azerbaijan, Art. 45 of the
p.000033: Constitution of the Republic of Belarus, Art. 37 of the Constitution of Georgia, Art. 29 of the Constitution of the
p.000033: Republic of Kazakhstan, Art. 34 of the Constitution of the Kyrgyz Republic, Art. 36 of the Constitution of the
p.000033: Republic of Moldova, Art. 41 of the Constitution of the Russian Federation, Art. 38 of the Constitution of the
p.000033: Republic of Tajikistan, Art. 49 of the Constitution of the Republic of the Ukraine, Art. 40 of the Constitution of the
p.000033: Republic of Uzbekistan).
p.000033: Majority of the CIS countries also declared in their constitutions the right for medical care in different forms
p.000033: (excluding three republics – Armenia, Azerbaijan and Uzbekistan: in these states guarantees of availability of
p.000033: health care for people are set at the level of branch laws regulating public relationships in the health care system).
p.000033: At the same time one should note that the issue of underfunding in regard to required amount of medical care today is
p.000033: still one of the most acute problems almost in all countries of the Commonwealth.
p.000033: States implement programs on population health protection, measures for environmental protection and provision of
p.000033: free access to reliable information on its status, living and working conditions, quality of food products
p.000033: and household goods, facilitate development of physical culture and sports, create opportunities for various
p.000033: forms of health insurance. Financial support is guaranteed to pregnant women11, mothers with small children and in
p.000033: case of children with disabilities – until they become older
p.000033: – to families with many children, persons with various diseases and drug abuse. The state provides special care
p.000033: for those who broke their health protecting state and common interests. An important issue is inclusion into the
p.000033: sphere of state policy and legal regulation of an issue of preservation of national gene pool.
p.000033: It is truly important that virtually all CIS countries adopted branch laws related to issues of health care and patient
p.000033: rights – the Law of the Republic of Armenia On Medical Care and on Services for Population (1996), the Law of the
p.000033: Republic of Azerbaijan On Protection of Population Health (26.07.1997),
p.000033: 11 Art. 16 and Art. 24 of the Constitutions of the Kyrgyz Republic and the Republic of Moldova,
p.000033: respectively.
p.000033:
p.000034: 34
p.000034:
p.000035: 35
p.000035:
p.000035: the Law of the Republic of Belarus On Health Care (1999), the Law of Georgia On Health Care (1997), the
p.000035: Law of the Republic of Kazakhstan On Protection of Population Health of the Republic of Kazakhstan (1991), the Law of
p.000035: the Kyrgyz Republic On Protection of Population Health of the Kyrgyz Republic (09.01.2005), the Law of the
p.000035: Republic of Moldova On Rights and Responsibility of Patient (27.10.2005), Basics of the Law of the Russian Federation
p.000035: On Protection of Citizen Health (22.07.1993), the Law of the Republic of Tajikistan On Protection of Population Health
p.000035: (15.05.1997), Basics of the Law of the Ukraine On Health Care (1992), the Law of the Republic of Uzbekistan On
p.000035: Protection of Citizen Health (29.08.1996). Legislation specifically related to protection of especially vulnerable
p.000035: groups of patients and subjects is of particular importance for regulation of biomedical activities including valuation
p.000035: of biomedical research. Virtually all countries adopted separate laws on psychiatric assistance to population,
p.000035: counteraction to HIV infection, donorship, transplantation, protection of children rights. These enactments reflect
p.000035: specificity of institutions of informed consent and patient confidentiality in some situations of biomedical int
p.000035: rventions as well as stipulate additional guarantees of rights of dependent groups of patients/ subjects. In many CIS
p.000035: countries laws and by-laws regulate various issues in the area of auxiliary methods of reproduction and genetic
p.000035: assistance to the population12. Two countries (the Russian Federation and the Ukraine)
p.000035: 12 For instance, in the Republic of Armenia – the Law of the Republic of Armenia On Reproductive Health
p.000035: and Reproductive Rights of Person, 12 of September 2002, in the Republic of Belarus – the Law of the
p.000035: Republic of Belarus On Safety of Gene Engineering Activities, 9 of January 2006, in the Republic of Kazakhstan – the
p.000035: Law of the Republic of Kazakhstan, 16 of July , 2004, N 565-2 On Reproductive Rights of Citizens and Guarantees of
p.000035: Implementation Thereof, in the Kyrgyz Republic – the Law of the Kyrgyz Republic, 20 of December 1999, On Reproductive
p.000035: Rights of Citizens, in the Russian Federation – the Order of the Ministry of Health of the Russian Federation. 26 of
p.000035: February 2003, N 67 On Utilization of Assisting Reproductive Technologies (ART) for Treatment of Female and Male
p.000035: Infertility, the Federal Law, 5 of July 1996, N 86-FZ On State Regulation in the Field of Gene-Engineering Activities,
p.000035: the Order of the Ministry of Health of the Russian Federation, 30 of December 1993, N 316 On Further Development of the
p.000035: Medical and Genetic Service of the Ministry of Health of the Russian Federation, in the Republic of Tajikistan – the
p.000035: Law of the Republic of Tajikistan, 2 of December 2002, No.72 On Reproductive Health and Reproductive Rights, the Order
p.000035: of the Ministry of Health of the Republic of Tajikistan No.974, 1 of October 1985, On Measures for Further Development
p.000035: of Medical and Genetic Assistance to the Population, in the Ukraine – the Joint Order of the Ministry of Health Care
p.000035: and Academy of Medical
p.000035: adopted laws prohibiting human cloning. At the same time, a range of actual issues related to specifics of genetic
p.000035: studies, experiments on embryos and utilization of embryo and fetal tissues for medical purposes, of psychological and
p.000035: sociological studies still require legal solutions.
p.000035: In general, one should note that among all other types of biomedical testing at the CIS space only clinical studies of
p.000035: medicinal substances underwent more consistent legal regulation13. All countries have special laws regulating public
...
p.000037: their patients, with third party persons and to intracorporate relations.
p.000037: Analyzing trends in development of ethical and legal control of biomedical activities in the Commonwealth
p.000037: countries one cannot but mention influence of religious tradition on this process. For instance, in some
p.000037: of the Central Middle Asia countries daily practice of medical workers and researchers to a large extent is based on
p.000037: norms of the Koran, Shariat, Hadises. An important role as a guideline for national policy formation in the field of
p.000037: ethical examination development of biomedical studies as well as for protection of the rights of patients and study
p.000037: subjects is played by the Code of Islam medical ethics. Countries with prevailing Orthodox religious tradition showed
p.000037: that a significant role for ethical consideration of medical science and practices is dedicated to Basics of the Social
p.000037: Concept of the Russian Orthodox Church (2000) containing official position on many of the most arguable bioethical
p.000037: issues.
p.000037: 15 For instance, The Code of Medical Ethics of Armenia, The Ethical Code of Medical Doctor of Georgia, The Ethical
p.000037: Code of Pharmacists of the Kyrgyz Republic, The Ethical Code of Nurse of Russia, The Oath of Medical Doctor of Russia,
p.000037: The Medical Ethics Code of Russia. In Uzbekistan the code on bioethics issues is under development, in Kazakhstan they
p.000037: started to develop The Code on National Health and the Health Care System, in 2007 it is planned to adopt The Ethical
p.000037: Code of Medical Doctor of the Republic of Kazakhstan.
p.000037: Features mentioned above illustrating specific properties of legal and ethical regulation are, mostly, in accord
p.000037: with general direction in legal development of the Commonwealth countries as socially-oriented states.
p.000037: Considering a social state as the most beneficial way for combination of fundamentals of freedom and power for
p.000037: provision of personal well-being and social wealth there is a real possibility for reaching social justice and
p.000037: solidarity. Translating the given point at the language of conflicts of interests that appear at the pace of scientific
p.000037: and technological progress in any sphere of human activities (including biology and medicine), one can notice
p.000037: crystallization of the main advantage of a social state being acknowledgement of the role of ethics for resolution of
p.000037: conflicts and interpretation of ethical principles as state control mechanisms.
p.000037: However, it is worth stressing that in order to protect social rights of citizens only legal mechanisms and procedures
p.000037: for prevention of breaching of these rights are far from being sufficient. Along with aforementioned versatile
p.000037: state activities aimed on development of conditions for execution of these rights and freedoms as well as readiness of
p.000037: society for their conscious perception and compliance are required.
p.000037: This process takes prolonged gradual movement on development of a complex mechanism for protection of
p.000037: human rights and constitutes of legal, administrative, economic and humanitarian means. Such objective is
p.000037: implemented in the most consistent fashion by the Inter-Parliamentary Assembly of the Commonwealth of Independent
p.000037: States, which as one of the main objectives takes development of mechanisms for interstate regulation of respect for
p.000037: human rights in the region. IPA CIS as an agency for inter- parliamentary cooperation accumulates information on
p.000037: political, economic, social and cultural, ecological, demographic and other constituents of life of the Commonwealth
p.000037: countries that provides effectiveness, timeliness and demand for produced recommendations on harmonization and
p.000037: convergence of legislation of the CIS countries. Activity of IPA CIS in this respect is versatile and includes a range
p.000037: of spheres and areas determined with specifics and competence of permanent commissions such as commission on social
p.000037: policy and human rights, on legal issues, on science and education, on foreign policy issues, on defense
p.000037: and security, etc. In 1998 the Council of IPA CIS as the higher leading authority of the Assembly approved the
p.000037: declaration that emphasized solidarity of national parliaments with ideology
p.000037:
p.000038: 38
p.000038:
p.000039: 39
p.000039:
p.000039: of the Universal Declaration of Human Rights and stressed that since the moment of its proclamation the field of human
p.000039: rights exhibited considerable progress in general and that efforts in the field of human rights undertaken within CIS
p.000039: are also directed on provision of common respect for them, facilitation of strengthening of atmosphere of
p.000039: friendship and trust, effective implementation of multi-party agreements where a special place is given to the CIS
p.000039: Convention on Human Rights and Fundamental Freedoms adopted in Minsk in 1995.
p.000039: Criminal, penal procedure and penal enforcement model codes adopted by IPA CIS being a basis for development of similar
p.000039: codes in some of the Commonwealth countries should be considered as norms of general type establishing crucial
p.000039: requirements to an order of legal act execution in regard to main freedoms and rights of citizens in the Commonwealth
p.000039: countries. Statements of the given model codes were also reflected in initiation and creation of many legislator
p.000039: enactments in the CIS countries in the field of criminal law and criminal procedures. The model civil code adopted by
p.000039: IPA CIS has special values for establishing of new conditions for administration and management in all spheres of
p.000039: activities and its main statements were to some extent practically embodied in civil legislation of all CIS countries.
p.000039: Activity of the Permanent Commission on social policy and human rights of IPA CIS has a special value from the
p.000039: point of harmonizing influence on the health care field. After initiatives of the said commission model laws
p.000039: determining main statements for a complex welfare system were adopted, a list of international conventions recommended
p.000039: for immediate ratification by the CIS countries was developed, a set of model laws on rights of human beings related to
p.000039: category of vulnerable population groups was approved, such as a law On Basic Children Rights and On Additional
p.000039: Guarantees to Child-Orphans and Children without Parental Guardians, Guidelines On Childhood Protection in Member
p.000039: Nations of CIS (1998) as well as The Charter for Older People and other socially significant documents.
p.000039: In accordance with basic statements on protection of human rights and freedoms there are being prepared model
p.000039: laws related to both forming of domestic policy in the Commonwealth countries in the field of health care and
p.000039: developing of common approaches to international cooperation of the states in this field. An important role for
p.000039: legislative regulation of special situations in the area of medical practice and their potential application
p.000039: to cases of
p.000039: biomedical studies and ethical review is assigned to the following model laws: On Sanitary and Epidemic
p.000039: Well-being of the Population, On Prevention of Spread of Diseases with Social Significance, the Concept on Formation of
p.000039: Legal Basics and Mechanisms for Implementation of Social State in the CIS Countries, the Charter of Social Rights and
p.000039: Guarantees for Citizens of Independent States (adopted by IPA CIS, 29.10.1994). Also many projects of model acts
p.000039: included into perspective plan of model law development are also important for formation of state policies of the CIS
p.000039: countries in the field of health care and biomedicine such as the following: On Social Protection of Handicapped, On
p.000039: Folk Medicine, Recommendations on National Legislations Adjustment of the CIS Member States in the Sphere of Social
p.000039: Protection and Medical Service for Liquidation Participants of the Disaster Consequences at the Chernobyl NPS, On
p.000039: Counteracting HIV/AIDS in the CIS Member States, Medical Code of the CIS Member States, On Preventing
p.000039: Distribution of Forged and Low-quality Drugs, On Natural Medical Resources, Medicinal- sanitary Areas and Resorts, and
p.000039: many others.
p.000039: Activity of IPA CIS also facilitates development of regional legal cooperation in the field of health care and
p.000039: social protection of the population at the level of heads of states and governments. As per initiatives of this
p.000039: authority the member states executed the following basic agreements:
p.000039: - Agreement on Cooperation in the Field of Protection of Population Health (Minsk, 26 of June 1992),
p.000039: - Agreement on Medical Services for Military Personnel and Their Family Members, Workers and Servants of
p.000039: Frontier Troops (Minsk, 26 of June, 1992),
p.000039: - Agreement on Provision for Population of Medicinal Drugs, Vaccines and Other Immunobiological Agents, Goods for
p.000039: Medicinal Use and Medical Equipment Manufactured at the Territory of the CIS Member States (Ashkhabat, 24 of
p.000039: December 1993),
p.000039: - Agreement on Social Security and Health Protection of Citizens Exposed to Ionizing Radiation as a Result of
p.000039: Chernobyl and Other Radiation Catastrophes and Accidents as well as Nuclear Testing (Moscow, 9 of September
p.000039: 1994),
p.000039: - Agreement on Cooperation for Resolution of Issues of Disability and Disabled (Moscow, 12 of April 1996),
p.000039:
p.000040: 40
p.000040:
p.000041: 41
p.000041:
p.000041: - Agreement on Provision of Medical Care to Citizens of the CIS Member States (Moscow, 27 of March 1997),
p.000041: - Convention on Transfer of Persons with Mental Disorders for Compulsory Treatment (Moscow, 28 of March 1997),
p.000041: - Agreement on Cooperation for Resolution of Issues of HIV Infection (Moscow, 25 of November 1998),
p.000041: - Agreement on Prevention of Iodine-deficient Disorders among Citizens of the CIS Member States (Minsk, 31
p.000041: of May, 2001),
p.000041: - Agreement on Cooperation of the CIS Member States in the Field of Protection of Population Health (Yalta, 18 of
p.000041: September 2003),
p.000041: - Decision on the Order of Medical Examination of a Donor of Blood and Components Thereof (Cholpon-Ata, 2 of April
p.000041: 2004),
p.000041: - Agreement on Order of Interaction for Hygienic Assessment of Potentially Hazardous Products Imported to the
p.000041: CIS Countries (Cholpon- Ata, 16 of April, 2004),
p.000041: - Agreement on Cooperation of the CIS Member States against Trafficking of human beings, Human Organs and
p.000041: Tissues (Moscow, 25 of November 2005)
p.000041: - Concept for Development of Social and Medical Basics for Improvement of Quality of Life and Prevention of Disability
p.000041: of War Veterans, Participants of Local Conflicts, Peace-making Operations and Terrorism Victims in the VIS Member
p.000041: States for 2006-2010 (Dushanbe, 25 of May 2006), etc.
p.000041: From the point of view of international legislative practice adoption of the Model Law on Protection of Human Rights
...
p.000041:
p.000042: 42
p.000042:
p.000043: 43
p.000043:
p.000043: integrity of cooperation of all stakeholders and it assumes wide and open discussions involving various social layers
p.000043: and international entities. The latter will facilitate formation of demand from the side of citizens of the CIS
p.000043: countries and international community for the fastest inclusion of the model law statements into professional,
p.000043: regulatory and general humanitarian spheres of life in the region countries. Certainly, this process, beside
p.000043: knowledge and confidence, will require signs of respect, acknowledgement, tolerance and mutual understanding in order
p.000043: to bring forth comprehensive dialogue with various social layers having final goal of reaching social and individual
p.000043: ethical legal sense in the space of the CIS member states and their full-grown inclusion in the global
p.000043: international regulatory framework on adherence and preservation of human rights and freedoms. It is gratifying to
p.000043: claim that value of the given model law for the international community was time and again demonstrated at its
p.000043: development by representatives of such international organizations as WHO, the Council of Europe, the European
p.000043: Commission, the European Forum for Good Clinical Practice, UNESCO, the World Medical Association, etc. Need for the
p.000043: model law implementation into national legislation of the CIS countries and readiness of corresponding structures for
p.000043: provision of enforcement of these statements was exhibited with universal response of leading specialists in the field
p.000043: of medicine, biology, ethics, legislation and sociology desiring to participate in promotion of the given regulatory
p.000043: document in their countries and to facilitate to parliaments and governments of their countries in reaching the said
p.000043: goal.
p.000043: In regard to continuation of regulatory initiatives of the FECCIS with IPA CIS there is work on-going on forming
p.000043: regulatory and ethical standards for counteraction against HIV/AIDS at the CIS space as well as development of the
p.000043: model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS within the
p.000043: framework of cooperation with the Permanent Commission of IPA CIS on Science and Education.
p.000043: Summarizing statements in common trends in ethical and legal regulation of public relationships on the
p.000043: field of medicine and biology in the CIS countries one should note that the policy of the Commonwealth countries
p.000043: including rational features of previous rich and versatile historical and cultural experience is open to
p.000043: interaction with world bioethical community and ready for rational collaboration in the region directed to development
p.000043: of optimal conditions for reaching ethical comfort in medicine and in research
p.000043: via building up of the society’s ethical self-consciousness, legal sense and attaining of a new type of relationships
p.000043: among individuals, social groups and states based on social partnership and dialogue in regard to the most crucial
p.000043: issues of ethical content.
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: References to international documents mentioned in the text are provided in the chapter for the member states.
p.000043: Texts of the model laws of IPA CIS are available at the web site: www.iacis.ru/html, the text of the model
p.000043: law of IPA CIS On Protection of Human Rights and Dignity in Biomedical Researches in the CIS and the text of
p.000043: the model guidelines On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS can be also
p.000043: found at the following web sites: www. feccis.net and www.pasteur-nii.spb.ru
p.000043:
p.000044: 44
p.000044:
p.000045: 45
p.000045:
p.000045: Chapter 2. CURREnt StAtUS AnD PERSPECtIVE oF tHE CIS’ REGIon PARtICIPAtIon
p.000045: In tHE IntERnAtIonAL BIoMEDICAL RESEARCH
p.000045:
p.000045: 2.1 Philosophical Aspects of the Biomedical Research (P.D.tishchenko, B.G.Yudin)
p.000045:
p.000045:
p.000045: Philosophy of modern biomedical research (BMR) is a limitless topic with multiplicity of versatile aspects. Here we
p.000045: would like to dwell on those of them that are to some extent are related to issues of ethical examination
p.000045:
p.000045: Specific Position of Science in the Modern Culture
p.000045: Understanding of trends of development of the modern biomedical research is impossible without taking
p.000045: into account on-going general civilization transformations of our days. First of all, let’s take a look at the
p.000045: most general context of the issue.
p.000045: In this respect it is necessary to remind about a central role that science have played and still plays in the modern
p.000045: culture. As to exact expression by E. Husserl: “When at the beginning of the New Age religious belief began
p.000045: to degenerate more and more into lifeless convention, intellectual humanity stood in a new great faith –
p.000045: faith into autonomous philosophy and science. Scientific judgments were to highlight and guide entire human culture
p.000045: providing it with new autonomous form.” (Husserl E. Cartesian Meditations, p.14). If to take into account that
p.000045: ideology of new European education to a large extent is a gradual process of mastering the system of scientific
p.000045: knowledge, then without exaggeration one can say that the modern man (unlike a person in the Christian culture) is
p.000045: created “in the image and likeness of a scientist”.
p.000045: The leading position of science is retained and considerably strengthened gaining qualitatively new forms. Along
p.000045: with that, in the modern cultural situation science becomes more tolerant to other forms of cognition
p.000045: and comprehending of the reality. Ideas, concepts and practices that several decades ago were considered
p.000045: as superstitions are rehabilitated and gain status of fully-developed modern doctrines. In the whole world
p.000045: one can
p.000045: observe revival of archaic (shamanism, cabala and other esoteric practices) and creation of new non-scientific
p.000045: (and often anti-scientific) ideologies. Appear new bridges for cooperation between science and traditional religions
p.000045: appear.
p.000045: Another process is ongoing along with this paradoxical one. Science is still a mainstream for resolution of human
p.000045: problems, protection of a man against unfavorable natural impacts (for instance, diseases). But the mightier is
p.000045: scientific control over the nature, the clearer hazards are – that is, risks, related to development of science and
p.000045: scientifically-targeted technologies. Along with realization of these risks there are two directions being formed that
p.000045: influence in ideological sense establishment of procedures of ethical examination for biomedical studies. We are
p.000045: talking about ecological movement and bioethics. The ecological movement is concerned with diagnostics and
p.000045: prevention of begotten by scientific and technical progress risks related to biological survival of the humanity
p.000045: and biosphere as a whole. Bioethics elaborates its own technologies for identification and neutralization
p.000045: of those risks that the progress brings forth for the moral well being of a human.
p.000045: At that, it is paradoxical that in regard to the risks science has a triple position – it is one of the main risk
p.000045: producers, virtually the only developer of reliable methods for their assessment as well as it develops mechanisms for
p.000045: prevention of undesirable consequences or handling them – when they are present.
p.000045: Sources for these shifts that radically change waypoints and setup for the scientific search can be, at least,
p.000045: partially, found in events taking place about 4 decades ago. Those days at the end of the 60’s, young people, mostly,
p.000045: students in many Western countries initiated strong protesting movements that resulted in serious social unrest.
p.000045: Targets for attacks of the “new left” were key social institutions of bourgeois society and its culture; in
p.000045: this context science was also strongly criticized.
p.000045: Firstly, it was perceived as a power carrying the light of intellect and closely bound to ideals of free critical
p.000045: thinking and, therefore, democracy. One of bright mouthpieces of this position was the well-known sociologist of
p.000045: science, R.Merton (Merton R. Sociology of science: theoretical and empirical investigations. Chicago: Wiley,
p.000045: 1973). However, another point of view also was fairly wide spread based on some neopositivism concepts
p.000045:
p.000046: 46
p.000046:
p.000047: 47
p.000047:
p.000047: and accenting utilitarian and pragmatic sides of scientific activity; it was expressed with neutral attitude to the
p.000047: social role of science. Now science critics interpreted it as a power closely linked to establishment, positioned too
p.000047: far from vital interests of common people and, moreover, even hostile to them, facilitating not democratic but
p.000047: totalitarian trends, dehumanizing the world, begetting and strengthening human alienation and enslavement.
p.000047: In this case we are not interested in one or another point of view for these counter-cultural and counter-scientific
p.000047: movements. But among many consequences they caused it is worth to note rather basic and distressful
p.000047: reappraisal of many values. It is characteristic that the criticism of science by these new lefts was quite effective
p.000047: although as it often happens in the history its further development took not the pace they dreamt of.
p.000047: As a result initially in the USA and then in the countries of Western Europe the range of expectations from the society
p.000047: considerably transformed along with scientific and technical policies of a state. Now scientific researches
p.000047: are required more and more that their results are to satisfy social needs and personal requirements.
p.000047:
p.000047: Science in the “Society of Knowledge”
p.000047: One of the developers of the term “society of knowledge” is the American sociologist, Piter Drucker, who in 1994
p.000047: set a question on developing in modern culture deep social transformations he determined as establishing of new
p.000047: institutions of the “society of knowledge”. The society of knowledge has altered nature of labor, higher education and
p.000047: ways of functioning for the entire society as a complicated interrelated system (P. Drucker. The Age of Social
p.000047: Transformation. The Atlantic Monthly, 274 – November 1994, 53-80). In our analysis we are going to use
p.000047: the Drucker’s ideas to some extent adding them with useful, from our point of view, results from other researchers.
p.000047: P.Drucker proceeded from that transformation of scientific knowledge into a main source of new technologies started as
p.000047: per historical measurements quite recently. He stated that yet in the XVIII century “no one even tried to talk over
p.000047: application of science for development of instruments of production, technologies and goods, i.e. about use of
p.000047: scientific knowledge in the field of techniques and technology. This idea matured only … in 1830 when the German
p.000047: chemist, Justus von Libikh (1803-1873), first invented
p.000047: artificial manure and then a method for storing animal proteins (P. Drucker. From Capitalism to Society of Knowledge.
p.000047: In: New Post-Industrial Wave in the West, edited by Inozemtsev V.L., M., 1999). According to Drucker that time the
p.000047: industrial revolution as a process of global transformation of the society and civilization on the basis of technical
p.000047: development began. At that, scientific knowledge took new, previously not characteristic role – as a factor actively
p.000047: influencing life of a man and society and dynamicizing it.
p.000047: In the context of technological application of science a research is not only an investigation of the
p.000047: world as it is, the natural world, but as transformation of this world, that is, as development of an
p.000047: artificial world (being more precise, worlds). And in such respect the research is a prototype of a technological
p.000047: method for learning and, moreover, vision of the world.
p.000047: This fact is of special importance for understanding how exactly biomedical technologies influence the
p.000047: very nature of a man. Now these technologies can wider and more effectively control existence of a man from
p.000047: stages prior to conception up to the death and even post-mortal existence (taking futurological ideas of “cryonics” as
p.000047: an example).
p.000047: Transfer from knowledge of reality to its artificial construction is associated with overestimation
p.000047: of truth status, which is more often substituted with ideas of “usefulness” and “effectiveness”. In technological
p.000047: context issues of truth and quality of knowledge are falling into background. One can say that in this context not
p.000047: research result by itself and not various interpretations of effects of a research system are of interest but the
p.000047: effect as it is – those transformations and conversions it provides. And while technological capacities
p.000047: hidden in experimental device and, in a wider meaning, in technological activities are being recognized,
p.000047: functions of science are being changed dramatically.
p.000047: At that, recognition of technological capacities of science is a mutual process, which includes both those
p.000047: involved in scientific activities and those of business and manufacture. As a result of the process
p.000047: people become not only more perceptive in regard to various new technologies but also, if one can say so, are
p.000047: “imbued” with technological mentality. Any serious problem they face starts being recognized and thought over
p.000047: as a significantly technological issue: initially it is distinguished as per canons set by technology, and then
p.000047: technological problems for its resolution are sought for and applied.
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p.000049:
p.000049: Nowadays the technological role of science became dominating and many even think that the only function of
p.000049: science is development of new technologies. At that, the way of practical implementation of scientific
p.000049: knowledge and technologies based on it appears to be something like the following. First, a theorist and/or a research
p.000049: laboratory discover something. Then the result of this study during the process called as development (or elaboration)
p.000049: is implemented in new technologies. The following stages of a process are related to the fact that each such new
p.000049: technology is – with more or less problems – implemented in practice of manufacture or any other sphere of
p.000049: human activity. In other words, the traditional order of things is characteristic with the following: first a
p.000049: technology is created, and then markets to sell it are searched for. Talking about issues we mean particularly the
p.000049: notorious one of “implementation”, which caused breaking lances in the USSR times for many years and which does
p.000049: not have any satisfactory solution so far.
p.000049: Therefore, it makes sense to think over that the way the problem is defined is likely to be incorrect. In
p.000049: our established views appearance of any new technology looks like a move beyond the given and already mastered order
p.000049: of things. This word, “implementation”, seems to be here rather characteristic since it bears, beside other
p.000049: issues, a sense that there is some influence from outside breaching the groove, something extraordinary.
p.000049: Today, however, we can if to use the term by the German sociologist, M.Weber, talk about routinization of this
p.000049: very process of technological upgrades when new technologies do not break into manufacturing activities, into lives
p.000049: of people, but are placed into preliminary prepared “cells”. In other words, new technologies are “custom-made”. More
p.000049: often this sequence is built in order directly opposite to the common way: development of a new technology starts only
p.000049: when and because there is already a demand for it.
p.000049:
p.000049: Phenomenon of “technoscience”
p.000049: Today in the beginning of the XXI century we have all grounds to say about qualitatively novel stage in
p.000049: development not only of science but its interaction with the society as well. One of the ways expressing it
p.000049: is establishment of a new type of interaction between science and technology that was called technoscience. For
p.000049: instance, the English sociologist Barry Barnes wrote: “The term technoscience now is widely used in academic
p.000049: sphere and is related to such activity within which framework science and technology form a kind of a mixture or a
p.000049: hybrid… technoscience should be perceived as specifically modern phenomenon” (B.Barnes. Elusive Memories of
p.000049: Technoscience. – Perspectives on Science: Historical, Philosophical, Social. Vol. 13, Issue 2 – Technoscientific
p.000049: Productivity, Summer 2005, pp. 142-165). The most evident sign of technoscience is considerably more profound
p.000049: than before built-in pattern of scientific cognition into activities on development and promotion of new technologies.
p.000049: According to the German sociologist and political scientist, Wolf Schäfer: “Technoscience is a hybrid of science-based
p.000049: technology and technology-based science. Global phone communications and genetically modified products are
p.000049: para-scientific things: their invasion into our world is due to complex interweaving of particular human
p.000049: interests with modern understanding of electricity, on one hand, and genetics, on the other.” (W.Schäfer. Global
p.000049: technoscience: the dark matter of social theory.Univ. of Maryland conf. on globalizations, April 2002.
p.000049: www.bsos.umd.edu/socy/conference). Here, as you can see, our attention is drawn to the fact that technoscience is not
p.000049: only the tightest link between science and technology, but also such symbiosis that includes also human aspirations and
p.000049: interests.
p.000049: However, relationships of science and technique in this symbiosis are internally contradictive. On one
p.000049: hand, science is a generator of new technologies and due to stable demand on these new technologies science
p.000049: enjoys some, and sometimes quite generous support. On the other hand, production of new technologies dictates
p.000049: demand on science of specific, if you wish limited, single-sided type, therefore, many potentials of science being
p.000049: used this way are still outstanding. Roughly speaking, science is required neither to explain, nor to
p.000049: understand things – it is quite sufficient that it makes possible to alter them effectively.
p.000049: Besides, it assumes understanding of human cognitive activities including the scientific one, as an
p.000049: activity being secondary to some extent, subjected to practical transformation, changing of both the world
p.000049: around and a man. Thus, reminding the said above, there is an opportunity for rethinking, or, being more
p.000049: specific – reversion – of the balance of science and technology established before. If traditionally this balance was
p.000049: perceived as technological application, utilization by someone and at some time produced scientific knowledge, now it
p.000049: turns out that the very activity for obtaining of
p.000049:
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p.000050:
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p.000051:
p.000051: such knowledge is built in into processes of creation and development of these or those technologies.
p.000051: It is interesting not only how such transformations take place in reality but also how they are comprehended. On the
p.000051: surface things seem to be the same: it is proclaimed that science is a leading force of the technological progress
p.000051: that, in turn, uses scientific achievements.
p.000051: This is the background for realization that so-called applied science deals with those problems that are
p.000051: determined with the very development of technologies, and, along with that, such “servicing” science becomes
p.000051: determinative both as to quantitative and financial or other supplies, and as to social recognition. As we already
p.000051: noted a regulator for scientific activity becomes not obtaining knowledge pretending to be the truth to some extent but
p.000051: gaining an effect that can be implemented into a technology in demand. One should say that also social expectations
p.000051: regarded to science today shows clear domination of demands for new effective technologies but not for explanation of
p.000051: the world. Such transformations of relationships among science, technology and society, particularly, real move
p.000051: of science from avant-garde to auxiliary roles are launched in the realm of natural sciences,
p.000051: but then spread to social and humanitarian sciences.
p.000051: Thus, both the society and the state including all authorities responsible for formation of policies in regard to
p.000051: science are more inclined to perceive both research activities and the very science as a machine capable of
p.000051: generating new technologies.
p.000051:
p.000051: Science on the Market
p.000051: Commercialization of science is another very peculiar feature in development of biomedical technologies.
p.000051: Emergence of the biotechnological industry in the USA as a new institution for not only applied science, but also for
p.000051: fundamental research at the 70’s of the XX century was provoked with several factors including: a) considerably grown
p.000051: abilities to “recombine”, “produce” and simply “manipulate” DNA and all other molecules; b) transformation of
p.000051: the administrative environment which should encourage rapid transition of research to applied problems such as changes
p.000051: in the patent law that not just supported but forced to commercialize inventions in both industrial and academic
p.000051: sectors; c) and in the limit case – fusion of state- funded scientific research with venture capital interested
p.000051: in investments
p.000051: for development of extended base of molecular and biological studies” (P.Rabinov. Making PCR: a story of
p.000051: biotechnology. Univ.of Chicago Press. 1996. p. 19). Commercialization made possible consolidation of resources
p.000051: necessary for breakthrough in biotechnologies that occurred at the end of XX – beginning of the XXI centuries. It has
p.000051: also resulted in reconstruction of self-identity of science and scientists we observe these days changing
p.000051: self-comprehension of science and creating new identity of “a businessman scientist”.
p.000051: Another important consequence of commercialization was changes of patenting practices. In 1980 the US Supreme Court
p.000051: decided that creation of new forms of life is subjected to the Federal Patent Law. It made possible, after some time,
p.000051: to start patenting of not only artificially developed organisms or laboratory animals, but also patenting of human
p.000051: genes, DNA sequences, embryo stem cells, etc. Pragmatic interest for investment protection has changed
p.000051: the world perception. In the form of a patent it provided fundamental scientific knowledge with a form
p.000051: of merchandise. From the point of view of philosophy it means radical fusion of cultural and natural horizons, ideas
p.000051: of discovery and invention. Science commercialization in the sphere of biotechnologies created a new market, a new type
p.000051: of goods, new property rights, boosting synchronous similar processes in other branches of biomedicine. And at
p.000051: that, not only living organisms or elements of human body (genes and cells) become objects of commercial utilization
p.000051: but genomes of entire nations. For instance, in 2000 in Iceland one private biotechnological company, DeCode Genetics
p.000051: “purchased” an exclusive right for commercial use of genome materials and data of the Iceland population for 12 years.
p.000051: Along with structural changes of scientific activities its main checkpoints are altered as well.
p.000051:
p.000051: Constructing a Human
p.000051: One of the main vectors that can be used to characterize direction in development of science and technologies in
p.000051: the last decade is its steady approaching to a man, his needs, aspirations, desires. As a result we can see, if
p.000051: one can say so, tighter “enveloping” of a man, his immersion into the world projected and equipped for him by
p.000051: science and technologies. Naturally, the case is not limited with only “servicing” for a man – science
p.000051:
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p.000053:
p.000053: and technologies approach him not only from outside, but, seemingly, from inside, in a sense making him their creation,
p.000053: projecting not only for him but also projecting himself. Literally speaking, it is done in some modern genetic,
p.000053: embryologic and other biomedical research, for instance, related to cloning16. As a result initially in the USA
p.000053: and then in the countries of Western Europe the range of expectations from the society considerably
p.000053: transformed along with scientific and technical policies of a state. Now scientific researches are
p.000053: required more and more that their results are to satisfy social needs and personal requirements.
p.000053: Financial flows directed to support science and technologies are re- oriented – more funds are allocated for
p.000053: researches in the field of environmental protection and especially – for biomedical studies. There were stated such
p.000053: ambitious objectives as overcoming cancer and cardiovascular diseases by preliminary set time points. And though these
p.000053: disorders were not completely eliminated successes achieved in this respect especially in regard to
p.000053: cardiovascular diseases appeared to be highly impressive. And as people as per their own knowledge of life felt those
p.000053: effects caused with these newest technologies, their demands and desired addressed to science and technology became
p.000053: more and more versatile and insistent. Thus, growing practical effectiveness of science and technology in those
p.000053: fields that are the closest to daily needs and interests of a common person started to act as a strong driver orienting
p.000053: and boosting development of science and technologies.
p.000053: Along with these changes in priorities of scientific and technological policy similar re-orientation takes place
p.000053: also in business that gained considerable success in re-targeting research interests on creation of what can be
p.000053: attractive for mass consumer. And it is characteristic that those branches of industry that had the closest links with
p.000053: medicine – pharmaceutical industry, medical device manufacture, biotechnological manufacture – were among the most
p.000053: successful. Thus, people become users of knowledge, technologies
p.000053:
p.000053: 16 See with this regard, e.g., Y.Habermas. Future of Human Nature. On the Way to Liberal Eugenics. M., 2002;
p.000053: F.Fukuyama. Out Post-human Future: Consequences of Biotech Revolution. M., 2004; Yudin B.G. About a Man,
p.000053: His Nature and Future. “Issues of Philosophy” (Voprosi Filosofii), 2004, V.2; L. Kass. Non-ageing Bodies,
p.000053: Happy Souls… “A Man” (Chelovek), 2003, V.6.
p.000053: and products developed due to biomedical researches and on corresponding production facilities to a larger extent.
p.000053: Here one terminological explanation is necessary. Generally speaking, any innovation, being a part of not only
p.000053: manufacturing process but also of our way of life and social practices, can be considered as a kind of
p.000053: “object” (even in case of symbolic understanding of this term in regard to, for instance, our social life). However,
p.000053: object-Centreed understanding quite often turns to be too narrow since this novelty is not only a particular object,
p.000053: but also particular practices of its use, operating, etc. Both from human and social points of view this is the matter
p.000053: which is the most significant, since consequences for a man and society usually beget not the object itself but the
p.000053: ways how we interact with them, results of these interactions and, finally, those changes in us that are caused with
p.000053: these interactions. In other words, in real life we deal not with objects and things per se but technologies.
p.000053: It is interesting to compare a pattern of development of biotechnologies with what happened in the same years in the
p.000053: field of informatics and computer technologies. In this respect, the crucial point was creation of a personal computer
p.000053: that swiftly extruded bulky and hard to operate computers of the past. And there we can again see the similar trend –
p.000053: modern technologies approach a man closer and closer changing radically his lifestyle and how and what he sees in the
p.000053: world and how he interacts with the world.
p.000053: In this respect it is worth to turn your attention to the following. In the beginning and middle of the previous
p.000053: century technical power of a man was associated mostly with cyclopean size of his creations such as hydroelectric power
p.000053: stations, nuclear ships, walking excavators, and gigantic electronic calculating machines. Today, contrariwise, the
p.000053: most impressive are those symbols of the technical progress that are proportional to a man. One can relate to them
p.000053: growing versatility of information technologies that are implemented within the scale of a personal computer, and
p.000053: biomedical technologies that, as to their definition, are of the similar scale with a man and that today make possible
p.000053: manipulations with human genes at the molecular level. Moreover, in the nearest time more attention is started to be
p.000053: drawn to nanotechnologies that allows influencing processes and events taking place at the level of separate
p.000053: atoms. It is significant that one of the most important directions for nanotechnology development becomes a search
p.000053: for possibilities of using
p.000053:
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p.000055:
p.000055: them in biomedicine; also it is peculiar that, first of all, in this very aspect of their development appears within
p.000055: the sphere of ethical analysis.
p.000055: Thus, scientific and technological progress is more and more oriented on interests and needs of an individual who is a
p.000055: main consumer of what is provided by the progress. New technologies turn to be such commodities oriented on mass
p.000055: consumption; without this large-scale involvement it would be impossible to provide effectiveness of a
p.000055: laboratory. In turn, interests and needs of consumers become strong drivers determining, to a large extent,
p.000055: directions and urging rates of the scientific and technical progress. As a result, there is a two-way connection
p.000055: between the laboratory producing new technologies and individuals being their consumers. The laboratory and mass
p.000055: individual consumer, in other words, are included into a single circuit.
p.000055: However, such closing of science to needs of a man does not come on its own – everything has the price. One of the most
p.000055: serious constituents of this payment is more and more acute necessity to study specifically what are actually human
p.000055: needs and requirements and how exactly to meet them. And it means that a man becomes more and more an object
p.000055: for various scientific researches. And to the extent, at which strength of scientific cognition is focused
p.000055: on him, with which newer, finer and more effective means of influencing on him are developed, elements of risk and
p.000055: hazard he is exposed to are growing inevitably. Therefore, a task of protecting a man, in whose direct interests
p.000055: science and technique is advancing, is actualized from negative consequences of this very project.
p.000055: The next constituent of the circuit described herein is business, enterprise capital. It funds the laboratory,
p.000055: thus, providing opportunities for development of new technologies. In turn, the mass consumer paying for technological
p.000055: novelties allows business not only to reimburse for incurred expenditures but also to gain profit, which often is again
p.000055: invested into the laboratory and development of other new technologies. It is important to stress stable type of
p.000055: connections among three discussed elements – business is involved into this circuit not every once in a while but
p.000055: becomes an integral part of permanently acting and steadily growing circuit. In society based on knowledge investments
p.000055: into the laboratory are the most promising ones.
p.000055: Science and Mass Media
p.000055: As a link for all said elements there is one more, this is mass media that has a range of functions within this
p.000055: circuit.
p.000055: First of all, they bring to potential customers information on appearance of technological innovations at the
p.000055: market. But the mass media function in this circuit is far from being limited with dispassionate informing. On the
p.000055: contrary, quite often they form demand for these or those technological products – in this respect it is sufficient to
p.000055: remind about how sophisticated, obtrusive and even aggressive advertising can be. We can note here that
p.000055: advertising of a hydro power station or, for instance, a walking excavator would be senseless – advertising is
p.000055: appropriate only there and when it is targeted on mass consumer. And mass media utilizing this function makes possible
p.000055: to include it into the described circuit.
p.000055: At that, the term “mass media” is used in actually wide and, possibly, not very accurate sense. Mass media here is,
p.000055: actually, various technologies of working with information, informational support for the circuit. Generally speaking,
p.000055: this element – information and communication technologies
p.000055: – is considered by many authors as crucial for the society of knowledge. “Informational and communicational
p.000055: technologies – one of the supports for so widely discussed society of knowledge and economics of knowledge;
p.000055: other supports are growing importance of science, scientific knowledge as well as knowledge originating from culture
p.000055: sources.” (J.Spanberger et al. The knowledge-based society: measuring sustainability of the information society.
p.000055: Futura, 2002). Or it could be said as follows: the term “mass media” in this sense is related to all social and
p.000055: humanitarian technologies which are substantially important, necessary for functioning of the circuit.
p.000055: For instance, a special sphere of activity within the circuit is to bring to a consumer not only information about a
p.000055: newly developed technology but the technology itself. Let’s say, as per some estimation, when producing new medicinal
p.000055: agent its development (i.e., the laboratory) takes about one tenth of all financial expenditures, and all other costs
p.000055: are incurred for promotion of a drug up to the stage of a marketed product. Naturally, an activity for new technology
p.000055: promotion is also built upon technological basis, and at that at these stages the main role is played by social and
p.000055: humanitarian technologies. It indicates once again that development of some product – in this case, a medicinal agent –
p.000055: within the framework of technoscience is nothing else but a
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p.000056:
p.000057: 57
p.000057:
p.000057: part of technological process and, thus, technoscience deals, first of all, not with objects as they are but with
p.000057: extensive circuits including, beside these objects, also joint, coordinated activity of various people and social
p.000057: structures.
p.000057: It does not matter how effective is advertising but one should not demonize it and consider as omnipotent. A
p.000057: consumer, generally speaking, is far from always being a puppet that is easy to manipulate. He has his own and not only
p.000057: dictated externally needs and preferences. Effectiveness of functioning of the technoscience circuit is, to a large
p.000057: extent, secured with built in mechanisms of identification of consumer interests and expectations. Due to use of
p.000057: social and humanitarian technologies these interests and expectations, in their turn, are brought to notice of
p.000057: the business and laboratory and become factors determining strategy of technology development.
p.000057: Further, it is necessary to mention another network where information circulates in the circuit. In this case we
p.000057: mean not mass but specialized information about desire of a businessman to invest in development of
p.000057: specific technologies, on one hand, and about technological possibilities and perspectives of this or that laboratory,
p.000057: on the other. In many cases but not always the laboratory is a constituent of a business company. If there are no such
p.000057: tight connections, then information mediator is required.
p.000057: Thus, in general, the technoscientific circuit includes four elements related with one another with direct
p.000057: and reverse informational, financial and commodity flows. It should be stressed that reverse connections within
p.000057: this circuit are positive: a signal coming from one element to another does not weaken as it happens in case of
p.000057: negative feedback but, contrariwise, strengthens. Thus, it provides unprecedented dynamism for functioning of the
p.000057: circuit.
p.000057: In practice, it looks approximately like the following: the laboratory purposefully works to meet demands of
p.000057: customers that it is aware of due to work of mass media; customers are ready to bear expenses for products meeting
p.000057: their demand; due to that a businessman gains profit which he, in turn, invests into the laboratory, thus, launching a
p.000057: new cycle for technology upgrade; mass media forms in mass consumers all new demands, making them interested in
p.000057: continuous replacement of goods and technologies they already have on new ones that become more effective, more useful
p.000057: and more attractive.
p.000057: Now we can note that, as it is known from cybernetics and a theory of system, circuits with negative feedback can
p.000057: be stable while circuits with positive feedback are, contrariwise, characterized with extreme instability. Any
p.000057: signal in such circuit, moving from an element to another, is enhanced, thus, fairly fast a system with positive
p.000057: feedback, so to say, overspeeds and either is destroyed or converts into qualitatively new state. Therefore, one can
p.000057: say that the circuit of technoscience we described is unstable. But, alas, neither cybernetics not the theory of
p.000057: systems can forecast future course of events.
p.000057:
p.000057: Industry of Biomedical Research
p.000057: Thus, scientific research to larger and larger scale is focused on cognition, on one hand, of various ways of
p.000057: influencing a man and, on the other, capacities of a man. Multiple experiments, where a man participates as a subject
p.000057: can be considered as the most characteristic expression of both. Each such experiment, generally speaking, is
p.000057: designed to extend our knowledge of properties of various agents, devices, methods of influencing a man, etc. At that,
p.000057: necessity for its conduct can be determined with needs of development of some particular section of biology, or
p.000057: medicine, or another field of knowledge. If, however, one attempts to imagine integral totality of such experiments
p.000057: (taken irrespective of subject specificity of each of them), than it turns out that it provides us with some knowledge
p.000057: about a man. We can claim: the more science pretends to serve interests and benefit of man, the more significant role
p.000057: there should be played with experiments involving human subjects.
p.000057: Several decades ago H.Jonas discussing issues of experiments involving a man, said perspicuously about a need to
p.000057: limit somehow “exorbitant appetite of the industry of scientific research”. Also he turned attention to the
p.000057: following - “now the scientific society will have to struggle with the strongest temptation – to switch to
p.000057: regular, daily experimenting with the most available human material: dependent ones due to various
p.000057: reasons, ignorant and suggestible disabled” (H.Jonas. Philosophical reflections on experiments with human
p.000057: subjects. In: Experimentation with human subjects, ed. by P.Freund, George Braziller Inc., 1970, p. 529).
p.000057: At the same time Jonas – and this was, generally, the commonly accepted point of view – could claim that
p.000057: experiments with human subjects
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p.000058:
p.000059: 59
p.000059:
p.000059: “we consider as extraordinary but not normal ways to serve to public good” (the same, p. 526). But
p.000059: those days no one disputed of the crucial principles of the Nuremberg Code: each of such experiments due to
p.000059: risks it is associated with can be justified only with paramount necessity. In other words, it is acceptable only when
p.000059: there is not other way to gain knowledge being extremely important for the society and science.
p.000059: During the past decades an industry of scientific research or, being more specific, biomedical research
p.000059: involving human subjects became full- scaled reality. At that, biomedical researches by themselves are more and more
p.000059: often considered not only from the point of view of risks, but also from the point of view of benefits that they can
p.000059: bring to a subject. Usually, a therapeutic effect of a developed novel medicinal agent or a new method of treatment is
p.000059: considered as such benefit.
p.000059: And the issue on which of these two interpretations of biomedical research is more acceptable is worth
p.000059: of specific discussion that we have no possibility to talk over herein. It is important for us to stress that
p.000059: ethical tracking for such researches became a commonly accepted principle. In other words, in the modern scientific
p.000059: practice fairly well developed mechanisms for ethical control over studies function.
p.000059:
p.000059: Ethos of new Science
p.000059: Transformation of cognition into production form creates a new kind of an ethos of scientific society that is
p.000059: completely different from a classical one as it was described in due time by R.Merton. In traditional academic science
p.000059: an owner of knowledge was an individual scientist. Idea of his personal responsibility corresponded to
p.000059: such state of affairs. In biotech companies there appears corporate ownership of gained knowledge. Space of
p.000059: personal responsibility shrinks dramatically. But at the same time there emerges idea of collective (corporate)
p.000059: responsibility or accountability to the society. From the point of view of ethics there appears a new type
p.000059: of a moral subject (“businessman scientist”), for whom similarly doubled ethos is characteristic. In English
p.000059: publications oppositions of these two ethos’s features is sometimes fixed in terminological sense as a relation of
p.000059: personal responsibility and corporate accountability for the society.
p.000059: From the R.Merton’s point of view scientific society ethos includes the following principles:
p.000059: 1. “Communism (collectivism)” – knowledge as a result of scientific activity is a public domain. Any scientific
p.000059: knowledge is built upon results of previous studies. Therefore, a scientist should comprehend himself as a
p.000059: member of scientific society who is able of implementing his destiny only cooperating with other. His duty is
p.000059: to share unselfishly his scientific results with other scientists and publish them in publications available to the
p.000059: public.
p.000059: 2. “Universalism” – assessment of importance of scientific achievements of a scientist should be based exclusively upon
p.000059: their objective assessments, irrelevantly to his nationality, association with this or that scientific
p.000059: institution, personal features, religious or political views.
p.000059: 3. “Disinterest” – scientific research shall be motivated only with a desire to arrive at the truth. It is
p.000059: necessary to exclude all non-scientific interests – economical, political, religious, and etc.
p.000059: 4. “Established skepticism” – researchers must be critical to results of work not only of others but also of their own.
p.000059: Only basing on systematical criticism scientific ideas can get rid of errors and come closer to the truth. A duty of a
p.000059: scientist is to question constantly obtained results.
p.000059: These aforementioned four Merton’s principles form scientific society ethos. The word “ethos” underlines the fact that
p.000059: principles are, at the same time, ethical standards for self-perfection of a scientist and methodological rules
p.000059: providing arrival at the truth.
p.000059: What is specificity of scientific ethos as a corporate activity at the market of knowledge and technologies?
p.000059: In other words, what is specificity of scientific society ethos where a hybrid of a scientist and a businessman is a
p.000059: subject?
p.000059: Ethos of this two-faced Janus is also similarly two-faced. Since science does not terminate to be science, than
p.000059: self-consciousness of scientists retains moral and methodological importance of principles formulated by Merton.
p.000059: However, these principles in cases when “a scientist” starts to play a role of a businessman are limited and appended
p.000059: with a system of other principles. This system was for the first time described by the American sociologist of
p.000059: science, Jan Mitroff, at the 70’s of the last century when a policy of commercialization in various
p.000059: spheres of scientific studies was launched. To some extent, these principles are directly opposite to the
p.000059: ones stated
p.000059:
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p.000060:
p.000061: 61
p.000061:
p.000061: by Merton. In regard to reality of biotechnological science the Mitroff’s principles can be stated as
p.000061: follows:
p.000061: 1. “Corporate egoism” (instead of communism) – knowledge as a result of scientific activity is a corporate
p.000061: domain. They are patented and in the form of patents can be sold to other members of scientific society.
p.000061: 2. “Particularism” (instead of universalism) – importance of scientific achievements of a scientist shall
p.000061: be assessed not so much basing on any objective grounds but on their practical usefulness for the given corporation
p.000061: (given research institution). A corporation shall support a trend to overrated assessment of own achievements and
p.000061: understated valuation of the ones of others.
p.000061: 3. “Interest” (instead of disinterest) – scientific studies are motivated, first of all, with corporate interest to
p.000061: maximize profits. Arrival at the truth is a concomitant issue during gaining economical benefit.
p.000061: 4. “Established dogmatism” (instead of established skepticism) – researchers must be critical to results of
p.000061: works of others. At the same time, adhering to the spirit of “team game” researchers shall abstain from critical
p.000061: discussion of results of activities of their own company. Negative results, i.e. results questioning efficacy or
p.000061: usefulness of commodities and services sold by the company (for instance, new vaccines or medicinal agents) practically
p.000061: are never published and are a matter of corporate “trade secret”.
p.000061: Contradiction between two types of scientific activity ethos is an essence of a conflict of interests – a moral issue
p.000061: which individual scientists often face at the sphere of development of biotechnologies. As a member of the scientific
p.000061: society he is obliged to adhere to the Merton’s ethos principles but as an employee of a biotech company he should
p.000061: follow principles described by J.Mitroff. This conflict appears to be the most acute when assessing risks associated
p.000061: with biotechnological activities. It is quite sufficient to point out to the still unfinished discussion among
p.000061: biotech companies producing genetically modified products and their opponents from a camp of ecological movement
p.000061: activists.
p.000061: 2.2 Characteristic of the Biomedical Research in the Region (o.I.Kubar, E.A.Malysheva)
p.000061:
p.000061: A biomedical study is a study involving human subjects held to investigate new diagnostic, therapeutic
p.000061: and/or preventive means and methods, gaining new knowledge on physiology and psychology of man in conditions of
p.000061: norm, disease and extreme situations. The biomedical research can stipulate both interests of a specific study
p.000061: participant and being held without direct use for a persons taking part in the study.
p.000061: Necessity of the biomedical research involving men as study subjects is obvious in general scientific and historical
p.000061: sense as the only objective, real and the most fruitful way for discovery of laws of physiology and pathology of man
p.000061: and the most important condition for successful struggle for health of every single individual and the humanity as a
p.000061: whole.
p.000061: In the XXI century the words of one of the founders of bioethics, Claude Bernand, he said at the end of the XIX
p.000061: century, sound quite fatefully: “a doctor of future is a doctor-experimenter” that convincingly coincides with novel
p.000061: capacities of modern medical science and practice not only to prevent and treat diseases but also to control human
p.000061: life.
p.000061: An issue of community of the biomedical research in the CIS region from the point of view of philosophical
p.000061: consideration of community of knowledge assumes, first of all, addressing characteristic of biomedical research on the
p.000061: basis of integral scientific, social and value-vision phenomenon.
p.000061: Since in the context herein there is no objective to describe structure and order of conduct as it is that is resolved
p.000061: in many of special methodical and regulatory documents we permit ourselves to utilize commonly accepted in
p.000061: international practice definitions and concepts that, by itself, demonstrates supranational scale in the CIS members
p.000061: states and makes possible to form some perspective characteristics and prognoses.
p.000061: However, both in any sphere of human activity and in the sphere of biomedical research to forecast future in a
p.000061: correct way it is necessary to have memory of the past and knowledge of the present. In this connection,
p.000061: consideration of main stages of establishment of biomedical research in the analyzed regional space at stages of
p.000061: its varying political and economical development gains fundamental value being governed with historical frames
p.000061: selected within the aspect of the given publication.
p.000061:
p.000062: 62
p.000062:
p.000063: 63
p.000063:
p.000063: To retain integrity of perception of materials herein as when defining common elements of ethical and legal trends in
p.000063: the sphere of biology and medicine there will be used similar parameters of chronological and logical consideration due
p.000063: to priority of their influence.
p.000063: Thus, from the point of view of historical community based on common ideological and social and economic
p.000063: inheritance of the countries in the region we should distinguish a set of important elements determining both
p.000063: closeness of positions in the region in regard to international participation in biomedical research and their
p.000063: specificity. First of all, one should note that the USSR had a regulated state system of organizing,
p.000063: examination, registration of medical use products that included regulatory and methodical requirements and standards
p.000063: for study conduct. From administrative point of view the system was purely “vertical” assuming a whole set for
p.000063: management, approval and setup only at the All-Soviet level excluding possibility for independent approving
p.000063: and executive structures to conduct biomedical research in individual republics of the former Soviet
p.000063: Union. Regulations determining this order were clearly determined and strictly controlled. Studies could be
p.000063: conducted only at clinical sites of the Pharmacological Committee being a central approving authority, and a
p.000063: list of the clinical sites was centrally approved. The clinical site list included only research medical facilities
p.000063: with corresponding staff and technical capacities. Representatives of developing entities were prohibited from
p.000063: contacting directly with facilities and performers of clinical studies. Representatives of sponsoring entities
p.000063: including accredited foreign pharmaceutical companies had contacts only at the level of central approving authorities.
p.000063: From research methodical point of view the system for setup and conduct of biomedical studies had clear pharmacological
p.000063: bias. Existing methodical guidelines and regulations on biomedical research conduct were developed for particular
p.000063: pharmacological groups of medicinal agents and took into account all specifics of their biological and
p.000063: pharmacological action. Such documents were produced with participation of only leading specialists in the
p.000063: corresponding field of pharmacology, biology and medicine. Then these documents were strictly examined at the level of
p.000063: specialized commissions (also distinguished as per a principle of pharmacological orientation of candidate
p.000063: agents) and later were to be discussed and approved at the international level (within the system for
p.000063: international cooperation defined
p.000063: by borders of the former socialist camp). At this level specialized, specialized profile approach for consideration and
p.000063: approval of documents was strictly followed.
p.000063: Such specialization could be tracked at all stages of biomedical research from examination of application
p.000063: documents at the level of specialized commissions to study conduct in specialized sites only. Even the list of
p.000063: clinical sites mentioned above did not assume participation of each of those facilities included in this list
p.000063: in biomedical research of any specialization but it was clearly structured in regard to capabilities for
p.000063: conduct of various studies. For instance, this list contained a system of headings that included lists of
p.000063: facilities where it was permitted to perform studies of immunobiological, antiviral, oncology, cardiovascular agents,
p.000063: etc. Practically it meant that a particular facility had a technical complex able of providing proper diagnostic degree
p.000063: and dynamic observation taking into account registration of parameters significant for this pathology that was
p.000063: stipulated with corresponding instructions as well as had specialists in this particular field. The given specification
p.000063: was not limited with only medicinal agents but also included medical devices and cosmetics. There was a system of
p.000063: specialized, central expert institutions.
p.000063: From the financial and economical point of view all studies (for institutions and research personnel) did not
p.000063: assume any additional financial investments and were based on the general budget of the institution. For some cases
p.000063: there was a system of bonuses for participation in international studies that was centrally defined.
p.000063: Structure of the conducted biomedical research included also studies involving volunteers in specifically established
p.000063: sites. There was an instruction on the order for conduct of studies involving volunteers approved by the Ministry of
p.000063: Health of the USSR with a list of facilities where such studies could be conducted. And in the 60’s of the last century
p.000063: there were established hospitals for testing vaccine strain candidates and for space-related studies. The order of
p.000063: participation of volunteers in these studies assumed their informed written consent and reimbursement for their
p.000063: participation.
p.000063: From the point of view of international status the USSR participated in all significant international conventions in
p.000063: this field, was a partner with WHO and some other international organizations, conventions of narcotics (1961),
p.000063: psychotropic agents (1971) were signed. In regard to patent protection the
p.000063:
p.000064: 64
p.000064:
p.000065: 65
p.000065:
p.000065: country was a member of the Paris Convention (1965), protection of patent rights covered invention, utility models and
p.000065: industrial designs and it lasted for 20 years for the whole world. At the beginning of the 90’s first (approved by
p.000065: authorized agencies) contract research organizations appeared.
p.000065: The entire set of these elements in combination with peculiarities of the system of health care and medical education
p.000065: determined unique features inherited from the former USSR providing motivation for pharmaceutical companies to conduct
p.000065: biomedical research in the CIS countries. All analytical reviews from all representatives of world pharmaceutical
p.000065: industry interested in conduct of studies made in the beginning of the 90’s of the XX century noted their interest for
p.000065: conduct of biomedical research in this region, first of all, due to the following reasons:
p.000065: - existence of centralized specialized Centres capable of inclusion large number of patients into a study within short
p.000065: term;
p.000065: - epidemiology of infectious and non-infectious diseases in conditions of absence of treatment standards approved
p.000065: for foreign practices (“naïve patients”);
p.000065: - high scientific and medical potential of researchers and research Centres;
p.000065: - knowledge of foreign languages by leading specialists, high quality of documenting;
p.000065: - interest of all stakeholders involved into a research process (state authorities, researchers and research
p.000065: Centres, high degree of trust of patients to medical personnel);
p.000065: - perspectives of future pharmaceutical market and low competitive strength of local pharmaceutical industry.
p.000065: Naturally, these capacities were not evenly distributed in all CIS countries but general trends were explicitly present
p.000065: and determined attractiveness of this region.
p.000065: However, it is necessary to introduce significant correction in the course of events presented above that
p.000065: coincided in time with deep social and economic depression of the initial stage of independence of the CIS countries
p.000065: making them “vulnerable” countries in regard to conduct of biomedical research. This “vulnerability” was
p.000065: characterized with high dependence of all parties indicated above involved into a research process (state agencies,
p.000065: researchers and research sites as well as patients) as to facts of considerable
p.000065: conflicts of interests, direct and indirect pressure due to absence of tangible assets, medicines, work, etc.
p.000065: The mostly civilized response on present situation was transition explicitly marked in all CIS countries to the
p.000065: level of global international interaction in the sphere of biomedical researches (described in details herein
p.000065: in chapters regarded to the CIS member states). Currently the basis of legal regulation of biomedical research in all
p.000065: CIS countries is formed by a set of international legal and recommendation documents among which, first of all, one can
p.000065: emphasize previously mentioned (1.2) Guidelines for Good Clinical Practice (ICH GCP) of 1996. This document
p.000065: along with a set of documents regulating the order of ethical examination to a large extent determined domestic
p.000065: regulation in the sphere of biomedical research in the CIS member states and added to the aforementioned parameters of
p.000065: attractiveness of the region in regard to the biomedical research setup the following features:
p.000065: - compliance with international research standards;
p.000065: - predictability and openness of approval systems;
p.000065: - availability for monitoring, audit and inspection.
p.000065: Activities of IPA CIS and the CIS Council on Cooperation in the Field of Health Care contributed a lot into this
p.000065: process and its unification within CIS identifying unity of views on a range of factors determining modern realia of
p.000065: development of the CIS countries.
p.000065: First of all, one should note that strengthening of health of the population as one of the main priorities
p.000065: for formation of a social state is included into a concept of legal basics and mechanisms for the social state
p.000065: implementation in the Commonwealth countries. Mechanism of state social and technical standard as norms and regulations
p.000065: providing implementation of constitution-guaranteed social rights of citizens and being, at the same time, checkpoints
p.000065: for implementation of social and economical policy of a social state is determined as the most important element of
p.000065: social policy. Value of this statement for the state regulation in any sphere of human activities is extremely high,
p.000065: and in regard to biomedical studies at the state legislative level it introduced an order for regulation on the basis
p.000065: of state standards, which established as highly important the standards for good preclinical, clinical and
p.000065: manufacture practices identical to international standards of GLP, GCP and GMP.
p.000065:
p.000066: 66
p.000066:
p.000067: 67
p.000067:
p.000067: Returning to statements of the aforementioned (1.2) model Law of IPA CIS On Protection of Human Rights and Dignity in
p.000067: Biomedical Researches in the CIS, it is necessary to indicate that even the text preamble of the law
p.000067: states that “the present law introduces state guarantees for protection of human rights, dignity, autonomy and
p.000067: integrity when conducting biomedical studies” and it is based on statements of the Constitution and a set of universal
p.000067: principles proclaimed by fundamental international documents.
p.000067: The sphere of action of the present law is spread on state citizens participating in biomedical research
p.000067: and is applied in regard to all facilities and persons being related to conduct of biomedical research at the territory
p.000067: of the state as well as it stipulates that foreign citizens and persons with absent nationality being present at
p.000067: the territory of the state in case of participation in a biomedical study can enjoy all rights established with
p.000067: the given law equally to citizens of this state. Such statement is quite significant in regard to situation in the
p.000067: CIS region due to openness of borders and notable migration processes.
p.000067: In regard to harmonization both within CIS and at the international level it is important that the law
p.000067: unifies terminology in compliance with GCP-approved definitions creating attitude for mutual understanding and
p.000067: development of a united information field of biomedical research. Some articles of the law stipulate the state
p.000067: policy standard and rights of participants of biomedical studies. Separate chapters are dedicated to study safety and
p.000067: an ethical review system, a format of an informed consent and compliance with confidentiality requirements, therefore,
p.000067: corresponding to the core of all international enactments in the sphere of biomedical research. There is a separate
p.000067: chapter on special situations of the biomedical study conduct including articles regarding biomedical
p.000067: research involving vulnerable persons, research in emergency clinical situations, epidemiological and social
p.000067: studies. In general, force of the law covers all types of biomedical research involving human subjects including the
p.000067: ones with embryos in vivo, but excluding research on embryos in vitro. Liability for breaching the law is also
p.000067: stipulated.
p.000067: Beside regulatory model regulation there is a functioning union for executive authorities of the
p.000067: Commonwealth countries as the Council on Cooperation in the Field of Health Care mentioned above which
p.000067: has the interstate commission on standardization, registration and control of quality
p.000067: of medicinal agents, products for medical use and medical equipment in the CIS member states.
p.000067: By the order of the Council on Cooperation in the Field of Health Care the CIS Executive Committee prepared and
p.000067: submitted final information of regulatory and legal documents in the field of sanitary and epidemiological regulations
p.000067: and provision of sanitary and epidemiological well-being of population in the CIS member states as well as
p.000067: concerning agreements and decisions on provision of coordinated actions of the CIS member states in the field of
p.000067: standardization, registration and quality control of medicinal agents, products for medical use and medical
p.000067: equipment.
p.000067: Acknowledging logic of closeness of conditions and problems of biomedical study conduct in the CIS region
p.000067: the coordinated harmonized actions include not only authorized state agencies but also public entities (for
p.000067: instance, the FECCIS) and professional associations of manufacturers of medicinal agents and pharmaceutical companies
p.000067: working at the market of the CIS member states. Within the framework of activity of the interstate commission on
p.000067: standardization, registration and quality control of medicinal agents, products of medical use and medical equipment
p.000067: along with the CIS Executive Committee there are being prepared documents for harmonization of requirements at all
p.000067: levels of medicinal agent promotion within the region space and globally through collaboration with corresponding
p.000067: international structures.
p.000067: These actions and documents are determinative for strategy of development of mutual cooperation.
p.000067: The world society for a long time acknowledged as one of the most important conditions for success in
...
p.000071: • Research involving healthyXpeople;
p.000071: • Research involving patients.
p.000071: In historical context, the concept of informed and voluntary consent of a research subject requires subdividing
p.000071: into separate groups within these categories
p.000071: Besides, both in healthy (e.g. prisoners and military men) and ill (e.g. persons with mental disorders or ill
p.000071: minors) research subjects, groups of vulnerable contingents should be distinguished, i.e. groups of persons who for
p.000071: social, legal, age-specific, intellectual, mental or other reasons have a limited capacity or do not
p.000071: have the capacity to make an independent, informed and voluntary decision to participate in a clinical research.
p.000071: It is also essential to distinguish different types of biomedical research depending on the character of the connection
p.000071: between the research goal and its actual clinical motivation.
p.000071: Research of the first type, defined in international documents as “therapeutic” (or clinical) biomedical
p.000071: research, implies the application of new diagnostic, therapeutic or preventive pharmaceuticals or methods, i.e.
p.000071: research conducted in the interests of a particular research subject.
p.000071: Research of the second type, defined as “non-therapeutic” (or non- clinical) biomedical research, does not
p.000071: imply actions in the interests of ill or healthy subjects. Biomedical research is carried out with the purpose of
p.000071: obtaining some scientific knowledge or studying how the human organism would respond to one or another condition or
p.000071: factor (pharmokinetic studies, studies in the field of normal physiology, in cosmonautics and sport, etc.).
p.000071: Each of the mentioned types of biomedical research forms and determines special ethical and legal
p.000071: relations. In historical context, the influence of ethical dialectics of each type of biomedical research on the
p.000071: current concept of bioethics is most essential.
p.000071: Thus, high moral principles of physicians (investigators) who conducted experiments on themselves gave rise to a symbol
p.000071: of heroic dedication - a “burning candle”, which personified the motto of medical profession “Aliis lucens uror”. The
p.000071: history of medicine knows many examples of heroic dedication to science, self-sacrifice and modesty. Often
p.000071: those experiments ended tragically and entered the chronicle of “tragic medicine” in the world history. Among
p.000071: devotees there are many physicians (investigators) representing peoples of the CIS countries, which is
p.000071: reflected in chapters describing the cultural and historical background of ethics development in each
p.000071: country. On the whole, the scientific feat of those people is of a supranational character, and arouses feelings of a
p.000071: deep respect and admiration. Their work served the purpose of scientific knowledge, saving people’s life and making
p.000071: achievements for the welfare of the humankind.
p.000071: Inhuman experiments on concentration camp prisoners carried out on an appallingly large scale and sanctioned by the
p.000071: state law of the Nazi regime arouse opposite emotions, and the very word “experiment” with regard to a human being has
p.000071: a dismal echo.
p.000071: However, the development of biomedical research is based not only on those polar, in terms of ethics, examples.
p.000071: International standards of implementation into the medical practice of new therapeutic, diagnostic and preventive
p.000071: pharmaceuticals and methods, as well as their scientific and moral resonance are reflected in historical stages of
p.000071: setting out legal concepts of bioethics.
p.000071: Currently, the list of international recommendations, declarations, codes, resolutions and other documents relating to
p.000071: bioethics is very extensive, and in the last decades it has a tendency to increase.
p.000071: One of the most important events in the history of bioethics in the XX century was the Nuremberg Code adopted by
p.000071: the International Military Tribunal in 1947. When commenting on this historical document, the world press emphasized
p.000071: that the accusatory sentence of the Nuremberg Trial “speaks on behalf of insulted human conscience”. The
p.000071: Nuremberg Code was the first document based on the “judgment of the victorious truth”, which declared the
p.000071: cardinal ethical principles with regard to an individual and stimulated the growth of public awareness and peoples’
p.000071: responsibility.
p.000071: Among international documents in which the ethical principles in medicine and their actual application were
p.000071: further developed, the Declaration
p.000071:
p.000072: 72
p.000072:
p.000073: 73
p.000073:
p.000073: of Helsinki is certainly the most important. It was adopted by World Medical Association in 1964, and has been
p.000073: continuously revised and updated.
p.000073: Recognizing the key role of the Nuremberg Code and the Helsinki Declaration with regard to ethical
p.000073: regulation of biomedical research, we should mention also some important documents that set up a kind of
p.000073: a base for those, and a number of documents facilitating the development and interpretation of the
p.000073: general principles set out in the Declaration of Helsinki and its actualization in connection with new
p.000073: conditions caused by the progress in biology and biomedicine in the last decades of the XX and in the beginning of the
p.000073: XXI century.
p.000073: The current concept of ethical regulation of biomedical research, asserting that an individual, and the
p.000073: society as a whole, has the right to benefit from scientific achievements and must be safeguarded against any
p.000073: risk or damage, developed only by the middle of the XX century. However, international community has also
p.000073: recognized some documents written in the end of the XIX and in the beginning of the XX century. Among
p.000073: the XIXcentury documents there Ethical Codes by Thomas Percival (Great Britain, 1803); William Beaumont (USA,
p.000073: 1833) и Claude Bernand (France, 1865).
p.000073: Dr. S. Fluss, the Scientific Councilor at the Council for International Organizations of Medical Sciences (CIOMS), in
p.000073: his historical analysis of materials relating to the ethics of medical research involving human subjects developed in
p.000073: the XX century, before the Declaration of Helsinki, mentions about 15 documents adopted in Germany (1900, 1931), USSR
p.000073: (1936, 1949),
p.000073: Netherlands (1955), Great Britain (1962-63) and Sweden (1963).
p.000073: Among significant international documents adopted in the period before the Declaration of Helsinki, we should mention
p.000073: the International Code of Medical Ethics (WMA, London, 1949). It states: “the physician shall act in the patient’s best
p.000073: interest when providing medical care that is to improve the patient’s physical and mental health”. Declaration of
p.000073: Geneva Adopted by the 2nd General Assembly of the World Medical Association (Geneva, Switzerland, September 1948)
p.000073: defined the physician’s duty: “The health of my patient will be my first consideration”.
p.000073: These canons of the physician’s behaviour entered the Preamble of the Declaration of Helsinki, which proves the
p.000073: significance of the abovementioned documents.
p.000073: Below is the chronology list of main documents aiming at developing ethical principles of biomedical research:
p.000073: • International Covenant on Civil and Political Rights adopted by the General Assembly of United Nations (UN, 1996)
p.000073: to enforce the “Universal Declaration of Human Rights” (General Assembly of United Nations, 1948);
p.000073: • International Ethical Guidelines for Biomedical research Involving Human Subjects (CIOMS in collaboration with
p.000073: WHO, Geneva, 1982);
p.000073: • International Guidelines for Ethical Review of Epidemiological Studies, СIOMS (Geneva, 1991);
...
p.000075: Senate of Russia endorsed the findings of the lower court, stating that “not obtaining the patient’s consent for
p.000075: surgery deprives medicine of its legal character and is the sign of overt neglect, giving the doctor’s deed the status
p.000075: of a criminally culpable act”. Already at that time, it had been accepted that a patient’s consent to a medical
p.000075: intervention should be sought (Tregubov “Ugolovnaia otvetstvennost vracha za vrachevanie bez soglasia bolnogo”
p.000075: (Physicians’ Criminal Liability for Treating the Patient without His Consent) St.-Petersburg, 1904, No. 12), and that
p.000075: the patient may make a conscious decision. According to the famous professor of criminal
p.000075: law, Tagantzev, “the patient’s consent is not always sufficient to prove that any particular case of medical
p.000075: practice is not indictable” (Pravo (Law) Journal, 1902, No. 12).
p.000075: An understanding of the ethical and legal issues with regard to organ transplantation and the necessity to obtain a
p.000075: written and documented consent from the donor and the recipient, as in a case described by the Dr B.V.Dmitriev in the
p.000075: beginning of the XX century (Medicinskoe Obozrenie (Medical Review) 1917, vol. LXXXVII, No. 13-14-15-16,), to a
p.000075: large extent reflects the modem view of the basic moral principles of biomedical research. Dr. Dmitriev sets out some
p.000075: other ethical norms of such surgical operation. The donor and recipient should be informed about potential consequences
p.000075: of the surgical intervention; there are requirements concerning the donor’s mental and physical health; the physician
p.000075: should guarantee that the harm done to the donor would be mild and transient. Dr. Dmitriev’s article contains
p.000075: a unique text, an early example of a carefully designed a patient’s informed consent form that is still valid today.
p.000075: It deserves to be quoted in full.
p.000075: “I, the undersigned E.R, by myself, without any external influences, offered a piece of my thyroid gland for
p.000075: transplantation. The piece would be of the size required for successful transplantation (approximately up to one eighth
p.000075: of the gland’s volume). I have had all the details explained to me and I am aware of all the risks I am subject to,
p.000075: i.e.:
p.000075: 1) as a result of an unsuccessful operation life-threatening bleeding can occur,
p.000075: 2) suppuration of neck and even blood contamination can follow which can result even in death.
p.000075: I was told that the effect of the operation on the human health is not yet known, because this operation is very rarely
p.000075: performed, and that in the books where it is described it is not stated how the people from whom pieces of thyroid
p.000075: gland were taken felt themselves, but experiments on animals prove that one can remove up to two-thirds of the thyroid
p.000075: gland without doing any harm to the animal, and that because with respect to the thyroid animals and human beings are
p.000075: similar, these conclusions are probably applicable to humans as well; and indeed, when the tumors of thyroids are
p.000075: removed, it can be enough to preserve a very small portion of it so that the person can continue living without
p.000075: experiencing troubles related to the absence of the thyroid gland. I am also aware how a shortage of thyroid gland
p.000075: affects the human.
p.000075:
p.000076: 76
p.000076:
p.000077: 77
p.000077:
p.000077: Then I was told that although I will have analgesic medicine injected under the skin for pain relief, I will
p.000077: possibly feel some pain during the surgery and afterwards. And finally, it was explained to me, that in the case
p.000077: of successful operation or especially if the wound suppurates I will have a scar for life on my neck about 7.5-10 cm
p.000077: long. And, despite all the facts mentioned above, I agree to the surgery, and whatever happens, I will never have any
p.000077: claims either against the doctors who will perform the surgery, or the patient who will receive my thyroid gland. I am
p.000077: signing this paper in the presence of doctors B.V.Dmitriev, E.K.Vinakurova, M.P.Alexeev and the nurse
p.000077: E.V.Shevchenko (signature); we witnessed the reading and signing of this paper and hereby certify that E.P. is an adult
p.000077: and mentally capacitated person (signatures of doctors and nurse)”.
p.000077: This document dated 1917, contains all elements of current ethical concept relating to biomedical
p.000077: research: confidentiality, respect for a person’s autonomy, information about all risks associated with the
p.000077: research, freedom of a voluntary choice, verification of the research subject’s social and mental maturity.
p.000077: All statements in Dmitriev’s article base on a legal concept of a famous lawyer A.F.Kony who testified to the
p.000077: absence of criminal deed in the case of the sale of organs for treatment purposes in accordance with the contract
p.000077: between the donor (seller) and recipient (buyer). At the same time he noted that “under these circumstances the
p.000077: only ethical issue that might arise concerned the permissibility of such a deal in a situation where the
p.000077: “seller” was a minor, imbecile, or a person in a state of artificial excitation, and where the “buyer” was a
p.000077: person who acted through psychological compulsion, deception, seduction, promise of profit or suggestion by authority.
p.000077: On the whole, the analysis of legal and ethical principles referring to biomedical research existing in the tsarist
p.000077: Russia in the beginning of the XX century shows that humanistic concepts of a voluntary and conscious choice made by
p.000077: the research subject and confidentiality have been combined with a responsible and merciful attitude on the part of a
p.000077: physician-investigator, and reinforced with accepted moral and ethical norms and legislative acts in force.
p.000077: Turning to a more recent period in national history, the following stages of Soviet law development illustrate how the
p.000077: issues in ethical and legal regulation of medical and biological research were interpreted in the USSR.
p.000077: In the law of the Russian Soviet Federal Socialistic Republic (RSFSR) on 1 of December 1924 “On the Professional
p.000077: Activity and Rights of Health Professionals” the need to obtain the patient’s consent, in particular when surgery is
p.000077: being planned, was declared. It was also stated that “with respect to those under 16 years of age or mentally disabled,
p.000077: the consent of their parents or care-givers”, i.e., their legal representatives, was necessary. Similar laws were
...
p.000079: representative’s consent prior to enrollment of the patient)” - this term of the Statute corresponds to the ethical
p.000079: principles formulated in articles 15, 20, 22
p.000079: and 24 of the Declaration of Helsinki;
p.000079: “when it is conducted after preliminary animal experimentation which is necessary and possible based on modern
p.000079: scientific data” - this term corresponds with article 11 of the Declaration of Helsinki;
p.000079: “any use of new medicines and methods defined in the present Statute should be documented in detail by the physician.
p.000079: The doctors in-charge of the institutions where the research is being conducted must report the results of the
p.000079: research”.
p.000079: As a whole, the Statute of 1936 was the first legal act of the Soviet health care system, which regulated the rules and
p.000079: conditions of the conduct of biomedical research, and defined the responsibility for observation of such
p.000079: regulations. As to its contents, the Statute illustrates a number of cardinal principles regulating the modem
p.000079: practice of biomedical research. However, the Statute did not declare the need to establish ethics committees, nor
p.000079: emphasize the need for independent ethical review, and the decisions on
p.000079: both professional and ethical aspects of the review were still the responsibility of the institutional organizations.
p.000079: On the whole, the significance of all these documents (considering their content and the time when they
p.000079: had been adopted) consists in the fact that the requirements concerning scientific justification and
p.000079: preliminary experiments on animals, research participants’ informed and conscious consent, high qualification of a
p.000079: physician-investigator and his responsibility in relation to research subjects fully coincide with modern norms of
p.000079: research ethics. The other important and positive aspect with regard to the analyzed documents is that the
p.000079: motivation to create those and their content has a protective legal character.
p.000079: At the same time, it should be noted that the Soviet legislation had a legal mechanism for the attribution
p.000079: of criminal liability for committing “crimes against Humankind”. (Decree of Presidium of the Supreme Council of the
p.000079: USSR on 19 of April 1943. Art. 1). There is an important historical document that reflected moral and legal
p.000079: understanding of experiments on live human beings – the protocols of a legal action conducted by the Military Tribunal
p.000079: of the USSR in Khabarovsk in 1949. It concerned the case of former Japanese military men accused of the development and
p.000079: use of biological weapons (“Indictment on the case of the former Japanese military men”; a supplement to Novoe Vremia
p.000079: (New Time) Journal, No 1, 1 of January 1950). The importance of the Conclusion adopted by the Tribunal in Khabarovsk is
p.000079: comparable with the importance of the Nuremberg Trials and the Code adopted there. In both cases the moral aspects of
p.000079: decisions concerned not only the individuals guilсссty of the crimes, but also the governmental policy and
p.000079: ideology which made these crimes possible.
p.000079: In the context of this Chapter the above documents are mentioned for the following purposes:
p.000079: • to eliminate informational vacuum existing in relation to the ethics of biomedical research in the former Soviet
p.000079: Union;
p.000079: • to clarify the reason of including the abovementioned documents into the international list on important documents
p.000079: of “pre-Helsinki” era to the CIOMS list;
p.000079: • to illustrate mutually enriching and complementary values of studying fundamentals of moral and cultural
p.000079: heritage;
p.000079:
p.000080: 80
p.000080:
p.000081: 81
p.000081:
p.000081: • to define the basis for a timely and harmonious assimilation of international universal norms of
p.000081: biomedical research ethics by the CIS countries.
p.000081: Summarizing the data on the ethical component of biomedical research at the time of the Soviet Union
p.000081: disintegration and formation of new independent states in the end of the nineteenths of the last century, we have
p.000081: to state that there existed efficient moral and ethical norms of medical practice and the governmental system
p.000081: regulating biomedical research. Although there were separate cases of establishing ethics committees at
p.000081: medical centres taking part in international studies, those were but of a “decorative” or “declarative” character, as
p.000081: they were established to meet the requirements of foreign pharmaceutical companies and did not have a legal status.
p.000081: The actual process of entering into the international system of ethical review began for the CIS countries also in the
p.000081: nineteenths of the last century. The rhythm and procedure for different CIS countries depended on their
p.000081: involvement in international biomedical research. As to the documents and international regulations that formed
p.000081: the basis for the development of national legislation, they were quite comparable. Materials presented for this
p.000081: book by the CIS country show all the details (See Chapter 3).
p.000081: To analyze common and specific features in the CIS region with regard to the topic, we have chosen key elements of the
p.000081: ethical concept of biomedical research. According to the interpretation of a number of international (adopted
p.000081: in the CIS countries) and national documents that have been usually developed on the basis of existing
p.000081: national legislation, the ethical review of biomedical research is performed by independent bodies – ethical committees
p.000081: (ECs). The ECs activity aims at protecting research subjects’ rights, well-being and health, as well as at providing
p.000081: additional guarantees of this protection through the review of research protocols, amendments to research protocols and
p.000081: the procedure of obtaining and documenting research subjects’ informed consent. The review is concluded with the EC
p.000081: decision relating to the proposed research project. The subject of the ethical review is the research compliance with
p.000081: ethical and legal requirements regulating biomedical research and set out in documents of various status and
p.000081: application sphere. Statements relating to a potential research subject’s voluntary consent to participate in
p.000081: the research, to providing adequate information on
p.000081: all aspects of the research and to confidentiality of all patient’s data obtained in the course of the research are of
p.000081: crucial importance.
p.000081: Here is seems reasonable to review main characteristics of these two elements of biomedical research ethics in the CIS
p.000081: countries and to determine perspectives for their development.
p.000081: When analyzing the situation in the CIS countries with regard to ECs activity and its compliance with standards of
p.000081: ethical review of biomedical research the following main problems should be mentioned:
p.000081: • usually there is no accurate distinction as to ECs functions, which creates potential conditions for the
p.000081: redoubling of the review and decisions;
p.000081: • ethical review conducted only at the level of the national EC (in some CIS countries) hampers the analysis of a
p.000081: specific character of a particular research centre and limits opportunities of a dynamic monitoring of ongoing
p.000081: research;
p.000081: • we cannot exclude cases of administrative and economic dependence of local EC on interests of research centres as
p.000081: they are highly motivated to conduct a research;
p.000081: • usually there is no legal system of appeal with regard to the EC decisions;
p.000081: • the lack of detailed regulations concerning EC financing;
p.000081: • the lack of state inspection of the EC activity;
p.000081: • the lack of demand for ethical review on the part of research subjects;
p.000081: • the lack of a regular state system for training EC members.
p.000081: The mentioned problems determine the leading trends in the development of the system of the EC performance and
p.000081: structure in the CIS countries:
p.000081: • to develop legislation ensuring the EC independent performance;
p.000081: • to separate power (responsibilities and rights) in the performance of EC on different levels (national, regional,
p.000081: local);
p.000081: • to create the system of EC interaction inside the country and on the international level;
p.000081: • to develop the demand for ethical review in all research subjects;
p.000081: • to eliminate informational vacuum with regard to issues of the protection of human rights and dignity in
p.000081: biomedical research;
p.000081: • to create an educational and informational programme on bioethics for medical professionals and other persons
p.000081: associated with the research;
p.000081:
p.000082: 82
p.000082:
p.000083: 83
p.000083:
p.000083: • to develop a special system for training EC members;
p.000083: • to introduce the practice of the state inspection and independent audit of EC performance;
p.000083: • to develop legal regulations for the EC economic activity.
p.000083: The analysis of the current state from the viewpoint of the principle of obtaining research subjects’ informed
p.000083: consent shows that a principal achievement of the CIS countries is a legal regulation of this procedure.
p.000083: Among issues requiring a further development we should mention first the need to work out guidelines and norms for
p.000083: interpreting separate statements in legislative acts, terms of their application and their harmonization with norms of
p.000083: international law in the field of bioethics. There is a particularly urgent need to create bioethics information
p.000083: field with potentials for a differential education of various population groups aiming at raising the
p.000083: level of public knowledge about human rights and moral responsibility in biomedical research.
p.000083: In the history of establishing a system of ethical review and ethics committees in the region the
p.000083: performance of the mentioned Forum for Ethics Committees in the Commonwealth of Independent States takes a
p.000083: special place as a public movement aiming at fulfilling this task in the region via creating a possibility for the
p.000083: access to the world experience in the development of ethical concept of biomedical research considering national
p.000083: cultural and moral values.
p.000083: The FECCIS was established on 21 of March 2001 according to the Resolution of the Conference for representatives of
p.000083: ethics committees and others authorized bodies from the CIS countries held in Saint-Petersburg, Russia. The FECCIS is
p.000083: one of the five regional forums, established in the framework of the WHO/SIDCER project.
p.000083: Sharing the basic priorities of the SIDCER project referring to the protection of human rights and dignity in
p.000083: biomedical research all over the world with respect to cultural, historical, religious and social differences, the
p.000083: FECCIS has defined as its the main objective to support the development of bioethics in the region with an emphasis on
p.000083: ethics of biomedical research involving human subjects.
p.000083: Over the period 2001-2006, the FECCIS activity has been directed to developing legislative and normative
p.000083: system in the field of research ethics, working out and implementing educational programmes for the EC
p.000083: members, developing informational space and a dialogue with all interested parties participating in the review of
p.000083: biomedical research.
p.000083: With regard to the legislative initiative, FECCIS, as mentioned above, has been concentrating its efforts on
p.000083: working out a legislative basis for protecting human rights in biomedical research through collaboration with the
p.000083: Permanent Commission on Social Policy and Human Rights of the Inter– Parliamentary Assembly of the Confederation of
p.000083: the Independent States. This collaboration resulted in the development of the IPA CIS model Law ‘On the Protection
p.000083: of Human Rights and Dignity in Biomedical Research in the CIS’ adopted in 2005 (see Chapters 1.2 and 2.2). In
p.000083: collaboration with the Permanent Commission on Science and Education of the IPA CIS the FECCIS worked out Model
p.000083: recommendations “ On Ethical and Legal Regulation and Safety of Medical Genetic Research in the CIS “.
p.000083: An important direction of the FECCIS activity is the development of mechanisms, fundamentals and conditions for an
p.000083: internal monitoring and independent surveying, and evaluating the EC performance, to ensure a due quality of ethical
p.000083: review.
p.000083: This direction of the FECCIS activity includes working out the Collection of model Standard Operational
p.000083: Procedures. Independent and competent representatives of the CIS countries and experts from all over the world took
p.000083: part in this work. Consultations, discussions and analysis of the main statements on the establishment,
p.000083: structure and operation of EC and advanced methods of ethical review in international practice laid the foundation for
p.000083: a dynamic development of standards and criteria for EC activity that are described in this book.
p.000083: The integrity of the model SOPs is achieved through the use of universal terminology, commonly accepted norms of
p.000083: bioethics reflected in documents that have been used and a consistent description of the EC operation at
p.000083: different stages and in different situations of ethical review of biomedical research.
p.000083: The Collection of model SOPs prepared at the FECCIS Secretariat is to become an available practical
p.000083: manual on working out SOPs as a universal instrument for achieving professionalism, openness, pluralism and
p.000083: independence of the EC practices and for ensuring a common methodological space for the CIS countries and the world
p.000083: community, which will facilitate the protection of rights and dignity of individuals and communities in
p.000083:
p.000084: 84
p.000084:
p.000085: 85
p.000085:
p.000085: biomedical research. The process of SOP implementation was accompanied with a thorough consideration for specific
p.000085: features and the potential of their practical applications. The Collection of model SOPs was presented and
p.000085: discussed at the FECCIS Workshops in St.-Petersburg, Russia (2003); Kiev, Ukraine (2004, 2006); Minsk, Republic Belarus
p.000085: (2005). Two editions of the Collection of model SOPs were published in 2004 and 2005. The development and
p.000085: publication of the Collection of model SOPs stimulates writing national manuals and methodical standards for ECs
p.000085: functioning on different levels. Publication of methodical guidelines in Ukraine (2006, in Ukrainian) is one of the
p.000085: examples.
p.000085: The other priority in the FECCIS activity is the design and development of educational programmes for training EC
p.000085: members that could be integrated into national programmes of professional education of cardinal problems of bioethics.
p.000085: The programmes can also be helpful in formation of a database on practical teaching materials referring to biomedical
p.000085: research ethics.
p.000085: To form the database, national programmes on bioethics adopted in the CIS countries have been displayed in the FECCIS
p.000085: website. New programmes have been developed by a FECCIS working group headed by professor
p.000085: B.G. Yudin in the framework of the Fogarty grant. Representatives of five CIS countries have attended the course
p.000085: “E-Education in Research Ethics: Central and Eastern Europe” organized by Albany Medical College (USA) in partnership
p.000085: with the Department of Medical History and Ethics of Vilnius University (Lithuania) and sponsored by the Fogarty
p.000085: International Centre.
p.000085: A special attention has been paid to a direct participation in organizing and conducting training seminars for the EC
p.000085: members in the framework of the SIDCER “Recognition Programme”. The Project objective is to promote the highest ethical
p.000085: and scientific standards of conducting ethical review of biomedical research. The Project includes the procedure
p.000085: of the EC self- evaluation, preparation for a follow-up survey and the survey that results in granting the
p.000085: “Recognition” status if the EC meets the standards of ethical review. The EC members are trained according
p.000085: programmes including lectures and seminars in working groups. Programmes offer the following Modules: “Human Subject
p.000085: Protection”, “Standard Operational Procedures” and “Inspection and Survey of the Ethics Committee”. This
p.000085: Project is actually the first stage of implementing the system of the EC accreditation, certification and survey in
p.000085: the CIS countries.
p.000085: Organization of 17 international seminars and conferences in 8 of 11 CIS countries has been very important with regard
p.000085: to the formation of the common informational field. Conference and seminars have been held in cooperation with
p.000085: different national and international structures. Conference materials have been published in Russian, English and
p.000085: national languages of the CIS countries.
p.000085: The conferences and seminars aimed at exchanging information and discussing topical issues of the development
p.000085: of regulation and educational standards relating to the protection of research participants’ rights, to the development
p.000085: of national systems of ethical review and to the creation of a harmonized legislation and methodology referring to
p.000085: biomedical research ethics both in the CIS region and in the global international space.
p.000085: Due to the development of these main initiatives, the following has been achieved and accomplished:
p.000085: • information exchange in the field of bioethics in the CIS region;
p.000085: • the analysis of issues relating to bioethical education in the region;
p.000085: • an open access to and discussion of international documents and guidelines on bioethics and research
p.000085: ethics (translation into national languages);
p.000085: • implementation of SOPs into the process of ethical review;
p.000085: • stimulation of efforts directed towards the development of national systems of ethical review in compliance
p.000085: with the GCP standards and international guidelines;
p.000085: • assistance in the organization of the EC members education and training in the region;
p.000085: • the EC preparation for the survey and evaluation of their performance;
p.000085: • raising the EC authority and their role in the development of international standards concerning the
p.000085: protection of research subjects’ rights;
p.000085: • assistance in the development of national Forums for Ethics Committees in the CIS countries;
p.000085: • the evaluation of the current legislation referring to the protection of human rights in biomedical research and
p.000085: medical practice in the region;
p.000085: • the performance as a regional centre for cooperation in the field of ethical review development;
p.000085:
p.000086: 86
p.000086:
p.000087: 87
p.000087:
p.000087: • assistance in the practical application of the SOPs for ethical review in the region in compliance with
p.000087: Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO, 2002);
p.000087: • coordination of the CIS countries in the sphere of bioethical issues and ethical review of biomedical research in
p.000087: the region.
p.000087: Summarizing the above said we should recognize that the history of the development of the system for ethical review of
p.000087: biomedical research in the CIS countries is a dialectic process of ethical and legal development of the national
p.000087: consciousness and legislation directed towards protecting rights, dignity and autonomy of an individual as a
p.000087: biomedical research subject, and providing moral and ethical guarantees to the society that biomedical research is
p.000087: conducted in a strict conformity with universal ethical standards.
p.000087: Chapter 3. EtHICAL REVIEW SYStEM FoR BIoMEDICAL RESEARCH
p.000087: In tHE CIS CoUntRIES
p.000087:
p.000087: 3.1 REPUBLIC oF ARMEnIA (G.D.Aslanyan, S.A.Davtyan)
p.000087:
p.000087: 3.1.1 Historical and Cultural Background
p.000087:
p.000087: Like any new field of knowledge related to the rise or appearance in the foreground of some new realities in the life
p.000087: of our society, bioethics needs to be considered first of all from the historical, cultural and religious perspective.
p.000087: Republic of Armenia is rich in objects of unsurpassed art. There are over 4000 monuments of architecture at the
p.000087: territory of today’s Armenia. “Armenian history, – wrote Valery Briusov, a Russian poet, – is as noteworthy as the
p.000087: history of the most famous peoples of the world, including Egyptians and peoples of today’s Europe, who made their
p.000087: unique contributions into the world culture”.
p.000087: “If asked in what place of the world one is likely to find the greatest number of wonders, I would name Armenia first
p.000087: of all. Here, in this tiny
p.000087: corner of the world, you can see monuments and meet people which can become treasure and pride for the world” (Rockwell
p.000087: Kent).
p.000087: Although much of cultural and artistic wealth of Medieval Armenia, including manuscripts, had been destroyed over ages
p.000087: by different invaders, around 24 thousands of manuscripts have survived to our time, and about half of them is
p.000087: currently kept at the Matenadaran Institute of Ancient Manuscripts named after Mesrop Mashtots in Yerevan. According to
p.000087: historian Ghazar Parbetsi (V c.) that was the most ancient collection formed already in the Vc. in Echmiadzin
p.000087: Patriarchy. One third of the survived manuscript collection is illuminated manuscripts. Among those, many concern
p.000087: problems of ethics, morals and law.
p.000087: Armenian culture roots back to the great antiquity, which is proved by numerous petroglyphs in Armenian Plateau,
p.000087: stone and bronze statuettes, skillfully decorated wooden carts, ornamented arm, ceramic and glass ware. In
p.000087: the beginning of the IX century B.C. these cultural strata related to the rise of Urartu art with its remarkable
p.000087: monuments of architecture, wall
p.000087:
p.000088: 88
p.000088:
p.000089: 89
p.000089:
p.000089: painting, sculpture and domestic ware. One of the art Centres was the town of Yeribuni (Yerevan) founded 3000 years
p.000089: ago.
p.000089: A powerful development and expansion of Armenian State in the Hellenic period, direct contacts with the
p.000089: Hellenic world and Roman Empire determined a rapid development of Armenian Hellenic culture, and many masterpieces
p.000089: survived up to now. Among those there are majestic colossal sculptures erected by the Yervadian dynasty on the Nemrut
p.000089: mountain, a cast bronze head of the goddess Anahit (nowadays in the British Museum), coins with portraits of Armenian
p.000089: tsars and rulers (starting from IV century B.C.), ornaments of a heathen temple and mosaic floor of a bath-house in
p.000089: Garni.
p.000089: Adoption of Christianity (III century) imparted new content and new trends to Armenian art. Antique steles were
p.000089: transformed into an entirely new sculpture style: “khachkary” (cross stones). These marvelous stone plates with tracery
p.000089: all over the surface surrounding carved crosses were erected as headstones or in honor of outstanding people or events.
p.000089: In medieval Armenian painting, alongside with frescoes, book illustrations (miniatures) are of great value. We find
p.000089: them in thousands of manuscripts starting from the VI century. Highly developed and widely spread art of
p.000089: Armenian miniature had its Centres (Van, Cilicia, Gladzor et al.). There were original schools representing different
p.000089: trends of one national style. Among miniaturists Toros Roslin (the XIII century) was particularly famous, in whose
p.000089: miniatures one may see many features of the Renaissance art.
p.000089: Armenian classical medicine that emerged in the great antiquity based on the experience of folk medicine during its
p.000089: centuries-old history had come a long way from empiricism to scientific knowledge. Being closely connected at the dawn
p.000089: of its development with the experience of traditional systems of the East (Mesopotamia, Egypt and India), later, in the
p.000089: period of establishing scientific basics of medicine, Armenian classical medicine had a beneficial impact from
p.000089: antique science. The influence of antique philosophers and physicians (Plato, Aristotle, Empedocles,
p.000089: Hippocrates and Galen) on the development of Armenian classical medicine was particularly strong. Due to the active
p.000089: translation from Greek language, during the period of the V- VII centuries texts of antique scientists had been
p.000089: translated into Armenian. Those texts inspired medieval Armenian physicians and naturalists, e.g. Grigor
p.000089: Magistros (X-XI c.), Mekhitar Heratsi (XII c.), Amirdovlat Amasiatsi (XV c.) et al.
p.000089: It is noteworthy that great Armenian philosophers (David the Invincible, Anania Shirakatsi et al.) placed high
p.000089: emphasis on the problems of good and evil, suffering and compassion, life and death. They considered those issues
p.000089: in light of Christian morals. Today Armenian Apostolic Church is continuing this tradition. Suffice it to say,
p.000089: that the Ararat Eparchy with its rich experience in propagating ideas of bioethics is planning to establish a Church
p.000089: Public Council for Medical Ethics. Armenian Apostolic Church takes a rather strict position on some problems of
p.000089: bioethics: it prohibits human cloning and cloning of human organs, euthanasia, artificial fertilization and abortion,
p.000089: which is considered as infringement of human life.
p.000089: In this context the views of David Anhaght (the Invincible) formulated in his works (“Definition of Philosophy”,
p.000089: “Commentary on Aristotle’s Analytics” and “Commentary on Porphyry’s Introduction”) are of much interest.
p.000089: David Anhaght took problems of medical ethics very much to heart. His ideas on the value of human life are of
p.000089: particular importance. In his book “Definition of Medicine” he mentioned views of the Stoics who tended to justify
p.000089: suicide under certain conditions: starvation, loss of close relatives, natural cataclysms, violation of human dignity,
p.000089: terminal illness and senile marasmus. Two last cases are directly related to medicine. The Stoics wrote: “A man who
p.000089: kills himself to rid himself of pain in his ill and wretched body, commits the righteous act. Thus, a philosopher
p.000089: who was half-paralyzed appealed to the emperor Julian: Half of my body is dead; the other half is still alive. Have
p.000089: pity on the half-alive philosopher and order either to heal or to kill me. Likewise, it would be right for a man who
p.000089: had reached old age to kill himself when he is delirious, confused and utters meaningless phrases”.
p.000089: David Anhaght did not share Stoic views on permissibility of suicides under conditions mentioned: “In this regard
p.000089: we say that no one should kill oneself – neither those who have the right to do this, nor those who don’t… Trials,
p.000089: whenever or wherever they happen, come to us not in order that we should kill ourselves, but so that we tried our soul.
p.000089: Like a good helmsman is tested not in still water, but in the stormy sea, the lofty soul goes to meet a trial”.
p.000089: Thus David Anhaght (the Invincible), in line with Nerses the Great, a prominent philosopher (V c.), gave a negative
p.000089: answer to the question “Does the physician have a moral right to hasten his patient’s death?”.
p.000089:
p.000090: 90
p.000090:
p.000091: 91
p.000091:
p.000091: Similar views we find in works of Armenian thinkers Mkhitar Hosha and Smbat Hundstabl (XIII c.). In “The Book
p.000091: of Laws” we read: “The physician who deliberately or through ignorance does harm to the patient’s health or, what
p.000091: is more, hastens the patient’s death, as well as the physician who educates a disciple, but does not give him proper
p.000091: knowledge deserves a severe punishment, up to death penalty”.
p.000091: This discussion started many ages ago is still topical nowadays. Neither lawsuits against physicians who
p.000091: support euthanasia thus violating one of the fundamental principles in The Hippocratic Oath (“To please no one will I
p.000091: prescribe a deadly drug nor give advice which may cause his death”), nor protests of public at large advocating
p.000091: traditional views do not guarantee that those who stick to more radical opinions will not triumph in the near future
p.000091: (alas!).
p.000091: Philosophical moral principles of the Hellenistic world had a great influence on the moral code of
p.000091: medieval Armenian medicine along with the highest values of the Christian ethics. The physician who violated The
p.000091: Hippocratic Oath and gave his patient “a deadly drug” was not merely reproached for that but treated as a
p.000091: criminal guilty of an innocent person’s death with all the corresponding consequences, as stated in the chapter “On
p.000091: Physicians Prescribing Deadly Drugs” in “The Book of Chrii”.
p.000091: In his treatise “The Usefulness of Medicine” Amirdovlat Amasiatsi, an outstanding Armenian physician (XV c.) writes:
p.000091: “The physician should be reasonable and have the sense of duty; he should be tolerant and ready to give advice. In no
p.000091: circumstance should he be a drunkard nor should he be greedy and mercenary-minded. He should love the poor and be
p.000091: merciful, faithful and god-fearing. If he does not understand the essence of the disease he should
p.000091: prescribe no drug in order not to stain his reputation. If the physician is ignorant it would be better not to call him
p.000091: to see a patient, and, in general, he should not be regarded as a physician.” These words showing an ideal image of the
p.000091: physician-humanist and his moral code are still essential for modern medicine that synthesized imperishable moral
p.000091: values set forth in medical systems of the East and the West.
p.000091: Today, each of the presented problems gives rise to many new questions. At the present stage of bioethics development
p.000091: we are more able to formulate the questions than to offer a comprehensive solution, and therefore most of them remain
p.000091: open.
p.000091: References
p.000091: 1. Amirdovlat Amasiatsi. The Good of Medicine. Yerevan, 1940, p. 9 (in Armenian).
p.000091: 2. Arevshatyan S.S. Early Armenian Translations and Their Cultural and Historical Significance. // Journal of
p.000091: History and Philology of Academy of Sciences of Armenian S.S.R. 1973, No 1, p. 23-37 (in Armenian).
p.000091: 3. Vardanyan S.A. Medical and Biological Views of David the Invincible. / Philosophy of David the
p.000091: Invincible. Moscow, 1984, pp. 83-93 (in Russian).
p.000091: 4. David Anhaght. Works. Moscow, 1980, pp. 84, 77, 71, 49, 72, 44, 75,
p.000091: 61, 63, 65 (in Russian).
p.000091: 5. Oganesyan L.A. The History of Armenian Medicine. Yerevan, 1946, Vol. 1, pp. 85-127, 141-143 (in Russian).
p.000091: 6. Vardanyan Stella. History de la medicine en Armenia. Paris, 1999. pp. 43-52.
p.000091: 7. Vardanyan S. Medicine and Philosophy in Early and Medieval Armenia. In: Collection of Scientific Works.
p.000091: Yerevan, 2005, pp. 644-647 (in Russian).
p.000091: 8. Informed Consent. UNESCO Chair in Bioethics, Editor: Prof. Amnon Carmi. – Israel, 2003.
p.000091: 9. Davtyan S.A. The Problem of Implementing New Approaches in the Process of Teaching Traditional Ethics and Bioethics.
p.000091: In: The Process of Implementing New Teaching and Scientific Technologies. Yerevan, 2003, pp. 40-42 (in Armenian).
p.000091: 10. Davtyan S. The traditions, customs, culture, and mentality of the nation and problem of Eutanasia in Armenia.
p.000091: Eilat, Israel, 2002, p. 10.
p.000091:
p.000091: 3.1.2 Legal Regulations
p.000091:
p.000091: Biomedical research and, particularly, a clinical trial is a complicated process requiring not only heavy financial and
p.000091: intellectual costs, but also a competent approach to research planning in order to obtain eventually a safe and
p.000091: effective pharmaceutical product or method.
p.000091: The development and study of new pharmaceutical products is impossible without research involving
p.000091: human subjects, and here we face two main problems. On the one hand, we have to obtain reliable data on
p.000091:
p.000092: 92
p.000092:
p.000093: 93
p.000093:
p.000093: the efficiency and safety of any new drug or method, while; on the other hand we must not expose human subjects
p.000093: participating in the research to an excessive risk.
p.000093: Modern rules of conducting clinical drug trials are very strict both in relation to the protection of human
p.000093: rights of research participants and in relation to reliability of research results. The history of biomedical
p.000093: research knows many examples proving the importance of such an approach.
p.000093: In connection with the broadening of international contacts and the increasing exchange of drugs, it is
p.000093: necessary to have uniform requirements of conducting experiments on animals, laboratory studies and clinical trials.
p.000093: Today principles and procedures of biomedical research involving human subjects, particularly of clinical trials, are
p.000093: most thoroughly elaborated, as biomedical research is an inevitable part of scientific activity aiming at
p.000093: developing a new drug or method or extending the list of indications for the application of a drug already known. Today
p.000093: the role of clinical trials has increased in connection with implementation of principles of evidence- based medicine
p.000093: into healthcare practice.
p.000093: The primary principle implies that individual clinical decisions on treatment of a certain patient should be
p.000093: based on strong evidenced scientific data which may be obtained in the course of a thoroughly planned and
p.000093: controlled clinical trials rather than on expert’s personal experience or views.
p.000093: Nowadays in conducting biomedical research the world community follows the rules stated in Guidelines on
p.000093: Good Clinical Practice. This document presents a set of regulations ensuring an unbiased evaluation and
p.000093: reliability of research outcomes, as well as protection of research participants. The protection of human
p.000093: rights is guaranteed by independent ethics committees that review documents relating to the clinical trial in view of
p.000093: evaluation of risks for patients and protection of their rights.
p.000093: As we know from the history of clinical trials, initially the organization and performance of those was lacking
p.000093: for an ordered and systematic approach, and there were problems regarding implementation of GCP guidelines
p.000093: in different countries. At the same time, it is clear that safe and reliable research outcomes may be obtained only if
p.000093: the rules are observed.
p.000093: To protect rights and health of human subjects involved into clinical trials of new drugs, treatment methods
p.000093: and medical technologies,
p.000093: Ethics Committee at the Ministry of Health of Republic of Armenia was established in 1996 on the initiative of the
p.000093: Agency for Drugs and Medical Technologies.
p.000093: With regard to legal regulation in the sphere of human rights protection, members of Ethics Committee are guided in
p.000093: their ethical review practice by the following documents:
p.000093: • Constitution of Republic of Armenia (Article 34)
p.000093: • Law on Healthcare in Armenia
p.000093: • Law on Drugs
p.000093: • Law on Social Protection of the Disabled
p.000093: • Law on the Rights of the Child
p.000093: • Law on the Prevention of HIV Infection
p.000093: • Law on Transplantation of Human Organs and/or Tissues
p.000093: • Law on Reproductive Health
p.000093: • Law on Providing Psychiatric Care
p.000093:
p.000093: As to international legal documents, Republic of Armenia ratified Convention on the Rights of the Child.
p.000093: The practice of ethical review is regulated by principles set in the relevant WHO and WMA documents as well as in
p.000093: other international legal and ethical documents.
p.000093:
p.000093: 3.1.3. Education in Bioethics
p.000093:
p.000093: At Yerevan State University named after M.Heratsi ethics and aesthetics have been traditionally taught over many
p.000093: decades. In 2000 bioethics was introduced into the programme of the Department of Social Sciences as a compulsory
p.000093: discipline.
p.000093: In the post-Soviet space, including Armenia, a different – “home” – model of bioethics has been developed, in which
p.000093: bioethics is an interdisciplinary, orientated on biology, modern field of knowledge analyzing moral problems of human
p.000093: existence and human attitude to life and to individual living organisms. This model covers the range from the
p.000093: development of ethical norms and principles regulating human practical activity in the process of studying nature and
p.000093: human beings to the study of the role and place of the human being in the context of biological reality and the
p.000093: estimate of the status of life and death categories.
p.000093:
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p.000094:
p.000095: 95
p.000095:
p.000095: In the beginning bioethics was taught only to students who were citizens of Armenia, but since 2003
p.000095: also to foreign students. The most important stimulus for introducing basics of bioethics into the syllabus was an
p.000095: essential need to harmonize our education programmes with international standards of education. Republic of Armenia
p.000095: enters the Council of Europe, and, accordingly, takes an active part in the work of its social and legal, healthcare,
p.000095: economical and culturological structures.
p.000095: At Yerevan State University lectures on bioethics are read in the first year at all faculties. Unfortunately, during
p.000095: last two years the time assigned for bioethics was reduced from 36 to 17 hours. Besides, now bioethics is an elective
p.000095: course for citizens of Armenia, while it is a compulsory discipline for foreign students (Russian- and
p.000095: English-speaking students from 18 countries). Thus, since the academic year 2006-2007 bioethics is included into the
p.000095: list of elective courses, and hence a number of students get their medical diplomas without training in bioethics.
p.000095: During the last two years the Chair of Social Sciences did its best in providing students with necessary teaching
p.000095: materials. Most of them were received from the Russian Federation, Belarus and Israel. However, as the new generation
p.000095: of students does not know either Russian or English language well enough, there is an urgent need for teaching
p.000095: materials on bioethics in Armenian language. The Department of Social Sciences has developed a brief course on
p.000095: bioethics in Armenian language. The course aims at:
p.000095: - providing students with some fundamental knowledge on the essence and principal problems of bioethics so that
p.000095: they would be capable to comprehend problems of life and death, health and life;
p.000095: - acquainting future physicians with moral aspects of topical problems of modern medicine and biomedical research
p.000095: associated with the application of modern technologies.
p.000095: The Manual has the following distinctive features:
p.000095: 1. It contains views and ideas of medieval Armenian thinkers, philosophers and physicians relating to
p.000095: the problems of life and death, good and evil, etc. In particular, it presents views of David Anhaght whose 1500th
p.000095: anniversary was celebrated by UNESCO in 1980 in Saloniki (Greece) and Yerevan.
p.000095: 2. It should be noted that the Manual presents results of sociological research on some issues conducted among
p.000095: the University students and
p.000095: teaching staff. The research was initiated by the Centre for the Study of Public Opinion on Bioethics
p.000095: Problems at the Chair of Social Sciences. It allowed the authors to enrich the theoretical material with the
p.000095: results of sociological studies.
p.000095: 3. The Supplement includes main legislative acts adopted not only by the international community but also by the
p.000095: National Assembly of Republic of Armenia.
p.000095: 4. The Supplement also contains different tests and questionnaires for the self-analysis, so that students could test
p.000095: to what extent they are morally and physiologically ready to follow rules and requirements of modern
p.000095: bioethics. Besides, there are Case Studies arousing lively discussions. Prof.
p.000095: A. Karmy from Israel kindly sent these Case Studies to us.
p.000095: In spite of all difficulties in teaching bioethics, we have a noteworthy experience of student’s work. Within the
p.000095: framework of internationalXstudent conferences, the Medical University organized round table
p.000095: discussions. In 2001 and 2003 two internationalXstudent conferences on the fundamental principles and norms of
p.000095: bioethics were held. The majority of both foreign and Armenian students for the first time began to learn
p.000095: elements of bioethics. For a more comprehensive study of such topics as patient—physician relationship, the
p.000095: culture of physician’s speech and professional communication, compulsory hospitalization, etc., we give several
p.000095: lectures in Yerevan theatres instead of University lecture halls. These theatres show specially and only
p.000095: for our students, such plays as “Psychosis” and “The Street-Car Named Desire” (Sandukian Academic Theatre),
p.000095: “The Dentist from the East” (Akop Paronian Theatre of Musical Comedy) and “Physiology of Family” (Malian Theatre). Each
p.000095: performance is followed by a vivid discussion with actors and directors, and after that students write their essays
p.000095: on a suggested topic. In addition to theatre performances, students are invited to watch relevant films
p.000095: (documentaries and feature films).
p.000095: Together with the Institute of Philosophy, Sociology and Law of the Academy of Science of Republic of Armenia
p.000095: our Chair is writing a brochure “Albert Schweizer: A Great Humanist”. We also prepare for publication the glossary on
p.000095: bioethics in Armenian language. We give a special attention to practical aspects of teaching bioethics. Thus we began
p.000095: to design special training programmes on bioethics for students of medical institutes in Armenia.
p.000095:
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p.000096:
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p.000097:
p.000097: TV programmes on cloning, euthanasia and other problems with participation of associate professor S.Davtyan
p.000097: evoked a wide public response. If we manage to resolve the problem of sponsorship in the nearest future, we shall
p.000097: be able to give a series of TV programmes on topical issues of bioethics. This would facilitate a more active
p.000097: propagation of bioethical knowledge in various strata of Armenian society. UNESCO Office in Yerevan may
p.000097: participate in financing of the projects.
p.000097: Despite all this work a considerable part of Armenian medical community are skeptical about bioethics.
p.000097: Some physicians and University professors believe that teaching bioethics is something needless, to put it mildly.
p.000097: Apart from implicit forms of discrediting teaching of bioethics, there are cases when lecturers openly tell students
p.000097: that there is no need to study bioethics, which, actually, creates the atmosphere of dislike and distrust for the
p.000097: discipline, and puts a psychological barrier between students and the teaching staff.
p.000097: Another problem is a shortage of young teachers who might lecture in English, Russian and Armenian and the
p.000097: absence of a system for training specialists on bioethics.
p.000097: In the period from September 2004 until February 2005 the Society for Bioethics Development of Republic of Armenia
p.000097: implemented the project aiming at acquainting medical community of Armenia with the principles and norms of
p.000097: bioethics. The Democracy Committee of the USA Embassy in Armenia sponsored the project. Within the framework of the
p.000097: project, the Committee published brochures in Armenian language distributed in the medical community and made
p.000097: a 30-minute publicistic film demonstrated on two national TV channels. At the same time specialists from
p.000097: Society for Bioethics Development held seminars where explained norms and principles of bioethics, discussed
p.000097: specific bioethical problems and focused the attention of the medical community on different bioethical issues. It is
p.000097: necessary to underline that this programme was developed according to recommendations of this fund. The main
p.000097: idea of the project was to develop foundations of democratic society and to raise the level of legal competence in the
p.000097: medical community and in public at large.
p.000097: Results of the research in the medical community (1600 participants from all regional municipal clinics in Armenia and
p.000097: Yerevan) revealed the scarcity of information on bioethics and the fact that the interest to bioethical
p.000097: problems rose sharply after the seminars. However, it is necessary to mention that literature on bioethics is
p.000097: available, if any, only in Russian and in English, which essentially hampers the accessXtoXinformation on bioethics for
p.000097: the medical community.
p.000097: Unfortunately, our experience shows that with regard to financing of different programs (international grants) Armenia
p.000097: is currently outside the zone of interests of donor organizations, while funds functioning in Armenia have mandates
p.000097: that do not correspond to our goals and tasks. Personal initiatives are also unrealizable for technical
p.000097: or financial reasons (e.g. implementation of a programme, attending international training seminars and conferences,
p.000097: etc.).
p.000097: It would be reasonable that The Division of Science and Technology Ethics within the Social and Human Sciences Sector
p.000097: at UNESCO did not confine its activity to providing information for national ethics and bioethics committees, but also
p.000097: furnished a financial support for our organization and for implementation of training courses as well as for
p.000097: publication of teaching materials on bioethics in Armenian language.
p.000097: It is clear that the development of teaching programmes on bioethics and research ethics in Armenia should be adapted
p.000097: to its national, social and spiritual traditions and its healthcare system. At the same time, it should correlate with
p.000097: actual models of modern bioethics, and therefore we make steps towards integrating Yerevan Medical University
p.000097: named after M. Heratsi into the system of UNESCO International Committee for Medical Schools.
p.000097: Universityadministrationdoesitsbestforinternationalacknowledgement of our University as a member of UNESCO
p.000097: International Committee for medical Schools by introducing new disciplines, including bioethics, into the syllabus. It
p.000097: would be expedient that out lecturers and professors could have a financial support to participate in the work of
p.000097: international conferences and seminars on bioethics.
p.000097: We would like to emphasize that here we mentioned only some of the most acute problems of teaching bioethics in
p.000097: Armenian medical institutes. However, this is enough to conclude that bioethics needs more attention from
p.000097: Health Ministry and Ministry of Education of Republic of Armenia, and from the Armenian Institute of Protection of
p.000097: Human Rights.
p.000097:
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p.000098:
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p.000099:
p.000099: 3.1.4 The System of Ethical Review
p.000099:
p.000099: In its activity Ethics Committee of Health Ministry of Armenia is guider by “The Order of Conducting Clinical
p.000099: Trials of New Drugs in Republic Armenia” approved by the Decree of Armenian Government (No 63, 24 of January
p.000099: 2002). This document regulates the practice of clinical trials in our country. According to the set order, clinical
p.000099: trials can be conducted only when approved by Ethics Committee. The entire responsibility for the accuracy and
p.000099: reliability of data obtained in the trial rests on the investigator.
p.000099: Presently, Ethics Committee of Armenian Health Ministry has 12 members who are independent experts
p.000099: and represent different social communities: physicians of different specialties, clinical pharmacologists, lawyers,
p.000099: nurses, representatives of culture, etc.
p.000099: Ethics Committee of Health Ministry of Republic of Armenia has the following responsibilities:
p.000099: - ethical review of clinical trials;
p.000099: - control of the trial process through a regular monitoring;
p.000099: - review of research protocol amendments;
p.000099: - protection of confidentiality.
p.000099: For a thorough and complete ethical review of clinical trials in Armenia the following documents are required:
p.000099: - research protocol,
p.000099: - informed consent form signed by the trial participant,
p.000099: - investigator’s brochure,
p.000099: - written information and promotion materials for potential trial participants
p.000099: - documents confirming investigator’s qualification.
p.000099: When reviewing the protocol of the clinical trial the following should be considered:
p.000099: - scientific justification of the trial goals and objectives;
p.000099: - data of pre-clinical studies;
p.000099: - results of previous clinical trials;
p.000099: - risk/benefit balance of the suggested treatment;
p.000099: - the justification of the treatment plan (dosages, duration of the treatment);
p.000099: - ethics of control choice (placebo, reference drug, no treatment);
p.000099: - criteria of recruitment of the trial participants (inclusion/exclusion criteria);
p.000099: - procedures of informing trial participants;
p.000099: - materials presented to the trial participant;
p.000099: - procedures of obtaining written informed consent to participate in the trial.
p.000099: In its activity Ethics Committee follows three main principles: scientific justification, risk/benefit balance,
p.000099: informed consent.
p.000099: Scientific justification. No scientific research can be considered ethical unless it has a comprehensive scientific
p.000099: justification. A poor justification may, at best, result in the loss of participants’ time, and, at worst, it may bring
p.000099: about an unwarranted risk. Ethics Committee has the right to reject the planned research if it repeats a similar
p.000099: research, and yields no new results.
p.000099: Risk/benefit balance. The main ethical requirement for clinical trials of new drugs is to gain benefit with the
p.000099: minimum risk for the patient. It is necessary to monitor clinical trials, and register all complications, not only
p.000099: physical but such as discomfort, invasion of participant’s privacy, etc. In many cases risks are unavoidable, but it
p.000099: must be minimum and under control.
p.000099: Informed consent. The main method of protecting the individual involved in the clinical trial is his/her
p.000099: informed consent and its approval by Ethics Committee.
p.000099: The procedure of obtaining informed consent is evaluated with regard to the following requirements:
p.000099: - the potential clinical trial participant must be provided with comprehensive information on the
p.000099: goals, methods, nature of the clinical trial and its expected results, as well as on recommended and alternative
p.000099: treatment and patients’ rights and measures for their protection; information should be given in a clear and
p.000099: understandable language;
...
p.000101: Commission, UNESCO, European Forum for Good Clinical Practice, World Medical Association, Department of Health &
p.000101: Human Service (DHHS), USA, and also representatives of Ethics Committees from Italy, Latvia, Lithuania and
p.000101: Estonia). Within the framework of the conference a join meeting of FECCIS and Permanent Commission on
p.000101: Science and Education of the Inter-Parliamentary Assembly of the Commonwealth of Independent States took place. At the
p.000101: conference the question about the development of model guidelines On Ethical and Legal Regulation and Safety of Medical
p.000101: Genetic Research in the CIS was raised for the first time, which later found its reflection in joint activities of
p.000101: FECCIS and Permanent Commission on Science and Education of the Inter-Parliamentary Assembly of the Commonwealth of
p.000101: Independent States. The Conference in Armenia was also the start ground for including CIS countries in SIDCER Project
p.000101: “Recognition”. Thus, for the first time, Module 1 of the programme “Human Subject Protection” for members of the
p.000101: National Ethics Committee of Republic Armenia and Armenian medical community was launched in October 2005 due to
p.000101: efforts of FECCIS and international experts.
p.000101: As to education in bioethics, the representatives from Republic of Armenia participated in the
p.000101: International Course on Research Ethics for Countries of Central and Eastern Europe at Albany Medical College
p.000101: (USA) and Vilnius University (Lithuania). The course received support from Fogarty Foundation. There are perspectives
p.000101: for participation of other representatives from Armenia in this Course.
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p.000103:
p.000103: 3.2. REPUBLIC oF AzERBAIjAn
p.000103: (А.А.Namazova, Z.G.Guseinova, T.G.Tagi-Zade)
p.000103:
p.000103: 3.2.1 Historical and Cultural Background
p.000103:
p.000103: Rich historical and cultural heritage reflected in works by progressive thinkers of the past and contemporary
p.000103: scientists, multinational and multiconfessional population of the republic are the factors contributing to the
p.000103: development of bioethics in Azerbaijan. Tolerance and respect for other national cultures and human dignity, esteem for
p.000103: elderly people, principles of mercy, concern and care for dying people, i.e. traditions that have been forming over
p.000103: centuries-long history, play a significant part in this process.
p.000103: Azerbaijan people, as many other peoples of Eastern countries find evidence of physicians’ search and
p.000103: reflection on philosophy and ethics in ancient medical manuscripts. The ancient world knew the name of a
p.000103: legendary physician Logman. In Azerbaijan secrets of medical knowledge and prescriptions for treatment and prevention
p.000103: of different diseases were passed across the generations in the name of Logman. Not long ago two Logman’s precepts
p.000103: were found. The first precept is about the noble mission of the physician: “Everything in the Earth is the
p.000103: fruit of human kindness/ And where the doctor is, there is always air of kindness”. The second one warns against
p.000103: excessive eating and drinking alcohol, i.e. advocates the culture of hygiene: “Do not thou fill thyself with vine/ Be
p.000103: moderate in eating pilaw and bread/ Or otherwise the world in which we live/ Will turn into a cattle-shed”.
p.000103: Fundamental principles of the physician’s ethical behaviour were set forth in an ancient monument of Azerbaijan
p.000103: literature – a folk epic poem “Dede Korkud”. There we find many pieces of useful advice on how to stay healthy and
p.000103: about significance of moral purity and health.
p.000103: Prominent thinkers, poets and scientists of ancient land of Azerbaijan, such as Bahmanyar Ibn Mirzaban, Nizami
p.000103: Gyandjavi, Hatib Tabrizi, Mahmud Shabustari, Omar Osmanogli, Seid Yahya Bakuvi, Nahchivani, Hagani, Fizuli,
p.000103: Vagif, and many others described in their works a hard unselfish and dedicated work of ancient physicians and fruitful
p.000103: results of their job [6]. They all contributed into the development of medical ethics in Azerbaijan.
p.000103: In the XI century the first madrasah schools were established in Azerbaijan where theology and medicine
p.000103: were taught. Those schools
p.000103: trained mullahs, imams and physicians. In the XII century a specialized medical school was founded in
p.000103: Azerbaijan. There under the direction of Omar Osmanogli, future physicians were provided medical education. Omar
p.000103: Osmanogli with his profound knowledge followed moral principles proclaimed by Logman, and he always taught his
p.000103: disciples that in his work the physician should be guided by love to the human being. His demands even went contrary to
p.000103: deep-rooted customs: “Do not thou turn you back on the enemy. Cure him.” Omar Osmanogli educated his pupils
p.000103: in the spirit of moral purity and patriotism. ”Be useful to your people even if it is contrary to your own interest”,
p.000103: “Do not be selfish”, “Work not just in order to make your way to paradise, and do not be afraid of hell” -- such were
p.000103: his mottos.
p.000103: In line with Omar Osman’s traditions, the famous poet Khagani wrote: “If you want your heart to be clear like a mirror,
p.000103: rid it of ten qualities: avarice, hypocrisy, envy, slander, anger, haughtiness, breach of the laws, duplicity,
p.000103: hostility and lie”. Nizami, a great poet and writer of Azerbaijan, who was one of the most educated men of his period,
p.000103: thought highly of medicine and medical profession. In his works he set forth a number of scientific ideas and
p.000103: conclusions characterizing some ways and means used in Azerbaijan folk medicine. He also wrote on nutrition hygiene,
p.000103: and his ideas did not lose their importance to present day.
p.000103: Not many know that in the XIII century there was a “Dar-Ash-Shafa” University (the House of Cure) in Azerbaijan, in
p.000103: which 5-7 thousands of students were educated. Many scientists from Iran, India, China, Syria, Egypt and from
p.000103: Central Asia were happy to visit this University. The ancient Azerbaijan capital attracted foreign scientists not only
p.000103: with its wealth and luxury but also with the possibility for scientific research and education.
p.000103: In many works of eminent Azerbaijan thinkers, such as Mirza Fatali Akhundov (1812-1814), Gasanbek Zardabi, Nariman
p.000103: Narimanov, Jalil Mamedguluzadeh known under the name of Molla Nasreddin (1866-1932) et al., we can find progressive
p.000103: views on medicine.
p.000103: Mirza Fatali Akhundov [3] is the author of immortal works on politics, natural sciences, medicine, ethics and
p.000103: aesthetics. When describing historical events, traditions and ways of life Mirza Fatali Akhundov always mentioned those
p.000103: national customs that negatively affected human health and moral qualities [5].
p.000103:
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p.000104:
p.000105: 105
p.000105:
p.000105: Gasanbek Melikov Zardabi (1842-1907) followed Akhundov on the thorny path of asserting the best moral qualities.
p.000105: In his book “Hygiene”, he wrote that physicians should be warm-hearted and honest; they should keep to the rules of
p.000105: personal hygiene, and watch over the hygiene of their patients and their homes.
p.000105: N.Narimanov (1870-1925) in his numerous works wrote about the social role of physicians: “Physicians should
p.000105: strictly criticize all medical institutions and their own actions, so as to extirpate everything that is not meeting
p.000105: patients’ interests, and, especially, what might hurt them. Patients’ interests should always be a priority, and all
p.000105: intellectual efforts should be devoted to meeting their needs” [1].
p.000105: Making good use of their rich heritage in the field of ethics medical professionals of Azerbaijan followed the
p.000105: traditions in later years. Today we may speak of a new historical situation in the development of medical ethics as an
p.000105: area of medical knowledge aimed at education of medical personnel.
p.000105: We know that the social environment plays an essential part in the development of medical ethics. Moral
p.000105: qualities of medical professionals are not innate but acquired. They reveal themselves in the social milieu in which a
p.000105: person grew up, studied and worked.
p.000105: Academician Zarifa Alieva (1923-1985), a well-known scientist, in her excellent work “The Noble Mission”
p.000105: emphasized the fundamental importance of ethics in the physician’s professional activity: “Medicine is
p.000105: progressing day by day, it cannot stay unchanged, and only one thing remains constant – high moral, ethical
p.000105: and professional standards demanded from the physician”.
p.000105: After the disintegration of the Soviet Union and declaration of Azerbaijan independence, the reformation of the
p.000105: healthcare system began. Professional education, creation of a new pharmaceutical market, etc, and, naturally, the main
p.000105: principles of medical ethics (the physician’s duty and responsibility, relationships with patients, colleagues and
p.000105: society) underwent a strong correction. Academicians Z.A.Alieva, A.T.Amiraslanov, A.A.Namazova et al. made a great
p.000105: contribution into the development of bioethics.
p.000105: An important milestone in the history of Azerbaijan was the year of 1999, when, on the initiative of UNESCO, the
p.000105: Presidium of National Academy of Sciences established the Committee on Bioethics and Technology Ethics (Decree
p.000105: 9/1).
p.000105: 3.2.2. Legal Regulations
p.000105:
p.000105: Health is one of a few subjective human values without which many other comforts and values lose their significance.
p.000105: Today every democratic country acknowledges the importance of human rights protection in all spheres of social
p.000105: life. Within last years, the National Assembly of Azerbaijan adopted legislative acts setting forth political,
p.000105: economic, social, cultural, scientific and medical measures for maintaining and strengthening physical and mental
p.000105: health of every person and providing medical care in case of loss of health. When drawing up the documents the
p.000105: experience of other countries was used, and the following legal norms based on international legal norms were adopted:
p.000105: - UN Convention on Children’s Rights (Decree of the National Assembly of Azerbaijan Republic. No 236; 21 of July 1992)
p.000105: - Law on Sanitary-and-epidemiologic Well-being of Population (10.11.1992)
p.000105: - Law on Preventing the Spread of the Disease Caused by HIV in Azerbaijan (16.04.1996)
p.000105: - Law on Pharmaceutical Activity (05.11.1996)
p.000105: - Law on Health Protection (26.07.1997)
p.000105: - Law on Medical Insurance (1997)
p.000105: - Law on Radiation Safety (30.12.1997)
p.000105: - Law on Children’s Rights (19.05.1998)
p.000105: - Law on Transplantation of Human Organs and Tissues (28.10.1999)
p.000105: - Law on Immunoprophylaxis of Infectious Diseases (14.04.2000)
p.000105: - Law on Tuberculosis Control in Azerbaijan (05.02.2000)
p.000105: - Law on Psychiatric Care (12.06.2001)
p.000105: - Law on Narcological Service and Control (29.06.2001)
p.000105: - Law on Nutrition of Newborns and Infants (17.06.2003)
p.000105: - Law on the State Care for Patients with Diabetes (23.12.2003)
p.000105: - Law on Iodination of Sodium Chloride for the Mass Prevention of Iodine Deficiency.
p.000105: - Law on Donorship of Blood, Blood Components and Blood Donor Service (03.05.2005)
p.000105: - Law on State Care for Patients with Hereditary Diseases Such as Hemophilia and Thalassemia (03.05.2005).
p.000105:
p.000106: 106
p.000106:
p.000107: 107
p.000107:
p.000107: 3.2.3. Education in Bioethics
p.000107:
p.000107: When considering problems of education we precede from the fact that bioethics, in relation to medicine, is
p.000107: nowadays a developing academic discipline with its inherent strict standards. We should start teaching
p.000107: bioethics in the period when students pass on from theoretical subjects to practical activity.
p.000107: In accordance with recommendations of the World Health Organization to introduce courses on medical ethics into the
p.000107: syllabus of medical schools everywhere in the world, an educational programme on bioethics was developed in
p.000107: Azerbaijan in the 1990s. The programme emphasizes the universal character of principles and rules of bioethics
p.000107: and covers all basic problems of bioethics with due consideration for the international experience and national
p.000107: traditions. The method of teaching aims at enabling medical professionals to acquire ethical skills in
p.000107: physician-patient relationships, professional decision-making and conducting scientific research.
p.000107: Education in bioethics at Azerbaijan Medical University (8,000 students) began in 2000. Considering an
p.000107: interdisciplinary character of the programme, issues of biomedical ethics are normally introduced into the
p.000107: teaching process of all faculties, especially, clinical ones.
p.000107: In 2000 an international conference “Methods of Teaching Medical Ethics” was held in Baku. On that occasion
p.000107: numerous methodical materials were prepared: methodical plans, textbooks, brochures and glossaries of
p.000107: bioethical terminology. The materials have been very helpful in training specialists with an experience in
p.000107: research and applied ethics who have received appropriate certificates.
p.000107: To improve the quality of teaching bioethics and to increase educational level of medical students, the initiative
p.000107: group of Azerbaijan Medical University including the academician of the Russian Academy of Medical Sciences and the
p.000107: National Academy of Sciences professor A.A.Namazova, professor G.A.Aliev, assistant professor Z.G.Guseinova,
p.000107: candidate of medical sciences T.G.Tagi-Zade developed a teaching and methodical programme “Introduction of
p.000107: Teaching Materials on Biomedical Ethics Into the Syllabus of Higher Educational Institutes”. For that purpose the group
p.000107: has made up the following materials: the first Azerbaijan manual on medical ethics «Tiabaiat etikasy», a number of
p.000107: methodical recommendations and
p.000107: such texts as “Ethical Principles in Medicine”, “Euthanasia: Bioethical Aspects”, “Deontology in Medicine” et
p.000107: al.
p.000107: Alongside with the abovementioned, sociological surveys in medical community and public at large were conducted in
p.000107: Azerbaijan with the aim to assess the level of awareness and knowledge about legal aspects of bioethical issues. The
p.000107: surveys are helpful in outlining ways of further activity in the field of education and scientific research.
p.000107: With the assistance of Azerbaijan Ministry of Health and international organizations, especially the Forum for
p.000107: Ethics Committees in the Commonwealth of Independent States, the initiative group develops standard operational
p.000107: procedures and protocols for ethics committees and proposals on adaptation and implementation of international
p.000107: standards for biomedicine in Azerbaijan.
p.000107:
p.000107: References
p.000107: 1. Ethical Problems in Azerbaijan. In: Materials of Regional Swiss Conference on Medical Ethics. Tbilisi,
p.000107: Georgia, 1999 (in Russian).
p.000107: 2. Implementation of Teaching Materials on Medical Ethics into the Syllabus of the Medical University. In:
p.000107: Materials of the International Seminar “Methods of Teaching Medical Ethics”. Baku, Republic of Azerbaijan, 2000 (in
p.000107: Russian).
p.000107: 3. The Role of Bioethics in Training Future Physicians. In: Materials of the First National Congress on Bioethics.
p.000107: Kiev, Ukraine, 2001, pp. 41-44 (in Russian).
p.000107: 4. The State of Ethical Review of Biomedical Research in Azerbaijan. In: Ethics Committees in Russia and other
p.000107: CIS Countries. International Seminar. St.-Petersburg, Russia, 2001, pp. 41-44 (in Russian).
p.000107: 5. Ethics’ in Pediatric Clinics. First International Conference «Clinical Trails in Russia». Moscow, Russia, 2001 (in
p.000107: Russian).
p.000107: 6. Medical Ethics and Deontology. - Medical Journal “Vita”, 2001, pp. 3-4.
p.000107: 7. Bioethical Aspects of Education in Medical Institutes. In: Good Ethical Practice in Biomedical
p.000107: Research. International Conference of the CIS Countries. Almaty, Republic of Kazakhstan, 2002, p. 87 (in Russian).
p.000107: 8. Ethical Principles in Medicine. Part 1. Methodical Manual. Baku, Republic of Azerbaijan, 2002, p. 32 (in
p.000107: Russian).
p.000107:
p.000108: 108
p.000108:
p.000109: 109
p.000109:
p.000109: 9. Euthanasia. Medical Journal «Vita», 2002, pp. 3-4.
p.000109: 10. Ethical Principles in Medicine. Part 2. Bioethical Aspects of Euthanasia. Methodical Manual. Baku,
p.000109: Republic of Azerbaijan, 2002, 32 p. (in Russian).
p.000109: 11. Ethical Standard Operational Procedures in Azerbaijan. “Ethics Committees in Russia and Other CIS Countries.
p.000109: International Seminar. St.- Petersburg, Russia, 2003, p. 15 (in Russian).
p.000109: 12. Medical Ethics. Baku, Republic of Azerbaijan, 2004, 100 p. (in Russian).
p.000109: 13. The Role and Meaning of Ethical Education of Medical University Graduates in the Protection of Patients’
p.000109: Rights in Biomedical Research. International Conference of CIS Countries. Kiev, Ukraine, 2004, pp. 23-25 (in
p.000109: Russian).
p.000109: 14. Ethical Education and Protection of Human Rights in Biomedical Research. Baku, Republic of Azerbaijan, 2004, pp.
p.000109: 65-67 (in Russian).
p.000109: 15. Moral and ethical aspects of healing. Azerbaijan Medical Journal, 2005, 1, p. 34.
p.000109: 16. Dictionary of Biomedical Ethics. Baku, Republic of Azerbaijan, 2007, 96 p. (in Russian).
p.000109:
p.000109: 3.2.4. The System of Ethical Review
p.000109:
p.000109: During the last years the issues of arranging conditions for the development of ethical review which is to
p.000109: safeguard rights and safety of patients and other persons involved into clinical trials are widely discussed.
p.000109: State regulation and control of drug quality is one of the principal ways to ensure protection of rights of individuals
p.000109: participating in trials.
p.000109: With that purpose, a Pharmaceutical Committee based on GCP principles was established at the Ministry of Health
p.000109: of Azerbaijan. Good clinical trials guarantee observance of ethical and other fundamental principles and
p.000109: requirements for organizing the research. Legal aspects are set forth in the “Law on Pharmaceutical Products”.
p.000109: In line with GCP principles, Azerbaijan Pharmacological Committee developed and endorsed a number of
p.000109: recommendations on the review of documents submitted for drug registration, on pre-clinical drug trials,
p.000109: on clinical drug trials, etc.
p.000109: Basic medical institutions with an adequate technical equipment and staff potential for conducting biomedical
p.000109: research were determined and appointed.
p.000109: The system of monitoring was developed. Basic medical institutions receive drugs through the Pharmacological
p.000109: Committee that approves the Research Protocol and then receives a report on results of trials. The drug is
p.000109: registered only after the survey of the review quality. This system is compulsory for every drug designed in
p.000109: Azerbaijan. There is also an effective system of licensing and accreditation. The Pharmacological Committee is planning
...
p.000111: The “working group” at Azerbaijan Medical University and Azerbaijan Medical Association was rendered a special support
p.000111: and assistance.
p.000111: In October 2004 the international conference “Health Legislation in Human Rights Protection and Access to
p.000111: Medicines in Health Research in the CIS” was held in Baku. It was organized with the assistance of
p.000111: FECCIS, Permanent Commission on Social Policy and Human Rights of the Inter-Parliamentary Assembly of CIS, and a
p.000111: number of international organizations (WHO, European Forum for Good Clinical Practice, World Medical Association, and
p.000111: DHHS, USA).
p.000111: In the framework of this conference, the open session of Permanent Commission on Social Policy and Human
p.000111: Rights of the Inter-Parliamentary Assembly of CIS together with scientists and specialists in bioethics from Baltic
p.000111: States and international organizations was held. At the Session, the draft project of the model law “On the
p.000111: Protection of Human Rights and Dignity in Biomedical Research in the CIS” was discussed in detail.
p.000111: Due to acquired experience, the initiative group succeeded in working out teaching and methodical materials.
p.000111: Perspective plans imply an extension of the network of bioethics committees and further broadening of relations and
p.000111: cooperation with FECCIS and other international organizations keeping to the strategy of World Health Organization.
p.000111:
p.000112: 112
p.000112:
p.000113: 113
p.000113:
p.000113: 3.3 REPUBLIC oF BELARUS (t.V. Mishatkina, Ya.S. Yaskevich)
p.000113:
p.000113: 3.3.1 Historical and Cultural Background
p.000113:
p.000113: A specific social and cultural development of Belarus had been predetermined by its geographical position and
p.000113: geopolitical features. Belarus Republic stands at the juncture of the Western and Eastern civilizations, and therefore
p.000113: its leading representatives of ethical and philosophical thought inherited the most essential tendencies in
p.000113: the development of European ethical theories, while the applied moral was, to a certain extent, influenced by
p.000113: Eastern traditions.
p.000113: Ethical ideology in Belarus roots back to the IX-XI centuries, and initially it was based on primitive
p.000113: magic, shamanism, pagan worship. Ethical ideas as such began to form only in the XI-XII centuries after the adoption
p.000113: of Christianity. Such thinkers as Evfrosinia Polotskaya and Kirill Turovsky, who were instilling Christian ideas in
p.000113: Byelorussia and polemized with heresy and paganism, were widely known for their enlightening activity. They
p.000113: were preaching the Bible commandments of love, kindness and unity. In the XIII-XVI centuries, when the territory of
p.000113: Belarus became a part of the Grand Duchy of Lithuania that later united with the Kingdom of Poland and formed the
p.000113: Polish-Lithuanian Commonwealth, works of Belarus philosophers Francis Scorina, Symon Budny and Vasily Tiapinsky
p.000113: reflected topical ideas of West-European culture, particularly, the idea of humanism. In the period of
p.000113: counter-Reformation (XVI-XVII c) Jesuit colleges and catholic universities actively used the rationalistic
p.000113: heritage of medieval scholastic ethics, and ethical teachings of Aristotle and Thomas of Aquinas were very popular
p.000113: among the educated part of Belarus population. The idea of the Unia (union) of Orthodoxy and Catholicism under the
p.000113: aegis of the Pope carried in itself ethical and philosophical values of religious tolerance. In the XVI-XVII
p.000113: centuries Orthodox communities also did extensive teaching popularizing the most important achievements of
p.000113: West-European countries among Orthodox believers in Belarus. Simeon Polotsky, one of the most outstanding figures in
p.000113: Belarus culture of that period, compiled a collection of poems that formulated, in a poetic form, basic ethical and
p.000113: moral principles of the Orthodoxy. The end of the XVIII and the beginning of the
p.000113: XIX century was marked by naturalistic ethical concepts that resulted from the development of exact and natural
p.000113: sciences and considered ethics in the spirit of theories of “natural law”, “social contract” and “rational egoism”
p.000113: asserting the necessity of universal secular education.
p.000113: After the October revolution and the collapse of the Russian Empire Belarus became Belarusian People’s Republic. The
p.000113: second decade of the XX century was characterized by a rapid growth of national self-awareness. Specific ethical
p.000113: traditions of the Belarusian ethnos and moral aspects of the revival of the Belarusian culture, as well as closeness to
p.000113: nature and healthy moral relations, were widely discussed and reflected in works by such thinkers and poets
p.000113: as F.Bogushevich, A.Pashkevich, Y.Kupala, Y.Kolas. However later, during the Soviet period, ethical thought in
p.000113: Belarusian SSR had been in conformity with the general authoritarian trend.
p.000113: In the last decade of the XX century the developments of Belarus ethics was marked with pluralism and
p.000113: attempts to pass from authoritarian to humanistic ethics. National features of moral self-awareness were analyzed;
p.000113: attempts were made to revise the fundamental moral values. It was the time, when new systems of substantiation of
p.000113: ethical ideas came into being, and trends of applied ethics began to develop. In the 1900s preconditions for the
p.000113: development of theoretical concepts of bioethics and biomedical ethics were formed (T.V.Mishatkina, Ya.S.Yaskevich,
p.000113: S.D.Denisov). First publications and presentations at scientific conferences on different levels appeared;
p.000113: ideas of bioethics find their reflection in the system of medical education [2-6]. Since that time, the ethical
p.000113: thought in Belarus steadily began to approach leading world tendencies in scientific bioethics.
p.000113: Important factors in this process have been specific features of national world-perception and spiritual culture of
p.000113: Belarus people, which revealed itself in such moral qualities as the tendency to self-determination, inherent
p.000113: feeling of self-respect in combination with tolerance and good-nature, as well as hospitality and openness, etc.
p.000113: Moral qualities of Belarus people are in a direct relation to specific features of Slavic national
p.000113: character. Nikolai Lossky, a Russian philosopher, proved this by associating those with such factors as vast
p.000113: expanses of East-European Plain and its climate (short summer), forming “the habit of excessive short-term
p.000113: strain of efforts” and “the ‘non-habit’ of a regular, continuous labour” [7]. Lossky’s comments on the Russian national
p.000113: character
p.000113:
p.000114: 114
p.000114:
p.000115: 115
p.000115:
p.000115: may be fully attributed to Belarus people: “Obeying the call of duty, Russian people develop in themselves an ability
p.000115: to fulfill a compulsory job accurately and honestly. However, if the job is not strictly compulsory, then they may be
p.000115: careless and inaccurate… Hence, there is often a loss of interest in the work begun and aversion for continuing it; the
p.000115: initial intention, idea and the general outline is often quite valuable, but inevitable imperfections would dim the
p.000115: enthusiasm, and people would be lazy to proceed with a thorough and detailed work.” Nevertheless, some effect of
p.000115: European Protestant ethics resulted in a more developed diligence and thoroughness in Belarus people. Nikolai Lossky
p.000115: mentioned also some other contradictory qualities of the Slavic soul: humaneness, mildness, kindness and, on the
p.000115: other hand, cruelty and tendency towards violence (e.g.: attitude to the death penalty in Belarus society); acute
p.000115: self-perception and impersonal collectivism; the feeling of belonging to the humankind and national
p.000115: self-boasting; humility and inclination to a revolt; love of freedom and a need for the authoritarian State system.
p.000115: These features show themselves distinctly in social life, business relations and scientific activity. Besides,
p.000115: Orthodoxy has always supported orientation towards a strong power, as the Orthodox Church believed that only
p.000115: a strong State system could struggle against evil. At the same time, Lossky noted that in their character the
p.000115: Slavs are more disposed to democracy, which shows itself, for example, in the protest against all sorts of
p.000115: conventionalities.
p.000115: Currently the Orthodox Church still has a strong effect on the development of bioethics in Belarus,
p.000115: which has both positive and negative aspects. The programme of interaction between the Orthodox Church of the country
p.000115: and the Belarus Health Ministry of is being realized. The programme helps to introduce moral constants into the medical
p.000115: community, facilitates moral and spiritual growth of the worldview of students (future specialists in medicine, biology
p.000115: and biotechnology) and the general growth of bioethical competence in the society. A rich experience in promoting ideas
p.000115: of bioethics has the Orthodox Medical Brotherhood at the Minsk Eparchy of the Belarus Exarchate. Charity Centre has
p.000115: been organized at the Parish of the Church of All Saints in Minsk. Belarus Children’s Hospice within Children’s Cancer
p.000115: Centre provides spiritual and medico-psychological care for terminally ill children. However we should not ignore the
p.000115: conservatism of the Orthodox Church and, in particular, with regard to topical bioethical problems. In
p.000115: relation to a number of bioethical problems, the Orthodox Church adheres to a very strict position: it prohibits human
p.000115: cloning and cloning of human organs (especially heart cloning) and euthanasia; expresses censure on artificial
p.000115: fertilization, abortion, sexual education of young people. They also hold to uncompromising position regarding some
p.000115: issues of transplantation of certain organs, which showed itself in the discussion of amendments to the “Law on
p.000115: Transplantation of the Republic of Belarus”.
p.000115: Since 1995 bioethics in Republic Belarus has been developing in parallel, along two main lines — theoretical
p.000115: and practice-organizing ones, and initially the connection between these lines was rather weak.
p.000115: Theoretical trend implied the analysis of bioethics as an interdisciplinary scientific knowledge showing, most
p.000115: fully, the tendencies of science development in the XX century. On the other hand, bioethics was analyzed as a
p.000115: special field of applied ethics with its distinctive features and modifications, and, at the same time, allegiant to
p.000115: fundamental ethical principles and general human values [8, part II, 9,10,13]. In choosing priorities we are guided,
p.000115: first of all, by general tendencies in the evolution of scientific knowledge as a whole, and ethics in particular, as
p.000115: well as by historical and cultural grounds for the development of bioethics.
p.000115: Organizational and practical trend of bioethics development in Republic of Belarus focuses on searching and working out
p.000115: mechanisms of institutional regulation of biomedical research.
p.000115: Today the society demands a socially responsible behaviour from investigators and obliges them to accept
p.000115: framework principles, standards and norms for the functioning of relevant structures. And here comes the organization
p.000115: ethics with its main task to understand how to make correct ethical decisions. All these principles, standards and
p.000115: norms are addressed not to an individual but to institutions as organized groups with their tasks, specific features
p.000115: and cultural traditions. Therefore ethics committees and ethical competence take on special significance.
p.000115: The Western model of bioethics is an institutionally organized social technology with a system of standardized
p.000115: liberal values ensuring the protection of human rights and freedoms in biomedicine. The protection of human rights
p.000115: from negative consequences resulting from the application of modern biomedical technologies is performed through
p.000115: ethic codes, laws, extending the sphere of responsibility of medical professionals and biologists
p.000115:
p.000116: 116
p.000116:
p.000117: 117
p.000117:
p.000117: and their social obligations not only fixed on their personal moral level but also stated by law. Mechanisms
p.000117: controlling ethical aspects in the activity of physicians and scientists are supplemented with a developed system of
p.000117: legal regulation, a special system of bioethics committees and education.
p.000117: In the post-Soviet space, including Belarus, a different – “home” – model of bioethics has been created, in which
p.000117: bioethics is an interdisciplinary, orientated on biology, field of theoretical knowledge analyzing moral
p.000117: problems of human existence and human attitude to life and to different living organisms. This model
p.000117: covers the range from the development of ethical norms and principles regulating human practical activity
p.000117: in the process of studying nature and human beings to the study of the role and place of the human being in the
p.000117: context of biological reality and the estimate of the status of life and death categories.
p.000117: At the same time, for Belarus with its post-Chernobyl crisis level of the balance in the “nature--society” system, when
p.000117: the data of biomedical studies prove a direct and evident threat to the public health and to the safety of gene pool
p.000117: because of the complex radiochemical pollution, practical measures are extremely important. Besides, the majority of
p.000117: physicians in Belarus still stick to the conventional paternalistic model of patient—physician relationships, which
p.000117: goes with a widespread legal and ethical nihilism in the medical community. Therefore the modern model of
p.000117: bioethics, as well as programmes of biomedical research, should be adapted to the national healthcare system, its
p.000117: scientific, socio-cultural, legal and spiritual traditions.
p.000117: At present, we have objective and subjective conditions for the development of bioethics in the form that is
p.000117: accepted in the West. We are developing ethical and legal norms regulating biomedical research and aiming to create
p.000117: adequate models of education. In compliance with the Order of the Health Ministry of Belarus “On Establishing Rules for
p.000117: Conducting Clinical Trials of Pharmaceutical Products”, a Republican Unitary Institution “The Centre of Expertise and
p.000117: Trials in Healthcare” was founded in 1999. A serious work has been carried out on organizing institutional activity of
p.000117: local ethics committees. Scientists, governing structures and public organizations put their efforts in creating
p.000117: the basis for establishing in Belarus the National Committee for Bioethics similar to those existing in many countries.
p.000117: The Committee can rightly represent Belarus on the international level and take initiatives in the protection of
p.000117: human rights in biomedicine, coordinate
p.000117: activity of local ECs and develop main concepts of professional and public education. The National Committee for
p.000117: Bioethics (NCBE) at the Health Ministry of Belarus was established in 2005 with the support of the National
p.000117: Commission of Belarus for UNESCO.
p.000117: At the same time there are still organizational and legislative problems in the development of bioethics in Belarus.
p.000117: This concerns an under-developed system of legal regulation of bioethics, a low level of ethical knowledge and legal
p.000117: culture in the medical community and in the population, and a high level of bureaucracy and conservatism in
p.000117: institutions that are to make decisions. Thus during a year, due to delays and impediments of the law, the question of
p.000117: the legal status of NCBE established on the instructions of Council of Ministers (26.07.2005) could not be
p.000117: decided, which certainly hampered NCBE activity.
p.000117:
p.000117: 3.3.2 Legal Regulations
p.000117:
p.000117: Like in the healthcare as a whole, in establishing local ECs and the NCBE
p.000117: Belarusfollowsinternationallegalandethicaldocuments. Thesedocumentsare: The Nuremberg Code (1947); Declaration of
p.000117: Helsinki (1964, with subsequent amendments); ICH GCP (1996); WHO Operational Guidelines for Ethics Committees
p.000117: That Review Medical Research (2002); UNESCO documents “The Declaration on the Principles of Tolerance”
p.000117: (1995); “The Universal Declaration on the Human Genome and Human Rights” (1997); UNESCO Guide No 1 “Establishing
p.000117: Bioethics Committees” (2005); UNESCO Guide No 2 “Bioethics Committees at Work: Procedures and Policies” (2005).
p.000117: The National Strategy of Steady Development and the Concept of Healthcare Development in Belarus (1995) are
p.000117: the basis for adopting legal acts and national programmes and determine particular measures and resources for ethical
p.000117: and legal control of biomedical research. Laws of Belarus “On Healthcare” (1999 with subsequent amendments), “On the
p.000117: Safety of Genetic Engineering” (2005), the Draft Law “On transplantation of Human Organs and Tissues”, orders and
p.000117: instructions of the Belarus Health Ministry of are in compliance with the main principles of bioethics set out by WHO.
p.000117: The central law determining the State policy in the sphere of citizens’ health protection, legal, economical and
p.000117: ethical principles of conducting biomedical and genetic research involving human subjects, as well as
p.000117:
p.000118: 118
p.000118:
p.000119: 119
p.000119:
p.000119: patients’ rights and responsibilities is the Law of Belarus on Healthcare. According to the Article 31 of the
p.000119: Law, clinical and biomedical research involving human subjects may be conducted for therapeutic purposes at
p.000119: national institutions of healthcare provided that the research is scientifically justified, and a written voluntary
p.000119: consent from a potential research subject informed about the goals, duration, expected results and an effect on his/
p.000119: her health has been obtained. It is not permitted to carry out clinical trials and biomedical research involving
p.000119: pregnant women and children unless the research is conducted for diagnostics or treatment of these particular classes.
p.000119: Research involving children may only be carried out after a written consent from a parent has been received. It
p.000119: is not permitted to conduct clinical trials and biomedical research involving children without parents, members of
p.000119: armedXforces, prisoners and persons underXarrest, persons with mental disorders or those who receive compulsory
p.000119: (involuntary) medical treatment. Thus, the Law is the legal implementation of the modern principle of respect for the
p.000119: patient’s autonomy based on the rule of informed consent.
p.000119: The Code of Medical Ethics (CME) adopted at the First Congress of Physicians of Republic of Belarus (1998)
p.000119: and approved by the Health Ministry of Belarus (1999) also includes rules of medical ethics and deontology
p.000119: reflecting fundamental principles of biomedical activity and patient-physician relationships.
p.000119: The Chapter “Physician-Patient Relationship” of the Code implies the following:
p.000119: • Equal rights of patients and physicians to respect for their human dignity (Art. 14);
p.000119: • Mutual trust and mutual responsibility of the patient and the physician, patient is an active participant of the
p.000119: treatment process (Art. 16);
p.000119: • Compulsory consent from the patient for a medical intervention, except for cases provided by law (Art.
p.000119: 21);
p.000119: • Compulsory written consent from a patient, his/her close relatives or legal representatives for removal
p.000119: organs or tissues for diagnostic or therapeutic purposes; removal of organs and tissues for other purposes may not
p.000119: be carried out (Art. 23);
p.000119: • Confidentiality of patients’ personal data obtained in the patient— physician relationship; it is not permitted to
p.000119: disclose the patient’s personal information even after the patient’s death (Art. 24).
p.000119: An analysis and classification of fundamental statements of the Law of Republic Belarus on Healthcare and the Code of
p.000119: Medical Ethics show how the documents reflect topical principles and problems of biomedical ethics. The principle of
p.000119: human life sanctity (value) directs the physician’s activity towards all possible care for patients and implies
p.000119: that euthanasia is
p.000119: unacceptable:
p.000119: - “The physician should relieve sufferings of a dying patient by every available and legal means. Euthanasia as an
p.000119: act of an intentional taking of one’s life is not permissible at the patient’s or his/her relative’s
p.000119: request” (Art. 25 CME).
p.000119: - “Medical or pharmaceutical professionals are not permitted to perform euthanasia. A person who
p.000119: consciously induces the patient to euthanasia and/or performs euthanasia shall bear criminal responsibility
p.000119: according to legislation of Republic of Belarus” (Art. 38 of the Law on Healthcare).
p.000119: Priority of a person’s interests implies that interests and well-being of an individual should prevail over scientific
p.000119: and public interests:
p.000119: - “In his/her scientific and research activity the physician should be guided by the priority of the
p.000119: patient’s benefit over scientific interests; clinical trials and research may only be carried out in compliance with
p.000119: the rules established by law and with the patient’s consent” (Art. 36 CME).
p.000119: Principle of tolerance implies that all citizens, with no exception, are guaranteed that the individual’s integrity,
p.000119: principal rights and freedoms shall be respected:
p.000119: - “The main goal of physician’s professional activity is to save an individual’s life and health…
p.000119: regardless of the patient’s sex, age, nationality, social and financial status, political convictions and religion”
p.000119: (Art. 2, CME);
p.000119: - “Physician shall in every possible way contribute into protection of population health and to
p.000119: struggle against any forms of cruelty and disparagement” (Art. 5 CME).
p.000119: Equal rights and cooperation in physician-patient relationship as a cardinal principle of modern deontology
p.000119: implies the following:
p.000119: - “Physician and patient have equal rights to respect for their human dignity and may protect it according to
p.000119: current legislation” (Art. 14 CME).
p.000119: Principle of physician’s and patient’s autonomy following from the above statement reveals itself in recognizing the
p.000119: autonomy of the physician:
p.000119:
p.000120: 120
p.000120:
p.000121: 121
p.000121:
p.000121: - “Physician shall bear responsibility for all his/her professional decisions and has the right to reject
p.000121: any attempts of pressure from colleagues, patients and other persons if their requests contradict ethical
p.000121: principles, professional duty and law.” (Art. 11 CME).
...
p.000123: confidentiality requirements.
p.000123: Medical and pharmaceutical professionals bear the responsibility for a breach of confidentiality in
p.000123: accordance with the current legislation of Belarus.” (Law on Healthcare, Art. 60)
p.000123: Besides basic principles of biomedical ethics, legislative acts of Belarus state that any intervention into a human
p.000123: body for research purposes should be performed in compliance with existing requirements and professional
p.000123: standards. Thus, Law on Healthcare states that:
p.000123: - “The permission to carry out clinical trials and biomedical research involving human subjects is granted by
p.000123: Health Ministry of Belarus.” (Art. 31).
p.000123: - “The procedure and conditions of anatomical donation are determined by the Health Ministry of
p.000123: Belarus” (Art. 39).
p.000123: - “The procedure of post-mortem examination and a list of cases for a compulsory post-mortem examination
p.000123: are determined by the Health Ministry of Belarus” (Art. 52).
p.000123: -“Regulations for an independent ethical review are approved by the Council of Ministers of Belarus” (Art. 53).
p.000123: Like the procedures of treatment and care provided to patients, clinical trials and biomedical research are also
p.000123: regulated by the above-mentioned documents.
p.000123:
p.000123: 3.3.3. Education in Bioethics
p.000123:
p.000123: Alongside with establishing local ECs, improving legislation referring to biomedical research and carrying out a
p.000123: theoretical analysis, we have been developing education in bioethics. Here is the chronology of establishing a system
p.000123: of education in bioethics in Belarus**:
p.000123: • In October 1997, on the initiative of the Minsk State Medical Institute and with the support from
p.000123: the Health Ministry of Belarus, the European Parliament, The Embassy of United Kingdom in Belarus,
p.000123: and World Association for the Protection of Animals, the international symposium “Ethical Problems of Using
p.000123: Animals in Teaching and Scientific Research” was held in Belarus. The Symposium stimulated the study of the problems of
p.000123: humanizing medical education. Members of the teaching staff and students from Belarus, Russia, United Kingdom and
p.000123: Sweden took part in the Symposium [14,16,18,19].
p.000123: • In 1999 recommendations “Teaching Basics of Medical Ethics and Deontology in the Course on Human Anatomy” (Denisov
p.000123: S.D., Yaroshevich S.P.) were published, as well as other works relating to ethical norms of handling
p.000123: anatomic preparations [3,15,17].
p.000123: • In 2000 Minsk hosted the international scientific-and-practical conference “Biomedical Ethics: Problems and
p.000123: Perspectives”; a volume of conference proceedings was published [9].
p.000123: • In 2000 one of the first text-books in CIS countries “Biomedical Ethics” (220 p.) for students studying
p.000123: medicine and biology approved by the Ministry of Education of Belarus was published [12]. The text-book includes a
p.000123: supplement in which leading scientists and physicians of Belarus of different age and specialties give their
p.000123: professional opinion on ethical problems.
p.000123: • In 2001 the International State Ecological University named after A.D.Sakharov introduced a course “Basics of
p.000123: Biomedical Ethics” (20 h) into the syllabus for students studying medicine and biology. Since 2003
p.000123:
p.000123: * Data by N.E. Luigas and C.D. Denisov
p.000123:
p.000124: 124
p.000124:
p.000125: 125
p.000125:
p.000125: the course in biomedical ethics (36 h) is taught at the Belarus State Medical University (BSMU) and other
p.000125: institutes of higher medical education. Teaching programmes “Basics of Biomedical Ethics” for undergraduate
p.000125: students and “Topical Problems of Biomedical Ethics” for medical post- graduates have been designed.
p.000125: • A programme in biomedical ethics has been developed for the system of raising the professional level of medical
p.000125: practitioners and teaching staff of medical institutes (18—36 h). Academy for Post-Graduate Education of Republic
p.000125: Belarus offers a course “Biomedical Ethics in Psychiatry” (for teaching professionals, clinical psychiatrists
p.000125: and investigators – 24 h).
p.000125: • In the framework of Russia—Belarus scientific-and-practical conferences on the problem of
p.000125: developing professional knowledge in bioethics (Kirov, 2003; Minsk, 2004) problems of teaching bioethics to
p.000125: medical students were discussed [17].
p.000125: In 2003 a second revised and amended edition of the text-book “Biomedical Ethics” is published [8]. The
p.000125: text-book supplement contains international guidelines, methodical recommendations for teachers, tests and
p.000125: case-studies.
p.000125: • In January (Moscow) and March (Minsk) 2005 in the framework of regional consultations for professionals in the
p.000125: field of education in ethics and bioethics held under the aegis of UNESCO experts from Belarus presented their relevant
p.000125: teaching programmes.
p.000125: • Since February 2005 BSMU offers a 64-hour course “Problems of Biomedical Ethics in Modern Theory and Practice” for
p.000125: BSMU teaching staff.
p.000125: • In May 2005 the republican student conference “Bioethics: Theory, Practice and Perspectives” was held and a volume
p.000125: of student papers was published.
p.000125: • In autumn 2005 BSMU held the student conference “AIDS: Information Practice. Formation of Positive Moral
p.000125: Values in Youth”.
p.000125: • In September 2005 BSMU organized a round table with Dr. Henry Williams (Head of the Tennessee Hospital, USA) and
p.000125: Dr. Joy Raily (Director of the Centre for Bioethics and Cell Technologies).
p.000125: • In May 2006 the Republican Scientific-and-Practical Conference “Medicine and Christianity” was held
p.000125: with a Section where bioethical problems were discussed in the context of the Orthodox worldview.
p.000125: • In November 2006 young scientists from the Institute for Post- Graduate Education of Belarus in
p.000125: cooperation with NCBE organized the scientific-and-practical conference “Humanization in the Education of
p.000125: Specialists in Medicine and Biology”; proceedings of conference were published [21].
p.000125: • The republican scientific-and-practical student conference “Culture and Medicine: interaction Paradigm” was held
p.000125: in May 2007.
p.000125: Thus, today we have relevant methodical materials including manuals, and national manuals.
p.000125: Besides, there are following teaching programmes for the system of high (undergraduate) medical education
p.000125: [11]:
p.000125: a. “General Ethics” (with sections “Bioethics” and “Ecological Ethics”)
p.000125: – for students of all specialties (Mishatkina T.V., Belyaeva E.V.) – 36 h;
p.000125: b. “Basics of Biomedical Ethics” – for medical undergraduate students (Mishatkina T.V., Denisov S.D., Kevra V.K.,
p.000125: Lugais N.E.) – 36 h;
p.000125: c. “Humanitarian Aspects of Modern Science (with Elements of Bioethics)” - for students of humanitarian
p.000125: specialties (Yaskevich Ya. S.) - 18 h;
p.000125: d. “The Conception of Modern Natural Sciences” – for students studying natural sciences (Yaskevich Ya.S.,
p.000125: Viazovkin V.S.) – 18 h;
p.000125: e. “Human Rights” – for students of all specialties (Yaskevich Ya.S., Gusev A.D., Gafarova Yu.Yu.) – 18 h;
p.000125: f. “Basics of Ecological Ethics” – for students in specialties “Ecology”, “Agricultural Science”, “Veterinary
p.000125: Science” (Mishatkina T.V., Boronnikova V.T., Silich T.V.) – 18 h.
p.000125: Today there are four institutes of higher medical education (in Minsk, Grodno, Gomel and Vitebsk)
p.000125: and the Faculty of Biomedicine at the International State Ecological University named after A.D. Sakharov.
p.000125: “Bioethics” as a subject is not included into the State Standard for Education, and, hence, there is no State system of
p.000125: education in bioethics.
p.000125: Therefore, bioethics is mostly taught within the Ethics Course (course duration depends on the decision of the
p.000125: Institute Council). At the BSMU bioethics is taught in the 1st and 2nd years (36 h). For senior students issues on
p.000125: biomedical ethics and deontology are included into courses on medical disciplines.
p.000125:
p.000126: 126
p.000126:
p.000127: 127
p.000127:
p.000127: With regard to bioethical education, we believe that it is essential to develop the ability to reflect on
p.000127: problems of human life and death, to form an understanding of the necessity to follow principles and rules of
p.000127: biomedical ethics in professional activity, to combine reason and feelings, intuition and logic, emotions and
p.000127: intellectual efforts. To achieve this goal, we have to define the problems we choose for bioethical education. From a
p.000127: variety of topics arising due to the development of biology, medicine and practical healthcare we chose
p.000127: most essential problems consistent with the principles of a system and holistic approach. Besides, to analyze
p.000127: ethical situations, we need to select from the whole volume of special knowledge sections that are most
p.000127: ethics-orientated and provide ethical and humanitarian comments by ethicists.
p.000127: At the same time, we are searching for interdisciplinary approaches to bring moral and ethical norms in conformity with
p.000127: the current medical and biological reality.
p.000127: An important achievement of the BSMU is that already at the stage of pre- clinical training medical students
p.000127: participate in resolving ethical problems relating to using dead human bodies in the teaching process and experiments
p.000127: on animals [14, 20]. In the course on human anatomy students are informed about legal, ethical and religious aspects of
p.000127: using a dead body of separate organs for an educational or scientific purpose. Learning ethical norms of handling
p.000127: anatomic preparations facilitates the development of the most essential humanistic quality – respect for a human
p.000127: being. Humane attitude to animals involved in experiments is very important for the development of compassion and
p.000127: empathy. Implementation of teaching aids alternative to experiments (computer programmes of experiments on virtual
p.000127: animals, video-films, CDs, three-dimensional models, etc.) allowed to exclude or minimize experiments on
p.000127: animals. As the result, students see that ethical principles are not merely postulated but implemented in practice.
p.000127: Medical students acquire bioethical knowledge out of class as well. Students of BSMU participate actively in
p.000127: the hospice movement. During several years they have been taking part in the BACCUP Programme at the Cardiff
p.000127: Medical University working as volunteers together with British medical students in summer holidays.
p.000127: Problems of bioethics, medical deontology and clinical ethics in medical practice can be successfully resolved only if
p.000127: medical professionals know the
p.000127: current legislation referring to healthcare. Therefore it is necessary, firstly, to regulate norms of medical activity
p.000127: according to new conditions in practical healthcare, and, secondly, to provide legal knowledge to medical specialists.
p.000127: Sociological surveys carried out in Belarus showed that, unfortunately, medical students, as a rule, do
p.000127: not have systematic knowledge in either deontology or medical ethics, or in medical and common law.
p.000127: A low level of education in ethics is typical of other categories: medical specialists and investigators, members of
p.000127: ECs, representatives of governing and legal institutions adopting laws and making decisions in healthcare and
p.000127: biomedicine, general public. This is a problem not only in Belarus or all regions of the post-Soviet space but in many
p.000127: other countries. Even when the level of education in bioethics may seem quite satisfactory, there is much of
p.000127: traditional paternalism. Thus, we still cannot get used to the idea that an individual’s right to life and
p.000127: death is his/her right and not the right of a physician, investigator or a legislator. Paternalism, in its turn, roots
p.000127: back to the authoritarian ethics in which interests of the society, State, science prevail over interests of an
p.000127: individual. Therefore we face the necessity to form new humanistic ethical way of thinking, which may be achieved
p.000127: through bioethical education.
p.000127: Today there are three levels of bioethical education in Belarus.
p.000127: The first level is teaching bioethics to medical undergraduates. The course “Basics of Biomedical Ethics” aims
p.000127: at forming a consciously ethical attitude to the alive and a devout attitude to human life. After completing the
p.000127: course, students have to:
p.000127: - know key conceptual models of bioethics and biomedical ethics, the history of their development and current
p.000127: state; understand their main concepts and categories;
p.000127: - be able to characterize the essence and basic problems of bioethics and biomedical ethics, their principles and
p.000127: values, moral aspects of topical problems of modern medicine and biomedical research;
p.000127: - be able to analyze specific character of bioethical knowledge and its role in resolving professional problems;
p.000127: - be able to analyze actual ethical situations in the context of the highest moral values and use normative and applied
p.000127: aspects of ethical knowledge in professional communication;
p.000127: - be able to make their own moral choice and bear the responsibility.
p.000127:
p.000128: 128
p.000128:
p.000129: 129
p.000129:
p.000129: It is desirable that during the Course medical students would acquire skill of ethical discussion and dialogue; would
p.000129: be able to prevent and resolve conflicts, develop an adequate self-evaluation, tolerance in evaluating their colleagues
p.000129: and an appropriate style of professional and personal behavior.
p.000129: Education at the second level aims at providing bioethical knowledge for medical practitioners through the system
p.000129: of raising their professional knowledge and post-graduate education. Here the situation is more
p.000129: complicated as the system is yet to be developed, though there are some achievements. At the Academy for Post-Graduate
p.000129: Education of Belarus at least four aspects of education in biomedical ethics are considered, though time given to these
p.000129: issues is insufficient (2-4 h). The four aspects are:
p.000129: – raising professional level of specialists with higher and secondary special education in medicine and
p.000129: pharmacy through education in bioethics
p.000129: – introducing courses on bioethics into syllabi and teaching programmes for retraining specialists with higher and
p.000129: secondary special education in medicine and pharmacy;
p.000129: - teaching bioethics within a programme for training teaching staff of high qualification (postgraduates, doctoral
p.000129: students);
p.000129: – raising professional level of professionals who organize and carry out clinical trials so that they could be admitted
p.000129: to this activity.
p.000129: However, we do not have a separate course on bioethics at the graduate and post-graduate levels. We also lack a State
p.000129: system of teaching GCP and a systematic training for EC members. Training courses in ethical review of clinical drug
p.000129: trials are held at the Republican Centre of Expertise and Trials in Healthcare. The course is very short (2-4 hours).
p.000129: There are no dissertation boards, and no dissertation on bioethics has been defended, as the Higher Certifying
p.000129: Commission does not have this discipline on the list of specialties. The first dissertation on bioethics as a basis of
p.000129: the physician’s professional culture is planned in the section of “Culturology”. Therefore, currently the question of
p.000129: introducing differentiated specialized courses on bioethics for different categories of postgraduate audience is under
p.000129: consideration.
p.000129: We also use some other opportunities to raise graduates’ and postgraduates’ professional level in
p.000129: bioethics, particularly, international grants received on one’s personal initiative. Thus V.K.Kevra participated in
p.000129: an Educational Project at the Lithuanian National Committee on Bioethics;
p.000129: O.P.Aizberg attended the Seminar on Bioethical Problems in Narcology organized by the “AWEF—AIDS: East-West”
p.000129: Foundation (Kiev, 2006).
p.000129: The third level – providing bioethical knowledge for the population
p.000129: – is the most “deserted” field of work. A low level of public awareness affecting the public opinion and
p.000129: decision making with regard to vitally important issues – from informed consent to adoption of laws – requires
p.000129: taking immediate measures to change the situation.
p.000129: Here we have high hopes for the Project “Education in Bioethics and Promotion of Bioethical Knowledge in Belarus”
p.000129: approved and supported by the Division of the Social Sciences and Humanities of the UNESCO Moscow Office.
p.000129: Within the next few years, the Project will help us to resolve the mentioned problems.
p.000129: The Project includes:
p.000129: • the development of teaching programmes in bioethics for ECs members considering their qualification and
p.000129: the content of EC work;
p.000129: • the development of guidelines for the system of raising the expertise level for EC members, organization of
p.000129: seminars on international documents relating to bioethics (UNESCO, WHO, Council of Europe, etc.);
p.000129: • the development of methodological basis and a long-term programme for raising the level of public awareness in
p.000129: bioethics.
p.000129: We hope that due to the use of necessary facilities, resources and ways of implementing the Project we shall be able to
p.000129: create a harmonious, logical and comprehensive theoretical model of biomedical ethics and a system programme
p.000129: of continuing education.
p.000129: Today in Belarus a number of highly qualified specialists are involved in theoretical work and in teaching
p.000129: bioethics. In the framework of the UNESCO Project, a list of experts in bioethics and bioethical education from
p.000129: Belarus has been compiled (49 experts). Among them, there are such leading specialists as Vismont F.I., Dr. of Medical
p.000129: Sciences, professor, corresponding member of the National Academy of Sciences, vice-chairman of the NCBE;
p.000129: Aizberg O.P., Candidate of Medical Sciences; Godovalnikov G.V., Candidate of Pharmaceutical Science, the director of
p.000129: the Republican Centre of Expertise and Trials in Healthcare; Denisov S.D., professor, prorector of BSMU; Lugais N.E.,
p.000129: Candidate of Historical Science, the secretary of NCBE; Mishatkina T.V., Ph.B., assistant professor, NCBE member;
p.000129: Morozkina T.S., professor, the State Prize laureate; Mosse I.B., Dr. of Biological Science,
p.000129:
p.000130: 130
p.000130:
p.000131: 131
p.000131:
p.000131: professor; Okeanov A.E., Dr. of Biological Science, professor; Silich T.V., senior staff scientist of the Central
p.000131: Scientific-and-Research Laboratory at the Medical Academy for Postgraduate Education of Belarus; Sliadneva N.E., the
p.000131: chief editor of newspapers “Animal World” and “Ecologist and Myself”; Yaskevich Ya.S., Ph.D., professor,
p.000131: vice-chairman of NCBE. Information about some of them is in the UNESCO site [22].
p.000131:
p.000131: 3.3.4. the System of Ethical Review*.
p.000131:
p.000131: Ethical review of clinical trials in Belarus is performed by Ethics Committees (local committees) at
p.000131: healthcare institutions authorized to carry out clinical trials, and at some institutions of the system of higher
p.000131: medical education (e.g.: BSMU and Medical Academy for Postgraduate Education of Belarus). National Committee on
p.000131: Bioethics (NCBE) established in April 2006 ensures public control with regard to the observance of ethical
p.000131: regulations in conducting clinical trials involving human subjects and experiments on animals.
p.000131: The process of establishing local ECs at healthcare institutions (hospital, out-patient clinic,
p.000131: scientific-and-research institute, scientific-an-practical centre) goes in parallel with the accreditation allowing
p.000131: to conduct clinical trials and in compliance with the Law on Healthcare (1993; amended in 2001); the Law on
p.000131: Pharmaceutical Products (2006); the Order No 254 of the Health Ministry of Belarus “On Approval of Guidelines for
p.000131: Clinical Trials of Pharmaceutical Products” (1999); Methodical Recommendations on Establishing ECs and their
p.000131: Operation (2000); Guidelines on Accreditation of Healthcare Institutions and Certification of Specialists
p.000131: Conducting Clinical Trials of Pharmaceutical Products, Medical Equipment and other Medical Goods (2004). The control of
p.000131: the process rests with the Republican Centre of Expertise and Trials in Healthcare authorized hereto by the Health
p.000131: Ministry of Belarus.
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: * This section has been written with the assistance of G.G. Voronov and G.V. Godovalnikov (Republican Centre of
p.000131: Expertise and Trials in Healthcare)
p.000131:
p.000132: 132
p.000132:
p.000133: 133
p.000133:
p.000133: In Belarus a gradual implementation of the procedure for a compulsory ethical review of clinical trials performed by
p.000133: ECs began in 1999 when the Order No 254 of the Health Ministry of Belarus was issued. The Order No 161 on 14 of May
p.000133: 1999 stimulated the process of accrediting healthcare institutions and certifying specialists conducting
p.000133: clinical trials. According to this Order, to gain the right to conduct clinical trials, an Ethics Committee should be
p.000133: established at accredited institutions in compliance with Methodical Recommendations. There also should be specialists
p.000133: with the knowledge in good clinical practice.
p.000133: Since 2000 the Republican Centre of Expertise and Trials has been organizing educational seminars on international
p.000133: regulations for carrying out clinical trials in compliance with GCP. During 7 years over 700 physicians and
p.000133: pharmacists, conducting clinical trials and participating in the EC activity, attended the seminar. This helped
p.000133: to create optimum conditions for the development
p.000133: of the network of local ECs, which formed the basis for implementing ethical review
p.000133: procedures into the practice of biomedical research.
p.000133: Due to the mentioned measures, currently, apart from the NCBE, 51 local ECs at healthcare institutions
p.000133: accredited to conduct clinical trials are functioning in Belarus. Among those there are, in particular,
p.000133: 11 regional and
p.000133: 20 city hospitals, 3 out-patient clinics, 9 Republican science-and-
p.000133: practical Centres; 3 scientific-and-research institutes. In 1998 the National Coordinating Safety Centre was
p.000133: established at the Institute of Genetics and Cytology of the National Academy of Sciences; in 2000 BSMU established an
p.000133: EC, and the International State Ecological University named after A.D. Sakharov established an EC in 2003. ECs at
p.000133: healthcare institutions work on implementing ethical review into the design of dissertation research that would precede
p.000133: the approval of the dissertation theme by the Scientific Council.
p.000133: While one of the main NCBE tasks is to facilitate public control ensuring the observance of ethical norms and
p.000133: regulations in pre-clinical and clinical trials, local ECs at healthcare institutions are implementing in practice the
p.000133: system of administrative and State control ensuring the protection trial subjects’ rights and interests.
p.000133: Presently, local ECs carry out ethical review, which includes the review of documents (research protocols,
p.000133: forms of individual registration cards, informed consent forms, etc.) relating to pre-registration (Phase I, II and III
p.000133: trials, generic bioequivalence studies) and post-registration (Phase
p.000133: IV) clinical trials in various fields of medicine (cardiology, oncology, gastroenterology, allergology,
p.000133: endocrinology, traumatology) including international multicentre trials.
p.000012: 12
p.000011: 11
p.000010: 10
p.000010: 10
p.000010:
p.000010:
p.000008: 8
p.000008:
p.000008:
p.000006: 6
p.000005: 5
p.000004: 4
p.000004: 4
p.000002: 2
p.000002: 2 1 1 1
p.000002:
p.000000: 0
p.000000: 1998 1999 2000 2001 2002 2003 2004
p.002005: 2005
p.002005:
p.002005:
p.002005: Multicentre clinical trials of pharmaceutical products in Belarus
p.002005: (1998-2005)
p.002005:
p.002005: When conducting ethical review ECs give a special attention to the protection of rights and interests of
p.002005: healthyXvolunteers involved in the Phase I clinical trials and in the clinical stage of bioequivalence studies. A
p.002005: special consideration is also given to research involving vulnerable groups (children, aged people, armedXforces
p.002005: personnel, etc.).
p.002005:
p.000134: 134
p.000134:
p.000135: 135
p.000135:
...
p.000137: etc.) functioning at different regulatory levels (national, regional, local). Committees belonging to
p.000137: each of these types have their goals and functions and find a common ground in solving ethical dilemmas arising
p.000137: in different fields of research and healthcare. The creation of the National Committee for
p.000137: Bioethics (NCBE) and its efficient functioning in compliance with the Project Proposal “Establishing the
p.000137: National Committee for Bioethics and Providing Bioethical Education to Specialists in Republic of Belarus” (in
p.000137: the framework of the Programme of Social Sciences and Humanities, UNESCO Moscow Office) aims to provide a competent
p.000137: ethical review of scientific research in healthcare, to organize forums for discussing problems of bioethics on a
p.000137: national level, and to have an impact on the development of legislation policy in the field of bioethics.
p.000137: The NCBE has been established as an advisory body to exercise public control of compliance with ethical norms and
p.000137: regulations in experiments on animals and research involving human subjects in order to safeguard human rights and
p.000137: freedoms when applying to them modern scientific achievements, and in educational, treatment-and-preventive and
p.000137: other activities. The Statement on the National Committee for Bioethics has been approved by the Order of the Health
p.000137: Ministry of Republic Belarus. The Statement sets out a wide range of the NCBE functions with regard to:
p.000137: - providing healthcare, monitoring clinical trials and registration of new pharmaceutical products and medical
p.000137: technologies;
p.000137: - disease treatment and prevention and scientific-research activity;
p.000137: - providing bioethical education to professionals and public at large;
p.000137: - legislative initiatives concerning healthcare and biomedical research;
p.000137: - resolving social and legal problems in nature-conservative activities [20].
p.000137: The NCBE is independent in its appraisals, opinions and decisions. It has the status of an advisory
p.000137: body, and does not make legal decisions but actively cooperates with legislative and executive bodies and
p.000137: with public organizations. In autumn 2006 the NCBE members T.V. Mishatkina and Ya.S. Yaskevich took part in the
p.000137: meeting of the Round Table at the National Assembly of Republic Belarus, where the Law Project “On the
p.000137: Transplantation of Human Organs and Tissues” was discussed [25,26]. The Law was adopted in March 2007.
p.000137: Thus, the NCBE should facilitate:
p.000137: - the development of a democratic mechanism for the discussion and analysis of difficult moral problems
p.000137: relating to the achievements in biomedical science and technology;
p.000137:
p.000138: 138
p.000138:
p.000139: 139
p.000139:
p.000139: - public control ensuring the protection of human rights according to criteria of biomedical ethics;
p.000139: - the development of proposals relating to the legal regulation in biomedicine;
p.000139: - EC establishing, regulation and coordination of their activity at different levels; education of the EC
p.000139: members;
p.000139: - raising the level of a continuing bioethical education in professional medical community (from undergraduate to
p.000139: postgraduate education);
p.000139: - creating the opportunity for international cooperation in bioethics;
p.000139: - promoting a healthy life-style and informing the population about achievements and current problems in
p.000139: bioethics.
p.000139:
p.000139: 3.3.5. Perspectives and Forms of International Cooperation
p.000139:
p.000139: Republic of Belarus has developed an effective partnership with the leading international organizations such
p.000139: as UNESCO and Forum for Ethics Committees in the Commonwealth of Independent States, as well as bilateral cooperation
p.000139: with The Institute of Philosophy of the Russian Academy of Sciences, the Ukraine State Medical University named after
p.000139: Bogomolets, the Ukrainian Association on Bioethics, Higher Medical School of Hanover, the Committee for Ethics in
p.000139: Science of the Warsaw University, the National Committee for Bioethics of Lithuania, the Lithuanian Association
p.000139: of Psychiatrists, the Fogarty International Centre and National Institute of Health (USA), etc. Results of
p.000139: scientific and teaching-and-methodical work are presented at international conferences. In particular,
p.000139: professionals from Belarus participated in the International Scientific Conference on Humanities in the
p.000139: Contemporary World (Saint-Petersburg, 2002) [10] in the International Scientific and Practical Seminar on Bioethics in
p.000139: the framework of the programme of Fogarty International Centre (Bulgaria, 2003) and in regular international seminars
p.000139: and symposia held in Kiev Materials prepared by Belarusian scientists in the framework of international cooperation are
p.000139: published in Russian and Ukrainian scientific journals and in volumes of conference proceedings [27-29].
p.000139: Participation of Belarus professionals in the FECCIS and, particularly, in meetings and symposia of the FECCIS in
p.000139: St.-Petersburg, Baku, Yerevan and Kiev is very essential for the development of bioethical thought and
p.000139: bioethics in Belarus. Seminars organized in the framework of the FECCIS and reports by leading specialists and experts
p.000139: of the international level are certainly very helpful for a more profound understanding of bioethical problems
p.000139: and dilemmas and facilitate education of persons concerned.
p.000139: During the last years, specialists in bioethics from Belarus have been taking part in activities undertaken by UNESCO,
p.000139: particularly, in meetings of regional experts in bioethics (January 2005, Moscow; March 2005, Minsk; September 2005,
p.000139: Vilnius). On the request of UNESCO, T.V.Mishatkina, an expert in ethics from Belarus, designed and submitted to
p.000139: the UNESCO Headquarters 11 educational programmes on the fundamentals of education in ethics and bioethics.
p.000139: Today the international cooperation in implementing bioethical principles and developing ethical review of
p.000139: biomedical research goes along three directions supported by UNESCO:
p.000139: – theoretical development of a conceptual model of bioethics;
p.000139: – practical work on the organization of the National Committee and on the development of local ECs activity;
p.000139: – providing bioethical education to professionals and general public in accordance with the Project Proposal
p.000139: within the Programme for Social Sciences and Humanities(UNESCO Moscow Office) “Bioethics Education in Republic of
p.000139: Belarus”.
p.000139: Cooperation in developing the theory of the ethics of biomedical research. A joint project “Social,
p.000139: Philosophical and Ethical Problems of Genomic Research and Clinical Medicine” is carried out in
p.000139: cooperation with the Institute of Philosophy of the Russian Academy of Sciences. The theme of the Project has been
p.000139: approved by the Belarusian Republican Fund of Fundamental Research at the National Academy of Science of Belarus and
p.000139: Russian Foundation for the Humanities (Project Directors: B.G. Yudin and T.V. Mishatkina; the term of the Project – two
p.000139: years).
p.000139:
p.000139: Project objectives:
p.000139: 1. on the basis of the interdisciplinary approach to make an inventory, description and analysis of social,
p.000139: philosophical and ethical problems in genomics, modern biotechnologies and clinical medicine;
p.000139: 2. to trace global and national tendencies of principles of bioethical regulation in research and medical practices;
p.000139:
p.000140: 140
p.000140:
p.000141: 141
p.000141:
p.000141: 3. to work out recommendations on methodology and procedures of humanitarian review in the above-mentioned
p.000141: fields;
p.000141: 4. to specify the conceptual model of biomedical ethics. To achieve the goals, we have to solve the following tasks:
p.000141: - theoretical and methodological analysis of interdisciplinary approaches and finding mechanisms for
p.000141: interaction between humanities and natural sciences;
p.000141: - definition of the methodological status of fundamental ethical problems referring to achievements in
p.000141: genomics, development of new biotechnologies and situations in modern biomedicine;
p.000141: - content structure determination, inventory, classification and interpretation of main elements of
p.000141: bioethical knowledge; investigation of its structure, functions, principles and specific nature of moral values;
p.000141: development of a conceptual model of bioethical ethics;
p.000141: - development of operational standards for a complex humanitarian expertise and control in the field of genomics,
p.000141: biotechnologies and clinical;
p.000141: - theoretical and methodological substantiation of the activity of the National Committee on Bioethics of Republic
p.000141: Belarus, the development of its Statute and recommendations for stimulating the activity of regional and local
p.000141: bioethics committees.
p.000141: Project Outcomes: the inventory and analysis of social, philosophical and ethical problems caused by the
p.000141: development of genomics, modern biotechnologies and clinical medicine as a methodological basis for the
p.000141: development of a conceptual model of biomedical ethics, and for working out recommendations for a complex
p.000141: humanitarian expertise and ethical regulations guiding the practice of biomedical research.
p.000141: The practical application of the Project results is possible in the following directions:
p.000141: а) in establishing and regulating practices of bioethical committees to conduct a complex humanitarian
p.000141: expertise and to monitor biomedical research and pharmacological trials involving human subjects, the process of
p.000141: implementing results of new biotechnologies and the compliance with ethical regulations in clinical practice;
p.000141: б) in developing the strategy and tactics of bioethical education and the system of a continual
p.000141: education to raise the professional level of specialists in medicine and biology; in designing manuals and
p.000141: methodical
p.000141: recommendations for teaching fundamentals of biomedical ethics to undergraduate medical students;
p.000141: в) in raising the level of bioethical culture and competence in the
p.000141: population.
p.000141: Results of this cooperation will be presented at an international scientific conference in 2007; the work on a
p.000141: collective monograph is under way.
p.000141: In the framework of international cooperation, we continue the analysis of bioethical consequences of genetic
p.000141: research. In October 2006 Minsk hosted the International Conference “The Evaluation of Risks from a
p.000141: Combined Effect of Anthropogenic Factors: Prognosis for the Future”. Co- Directors of the Conference were prof.
p.000141: C.Mazersill (McMaster University, Hamilton, Canada) and prof. I.B.Mosse (Minsk, National Academy of Science,
p.000141: Republic Belarus). Leading specialists from 16 countries (USA, Canada, England, Norway, Italy, Portugal, Ireland,
p.000141: Russia, Belarus and other countries of East Europe, Asia and Africa) attended the Conference. Forty- five presentations
p.000141: made at the Conference reflected the current situation with regard to the environment pollution with radiation and
p.000141: chemical products. The speakers suggested possible ways of preventing negative consequences caused by anthropogenic
p.000141: factors. Reported data are of a great interest for the Belarusian science. They also are helpful in outlining ways for
p.000141: the use of achievements of modern science taking into account bioethical problems. Joint scientific projects aiming at
p.000141: the elimination of consequences from a combined effect of anthropogenic factors were designed in the framework of
p.000141: international scientific-and-technical programmes. Full texts of the Conference reports (about 1000 pages) will
p.000141: be published in a monograph. The co-editor of the monograph from Belarus is prof. I.B. Mosse.
p.000141: Cooperation in the field of bioethical education is focused on the development of teaching programmes and
p.000141: on the exchange of methods, materials and experience in bioethical education with countries which are most
p.000141: developed in this respect. In the post-Soviet space, our partners are Russia, Lithuania (Lithuanian Bioethical
p.000141: Committee, Medical Faculty of the Vilnius University, Kaunas Medical University), Ukraine (Ukrainian
p.000141: Association on Bioethics, the Medical Academy of Post-Graduate Education of Ukraine); Moldova and Armenia are our
p.000141: prospective partners.
p.000141: Cooperation in this field aims at enhancing the access to existing information resources and widening
p.000141: contacts between experts in bioethics.
p.000141:
p.000142: 142
p.000142:
p.000143: 143
p.000143:
p.000143: Another objective is to develop and introduce into practice teaching programmes, methods and approaches
p.000143: ensuring the acknowledgement and understanding of principal bioethical problems in medical community and in public at
p.000143: large.
p.000143: Main ways of cooperation here are the design and subsequent use of modules of teaching programmes on biomedical ethics
p.000143: for a differentiated ethical education in different social communities.
p.000143: One of the last events demonstrating the cooperation in bioethical education was a Scientific-and-Practical
p.000143: Seminar “Humanization in the Education of Specialists in Medicine and Biology” held by young scientists of the
p.000143: Belarus Academy of Post-Graduate Education. The Seminar was supported by the Health Ministry of Republic
p.000143: Belarus, the National Committee on Bioethics and the Belarusian Republican Fund of Fundamental Research at the National
p.000143: Academy of Science of Belarus. Experts from UNESCO, InterNICHE (United Kingdom) and Centre for Protection Animals’
p.000143: Rights “Vita” (Russia) participated in the Seminar. The main objectives of the seminar were the
p.000143: discussions relating to the observance of principles of bioethics in scientific and educational activity,
p.000143: and, in particular, the use of laboratory animals in science and education and the application of new alternative
p.000143: technologies in education and in scientific experiments [39-42].
p.000143: International cooperation on establishing the National Committee on Bioethics in Belarus. The starting
p.000143: point in establishing the National Committee on Bioethics in Belarus was an International Seminar “The
p.000143: National Committee on Bioethics of Belarus Republic and the Activity of Local (Regional) Committees on
p.000143: Bioethics: the Experience of the East and Central Europe”. The seminar aimed at providing knowledge on ECs operation
p.000143: and the procedure of ethical review of biomedical research in the context of European experience. The
p.000143: Seminar was supported by the UNESCO Moscow Office and the Belarusian Commission for UNESCO. Other partners in
p.000143: organization and holding the Seminar were the FECCIS, GCP Alliance – Europe, the Health Ministry of Republic of
p.000143: Belarus, the Centre for Expertise and Trials in Healthcare, Belarus State Medical University, the State
p.000143: Economical University of Belarus (Institute of Education in Social Sciences and Humanities), the
p.000143: Belarus Academy of Post-Graduate Education, International State Ecological University named after A.D. Sakharov.
p.000143: International experts in bioethics and research ethics, prof. O.I. Kubar
p.000143: – the Chairperson of the FECCIS, prof. B.G.Yudin and representatives from Latvia, Lithuania, Moldova, Poland,
p.000143: Russia and Ukraine attended the Seminar. Members of Belarus local and regional ECs also took part in the Seminar.
p.000143: Participants discussed issues relating to the creation and functioning of National Committees on Bioethics in the light
p.000143: of Universal Declaration on Bioethics and Human Rights adopted by UNESCO in 2005. Other issues discussed at the Seminar
...
p.000145: S.D.Denisov, Ya.S.Yaskevich. Minsk, 2003, 320 p. (in Russian)
p.000145: 9. Biomedical ethics: problems and perspectives. Proceedings of international conference, Minsk, 12-13 October
p.000145: 2000. Ed. by T.V.Mishatkina, S.D.Denisov, Ya.S.Yaskevich. Minsk, 2000. (in Russian)
p.000145: 10. Mishatkina Т.V. Biomedical ethics: status and the round of problems.
p.000145: Ibid.
p.000145: 11. Mishatkina Т.V. Bases of biomedical ethics: the programme of
p.000145: training course. Ibid., 23rd issue, pp. 355-360.
p.000145: 12. Biomedical ethics. Teaching manual. Ed. by T.V.Mishatkina, S.D.Denisov. Minsk, MSMU publications, 2001.
p.000145: 256 pp. (in Russian)
p.000145: 13. Yaskevich Ya.S., Kuznetsova L.F., Barkovskaya А.V. Contemporary
p.000145: science: value orientation. Teaching manual. Minsk, 2003. (in Russian)
p.000145: 14. Denisov S.D. Humanistic attitude to animals – one of main goals in humanization of higher medical education.
p.000145: Abstracts of Belarus-Britain symposium “Ethical aspects of animal use in training process and in research”
p.000145: (October 1997, Minsk, MSMI). Ed. by S.D.Denisov. Minsk, 1998. (in Russian)
p.000145: 15. Denisov S.D. Medical students should not kill. Proceedings of the international symposium “Bioethics on the eve of
p.000145: XXI century”. Kharkov, October 2000. (in Russian)
p.000145: 16. Denisov S.D. Requirements to scientific experiment with animals. Public Health, 2001, N 4. (in Russian)
p.000145: 17. Morozkina T.S. Deontological aspects of animal use in teaching process. Higher School, 1996, N 1, p. 30-35.
p.000145: (in Russian)
p.000145: 18. Morozkina T.S., Denisov S.D. Implementation of the principles of the three RS in Belarus: reality and perspective.
p.000145: Abstracts of the 3th World Congress on Alternatives and Animal Use in the Life Sciences. Bologna, Italy, 1999, p. 397.
p.000145: 19. National and local bioethics committees: the experience of Central and Eastern Europe. Materials of
p.000145: international conferences on bioethics. Minsk, 2006. (in English)
p.000145: 20. Bioethics: theory, practice, perspectives. Proceedings of the Republican student conference. Ed. by
p.000145: S.D.Denisov. Minsk, BSMU, 2005. (in Russian)
p.000145: 21. Mishatkina Т.V. Ethical and humanistic bases of contemporary biomedical education. Humanization of teaching
p.000145: of medical and biological specialists (in Russian)
p.000145: 22. Ethical training in Belarus (Programmes of bioethics courses). UNESCO web-site www.bioethics.ru (in Russian)
p.000145: 23. Mishatkina Т.V. Three circles of ethics. “Chelovek”, 2006, N 5, p.
p.000145: 89-98. (in Russian)
p.000145: 24. Mishatkina Т.V., Yaskevich Ya.S. Collaboration of ethics committees with patients during biomedical research
p.000145: in Belarus. Proceedings of the international conference of FEC CIS. Erevan, 2005. (in Russian)
p.000145: 25. Yaskevich Ya.S. Moral, ethical, legislative and organizational bases of organ and tissue transplantation. Materials
p.000145: of round-table of the Belarus National Assembly for discussion of the druft of Belarussian Law “On
p.000145:
p.000145:
p.000146: 146
p.000146:
p.000147: 147
p.000147:
p.000147: transplantation of human organs and tissues”. Minsk, 2006, p. 27-31. (in Russian)
p.000147: 26. Mishatkina Т.V. Biomedical ethics as a science and as teaching discipline. Values of the world: ethics and
p.000147: bioethics. Scientific Forum. Kiev, 2005. (in Russian)
p.000147: 27. Mishatkina Т.V. Existencial meaning of suffering and compassion in biomedical ethics. Proceedings of the Russian
p.000147: scientific conference with international participation “Anthropological bases for bioethics”. Tomsk, 2006,
p.000147: p.125-127. (in Russian)
p.000147: 28. Yaskevich Ya.S. Anthropological, social and cultural bases for bioethics. Ibid, p. 232-237. (in Russian)
p.000147: 29. Mosse I.B. Modification of radiation-induced bystander effect with melanin. Abstracts of the 52th annual
p.000147: meeting of the Radiation research society (Denver, Colorado, USA, – November 16-19, 2005). (in English).
p.000147: 3.4. GEoRGIA
p.000147: (G.Kiknadze, G.Dgaviashvily, t.Kurtanidze)
p.000147:
p.000147: Like many other developing countries, Georgia experiences considerable difficulties. One may suggest that it is not
p.000147: time to speak about research ethics when you hear everyday, that fundamental rights of citizens, including right to
p.000147: life, are violated (e.g. in terms of regional conflicts). However, it is never too early or too late to speak about the
p.000147: rights and freedoms of individuals, particularly in the field of health and biomedical research as far as various
p.000147: biomedical researches are being carried out currently in those countries. So, we have to do something to ensure the
p.000147: safety of people in this sphere.
p.000147: Georgia has made considerable step forward in establishing legal framework for human rights protection in
p.000147: the field of health care and biomedicine, including specific legislation on protection of research subjects.
p.000147: Georgia has signed and ratified all major documents of the Council of Europe in this sphere and endorsed various
p.000147: international texts. Moreover, national legislation has been brought in harmony with internationally accepted
p.000147: standards of human rights protection. These steps have been followed by educational activities to raise awareness of
p.000147: the society.
p.000147: However, there is a lot of work to be done to effectively implement aforementioned legislation, particularly in the
p.000147: field of biomedical research. The most topical issue for Georgia now is the development of effective system
p.000147: of ethical review of research projects. Although, certain type of system is operating, it needs
p.000147: improvement in terms of accessibility and quality.
p.000147:
p.000147: 3.4.1 Historical and Cultural Background
p.000147:
p.000147: Georgia is situated on the border of Europe and Asia. It occupies the Central and Western parts of the Caucasus. The
p.000147: Western part of the country is washed by the Black Sea. The Northern boundaries of Georgia run along the Great
p.000147: Caucasian Range. Citizens of Georgian nationality comprise about 70% of the whole population. Other nationalities
p.000147: are Russians, Osetians, Abkhazians, Azerbaijanis, Armenians, Greeks.
p.000147: Georgia is a newly independent Republic (It restored its independence in April 1991). At the same time it has
p.000147: a long history of Statehood.
p.000147:
p.000148: 148
p.000148:
p.000149: 149
p.000149:
p.000149: Georgian slave-owning kingdoms Kolkheti and Iberia emerged in the 6th- 4th centuries BC. The unification of
p.000149: Georgia in the form of the united kingdom started in XI century. In 1801 Georgia lost its independence as a
p.000149: result of the expansive policy of Russian Empire. In 1918 independence of Georgia was re-announced (Republic of
p.000149: Georgia), which lasted only up to 1921, when intervention of Russia resulted in incorporation of Georgia in the Soviet
p.000149: Union.
p.000149: Georgia has little experience in building the civil society. However, it has definitively moves towards the
p.000149: integration with the Western World and harmonisation with the western law. The legislative basis apparently is one
p.000149: of the most important points in the process of establishing common anthropocentric values and viewpoint of the civil,
p.000149: open society.
p.000149: The history of the Georgian state and law dates back to ancient times. Due to the historical misfortunes Georgia never
p.000149: participated in the process of great codifications. In this connection legislative activity of the King
p.000149: Vakhtang VI (XVII-XVIII cc) deserves major attention. Chronologically this period coincides with the epoch of
p.000149: creation of the basis for the modern law and state in Western Europe. Drafting of King Vakhtang’s Law Book can be
p.000149: considered to be an attempt to get closer to the cultural world, at which Georgia aspired during its whole history. In
p.000149: some regions of Georgia the code of Vakhtang’s Laws was in force up to the second half of the XIX century.
p.000149: An attempt to build a modern independent state in 1918-1921 was not successful due to the expansion of Russia. As a
p.000149: result Georgia became the part of the communistic space for the next 70 years. Thus, formation of the civil
p.000149: society in Georgia started within the borders of anotherXcountry (Soviet Union), making Georgia unable to develop
p.000149: its own legislation independently.
p.000149: During aforementioned 70 years legislative activity in Georgia was restricted to the slight alteration or, at
p.000149: best, adaptation of the frame laws, provided by the central authorities (Moscow). As well as in other republics of the
p.000149: Soviet Union there was no tradition of training the legal professionals for the health care system in Georgia. Before
p.000149: re-establishment of Georgia’s sovereignty, the Law on Health Care, adopted in 1972 by Soviet Government, was in force.
p.000149: This document showed significant negligence of individual rights of patients. Almost none of the basic principles of
p.000149: ensuring patients’
p.000149: autonomy and self-determination (except the right to keep personal data confidentially) were even declared.
p.000149: The creation of national legislation is an essential condition for building the national and democratic state and a
p.000149: civil society. Adoption of Georgian Constitution (24 of August 1995) and Georgian Civil Code (26 of June 1997) is
p.000149: definitely significant step toward establishment of national state.
p.000149:
p.000149: 3.4.2 Legal Regulations
p.000149:
p.000149: Legislation of Georgia related to health, biomedicine and human rights comprise laws which regulate
p.000149: various aspects of medicine/health care: rights of patients and research subjects (including vulnerable groups; such
p.000149: as minors, persons with mental disorders, patients with HIV/AIDS etc.), duties and responsibilities of health
p.000149: care professionals, human organ transplantation, assisted reproductive technologies etc.
p.000149: From the above-mentioned laws the Law of Georgia on Health Care (adopted by the Parliament of Georgia in 1997)
p.000149: is considered to be the framework law, which determines the priorities and sets out fundamental principles of the
p.000149: health care legislation of Georgia. It covers full range of problems related to health, including issues related to
p.000149: protection of research subjects.
p.000149: In general, there are three major documents serving the legal basis for biomedical research involving human subjects.
p.000149: These legal texts are:
p.000149: • Convention on Human Rights and Biomedicine (Signed by Georgia in May 2000; Ratified by the Parliament in September
p.000149: 2002; Entered into force on 1 of March 2001);
p.000149: • Law of Georgia on Health Care (Adopted by the Parliament of Georgia in December, 1997);
p.000149: • Law of Georgia on Drug and Pharmaceutical Activity (Adopted by the Parliament of Georgia in 1995; Updated in
p.000149: 2001).
p.000149: The draft of specific law on biomedical research –“Law on Biomedical Research Involving Human Subjects” will be
p.000149: the fourth and the most comprehensive document regulating research on human subject. Draft “Law on
p.000149: Biomedical Research Involving Human Subjects” (originally drafted in 1999) has been reviewed by the expert
p.000149: appointed by the Council of Europe in 2000 and updated according to the comments provided.
p.000149:
p.000150: 150
p.000150:
p.000151: 151
p.000151:
p.000151: It was submitted to the Government in 2000 and to the parliament of Georgia by the President in 2002.
p.000151: However, in 2005 it was taken back by the Government for further consideration against the background of the latest
p.000151: developments of the Council of Europe. In 2006 the draft law was reviewed by the working group based on the
p.000151: comments of the experts, including experts appointed by the Council of Europe. The draft law was the subject of
p.000151: debates during the international conference “The Council of Europe and Promotion of Research Ethics in East
p.000151: European States” organized by the Council of Europe and the Government of Georgia in Tbilisi in October
p.000151: 2006.
p.000151: Since the Convention on Human Rights and Biomedicine entered into force in Georgia it becomes the integral part
p.000151: of Georgian legislation, taking precedence over other laws and coming after the Constitution in the hierarchy of law.
p.000151: So, provisions of the Convention related to the research on human subjects is applicable to all relevant
p.000151: research projects being carried within jurisdiction of Georgia. However, more specific impact on biomedical
p.000151: research and its ethical evaluation will have its Additional Protocol on Biomedical Research, which has been signed by
p.000151: Georgia but is not yet ratified.
p.000151: The law of Georgia on Health Care includes separate chapter – Chapter XIX “Biomedical Research”, in which basic
p.000151: principles regulating biomedical research are set out. Particularly according to the above-mentioned law:
p.000151: • aims, objectives, methods and possible outcomes of the research should be specified in the research
p.000151: protocol; research should be carried out only within the frames of the research protocol;
p.000151: • research protocol should be reviewed by independent body and ethics committee;
p.000151: • risks and benefits of the research should be assessed; risk associated with the research should not be
p.000151: disproportional to the expected benefits;
p.000151: • research subject should be fully informed about the details of the research (objectives, methods, potential
p.000151: benefits, risks, alternatives etc.);
p.000151: • research should not be started without informed consent of the research subject;
p.000151: • research subject has the right to refuse to participate in the research or withdraw from the research at any
p.000151: time despite already given written informed consent.
p.000151: The law also outlines general principles for the protection of incapable persons and minorities in the context of
p.000151: biomedical research.
p.000151: The law on Drug and Pharmaceutical Activity sets out the rules for organizing drug trials including trials in
p.000151: clinical phase when human beings are involved in the research programme. It requires that ethics committee to be
p.000151: created at the institution where the trial is to be carried out. Interestingly, this law specifically mentions
p.000151: recommendations set out in WMA Declaration of Helsinki to be the basis for conducting clinical trials on human beings.
p.000151: As already mentioned the most specific law on the protection of the research subjects will be the Law on
p.000151: Biomedical Research involving Human Subjects, which is being submitted to the Government this year. The aim of the
p.000151: draft law is protection of the rights, health and life of a research subject of biomedical research and provision of
p.000151: safety and respect for dignity during the research. The draft law concerns any type of research aiming at obtaining
p.000151: information and broadening knowledge in the sphere of biomedicine, which serves the interests of human health
p.000151: protection and implies:
p.000151: • Physical intervention on human being;
p.000151: • Research on biological materials which initially were taken and stored with other purpose;
p.000151: • Intervention which doesn’t imply physical intervention on human being but can pose danger to mental health or
p.000151: psychological condition of human being;
p.000151: • Research on foetus and/or embryo in vivo (The Law does not apply to research on embryos in vitro.
p.000151: The draft Law on Biomedical Research involving Human Subjects is based on the following core principles:
p.000151: • Primacy of the human being;
p.000151: • Autonomy of research subjects: information, informed consent, confidentiality and privacy;
p.000151: • Scientific quality;
p.000151: • Minimizing risks and keeping adequate risk-benefit ratio;
p.000151: • Safety;
p.000151: • Protection of vulnerable groups;
p.000151: • Multidisciplinary review of ethical acceptability of research protocol and its approval by an ethics committee.
p.000151:
p.000152: 152
p.000152:
p.000153: 153
p.000153:
p.000153: Side by side with legislation certain impact on the ethical conduct of health care providers as researchers has ethical
p.000153: regulations, which could be considered as soft legal instruments. In April 2003 the Congress of Georgian Physicians
p.000153: endorsed the Ethics Code of Physician of Georgia. The code was developed by Georgian Health Law and Bioethics Society
p.000153: (GHLBS) and the Health Legislation and Bioethics Department of the National Institute of Health. The first version of
p.000153: the Code was discussed by the participants of the Congress and was submitted to further considerations to the National
p.000153: Council on Bioethics. The letter considered the document during its three different sittings and finally published the
p.000153: final text of the Code, which was adopted at the last session of the First Congress of Physicians of Georgia.
p.000153: The Ethics Code of Physician of Georgia is the first national code of ethics in the sphere of biomedicine. It includes
p.000153: specific provisions aiming at protecting research subjects. Particularly it says the following:
p.000153: “Patient’s interests are supreme in scientific research on human being. The research goals and its possible outcomes
p.000153: never interfere with the main mission of a physician – to serve for patient’s health and life.”
p.000153: Although much has been done in building of the legal protection of the research subjects, many problems
p.000153: are remained to be addressed. Just to mention, no sanctions are yet introduced against violation of the rights of
p.000153: research subjects and infringement of the principles reflected in existing legislation on biomedical research. Also,
p.000153: existing ethics committees need be improved and the new system of research ethics committees is to be
p.000153: implemented. The draft regulation for the new system of research ethics committees has been already
p.000153: prepared. Its legitimisation will become possible after ratification of the Law on Biomedical Research
p.000153: Involving Human Subjects.
p.000153:
p.000153: 3.4.3 Education in Bioethics
p.000153:
p.000153: Education in the field of Bioethics in Georgia has developed chiefly in two domains: on one hand, high medical
p.000153: education system at Tbilisi State Medical University; on the other hand, in the shape implementation of legislation
p.000153: related to human rights, health and biomedicine developed by Health legislation and bioethics group at National
p.000153: Institute of Health (former National Health Management Centre) and Georgian Health Law
p.000153: and Bioethics Society. Since its establishment GHLBS has been actively involved in educational programmes in the field
p.000153: of Bioethics and has been incessantly organizing various training courses aiming at rising awareness of, on one
p.000153: hand, patients and general public, and on another, medical society.
p.000153: Currently, Tbilisi states medical university offers courses in Bioethics at different levels: on undergraduate level –
p.000153: for medical students, and on postgraduate level – for residents. Both courses are obligatory and constitute integral
p.000153: part of study curriculum.
p.000153: Individuals who successfully enter residency-training program after graduation of high medical school are expected to
p.000153: take one-week obligatory program in bioethics during their residency training. The course focuses on raising
p.000153: awareness of residents about modern principles of bioethics/ medical ethics and of relevant legislation of
p.000153: Georgia and assisting them in developing skills for coping with various ethical problems/dilemmas which may
p.000153: arise during their professional medical activity. During the course the audience is introduces with the issues
p.000153: related to various ethical problems associated with development of new technologies in the field of health
p.000153: care/biomedicine: the role of ethics and law in health care; individual rights of patients, Georgian legislation
p.000153: on individual rights of patients; informed consent; competency and decision making capacity; specific groups
p.000153: of patients; genetics, ethics and law; ethics, law and biomedical research involving human subjects, etc.
p.000153: Healthcare professionals have an opportunity to take short CME courses with credit hours. The course has been
p.000153: developed and submitted for accreditation by GHLBS. It offers the audience the variety of topical issues related to
p.000153: ethics inherent in doctor-patient relationship: basic principles of modern medical ethics; the rights of
p.000153: patients with the principles of modern medical ethics; active legislation of Georgia on patient’s rights; ethical
p.000153: basis of informed consent, regulations about informed consent in Georgian legislation; necessity of obtaining a written
p.000153: informed consent and protection of dignity of a patient, protect confidentiality and privacy in the process of teaching
p.000153: students and residents, role of Ethics committees, etc. There is one more programme specifically developed for
p.000153: doctoral students. This one day programme is focused on research ethics and covers
p.000153: all aspects of ethical and legal regulation of biomedical research.
p.000153:
p.000154: 154
p.000154:
p.000155: 155
p.000155:
p.000155: 3.4.4 The System of Ethical Review
p.000155:
p.000155: Below is given unofficial data collected about the drug trials being conducted in Georgia.
p.000155: In 1998-2002 12 internationally sponsored drug trials have been conducted in Georgia. About 15 medical
p.000155: centres participated in it and it included about two thousand people. As to the local trials, their
p.000155: total number is about 55, but number of participants is not so large.
p.000155: On the other hand several hundred biomedical researches are being conducted unnoticed. They are not related to
p.000155: drug experiments (which usually attract more public interest), however many of these researches include
p.000155: human subjects. Just to give idea about their number - in only one academic institution 50 research plans
p.000155: are approved annually. Most of experiments conducted or to be conducted in the framework of these research plans,
p.000155: involve human subjects, but yet only scientific merit of these studies are assessed without evaluating its
p.000155: ethical acceptability.
p.000155: It is expected that the number of international multi-centre biomedical research (mostly drug trials) will dramatically
p.000155: increase in this region and many thousand of people will participate in it. Therefore, the issue becomes very important
p.000155: and appropriate mechanisms should put on place to ensure that biomedical research involving human subjects is conducted
...
p.000157: In 1995-97 the law regulating generally almost all fields of healthcare, was drafted. This document – The Law of
p.000157: Georgia on Health Care - was thought to be the framework law for ongoing healthcare reforming process in Georgia. The
p.000157: Law was enacted in 1997. It lays down the legal basis for the establishment of the research ethics committees, which
p.000157: shall carry out ethical review of all research protocols (not only research protocols related to drug testing). So,
p.000157: currently “a scientific research plan shall be considered and reviewed …by the ethics committee” (article 107; the Law
p.000157: of Georgia on Health Care).
p.000157: At the first stage due to the lack of appropriately trained professionals it was considered wise to establish ethics
p.000157: committees bearing the functions of hospital ethics committees as well as research ethics committees. So the first
p.000157: version of the draft regulation for the so-called Medical Ethics Committees (prepared according to the Presidents
p.000157: Decree #15 on 12 of January 1998) was prepared.
p.000157: In 1999 two separate documents were drafted – the first one lays down principles of establishment and operation of
p.000157: Medical (Hospital) Ethics Committees (already adopted by the Order of the Minister of Labour, Health and Social
p.000157: Affairs) and the second one will regulate the activity of Research Ethics Committees. According to latter document
p.000157: the two-tiered network of committees on the regional level will be created in Georgia. The central
p.000157:
p.000158: 158
p.000158:
p.000159: 159
p.000159:
p.000159: research ethics committee shall coordinate the activity of regional research ethics committees.
p.000159: Unfortunately the statute for the Research Ethics Committees has not been yet approved, because of the comments
p.000159: of the Ministry of Justice stating that establishment of the separate committees for research ethics is not
p.000159: required by existing legislation (law in force or the Presidents Order). Therefore, it is suggested to amend the draft
p.000159: law on “Biomedical Research Involving Human Subjects” (which is now before Parliament) by introducing in it basic
p.000159: statements from the above-mentioned draft statute.
p.000159: About 15 research ethics committees were established during the last 5-6 years, from which about 6 would function at
p.000159: the moment. They have been created at the institutions that used to participate in the multi-centre trans-national drug
p.000159: trials. Without having such committees they would not have been able to participate in such trials. Only few of them
p.000159: would have their own regulation/bylaw. The number of the members would vary from 5 to 11 (mostly their number is 5 as
p.000159: it is defined in the Law on Drug and Pharmaceutical Activity).
p.000159: Finally, the National Council on Bioethics would exceptionally review some research protocols that reflect
p.000159: international multi-central biomedical research, because still there is no central research ethics committee
p.000159: in Georgia that would be in charge of carrying out ethical review of multi- central studies.
p.000159: Below is given brief schematic summary of what have has done and what is to be done in Georgia for the protection of
p.000159: research subjects in the sphere of biomedicine.
p.000159: Has been done:
p.000159: • General legal framework outlining basic principles for conducting biomedical research involving human subjects is
p.000159: created (law on health care; adopted in 1997) and requirements for organizing drug trials are specified (law on drug
p.000159: and pharmaceutical activity; adopted in 1995),
p.000159: • Convention on Human Rights and Biomedicine is signed and ratified (entered into force in Georgia on 1.03.01);
p.000159: also, its additional protocol on Biomedical Research has been signed;
p.000159: • First research (institutional) ethics committees for drug trials are established;
p.000159: • Specific law on biomedical research involving human subjects has been drafted and submitted to the Government;
p.000159: • Concept on the establishment of the two-tired network of research ethics committees on the regional level has been
p.000159: drafted (central research ethics committee and regional research ethics committees);
p.000159: • National council on bioethics stresses the importance of strengthening the system of ethical review of
p.000159: research protocols and advocates for the speeding up of the process of adoption of the specific law on biomedical
p.000159: research;
p.000159: • Teaching programmes in bioethics, including research ethics have been introduced on undergraduate as
p.000159: well as postgraduate level (programmes for residents and doctoral students as well as continuing medical
p.000159: education programmes for practicing physicians) of medial education/training.
p.000159: Is to be done:
p.000159: • Stimulation and speeding up the process of ratification of the law on biomedical research involving human
p.000159: subjects;
p.000159: • Introduction of sanctions in administrative and criminal code of Georgia for the infringement of the
p.000159: principles set out in the legislation related to the protection of research subjects;
p.000159: • Enforcement of the above mentioned concept on ethics committees (order of the minister of health or inclusion of
p.000159: the main statements of the concept in the draft law on biomedical research during the discussions at the parliament);
p.000159: • Education: undergraduate, postgraduate education; education of potential members of research ethics
p.000159: committees;
p.000159: • Establishment of central and regional ethics committees;
p.000159: • Setting up quality assurance system for research ethics committees.
p.000159:
p.000159: Finally, step-by-step we have to strengthen mechanisms, which will ensure that the rights and dignity of
p.000159: human research subjects are duly protected. This will be one more brick in the wall in the process of building
p.000159: democratic society, which doesn’t allows injustice to take place among people.
p.000159:
p.000159:
p.000160: 160
p.000160:
p.000161: 161
p.000161:
p.000161: 3.4.5 Perspectives and Forms of International Cooperation
p.000161:
p.000161: Georgia is the member of all international cooperation in the field of protection human rights in
p.000161: biology and medicine. Collaboration develops through the representatives of Georgia in international
p.000161: bodies and organisations, by following the international regulations, involving in educational and training
p.000161: programmes on bioethics and research ethics and by participation in scientific and practical conferences and
p.000161: workshops organized on global and regional levels. Scientific publication and common international projects help to
p.000161: share the experience and to build the harmonized relations in the bioethics in the frame of international
p.000161: informational, legal and research space.
p.000161: 3.5. REPUBLIC oF KAzAKHStAn
p.000161: (А.B.Sadykova, B.Е.Sarymsakova)
p.000161:
p.000161: 3.5.1. Historical and Cultural Background
p.000161:
p.000161: Kazakhstan is a country with very rich historical and cultural past time. Being geographically located in the Centre of
p.000161: Eurasia Kazakhstan was on the crossroad of ancient world civilizations, on the cross of transportation arteries,
p.000161: social and economic, cultural and ideological relations between East and West, South and North, between
p.000161: Europe and Asia, between the largest states of Eurasian continent. At different phases of the history states with
p.000161: original cultural history were organized and developed at the territory of Kazakhstan; the modern Kazakhstan is
p.000161: the inheritor of this cultural history. In the middle of XV century Kazakhs united in the unique khanate but after
p.000161: the death of khan Tauke and invasions of Djungars the country disintegrated and was divided into 3 “zhuzes”
p.000161: (sub-countries) each of which was practically independent of others. The khan of Jounger Zhuz applied to Russia for
p.000161: protection – so since that time the incorporation of Kazakh territories started.
p.000161: In 1866 all Kazakh territories were under the political power of Russia but some part of Older Zhuz and Middle Zhuz was
p.000161: incorporated into the Czinn Empire.
p.000161: In 1917 «Alash-Ordy» declared its autonomy.
p.000161: In 1920 Kirgyz Autonomic Republic was organized as a part of the Russian Federation.
p.000161: In 1925 the republic received the name of Kazakh Autonomic Republic with the capital in Almaty and in 1936 it was
p.000161: transformed into Kazakhskaya Soviet Socialist Republic.
p.000161: In 1956 some part of republican territory was adjoined to Omskaya province and Altaysky krai.
p.000161: On 16th of December 1991 Kazakhstan became independent republic. The official name of the country is the
p.000161: “Republic of Kazakhstan” (RK). Astana is the capital of the country, Almaty – the biggest city of the country. The
p.000161: territory of Kazakhstan is equal to 2,717,300 sq. km.
p.000161: The population size of the country (data of 2006) is equal to 15.3 million citizens. Around 53% of the population is
p.000161: urban citizens. There are over
p.000161:
p.000162: 162
p.000162:
p.000163: 163
p.000163:
p.000163: 120 nationalities in Kazakhstan, among them Kazakhs – 58.9%, Russians
p.000163: – 25.9%, Ukranians - 15,2%, and Uzbeks, Germans, Tatars, Uygurs and representatives of other nationalities.
p.000163: Medicine as a part of population culture is the result of practical and scientific selection of methods for the
p.000163: treatment of different diseases. It is well known that even ancient healers used infusions, decoctions, blood-
p.000163: lettings and other traditional methods of treatment (1).
p.000163: Multiple archeological findings on the territory of Kazakhstan proves the existence of drug therapy, surgery,
p.000163: neurosurgery. For example, the scull with marks of trepanation was found in Karagandinskaya province and the origin of
p.000163: this scull was dated by V-IV centuries B.C. Mortars for preparation of medical drugs from the same epoch were
p.000163: found not far away from Shymkent. Due to achievements of Arabic and Greek medicine, Kazakh healers’
p.000163: medicine in middle ages was characterized with deep knowledge in the area of disease prognosis, prevention and timely
p.000163: treatment. There are definite data that healers of that era used already laparathomy, abdomen punctures, and
p.000163: surgery for hernias and cataract surgery.
p.000163: The great scientist and healer Oteyboidak Tleukabyl uly (1397-1492) underlined the importance of combination use
p.000163: of traditional treatment with innovation methods and considered that such approach improved the diagnostics of
p.000163: diseases and increased the efficacy of treatment.
p.000163: In the middle of XVIII century when Kazakh territories began tom unite with Russia the first
p.000163: professional health care workers appeared on the territory of Kazakhstan and together with them the first
p.000163: health care institutions were created – such as hospitals and military medical units of the Siberian Cossack army.
p.000163: In 1827 and in 1831 several epidemics of smallpox spread in Kazakhs steps. To take urgent measures, khan Zhangir had
p.000163: sent Sarlybay Zhanibekov for medical studies to Orenburg and in 1828 Sarlybay returned to Kazakhstan as professional
p.000163: smallpox vaccinator and surgeon’s assistant. Since that time mass immunization of local population against smallpox
p.000163: started.
p.000163: In 1920 special anti-plague laboratories were organized to control social diseases in the country. In 1922 the
p.000163: Scientific Medical Council was created under the Commissariat of Public Health.
p.000163: On 10 of October 1925 the first scientific institution was founded in Kzyl-Orda – The Regional Institute of Sanitation
p.000163: and Bacteriology. In meant
p.000163: the organization of the national medical science of Kazakhstan. Konstantin Ivanovich Skryabin gave very valuable help
p.000163: in the process of medical science development; due to his initiative anti-helminthic unit was organized in the city of
p.000163: Kzyl-Orda, special laboratory in the city of Dzhambul, parasitological laboratory at the Institute of Zoology of the
p.000163: Academy of Sciences of the Kazakhstan Soviet Socialist Republic. Special scientific journal “Public Health of
p.000163: Kazakhstan” was founded in for dissemination of scientific knowledge and best practice; this journal played the
p.000163: distinguished role in the development of Kazakhstan’s science.
p.000163: In 1930s several research institutions were organized actively; these Centres began to develop
p.000163: scientifically based recommendations on prevention, early diagnostics and treatment of diseases.
p.000163: During the first years of the Great Patriotic War 112 military hospitals were organized at the territory of Kazakhstan.
p.000163: During the war in spite of very complicated situation medical scientists of Kazakhstan continued their research
p.000163: activity and enriched the practice with very important discoveries and patents that did not loose their
p.000163: actuality even after the war. Academician N.F.Gamaleya – the founder of the Russian microbiology
p.000163: – after experiments on himself developed the drug for the treatment of tuberculosis. Professor
p.000163: A.P.Polosukhin developed an effective drug for shock treatment; Dr. A. N. Syzganov proposed and scientifically
p.000163: based the use of salicylic acid and acidophilic cream for the treatment of infected wounds and frostbites;
p.000163: Dr. V.V.Zikeev used formalized bone transplants for the treatment of pseudo-arthroses.
p.000163: During the war research institutions of Kazakhstan did not interrupt their activity; immediately after the war
p.000163: several medical research institutions were organized under the Academy of Sciences of Kazakhstan Republic: the
p.000163: Institute of Regional Pathology, the Institute of Clinical and Experimental Surgery, the Institute of Physiology.
p.000163: World-known academician Nikolai Dmitrievich Beklemishev – doctor of medical sciences, professor, honored scientist of
p.000163: Kazakhstan Republic and the winner of the State Prize – made a great input in the study and control of
p.000163: brucellosis. His monograph “Chronic brucellosis” was included as big section in the manual «Die brucellose des
p.000163: Menschen» that was edited and published in Berlin by J.Parms and in recommendations published by the World Health
p.000163: Organization.
p.000163:
p.000164: 164
p.000164:
p.000165: 165
p.000165:
p.000165: When Kazakhstan became independent country the public health sector in the country changed dramatically.
p.000165: The president of the state N.A.Nazarbaev declared the health of the population as the most important value in the
p.000165: country and formulated the specific goals of the policy – the improvement of the population health, support to the
p.000165: public health system and advocacy for the healthy lifestyle.
p.000165: Taking into consideration more strict demands and requirements for the quality of medical aid to
p.000165: population several social programmes were developed and approved in the country including the State Programme “The
p.000165: Health of Population”, “The program for the Control of Illegal Drug Use and Drugs Traffic”, the conception “On the
p.000165: development of Medical Sciences in Kazakhstan Republic”, the complex programme “The healthy lifestyle”, the State
p.000165: Programme “On reforms of Public Health System and its future development in 2005-2010” and other programmes.
p.000165: During the last several years new methods for treatment of patients were developed successfully in the
p.000165: Republic as well as new directions in medical sciences were created. Research studies were conducted on clinical
p.000165: efficacy of transplantations of pancreatic B-cells and embryonic liver cells. The National Genetic Register was
p.000165: organized. Public health authorities spend great efforts to implement the best results and discoveries of medical
p.000165: science into everyday practice of health care institutions. At the same time medical professionals like the Association
p.000165: of Physicians and Pharmacists of Kazakhstan (APPK) started very serious dialogue with the Government and society on
p.000165: such complicated issues as protection of human rights of participants of research studies and experiments.
p.000165: At all international conferences members of this Association stressed that the research activity should not harm the
p.000165: health and life of human beings. The importance of this problem found very positive response in the Government of the
p.000165: country. As a result in September 2005 the Commission on Bioethics was organized in frames of the National Coordination
p.000165: Council for Health Protection under Kazakhstan Government.
p.000165:
p.000165: 3.5.2. Legal Regulations
p.000165:
p.000165: During the last decade several very important social laws were approved in Kazakhstan. In 1991 special law “On Health
p.000165: Protection of Citizens of
p.000165: the Republic of Kazakhstan” was adopted, in 1994 – “On Prevention of AIDS”, in 1997 – “On Psychiatric Aid
p.000165: and Guarantees of Patient Rights during Treatment”, in 1998 – “On Radioactive Safety of Population”, in 1999
p.000165: – “On Physical Culture and Sports”, in 2002 – “On Medical and Social Rehabilitation of Persons with Drug Addiction”
p.000165: and “On Prevention and Control of Tobacco Use” and “On Sanitary and Epidemiological Protection of Population”.
p.000165: Several laws – such as “On Health Protection of Citizens”, “On the System of Public Health”, “On Medical Drugs” that
p.000165: were adopted in 2004-2005 – have the greatest importance in area of bioethics (2).
p.000165: Ethical problems of biomedical research in Kazakhstan were discussed actively since 2001 when according to
p.000165: initiative of the Association of Physicians and Pharmacists of Kazakhstan (APPK) and with the support from
p.000165: FECCIS and WHO the republican conference was organized and later
p.000165: – international conferences (in 2002 and 2005) under the common title – “High quality ethical practice for biomedical
p.000165: research in the Republic of Kazakhstan”.
p.000165: At present time there are definite trends for increase of attention to bioethical issues in the Republic
p.000165: of Kazakhstan not only from the state but from the general population too. These trends are reflected
p.000165: by the improvement of legal regulations in Kazakhstan.
p.000165: The article 29 of the “Constitution of the Republic of Kazakhstan” says that all Kazakhstan citizens have the right for
p.000165: health protection. The article 29 of the Constitution says that administrative persons that keep the secret on the
p.000165: facts and circumstances that are dangerous for population health and life can be prosecuted according to the Law (3).
p.000165: In July 2006 new version of the Law of Kazakhstan Republic “On Health Protection of Citizens” was
p.000165: approved. Requirements to preclinical studies and medical and biological experiments as well as to clinical trials
p.000165: or implementation of new methods and means of disease prevention, diagnostics, treatment and medical rehabilitation are
p.000165: described in the article 31 (4):
p.000165: - Preclinical studies and medical and biological experiments should be done in animals only.
p.000165: - Clinical trials in human beings can be done only with written informed consent or according to a special agreement
p.000165: between the person and health care institution after getting positive results of preclinical studies and medical and
p.000165: biological experiments in animals.
p.000165:
p.000166: 166
p.000166:
p.000167: 167
p.000167:
p.000167: - Clinical trials should be interrupted immediately according to the will of a person participating in such trials as
p.000167: well as in the situation that can be dangerous for the health or life of a patient.
p.000167: - The use of new methods and means of disease prevention, diagnostics, treatment and medical rehabilitation is possible
p.000167: only after positive results of clinical trials were obtained.
p.000167: According to the article 9 of the same law (“The competence of responsible institution”) the Ministry of Health of
p.000167: Kazakhstan has the right to:
p.000167: - determine the requirements for the use of new methods and means of disease prevention, diagnostics, treatment and
p.000167: medical rehabilitation;
p.000167: - determine the requirements for implementation of preclinical studies and medical and biological experiments as well
p.000167: as to clinical trials;
p.000167: - develop and approve the order and conditions of collection, conservation and transplantation of
p.000167: tissues and (or) organs (fragments of organs) from human to human, from the dead body to human and
p.000167: from animals to humans.
p.000167: According to the article 14 of this law every person has the right to receive the information on possible methods of
p.000167: treatment and consequences of clinical trials from public health institutions.
p.000167: According to the article 15 any person has a right to apply to independent experts for assessment of the quality of
p.000167: medical procedures that were offered to this person.
p.000167: The law “On Medical Drugs” approved on 13th of January 2004 contains articles 18, 19 and 20 that describe the
p.000167: order of development of biologically active substances and their preclinical studies or clinical trials of medical
p.000167: drugs. These articles were developed in the line with international experience (5):
p.000167: - the participation of the patient in clinical trials and (or) in testing of pharmaceutical substance or
p.000167: medical drug should be voluntary and is possible with his/her written informed consent only;
p.000167: - before clinical trials and (or) testing all information on the substance/ drug, on the contents of trials or tests,
p.000167: on safety and risks for patients health, on actions in the case of unforeseen effects of pharmaceutical substance or
p.000167: medical drug for the patient’s health as well as on patient’s health and life insurance should be provided to the
p.000167: patient;
p.000167: - the patient has a right to interrupt his/her participation in trials and (or) tests of pharmaceutical substance or
p.000167: medical drug at any phase of such trials or tests;
p.000167: - it is strictly prohibited to perform clinical trials and (or) tests of pharmaceutical substances or
p.000167: medical drugs with participation of: children and adolescents; pregnant women; military persons; imprisoned
p.000167: or incarcerated persons; non-competent persons.
p.000167: At the web-site www.medik.kz the Association of Physicians and Pharmacists of Kazakhstan has the page, where
p.000167: all legislative and regulatory documents in public health area. At present time specialists began to develop the Code
p.000167: of Republic of Kazakhstan “On Population Health and Public Health System” that will take into consideration all
p.000167: international legislative experience including legislative acts in area of biological and medical studies. For
p.000167: example, on 22nd of January 2007 the Frame Convention on Tobacco Control was officially ratified by the Republic of
p.000167: Kazakhstan; it is planned to bring laws of Kazakhstan in line with international documents that can ensure good
p.000167: clinical practice and improvement of activity of ethical committees [6].
p.000167: In 1995 according to initiative of the Association of Physicians and Pharmacists of Kazakhstan drafts of “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan” and “The Oath of Physician of the Republic of Kazakhstan” were
p.000167: developed. In 2002 the Second Congress of Physicians and Pharmacists approved the text of “The Oath of Physician of the
p.000167: Republic of Kazakhstan” that was reflected in special Decree of the Government of the Republic of Kazakhstan No/ 1189
p.000167: published on 27th of November 2003 and in the article 50 of the Law of the Republic of Kazakhstan “On the
p.000167: System of Public Health” [7, 8].
p.000167: The Third Congress of Physicians and Pharmacists should be organized in 2007; the participants will discuss “The
p.000167: Ethical Code of Physician of the Republic of Kazakhstan”.
p.000167: In 2006 according the law “On changes and additions to some legislative documents on public health of the Republic of
p.000167: Kazakhstan” the article 20 was supplemented with the following paragraphs:
p.000167: «it is prohibited to perform clinical trials and(or) testing of pharmaceutical substances or medical drugs with
p.000167: participation of:
p.000167:
p.000167:
p.000168: 168
p.000168:
p.000169: 169
p.000169:
p.000169: - persons before coming to age with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treatment of children diseases or when the goal of clinical trial is to collect data on the optimal dosage of this
p.000169: medical drug supposed for usage in children and adolescents. In the last case clinical studies of any medical drug in
p.000169: adults should precede clinical studies in persons before coming to age. When clinical trials of medical drugs
p.000169: are performed in children or adolescents the written permission from their parents is absolutely necessary;
p.000169: - it is prohibited to perform clinical trials of medical drugs in children and adolescents without parents;
p.000169: - pregnant women with the exception of cases when the medical drug under trial is specifically aimed to treat pregnant
p.000169: women and when necessary information can be collected only during clinical trials in pregnant women and when any
p.000169: risk of harmful consequences for pregnant woman or her child is excluded;
p.000169: - military personnel;
p.000169: - persons in prisons or detention Centres;
p.000169: - persons that are non-competent with the exception of cases when the medical drug under trial is specifically aimed to
p.000169: treat psychiatric disorders and persons that were considered non-competent according to official legislative
p.000169: procedure of the Republic of Kazakhstan (9).
p.000169: The article 43 of the Law of the Republic of Kazakhstan “On the System of Public Health” published on 4th
p.000169: June 2003 contains the juridical definition of scientific medical expertise; in this article it is indicated that
p.000169: objects of scientific medical expertise are as follows:
p.000169: - drafts of programmes of basic and applied scientific research;
p.000169: - republican targeted scientific medical programmes;
p.000169: - results of completed scientific medical programmes and projects;
p.000169: - scientific research that were nominated for the state awards of the Republic of Kazakhstan;
p.000169: - results of scientific medical programmes that are supposed to be implemented into public health practice.
p.000169: The order of scientific medical expertise is determined by the national authority in public health area.
p.000169: The article 42 “Expertise of medical drug” of the same Law says that the expertise of medical drug represents a study
p.000169: or a trial of medical drug
p.000169: for its safety, efficacy and quality and that physical, chemical and biological tests as well as clinical trials should
p.000169: be used for this process; besides all documentation for this medical drug should be assessed thoroughly; the order of
p.000169: all these tests and trials is determined by the national authority in public health area. Paragraphs 2 and 3 of the
p.000169: article 42 clarify that “assessment of safety, efficacy and quality of medical drugs should be performed by expert
p.000169: commissions via expertise of medical drug according to specification and other documents in the order determined by the
p.000169: national authority in public health area”. The expertise should be performed by institutions and persons that did not
p.000169: participate in the process of development and production of this specific medical drug.
p.000169: In 2005 two official documents were approved by the orders of the Ministry of Health №3493 and №3494 on 15th
p.000169: of March 2005: “On approval of instructions on clinical trials and studies and (or) tests of pharmaceutical substances
p.000169: and medical drugs in Kazakhstan” and №3489 on 14th of March “On approval of instructions on monitoring of adverse
p.000169: reactions produced by medical drugs”. These instructions were developed in accordance to international
p.000169: standards GLP and GCP.
p.000169: Mentioned legislative and regulatory documents formulated the unified requirements to planning, implementation,
p.000169: documentation and control of clinical trials in the Republic of Kazakhstan. They ensure the protection of
p.000169: rights, safety and health of persons participating in trials as well as reliability and good quality of data
p.000169: collected during such trials. The right for supervision of clinical trials was delegated to the National Centre for
p.000169: expertise of medical drugs, medical devices and medical equipment of the Ministry of Public Health of Kazakhstan.
p.000169: The important rule that was introduced in obligatory conditions for clinical trials was the necessity to obtain the
p.000169: inform consent of each participant of studies/experiments; this consent should be provided in the written form.
p.000169: The rule on the control of biological and medical studies was implemented for the first time in Kazakhstan. Special
p.000169: commission on ethics is responsible for these functions. The commission consists of specialists in public health and
p.000169: researches, representatives of non-governmental organizations who should protect the rights, safety and welfare of
p.000169: all participants and researches of trials or studies. The commission is responsible for ethical, moral and juridical
p.000169: assessment of all materials of clinical trials.
p.000169:
p.000170: 170
p.000170:
p.000171: 171
p.000171:
p.000171: The order regulates the development of standard operational procedures that should be prepared in the form of detailed
p.000171: written instructions.
p.000171: The serious progress in the field of protection of human rights of persons participating in clinical trials was the
p.000171: description by this Order of norms that allow the ethical commission to formulate the conclusion on possibility of
p.000171: clinical trials or on refusal. At the same time there is some controversy in this document, namely the delegation
p.000171: of monopolistic/exclusive right for conclusion on approval or disapproval of clinical trial to such institution as
p.000171: National Centre.
p.000171: For protection of rights of persons participating in studies or trials the article 35 clarifies that the person “can be
p.000171: included in the trial only after receiving of information”:
p.000171: 1) on medical drug and on the principles of its clinical trial;
p.000171: 2) on safety and efficacy of medical drug as well as on the potential risks for the health of the participant;
p.000171: 3) on actions to be taken in case of unforeseen effects of medical drug on the health of trials participant;
p.000171: 4) on terms of medical insurance of participant’s health”.
p.000171: The Order contains several annexes, including the standard form of informed consent; using this form the
p.000171: potential participant can refuse to participate or to continue the clinical trials of pharmaceutical
p.000171: substance or medical drug during any phase of the trial. This Order is comparatively big document because it contains
p.000171: detailed descriptions of application form and process, protocol of the study, the form of conclusion, the structure and
p.000171: contents of researcher brochure and so on.
p.000171: In this Order the special attention is given to the “Instructions on activity of ethical commission and on performance
p.000171: of ethical assessment of clinical trials”. This instructions clarifies the basic requirements to assessment of ethical,
p.000171: moral and legislative aspects of materials of clinical trials that can be done in patients. The principal goals and
p.000171: targets of the commission are described as follows:
p.000171: 1) protection of rights and interests of participants involved in clinical trials;
p.000171: 2) protection of rights and interests of researches;
p.000171: 3) assessment of importance and reliability of clinical trials goals;
p.000171: 4) ensuring the ethical, moral and legislative assessment of materials of clinical trials.
p.000171: The main principles of commission activity include independence, competence, pluralism, openness, high
p.000171: professional standards, internal believes “for good only and never to harm people”, interests of participant prevails
p.000171: over interests of any scientific research, positive effects are much greater in comparison with potential risks.
p.000171: It is anticipated that commissions to be organized under the responsible institution will have responsibility of the
p.000171: Republican Ethical Commission. Regional commissions will be organized under local authorities of the state system of
p.000171: public health, and local commissions will be organized in separate public health and medical institutions.
p.000171: The main functions of the Republican Ethical Commission are as described below:
p.000171: 1) assessment of the activity of regional and local commissions responsible for ethical review of clinical
p.000171: trials as well as their membership and development of standard operational procedures;
p.000171: 2) arbitration of complex aspects on ethical assessment performed by regional and local commissions;
p.000171: 3) counseling and training of members of regional and local commissions on different aspects of ethics;
p.000171: 4) development and implementation of measures for improvement of the process of ethical assessment.
p.000171: The main functions of regional commissions are as follows:
p.000171: 1) assessment and coordination of the activity of local commissions responsible for ethical reviews of
p.000171: clinical trials;
p.000171: 2) arbitration of complex aspects on ethical assessment performed by local commissions;
p.000171: 3) registration of clinical trials that are performed in the province or in the city;
p.000171: 4) counseling of members of local commissions.
p.000171: The main functions of local commissions responsible for ethical reviews are as follows:
p.000171: 1) performance of ethical assessment of all documentation on clinical trials;
p.000171:
p.000171:
p.000172: 172
p.000172:
p.000173: 173
p.000173:
p.000173: 2) performance of ethical assessment of all changes and additions to documentation on clinical trials;
p.000173: 3) conclusions on agreement or refusal for the beginning or continuation of clinical trials;
p.000173: 4) assessment of following ethical, moral and juridical norms in the process of clinical trials and after
p.000173: their end.
p.000173: The commission should include sufficient number of members that would have the necessary experience and
p.000173: qualification to be able to assess all ethical, moral and juridical aspects of planned research; besides commission
p.000173: members should be independent of researches and sponsors and should not participate in the planned
p.000173: clinical research. The commission should include at least 5 members, namely specialists that are competent
p.000173: in the area of clinical trials as well as persons who are not researches themselves, specialist in legislation,
p.000173: representatives of religious community and of non- governmental organizations; the commission should include
p.000173: males and females of different age groups.
p.000173:
p.000173: 3.5.3. Education in Bioethics
p.000173:
p.000173: During the last decades due to new approaches to moral and ethical problems in medicine and science,
p.000173: development of bioethics as a interdisciplinary field, it was necessary to revise the respective educational
p.000173: programmes at all levels.
p.000173: The science “Bioethics” as a separate science was not included in the State standard of university medical education in
p.000173: the Republic of Kazakhstan, but many aspects related to bioethics were included in other programmes (specialties). For
p.000173: example, at the Semipalatinsk State Medical Academy problems of biomedical ethics were included in the programme
p.000173: of discipline “Communicative skills” at the department of internal diseases. At the moment special training
p.000173: programme is under the process of development. At the Kazakhstan State Medical Academy (in Astana) problems of
p.000173: biomedical ethics were included in the training programme at the department of public health. Similar situation took
p.000173: place in other medical universities of the country. In December 2006 the Scientific Council of the Almaty
p.000173: Institute for Postgraduate Training has decided to organize the Department of health legislation and bioethics in
p.000173: 2007. It will allow to introduce widely into
p.000173: the practice main principles of human rights protection of persons who participate in studies or experiments.
p.000173: At present time different aspects of scientific research ethics are often included in programmes of postgraduate
p.000173: training. For example, since 2001 the Higher School of Public Health (HSPH) began to realize training programmes for
p.000173: researches of the public health system. Starting since 2002 the Higher School of Public Health became the participant
p.000173: of the international programme “Intensive training on bioethics”. Together with Bangladesh Council on Medical
p.000173: Research with financial and technical support from the International Educational Reward in Bioethics and Carrier
p.000173: Development of the Fogarty International Centre (FIC) and National Institutes of Health (NIH), USA, several workshops
p.000173: were conducted in Almaty for physicians of Kazakhstan.
p.000173: The programme of these workshops had the following main goals:
p.000173: 1. The development of complete training plan/programme for the workshop on bioethics;
p.000173: 2. Training of young researches of different scientific specialties in the area of bioethics of scientific research.
p.000173: Many important topics were discussed during these workshops including: historical perspectives of ethics
p.000173: of scientific research in public health area; international declarations and manuals on scientific research
p.000173: with participation of human beings; informed consent; confidentiality; motivation; ethics of clinical studies;
p.000173: ethics of population and demographic studies; ethical aspects of scientific research in the area of health of children
p.000173: and reproductive health; functions of ethical committees; manuals on ethical review; organization of scientific
p.000173: research in developing countries; religion and culture in ethics and other topics.
p.000173: Around 20 specialists from different research institutions of the country participated in the development of
p.000173: programmes for workshops that were organized at the Higher School of Public Health. In future the Consultative
p.000173: Committee will be responsible for the general management of the programme, its monitoring and assessment. The programme
p.000173: was translated into English and sent for revision to international consultants.
p.000173: Recently programmes on bioethics were developed at the department of pharmaceutical management of the Higher School of
p.000173: Public Health for public health managers (18 training hours) and for public health masters (45
p.000173:
p.000174: 174
p.000174:
p.000175: 175
p.000175:
p.000175: training hours). At the same time it is necessary to mention that programmes that were developed not fulfill completely
p.000175: the growing demands of education in bioethics area.
p.000175: The level of knowledge and education on legislation among general public seeking health care improved
p.000175: recently; the network of ethical committees in research institutions of the country enlarged significantly, the
p.000175: role of Kazakhstan’s scientists in international research increased including multi-centre clinical trials of
p.000175: medical drugs. That is why educational programmes in the area of bioethics should be revised and improved for
p.000175: medical students and graduate physicians, researches, nurses, members of ethical committees and other specialists.
p.000175:
p.000175: 3.5.4. The System of Ethical Review
...
p.000177: Addiction» N325 of 27 May 2002, the last revision date: 20.12.2004, No 12306 in the State List (Inventory); «On
p.000177: Prevention and Control of Tobacco Use» от 10 июля 2002 года N340 N340 of 10 July 2002, the last revision date:
p.000177: 11.12.2006, No 12697 in the State List (Inventory); «On the System of Public Health» N430 of 4 June 2003, the last
p.000177: revision date: 29.12.2006, № 15742 in the State List (Inventory); «On Physical Culture and Sports» N490 of 2 December
p.000177: 1999, the last revision date: 05.07.2006, No 4761 in the State List (Inventory).
p.000177: 3. «The Constitution of the Republic of Kazakhstan», adopted during the republican referendum on 30 August 1995,
p.000177: the last revision date: 07.10.1998, No 1 in the State List (Inventory).
p.000177: 4. «On Health Protection of Population». The Law of the Republic of Kazakhstan N170 of 7 July 2006, the last
p.000177: revision date: 07.07.2006, No 28793 in the State List (Inventory).
p.000177: 5. «On Medical Drugs». The Law of the Republic of Kazakhstan N522 of 13 January 2004, the last revision date:
p.000177: 29.12.2006 No 18187 in the State List (Inventory).
p.000177: 6. «On Prevention and Control of Tobacco Use». The Law of the Republic of Kazakhstan N340 of 10 July 2002, the last
p.000177: revision date: 11.12.2006, No 12697 in the State List (Inventory).
p.000177: 7. Law PK «The Oath of Physician of the Republic of Kazakhstan». The Resolution of the Government of the Republic of
p.000177: Kazakhstan №1189 of 27.11.2003.
p.000177: 8. «On the System of Public Health». The Law of the Republic of Kazakhstan N430 of 4 June 2003, the
p.000177: last revision date: 29.12.2006, № 15742 in the State List (Inventory).
p.000177: 9. «On Changes and Additions to Several Laws of the Republic of Kazakhstan on Public Health». The Law
p.000177: of the Republic of Kazakhstan N171 of 7 July 2006, the last revision date: 07.07.2006, № 28850 in the State List
p.000177: (Inventory).
p.000177:
p.000177:
p.000178: 178
p.000178:
p.000179: 179
p.000179:
p.000179: 3.6. KYRGYz REPUBLIC (A.z.zurdinov, U.M.tilekeeva, B.A.Alisherov)
p.000179:
p.000179: 3.6.1. Historical and Cultural Background
p.000179:
p.000179: Kyrgyz Republic is a country in the middle part of Central Asia; most of it is located in the Tenir-Too
p.000179: mountainous region. The territory of Kyrgyzstan is equal to 198.5 thousands sq. km; nearly 90% of the territory is 1500
p.000179: m above the sea level. According to 1999 census, the population is 4.8 million people including 3.1 million of
p.000179: ethnic Kyrgyz. About one third of Kyrgyzstan population (35%) lives in urban areas and 65% are rural population
p.000179: (1999).
p.000179: Kyrgyzstan is a multinational unitary state. The country is divided into seven administrative regions: Batken,
p.000179: Zhalal-Abad, Naryn, Osh, Talass, Chuisk, Issyk-Kul. The capital of Kyrgyz Republic is Bishkek, the form of
p.000179: government – republic.
p.000179: The land of Kyrgyzstan, like all Central Asia, is one of the most ancient places of human civilization. Archeological
p.000179: studies show that primitive men settled there in the time of the Stone Age. Kyrgyz ethnos that was known in Central
p.000179: Asia since the first millennium BC retained its self-name to our time. First politically organized communities in the
p.000179: territory of the present-
p.000179: day Kyrgyzstan appeared in the II century BC when southern agricultural regions joined the State of Parkan.
p.000179: During the IV and III centuries BC early Kyrgyz formed part of powerful unions of nomadic tribes that were a
p.000179: serious problem for China. It was the time when the Great Wall of China began to be built. During the II and I
p.000179: centuries BC a part of Kyrgyz tribes got away from the power of Hunnu State and moved to Enisei (the Kyrzys meaning of
p.000179: “Ene-sai” is the Mother-River) and Baikal (Rich Lake) regions. There they founded their first state Kyrgyz Kaganat that
p.000179: became the centre of the Kyrgyz consolidation and the centre of their culture where their written language
p.000179: developed. Runic inscriptions still can be seen on stone monuments. Invaders destroyed the state but they could not
p.000179: destroy people’s memory, although the written language was lost.
p.000179: During the V century the transition from nomadic to settled lifestyle began in the North of Kyrgyzstan. First written
p.000179: sources mentioning Kyrgyz tribes inhabiting Tian Shan date back to the X century.
p.000179: Petroglyphs of Saimaly Tash, one of the oldest and biggest collections of rock pictures, demonstrate a high level of
p.000179: Kyrgyz civilization. The Burana Tower and Uzgen architecture complex are examples of an amazing mastery of architects
p.000179: and builders.
p.000179: From the middle of the IX century to the beginning of the X century AD the Great Kyrgyz Khanate extended to the South
p.000179: Siberia, Mongolia, Baikal, the Upper Irtysh, Issyk Kul and Talas. This period was not only the time of conquests but
p.000179: also time of an active trade with China, Tibet and peoples of South Siberia and Central Asia. It was the period when
p.000179: after defeating the Uighur Kaganat the Kyrgyz for the first time entered the Tian Shan territory. In the X century,
p.000179: however, the Kyrgyz domination had shrunk to South Siberia, Altai and South-West of Mongolia and in the XI and
p.000179: XIIcenturies to Altai and Sayan Mountains. Nevertheless, parts of Kyrgyz tribes scattered over a large territory
p.000179: participated actively in numerous historical events in Central Asia. They managed to keep their ethnic
p.000179: independence and became the centre of attraction for other ethnic groups. The final stage of ethnogenesis related
p.000179: Kyrgyz people to Oirot (Kalmats), Naiman and other peoples of Central Asia.
p.000179: Starting from the XIII century Kyrgyz people had to fight wars of independence from different invaders. In
p.000179: the second half of the XV century Kyrgyz tribes joined in an independent khanate that embraced a major part of Kyrgyz
p.000179: people. The Great Silk Road was very important for Kyrgyzstan. The town of Osh – the main city in the south of the
p.000179: present-day Kyrgyzstan
p.000179: – due to its favorable geographic location was a transit town in the Fergana line of the Great Silk Road.
p.000179: In 1863 the North Kyrgyzstan and in 1876 the South Kyrgyzstan were incorporated into the Russian Empire. After the
p.000179: Great October Revolution Kyrgyz people, as other peoples of former tsarist Russia entered the Soviet Republic
p.000179: In 1918 Kyrgyzstan formed a part of Turkistan Autonomous Soviet Socialist Republic. In 1924 the Kara-Kyrgyz
p.000179: Autonomous Region within the Russian SFSR was established. In 1926 it was transformed into the Kyrgyz Autonomous
p.000179: Republic, and in 1936 – into the Kyrgyz Republic. On 31 of August 1999, Kyrgyzstan declared its independence.
p.000179: We know that myths and legends form the base of every culture. Nomadic life-style and the loss of written
p.000179: language of early Kyrgyz people
p.000179:
p.000180: 180
p.000180:
p.000181: 181
p.000181:
p.000181: stimulated the rise of a special philosophy that revealed itself in poetic folklore. It has accumulated the
p.000181: basic problems of human existence, mental and philosophic activity and spirituality.
p.000181: To reconstruct spiritual life of the Kyrgyz ancestors, we should mention an epic poem “Manas” that depicted
p.000181: historical events and ethnographic details, different aspects of the Kyrgyz life, worldview and national outlook
p.000181: from the III century BC (the Hunnu period) and to the beginning of the XX century. As a concentrated representation
p.000181: of folk philosophy, “Manas” is both the result of creative thinking across generations and the evidence of ancient
p.000181: Kyrgyz civilization. In fact, “Manas” is a moral code of the nomads and still a source of morals and humanism,
p.000181: as it describes customs and moral traditions, philosophical and aesthetic views, moral principles and norms
p.000181: of behaviour. With regard to its moral significance, “Manas” may be compared to Confucian Pentateuch. Like
p.000181: Confucian ethics, “Manas” depicts a model of putting the world into good order. Much attention is given
p.000181: to the struggle against chaos, which is expressed through regulation of human relationships, i.e. by establishing norms
p.000181: of behaviour, the system of prohibitions and social stratification.
p.000181: “Manas” is called a “cultural encyclopedia” of Kyrgyz people. It ranks among outstanding monuments of world
p.000181: culture, such as “Iliad” and “Odissey”, “Mahabharata”, “Epic of Gilgamesh”, “Kalevala”, “Rigveda” and many
p.000181: others. The Turkic epic poem “Manas” differs from west European, Slavonic and other epic poems not just in its
p.000181: volume. It covers a long historical period and gives a detailed genealogy and a distinct biographical line of
p.000181: athlete Manas – the central hero of the epic poem – from the moment of his birth to his death including the description
p.000181: of main events of his life. Poems, songs and legends passed across the generations served as a teaching
p.000181: material in folk pedagogics. The unique nature of oral folklore allows people to pass their moral knowledge to
p.000181: future generations within a family and within a clan thus ensuring continuity of spiritual life and
p.000181: connection between epochs. Another equally efficient method of education was joining to folk customs and traditions.
p.000181: Epic poems embraced all sides
p.000181: Ethical views of the early Kyrgyz make up a system of values, norms and rules based on aspiration for happiness.
p.000181: Therefore, ethics of the ancient Kyrgyz may be defined as the ethics of positive eudemonism19, and their overall
p.000181: worldview as world- and life-asserting.
p.000181: Although the epic poem does not contain distinctly formulated precepts, moral lessons learned from centuries-long
p.000181: history formed a traditional system of moral values that has survived to our days:
p.000181: 1. unity and solidarity of the nation,
p.000181: 2. international accord,
p.000181: 3. national honour,
p.000181: 4. movement towards prosperity and well-being through a continuous labour and knowledge,
p.000181: 5. humanism, generosity, tolerance,
p.000181: 6. harmony with nature,
p.000181: 7. strengthening and protection of Kyrgyzstan state system.
p.000181: Ethical norms in “Manas” are based on four cardinal virtues (wisdom, patience, conscience and generosity) that are
p.000181: personified in images. They are opposed by four vices: laziness, wickedness, greed and arrogance. It is said that a
p.000181: clever person is always able by using one’s mind which is “the best of all treasures” to oppose positive qualities to
p.000181: negative ones and defeat the evil by kindness, wickedness by patience, greed by generosity. Hence, the person has to
p.000181: make every effort to improve his or her moral nature, to overcome evil elements and to change the surrounding world.
p.000181: Among human qualities most valued in Kyrgyz culture are health and longevity, diligence and valour, sense of duty and
p.000181: honour, modesty, self- control and wisdom. These virtues ensure a harmonious life of the individual [5]. Openness, love
p.000181: for children, hospitality, generosity, humanism, patience, firmness, goodwill, respect for old age and other qualities
p.000181: inherent in Kyrgyz people form the basis of moral and ethical principles of their life [1].
p.000181: Historical conditions dictated to Kyrgyz people the necessity to stand up for their freedom and integrity in the fight
p.000181: with stronger neighboring states. Severe war conditions required from men who were admitted to military
p.000181: of people’s life. Over many ages, people’s ideals have been associated
p.000181:
p.000181:
p.000181: with “Manas”; ethical norms and concepts of the good and the evil were exemplified by the acts and deeds of “Manas”
p.000181: characters.
p.000181: 19 The word eudemonism comes from the Greek word for happiness or flourishing
p.000181: (eudaimonia), and refers to any conception of ethics that puts human happiness and the complete life of
p.000181: the individual at the Centre of ethical concern.
p.000181:
p.000181:
p.000182: 182
p.000182:
p.000183: 183
p.000183:
p.000183: service not only physical strength, but also moral maturity. Wars depicted in “Manas” and episodes associated with
p.000183: those exemplify heroic traditions implying the observance of the rule of military necessity and an innate
p.000183: aversion to violence, as well as a wish to live in peace. Kyrgyz warriors regarded their sacred duty not to harm
p.000183: peaceful population of conquered peoples. It was forbidden to plunder or humiliate them. Thus an epic sage Bakai
p.000183: addresses his warriors:
p.000183: “Do not thou slaughter their cattle more that thou need for food, A foe today may be kinsman tomorrow,
p.000183: Do not thou harm them”.
p.000183: The early Kyrgyzstan was located on the crossroad of the Great Silk Road routs, which made it “a bastion of
p.000183: religious syncretism” where representatives of different confessions could coexist. This is, perhaps, the
p.000183: reason for a remarkable tolerance in the Kyrgyz in relation to other confessions and cultures of people
p.000183: inhabiting Kyrgyzstan.
p.000183: “The Beneficial Knowledge” by Jusup Balasagyn (XI c.) is another treasure of the Kyrgyz. The treatise was so
p.000183: perfect that in China it was titled “The Code of Decent Men”, in Iran – “The Book of Shahs” and in Turania
p.000183: – “The Book of Precepts for Rulers”. For Turkic peoples “The Beneficial Knowledge” “was as much important as “Lay of
p.000183: Igor’s Warfare” for Slavic peoples” (Naum Grebnev).
p.000183: “The Beneficial Knowledge” covers problems of sociology, ethics, aesthetics, theology and social psychology. It
p.000183: presents a sum of knowledge in different fields of science and culture of that time. The treatise presents a
p.000183: comprehensive system setting forth and analyzing philosophical problems relating to sense and meaning of human life. It
p.000183: defines human duties and norms of behaviour in the community and reflects “moral and ethical ideals with regard to
p.000183: life-style, culture and ideology of settled Turkic peoples still retaining the memories about their nomadic
p.000183: civilization” [13].
p.000183: According to “The Beneficial Knowledge” just and fair laws are the cardinal mechanism ensuring stability in the
p.000183: society, and everyone, be it a ruler or a subject should follow the laws.
p.000183: Law rules the world – we shan’t forget this, It is a sign of humanity inherent in people.
p.000183: In its character, “The Beneficial Knowledge” is an ethical and didactic poem written with the purpose to show the way
p.000183: towards learning the wisdom
p.000183: of government, every-day life and relationships between people on different occasions. Jusup Balasagyn describes
p.000183: qualities necessary for viziers, military commanders, secretaries, ambassadors, penmen and copyists,
p.000183: treasurers, cooks, cup-bearers, scientists, physicians, dream interpreters, magi, astrologers, merchants,
p.000183: cattle-breeders, craftsmen and others. He also writes how people should behave, reflects on human
p.000183: responsibilities and duties, virtues and vices. For Balasagyn sees “dissolution of morals and depreciation
p.000183: of spiritual values as one of the worst vices of his time” [8].
p.000183: A peculiar feature of “The Beneficial Knowledge” is that the author allows the reader to himself to gain an
p.000183: understanding of sense of life, of virtues and vices. Jusup Balasagyn argues that everyone should know and observe
p.000183: moral norms and rules of behaviour. “The Beneficial Knowledge” is a peculiar moral code of its time. Over a long time
p.000183: Kyrgyz ethnos had been existing in form of clans. Relationships within the community had been forming during
p.000183: a long historical period. Changes, if any, occurred due to the influence of external environment forming the worldview:
p.000183: the sense of sharing needs and interests of other people, feelings of mutual aid and collectivism. Kyrgyz people
p.000183: survived in crisis situations only due to spiritual and genetic health of their ancestors. People retained and
p.000183: developed clan traditions, upbringing practices, code of ancestral honour. Clan honour for Kyrgyz people is one of
p.000183: the most essential concepts. Every Kyrgyz had his ancestors, his land and his clan. Each clan had its hierarchy
p.000183: at the head of which was the most respected clan member. Collectivism, mutual aid, empathy, respect for other
p.000183: people – those were the qualities inherent in Kyrgyz mentality.
p.000183: Cultural and historical sources reveal respect to women in nomadic tribes, however there were conflicting
p.000183: traditions with regard to this issue. It is noteworthy that women had a high socialXstatus in Kyrgyz society [6].
p.000183: Ethical ideas in works by Kyrgyz thinkers. Spiritual culture of Kyrgyz people reflected in philosophical and poetic art
p.000183: of akyns20 is characterized by the search for perfection. Problems of upbringing and education, of humanism
p.000183: and love for people have a significant place in philosophical poetry of Kyrgyz thinkers, and therefore there
p.000183: is every reason to consider
p.000183: 20 Akyn is an improvising poet and singer in the Kazakh and Kyrgyz cultures. Akyns played and important role in terms
p.000183: of expressing people’s thoughts and feelings, exposing social vices, and glorifying heroes.
p.000183:
p.000184: 184
p.000184:
p.000185: 185
p.000185:
p.000185: it as a code of moral and ethical norms on human behaviour in Kyrgyz culture. Some scientists associate
p.000185: this special attention to moral issues with an access to Chinese sources known for their interest in ethics. The
p.000185: history of development of ethical and philosophical ideas in Kyrgyz culture may be divided into three stages. The first
p.000185: stage is associated with names of late medieval Kyrgyz thinkers: Asan-Kaigy (XV c), Tolubai Synchi and Sanch- Synchi
p.000185: (XIII c) [3]. Kyrgyz people justly call them legendary thinkers, folk sages (akylmanam). We know about these
p.000185: Kyrgyz thinkers from folk legends. Only fragments of their sayings survived to our time.
p.000185: The epoch of late Middle Ages with its patriarchal and feudal system sets a number of moral tasks. Undoubtedly, moral
p.000185: in a class society was at all times an instrument for ruling people, however, in akyns’ philosophical poetry one may
p.000185: find an unbiased opinion on moral and ethical issues. They reflected on the eternal question about struggle with
p.000185: the evil and dreamt about “universal well-being”. Due to reconstruction of Asan Kaigy’s ethical ideas, we may see
p.000185: that empathy, compassion, sympathy for others are the main principles of his moral.
p.000185: Considering the time when the sage lived and worked, it would be appropriate to note that the call for
p.000185: compassion and love for all living beings related mostly to the oppressed people, disunited by internecine
p.000185: feud, and the compassion might be interpreted as a protest against the existing system of inequality. Therefore Asan
p.000185: Kaigy saw his task in cultivating love and compassion not only for human beings but also for everything alive.
p.000185: Actually, Asan Kaigy proclaimed a categorical imperative “treat others as you would like to be treated, if you were
p.000185: them” and gave everyone the right to be understood. Only if a person follows this rule, he will rid his soul of evil
p.000185: and find harmony. Asan Kaigy was telling people that they should love and respect others and thus to contribute to
p.000185: their happiness [4].
p.000185: Tolubai Synchi also focused his attention on analyzing relationships between people and cultivating
p.000185: magnanimity that, in his view, was a combination of such virtues as nobleness, generosity, justice in compassion,
p.000185: love and respect for people. For him greed is the worst vice: “A generous man is a good man; a greedy man is a
p.000185: good-for-nothing man” [12]. Like Asan Kaigy, Tolubai-Synchi was also searching after ways to happiness. His maxims
p.000185: based on opposing the good and the evil, kind and wicked acts have
p.000185: the form of edifications. Like Asan Kaigy he tried to avoid blaming actively the existing state system.
p.000185: Another humanist-philosopher was Sanchi-Synchi. Unlike Asan-Kaigy and Tolubai-Synchi, he mostly valued the active
p.000185: elements of human nature: strong will, strength of mind, persistency in the struggle against the evil. Sanchi-Synchi
p.000185: called people for an active struggle for the sake of Justice. In his songs he developed the idea of righteous
p.000185: retribution and blamed the oppressors.
p.000185: The heritage of legendary thinkers allows us to return to forgotten spiritual values of Kyrgyz people
p.000185: based on love, compassion, empathy, clear conscience, peaceable disposition and feeling that they are a part of the
p.000185: universe. They felt aversion to violence and rudeness. Throughout the course of ethics development, starting from
p.000185: legendary thinkers to akyns- democrats, the care for widows and orphans was the responsibility of all clan members.
p.000185: The next stage of development of ethics philosophy is represented by akyn-zamanists21 Kalygul Bai Uulu
p.000185: (1785-1855), Arstanbek Bailashuulu (1866-1917) and Moldo Kylych Sharymkanov (1866). They lived in the time
p.000185: of global changes resulting from the decay of patriarchal feudalism and the rise of capitalistic relations.
p.000185: Besides in 1876 the territory inhabited by Kyrgyz people was incorporated into the Russian Empire [9-11]. All
p.000185: those processes were reflected in akyns’ poetry. In their poems “Time of Downfall”, “Time of Poverty” and “Time of
p.000185: Sorrow” akyn-zamanists called their epoch the time of degradation and decay. Moldo Kylych, being a son of a learned
p.000185: man, received a good education. He was acquainted with works by eastern classics Firdousi, Navoi, Jami, Yasavi and
p.000185: others. He wrote about his time: “Morals and manners show the loss of people’s well-being”. In his poem “Time of
p.000185: Sorrow” he noted that moral bankruptcy, degradation of moral principles, moral apathy were frightening features of the
p.000185: time. In their attitudes zamanists were close to French philosophers of the Age of Enlightenment (J.-J. Russo, Voltaire
p.000185: et al.).
p.000185: At the same time akyn-zamanists’ poetry contained some optimism and faith in moral potential of Kyrgyz people that
p.000185: would help them to overcome all difficulties. Kalygul Bai Uulu associated with the image of a spiritual
p.000185: 21 Zamanism – philosophical teaching about frailty and an inevitable tragic end of the world
p.000185:
p.000186: 186
p.000186:
p.000187: 187
p.000187:
p.000187: leader expressing expectations of Kyrgyz people through his poetry inspires their hopes.
p.000187: Problems of justice are very essential for Kalygul. Being a judge, he proclaims a kind of ethical code comprising
p.000187: universal values and norms of human behaviour: honesty, unselfishness, justice, mutual respect.
p.000187: Criticizing the state system of their time as a form of social inequality akyns offered a moral characteristic of
p.000187: behaviour in different social strata. Akyn-democrats tended to give a realistic picture of the world. Thus
p.000187: Toktogul Saltyganov presents his ethical views through opposing the good to the evil. Jenijok taught that every man
p.000187: should strive for self-perfection from his young days [7].
p.000187: Akyn-zamanists were spiritual elite of Kyrgyz society and true patriots. Their laments were neither the echo of
p.000187: feudalism nor an attempt to stop the development of the society. Those were the thoughts about the traditional culture
p.000187: that in their time was at a deadlock and could not find way out of it; thoughts about the future of Kyrgyz people. They
p.000187: understood well a close connection between the destiny of their people and the integrity of ethno- cultural space.
p.000187: Today we may rightly say that zamanism is a special king of creative work of poetry initially establishing in set
p.000187: verbal formulae a system of moral and ethical priorities of nomadic peoples. Zamanists lived in the epoch of
p.000187: disintegration of traditional Kyrgyz community, and therefore efforts were required to form an integrated Kyrgyz
p.000187: nation. They realized the hardship of that mission and used for that purpose moral norms and rules of behaviour that
p.000187: did not lose their significance to our days.
p.000187: The next stage in ethics development is associated with names of akyn- democrats Toktogul Satylganov (1864-1993),
p.000187: Togolok Moldo (1860-1942), Jenijok (1860-1918), Varna Alykulov (1884-1949). In contrast to their predecessors,
p.000187: they actively expressed ethical views of oppressed sections of Kyrgyz population.
p.000187:
p.000187: References
p.000187: 1. Abramzon S.M. Kyrgyz People and their Ethno-Genetic, Historical and Cultural Contacts. Leningrad, 1971, p. 152 (in
p.000187: Russian)
p.000187: 2. Akmoldoeva Sh. B. Spiritual World of the Early Kyrgyz (Analyzing Epos). “Manas” and Concepts of Geneva
p.000187: Conventions. Bishkek, 1999, p. 211 (in Russian)
p.000187: 3. Amanaliev A. From the History of Kyrgyz Philosophy. Frunze, 1863 (in Russian).
p.000187: 4. Asan-Kaigy. In: Anthology of Kyrgyz Portry. Bishkek, 1999 (in Kyrgyz)
p.000187: 5. Valikhanov Ch. Collected Works. Vol. 1-5. Alma-Ata, 1961-1972 (in Russian)
p.000187: 6. Kurmanjan the Mountain Queen and Her Time. Bishkek, 2002 (in Russian)
p.000187: 7. Jenijok. Poetic Works. Frunze, 1982 (in Kyrgyz)
p.000187: 8. Jusup Balasagyn “The Beneficial Knowledge”. Frunze, 1988, p. 339 (in Russian)
p.000187: 9. Kalygul Bai Uulu In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 10. Moldo Kylych. Time of Sorrow. Manuscript No 56, Library of the Kyrgyz Academy of Sciences (in Kyrgyz)
p.000187: 11. Moldo Kylych Shamyrkan Uulu. Time of Sorrow. In: Anthology of Kyrgyz Poetry. Bishkek, 1999 (in Kyrgyz)
p.000187: 12. Tolubai-Synchi. Ibid.
p.000187: 13. http://www.peoples.ru/art/literatur...age/balasaguny.
p.000187:
p.000187: 3.6.2. Legal Regulations
p.000187:
p.000187: In Kyrgyz Republic biomedical research and protection of human rights in this sphere is regulated by a number of
p.000187: national legal acts, and first of all by Constitution.
p.000187: According to the principal Law, residents of the Kyrgyz republic have the right to health protection, free health
p.000187: care provision by a network of state healthcare institutions. The Constitution guarantees rights to healthy
p.000187: environment and to indemnification for harm caused to health or property due to actions in the sphere of nature
p.000187: management.
p.000187: Article 18 of the Constitution states that no medical, biological, and psychological experiments on human subjects
p.000187: shall be permitted unless there is a voluntary consent of the potential research subject, properly expressed and duly
p.000187: authenticated.
p.000187: The legal basis for the protection of human subjects in biomedical research are the Constitution provisions
p.000187: ensuring every individual’s right
p.000187:
p.000188: 188
p.000188:
p.000189: 189
p.000189:
p.000189: to life, physical and moral inviolability; the right to freedom and safety, the right to a free development of one’s
p.000189: personality; right to dignity and freedom of private life, confidentiality of personal and family information et al.
p.000189: The Law “On Health Protection of Citizens of Kyrgyz Republic” (adopted in November 2004) sets essential
p.000189: rules relating to medical research. Article 27 of the said Law states patients’ right to participate in scientific
p.000189: and medical research on the condition of their written consent and in accordance with the procedure established by
p.000189: authorized healthcare state institutions of Kyrgyz Republic. This Article also stipulates that patients have
p.000189: the right to refuse the participation of medical students in the process of their diagnostics and treatment.
p.000189: According to Article 74 of the Law, no medical intervention, including medical research, may be carried out unless a
p.000189: voluntary person’s consent is obtained. According to law, where a minor or an adult does not have the capacity to
p.000189: consent to an intervention the intervention may only be carried out with the authorization of his or her legal
p.000189: representative.
p.000189: The mentioned Law states rights of different categories of vulnerable individuals – pregnant women, mothers of minors,
p.000189: elderly persons, disabled persons, persons who had suffered from an emergencyXsituation and residents of ecologically
p.000189: unfavorable regions (Art. 67, 68, 69, 70, 71).
p.000189: The Law on Pharmaceutical Products (March 2003) regulates clinical trials of pharmaceutical products.
p.000189: According to this Law, no clinical trials of pharmaceutical products in Kyrgyz Republic may be carried out
p.000189: without the permission granted by the authorized healthcare state institution of Kyrgyz Republic. Those guilty of
p.000189: violating rules of clinical trials, falsifying clinical results obtained in clinical trials of pharmaceutical
p.000189: products or conducting the trials without the permission granted by an authorized healthcare state institutions of
p.000189: Kyrgyz Republic bear the responsibility according to the relevant legislation.
p.000189: Article 27 of the Law on Pharmaceutical Products if particularly important as it sets a list of documents
p.000189: necessary for an authorized healthcare state institutions of Kyrgyz Republic to make a decision about a clinical trial
p.000189: of a pharmaceutical product. The list includes an approval by the ethics committee of an authorized
p.000189: healthcare state institution of Kyrgyz Republic. Article 27 states that the ethics committee of an authorized
p.000189: healthcare state
p.000189: institution of Kyrgyz Republic participates in the design of a clinical trial programme.
p.000189: According to this Article, clinical trial results are referred only to the authorized healthcare state institution of
p.000189: Kyrgyz Republic. It is forbidden to provide any information about the process and results of a clinical trial of a
p.000189: pharmaceutical to a research sponsor without the permission from an authorized healthcare state institution of Kyrgyz
p.000189: Republic.
p.000189: Article 28 of the Law states the procedure of establishing ethics board: “Ethics Boards are composed of
p.000189: medical professionals, lawyers and persons representing public organizations. The Statute of the Ethics Board and
p.000189: membership requirements are adopted by an authorized healthcare state institution of Kyrgyz Republic in
p.000189: compliance with the principles of Declaration of Helsinki”. According to the Law, ethics board at an authorized
p.000189: healthcare state institutions of Kyrgyz Republic and at healthcare institutions carry out an expert evaluation with
p.000189: regard to ethical criteria, consider moral and ethical problems arising in the course of clinical trials of
p.000189: pharmaceutical products and ensure the protection of patient’s rights.
p.000189: This Law contains important provisions concerning human rights in clinical trials of pharmaceutical
p.000189: products. In particular, it says that a patient gives his or her written consent to participate in a clinical
p.000189: trial of a pharmaceutical product and has the right to withdraw his or her consent at any stage of the research. Before
p.000189: obtaining the informed consent, patients should be informed about
p.000189: - the pharmaceutical product used in the clinical trial and the essence of clinical trials of pharmaceutical products;
p.000189: - the expected efficiency of the pharmaceutical product and the degree of risk to the patient;
p.000189: - patient’s actions in case of unforeseeable effects of the pharmaceutical product on the patient’s health;
p.000189: - terms of the patient’s health insurance.
p.000189: The Law on Pharmaceutical Products states that no clinical trials of pharmaceutical products may be carried
p.000189: out in such vulnerable patients as children without parents; military personnel; prisoners and persons under
p.000189: investigation in detention Centres; pregnant women (except for cases when clinical trials are designed specially
p.000189: for pregnant women and when the
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000191: 191
p.000191:
p.000191: necessary information can only be obtained in a clinical trial provided that the trail is not hazardous to a woman or
p.000191: to a fetus).
p.000191: Besides, the Law sets certain restrictions relating to clinical trials involving children. Thus the trials are
p.000191: only permitted if the investigational pharmaceutical product is specially indicated for use in children or to obtain
p.000191: knowledge relevant to the health needs of children (e.g. to determine the best dosages for treating diseases of
p.000191: childhood).
p.000191: The Law on Pharmaceutical Products permits clinical trials of pharmaceutical products designed for the
p.000191: therapy of mental disorders and involving subjects who by reason of mental disorders are not capable of
p.000191: giving adequately informed consent. Clinical trials involving subjects with mental disorders should be carried out in
p.000191: compliance with the Law of Kyrgyz Republic “On Providing Psychiatric Care and Safeguarding Human Rights”. Clinical
p.000191: trials of pharmaceutical products involving subjects with mental disorders may only be carried out after
p.000191: obtaining a written informed consent from a legally authorized representative in accordance with applicable law.
p.000191: Protection of patients’ rights in biomedical research and other interventions in Kyrgyz Republic are
p.000191: also regulated by the following laws:
p.000191: - “On Narcotic and Psychoactive Drugs and Precursors” (No 66, 22 May 1998);
p.000191: - “On Donorship of Blood and Blood Components in Kyrgyz Republic” (No 951-XII, 3 July 1992);
p.000191: - “On Tuberculosis Prevention in Kyrgyz Republic” (No 56, 18 May 1998);
p.000191: - “On Prevention of Diseases Caused by Iodine Deficit” (No 40, 8 February 2000);
p.000191: - “On Citizens’ Medical Insurance in Kyrgyz Republic” (No 208, 28 December 2006);
p.000191: - “On HIV/AIDS Prevention in Kyrgyz Republic” (No 149, 13 August 2005);
p.000191: - “On Citizens’ Reproductive Rights” (No 5, 13 January 2000).
p.000191: Statements of civil, administrative and criminal codes set the responsibility in case of violating
p.000191: patients’ rights in medical interventions and in case of violating the legally established order of practice in
p.000191: healthcare and biomedicine.
p.000191: 3.6.3. Education in Bioethics
p.000191:
p.000191: Today Kyrgyz Republic has several institutions for a higher medical education: the Kyrgyz State Medical Academy,
p.000191: Medical Faculty of the Kyrgyz-Russian (Slavic) University, Medical Faculty at the International University of
p.000191: Kyrgyzstan and Medical Faculty at the Osh State University.
p.000191: The State Standard of Education in Kyrgyz Republic does not include bioethics as a separate subject. Nevertheless,
p.000191: bioethics has been introduced into the syllabus of the Kyrgyz State Medical Academy and is taught to
p.000191: undergraduate students. The course in bioethics consists of lectures (36
p.000191: h) and practical seminars (18 h). One of the course topics is “Ethical and Legal Control of Biomedical Research”.
p.000191: Bioethics is also taught at Chairs of Clinical Medicine and Pediatrics of the Medical Faculty at the Kyrgyz- Russian
p.000191: (Slavic) University (lectures – 19 h and seminars – 19 h). Bioethics is not taught at the postgraduate level.
p.000191: Presently, there is no state system of teaching GCP to members of ethics committees. However courses on basic and
p.000191: clinical pharmacology provide information on clinical trials and GCP principles to students at all faculties of the
p.000191: Kyrgyz State Medical Academy.
p.000191: Two staff-members from the Department of Basic and Clinical Pharmacology of the Kyrgyz State Medical
p.000191: Academy (one of them is the Chairman of Independent Ethics Committee and the other one the Chairman of the
p.000191: Pharmacological Committee) and three professionals from the Department for Providing Pharmaceutical Products and
p.000191: Medical Facilities have attended training courses in GCP conducted by WHO.
p.000191: Two members of the Independent Ethics Committee for Biomedical Research and the Chairman of the Pharmacological
p.000191: Committee have attended Module 1 and Module 2 Training Courses in the framework of FECCIS Worcshop on SIDCER
p.000191: «Recognition programme» (Tashkent, 2006).
p.000191: No dissertations in bioethics were defended. In the list of specialties there is no specialty “Bioethics”. Scientific
p.000191: and research works in bioethics as an allied subject are planned.
p.000191: Today we do not have manuals on bioethics by national authors. Monographs and guidelines on bioethics we
p.000191: use have been published in Russia and Ukraine.
p.000191:
p.000191:
p.000192: 192
p.000192:
p.000193: 193
p.000193:
p.000193: 3.6.4. The System of Ethical Review
p.000193:
p.000193: In Kyrgyz Republic the Ministry of Health is responsible for establishing ethics committees at all levels. At present
p.000193: we lack a developed system of ethical review. Therefore functions and authorities of ethics committees on
p.000193: different levels have not been outlined, and activities relating to ethical review are performed on the national level.
p.000193: The National Ethics Committee responsible for decisions concerning ethical review of both national and international
p.000193: biomedical research was established in 1998 at the Ministry of Health of Kyrgyz Republic to implement state policy in
p.000193: providing pharmaceutical products. The Committee was established as a separate and independent body registered at
p.000193: the Ministry of Justice of Kyrgyz Republic. The Committee consists of 13 members and includes medical professionals
p.000193: representing practical healthcare, medical research institutions and medical laboratory service, as well as
p.000193: a lawyer, leading specialists from the Health Ministry, representatives of the Medical Association and Trade-Union
p.000193: Federation.
p.000193: The procedure of ethical review is regulated by legal and normative documents of Kyrgyz Republic. Thus, the rules
p.000193: regulating tasks and activity of ethics committees are set out in the Law “On Pharmaceutical Products” adopted in 1997
p.000193: and revised and amended in 2003 in compliance with general provisions, tasks and operations of the Ethics
p.000193: Committee at the Health Ministry of Kyrgyz Republic. Chapter 7 of the Law “On Pharmaceutical Products” entitled
p.000193: “Design, Pre-Clinical and Clinical Trials of Pharmaceutical Products” includes 5 Articles, 3 of which directly
p.000193: concern clinical trials. Article 28 emphasizes rights of the patients involved into clinical trials of pharmaceutical
p.000193: products stating that boards at authorized healthcare state institutions of Kyrgyz Republic “are guarantees for
p.000193: the patients’ rights”. Besides a set of documents has been designed in compliance with GCP international
p.000193: standards.
p.000193: All documents relating to pharmaceutical products submitted to the Pharmacological Committee (the
p.000193: institution responsible for ethical review of research protocols) are simultaneously submitted to the
p.000193: Ethics Committee for ethical review. There is a certain algorithm of conducting ethical review using standard
p.000193: operational procedures; however we lack a complete and comprehensive SOP system. According to the Statute of the
p.000193: Ethics Committee, a decision is made within 30 days after submitting the complete set of documents.
p.000193: Currently Kyrgyz Republic does not have systems of certifying ethics committees and surveying ethical review practices;
p.000193: neither has it a procedure for appealing against decisions. During last eight years The Ethics Committee has carried
p.000193: out ethical review of 23 clinical trial protocols, mostly phase 3 and 4 trials. Phase 1 clinical trials do not involve
p.000193: volunteers.
p.000193: Education and training for members of ethics committees is essential for their efficient work. Meanwhile there is no
...
p.000195: time of king Burebista (+80
p.000195: - 44 B.C.) Dechebal (87-106) was the last Dacian king. In 106 Dacia was conquered by the Romans and turned to be a
p.000195: province. That was the last province of the Roman Empire. It was followed by Roman epoch (106-
p.000195: 271) with the Romanization of Dacian population, the Latinization of the
p.000195: language and evangelization. There was the ethnogenesis of Romanians (from “Romans”) later.
p.000195: Development of feudal relationship was attested in the X century. Three principalities were formed in the one-time
p.000195: Dacian territory: Transylvania, which felt under the reign of Hungarians (Hungarians are Finno-Ugric trans- Ural tribes
p.000195: settled here by the end of the IX century) in the beginning of the X century, Ţara Românească (or Walachia, Muntenia);
p.000195: Ţara Moldovei. The first written diplomas mentioning political and military strength of Ţara Românească and
p.000195: Moldova are referred to the years 1330 and 1359, respectively.
p.000195: During the Middle Age Moldova kept suffering from raids of the Tatars, the Turks, the Hungarians and the Poles.
p.000195: Historical Moldova covered the territory between Eastern Carpathians, woody Carpathians, the Dniester, the Black
p.000195: Sea and the Danube under Roman 1 of Moldavia (1392-1394). Geographic location of the territory was favorable as
p.000195: to the nature and life resources and at the same time unfavorable as to geopolitical strategic aspect. The country
p.000195: was located in the strategic pass connecting Eastern and Western Europe, being situated between the Carpathians and the
p.000195: Black Sea. The Silk Road, i.e. the longest commercial route connecting the Far East with the western European countries
p.000195: was there in the Middle Age. Since the first centuries AD and until now great states, trying to preserve the influence
p.000195: here had strategic interests in common. Our people have never been involved in wars of aggression but only defensive
p.000195: ones. Such state of affairs left a deep track in the spiritual life of the country. Spirituality of the inhabitants,
p.000195: philosophic thoughts are of the patriotic and the humanist nature. The ideas of the Italian Renaissance were taken here
p.000195: caught on with some works of some local cultural figures.
p.000195: Ştefan cel Mare şi Sfânt (Stephen the Great and Holy) (1457-1504) ruled Moldova during the most
p.000195: difficult times. He provided a long-term unity of the state, its economical growth and prosperity of
p.000195: cultural life. Protecting his land from invasion he stopped the advance of the invaders to the Western Europe. The
p.000195: Patriarch of Rome for that time deemed him verus christianae fidei athleta (true Champion of Christian Faith) for his
p.000195: services. Soon after the king’s death in 1513 Moldova had to resign to regime of the Ottoman suzerainty.
p.000195:
p.000195:
p.000196: 196
p.000196:
p.000197: 197
p.000197:
p.000197: In 1600 Mihai Viteazul (Michael the Brave) (1595-1601) united for the first time and for a short period
p.000197: Moldavia, Wallachia and Transylvania. Several territorial breaking-ups happened after that. During the Russian-
p.000197: Turkish War of 1768–1774 Austria took the north of Moldova including the ancient capital of Suceava. However the
p.000197: painful and drastic re-allotment of Moldova happened in 1812 when as a result of the other Russian-
p.000197: Turkish War the Russian Empire took the territory between the Prut, the Dniester, the Danube and the
p.000197: north-eastern part of Bucovina, having called it Bessarabia.
p.000197: In 1859 the rest of Moldova was united with Muntenia (Wallachia) forming a new state - Romania.
p.000197: In 1917 Sfatul Ţării was formed as a representative body of Bessarabia, which during World War I and revolution in
p.000197: Russia declared Bessarabia’s independence as the Moldavian People’s Republic. In 1918 Sfatul Ţării declared
p.000197: consolidation with Romania. Transylvania joined Romania being under the Austro-Hungarian Empire the same year.
p.000197: Clause 3 of the secret Annex to the Molotov-Ribbentrop Pact signed on 23 of August, 1939, was devoted to the
p.000197: south-east of Europe and Bessarabia in particular: as a result Soviet government required Romania to cede Bessarabia
p.000197: and the demand was satisfied. On 2 of August 1940, a Moldavian Soviet Socialist Republic was established. On 23 of May
p.000197: 1991, it was renamed to the Republic of Moldova.
p.000197: Pursuant to the decision of the Great National Meeting on 27 of August 1991, the Parliament adopted the
p.000197: Declaration of Independence of the Republic of Moldova. On 2 of March 1992 the Republic of Moldova became a full member
p.000197: of the U.N.
p.000197: It is possible to find ethic attitude to life, living beings, covering some aspects of medical treatment or medicine in
p.000197: works or actions to some extent of a number of persons. Such as:
p.000197: Neagoe Basarab (ruled - 1512-1521), Dimitrie Cantemir (1673-1723), Constantin Virnav (1806-1877), Zamfir Ralli
p.000197: Arbore (1848-1933), Toma Chorbe (1864-1936), Anatolie Kotovski (1864-1937), Nicoale Testemitanu (1927-1986).
p.000197: Neagoe Basarab was one of the rulers of the XVI century whose works influenced various issues of the ethics of life. It
p.000197: is necessary to mention his fundamental work called Advice of Neagoe Basarab to his Son Theodosius.
p.000197: Dimitrie Cantemir was a talented ruler of Moldova of the 18th century and at the same time an outstanding
p.000197: scientist and man of culture. It is necessary to state that he was a member of two Academies – Berlin and Saint-
p.000197: Petersburg, spoke 12 languages. He is considered to be the first national philosopher, first theorist and historian of
p.000197: medicine. Cantemir is known as the author of philosophic and physiological works. The works of Cantemir include The
p.000197: Divan or The Wise Man’s Parley with the World; Metaphysics; General Brief Logics; Research of the Nature of Monarchies;
p.000197: The History of the Growth and Decay of the Ottoman Empire; Geographical, Ethnographical and Economic Description of
p.000197: Moldavia; The Life of Constantine Cantemir; Events from the Life of the Cantacusins and the Brunkovyans; The System or
p.000197: the State of Muhammad Religion; The Hieroglyphic History. Works of Cantemir on the history of the Ottoman Empire
p.000197: were considered classic research and were translated into English, German, and French. Voltaire called this
p.000197: work his reference book on the East. His works are of high value until today.
p.000197: Constantin Virnav is one of the scientists-medics of the XIX century, whose activity as the doctor and civilian
p.000197: had a great significance for development of the public health care and medical ideas in the area. He is
p.000197: the first doctor of medicine in Moldova (he defended his dissertation in 1836 in the city of Buda, Hungary). He is the
p.000197: author of numerous scientific researches. His ethical ideas, application in treatment practice are especially valuable.
p.000197: Zamfir Ralli Arbore was a doctor, the Encyclopaedist, writer and public figure, graduate of the Saint Petersburg
p.000197: Medical and Surgery Academy, a person of encyclopedic learning. During his student years he jointed the
p.000197: narodnik movement and was jailed in St. Peter and Paul Fortress. He went back to Bessarabia. Later, being afraid
p.000197: of new prosecution of the tsar’s secret political police he settled in Romania. He is the author of numerous
p.000197: scientific researches. His encyclopedias are highly valuable. He was an excellent humanist and moralist. He
p.000197: supported active propaganda of high moral values on different levels.
p.000197: Anatolie Kotovski – leading doctor, reformer of the mental health service in Bessarabia, scientist, public figure who
p.000197: made plenty for the development of the social medicine of Moldavia. Many of rules considered bioethical today
p.000197: were applied to his activity.
p.000197:
p.000198: 198
p.000198:
p.000199: 199
p.000199:
p.000199: Toma Chorbe is considered as one of the great doctors-humanists, founder of sanitary and epidemiologic service
p.000199: in the area. He won the name of the unmercenary doctor rightfully. He advocated strongly spreading and efficient
p.000199: introduction of ethic norms and values in medicine.
p.000199: Nicoale Testemitanu is an outstanding scientist, public figure and manager of modern medicine, Doctor of
p.000199: Medicine, professor. He served as: Chief of the Traumatic Surgery Department of the Republican Territory Hospital,
p.000199: the Minister of Public Health, President of the Chisinau State Medical Institute, Chief of the Department
p.000199: of Public Health and Social Medicine Department. He is the most prominent organizer of national medicine
p.000199: of the second part of the XX century. His works on organization of public health care examining medical ethics and
p.000199: deontology are especially valuable. He strongly supported introduction to the practice of moral medical principles. In
p.000199: this respect his everyday activity was a bright example.
p.000199: Any event in nature and especially in the society is known to have strictly defined grounds, knowledge of which allow
p.000199: researchers analyzing them deeply and widely, determine their (fundamentals) role in formation and development of this
p.000199: phenomenon, to evaluate significance of the latter in formation of social conscience at the level of country, region
p.000199: and even mankind in general. Such fact as biomedical researches is not an exception in this sense.
p.000199: Cultural and historical grounds of biomedical researches in the Republic of Moldova may be examined from several
p.000199: aspects.
p.000199: Firstly, cultural traditions of our country initially suppose existence of stable moral system, reality of
p.000199: which allows rather accurate control of different actions including science. Public mentality is strived to
p.000199: carry out true moral appraisal. Such situation dominates both in public social consciousness and in
p.000199: traditions, folk and literary works.
p.000199: Social and cultural life of Moldova is defined to a large extent by demographic situation. Density of
p.000199: population equal to 127 people per 1 square km is high comparing to other regions of the southeastern Europe. In
p.000199: addition the distance between settlements is small. Hence there appears singularity of information process.
p.000199: Moldova to strengthen its economy and independence besides critical times kept original scientific traditions
p.000199: practically in all fields of knowledge. Medicine, pharmacy, biology, ecology, philosophy and science of culture
p.000199: exhibited considerable development.
p.000199: Efficient ways for establishing of bioethics were found in Moldova. As a result, significant progress as to this field
p.000199: was made in a short period of time.
p.000199: First bioethical ideas entered our Republic in the end of the 80’s of the last century, as the ex-USSR though. However,
p.000199: they found true response in the scientific circles in the beginning of the 90’s. Comparing to western countries
p.000199: establishment of bioethics in the Republic of Moldova happened rather late - in the first part of the last decade of
p.000199: the XX century. This is the first stage of bioethics development in the local, national territory. Bioethical problems
p.000199: of this stage were however at the background due to large-scale social shock happened during that time: collapse of the
p.000199: USSR, declaration of the Republic’s independency, Transdniestria conflict, etc. Notwithstanding abovementioned small
p.000199: group of scientists examined consistently possibilities for bioethics development in our country.
p.000199: The second stage includes the period from 1995 trough 1999. It is necessary to stress that in such a
p.000199: contingency the Department Philosophy (since 1999 – Department of Philosophy and Bioethics) of the State University of
p.000199: Medicine and Pharmacy named after Testemitsanu N.F. became the core or the Centre for establishment and development of
p.000199: bioethics in the Republic of Moldova. Academician Theodor Tsidrya, chief of the Department of Philosophy, was
p.000199: the initiator for distribution of bioethics ideas in Moldova. He created efficient grounds for introduction of
p.000199: bioethics into different fields of operation especially in scientific and educational spheres, first alone, then
p.000199: together with the staff of the Department. Lectures of the famous Italian expert in philosophy - Pietro Cavasin – in
p.000199: the past director of one of the Italian bioethics institutes - became a stimulus. Taking into consideration his
p.000199: activity in promotion of bioethical knowledge in the Republic of Moldova in 2001, the University conferred him with
p.000199: Doctor Honoris Causa title.
p.000199: Professor and teacher’s group of the Department became a prime scientific, teaching and methodological and
p.000199: practical Centre of bioethics development in the Republic of Moldova. We need to stress great support of the
p.000199: National Commission for UNESCO Affairs in organization of the National Bioethics Centre in the Republic of Moldova on
p.000199: 10 of November 2004, and holding of different events. Mission of the Centre includes first of all the following: 1)
p.000199: harmonization and coordination of joint actions in this field between the Department, Bioethics Association and
p.000199: National Commission for UNESCO Affairs in the Republic of Moldova and the Ministry of Health
p.000199:
p.000200: 200
p.000200:
p.000201: 201
p.000201:
p.000201: Care and Social Security; 2) consolidation of all competent bodies at the national level to organize different events
p.000201: and implementations; 3) effectual promotion of bioethical knowledge; 4) facilitation of implementation of
p.000201: research results into different activities’ areas; 5) coordination of various activities in the bioethics at the
p.000201: national level.
p.000201: Since 2005 expansion of different activities connected with further establishing of bioethical ideas in our
p.000201: country is noticed: increase of academic hours in subject block for bioethics for students, doctoral
p.000201: candidates, applicants and residents, introduction of bioethical training for medical and nursery medical personnel of
p.000201: medical institutions of the Republic; publication of text-books and set of training materials; expansion of scientific
p.000201: research themes; holding of topical workshops; regular organization of round-tables with invitation of experts in
p.000201: gynecology, transplantology, resuscitation science, intensive care, biology, genetics, forensic medicine, psychiatry
p.000201: etc.; increase of student’s interest to bioethical issues through participation in student philosophic study
p.000201: groups, extending of international relations.
p.000201: Other advances were rather marked as well. However, the main achievement of this stage was foundation of true
p.000201: scientific bioethical school in our country.
p.000201: Prime bioethics development trends in the Republic of Moldova:
p.000201: 1) organization of training process in bioethics; 2) organizational and practical events; 3) scientific
p.000201: activity.
p.000201: Organizational and practical events include the whole set of activities: holding of different workshops and
p.000201: lectures in medical institutions, organization of programs on the Republic’s television and radio channels;
p.000201: presentation of books, information exchange with foreign organizations involved in bioethical issues; permanent
p.000201: advisory service for executives of medical institutions, drug stores, laboratories, sanitary and epidemiological
p.000201: stations on issues of documentation creation and set-up of bioethics committees; development and
p.000201: improvement of regulations, provisions, participation in adoption of laws; sample by-laws for bioethics committees
p.000201: under hospitals of our country were worked out.
p.000201: Main tasks of scientific activity: elaboration of comprehensive bioethical researches; intensification of
p.000201: researches on theoretical bioethics; examination of bioethical issues of clinical medicine (i.e. practical bioethics);
p.000201: identification set of issues of related subjects, where bioethics development
p.000201: is a catalyst of their demonstration; creation of practical teaching aids for bioethics intended for doctors majoring
p.000201: in other fields.
p.000201: It is possible to conclude that significant work was performed in the Republic of Moldova during rather short period of
p.000201: time as to development and introduction of bioethical knowledge as well as to research and solving of different issues
p.000201: in the sphere. That was the solid base for introduction and functioning of ethical review of biomedical research
p.000201: system.
p.000201:
p.000201: 3.7.2. Legal Regulations
p.000201:
p.000201: Regulations for clinical researches have been introduced in Moldova since the middle of the 90’s. Prime legal
p.000201: documents of the Republic of Moldova as to biomedical researches are as follows:
p.000201: 1. The Law of the Republic of Moldova On Pharmaceutical Products
p.000201: No. 1409 of 17.12.1997.
p.000201: 2. Law On the Rights and Responsibility of a Patient No. 263 of 27.10.2005
p.000201: Legal and ethical issues at clinical research are addressed in the Law of the Republic of Moldova On Pharmaceutical
p.000201: Products elaborated taking into consideration a series of international documents. So, Article 11 “Clinical Researches”
p.000201: particularly states:
p.000201: 1) Clinical researches of pharmaceuticals shall be performed in accordance with the Rules on Good
p.000201: Clinical Practice approved by the Ministry of Health Care.
p.000201: 2) Application on performance of clinical research of medicament shall be filed to the Ministry of Health Care
p.000201: or to an authorized institution. The application shall be filed with materials containing general information on a
p.000201: medicinal agent, agent samples, and results of pre-clinical studies, draft design of clinical researches.
p.000201: 3) Permit for clinical research shall be given in case of:
p.000201: a) positive conclusion of review on efficacy and safety of a medicinal agent held basing on materials of pre-clinical
p.000201: research;
p.000201: b) availability of accurate data on the fact that the risk of adverse events of the medicinal agent will
p.000201: be less than expected benefit.
p.000201: 4) Procedure for clinical research materials review shall be established by the Ministry of Health Care or by the
p.000201: authorized body.
p.000201:
p.000202: 202
p.000202:
p.000203: 203
p.000203:
p.000203: 5) Clinical research must be performed by skilled specialists in the relevant sphere.
p.000203: 6) Clinical research of the medicinal agent may be permitted only after receipt of positive conclusion on
p.000203: ethical and moral and legal issues of research program issued by ethics commissions created and operating at patient
p.000203: treatment and prevention facilities having held clinical researches.
p.000203: 7) Ethics Commissions shall be formed in each medical institution empowered by the Ministry of Health Care to
p.000203: perform clinical researches. Ethics Commission includes therapists, pharmacists, pharmacologists, layers, and
p.000203: representatives of professional and public organizations.
p.000203: 8) A sponsor of clinical research shall have the right to obtain information on pharmaceuticals research
p.000203: process, results of review and demand substitution of medical institution carrying out the research;
p.000203: 9) Inspection of clinical research shall be carried out by the Ministry of Health Care or by the authorized body.
p.000203: Article 12 of the Law “On Pharmaceutical Products” is fully devoted to protection of patient (volunteer) rights:
p.000203: 1) Clinical researches shall be performed on volunteers (healthyXpeople) and on patients during their disease
p.000203: treatment;
p.000203: 2) Clinical research shall be performed only with written consent of the patient or volunteer, and in case of
...
p.000203:
p.000204: 204
p.000204:
p.000205: 205
p.000205:
...
p.000205:
p.000205: 3.7.3. Education in Bioethics
p.000205:
p.000205: There is no doubts that training and education in bioethics for population and firstly for youth has become a
p.000205: necessity, a requirement of the time and not a fashion or somebody’s ambition. This imperative is caused
p.000205: by anthropoecological and anthropogenic crisis sweeping today the Earth as a result of natural and even
p.000205: unrestrained activities of a man and world community in general to provide human existence. In this connection
p.000205: it is necessary concentrate human powers firstly intellectual ones for safety
p.000205:
p.000206: 206
p.000206:
p.000207: 207
p.000207:
p.000207: development of modern civilization. This is the time to elaborate new approaches to human survival strategy,
p.000207: which would provide opportunities of more efficient handling of global anthropoecological crisis, exclude
p.000207: planetary omnicide that closely follows tracks of the modern world.
p.000207: Bioethics as it is well known is an efficient mechanism in securing safety development of the society. That
p.000207: means that well-established training and education of population in this practical philosophy would facilitate
p.000207: solutions for many issues related to survival of mankind. The Republic of Moldova performs a lot as to the issue:
p.000207: Firstly, for purposeful coordination of this work the Bioethics Association of the Republic of
p.000207: Moldova was created in the country in 2001 (31 of May), and the National Bioethics Centre was founded (10 of
p.000207: November 2004) uniting experts in this science and practical philosophy of all country higher educational
p.000207: institutions, other scientific institutions, for effectual organization and implementation of different
p.000207: decisions and advises in this field with the help of UNESCO together with the Department of Philosophy and Bioethics
p.000207: project called Extension of Development and Promotion of Knowledge in Bioethics in the Republic of Moldova.
p.000207: Secondly, for purposeful teaching of bioethics in students circles and primary at the biomedical,
p.000207: agronomical, veterinarian and similar departments, traditional Department of Philosophy has been reorganized
p.000207: into the Department of Philosophy and Bioethics in 1999 under the Order of the President of State University of
p.000207: Medicine and Pharmacy named after Testemitianu N.A., which undertook solving of all issues related to teaching of this
p.000207: discipline to students. They include: working out of text-books and teaching aids, dictionaries, elaboration of
p.000207: thematic plans, curriculums and workshop projects, tests, staff training, method teaching and methodological training
p.000207: of teachers of higher education institutions, colleges and lyceums of the Republic including in bioethics.
p.000207: 64-hour training course for students of our institution and 32-hour course for other universities has been worked out
p.000207: by the Department. Several text- books and teaching aids on this discipline were published in Romanian and Russian, we
p.000207: will point of the following:
p.000207: - Philosophy and Bioethics: History, personalities, paradigms.), Chisinau, 2000, 256 p.
p.000207: - Philosophy (with Bioethics course). Chisinau, 2002, 552 p.
p.000207: - Philosophy and Bioethics Dictionary. Chisinau, 2004, 441 p.
p.000207: - Elements of Bioethics. Chisinau, 2005, 176 p.
p.000207: - Bioethics: origin, dilemma, trends. Chisinau, 2005, 234 p.
p.000207: These and other training and methodological and scientific works of the Department staff allowed organization and
p.000207: holding of training not only for students but for a certain number of professors of universities and colleges of the
p.000207: country in accordance with detailed program on Bioethics through the National Bioethics Centre and Bioethics
p.000207: Association of the Republic of Moldova. More than 50 persons who would be able to give lectures on bioethics in the
p.000207: higher and secondary specialized educational institutions of our country as well as in lyceums underwent advanced
p.000207: training in science and method training related to this field at these national workshops.
p.000207: Thirdly, the Department of Philosophy and Bioethics of State University of Medicine and Pharmacy named after
p.000207: Testemitianu N.A., the National Bioethics Centre carries out permanent research work in bioethical knowledge
p.000207: considering bioethics in the widest definition of this term (as per V.P. Rotter). Since 1995 until 2006 the
p.000207: Department has organized and held eleven international scientific workshops on topic Bioethics, Philosophy and
p.000207: Medicine in Human Survival Strategy. Scientists and practitioners from many world countries (the Ukraine, the Russian
p.000207: Federation, Bulgaria, Romania, Canada, the USA, the Republic of Moldova, etc.) and other specialties (philosophers,
p.000207: medics, biologists, ecologists, engineers, economists, agronomists etc.) participate in such workshops
p.000207: contributing to bioethical development in close connection with biomedicine, philosophy, ecology, economy, technique,
p.000207: other fields of knowledge. This promoted development of researches in ethics of life not only in the Department of
p.000207: Philosophy and Bioethics of State University of Medicine and Pharmacy named after Testemitianu N.A. but in other higher
p.000207: educational institutions of the country.
p.000207: Since 2002 the Department offers post-gradual studies (daily and distant training), doctor of science (distant) and
p.000207: master (daily) training in bioethical sphere where graduates of philosophic, medical, theological, agricultural and
p.000207: other department study. After graduation and successful defense of works they are conferred the degree of doctor or
p.000207: doctor habilitate of philosophic science (majoring in bioethics) and master on bioethics, respectively.
p.000207: If we are to continue to develop our ideas related to organization of training process in bioethical knowledge in
p.000207: our country it is necessary
p.000207:
p.000208: 208
p.000208:
p.000209: 209
p.000209:
p.000209: to especially stress the work of the Department, Association and the National Bioethics Centre in
p.000209: popularization of this phenomenon among the population of the Republic and primarily among the youth.
p.000209: Introduction into Bioethics program is of special popularity among the radio and television auditoria. Over
p.000209: last 3 years the personnel of the Centre and the Department organized and held about 20 talks (radio and television) of
p.000209: 15 to 45 minutes each on basic themes of this type of practical philosophy. Such programs as Bioethics –
p.000209: The Science of Survival, Euthanasia from the Point of View of Bioethics, Cloning in the Contest of Bioethics,
p.000209: Bioethical Aspects of Artificial Human Reproduction, Experiments in Humans and Animals in Biomedical Sphere:
p.000209: Bioethical Aspects, Religion and Bioethics and other with participation of bioethics specialists, biologists,
p.000209: medics and religious theologists can be marked among them, as well as From Anthropocentrism to
p.000209: Biospherocentrism, Backgrounds of Bioethics, From Ethics to Biological Ethics, Abortion and Bioethics, Bioethical
p.000209: Education of Society – Requirement of the Human Survival Strategy, Transplantology and Bioethics, Human Genome and
p.000209: Bioethics, Biomedical and Spiritual World: Comparative Analysis, Principles and Imperatives of Bioethics,
p.000209: Paternalism and Antipaternalism in Human Activity, Informative Consent and Interpretation in Medical Practice and
p.000209: others.. Here we started to check the interest in some ideas from social bioethics, such as Senility and Bioethics,
p.000209: Terrorism and Bioethics, Homosexualism, Transsexualism and Travestism in the Contest of Bioethics, Suicide and
p.000209: Bioethics, Homeless in the Light of Bioethics, Bioethics and AIDS, People with Physical Incapability in the Light of
p.000209: Bioethics, Asceticism and Bioethical Knowledge, Sadism and Masochism in the Contest of Bioethics etc. All that promotes
p.000209: propaganda of bioethical knowledge among the population both of the cities and rural settlements, formation of skill to
p.000209: care about living and biosphere in general.
p.000209: Periodicals with regular publication of interviews, articles and, for
p.000209: example, such newspapers as Komsomolskaya Pravda, Argumenty i Fakty, Nezavisimaya Moldova, Făclia, Moldova
p.000209: Suverană, Literatura şi arta are used to the same extent, i.e. for propaganda and promotion of knowledge
p.000209: in bioethics. We will underline several of them: Philosophy (With Bioethics Course), the Svetoch newspaper, No.
p.000209: 14 of 5 April 2003,
p.000209: p.6 (in Romanian); Homo Sapiens, be a Human!, the Argumenty i Fakty newspaper, No. 21, May 2005, p.3 (in
p.000209: Russian); Bioethics, Philosophy,
p.000209: Economics and Medicine in the Strategy of Humane Safety Ensuring, the Literatura i Iskusstvo weekly, No. 11, 17 of
p.000209: March 2005, p.2; Philosophy and Bioethics, the Literatura i Iskusstvo weekly, No. 35, 1 of September 2005, p.7; And
p.000209: Philosophers May Safe the Mankind, the Svetoch newspaper on 19 of February 2000, p.6, etc.
p.000209: Traditions of extensive participation of the community in formation of moral principles of social life are rather
p.000209: strong in our country as in other CIS countries. As it was said before, the first public officially
p.000209: registered organization in 2001 undertaking responsibility to promote ideas of bioethics in the
p.000209: Republic was Bioethics Association, united philosophers, medics, lawyers, theologists, biologists, scientists,
p.000209: students and other public representatives. All bioethics commissions created in local hospitals, scientific
p.000209: institutions and others are the result of the activity of the Association and the National Bioethics Centre. Today,
p.000209: bioethics commissions operate in practically all patient care and preventive and scientific and biomedical
p.000209: institutions, elaborating procedures for operation and standard operation procedures based on model regulation.
p.000209: It is necessary to underline the role of bioethics committees in organization and holding of training and
p.000209: educational process starting with the National Ethics Committee under the Ministry of Health Care and Social Security
p.000209: and to basic levels of this system. First of all, we set up trainings for members of the committees at workshops, and
p.000209: then they perform the same work in their teams, i.e. promote bioethical knowledge.
p.000209: So, successful set up of bioethical training is important for the Republic of Moldova from various points of
p.000209: view, and, first of all at the point of integration of our country into European and world community. From one
p.000209: side use of experience of other countries in this process is the condition for formation of moral
p.000209: mechanisms embodiment for ensuring of secure development strategy for our region, further democratization of
p.000209: social life. From the other side, the experience of the Bioethics Association of the Republic of Moldova,
p.000209: the National Bioethics Centre on bioethics and the Department of Philosophy and Bioethics of the State University of
p.000209: Medicine and Pharmacy named after Testemitianu N.A. on set up of trainings and education of inhabitants in
p.000209: bioethical interconnections and interactions among humans, society and biosphere, i.e. in implementation of one of
p.000209: the significant principles of bioethics – the co-evolutional one.
p.000209:
p.000210: 210
p.000210:
p.000211: 211
p.000211:
p.000211: And finally, wide spread of the experience and practice of the state and public formations in training and educational
p.000211: process of bioethical knowledge will favor integration in social life of new ethical and legal approaches,
p.000211: principles and values, the help of which may not only reasonably use achievements of current scientific and
p.000211: technological progress but promote implementation of modern strategy of the world community meaning survival of
p.000211: the mankind through steady and safe development.
p.000211: These are summary results of our works during the last 10-12 years in organization of training, education and promotion
p.000211: of bioethical knowledge among people of our country, and, first of all, among the youth. The work we have performed
p.000211: undoubtedly will be a serious base for further extension and strengthening of the developed system especially in
p.000211: carrying on of bioethical education of young students, future specialists of all types.
p.000211:
p.000211: References
p.000211: 1. Bioethics: principles, rules, issues. Edited by Yudin B.G. М., 1998,
p.000211: 472 p. (in Russian)
p.000211: 2. Vekovshinina S.V., Kulinichenko V.L. Bioethics: onset and rationale (philosophy and methodological analysis).
p.000211: Kiev, 2002, 152 p. (in Russian)
p.000211: 3. Second National Congress on Bioethics. 29.09 – 2.10 2004. Kiev, 2004, 305 p. (in Russian)
p.000211: 4. Testemitsanu N.A., Popushoy Ye.P., Ioksa V.A. Famous Doctors of Moldavia. Chisinau, 1985, 231 p. (in Russian)
p.000211: 5. Tsirdya T.N., Berlinsky P.V. Philosophy (with course on bioethics). Chisinau, 2002, 553 p. (in Russian)
...
p.000213: principle requires participation in discussion as far as possible for all members of the committee to reflect different
p.000213: views on this or that topics.
p.000213: Principle of objectivity at consideration of the CT materials is implemented through exclusion of
p.000213: a “conflict of interests”. Besides, the rights of all participants of the research, particularly, not only
p.000213: patients but doctors as well, are taken into consideration at review.
p.000213: Adherence to confidentiality is required in respect to the CT materials, persons involved in the research.
p.000213: Collective nature is usually expressed in consensus manner of discussion and decision making.
p.000213: One more significant principle of the NEC activities, if possible to say so, an ideological principle of ethical review
p.000213: is inadmissibility of prohibitions. None of the international document devoted to the ethics committees
p.000213: include the word ‘permitted’ or ‘prohibited’. Prohibition limits the freedom of personality that is impossible to
p.000213: recognize as ethical. That is why the ethics committee makes its conclusion leaving to a researcher or sponsor to
p.000213: take into consideration or not (however, pursuant to the GCP regulations absence of the ethics committee permit is a
p.000213: ground for prohibition actions of controlling and regulatory bodies).
p.000213: General aspects of the operation of the ethics committee are as follows:
p.000213: a) independence of the parties participating in the research;
p.000213: b) non-pursuing commercial or any other tangible interests;
p.000213: c) being a public body with certain authorities provided by the law, such as:
p.000213: • to review documents related to conduct of clinical researches and, when necessary, to require amending or altering
p.000213: the documents;
p.000213: • to make decision on possibility to perform or to continue clinical research;
p.000213: • to control how CT is performed.
p.000213: For its work the NEC elaborated and observes strictly its standard operation procedures governed by
p.000213: international and national laws for clinical researches. SOP are fixed on paper, create principles and regulations
p.000213: for committee activities. That is why researches and study sponsors pay to them more attention. Published collections
p.000213: of SOP allow improvement of the ethics review process by means of methodological and legal integrity of structure and
p.000213: functions of the Ethics Committee.
p.000213:
p.000214: 214
p.000214:
p.000215: 215
p.000215:
p.000215: Ethical standard for operation of the NEC in the country is worked out based on mutual respect to cultural,
p.000215: religious, national differences and acknowledgement of universal values. Elaborated national collection of SOP is a
...
p.000215: - ability to enroll subject cohorts within scheduled study time;
p.000215: - provision of clinic with necessary personnel: diagnostic and patient care equipment, communication facilities,
p.000215: computer equipment;
p.000215: - ability to provide emergency medical care in case of adverse events and side effects.
p.000215: 4. Procedure for attraction of possible study subjects (advertising, announcements, etc.), evaluation of
p.000215: correspondence of provided information to ethical norms.
p.000215: 5. Patient insurance procedure and payment of remuneration.
p.000215: 6. Content of research information provided to the patient.
p.000215: 7. Procedure for obtaining of the patient written consent for participation in the research;
p.000215:
p.000216: 216
p.000216:
p.000217: 217
p.000217:
p.000217: Only members of the ethics committee independent from sponsor and researcher take part in decision-making
p.000217: process as to certain clinical research.
p.000217: Decision of the ethics committee is given in accordance with one of the following variants:
p.000217: a) Permission to perform of a clinical research (approved opinion);
p.000217: b) Amendments are required to produce a positive decision;
p.000217: c) Negative decision;
p.000217: d) Cancellation of any previously made decision.
p.000217: During a clinical research an investigator must inform the Ethics Committee on necessity to introduce certain
p.000217: amendments and alterations to the clinical study protocol and to the information provided to study subjects, as well on
p.000217: occurrence of severe and/or unexpected adverse events and side effects and on any new data on possible impact of the
p.000217: tested article on humans. Based on results of review of materials provided by the investigator, the Ethics Committee
p.000217: makes decision on possible introduction of these or those alterations and amendments, continuation of clinical research
p.000217: or its separate stages, on measures which must be taken to ensure safety and protection of study subject rights.
p.000217: The Ministry of Health Care and Social Security and authorized agencies pay great attention to settlement of such
p.000217: complicated and diverse ethical and legal issues arising during clinical researches. We are trying to observe the
p.000217: following main principles in operation of the committee involved in ethical issues of the CT:
p.000217: - unified methodological approach based on GCP guidelines;
p.000217: - striving to independence of decisions to promote protection of study subject rights.
p.000217: - special attention is paid to patient informed consent
p.000217: - assistance to educational programs for members of the ethics committees, for doctors- researchers,
p.000217: patients.
p.000217: - inclusion all researches (pharmaceutical products as well as biological active substances,
p.000217: technologies, materials, devices and items for medical use involving human subjects as a study object) into the sphere
p.000217: of activities of the ethics committee
p.000217: - maintenance of ethical environment using medical publications issuing only results of researches that passed
p.000217: ethical review by ethics committees.
p.000217: New documents devoted to ethical and legal aspects of clinical researches are elaborated annually, changes are made to
p.000217: existing documents. General provisions of international laws, in particular, ICH GCP are reflected in
p.000217: guidelines produced by the Agency for Pharmaceutical Products of the Ministry of Health Care and Social
p.000217: Security of Moldova. There is a process of regular and consistent introduction of GCP principles into the practice of
p.000217: organization and performance of clinical researches of medical agents. Up- to-date task is creation of local ethics
p.000217: committees in Moldova. Creation of such independent committees authorized with relevant powers will promote active
p.000217: participation of Moldova clinics in multi-Centreed international researches, allow controlling observance of the
p.000217: rights and safety of study subjects not only at the stage of setting up but also during the study course.
p.000217:
p.000217: 3.7.5. Perspectives and Forms of International Cooperation
p.000217:
p.000217: There are no doubts that successful education in bioethics, improvement of ethical review system for biomedical
p.000217: researches mainly depend on involvement of the country, its governmental bodies, public entities, scientific
p.000217: communities in different international events connected with provision of safe development of society,
p.000217: cooperation with other states, international organizations for improvement of research work in bioethics (to a
p.000217: large extent), in promotion and popularization of bioethical knowledge, in performance of biomedical researches
p.000217: involving human and animal subjects, etc.
p.000217: Certain experience in international cooperation related to this field is gained by the Republic of
p.000217: Moldova. First, we would like to remind about organization and holding of scientific workshops with international
p.000217: participation of many European countries on bioethical topics in our country and abroad, first of all, about a role of
p.000217: bioethization of the society to ensure safety of the modern world. During the last 11 years the same number of
p.000217: scientific conferences was held and eleven books were published with materials of speakers at these scientific
p.000217: forums (organizers: Department of Philosophy and Bioethics of State University of Medicine and Pharmacy named after
p.000217: Testemitianu N.A., the National Bioethics Centre of the Republic of Moldova).
p.000217: Since 2000 the National Ethics Committee is a member of the FEC CIS. Moldova collaborates with ethics
p.000217: committees of the CIS countries
p.000217:
p.000218: 218
p.000218:
p.000219: 219
p.000219:
p.000219: through this Forum. As to international cooperation and as a member of the Forum, representatives of our committee were
p.000219: participants of the majority of conducted conferences and workshops of the FECCIS: Saint-Petersburg, Russia, 2001;
p.000219: Kiev, Ukraine, 2001; Almaty, the Republic of Kazakhstan, 2002; , Kiev, Ukraine, 2004; Saint-Petersburg, Russia,
p.000219: 2003; Baku, the Republic of Azerbaijan, 2004; Saint-Petersburg, Russia, 2004; Minsk, Belarus, 2005; Almaty,
p.000219: the Republic of Kazakhstan, 2005; Tashkent, the Republic of Uzbekistan, 2005; Yerevan, the Republic of Armenia,
p.000219: 2005.
p.000219: In 2006 the workshop on “Human Rights Protection &. Standard Operation Procedures” with participation the
p.000219: representatives from FECCIS (Russia, Ukraine, Moldova) and SIDCER (WHO) and EFGCP (Belgium) was held in Chicinau.
p.000219: Chairman of the National Ethics Committee of the Republic of Moldova, Professor Gikavy V.I. took part in the workshop
p.000219: of the Commission of the Council of Europe on Ethical Issues (Ljubljana, 2004). Professor M. Gavrilyuk, Deputy-director
p.000219: of the Neurology and Neurosurgery Institute of the Ministry of Health Care and Social Security is a permanent
p.000219: representative of the Republic in the Commission of the Council of Europe on ethics of biomedical researches since
p.000219: 2005.
p.000219: Secondly, the staff of the State University of Medicine and Pharmacy named after Testemitianu N.A., the State
p.000219: University of Moldova, the State Agricultural University and other, members of the National Bioethics Centre of
p.000219: the Republic of Moldova take part on a regular basis in scientific conferences organized in other countries, exchange
p.000219: with their experience, mainly, on scientific and educational publications, activity of bioethical committees,
p.000219: etc. Four workers of the Department of the Philosophy and Bioethics just for the last 3-4 years took
p.000219: part and made presentations at the 2nd National Bioethics Congress (Kiev, 2004), the same number of
p.000219: presentations was made at the 4th Bioethics Symposium (Kiev, 2006), four presentations were made at the
p.000219: International Conference on bioethical education (Romania, Keya, 2006 and Romania, Bucharest, 2006), with
p.000219: presentations at the International seminar on issues of ethical review in biomedical researches (Ukraine,
p.000219: Kiev, 2006), with presentations on issues of students bioethics education (Croatia, Split, 2006), etc.
p.000219: Thirdly, professors of philosophy, philosophy and bioethics departments of many of higher educational institutions
p.000219: of Chisinau published lately materials on bioethics in different scientific journals, other foreign
p.000219: publications, for example in Kursk (Russian Federation) – 5 articles, in Yassy (Romania) – 2 articles,
p.000219: in Arad (Romania) – 2 articles, in Galatia (Romania) – 2 articles, in Lvov (Ukraine) – 1 article, etc. Our
p.000219: colleagues from these scientific Centres publish their works in scientific publications of Chisinau (journals,
p.000219: university research works, conference materials, etc.).
p.000219: During the last years the Department of Philosophy and Bioethics of the State University of Medicine and Pharmacy named
p.000219: after Testemitianu N.A. is trying to enter different international projects related to training programs on bioethics,
p.000219: performance of ethical review of biomedical researches, staff training, etc. To this extent we are looking for
p.000219: forms of international scientific and pedagogical cooperation in bioethics with the CIS countries, and especially with
p.000219: those states where large educational experience for this subject was already gained, where large-scale research work is
p.000219: carried out.
p.000219: To improve training programs in bioethics and its lecturing in the State University of Medicine and Pharmacy named
p.000219: after Testemitianu N.A., a famous Italian specialist in these spheres of practical philosophy, Pietro
p.000219: Cavasin, give lectures to students and doctor candidates for 5 years in the State University of Moldova. There was
p.000219: constant exchange of both scientific and educational literature here.
p.000219: Since 2004 we expanded relationship with foreign colleagues as to training of high-qualified specialists, i.e.
p.000219: through post-graduate and master studies in bioethics. Anna Marin, post-graduate of the Department prepares
p.000219: dissertation in bioethics under guidance of two specialists now: Doctor of Philosophy Raymond Massé – Laval University
p.000219: (Canada) and professors of our Department. Two professors of the Department gained master degree majoring in
p.000219: bioethics in French in Bucharest, and one more staff member got training in the University of Angers
p.000219: (France). All expenses on implementation of these projects were covered by the French-speaking Agency for the Republic
p.000219: of Moldova.
p.000219: We consider for the future (as a suggestion) as useful and, more important, as necessary development and publication of
p.000219: a text-book for the University students under the title The Fundamentals of Bioethics by scientists of the CIS
p.000219: countries. It could be started now without any long-term delay, let’s say, from January 2007 under general scientific
p.000219: and methodological guidance of heads of departments where this subject is a part of a curriculum of a higher
p.000219: educational facility, where it is taught, where teaching aids were published, and
p.000219:
p.000220: 220
p.000220:
p.000221: 221
p.000221:
p.000221: some experience in this sphere was gained. At least, our Department as well as plenty of other groups from other
p.000221: countries are ready to participate in such project. It would be rational and useful to organize regular educational and
p.000221: methodical workshops for professors lecturing bioethics in scientific Centres of different CIS countries (Kiev, Moscow,
p.000221: Chisinau, Baku, Yerevan, etc.)
p.000221: We also consider as useful the initiative of Moscow colleagues with participation of other CIS countries on
p.000221: development of a training course in bioethics for highest qualification specialists with duration of 320 academic hours
p.000221: (it is possible to reduce the time if to consider that information sciences and foreign languages were already taught
p.000221: to young university professors of higher educational facilities). This is the beginning of the large work and we hope
p.000221: to see it finished in the nearest future as a good example of cooperation among the CIS countries.
p.000221: 3.8 RUSSIAn FEDERAtIon (G.L.Mikirtichian, A.F.nikitina, A.S.Sozinov,
p.000221: M.E.Guryleva, E.A.Malysheva)
p.000221:
p.000221: 3.8.1 Historical and Cultural Background
p.000221:
p.000221: During the period of its existence Russian medicine has accumulated the great volume of ethic knowledge both in
p.000221: theoretical research and in practice. Founding and development of medical ethics as predecessor of bioethics in Russia
p.000221: was determined by social and economical factors, historical, cultural and national features, religious and moral
p.000221: traditions of the peoples living over the country.
p.000221: Chapter 5 From the beginning Russia was multinational state with multinational neighbors. This
p.000221: multinationality influenced the foundation of Russian culture. Geographical position of the state at the junction of
p.000221: Europe and Asia resulted in ambivalence of people nature and state organization as European as Asian and gave birth to
p.000221: a philosophical concept of eurasianism, that was founded by one of the most universal Russian thinkers
p.000221: abroad N.S.Trubetskoy (1890-1938). D.L.Lihachev believed that universality and belonging to East and West were
p.000221: the most characteristic features of the Russian culture (14). Junction of East and West civilizations, crossing of
p.000221: two pole streams of culture, which pushed off each other and could not be joined but co-existed, have determined such
p.000221: features of Russian soul, as its polarity, apocalyptic character and nihilism, which “do not admit a middle kingdom of
p.000221: the culture” (1).
p.000221: Habitat, the geographical position, nature and climate where people were settled in the result of
p.000221: historical processes of moving and settling, determined the formation of Russian national character. Famous
p.000221: historian V.O.Kluchevskiy believed that external nature always and everywhere determines the mankind in
p.000221: different way. The different determination specified features of people, first of all everyday and mental, which
p.000221: form the national character; in this case they are the humanitarian foundations characterizing Russians (9).
p.000221: Russian ethnos originated and evaluated on great Russian plains that determined particular life style and view on
p.000221: external world, so-called “Russian soul breadth”. Social surroundings, relationships and labor system
p.000221:
p.000222: 222
p.000222:
p.000223: 223
p.000223:
p.000223: had the great influence on formation of the Russian national character. Humanity, placability and openness
p.000223: of our ancestors soul were formed under the influence of their main activities such as arable farming, cattle
p.000223: breeding and workmanship, and of community social order, which had been lasting longer then at other peoples. Among
p.000223: values of community it should be mentioned justice, power of “world”, thrifty housekeeping, knowing of folk wisdom,
p.000223: bogatyr (a Russian hero) strength, etc. Having given voluntary his destiny over to the community, man condemned himself
p.000223: to be tolerant and obedient. The community, by means of which the Russian people were able to keep their ethnos
p.000223: independent in spite of numerous invasions, had also the high value. For the sake of the community a Russian was ready
p.000223: to suffer, tolerate and sacrifice almost everything. Nevertheless, historical facts demonstrated examples of “Slavic
p.000223: freedom” from Cossacks, drinking- bouts, revelries, disorder, “fantastically fast life” to rebel and revolutions.
p.000223: The Russian culture is well known to exist inasmuch as Russian (and Old Russian) words meaning cultural
p.000223: contents exist. Contemporary analysis of the word “personality” (autonomy of “personality” is one of the
p.000223: principles of bioethics) in Russian and European languages showed that word “personality” is rather young
p.000223: for the Russian language, it was absent in the Old Russian language and in the modern Russian it handed its
p.000223: meaning to word “person” (15). As regards the notion “individuality” it has been adopted slowly and hardly in modern
p.000223: word usage. This fact differs Russia from Western Europe where individuality became the main value of the Modern time.
p.000223: The idea of person, personality itself began to form here in XIII century. And today in Western Europe the notion of
p.000223: personality is central, important as daily bread, and it is not high but everyday, though in Russia the word
p.000223: “personality” is in one row with the high notions and its meanings are not everyday.
p.000223: Speaking about language as means of communication one should note one more feature which is important for
p.000223: doctor-patient relations. The Russian language in contrast with the Romance and German languages is synthetic, not
p.000223: analytical, i.e. it may be axiomatizated hardly but is able to express emotions and feelings (22,27).
p.000223: Folk proverbs are very important feature of ethnos awareness and national mentality. They accumulate important
p.000223: conclusions and observations about nature and society laws. Many of them assert group priority over
p.000223: personality, collective things priority over individual, necessity to obey any group law. Man strength is in his group
p.000223: membership, whilst his personnel responsibility is vogue (25).
p.000223: Russians were characterized to have many interethnic contacts with people of different origin, cultural
p.000223: traditions and language that influenced undoubtedly the general Slavic culture foundation. Connections with
p.000223: Byzantine, a godmother and keeper of ancient civilization where Orthodoxy became a state religion, were the most
p.000223: fruitful for the Old Russian culture. Together with adoption of Christianity a Byzantine philosophy related to the
p.000223: Plato’s Hellenism, which gave it anthropological and historiosophy orientation, had penetrated to
p.000223: Russia. Anthropocentrism of Russian philosophical researches became one of characteristic principles of Russian
p.000223: philosophy. From Nil Sorskiy to A.N.Radischev, from Radischev to Soloviev and Berdiaev a Russian thought has been
p.000223: always attracted by cognition of mystery of person, his death and immortality (3). The Russian philosophy created
p.000223: “philosophy of life” long before birth of western European existentialism and pragmatism. Peculiarity
p.000223: of the Russian philosophy is in the fact that the Russian thought has always been (and will be forever) connected with
p.000223: its religion element and grounding and inspiration of freedom valued at any time by Russian minds had never died inside
p.000223: of church awareness. First of all everywhere dominance of morality evidences that. We can see it in works of nearly all
p.000223: Russian thinkers even those who had no works devoted to moral problems.
p.000223: Adoption of Christianity determined evaluation of Russian spirituality in subsequent periods. Founding on traditions of
p.000223: eastern orthodoxy, ideas of spirituality, shame and conscience, love to neighbor were brought in Old Russia, a
p.000223: spiritual foundation of charity as everyday piety was formed. Alms as early form of personnel charity was spread among
p.000223: all social classes, it was not only simple execution of commandment of love to a neighbor, but a true need. It was
p.000223: personnel charity that created the foundation necessary for helping the poor at the following times. It was forming
p.000223: morality, the most important social and philological category of national self-awareness (16).
p.000223: Establishment of monasteries on the north territories of Russia became considerable event for keeping the original
p.000223: Russian culture. Their foundation was connected with the names of outstanding well educated people with
p.000223: universal knowledge including medicine such as Kiril Belozerskiy, Sergiy
p.000223:
p.000224: 224
p.000224:
p.000225: 225
p.000225:
p.000225: Radonezhskiy, Stephan Permskiy, etc. First Russian libraries consisting of Greek and Byzantium manuscripts were
p.000225: collected there. In Middle Age Russia monasteries were not only religious institutions but presented a form of
p.000225: people social life organization on the basis of common views (19).
p.000225: Under church influence and with its participation care for people in need for medical and social help
p.000225: was brought to life and principles of mercy, charity, sympathy, concern were actively embodied. Together with
p.000225: monasteries, monastery and church hospitals and hospices were founded, monastery medicine appeared. Monasteries
p.000225: accumulated reserves of food, which were used in case of national disasters, wars, epidemics and bad harvest
p.000225: years. During that period they also defended people and served as refuge for mentally persecuted, hungry people, for
p.000225: all people being needy, mentally sick persons received help here, special wards were settled for wounded
p.000225: soldiers.
p.000225: Certainly, our ancestors could not be regarded absolutely irreproachable in their moral live. The soul of
p.000225: Russians was so broad that there were evidenced many vices and heave sins along with feat of great
p.000225: holiness. F.M.Dostoevskiy had reason to say that there were two abysses in the soul of a Russian man. Moral state of a
p.000225: Russian can raise him up to the heavens or drop him down to depth of hell.
p.000225: Following form of charity in Old Russia was zemsko-parish, which based on church parish that was an
p.000225: administrative, tax and territory unit. Self-organized financially independent parishes could keep and support
p.000225: thousands of disabled, old people and orphans. In the 50’s of XVI century they attempted to place a part of care
p.000225: for people health, social support for sick and weak people on the state. Stoglav, a great council of Russian
p.000225: bishops held in 1551, together with tsar and boyar Duma ordered to found everywhere hospices for “leprous, aged,
p.000225: lying in boxes on the streets, carrying carts and sledges and having no place to sleep”. “Desyatina”, the tenth
p.000225: part of funds from sale of bread, cattle and from rent, was brought in to keep churches, monasteries, hospitals,
p.000225: hospices and receive odd and poor people. At the same time representatives of different social classes donated money
p.000225: for church and charity needs.
p.000225: Breakup between secular and church ideologies that began in the second half of the XVII century became wider in the
p.000225: XVIII century. Peter I activity is characterized with two mutually exclusive tendencies: strengthening
p.000225: of absolutism and europeisation of Russia. Implementing reforms for strengthening of role of the state in all
p.000225: spheres Peter I included the Orthodox church in government structure and strengthen state control on it and
p.000225: consequently on church charity. On Peter’s initiative social charity became state one. At Peter I times they took
p.000225: measures against beggary, parish as self- organized church and social unit was abolished.
p.000225: At the same time in the XVIII century higher medical education was formed in Russia. Hospital schools, medical
p.000225: department of the Moscow University, surgery academies were founded. In these circumstances the following
p.000225: feature of Russian nature revealed: to study and to alter forms and methods of organization appeared in other
p.000225: countries. For example, based on medical education system in Western Europe, in Holland particularly, in Russia it
p.000225: certainly had disadvantages but it had no breakup between interns and sergeants, between theoretical and clinical
p.000225: educations, students were trained “at patient bed”.
p.000225: Students of religious schools were studying medicine because of specific features of the Russian society
p.000225: of the XVIII century. They were raznochinets, Russian intellectuals not of gentle birth, they knew Greek and Latin.
p.000225: This fact explains such features of Russian doctors and scientists as democracy and patriotism, self-denying service to
p.000225: people. Activity of such scientists as C.G.Zabelin, D.S.Samoilovich, N.M.Maximovich-Ambodic, M.G.Shein,
p.000225: A.S.Shumlyanskiy exemplify it. Physicians of the XIX century such as M.Y.Muromov, E.O.Mukhin. N.I.Pirogov,
p.000225: A.M.Filomafitskiy, S.F.Hotovitskiy, F.I.Inozemtsev and others maintained this tradition. Their professional activity
p.000225: and civil position were based on moral ideals. They wrote works where they discuss qualities characterizing a
p.000225: doctor, ethical aspects of relations with society, patients and colleagues. In everyday activity they pointed and
p.000225: solved problems, which were beginnings of bioethics principles and rules. They used method of experiment,
p.000225: observing disease activity and experimented on animals. At that time ethical approaches to experiments were formed.
p.000225: So, A.M.Filomafitckiy (11807-1849), the first Russian scientist, who made vivisection and surgery method as the base
p.000225: of physiology, said: “... Experiment made by inexperienced hand and aimlessly should be severely punished,
p.000225: especially if sufferings of an animal after blood operation are lengthened without any need, but experiments made
p.000225: by hands of a skillful and loyal observer are necessary for science and saving
p.000225:
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p.000226:
p.000227: 227
p.000227:
p.000227: of mankind...” (11). D.S.Samoylovich (1744-1805), founder of the Russian epidemiology, self-tested plague infection
p.000227: and its course. There were negative examples. In the middle of the XIX century in Moscow foundling hospital they
p.000227: were searching for substitute of breast milk for children, and among others Libihovskiy beef broth was studied. As a
p.000227: result many children fell ill and so it was concluded to be harmful (8).
p.000227: One of the first who began to defend rights of prisoners on health and medical help was F.P.Gaaz (1780-1853). In his
p.000227: everyday practice he defended and implemented the slogan “hurry up to make good”, displaying humane attitude to most
p.000227: miserable people such as exiles, convicts, he supported them morally and gave medical and social help, took care about
p.000227: their children. He both worked with selfless devotion and attracted unselfish assistants being of different classes and
p.000227: generations.
p.000227: Moral position of N.I.Pirogov (1810-1881) displays principle of honesty in Russia. He paid special attention to medical
p.000227: mistakes. In contrast with existing in medical society opinion he believed that every honest man should be able to
p.000227: admit and proclaim his mistakes to warn against them not well- informed people (24). Many Russian physicians became his
p.000227: followers and were able to admit and analyze their mistakes. They were A.Y.Krasovskiy, C.P.Kolomina, F.I.Sinitsin and
p.000227: others.
p.000227: An issue of patient consent for surgery was discussed by physicians in the past. N.I.Pirogov remembered in the Old
p.000227: Doctor Dairy, that an inspector of medical institutions I.Rule required from doctors in the hospital not to do any
p.000227: surgery without patient agreement.
p.000227: The time since the end of the XVIII century till beginning of the XIX century one can state as a
p.000227: birth of public medicine. First medical papers, medical societies, public hospitals and chemist’s shops,
p.000227: charity organizations were founded in Russia. One of the forms of public movement was movement of narodniks, which in
p.000227: the 60-70’s of the XIX century became mass ideology of intelligence not of gentle birth trying to be spokesman of
p.000227: peasants. At the call of members of organization Narodnaya Volya (People’s Will) Russian teachers and doctors went
p.000227: willingly “close to the people” and went to work in the depth of Russia (13).
p.000227: Conditions existing in Russia after abolition of serfdom such as quick development of capitalism and
p.000227: industrial and urban growth changed medicine very much. In the second half of the XIX century medicine became
p.000227: scientific and based on experimental methods. Medicine was differenced and integrated. Owing to scientific and
p.000227: technical progress many discoveries were made in biology and medicine, they changed conceptions of etiology and
p.000227: pathogenesis of diseases, diagnostics and treatments methods were improved. At this time many outstanding
p.000227: scientists, who gave us lessons of morality, lived, and scientific medical schools were established. They
p.000227: could not exist without succession between generations of researchers of traditions of handling not only knowledge and
p.000227: ideas but skills of research and truth comprehension, way of thinking and work, peculiar cooperation and creative work.
p.000227: The Pirogov’s medical association became a Centre of public medical thinking in Russia in the beginning of the
p.000227: 80’s. It grew from narrow professional community of physicians into a specific forum of Russian
p.000227: intelligence discussing social, political and moral problems. Its founders and leaders were famous
p.000227: physicians N.V. Sklifosovskiy, S,S, Korsakov,
p.000227: A.Y. Krasovskiy, F.F. Arisman, E.A. Osipov, G,E. Rain and others. The association held Pirogov’s congresses where
p.000227: the most urgent problems of medicine health protection such as fight against epidemics, management of medical
p.000227: care, medical organization at the front and home front and others were discussed. Congresses sent to the
p.000227: government decisions and applications and though most of them were not answered some of them were
p.000227: followed by orders. They were: decision on foundation of the Women Medical Institute (1902), manifest of corporal
p.000227: punishment abolition for all peasants in Russia and some others. Many times the Pirogov association discussed ethic
p.000227: issues such as status of physicians in Russia, problems of private practice and treatment payment, physicians’ mutual
p.000227: aid, physician right to treat without patient and his relatives’ consent and others (12).
p.000227: One more considerable page of Russian public medicine history has moral accent and is connected with struggle
p.000227: of progressive public persons for women rights and their political emancipation, the right for higher medical education
p.000227: and independent practice. Progressive university professors, scientists and writers supported these demands.
p.000227: Supporters of equal rights for women were S.P. Botkin, I.M. Sechenov, A.L. Krasovskiy, P.F. Lesgaft,
p.000227: V.L. Gruber, etc. They opened the door of their classes for first women and give them equal opportunities with men.
p.000227: Progressive media magazines and newspapers such as Medicine bulletin, Modern medicine, Saint-Petersburg
p.000227:
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p.000228:
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p.000229:
p.000229: Bulletin wrote about a need for the country to have women-doctors, about their role in propagation of hygiene,
p.000229: necessity of treatment of women whose shame often “results in great evil in medical practice”. Foundation of the Higher
p.000229: Women Medical Courses (1872, 1876) was the beginning of higher women medical education in our country, thus, Russia
p.000229: left behind almost all European states, besides Switzerland and the USA (the College of 1864). Courses could exist
p.000229: only on private donations. Means were collected in favor of the Courses. Zemskiy doctors sent part of their
p.000229: salary in favor of the courses. Association of mutual aid of women-doctors founded in 1890 was very useful. In 1897
p.000229: efforts of progressive society resulted in foundation of the first Russian Women Medical Institute, which was opened in
p.000229: Saint- Petersburg (now the Saint-Petersburg Medical University named after I.P. Pavlov).
p.000229: Events in medicine and health protection happened in period from 2nd half of the XIX — beginning of the XX century
p.000229: stimulated development of medical ethical ideas. Many old problems became more acute and new ones appeared, relations
p.000229: of doctor and society, doctor and patient, intercolleagueal relations in medicine were changed. Russian physicians were
p.000229: characteristic of not only speeches and declarations, talks about duty and morality but of deeds, behavior, example,
p.000229: and demonstration – quite often during dozens of years or even during their whole life - of what a doctor should be.
p.000229: Open discussion of “complicated” medical issues not only inside of medical society can be considered as
p.000229: a root of such bioethics feature as openness, transparency, necessity in public monitoring of biological
p.000229: researches.
p.000229: Development of a method of chronic experiment in animals is linked to the name of I.P.Pavlov (1849-1936). In 1876 at
p.000229: the Botkin’s clinic of the Medical Military Academy in Saint-Petersburg an experimental laboratory was founded. In
p.000229: 1878-1889 I.P.Pavlov made his researches here. Approval of experiments with animals as a basis of medicine
p.000229: resulted in usage of many animals and their death. It caused reproaches to experimentalists in cruelty, their
p.000229: accusation in misuse of vivisection. In reply to the letter of the Russian association of animal patronage “On
p.000229: vivisection as shocking and useless misused in the sake of science” of January 17, 1904, the commission
p.000229: consisting of professors P.M. Albitskiy, I.P. Pavlov and N.P. Kravkov was founded in the Medical Military
p.000229: Academy. This commission
p.000229: presented its conclusions on this letter. Conclusions showed disagreements with accusations, the statements of the
p.000229: letter were named anti-scientific and sanctimonious. Nevertheless this case forced to think about humanity of
p.000229: experiments in animals and improvements of conditions of their keeping.
p.000229: At the same time legitimacy of trials with human subjects is under discussion in the society. In connection
p.000229: with achievements in microbiology doctors by way of self-experimenting researched contagiousness of infectious diseases
p.000229: even the highly harmful ones. Self-experimentations carried out by physicians have never been disapproved of; they were
p.000229: rather perceived as acts of heroism and admired. There were a great number of such examples. In 70-s of the XIX century
p.000229: O.O. Motchutkovskiy, a physician from Odessa, several times made self injections with blood samples from patients
p.000229: infected with epidemic typhus and got severely diseased. After injecting themselves with blood samples from patients
p.000229: infected with relapsing fever, G. N. Mikh and N.I. Mechnikov also suffered through severe illnesses. N.F. Gamaleja,
p.000229: N.I. Metchnikov, D.K. Zabolotnyi, M. Pettnkofer took pure culture of cholera vibrio. Such examples can be
p.000229: continued.
p.000229: In relation to experiments with other human subjects many researchers were guided by the respectful opinion of
p.000229: S.P. Botkin (1832-1889): “It is evident that trials with human subjects are permitted only in extraordinary cases
p.000229: when we can be sure of their harmlessness otherwise we resort to experiments with animals, conditions for
p.000229: our observations being significantly simplified”.
p.000229: In early XX century a book by V.V. Veresaev “Doctor’s notes” produced great social aftersound. It can be
p.000229: regarded as social and cultural assessment of many problems in medical ethics which are of concern even today in the
p.000229: rise of the XXI century. It contained sharp criticism towards a common practice of that time to neglect patients’
p.000229: rights and needs including subjects of biomedical research. V.V. Veresaev (1867-1945) provides ample evidence of
p.000229: cruel experiments with human subjects and puts under question the researchers’ reports that these trials were performed
p.000229: with those people’s consent. V.V. Veresaev was courageous to disclose and put under public scrutiny the secrets of
p.000229: medical community. Thoroughly, providing great number of examples he showed the destitute position of an average
p.000229: practicing doctor, his vulnerability. And at the same time he stressed the high requirements that the
p.000229: community imposed over a physician (5, 6).
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p.000230:
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p.000231:
p.000231: V.A. Manassein (1841-1901), a noted general practitioner, editor of “The Doctor” magazine, a person who won a
p.000231: name of a ‘knight of medical ethics’, ‘conscience of medical community’ stressed the necessity for a doctor to
p.000231: comply with medical confidentiality even at the expense of his own benefits. A contrary position was expressed by a
p.000231: denoted lawyer A.F. Kony (1844-1927), who considered that in situations of grave threat needs of the society should
p.000231: prevail over the ban to disclose patients’ secrets. At the same time he advocated the idea of sticking to medical
p.000231: confidentiality after a patient’s death. A.F. Kony also stipulated the conditions which allowed active euthanasia both
p.000231: legally and ethically.
p.000231: In he beginning of the XX century it was acknowledged that relationship of physicians with the community require
p.000231: dramatic revision especially when it comes to correlation of a doctor’s right to perform medical assistance essential
p.000231: for a patient and consent of the latter to have it in terms of observing or violating the principle of physical
p.000231: integrity (“Court newspaper”, 1901, №№ 51, 52) and also about the legal grounds and limits of criminal responsibility
p.000231: for the harm caused to patients health (‘Law”, 1902, №51). The issue to what extent the patient’s consent for medical
p.000231: treatment should be based upon his conscious understanding of the nature of this treatment especially if it is
p.000231: performed not only for the benefit of a patient but out of experimental needs. Prominent law experts A.F. Kony, N.G.
p.000231: Tagantsev, I.G. Sceglovitov, S.N. Tregubov and others come to join this discussion. According to Professor of Criminal
p.000231: Law N.G. Tagantsev “patients consent is incapable of setting impunity to all medical cases”. The fundamental principles
p.000231: of biomedical research in connection with thyroid gland transplantation were described from both legal and ethical
p.000231: sides in 1917 in an article by B.V. Dmitriev, a physician who worked for a machine factory in Kolomna and whose
p.000231: expertise was based on the consultation that the author obtained from A.F. Kony (12). Considering legal aspect of
p.000231: a doctor’s right for transplanting organs and tissues B.V. Dmitriev asked: “Whether a physician is granted
p.000231: any right to cause even minute and fleeting harm to a healthy person for the sake of another human being? Whether he is
p.000231: competent to decide in every particular situation if the benefit for one patient compensates for the harm done to the
p.000231: other, having the widest sense of the words benefit and harm in mind, that means not only in relation to physical
p.000231: health of these individuals but taking into account a complex of spiritual and physical strength of both?”.
p.000231: In response to these concerns Doctor Dmitriev stated the main provisions of implementing a medical
p.000231: research, the most essential of which are providing information and obtaining a conscious consent (of a donor in this
p.000231: case) which fully complies with the modern requirements. The same article provides a text of the first Russian
p.000231: full-scale minutely formulated patient’s informed consent form which retains its actual continuity up to
p.000231: contemporary time.
p.000231: Achievements of academic medicine did not significantly influence public health factors and demographic
p.000231: processes. Mortality and morbidity rates among population were high, infant mortality was common, there were
p.000231: many physically retarded children. Russia was shaken by epidemics of epidemic typhus, cholera, smallpox, malaria, and
p.000231: diphtheria and other. Medical facilities were scattered between different authorities and were mainly financed
p.000231: through beneficent funds.
p.000231: The number of physicians and hospitals was inadequate to provide citizens with medical service. In late XIX –
p.000231: early XX centuries there were 10 hospital beds and 1.8 physicians for every 10000 people in Russia. Medical service was
p.000231: mainly available in large cities. Out of 257 sanitation physicians 135 worked in Moscow and Saint-Petersburg. According
p.000231: to the data of 1913 allocations in health care accounted for 91 kopeks, for sanitation – 1.25 kopeks per
p.000231: year per capita. The major, rural, part of Russian population was almost completely deprived of medical
p.000231: service. In these conditions the position of F.F Erisman and V.V. Veresaev is a notable one, they called for not
p.000231: staying indifferent to the reasons inducing such situation, not to “powerlessly grumble about the unfair destiny”, but
p.000231: to consider it a moral duty to “take all possible steps to prevent such undue events from happening”
p.000231: Development of country medicine was a great event, the establishing of which was tightly connected with the community
p.000231: mode of life characteristic of Russian people and with the so-called country self-administration introduced in
p.000231: the 60-s of the XIX century. Subsequently, country medicine widely implemented in 34 provinces in European part of
p.000231: Russia (in 1911 6 more were added) appeared at that time most reasonable form of medical service for rural population
p.000231: and was unique to our country.
p.000231: The most important achievement of country medicine, which was far ahead of its time, was a declared and practically
p.000231: implemented combination of medical and sanitary activities. In the frameworks of country medicine
p.000231:
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p.000232:
p.000233: 233
p.000233:
p.000233: the approach of providing local service for rural population was introduced, the approach that made its way
p.000233: successfully through time and up to now is applied in health care systems of many countries. It was the country doctors
p.000233: who came up with the idea of sanitary and preventive activities as priority in health care. Up to the present day in
p.000233: rural health care the stage-by-stage approach is applied in medical service provision. Great impact was made in the
p.000233: development of medical statistics and expanding medical geography. Moreover, country doctors strived for introduction
p.000233: of free medical service not only out of general humanistic ideas but also because of understanding that even a smallest
p.000233: charge for medical advice, medication, and in-hospital treatment decreased seeking for medical help. And this
p.000233: deprived country physicians, in particular, of an opportunity to detect contagious cases in due time and efficiently
p.000233: combat epidemics, which meant undermining social and sanitary significance of country medicine as such.
p.000233: The key features of country medicine were determined by country physicians who were greatly influenced by
p.000233: ideas of democracy, had deep community links with peasants, and considered it to be their duty to protect the peasants’
p.000233: interests. That is why one can say that the period went a long way with reinforcement of pattern like approach in
p.000233: Russian medicine.
p.000233: Many of the practicing country doctors were active both medically and socially and grew into eminent
p.000233: representatives of public medicine (E.A Osipov, I.I. Molleson, P.I. Kurkin, F.F. Erisman and others). The main
p.000233: treasure of country medicine were medical doctors, whose itinerant activities were described by such remarkable
p.000233: Russian writers and physicians, who themselves received first-hand experience of country medicine, as A.P.
p.000233: Tchekhov, V.V. Veresaev, M.A. Bulgakov.
p.000233: “Country medicine with its relative freedom and opportunity to study, educate, and serve people
p.000233: attracted good number of conscientious, ideologically aware colleagues, - noted country doctor S. Igumnov during the
p.000233: 11th Pirogov conference - neglecting personal comfort, abandoning attractive and profitable careers, went
p.000233: into country medicine, moved to remote rural areas, dark and cold shanties; some doctors hired themselves as
p.000233: medical assistants, worked for salaries of medical assistants; some shared one job and salary; sometimes refused part
p.000233: of the salary for the sake of building a hospital or organizing a new health locality; perceived country medicine not
p.000233: as employment but rather as a moral duty”. However, Igumnov mentioned:
p.000233: “I am far from idealizing that time and certainly far from thinking that all physicians of those times were
p.000233: ideologically aware and inspired by ideas of populism. Those were a minority and even a tiny minority, but it was that
p.000233: minority that coined country medicine”.
p.000233: Russian physicians more than once informed the international community about achievements of country medicine and it
p.000233: obtained due reputation and recognition overseas. Thus in 1934 the League of Nations Committee for Hygiene advised
p.000233: other nations to adopt the practice of country medicine in order to provide rural population with due medical service.
p.000233: It was confirmed in 1952 in the World Health Organization Assembly guidelines on country medicine development.
p.000233: Importance of organizing medical service by health localities, the approach introduced alongside with country medicine,
p.000233: was well demonstrated at the WHO conference on primary medical and sanitary care issues in Alma-Ata in 1978.
p.000233: It is important stress the role of country medicine in public health care system setup after October 1917. Almost all
p.000233: of its main trends – such as free service and accessibility, preventive trend, involving the community, the citizens
p.000233: themselves into health care, integrity of academic and practical medicine – became determining aspects of the Soviet
p.000233: health care.
p.000233: After the revolution of 1917 medical ethics in the USSR underwent it way of development and was influenced by a range
p.000233: of factors.
p.000233: Medicine started to be perceived from a position of class, individualistic bourgeois medicine being matched against
p.000233: collectivist and proletarian, which led to neglecting a personal value of a human being and it absolute humility to
p.000233: social use. In terms of ethics and morality key significance also belonged to class approach. It was promoted that
p.000233: medical ethics represented corporate and class ideology alien to the working class needs. In contrast to medical ethics
p.000233: common ethical norms of communist morality were pushed forward. These conditions altered social perception of a medical
p.000233: doctor. In the early years of the Soviet regime a physician was seen as representing hostile bourgeois class and
p.000233: should have been tolerated as a specialist but was allowed to practice only under rigid supervision of
p.000233: the working class. Subsequently, physicians suffered political and ideological pressure. Unfortunately, repressions
p.000233: against medical professionals were started time and again and they were accused of poisoning and killing both
p.000233: common citizens and party and state leaders. Priority trends in medicine and health
p.000233:
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p.000234:
p.000235: 235
p.000235:
p.000235: care were determined not by logical development of science and essential needs but were rather dictated by economic
p.000235: policy, ideology and conformist ideas.
p.000235: Repressive measures taken against genetics, pedology; campaigns restricting research in physiology, psychology
p.000235: and other areas that impeded and even set back many promising academic and applied directions of science can
p.000235: serve us a good example.
p.000235: There was a target to stipulate ideology for a physician of a new type. The contrast in moral portrait of doctors in
p.000235: capitalist and socialist societies is rendered in the lines by first People’s Commissar for health care N.A. Semashko:
p.000235: “Certainly among foreign physicians there are doctors who perceive there duties the way their humane profession
p.000235: suggests them. But is it a rule and what is an exception? This would depend on the ground where these phenomena bud.
p.000235: Capitalistic ground is rocky and not suited to growing humanistic ideas. If in a capitalistic society “dog eats dogs”,
p.000235: how can we speak of any humanistic feelings? All this finds its way into a physician’s behavior… It is clear that the
p.000235: problems of the so called medical ethics are solved completely differently in our country and in the
p.000235: capitalist world. Ethics for a soviet physician means the ethics of our socialist Motherland, the ethics appropriate
p.000235: for a creator of communism; it is communist morality which is above class distinctions. That is why we see the concept
p.000235: of medical ethics and high ethical standards of a Soviet Union citizen as integral”.
p.000235: Many achievements of ideas in medical ethics were declared left-overs of capitalistic approach to medicine and
p.000235: should have been dumped to a landfill of history. In this respect a bringing under discussion an issue of medical
p.000235: confidentiality is natural and N. A. Semashko claimed “firm course towards eradicating medical secrecy”, although in
p.000235: the years to follow he came back to classical understanding of this problem.
p.000235: Ambiguous attitude of governmental bodies to medical ethics brought to life medical deontology (28). A prominent
p.000235: surgeon in oncology N.N. Petrov in 1944 came to publish his work “Issues of Surgical Deontology” which was reedited
p.000235: several times. It saw into many problems of doctor patient relationship like providing information and
p.000235: obtaining an informed consent form, which are first and foremost principles today. Deontology provided an opportunity
p.000235: to sustain public attention to staple points of humanism in medical practice.
p.000235: In the 60-70’s the interest towards medical deontology grew. Five All- Soviet Union conferences were devoted to the
p.000235: issues of medical deontology, first of which took place in Moscow on January, 28-29 in 1969. One could then observe a
p.000235: singular outburst of publications on aspects of deontology in different fields. A two volume manual “Deontology
p.000235: in Medicine”, published in 1988 and edited by academician B.V. Petrovskiy exercised great influence.
p.000235: Management and funding in medicine and health care in the Soviet years were of centralized character and were
p.000235: characterized by well developed intrabranch links, which were mainly supported by administrative and
p.000235: bureaucratic type of management and planning gaining a narrow corporate nature and becoming almost unavailable to
p.000235: public control. A medical doctor became a civil servant, whose activities were regulated by great number of
p.000235: departmental guidelines and to a large scale were limited to drawing reports.
p.000235: Nevertheless, within relatively short time period based on virtually efficient grounds and principles of
p.000235: public health care system a coherent framework of medical, preventive treatment and epidemiological services was
p.000235: organized. Assessment of health care system developments was done primarily quantitatively, but qualitative data
p.000235: within this field showed impressive success. Many infectious fevers were eradicated, infant mortality drastically
p.000235: dropped, average life expectancy increased. Effectiveness of primary medical was distinguished by the
p.000235: medical community in 1978 during the WHO and UNICEF international conference in Alma-Ata (Kazakhstan).
p.000235: Many achievements in medicine and health care were made due to enthusiasm and responsible attitude of medical
p.000235: professionals, retaining ideas of self-denying and generosity in medical community, pursuit of classical ideas of
p.000235: medical ethics.
p.000235: Gradually in the 70-80’s in the society there started to occur shortcomings underpinned by lack of
p.000235: attention that the government paid to social spheres including health care, insufficient budget allocation that led to
p.000235: decline in provision of up-to-date technical equipment and medications, failure to comply with capital construction
p.000235: projects and health care facilities reconstruction plans, low and leveling salaries for medical staff, lack
p.000235: of opportunities to immediately apply recent developments of medical science,
p.000235:
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p.000236:
p.000237: 237
p.000237:
p.000237: low availability of quality medical service and other. There were indicated adverse trends in public health, in medical
p.000237: and demographic values: drop in birth rate, growth in mortality rate, decrease of mean life expectancy.
p.000237: Retaining an essential principle of free medical care health care system found itself unable to meet the
p.000237: citizens’ needs in provision of high quality of service. Various forms of financing medical service started to be
p.000237: implemented. Apart from that the declared idea of free service brought up consumptive attitude to medicine among
p.000237: citizens, lowered public responsibility for their health issues, deteriorated medical activity of citizens. There was
p.000237: indicated a multilevel approach in medical service provision for different groups of patients. With the growing
p.000237: differentiation and narrow fields of medical activity and no relevant integration processes there occurred
p.000237: “fragmentation” of medical responsibility, weakening of the inner moral control mechanisms, perception of a patient
p.000237: as one whole was lost. In these conditions the controversy between the declared moral principles of medical
p.000237: service and the way they were put into practice became outstanding. Staples of medical ethics alongside with legal
p.000237: standards became increasingly irrelevant to real life social practices. In medicine moral strain became ever
p.000237: increasing; such vital principles as humane and respectful attitude to a patient, medical confidentiality were
p.000237: violated. Increasing intensity of flaws in the field of ethics resulted in decline in medical doctors’ prestige
p.000237: and influence in society, aroused disaffection with their work among doctors, affected the moral climate in the
p.000237: society in general (10).
p.000237: All these issues developed alongside with lack of regulatory framework in the environment of legal and ethical
p.000237: unpreparedness of the citizens to work in new economic situation on the one hand and the growing application of new
p.000237: medical technology on the other.
p.000237: Political, economic and social reforms in the XX century 90’s badly affected all areas of social and spiritual life of
p.000237: people. Unfortunately they were not scientifically proved and never underwent ethical evaluation. The following
p.000237: years demonstrated that immoral economy does not prove effective. But above all – drastic large scale changes
p.000237: in the country significantly influenced the state of mind and mentality of the general public suffering
p.000237: through the pressure of social changes. Because of being psychologically unprepared for the current events, for the
p.000237: suddenly acquired freedom both individuals and certain social groups showed deadaptation
p.000237: which was demonstrated through manifested sense of social destitution and injustice, extraneity to novel social norms,
p.000237: culture and values, awareness of helplessness and alienation (2). The results of the social surveys
p.000237: demonstrated “collapse’ of such traits, traditionally characteristic of the Russians, as friendliness, warm
p.000237: heartedness, sincerity, self-forgetfulness” alongside with the evidently growing manifests of aggressiveness
p.000237: and cynicism (23). All this drastically affected medicine and health care, the medical community and the
p.000237: eventual patients. Availability of not only technology intensive methods of diagnostics and treatment but also
p.000237: common routine manipulations, vitally essential medications dramatically dropped. A far more important role in the
p.000237: market economy environment now belonged to private commercial firms, companies and foundations, which
p.000237: implemented research of new medications and promoted them in the pharmaceutical market as part of their
p.000237: business activity, often being driven by the idea of profit and seeing pragmatic solution to problems at the expense
p.000237: of ethics and morality as priority.
p.000237: Changes in the social and political life of Russia, setback from principles of socialism made creating health care
p.000237: model in the new environment a burning issue. And the most complicated task was to work out new
p.000237: approaches at the same time retaining the entire positive that with no doubt the previous experience of health
p.000237: care development in Russia contained. In this respect the most critical issues are those related to fair
p.000237: distribution of limited resources in health care, determining priorities of allocation, organizing supervision
p.000237: of these processes.
p.000237: It became evident in early 90’s that without ethical framework integrating into the world community would not be
p.000237: possible. Publications on issues of bioethics started to occur (I. Frolov, B. Judin, P. Tistchenko, I. Silujanova,
p.000237: N. Sedova, E. Mikhailovska-Karlova, V. Orlov, V. Vlasov, A. Ivanjushkin,
p.000237: A. Zilber, R. Korotkikh, M. Jarovinskiy and others) Great impact was made by the Human magazine (editor in chief B.
p.000237: Judin).
p.000237: The 90’s in Russia saw the set up of infrastructure in bioethics, 5 Central Committees on Bioethics
p.000237: were organized. First in 1993 there was established the Russian Academy of Science National Committee on
p.000237: Bioethics. It was followed by the Committee of Presidium of Russian Academy of Medical Science, Committee of Russian
p.000237: Medical Association (RMA), Committee of Medical Doctors’ Association, and Committee of the
p.000237:
p.000238: 238
p.000238:
p.000239: 239
p.000239:
p.000239: Russian Federation Public Health Ministry. After the RF Act On Medical Agents and in compliance with article 37 of this
p.000239: act there was established the Ethical Committee of Federal Agency for Control over Medical Agents (prior to that
p.000239: ethical evaluation of clinical research protocols was carried out by the Special Board of RMA National
p.000239: Committee). In the same 2000 year a spearhead of health care professionals set up the Independent Multidisciplinary
p.000239: Committee on Ethical Evaluation of Clinical Research which was aimed at answering various requests and appeals on
p.000239: voluntary basis. Local and regional ethical committees are set up with lower activity but their number gradually grows
p.000239: (22).
p.000239: The current stage is characterized by booming information and communication technology, rapid
p.000239: development of market economy, drastic changes in demography, persistent urbanization process, and trends towards
p.000239: development of open society. Signs of two controversial tendencies: globalization on the one hand and on
p.000239: the other – increased attention of people to their national and cultural traditions.
p.000239: After seventy years of atheism as state ideology and withdrawal from those ideas and values that the society was
p.000239: governed by, the caused moral vacuum in Russia failed to be compensated with a more or less integral
p.000239: framework of secular ideas and values clear and conventional to people and capable of appealing to people and give them
p.000239: hope. A distinguishing feature of the Russian society is that conventional factors invariably play significant role in
p.000239: many walks of social life, adherence to traditional ideological and social values which saw little influence
p.000239: of the changing social and economic systems, political regimes as well as fresh social and ideological paradigms for
p.000239: development declared in the recent decades of the XX century. Under any state system – monarchical or collective type,
p.000239: totalitarian or liberal – an impact of a number of constants which determine a civilization portrait of Russia is
p.000239: feasibly evident. Among them a crucial role belongs to religion, first and foremost the Orthodox Christian Church which
p.000239: by masses of population is perceived not only as an institution with the main function of not just disseminating the
p.000239: ideas of Christianity but mostly as preserver of the Russian national values and traditions (by different social
p.000239: studies three fourths of believers who are almost half of the population in Russia are Orthodox Christians). The same
p.000239: can be said about the Islam – second confession in Russia in terms of adherents’ number and influence (about 19% among
p.000239: believers) (20).
p.000239: Today religious organizations prove active in most different fields: religion itself, education, health care,
p.000239: culture, charity and mercy, business and economic. Changes occurring in the society and the Church demanded for a
p.000239: comprehensive philosophy that would reflect general attitude of the Church to issues of state and the Church
p.000239: relations and concerns of the modern society on the whole.
p.000239: At the Anniversary Episcopal Assembly in 2000 the Basic Social Conception of Russian Orthodox Church was
p.000239: adopted. The conception falls into 16 sections covering most various issues related to life of a Christian believer in
p.000239: secular world. In section 11 – “Public and Individual Health” – the attitude of Orthodox Church to disease and health
p.000239: is rendered, importance of church activities in health care is stressed, necessity of society and church cooperation in
p.000239: public health care issues is emphasized. It covers such vital from religious viewpoint principles as doctor and patient
p.000239: relationship which should be based with respect to integrity, free choice and “personal dignity”. In particular it
p.000239: stresses: “We should by all means encourage a dialogue between a doctor and a patient that is
p.000239: characteristic of current medical approach. This approach is undoubtedly engrained in the Christian tradition,
p.000239: although there is a temptation to relegate it to a level of merely agreement relationship. At the same time one should
p.000239: admit that a more conventional “pattern like” model of physician and patient relationship which is fairly criticized
p.000239: for numerous attempts to justify medical power abuse may as well represent a truly fatherly attitude to patient that
p.000239: depend on doctor’s morality. Not giving preference to any of the health care organization models the Church
p.000239: considers that this service should work efficiently at its maximum and must be available to all members of society
p.000239: disregarding their financial and socialXstatus even with limited medical resources distributed. For such distribution
p.000239: to be fair the aspect of “vital requirements” should prevail over the aspect of “market relations”. The doctor should
p.000239: not see the degree of their responsibility for medical service in relation with financial reward and its amount only by
p.000239: this turning his profession into pure profit making. At the same time decent payment for medical professionals is seen
p.000239: as an essential task for the society and the state (26).
p.000239: Section 12 “Bioethical Issues” shows the official position of RCOC
p.000239: on a range of aspects which currently are concerning in the society and are brought about by blooming development of
p.000239: biomedical technology in late the
p.000239:
p.000240: 240
p.000240:
p.000241: 241
p.000241:
p.000241: XX century. These completely new challenges are once again comprehended and reinterpreted in the context of ideas of
p.000241: human life and personal dignity which are entrenched in the “Divine afflation”. It shows attitude of the
p.000241: Church to abortion, new reproductive methods, medical genetic methods of diagnostics, tissue and organ
p.000241: transplantation, reanimation and help to the parting, sexual issues. Moreover some sections of the social
p.000241: conception are devoted to the questions of marriage and family, psychological health, problems of drug and alcohol
p.000241: addiction, health care and the ecological environment (7).
p.000241: The current trend is towards younger age among religious groups of society. A study by VCIOM showed that 58% of young
p.000241: Russian citizens under the age of 25 refer to themselves as Orthodox Christians, a similar trend can be observed among
p.000241: adherents of the Islam.
p.000241: It should be particularly stressed that among young believers patriotic, pro-governmental ideas, believe that there is
p.000241: a necessity to restore the decent position of Russia in the world community, strive for order, strong power, collective
p.000241: like, collegial philosophies, support of the current government and antagonism to liberal western ideas
p.000241: prevail. A common trend among all young interviewees, disregarding distinctions in their philosophic and
p.000241: religious ideas, towards moral and spiritual values is demonstrated, for instance, the way they reacted to the
p.000241: concept of ‘morality’ (positive 87.9% among believers and 81.8% among non-believers, negative 12.1% and 18.2%
p.000241: respectively), ‘justice’(positive 96.6% and 94.3%, negative 3.4%
p.000241: and 5.7%), ‘faith’ (positive 97.1% and 85.9%, negative 2.9% and 14.1%),
p.000241: ‘prayer’ (positive 92.3% and 56.3%, negative 7.7% and 43.8%). A particular part of young believers and
p.000241: non-believers advocates the idea of paternal mode of relations, sticks to the idea of conventional patriarchal
p.000241: views in family pattern, supporting filial piety within the family, male dominance in family relations (believers 28%,
p.000241: non-believers 21.9%).
p.000241: For the Russian medicine and health care a paternal model of doctor and patient relations is a typical one. Genesis of
p.000241: these relations can not be seen apart either from economic and cultural development of Russia on the whole or from the
p.000241: ethical staples of medical activity in Russia. Orthodox theological ideas and Russian religious philosophy to a
p.000241: significant extent reinforced the paternal model of doctor and patient relations, promoting ideas of humbling,
p.000241: non-resistance, and respect to universal hierarchy.
p.000241: Developments in medical science and biotechnology increased the power and responsibility of a medical doctor in
p.000241: terms of understanding what life and death and use harm mean. A simultaneous turn of mind in social ideas and mentality
p.000241: of people brought about by a wide spread liberal ideas gave a great impetus to new attitudes based on ideas of personal
p.000241: rights and freedom. All this entailed a necessity to seek for such grounds in doctor and patient
p.000241: communication as recognizing patients’ autonomy, their right for identity and decision making. Process of shifting
p.000241: towards non-paternal model in our country is not a smooth one.
p.000241: One can judge about the steadiness of paternal model by numerous interviews among doctors and patients
p.000241: carried out in recent years. The results of medical and social study in the St-Petersburg Pediatric Academy in 2002-
p.000241: 2004, viewpoints of doctors and citizens on the staple issues of medical ethics (bioethics) depending on
p.000241: their status revealed that currently only few doctors as well as their patients are prepared to apply an
p.000241: antipaternal relationship model in practice (17, 18). Big number of doctors sticks to paternal positions
p.000241: in communication with patients. This situation is also seen as psychologically favorable by many patients who
p.000241: lack desire to take decisions for their own health issues either partly or completely, they are happy to shift this
p.000241: responsibility to doctors.
p.000241: The study reveals that attitude of many doctors and patients to current biotechnology is not yet coined; there is no
p.000241: solid ethical basis. Opinions of church-going interviewees differs drastically from that of non-believers’ and to
p.000241: greater extent meets the provisions of religious and medical ethics. At the same time among church-going doctors great
p.000241: number of interviewees proved not prepared to solving current ethical tasks and either refused to answer questions of
p.000241: the interview or found them too challenging.
p.000241: Russia has not yet determined the answer to the question of referring itself to a civilization – Western or Eastern. In
p.000241: the early 1990’s the strategy was linked to the opportunity for Russia to be integrated into the Western community, and
p.000241: it was first of all seen through attitude to values and interests. Integrity of values in Russia and in the West is
p.000241: retained today in recognition of such values as freedom, justice, material well-being and other. However, our country
p.000241: yet has not seen them implemented fully. Establishing value system in the field of medicine which represent perhaps the
p.000241: most conventional block in the general system of values is still under way. In the mentality of citizens of
p.000241:
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p.000242:
p.000243: 243
p.000243:
p.000243: Russia the principles of identity typical of the West are still underdeveloped. The basis of human rights theory is yet
p.000243: being established. Majority of Russian citizens as social studies show, reject the imposed ‘alien’
p.000243: communication schemes, for instance, the Western view over various issues of personal and social life not out of
p.000243: reasonable arguments or some ideological efforts but out of their inconsistency with customary ideas and values.
p.000243: This gives grounds for discussion and implementation of the bioethical staple principles and provisions in
p.000243: countries with various ethnic, culture and religious traditions, creates challenges because of peculiarities
p.000243: and inconsistencies between the Russian and western ethical systems in health care and medicine. In this respect it is
p.000243: reasonable to draw guidelines and interpret specific regulations and acts and their provisions taking into
p.000243: account two main aspects: culture and ethnical traditions of given states and their compliance with the common norms of
p.000243: international laws in the field of bioethics.
p.000243:
p.000243: References
p.000243: 1. Berdiaev N.A. Destiny of Russia: Selected Works. M., Kharkov: EKSMO Press Folio, 1998, 736 p. (herein and
p.000243: hereinafter in Russian)
p.000243: 2. Dmitrieva T.B., Polozgiy B.S. Psychological Health of Russian
p.000243: Citizens. Human, 2002, №6, p. 21-31.
p.000243: 3. Zamalaev. А.F. Lectures on history of Russian philosophy: XI –
p.000243: early XX cc. StP., 1994.
p.000243: 4. Zenkovskiy V.V. History of Russian philosophy. L., Eko, 1991, p. I,
p.000243: p. II, p. b.
p.000243: 5. Ivanjushkin A.J. Medical ethics in Russia (XIX - early XX cc.). In
p.000243: bk.: Bioethics: principles, regulations, problems. М., 1998, p. 93–110.
p.000243: 6. Ivanjushkin A.J. History of medical ethics and biomedical experiments in human and animal parties.
p.000243: In bk.: Introduction to bioethics. М., 1998, p. 95-133.
p.000243: 7. Cirill, metropolite. On «Basic social conception of Russian Orthodox Church». Anniversary Episcopal Assembly RCOC.
p.000243: StPb, 2000, p. 133-149.
p.000243: 8. Klementovskiy А.I. On application of Libikhov meat extract (broth) for a child at the breast. Moscow medical
p.000243: newspaper, 1859, №34, p. 269- 272; №35, p. 278-280; №36, p. 285-287.
p.000243: 9. Kljutchevskiy V.О. Selected Works. М., 1987, v.1, p.1, p. 78-79.
p.000243: 10. Korotkikh R.V. Legal and ethical issues of health care in Russia in period of reforms. In bk.: Biomedical
p.000243: ethics (edited by. V.I.Pokrovskiy). М., 1997, p. 47-58.
p.000243: 11. Koshtojantz Kh.S. Study on history of physiology in Russia.
p.000243: М., 1946, p. 111.
p.000243: 12. Kubar О.I. Ethical and legal issues of research in human parties: in history of Russia XX century. Human, 2001, №3.
p.000243: 13. Levit М.М. Establishing public medicine in Russia. М.: 1974,
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p.000243: 14. Likhatchev D.S. Russian culture. М.: Art, 2000, 438 p.
p.000243: 15. Ljubargskiy G.J. Human, 2004, №3, p. 186.
p.000243: 16. Maksimov Е.D. Study of historical development and current situation in public charity in Russia.
p.000243: In bk.: Public and personal care in Russia. StP, 1907, p. 4.
p.000243: 17. Mikirtitchan G.L., Filimonov S.V. Opinion of doctors and patients on problems of information and obtaining informed
p.000243: consent form. In bk.: Actual problems of diagnostics, treatment and disease prevention, issue. 3. StP, 2004, p.
p.000243: 291-302.
p.000243: 18. Mikirtitchan G.L., Filimonov S.V. Results of social study attitudes among doctors and patients to some
p.000243: genetic methods. International conference of CIS countries Forum for Ethics Committee. Yerevan, 2005, p. 52-56.
p.000243: 19. Mirskiy М.B. Medicine in Russia XVI - XIX cc. М., 1996, p.
p.000243: 301- 309.
p.000243: 20. Mtchedlov М.P. Are young citizens of Russia religious? Human, 2005, №6, p. 111-118.
p.000243: 21. Nikolay Ivanovitch Pirogov and his heritage. Pirogov’s conferences.
p.000243: B/м. B/g. 253 p.
p.000243: 22. Petrov V., Sedova N. Bioethics in practice. М., 2002, p. 60-89.
p.000243: 23. Petukhov V.V. The proper and the real in moral mentality of Russian
p.000243: citizens. Human, 2006, №3, p. 148-149.
p.000243: 24. Pirogov N.I. Selected works. М., v.2, p. 286.
p.000243: 25. Savina E.А., Degtjarenko L.J. Life psychology in Russian sayings and proverbs. Human, 2001, №5, p.186-192.
p.000243: 26. Anniversary Episcopal Assembly RCOC August, 13-16, 2000.
p.000243: Digest of abstracts and documents. Chapters Х-ХII. SPb, 2000, p. 192-200.
p.000243:
p.000244: 244
p.000244:
p.000245: 245
p.000245:
p.000245: 27. Judin B.G. National specific of establishing bioethics in Russia. In
p.000245: bk.: Philosophy of biomedical research. М., 2004, p. 71-90.
p.000245: 28. Jarovinskiy М.J. Lectures on medical ethics (bioethics). М., 2004,
p.000245: 528 p.
p.000245:
p.000245: 3.8.2 Legal Regulations
p.000245:
p.000245: The ethical review of biomedical research involving human subjects is the important component in rights, interests and
p.000245: dignity of human subjects and in the same time is the necessary condition for further development of medical science
p.000245: and technology.
p.000245: The basis for legal regulation of biomedical research and its ethical evaluation is laid by a complex of
p.000245: international acts both of legal and ethical character.
p.000245: First of all we could mention Nuremberg Code (1947), the Declaration of Helsinki (1964, with all further
p.000245: revisions) – the documents which in many points determined the Russian policy on regulation of biomedicine and
p.000245: healthcare sphere22.
p.000245: The serious stimulus for Russian domestic legislative activity and for biomedical practice is also produced by other
p.000245: documents of recommending character, which are devoted to general and specific questions of biomedical research. Here
p.000245: are some examples of such documents: International Ethical Guidelines for Biomedical Research Involving Human
p.000245: Subjects (1982, 1993, 2002), International Guidelines for Ethical Review of Epidemiological Studies (CIOMS, 1991), ICH
p.000245: GCP (1996), Operational Guidelines for Ethics Committees that Review Biomedical Research (2000) and others23.
p.000245:
p.000245: 22 “Nurnberg code” (The sentence of Nurnberg Tribunal)//Medical doctor.1993. N7, Helsinki Declaration (WMA)
p.000245: 1964//Collection of official documents of Association of medical doctors of Russia: medical associations,
p.000245: medical ethics and general medical problems/Ed. V.Uranov. M.:PAIMS.1995.
p.000245: 23 International Ethical Guidelines for Biomedical Research Involving Human Subjects (1982, 1993,
p.000245: 2002)//World Health Organization, Geneva, 1993, International Guidelines for Ethical Review of Epidemiological Studies
p.000245: (CIOMS, 1991)///CIOMS- Geneva. – 1993, ICH Harmonized Tripartite Guideline for GCP
p.000245: //http://www.ich.org/LOB/media/MEDIA482.pdf, Operational guidelines for ethics committees that review biomedical
...
p.000247: biomedical research the patient should be informed about goals, methods, side effects, possible risk, duration and
p.000247: expected results of the investigation.
p.000247:
p.000247: 28 Constitution of the Russian Federation, St-Pb, 1995.
p.000247: 29 Fundamental principals of Legislation of Russian Federation Concerning Public Healthcare?
p.000247: on 22 of July 1993// Rossiyskaya Gaseta, August 18, 1993. № 158.
p.000247: The given Article sets rather strict limitations on research involving minors (under 15 – in general
p.000247: cases, and under 16 in the case of drug addicts). In this case, the methods of disease prevention, diagnostics
p.000247: and treatment, as well as pharmaceuticals that are not officially permitted but are under consideration may only be
p.000247: applied for the treatment of minors if there is a direct threat to their life and with a written consent
p.000247: of their legal representatives. Here we should mention the Act “On Applying Pharmaceutical Products according
p.000247: to the Necessities of life” adopted by the Order of Ministry of Health and Social Development (09.08.2005, No. 494).30
p.000247: This Act regulates issues relating to the individual case of application, according to the necessities of life, of a
p.000247: pharmaceutical product that is not registered in Russian Federation. This is a matter of non-interventional
p.000247: research. The decision about the use of a pharmaceutical product in this case is made via the Federal
p.000247: specialized medical commission; the protocol is documented and signed by the medical director of the director of the
p.000247: Federal specialized medical commission. This document emphasizes again the need to seek the patient’s voluntary written
p.000247: consent (in cases provided by law the consent from the patient’s legal representatives) to apply an
p.000247: unregistered pharmaceutical product. The physician should inform the patient about the pharmaceutical product, its
p.000247: expected benefit, safety and the degree of risk. The physician should also explain measures that will be taken in the
p.000247: case of unexpected effect of the pharmaceutical product on the patient’s health.
p.000247: The Article 29 of the Fundamental principles of Legislation also imposes the ban on biomedical trials involving persons
p.000247: under any form of detention or imprisonment.
p.000247: The strict character of legal norms relating to biomedical trials involving two categories of vulnerable subjects –
p.000247: minors and persons under detention or imprisonment – from the one hand is the sign of the law-maker’s intention to
p.000247: prevent the possibility of abuse of depending persons, from the other hand
p.000247: - it actually means the limitation of rights of mentioned persons to access to new medicines, diagnostic and
p.000247: prophylactic methods.
p.000247: At the same time it is to be taken into account that the Federal aw of the Russian Federation ”On Pharmaceutical
p.000247: Products” on 22 of June 1998
p.000247: 30 Order “On Applying Pharmaceutical Products according to the Necessities of life” adopted by the Order of Ministry
p.000247: of Health and Social Development (09.08.2005, No. 494) //Bulletin of normative acts of Federal Executive Authorities.
p.000247: No 36, 05.09.2005.
p.000247:
p.000248: 248
p.000248:
p.000249: 249
p.000249:
p.000249: N86-FZ fixes another approach towards some vulnerable contingents31. This document takes the central place in
p.000249: legal regulation of preclinical and clinical study of pharmaceutical products.
p.000249: The issues concerning rights of patients participating in clinical trials are touched on by the Article 40 of the
p.000249: mentioned law. The general rules of obtaining the informed consent for participating in research constituted by this
p.000249: article correspond in a whole with the discussed provisions of the Fundamental principles of Legislation. The
p.000249: noteworthy point is the more detailed description of information which should be given to subject, namely: 1)
p.000249: information on pharmaceutical products and nature of clinical trials of this drugs; 2) information on anticipated
p.000249: efficiency, the drug safety, and the degree of risks for the patient; 3) information on measures in the case of
p.000249: unforeseeable effects of pharmaceutical product on his health;
p.000249: 4) information on the terms of patient’s health insurance.
p.000249: The provision of the Law concerning the necessity of health insurance as well as insurance of civil liability of
p.000249: persons who carry out the study (items 3, 9 of the article 40, items 2 of the article 38) ensures an important
p.000249: additional guarantee of protection of subjects’ interests.
p.000249: At the same time, we cannot but mention an excessively “soft” approach to the question of terminating a clinical trial
p.000249: in the case of events that may be hazardous to the patient’s health. The Law states only that clinical trials may be
p.000249: terminated, while it should state that clinical trials must be terminated.
p.000249: Aiming at safeguarding the rights and interests of vulnerable contingents the Law forbids or
p.000249: limits their participation in clinical trials of medicines. Particularly clinical trials involving minors who
p.000249: don’t have parents, soldiers, persons under any form of detention or imprisonment is absolutely forbidden. The Law also
p.000249: sets up the limitation for the cases of clinical studies involving minors who have parents – such studies may be
p.000249: conducted only if pharmaceutical product is proposed for treatment of child diseases or if the aim of clinical trial is
p.000249: the getting the information about the best dosing of drug for therapy of minors. In latter situation the clinical trial
p.000249: may only be carried out after clinical investigation on adults.
p.000249: Pregnant women represent another category of vulnerable contingents who can participate in clinical studies of
p.000249: drugs in clearly named cases.
p.000249:
p.000249: 31 Federal Law of the RF “On Pharmaceutical Products” of 22.06.1998// Rossiyskaya Gaseta, N 118, 25.06.1998
p.000249: The general rule which prohibits recruiting this contingent to participate in clinical trials has one exclusion under
p.000249: three following conditions: the drug which is studied is proposed for pregnant women; the necessary data can be only
p.000249: obtained in the clinical trials on pregnant women; the risk of harm to pregnant woman and to a fetus is completely
p.000249: excluded. Although the last situation looks improbable nevertheless this provision allows us to assume the indirect
p.000249: legislative protection of fetuses “in uterus”.
p.000249: Notable feature of the Law is that it covers the issue of clinical studies involving patients with mental diseases and
p.000249: recognized as legally incapable persons. The Law addresses us to another Federal law of the Russian
p.000249: Federation “On Psychiatric Assistance and Related Guarantees of Citizens” and also remarks that such trials may be
p.000249: carried out only after obtaining the written consent of legal guardians of these persons32.
p.000249: The latter Law states that all persons with mental disorders have to right for the preliminary consent or to refusal at
p.000249: any time to be used as a subject of trials of drugs and medical methods, scientific investigations or study
p.000249: process, video or photo or film shooting (item 2 of the article 2).
p.000249: Besides the Article 11 of this Law clarifies that the clinical trials involving persons under compulsory
p.000249: medical treatment or involuntarily hospitalized persons are absolutely prohibited.
p.000249: Such a key element of the ethical review as confidentiality of the information about patient and
p.000249: received from the patient throughout biomedical research is guarantied by means of the institute of medical
p.000249: secrecy stipulated by the Fundamental principles of Legislation and by the institute of personal and family secrecy
p.000249: (privacy) provided by the Constitution of the Russian Federation (the Article 23). It is also necessary to take into
p.000249: account the general norms guarantying the protection of personal data which are fixed by the Federal Law
p.000249: of the Russian Federation “On information, information technologies and protection of information” of 27 July
p.000249: 2006 and by the Federal Law of the Russian Federation “On personal data” of 27 July 200633.
p.000249: 32 Federal Law of Russian Federation “On psychiatric assistance and related guarantees of citizens” N 3185-1 of July
p.000249: 2, 1992 // Vedomosty of CND and VS RF, 20 of August 1992.
p.000249: № 33, article 1913.
p.000249: 33 Federal Law of Russian Federation “On information, information technologies and protection of
p.000249: information” of July, 27 2006, Federal Law of Russian Federation “On personal data” on 27 of July 2006// Rossiyskaya
p.000249: Gaseta, N 165, 29.07.2006
p.000249:
p.000250: 250
p.000250:
p.000251: 251
p.000251:
p.000251: The legal rules on specifics of the institutes of informed consent and medical secrecy in some particular situations as
p.000251: well as norms concerning guaranties of the other rights of patients/subjects were also reflected in the following acts:
p.000251: the Federal Law of the Russian Federation “On transplantation of human organ and tissues” on 22 of December 1992, N
p.000251: 4180-1, the Federal Law of the Russian Federation “On blood donation” on 9 of June 1993, N 5142-1, the
p.000251: Federal Law of the Russian Federation “On prevention of dissemination of the disease caused by HIV” on 30 of March
p.000251: 1995, N 38- FZ, the Federal Law of the Russian Federation “On immune prophylactics of infection diseases” on 17 of
p.000251: September 1998, N 157- FZ34.
p.000251: The norms related to some organizational, administrative and financial aspects of biomedical research have also
p.000251: the crucial importance for the effectiveness of ethical evaluation.
p.000251: In particular, the issues of planning and conducting studies involving human, standards of the recording and presenting
p.000251: of findings, are ruled by the mentioned Federal law of the Russian Federation “ On Pharmaceutical Products”, as well
p.000251: as by-laws: The Rules of Clinical Practice in the Russian Federation”, adopted by the order of Ministry of
p.000251: Public Health of the Russian Federation on 19 of June 2003, N 266, the national standard “Good Clinical Practice.
p.000251: GOST- R 52379-2005 “ on 27 of September 2005, N 232- st., adopted by the order of the Federal agency for
p.000251: technical regulation and metrology, The Instruction “On the Organization and Conducting of Expertise,
p.000251: Clinical Trials and Registering of Foreign Medicines and Substances” on 15 of May 1996, adopted by the
p.000251: order of the Ministry of Public Health and medical industries of the Russian Federation, the Operating
p.000251: Instruction “Conducting qualitative studies of bioequivalence “ on 10 August 2004, adopted by Ministry of
p.000251: Public Health of the Russian Federation, the Instruction “On Expertise and Trials of Medical Immunobiological Products
p.000251: with the Purpose of Registration “
p.000251:
p.000251: 34 Federal Law of Russian Federation “On transplantation of human organ and tissues” on 22 of December
p.000251: 1992, N 4180-1// Vedomosty of CND and VS RF, 1993. № 2, article 62, Federal Law of Russian Federation “On blood
p.000251: donation”, 9 of June 1993, N 5142-1// Vedomosty of CND and VS RF, 1993. № 28, article 1064, Federal Law of Russian
p.000251: Federation “On prevention of dissemination of the disease caused by HIV” on 30 of March 1995, N 38-FZ//Sobranie
p.000251: zakonodatelstva, 03/04/1995, N 14, article 1212, Federal Law of Russian Federation “On immune prophylactics of
p.000251: infection diseases” on 17 of September 1998, N 157- FZ// Sobranie zakonodatelstva, 21.09.1998, N 38, article 4736.
p.000251: on 15 April 1999, N 129, adopted by the order of Ministry of Public Health of the Russian Federation, the Branch
p.000251: Standard “ Clinical and economic research. General provisions” (OST 91500.14.0001-2002) on 27 of May 2002, N 163,
p.000251: adopted by the order of Ministry of Public Health of the Russian Federation and other documents35.
p.000251: The provisions of these legal acts set out requirements to the scientific validity of biomedical research, the
p.000251: risk and benefit ratio, safety of the investigational products or medical methods, the follow-up procedure to
p.000251: monitor the reliability of the research findings, and a number of other requirements that should be met when
p.000251: conducting biomedical research in Russia.
p.000251: With regard to regulation of ethical review of biomedical research it should be marked the importance of the positions
p.000251: of chapter IX of the Federal Law of the Russian Federation “On Pharmaceutical Products”, namely item 2 of the article
p.000251: 37 and item 1 of the article 39. These norms mention two forms of ethics committees, which participate in taking the
p.000251: decision on the forthcoming research.
...
p.000253: The committee may include persons who are not directly dependent on the researchers and sponsor. The members of the
p.000253: committee should have the proper qualification and experience of ethics review of scientific, medical and ethical
p.000253: aspects of different studies. The committee may include the representatives of the public (lawyers,
p.000253: journalists, priests, etc.).
p.000253: Among documents which are important for development of the system of ethical review in Russia we should also point out
p.000253: the mentioned “Rules of Clinical Practice in the Russian Federation” (Rules of Clinical Practice) and the national
p.000253: standard “Good Clinical Practice. GOST- R 52379-2005 “ (National standard).
p.000253: Today the Rules of Clinical Practice have limited application caused by essential reorganization of the system of
p.000253: control and assessment of effectiveness and safety of products, processes and services, including those in medical
p.000253: sphere.
p.000253: The National standard that entered into force in April, 2006 is more meaningful document in this sphere.
p.000253: This act is the element of the system of technical regulation and develops the provisions of the Federal Law “On
p.000253: Technical Regulation”, which establishes the requirements for products, manufacturing, exploitation, storage,
p.000253: transportation, realization and utilization, service delivery, etc.
p.000253: The national standard is the Russian version of ICH GCP and by its status is recommending document. It establishes the
p.000253: ethical and scientific standard of the quality of planning and conducting research involving human subjects as well as
p.000253: the standard of recording and registering the study results.
p.000253: These standards may be applied not only to the studies of medicines, but also to “other clinical experiments, which can
p.000253: affect the safety and well- being of a subject”.
p.000253: The observation of the rules of the national standard is the guarantee of the validity of research results, safety of
p.000253: subjects and protection of their rights and health in accordance with the basic principles of Helsinki Declaration.
...
p.000257: testing, storage, transportation, realization, application and utilization”.
p.000257: In contrast to current federal laws, this bill proposes the more detailed regulation of process of the clinical
p.000257: drug research ethical review. It also constitutes research subjects’ rights and guarantees of these rights
p.000257: in accordance with the most progressive international standards in this field.
p.000257: Legislation initiatives in the sphere of protection of patients’ rights40, activity directed to adaptation of
p.000257: international guidelines, as well as transformation of the positions of international declarations and conventions
p.000257: in the sphere of biomedicine into the domestic legal acts, give us the reason to expect the strengthening and
p.000257: development of the institute of ethical review in our country.
p.000257:
p.000257: 3.8.3 Education in Bioethics
p.000257:
p.000257: Issues on education of medical ethics and deontology in medical schools and colleges of the USSR were
p.000257: started to discuss in the 60’s of the XX century after the 1st All-Union Conference on issues of medical
p.000257: deontology in 1969 being a kind of triggering point for revival of talks on them. The final resolution, in particular,
p.000257: said: “The Conference would like to draw attention of the Chief Agency on Educational Facilities of the Ministry of
p.000257: Health of the USSR on necessity to implement medical deontology into education process”.
p.000257:
p.000257:
p.000257: 40 For example, Draft Law “On legal basis of bioethics and its guaranties”, “On reproductive rights of citizens”,
p.000257: “On additions to Criminal Code of the Russian Federation regarding to criminal liability for conducting
p.000257: medical trials involving human subjects without their voluntary consent” and others.
p.000257: Many medical schools developed medical oaths based on the Hippocratic Oath. In 1971 the Presidium of the Supreme Soviet
p.000257: of the USSR approved an official text of the Oath of Medical Doctor of the Soviet Union.
p.000257: In 1976 the Ministry of Health of the USSR approved interdepartmental curriculum on medical ethics (deontology)
p.000257: for higher medical and pharmaceutical educational facilities. The curriculum distributed the course along the
p.000257: entire educational process basing on that “concepts of morals and morality, development of higher feelings and medical
p.000257: ethics is an integral part of the entire educational process and should be implemented in various aspects during all
p.000257: years of training at all departments“.
p.000257: The curriculum stipulated one lecture for the 1 year students: “Medical ethics and medical
p.000257: deontology, their role for formation of a medical doctor and pharmacist” (Introduction for the subject);
p.000257: 5 lectures for the 2 year students: “Soviet health care as qualitatively new system“ (Department of
p.000257: Social Hygiene and Health Care Management), “Main peculiarities of deontology development at different stages of
p.000257: health care formation” (Department of History of Medicine), “Categories of medical ethics” (Department of Marx and
p.000257: Lenin Philosophy), “Modern concepts on medical and psychological aspects of an individuality” (Course on medical
p.000257: psychology), “Deontological issues in disease diagnostics” (Department of Preliminary Studies of Internal
p.000257: Diseases); 1 lecture for 3 year students: “Deontological issues of treatment” (Department of Faculty Therapy); 2
p.000257: lectures for 5 year students: “Deontological issues for work of district physician” (Department of
p.000257: Hospital Therapy) and “Legal principles of medical services for working population in the USSR”
p.000257: (Department of Forensics Medicine). The curriculum was widely discussed in mass media and majority of comments were
p.000257: that it was inefficient, did not cover many important issues, which are of tremendous value for medical practice, for
p.000257: instance, no definition of patient rights was given, it did not dwell on issues of brain death, refusal of
p.000257: extraordinary treatment for dying patients, it never mentioned the Nuremberg Code or the Declaration of Helsinki, etc.
p.000257: In 1977 and 1982 two other All-Union conferences on medical deontology were held. There were published
p.000257: multiple books on issues of medical ethics and deontology for various medical fields. It indicated that in 70-80’s
p.000257: the system of Soviet higher medical education had professors who not only fully understood a role of medical
p.000257: deontology for education
p.000257:
p.000258: 258
p.000258:
p.000259: 259
p.000259:
p.000259: and training of undergraduate doctors but also contributed considerably for development of the content of this
p.000259: subject (Evlashko Y.P., Kosarev I. I., Leschinsky L.A., Orlov A.N., Suvorova R.V., Rokitsky M.R., Shamov I. A.,
p.000259: Jarovinsky M.Ya., etc.). In 1988 two volume manual Deontology on Medicine was published edited by Petrovsky
p.000259: B.V.
p.000259: In the 80’s the educational curriculum of medical nurse colleges had some academic hours assigned to medical
p.000259: deontology – the course was called as Basics of medical psychology, ethics and deontology. In 1992 the Pledge of
p.000259: Medical Doctor of Russia came into force.
p.000259: In 1993 the Vrach (Doctor) magazine published an appeal to scientific community and heads of the Russian science from
p.000259: members of the Russian national committee on bioethics (“Bioethics in Russia: Beginning of the way”). The Appeal
p.000259: stated: “Modern medicine requires modern moral consciousness. In the whole world principles of bioethics for a
p.000259: long time are an integral part of professional life of medical workers ... Absence in our country of the said
p.000259: mechanisms of ethical control results in a range of negative consequences, hinders improvement of moral environment
p.000259: within our scientific community; it is one of the main reasons for distrust of the society to science (that, by the
p.000259: way, impacts the society readiness provide science with tangible support); it is a direct violation of
p.000259: international acts enforced in this field...” In this document the most well-known medical scientists of the
p.000259: country wrote with anxiety about those harmful consequences indicating absence of proper ethical control on
p.000259: scientific experiments. Neglect of elementary medical and ethical norms in practical health care being widely spread in
p.000259: our days looks similarly dangerous. It was noted by many speakers at the XVIII All-Russia Pirogov’s Conference of
p.000259: Medical Doctors held in Moscow in 1997. The Conference approved a new text for the Oath of Russian Medical Doctor and
p.000259: the Code of Medical Ethics presented by the National Ethics Committee – Russian Medical Association.
p.000259: In October 1994 in Geneva the 4th WHO Conference on issues of medical ethics education was held where
p.000259: participant unanimously stated that education to ethics (bioethics) issues should be mandatory rather than optional.
p.000259: The Conference participants agreed that medical ethics should become an integral part of medical education and
p.000259: that its coaching should be obligatory and continuous during the entire pre-graduate educational
p.000259: process and for post-graduate education, therefore, all medical schools were to have a department on medical ethics and
p.000259: appropriate number of trained professors.
p.000259: In 1997 under the aegis of the Ministry of Health of the Russian Federation the meeting on issues of
p.000259: medical ethics education was held where necessity of introduction of bioethics learning was acknowledged. It
p.000259: is necessary to note that the Russian Orthodox Church supported introduction of the biomedical ethics education
p.000259: into the medical education system of Russia. It is indicated with the appeal to the ministries of health care and
p.000259: vocational education of the Russian Federation approved during the VI International Christmas educational
p.000259: lectures of 1998 held by the Moscow Patriarch of the Russian Orthodox Church.
p.000259: Some of higher educational facilities of medical as well as philosophy, law and other fields as per initiative
p.000259: of those enthusiasts-professors the bioethics education process was launched as well. Since the beginning
p.000259: of the 90’s the separate course on biomedical ethics was provided in the Moscow State University named after Lomonosov
p.000259: M.V. at the Departments of philosophy and psychology, and since 1994 it was also introduced at the medical department.
p.000259: The most capacious course in regard to number of academic hours assigned was provided at the nurse department
p.000259: for the 1st year students of the Moscow Medical Academy named after Sechenov I.M. - 56 hrs (30 hrs of lectures and 26
p.000259: hrs of seminars). Actually, this subject was given at the Department of history of medicine since 1994, and as a
p.000259: separate course – since 1995. Another issue is even more important: at this department biomedical ethics was included
p.000259: into the state educational standard, i.e. it is obligatory for all 22 departments of the higher nurse education in
p.000259: Russia. Making this subject as mandatory from the point of view of educational minimum for this category of medical
p.000259: workers, naturally, required generation of appropriate curriculum (author – Professor Yarovinsky M.Ya.).
p.000259: In the Russian State Medical University since 1996 the Department of philosophy and culture sciences was called as the
p.000259: Department of philosophy and culture sciences with a course on bioethics, and there the biomedical education course (22
p.000259: academic hours: 18 hours of lectures and 4 hours of seminars) is provided since 1996 for all 4 year students of
p.000259: physician and pediatric departments.
p.000259:
p.000260: 260
p.000260:
p.000261: 261
p.000261:
p.000261: Also since 1996 the course on bioethics was provided in the St- Petersburg Pediatric Medical Academy at the
p.000261: Department of humanitarian subjects and bioethics and in the Kazan Medical University. The Department of philosophy of
p.000261: the Moscow Medical Dentistry Institute since 1997 was called the Department of philosophy and biomedical ethics, the
p.000261: course of biomedical ethics there (40 academic hours) is provided at the dentistry department for 1-year
p.000261: students, and at the physician department — for 3- year students. At the evening education department for 1-year
p.000261: students this subject was assigned with 20 academic hours. As an option biomedical ethics was suggested for
p.000261: students since 1993. In the Krasnoyarsk Medical Academy the course on professional medical ethics was provided for pre-
p.000261: graduate students (48 academic hours), and at the higher nurse education department (40 academic hours).
p.000261: The next step for establishing of this subject education was the All- Russian Educational and Methodical
p.000261: Conference Biomedical Ethics in Higher Medical Education Facilities held by the Ministry of Health of the Russian
p.000261: Federation in 1999; since 2000 bioethics became an obligatory subject in medical schools. Introduction of
p.000261: biomedical ethics into a set of humanitarian subjects of medical education is one of the evidences of real renewal of
p.000261: humanitarian training of medical students in Russia.
p.000261: Currently educational system in the Russian Federation has curriculums for general (beginning, secondary) and
p.000261: professional (secondary, higher, additional) education. Their content is determined by state educational
p.000261: standards. Standards for “secondary” and nurse vocational training do not contain bioethical issues.
p.000261: At the stage of higher vocational training bioethics become an integral part of curriculums of medical
p.000261: or pharmaceutical fields (a course of humanitarian and social and economic subjects), for such majors as Law,
p.000261: International Relations, Social Work (natural sciences part in the course Concepts of modern natural sciences),
p.000261: Biology and Bioecology (a part of general vocational subjects). As a negative sign it should be noted that
p.000261: bioethics education is not stipulated for such major as Philosophy. Existence of national and regional (school-
p.000261: related) component in state standards and the right to some extent to alter curriculum content allows for many of
p.000261: educational facilities in Russia to include bioethics into education of future agriculture workers, veterinaries,
p.000261: teachers, philosophers and other trades.
p.000261: At the same time there is no trade of bioethics in the All-Russian Classifier of Educational Trades as well
p.000261: as it is not mentioned in the List of Scientific Specialist Trades. Therefore, targeted training of specialists
p.000261: including specialists of higher qualification (masters and doctors of science) in regard to bioethics is not
p.000261: provided. However, theses or dissertations for master or doctor degree covering to some extent bioethics
p.000261: issues are defended using reference numbers of other trades such as philosophy, sociology, public health.
p.000261: Currently training of medical doctors and pharmacists is conducted in 47 universities and academies subjected to the
p.000261: Federal Agency on health care and social development as well as 25 departments and institutions of the Russian
p.000261: education ministry, 5 military medical educational facilities, 10 private higher educational facilities as well as in
p.000261: the Kyrgyz-Russian Slavic University accredited in Russia.
p.000261: Typical unified program of education in higher medical educational facilities in Russia was developed in 2001 by the
p.000261: group of Moscow scientists, and in 2003 the reference curriculum on bioethics for Pharmacy trade was published (authors
p.000261: – workers of the Moscow Medical Academy named after Sechenov I.M.), which are planned for 36 academic hours of class
p.000261: work (18 hours of lectures and 18 hours of seminars) and 18 hours of independent work in the 2nd semester. The
p.000261: curriculum stipulates learning of history and traditions of Russian ethics, theoretical basics of biomedical ethics,
p.000261: models and rules of relationships between doctor and patient, patient rights, analysis of bioethical issues of
p.000261: experimental medicine, reproductive technologies, euthanasia, transplantology and medical genetics, HIV infection,
p.000261: ethics in psychiatry, moral issues of distribution of health care resources. Working educational programs that the
p.000261: education is based upon are developed by departments implementing them.
p.000261: Currently training in bioethics at the specialized department is conducted only in one higher educational facility, the
p.000261: Russian State Medical University. Three cities (Ivanovo, Kazan, Samara) have departments on bioethics and law
p.000261: associated with other subjects (forensics medicine, history of medicine) or without it. Five educational
p.000261: facilities provide such education at the departments of philosophy, another five changed department titles to
p.000261: mention “philosophy and bioethics”. Three cities delegated this coaching to health care management department. In every
p.000261: third of medical educational facilities
p.000261:
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p.000262:
p.000263: 263
p.000263:
p.000263: bioethics is learned at departments of humanitarian and social and economic type. Finally, another three higher
p.000263: educational facilities (Astrakhan Medical Academy, St-Petersburg Medical University named after Pavlov I.P. and
p.000263: Stavropol Medical Academy) formed interdepartmental teams for teaching the subject involving clinicians (clinical
p.000263: pharmacologists, psychiatrists).
p.000263: Majority of medical academies and universities has the amount of academic hours complying with the curriculum
p.000263: stipulated one – 36 hours, two – shrank it insignificantly up to 32 hours, and in one academy – to 19 hours.
p.000263: More than a half of medical educational facilities in Russia managed in their curriculum to move the classes from 1st
p.000263: year students to more trained ones up to the pre-graduates at their last year training (Volgograd, Kursk, Ryazan,
p.000263: St-Petersburg Pediatric Medical Academy).
p.000263: An important feature of the modern stage of development of biomedical education in medical education facilities is
p.000263: its close organizational and methodical association with coaching in jurisprudence and medical law. It is not by
p.000263: chance that one of the main magazines publishing articles and other materials on bioethics-related topics is
p.000263: Medical Law included into the list of magazines recommended by the Higher Attestation Commission for publication of
p.000263: results of dissertation research.
p.000263: Special departments on medical law were established in two Moscow facilities (Moscow Medical Academy named after
p.000263: Sechenov I.M. and Moscow State Medical and Dentistry University), in 11 cities the law training is
p.000263: provided in the departments, which titles mention law. In 7 cases these are departments of humanitarian and
p.000263: social and economic field: bioethics, philosophy, political sciences, economics, sociology, psychology and pedagogics;
p.000263: in 4 cases – forensics medicine.
p.000263: Four universities set up the educational process on jurisprudence at humanitarian departments
p.000263: (humanitarian sciences - 2, social and humanitarian - 2), four – at departments of forensics medicine and
p.000263: four – at departments of public health and health care. In Astrakhan they decided to involve professors of three
p.000263: departments: philosophy, public health and forensic medicine.
p.000263: Objectives of bioethics and law coaching are to identify, formulate and bring to students those norms of
p.000263: morals and law that will protect their patient and, at the same time, will not hinder innovations in medicine and,
p.000263: moreover, beneficial use of modern diagnostic and medicinal technologies. Achievement of this goal is based on complex,
p.000263: interdisciplinary approach to the educational process as it is required by the essence of bioethics.
p.000263: Bioethics as it is should be in the Centre integrating common efforts of men of law, forensic medicine specialists,
p.000263: philosophers and other representative of humanitarian departments and, naturally, clinicians and health care
p.000263: managers as well as university administration for training and education of future specialists. Some actions
p.000263: in this respect are performed (Moscow State Medical and Dentistry University, etc.). Maybe, it makes sense to
p.000263: set a task to prepare a typical reference curriculum at the federal level that could be an assistance and incentive for
p.000263: universities. We should also take into account strong and weak points of the Interdepartmental Curriculum on medical
p.000263: ethics and deontology implemented in the USSR in 70’s and 80’s of the ХХ century. That curriculum could be considered
p.000263: as a historical prerequisite for education in the field of bioethics for all Post-Soviet countries. At the
p.000263: same time, the XXI century requirements show necessity for inclusion into the training course of completely new issues.
p.000263: In particular, it seems of significant importance to include there issues on evidence-based medicine. Nowadays this
p.000263: field of medical science is unfairly considered as the outskirts of educational curriculums, while it allows giving
p.000263: grounds to clinical practice with quantitative and qualitative analysis of world research data rather than basing it on
p.000263: intuition, traditions and experience which young specialists just do not possess.
p.000263: Educational and methodical basis for bioethics currently cannot be called as perfect but despite that currently
p.000263: there are good monographs that, regretfully, are not fully available in university libraries. Such publications are:
p.000263: Biomedical Ethics//Edited by Pokrovsky V.I.Vol.1. - M., 1997 and Biomedical Ethics//Edited by Pokrovsky V.I.
p.000263: and Lopukhin Y.M. Vol.2. - M., 1999;. Bioethics: principles, rules, issues//Edited by Yudin B.G.- M., 1998; .
p.000263: Introduction for Bioethics. - M., 1998, etc.
p.000263: In 2005 a handbook for higher educational facilities fir the Pharmacy trade edited by Lopatin P.V. was published, and a
p.000263: year before – a teaching aid Medical Ethics edited by Academician of the Russian Academy of Medical Sciences,
p.000263: Professor Lopukhin Y.M. and Corresponding member of the Russian academy of Sciences, Professor Yudin B.G.
p.000263: (translated from English). In 2006 Publishing House Meditsina (Medicine) issued a handbook
p.000263:
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p.000265: 265
p.000265:
p.000265: on medical ethics by Shamov I.A. where the author suggested introducing continuous education of the subject and
p.000265: provides a curriculum for the entire period of study.
p.000265: A handbook for students in medical schools recommended by the Education and Methodical Association of
p.000265: medical and pharmaceutical universities of Russia is handbook Medical Ethics (Bioethics) by Yarovinsky M.Ya. (M.,
p.000265: 2006). Besides, there are publications prepared directly by educational facilities, for instance, by the Samara
p.000265: State Medical University (Sergeyev V.V., Nasledkov V.N. et al. Lectures on Bioethics. Samara, 2005), as well
p.000265: as monographs and collections of articles, foreign manual, for instance, the ones approved in the Republic of Belarus.
p.000265: Some role was played by monograph Ethics of Treatment by Siluyanova I.V. (M., 2001).
p.000265: Also departments providing bioethics education start to interact. In 2005 the All-Russian Educational and Methodical
p.000265: Conference Biomedical Ethics in the higher medical educational facilities of Russia (the Russian State
p.000265: Medical University) was held which summarized experience accumulated in the field of bioethics education in various
p.000265: universities and schools.
p.000265: Motivation to study bioethics among students and specialists is quite high. Sociological polls found that more than 80%
p.000265: of students and young medical doctors realize necessity to master bioethics knowledge. And experienced doctors
p.000265: who, in their majority, never studied biomedical ethics, as it is currently understood, quite often do not
p.000265: express any determined opinion.
p.000265: Importance of specific training for doctors with more than 10-year professional experience, and they are
p.000265: the basis of the industry human resources, in regard to ethical and legal issues, is rather
p.000265: considerable. It is confirmed with the questionnaire data we obtained. “Is there a need in ethical committees in
p.000265: treatment and prevention facilities?” The answer is “No” among more than 25% (!) of MD’s vs. students. Such prevalence
p.000265: of answers is caused, naturally, not by neglecting of ethical values but with ignorance of the subject. Obviously,
p.000265: post-graduate education shall become a foremost objective.
p.000265: Nowadays, there is no practice of systematic organization of training course on bioethics issues for medical doctors
p.000265: and other specialists at the post- graduate period. The exclusion is a regular topical post-graduate education cycle
p.000265: for medical doctors and researchers Methods for Set-up and Conduct
p.000265: of Clinical Studies of Pharmaceutical Products in the Russian State Medical University. On their own Russian
p.000265: specialists can get bioethical training within the framework of programs supported by international organizations
p.000265: or universities, for instance in the school on bioethics in Vilnius at the Vilnius University and Albany
p.000265: Medical College-Graduate College of Union University Bioethics Program (Schenectady, New York).
p.000265: Improvement of doctor and researcher knowledge in regard to protection of rights of biomedical research participants is
p.000265: significantly facilitated with the conduct of training cycles on rules of Good Clinical Practice by medical
p.000265: universities (Moscow Medical Academy, Russian State Medical University) and large contract research organizations
p.000265: (Smolensk, Saint-Petersburg).
p.000265: A specific value for ethical review system setup in the country is provided by training of the ethical
p.000265: committee members. Such trainings are organized under the aegis of the Forum for Ethics Committees in CIS Countries
p.000265: as well as by initiatives of particular ethical committees.
p.000265: The Russian Federation joining to the Bologna Club (September, 2004), that is, to states participating in processes of
p.000265: reforming of European education on the basis of Bologna Declaration principles (1998), raised necessity in resolving
p.000265: of some new issues by those organizing bioethical education. It includes struggle for the place of the subject
p.000265: of bioethics in the part of curriculums that is compiled in accordance with the Bologna Declaration requirements to be
p.000265: implemented on mandatory rather than optional basis; for appropriate rate of work content and assessment in the system
p.000265: of ECTS credits; preparation of various educational and methodical materials for independent work of students
p.000265: (multimedia aids, readers, case collections, business games, tests); development of control and measurement materials
p.000265: and, naturally, targeted specialized training of professor competitive in conditions of higher educational
p.000265: mobility of their students.
p.000265: In general, one can come to a conclusion on a need for creation in the Russian Federation specialized educational
p.000265: facilities of organizational, design and methodical basis for teaching bioethics. During the last years one can
p.000265: observe a notable trend for transformation of bioethics education into specialized courses and departments. At the same
p.000265: time, it is necessary to make efforts to develop state educational standards, typical unified and working educational
p.000265: programs to comply with scientific and practical
p.000265:
p.000266: 266
p.000266:
p.000267: 267
p.000267:
p.000267: requirements, to coordinate activities of university departments on teaching issues of legal and ethical control in
p.000267: medicine.
p.000267: The main task is to be planned preparation of qualified staff of professors, which requires set up of special
p.000267: post-graduate study system, including post- graduate research and vocational training at the course of general and
p.000267: topical post-graduate education, establishment of the bioethics grade.
p.000267:
p.000267: 3.8.4. System of Ethical Review
p.000267:
p.000267: The Russian legislation in the field of ethical and legal provision for biomedical research is represented with a range
p.000267: of documents. First of all, it is the Constitution of the Russian Federation (Art.21), which states: “… no one can be
p.000267: made undergo medical, scientific or other experiments without his/her consent.” Beside, there is the Basics of the
p.000267: Legislation of the Russian Federation on Protection of Health of Citizens where Article 43 considers issues on
p.000267: application of new methods of prevention, diagnostics, treatment; medical agents, immunobiological agents and
p.000267: disinfecting agents and biomedical research conduct. However, this article is declarative to a large extent: rights
p.000267: of citizens involved in biomedical studies stipulated there do not have any mechanisms of implementation and
p.000267: enforcement, including the ones via ethical review of applications for research conduct. At the same time,
p.000267: in accordance with this document children of age below 15 can participate in studies of new medicinal agents, methods,
p.000267: etc, only in case of vital indications though in real life this statement is constantly breached that is inevitable and
p.000267: determined with realia of medical practice development and scientific progress. Article 29 of this document prohibits
p.000267: involvement into studies of those arrested or convicted though, in some cases these persons can benefit from
p.000267: their participation in clinical biomedical research. In this respect the Russian legislation differs from
p.000267: European norms that allow in case of specific and clearly defined conditions to hold studies with involvement of
p.000267: those categories of citizens. Another document regulating possibility for conduct of biomedical studies in the Russian
p.000267: Federation is the Law on Psychiatric Care where Article 5 proclaims the right of a person with mental disorder to
p.000267: consent or to refuse of participation in such studies though necessity for such action is not stipulated. The Law on
p.000267: Pharmaceutical Products analyzes quite profoundly those norms regulating research on new
p.000267: medicinal agents but, regretfully, it covers only one though rather important sphere of biomedical research – studies
p.000267: of pharmaceuticals. This law as it is shown by the text is written basing on an assumption that each study is premised
p.000267: with an examination held by an ethical committee but either status, or authority, or order of creation, or composition
p.000267: of ethical committees are not stipulated by the Law; there only guidelines that “the ethical committee acts at the
p.000267: federal executive authority which competence covers state control and surveillance in the sphere of pharmaceuticals”
p.000267: (Art. 37). There is also no such mechanism for creation and activities of such organization in any other Russian legal
p.000267: document. The National standard of the Russian Federation GOST R52379-2005 “Good Clinical Practice” adopted in 2006
p.000267: defines the term “Independent Ethical Committee” as an independent group (review council or committee acting at
p.000267: the facility, regional or international level) consisting of medical workers as well as persons not related to medical
p.000267: trade that provides protection of rights, safety and well-being of study subjects and for the society it is a guarantor
p.000267: for such protection, in particular, through review, adoption/approval of study protocol, investigator
p.000267: personalities, study sites as well as materials and methods to be used for obtaining and documenting informed consent
p.000267: from the study subjects. EC should function in compliance with the principles of good clinical practice“.
p.000267: Thus, basing on analysis of existing legislation one can conclude that the biomedical research ethical review in the
p.000267: Russian Federation is conducted by ethical committees acting in health care or research facilities including the ones
p.000267: of the Ministry of Health Care of the Russian Federation, Russian Academy of Medical Sciences, medical
p.000267: associations, research medical Centres, hospitals. In majority of cases such activity is borne by local ethical
p.000267: committees.
p.000267: First ethical committees in Russia were created not more than 10 years ago. Initially such committees were created at
p.000267: research Centres where multi- Centre international studies were held and the need of their creation was caused when
p.000267: studies were initiated by foreign sponsors, pharmaceutical companies requiring the EC approval for their
...
p.000269: well justified, to provide fair selection of them, to provide control over complete and adequate informing the patients
p.000269: and obtaining the informed consent, confidentiality terms, protection for vulnerable population groups.
p.000269: When examining the clinical study protocol, specialists consider possibility of reaching study objectives with
p.000269: involvement of less amount of subjects, assess inclusion and exclusion criteria, early exclusion criteria from
p.000269: participating in the clinical study, conditions of the study termination, objective control methods, expected
p.000269: adverse events and inconveniences for patients.
p.000269: Reviewing the Investigator Brochure there are examined data on efficacy and safety, pharmacological, pharmaceutical and
p.000269: toxicological properties of the tested medical agent as well as data on results of previously conducted preclinical and
p.000269: clinical studies.
p.000269: Requirements for information on the study provided to a candidate subject are very strict. It must
p.000269: correspond to a level of understanding of those to be involved in the study, to be easy to read and not to
p.000269: contain many medical terms. This document must describe the following: study purpose and objectives; description of the
p.000269: tested medicinal article; concomitant treatment permitted or prohibited in the given the trial’s subjects. probability
p.000269: of random assignment in one of the study groups (including the control that might be treated with placebo. Explanations
p.000269: for all terms and concepts, for instance, placebo, is obligatory!); objectively expected benefit for the patient as
p.000269: well as inconveniences and objectively expected risks for both patients/healthyXvolunteers and a fetus or infants; all
p.000269: study procedures (especially accurately
p.000269:
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p.000270:
p.000271: 271
p.000271:
p.000271: there shall be highlighted issues on all invasive procedures planned during the study); obligations of the
p.000271: subject-participant; compensation and/or treatment the subject might expect in case the damage is incurred to his/her
p.000271: health during the study. The information note for the patient must contain a declaration that his/her participation
p.000271: in the study is voluntary and that he/she can in any moment of time refuse of participation in the study or to
p.000271: discontinue it without any sanctions or his/her rights infringement; there shall be clearly identified a list
p.000271: of persons that will be granted with direct accessXtoXinformation in the primary medical documentation (investigators,
p.000271: auditors, regulatory authorities, ethical committee members), and provided assurance that data identifying
p.000271: personality of the study subject will be kept secret and its disclosure is possible only within the limits
p.000271: stipulated with corresponding laws and/or by-laws. For instance, in case of public representation and
p.000271: publication of the study results anonymity of its subjects (confidentiality of information about them) is
p.000271: guaranteed. The patient information note must indicate investigator obligations in case of appearance of new data
p.000271: in the given CT that can influence the subject decision on continuing participation in the study to
p.000271: immediately inform the study subject or his/her legal representative about them, define a list of persons that one can
p.000271: address if it is necessary to obtain additional data concerning this CT the subject-participant and the rights of the
p.000271: subject as well as other specialists that the study subject can contact in case his/her health is
p.000271: compromised during the study (these are representative of the study team, local EC). It is obligatory to provide
p.000271: conditions when participation of the patient/healthy volunteer can be discontinued without his/her consent, suggested
p.000271: duration of the study, and approximate number of the subjects in different regions and in the given clinical site. The
p.000271: information provided to the patient shall be logically completed with the informed consent form, which exhibits, if
p.000271: signed by the patient or his/her legal representative, that he/she agrees on participation in the study, grants
p.000271: permission to stakeholders to access the documentation showing his/her health status. Any medical interventions in
p.000271: regard to patients can be performed only after he/she gets acquainted with the information on the clinical study,
p.000271: signs and dates himself/herself the informed consent sheet.
p.000271: An ethical committee can approve clinical study conduct only in case
p.000271: if its potential benefits for study subjects exceeds all known and expected
p.000271: kinds of risk for them. If it is necessary, EC has the right to request from an applicant (an investigator and a
p.000271: sponsor) any additional information on the given project if it can influence risk assessment for study subjects.
p.000271: Special attention is paid to issues of ethical acceptability in case a study is to involve so called vulnerable
p.000271: population groups (minors, pregnant women, patients in urgent situations, incurable patients, military people,
p.000271: prisoners, students, persons living in retirement home, homeless, refugees, unemployed, low-income people, persons
p.000271: incapable of signing the IC form).
p.000271: An integral part of the biomedical research ethical review is examination during the study which
p.000271: becomes necessary if the sponsoring company introduces amendments into the protocol, changes conditions for rights
p.000271: protection of the study subjects, corrections into patient information note when new data on a tested medicinal article
p.000271: or method appear. The Ethics Committee is to review the following: study protocol amendments introduced after project
p.000271: run onset, new data on on-going or completed studies of the given medicinal agent or method, messages on serious
p.000271: adverse events developed during its use, makes decisions on interventions into course of the study if there is high
p.000271: probability to expose to danger the subjects.
p.000271: Any changes in study design can be associated with potential risk increase for its subjects, which is
p.000271: quite possible in case of adding or cancelling treatment, any changes of inclusion/exclusion criteria,
p.000271: alterations of the drug introduction routes, its doses, and significant changes in number of the CT subjects. An ethics
p.000271: committee can approve amendments to the clinical study conduct only if presented changes do not lead to worsening of
p.000271: conditions for subjects.
p.000271: After the application review an ethics committee can make one of the following decisions: to approve study
p.000271: conduct; to approve a study with minor changes, and after they are introduced the EC decision on the study can be
p.000271: granted to an investigator with no need of repeated examination; to require amendments of study
p.000271: procedures and materials and to submit documents once again for examination; not to approve study conduct
p.000271: (indicating reasons for refusal, if necessary – with recommendations on elimination of identified defects).
...
p.000277: biomedical research potential subjects.
p.000277:
p.000277: 3.8.5. Perspectives and Forms of International Cooperation
p.000277:
p.000277: Perspectives for cooperation in the field of ethical review are related to creation of common ethical and legal
p.000277: environment in the countries of the Commonwealth of Independent States, Europe and the world. There are
p.000277: three main areas of activities in cooperation with foreign partners are especially important for Russia:
p.000277: legislation harmonization, joint research and educational activities.
p.000277: In regard to legislation unification quite significant event was adoption in 2005 of the National Standard of the
p.000277: Russian Federation GOST R 52379- 2005 “Good Clinical Practice” (approved by the Order of the Federal Agency on
p.000277: technical regulations and metrology of September 27, 2005, No.232). This document completely implemented GCP, which is
p.000277: an international ethical and scientific standard of design and conduct of research involving human subjects as well as
p.000277: a standard of documentary registration and presentation of results of such studies, into the Russian legislation. It
p.000277: was identical to the Guidelines for Good Clinical Practice of the International Conference on Harmonization of
p.000277: Technical Requirements for Registration Pharmaceuticals for Human Use, which, in turn, was developed with consideration
p.000277: of acting requirements of good clinical practice of the European Union, the USA and Japan, as well as
p.000277: Australia, Canada and WHO. Compliance with this document makes possible to our country to adhere to united
p.000277: rules with countries of the European Union, the USA and Japan, that should facilitate mutual recognition of
p.000277: clinical study results with authorized agencies in these countries and become a basis to extend conduct of
p.000277: multicentre studies, eliminate practice of duplicating medical and biological studies in different regions of the world
p.000277: allowing to Russia to become full-fledged participant in process of international studies and, eventually, to
p.000277: result in mutual acknowledgement of pharmaceuticals approval.
p.000277: To secure state guarantees for protection of personal rights, dignity, autonomy and integrity conducting biomedical
p.000277: research in the CIS member
p.000277: states in 2005 there was issuesd a model Law On Protection of Human Rights and Dignity in Biomedical Researches in the
p.000277: CIS, which corresponded to all principles of biomedical ethics and medical law, interstate agreements in the field of
p.000277: biomedical research ethics. This document allows attaining common understanding of protection of human rights
p.000277: and fundamental freedoms in the sphere of biology and medicine application, to unite efforts of scientists
p.000277: and politicians from all CIS countries in the common legal and ethical environment for biomedical researches
p.000277: that covers all types of impacting a man, including studies on embryos in vivo. Along with that, the law
p.000277: enforcement is secured via creation of interstate and national systems of ethical review that is
p.000277: designed in accordance with ideology of the WHO program SIDCER and initiated by the Forum for Ethics Committees in
p.000277: the CIS.
p.000277: Currently we came to understanding that all biomedical projects held in the CIS countries shall undergo independent
p.000277: ethical review at the national level; there were established ethics committees forming a mechanism for provision of
p.000277: ethical review quality and research project safety through control at all stages of informed consent
p.000277: obtaining from candidate study subjects (in case of participation of subjects unable to provide such consent
p.000277: independently – from their legal representatives), ethical research support at all stages until project completion.
p.000277: Special situation of biomedical research conduct are specially controlled by ethical committees when study subjects are
p.000277: related to vulnerable population categories (due to their age, intellectual, mental, or social immaturity or
p.000277: vulnerability) or when studies stipulate obtaining information on genetic code of the study subject.
p.000277: Ethical committees of the CIS countries reached common understanding on necessity of ethical review, they
p.000277: approved common basics for their activities, and the next stage is building up the ethical control
p.000277: vertical system and making this process transparent both within the country and the Commonwealth that is possible
p.000277: through implementation of Acknowledgement program initiated by WHO and suggested for implementation in the post- Soviet
p.000277: countries by FECCIS. This program stipulated ethical committee certification that was a guarantee for
p.000277: compliance to highest quality standards of ethical review and development of a system of effective control
p.000277: over research activities in the country for the world community. Russia started preparation of ethical committees for
p.000277: participation in this procedure.
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p.000279:
p.000279: Realization of significance of ethical review of biomedical studies facilitates attraction of grants from
p.000279: various funds and organizations to this field: these are foreign educational grants offered at the territory of Russia,
p.000279: for instance, by the Fogarty Fund, U.S. Civilian Research and Development Foundation (CRDF), or support for research
p.000279: projects in particular entities of the Russian Federation (for instance, a grant of the Academy of Sciences of the
p.000279: Republic of Tatarstan). They all facilitate wide spread of bioethical knowledge, realization of necessity for conduct
p.000279: of civilized ethical review of research projects in the sphere of medicine and provision of population safety during
p.000279: their conduct. In perspective, it will make possible for Russia to become a fully-functional participant in
p.000279: international biomedical researches and, eventually, result in closer cooperation of various countries in this sphere,
p.000279: strengthening of mutual trust, and at the next stage – mutual acknowledgement of approval for medicinal agents,
p.000279: new methods of treatment, products for medical use.
p.000279: There is the UNESCO Moscow Office (www.unesco.ru), which objectives are cooperation with Russia and
p.000279: post-Soviet countries in various educational and scientific programs including the ones on bioethics. Its
p.000279: activity Social and Humanitarian Sciences for promotion of knowledge, development of norms and establishment of
p.000279: intellectual cooperation in order to assist to social transformations includes cluster on Ethics of Science and
p.000279: Technology with emphasis on bioethics. The UNESCO Office facilitates development of institutions in the field
p.000279: of protection of human rights and dignity due to advances of biomedical researches. And starting from 2002 as to an
p.000279: initiative and with support of this organization there were conducted educational workshops, conferences for experience
p.000279: and knowledge exchange on bioethics issues – for instance, the International meeting of experts for development of
p.000279: cooperation in the sphere of ethics and bioethics in Minsk, 2005, for CIS and Baltic state, Promotion of
p.000279: knowledge in bioethics, Moldova, 2005; Social justice in health care: justice and human rights, Moscow,
p.000279: 2005.
p.000279: Current international scientific cooperation allows presenting scientific research results at conferences, meetings,
p.000279: and other scientific forums with bioethical orientation. At the same time, possibilities for joint organization of
p.000279: research conduct in this important field are still utilized insufficiently. It seems to be advisable to use
p.000279: financial support of international funds
p.000279: for transcultural studies, to set-up a specialized magazine to publish their results, to conduct on a regular
p.000279: basis specific scientific meetings within CIS that will provide opportunities for experience exchange,
p.000279: analysis of complex cases, collisions, and, possibly, for search for consensus in case of discrepancies and
p.000279: disagreements within CIS. Possibly, it makes sense to establish the Centre on Bioethics coordinating researches
p.000279: in this field, training specialists, promoting bioethics ideas and principles among various population groups. Also it
p.000279: appears to be of similar importance to introduce a separate trade, bioethics, within the list approved by the Higher
p.000279: Attestation Commission that will facilitate activation of research with participation of specialists of highest
p.000279: qualification.
p.000279: It is still of importance to provide methodical assistance to some of the CIS states for development of the ethical
p.000279: review system there, for helping them in developing positive public attitude in regard to necessity of such structures
p.000279: within the state, for training specialists able of conducting ethical review of biomedical researches. Ethical
p.000279: committees that have been created quite recently were yet unable to find their place in the society; they make just
p.000279: their first steps and require assistance. For that those ethical committees actually working in Russia through
p.000279: involving specialists of appropriate trade – full professors and professors of departments working on issues of
p.000279: biomedical ethics and medical law – are ready to set up and conduct educational cycles for members of ethical
p.000279: committees, clinical researchers, medical community. Ethical committees of Russia are open for discussion of joint
p.000279: scientific research for all comers. They are ready to assist in preparation of constituent documents and basics for
p.000279: methods of practical activities, to participate in development of ethical programs in various fields.
p.000279: From the point of view of harmonization of curriculum in different countries and, first of all, Europe,
p.000279: new opportunities are provided by the Bologna process. Joining of Russia to this process (de jure since
p.000279: September 2003) did not formally mean that the country should develop curriculum of set content but the very
p.000279: spirit of Bologna process (which main essence is consolidation of resources in Europe for effective competition at the
p.000279: educational market) implies convergence. Otherwise it would be impossible to attain mutual acknowledgement of
p.000279: educational qualifications and mobility of students and professors.
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p.000281:
p.000281: In regard to bioethical and legal education for the entire population Russia is in conditions bringing
p.000281: it closer to other post-Soviet states and making it different from countries of traditional democracy, since
p.000281: democratic changes emerged there in last decades only. Therefore, it seems of paramount importance to acquaint Russians
p.000281: with problems, tasks and possibilities of legal and bioethical regulation in the field of health care and biomedical
p.000281: science basing on effective experience of other countries and, especially, the ones of the so-called “near abroad”. It
p.000281: could be attained through creation of topical TV shows, round tables with specialists in various fields of biology and
p.000281: medicine, publications series of articles on pressing issues of bioethics and medical legislation, creation of Internet
p.000281: resources with this orientation. Changes of the Russian legislation that are awaited for a long time and,
p.000281: which is important, proper execution of legal and bioethical norms, without which it is impossible to secure
p.000281: respectful attitude to human rights and dignity in the sphere of bioethics, depend on general legal culture of
p.000281: people, their bioethical “maturity”.
p.000281: 3.9 REPUBLIC oF tAjIKIStAn (S.D.Achrorova)
p.000281:
p.000281: 3.9.1 Historical and Cultural Background
p.000281:
p.000281: Nowadays in Republic of Tajikistan, like all over the world, the need for biomedical research is growing steadily, as
p.000281: well as the concern for such human values as a person’s health, rights and dignity. Therefore, people of
p.000281: different professions, religions and nationalities have come together to form medical ethics committees that would
p.000281: perform ethical review of each research involving human subjects.
p.000281: The first Tajik State with the centre in Bukhara was founded by Ismail Samani in 875. In 999 the Samanide State
p.000281: was destroyed because of dissensions concerning territorial claims of Ismail Samani’s heirs.
p.000281: Later the land of Tajikistan formed a part of different states (Iran: 1212-1220 and 1740-1747; Genghis
p.000281: Khan Mongol Empire: 1220-1370; the State of Timurids: 1370-1740; Bukhara Khanate – the so called East
p.000281: Bukhara: 1747-1920). In 1867 northern territories of Tajikistan with the city of Khodjent entered the
p.000281: Russian Empire and were industrialized. In 1925 the Tajik Autonomous Soviet Socialist Republic was created as a
p.000281: part of Uzbekistan Republic, but in 1929 the Tajik Soviet Socialist Republic was made a separate constituent
p.000281: republic with the city of Dushanbe as its capital. In 1991 the Soviet Union collapsed, and Tajikistan declared
p.000281: its independence.
p.000281: Tajikistan is a mountainous landlocked country in Central Asia. Afghanistan borders to the south,
p.000281: Uzbekistan to the west, Kyrgyzstan to the North, and China to the east. The total area of Tajikistan Republic is
p.000281: 143.1 thousands of square km, and it has a population of 7,163,506 citizens. Tajikistan consists of 4 administrative
p.000281: divisions: 2 provinces (Sughd in the north and Khatlon in the south), 1 autonomous province (Gorno-Badakhshan
p.000281: - Pamir), and disrtricts of republican subordination around Dushanbe.
p.000281: Tajikistan is an agrarian-industrial country and has a considerable potential. Lengthy wars caused
p.000281: devastations and human losses, which resulted in a dramatic economic recession. However, during the last peaceful
p.000281: years the economics and living standard have notably increased.
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p.000283:
p.000283: The Tajik people have a rich and ancient culture. Since antiquity to the period of feudalism moral and
p.000283: ethical issues took an important place in religious and philosophical outlook. Until the IX century it had
p.000283: been developing in the context of Iranian philosophy, and later, since the 9th to the XV century in the
p.000283: context of Arabic philosophy. Due to the ethnic, language, social and political commonality in antiquity and the early
p.000283: Middle Ages particularly close relations were between East-Iranian (ancestors of the Tajiks) and West-Iranian
p.000283: (ancestors of the Persians) people. The Tajik- Persian philosophical thought had also a connection with Indian and
p.000283: Greek philosophy. However the closest links connected the Tajik culture and spiritual and philosophic outlook
p.000283: with cultures of Turkic peoples of Central Asia and Azerbaijan. There was a mutual enrichment of cultures, spiritual
p.000283: values and scientific achievements.
p.000283: Religious and philosophical ideas of Tajik ancestors roots back to an ancient monument of spiritual
p.000283: culture “Avesta” the holy canon of Zoroastrism (Mazdeism) containing not only religious dogmas but also
p.000283: ideas on cosmogony, philosophy, morals and law. The characteristic feature of Zoroastrianism is dualism, i.e. the view
p.000283: that two fundamental concepts exist, such as good and evil, and the struggle between these is the pivot and content of
p.000283: the universe. Zoroastrianism formulated a ternary ideal of the righteous man (“good thoughts”, “good words” and
p.000283: “good deeds”) opposed to the ternary ideal of the infidels (“wicked thoughts”, “wicked words” and “wicked deeds”). The
p.000283: Zoroastrian idea about infinite time as an initial substance gave rise to zervanism – a teaching in the framework of
p.000283: which a materialistic trend developed that denied the creation, and god as the creator of the universe, and
p.000283: affirmed the belief in the eternity of the world. In the end of the slave-owning system and in the beginning of
p.000283: feudalism, Manichaeism (Mani, 215-276) and Mazdakism (Mazdak, the end of the V - the beginning of the VI century)
p.000283: became very influential. Those philosophical trends assimilated the Zoroastrian ideal about the struggle
p.000283: between the good and the evil. The social doctrine of Mazdakism proclaimed ideas of justice and equality.
p.000283: The earliest written evidence that peoples of Central Asia had a good knowledge of mathematics and astronomy is
p.000283: “Avesta” containing data on the movement of celestial bodies, the system of time count and some mathematical rules.
p.000283: In that period, early states in Central Asia achieved a high
p.000283: level of material production and culture: crafts, agriculture, architecture and art. That was the time when many
p.000283: written monuments of religious, political and scientific thought were created, many of which were destroyed during the
p.000283: invasion of the army of the Arab Caliphate (VII-VIII centuries).
p.000283: During the VIII-XV centuries philosophical, social and political ideas were developing in the atmosphere of
p.000283: Arabian conquests and a forcible spreading of Islam. Spiritual cultures of Iranian and Arabic peoples became most
p.000283: closely linked. During the VIII-IX centuries, in Maverannahr (the right bank of Amudarya) and Khorosan the tendency to
p.000283: the territorial, language and cultural integration broken by the Arabian conquest had been growing. During the period
p.000283: of the Samanids rule (874-1005 AD), the Tajiks developed as a nation with its State system and
p.000283: literary language. In the IX-XI centuries, Central Asia was one of the most important centres of oriental
p.000283: science. That was the time when astronomical observatories, “Houses of Wisdom” and libraries were built.
p.000283: Scientists from Central Asia translated and commented the scientific heritage of ancient Greece and India and
p.000283: wrote original works on mathematics, astronomy, mineralogy, applied mechanics, physics, chemistry and medicine.
p.000283: Mohammed ibn Musa al-Khorezmi, Abdul Marvazi, Usman Balhi al-Fergani (IX c.), Abul-Vefa al-Buzjani, Abulmahmud Hudjani
p.000283: (X c.) and many others made an essential contribution to science. In the XI-XIV centuries Khorezm, Bukhara,
p.000283: Merv, Gazna and other towns, and later, in the XV century, Samarkand with the Ulugbek’s observatory,
p.000283: were outstanding scientific centres. The names of Biruni (X-XI c.), Omar Khayyam (XI-XII c.), al-Djurjani
p.000283: (XII c.), Naseeruddin Tusi, Shamsiddine Samarkandi, Djamaleddine Bukhoroi, Alishakh Buhoroi (XIIc.), Mohammed
p.000283: Samarkandi, Ansori (XIV c.) and others are associated with medieval towns. The leading scientists of the
p.000283: Samarkand scientific school were Kazi-zade ar-Rumi, Djemshid al-Kashi
p.000283: (XIV-XV c.), Ali Kushchi (XV c.), Abu Ali Ibn Sina and others.
p.000283: Ethics as a scientific trend had a significant place in works of prominent oriental thinkers, and Ali Ibn Sina
p.000283: (Abu Ali al-Husain ibn Sina-e Balkhi (Latinized Avicenna) one of them; a philosopher, musician, poet, physician,
p.000283: the follower of Aristotle, he was a scientist of encyclopaedic knowledge and one of the greatest minds of the Middle
p.000283: Ages. Roger Bacon was certainly right when he wrote that Ibn Sina was “the greatest teacher of philosophy after
p.000283: Aristotle”. The Tajik by birth, he was born in the suburb of Bukhara
p.000283:
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p.000285:
p.000285: (Afshon) in 980, lived in different cities of the Central Asia and Iran, served various rulers as a court
p.000285: physician and vizier, and died in 1037 near Hamadan.
p.000285: Abu Ali Ibn Sina wrote in the Arabic and Tajik languages. He left a rich scientific heritage – about 300 works, and
p.000285: among those “Book of Healing”, “Book of Knowledge”, “Book of Directions and Remarks”, “Book of Salvation” and
p.000285: “Canon of Medical Science”. The latter had been considered as one of the fundamental medical guidelines during
p.000285: five centuries. He was the author of works on philosophy (e.g. commentaries on Aristotle’s “Poetics”), wrote lyrical
p.000285: poetry, and some poems have survived to out time. Ibn Sina’s “Book of Healing” was the highest achievement of the
p.000285: medieval philosophy, particularly, as it tried to reconcile rationalistic thinking and religion. A great
p.000285: number of his works were translated into Latin in the second half of the XII century.
p.000285: “Book of Healing” in 18 volumes included “Logic”, “Poetics”, “Rhetoric”, “Physics” (in eight
p.000285: chapters; the sixth chapter was entitled “On the Soul”) and “Metaphysics”. Dominique Gundisalvi from
p.000285: Toledo completed the latter in 1180.
p.000285: Following Aristotle, Abu Ali Ibn Sina classified knowledge into theoretical and practical trends, and
p.000285: attributed ethics, economics and politics to the practical area. He considered problems of essence and existence in the
p.000285: light of Neoplatonism.
p.000285: The starting point of Aristotle’s ethical teaching was the theory that social life of human beings is realized
p.000285: in actions and in their interaction. Already in the first paragraph of “Great Ethics” Aristotle wrote that to act in
p.000285: social life, one should have certain ethical qualities and be a worthy man. To be a worthy man means to have virtues.
p.000285: Therefore, the one who intends to act in social and political life should be a virtuous man. Substance and form cannot
p.000285: exist independently, they are interconnected. In the so called “dispute of universalia”– one of the fundamental
p.000285: problems in medieval scholasticism – Abu Ali Ibn Sina followed Aristotle’s theory of interrelation of substance and
p.000285: form and believed that universalia exist both in things and in human mind. The latter elicits universalia from
p.000285: things, and even ante things (ante res) and after things (post res). Ibn Sina did not doubt that the world is
p.000285: intelligible and stressed the importance of logic considering it as an introduction to every science. With regard to
p.000285: psychology, Ibn Sina also
p.000285: followed Aristotle and distinguished the vegetable, animal and rational soul. He gave a special attention to
p.000285: the human soul and did not deny its immortality, not in the direct, but in the philosophical sense, i.e. he
p.000285: did not believe in metempsychosis. Neoplatonic ideas of Aristotle are present also in those philosophical views of Abu
p.000285: Ali Ibn Sina that contain elements of Sufism. Aristotle’s philosophy developed by Abu Ali Ibn Sina and his followers
p.000285: (including Omar Khayyam) was very popular in the orient. The teaching of Ibn Sina contained some materialistic elements
p.000285: (the idea of the eternal material world, sensualist elements in the theory of cognition, etc.). Ibn Sina’s talent shows
p.000285: itself most fully in the analysis of Neoplatonism philosophy. His works “Book of Healing” and “Book of Salvation” are
p.000285: still considered encyclopaedias of Muslim Neoplatonism. Another work by Ibn Sina “The Justice” that has not survived to
p.000285: our days presented an analysis and comparison of views of Alexandria and Baghdad schools of Neoplatonism. In “The
p.000285: Justice” Abu Ali Ibn Sina is an arbitrator between the two quite famous medieval philosophical schools. His book
p.000285: “Oriental Wisdom”, probably, also offered an analysis of works by oriental philosophers who commented on
p.000285: Neoplatonism considering views of Alexandria scientists. “Book of Directions” that was, by legend, Ibn Sina’s last
p.000285: work shows the author’s Sufi views. A number of works consider the problem of free will. Abu Ibn Sina associated
p.000285: free will with active, practical intellect, which stressed a purely ethical, not psychological, nature of his
p.000285: theory. A.K.Zakuev rightly noted that Ibn Sina’s teaching covers problems of regulating human behaviour, moral
p.000285: judgments, and of ethical compliance of human behaviour with commonly recognized moral principles and with an
p.000285: individual’s own views derived from those principles for regulating his/her behaviour of his/
p.000285: her own volition.
p.000285: Some works by Ibn Sina show us his adherence to certain aspects of Sufism and mystical symbolism. Famous for its
p.000285: encyclopaedic character, his philosophy served for reconciliation of religious views and rationalistic sciences, which
p.000285: alone would suffice to consider him an original philosopher. Avicenna had a noticeable influence on views of
p.000285: Thomas d’Aquin and Albert the Great – the two prominent medieval philosophers. Agiographic texts abound in
p.000285: evidences on remarkable abilities of Hadji Naseeruddin Obaidullah Ahmar from Maverannahr (1404-1490), a religious
p.000285: figure, who worked miracles to protect order, justice and the oppressed. His actions
p.000285:
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p.000287:
p.000287: showed his mercy to the oppressed and sternness towards oppressors and their accomplices who forgot the moral norms of
p.000287: Sharia. His style of behaviour demonstrated norms of righteousness, good deeds and ethical conduct.
p.000287: Abu Ali Ibn Sina was very popular among European scholastics (especially in the XIII c.). In the Middle
p.000287: Ages separate chapters from Avicenna’s “Book of Healing”, such as “Logic”, “On the Soul” and
p.000287: “Metaphysics” were translated into Latin, and Christian philosophers all over Europe considered themselves
p.000287: either followers of admirers of Abu Ali Ibn Sina.
p.000287: Ethical views of another great Tajik scientist, thinker and political figure of the XIII century Naseeruddin
p.000287: Tusi on the essence and norms of morals we find in his work “Ahloki Nosiri” composed of two parts: “On the fundamentals
p.000287: of morals” and “Doctrine of the purpose”. For him ethics as a science of behaviour is an essence of not only innate but
p.000287: also of acquired qualities, and being a product of social relations it may change according to social events. The
p.000287: author describes factors causing ethical changes.
p.000287: Ar-Razi proceeded from the materialistic tradition of Democritus who recognized natural regularities of nature
p.000287: and society and affirmed the cognoscibility of the world. Advanced ideas of Biruni who opposed the
p.000287: natural-science approach to the religious worldview were widespread. During the IX-XIV century, kalam, a scholastic
p.000287: philosophy of Islam that emerged in the VIII century, gained popularity and was opposing progressive views of Ibn Sina
p.000287: and his followers. Kalam defenders (Gazalii Fahruddin Rosi) advocated the idea of the Creation and believed that the
p.000287: world depends on the divine will. In the XI century, the teachings of Ismailism (a philosophical doctrine of Ismailism
p.000287: based on Neoplatonic and Aristotle’s views) became very influential (Nasir Hisrov). In their teaching on the
p.000287: harmony of the universe the Ismailis likened the constitution of the universe (“macrocosm”) to the constitution of
p.000287: human body (“microcosm”).
p.000287: Continuous internal wars in khanates of the Central Asia over XVI-XIX centuries resulted in the decline of productive
p.000287: forces, and living conditions of working masses changed for the worse. During that period, reactionary clergy was
p.000287: extremely influential, and repressed any scientific thought. The main attention was given to Muslim theology and
p.000287: ethics. The influence of the Sufi doctrine and literature with biographies of Sufi sheikhs and moral regulations of
p.000287: various Sufi Orders was particularly strong. Progressive
p.000287: tendencies and anti-feudal views were expressed in works by Tajik poets and thinkers, such as Binoi (1453-1512), Vasifi
p.000287: (1485-1551), Hiloli (executed in 1529), Saiido Nasafi (died in 1707 or in 1711), Bedil (1644-1721) and others. Their
p.000287: works reflected interests of working people and their protest against a feudal exploitation.
p.000287: Starting from the second half of the XIX century, the Russian Empire had a favourable influence on the development of
p.000287: philosophical and socio- political thought of the Tajik and other peoples of the Central Asia. Under the influence of
p.000287: Russian culture, democratic and enlightening views paved the way to Marxist-Leninist ideology. The involvement in the
p.000287: sphere of economic and scientific interests of Russia, despite an imperial policy of tsarism, facilitated the
p.000287: process of the implementation in Tajikistan of new and more developed agricultural and industrial machinery, transport
p.000287: equipment, new methods of farming and new crops. In the period from the end of the XIX to the beginning of the XX
p.000287: century, Russian culture influenced the development of the Tajik philosophical, scientific and engineering thought.
p.000287: Ahmad Donish, Hodji Halif, Hodji Jusup, Yakubi Farang, Hairat, Somi, Sobir, Asiri, Siddiki, Aini and others advocated
p.000287: ideas of national progress and social justice and criticized medieval feudal system. Scientific centres of Moscow,
p.000287: Leningrad and other cities were helpful in rising Tajik philosophers. The study of the history of Tajik philosophy and
p.000287: teachings of ancient peoples of the Central Asia was also very important. S.Aini, A.A.Semenov, A.M.Bogoutdinov,
p.000287: Z.Sh.Radzhabov, M.Boltaev, G.A.Ashurov, M.Dinorshoev, M.Radjabov and others analyzed in their works problems of the
p.000287: unity of the national and the international in the history of Tajik culture and philosophy, revealed special
p.000287: regularities of their development, the character of interaction with other philosophical trends and unmasked
p.000287: reactionary nature of Europocentric and Asiacentric concepts. Tajik scientists carried out studies in the
p.000287: sphere of dialectical, historical materialism and philosophy of natural sciences; they analyzed laws and categories of
p.000287: materialistic dialectics, objective regularities of historical development and conscious human activity,
p.000287: problems of education, formation of socialist nations, methodology of modern science, etc. (S.Umarov, M.S.Asimov,
p.000287: S.B.Morochnik, V.I.Pripisnov, M.Gafarova, A.Tursunov, I.Sharipov, S.A.Radjabov, K.Sabirov, M.Kamilov). The works on
p.000287: scientific atheism analyzed problems of developing a scientific and materialistic worldview, causes for
p.000287: survival of religious views and ways
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p.000289:
p.000289: to overcome the problem; gave a critical analysis of various religious concepts (A.Bazarov, R.Madjiev). There
p.000289: were also new studies in the field of sociology, ethics and aesthetics.
p.000289: The late eighties and early nineties were marked with complicated and contradictory events, the most significant
p.000289: of which was a disappearance of such a state as the USSR on the map of the world. Instead, about 15
p.000289: new independent states appeared, and Tajikistan among those. Thus, within a short historical interval Tajikistan
p.000289: moved from one historical period to another; the state and power structure changed, as well as its
p.000289: attributes. The former political system was destroyed, which resulted in the change of ownership patterns and social
p.000289: relations.
p.000289: The development of Tajikistan as an independent secular republic in the post-Soviet space was accompanied
p.000289: with economic, political and social instability. A significant support from the international community was
p.000289: directed to the needs associated with the civil was (1992-1995) and its consequences. Emergency measures of
p.000289: providing medicines, vaccines, bandaging material taken by the international community made an essential contribution
p.000289: into the solution of healthcare problems. At the same time, there was a need in more thorough structural changes that
p.000289: would help to overcome existing problems and facilitate the development of safe mechanisms for providing
p.000289: healthcare and safeguarding patients’ rights.
p.000289: As current biomedical researches are carried out at a large scale and at many Centres, they affect interests of many
p.000289: people and many countries. New problems emerge, because “rich” countries carry over their biomedical research to other,
p.000289: “poorer” countries, and use the results of the research at home, as, “poor” countries cannot afford to use the research
p.000289: findings for economic reasons. To eliminate this injustice, the medical community took certain measures. The WMA
p.000289: Declaration of Helsinki and the additional Protocol to the CE Convention on Human Rights and Biomedicine require
p.000289: that in the countries where a biomedical research is planned the permission should be sought from state structures, and
p.000289: interests of people who live there and who are potential research subjects should be considered.
p.000289: The involvement of Republic of Tajikistan, as an independent state, in international research projects
p.000289: requiring ethical review to ensure the compliance with international regulations triggered the process of
p.000289: establishing in Tajikistan the Committee on Medical Ethics and developing the system
p.000289: of State registration of pharmaceutical products, medical facilities and other medical goods.
p.000289: For a further development of medical ethical review of scientific-research projects, the Ministry of Health established
p.000289: the Republican Committee on Medical Ethics at the Department of the Management of Medical Personnel and Science (Order
p.000289: No 250; 4 of June 2004). The first research project that had to undergo ethical review to ensure the compliance
p.000289: with documents setting international rules in ethics was a joint Tajik-American research on AIDS and hepatitis C in
p.000289: drug addicts.
p.000289:
p.000289: 3.9.2. Legal Regulations
p.000289:
...
p.000291: competent design of biomedical research in Tajikistan – a Moslem country and an officially secular State – is not
p.000291: possible. Besides, there are strong believers practicing Islam and observing all religious holidays. Thus, many
p.000291: people keep the strict fast during the Ramadan. In this period people suffering from severe diseases, refuse taking
p.000291: medicines both per os and by injection, which is harmful to their health. Thus, for example, patients who have had
p.000291: operations for glaucoma refuse courses of conservative supportive therapy or keep the fast, which weakens visual
p.000291: functions. Quite often during the Ramadan people
p.000291: get to the surgery department of the emergency station with pancreonecrosis after having a rich and fat meal (pilaw) in
p.000291: the night after fasting during the day. In some cases this situation has a lethal outcome. Islamic traditions dictate a
p.000291: respectful attitude to the human body even after a person’s death and therefore relatives of the deceased do not
p.000291: consent to the post-mortem examination and removal of organs for transplantation. According to Moslem religion, the
p.000291: soul of the embryo appears in the first week of the fourth month of pregnancy, and the law prohibits abortion after
p.000291: this term. Besides, Tajikistan population is not disposed to contraception measures or abortion, and therefore Tajik
p.000291: families are commonly having many children. When carrying out preventive health examination of strong believers, it is
p.000291: important to divide them into separate streams according to sex.
p.000291: Artificial fertilization in Tajikistan is permitted. It is desirable to use sperm of the woman’s husband provided that
p.000291: his consent has been obtained. There are no strict religious restrictions with regard to transplantation and removal
p.000291: donor organs. Sharia laws state that medical professionals should struggle for a patient’s life to the last moment and
p.000291: totally reject euthanasia. These and other similar examples emphasize the necessity to consider cultural
p.000291: aspects with regard to providing medical care and conducting biomedical research in Tajikistan.
p.000291: Biomedical research if conducted without considering cultural and religious aspects may have negative
p.000291: consequences. The physician should follow certain rules not to harm religious feelings. This is essential both in
p.000291: planned and emergency treatment. However, often, particularly in providing emergency care, the physician, voluntarily
p.000291: or not, may be in a situation when he/she is violating a religious rule.
p.000291: When developing legislative acts referring to healthcare in Tajikistan we have followed the fundamental principles of
p.000291: the protection of human rights and dignity in biomedicine. The basic document is the Constitution of Tajikistan. The
p.000291: current Constitution is ensuring the priority of providing healthcare to the population of Tajikistan.
p.000291: The Constitution of Tajikistan proclaims citizens’ rights and freedoms and determines responsibilities of natural
p.000291: and juridical persons. One of the rights guaranteed by the Constitution is the right for health protection implying
p.000291: the following:
p.000291: - medical care and social protection;
p.000291:
p.000292: 292
p.000292:
p.000293: 293
p.000293:
p.000293: - safe environment, food products and drinking water;
p.000293: - qualified medical and sanitary care including a free choice of a physician and healthcare institution;
p.000293: - safe and healthy living and working conditions, as well as safe and healthy conditions for rest, education and
p.000293: upbringing;
p.000293: - sanitary and epidemiologic well-being in the territory where a person lives;
p.000293: - truthful and timely information about an individual’s health including existing and potential risks and the degree of
p.000293: risk;
p.000293: - participation in measures on health protection and public expertise with regard to these issues;
p.000293: - possibility to create public organizations for the purpose of facilitating health protection and protection of human
p.000293: rights;
p.000293: - legal assistance in any case of discrimination referring to health condition;
p.000293: - compensation for a caused harm;
p.000293: - making an appeal in the event of wrongful decisions or actions of healthcare professionals;
p.000293: - independent medical expertise in case of discordance with the decision of the State expertise.
p.000293: The healthcare legislation in Tajikistan includes Constitution norms, Tajikistan law “On the Protection
p.000293: of Population Health” and other national legislation acts, international regulations adopted by
p.000293: Tajikistan, international treaties and normative documents issued by state structures. All these documents state that
p.000293: the society and government are responsible to contemporaries and future generations for the health level of the
p.000293: Tajikistan population. The current legislation is regulating social relations in the sphere of healthcare covering a
p.000293: wide range of issues from a harmonious physical and spiritual development and the improvement of heredity to social and
p.000293: legal protection of the patient. The laws aim at improving conditions of work, life and rest, resolving
p.000293: ecological problems, developing the quality of medical care and promoting a healthy life-style.
p.000293: The first steps of the independent Tajikistan were accompanied with economic crisis in all fields including healthcare.
p.000293: Economic, political and social recession affected indices of the population health. Most urgent were problems
p.000293: concerning food, water supply, sanitary situation, the growth of
p.000293: infectious diseases (typhoid, malaria, tuberculosis, diphtheria, acute viral hepatitis) acute respiratory
p.000293: diseases, anemia, diseases caused by iodine deficit and reproductive health. Despite instability in
p.000293: political and socio- economic life during the first years of independence, Tajikistan Government took comprehensive
p.000293: measures on the protection of the population health. During that period, Tajikistan ratified important
p.000293: international documents referring to the protection of human rights such as the Convention on the Elimination of All
p.000293: Forms of Discrimination against Women (ratified in 1993), Convention on Children’s Rights (ratified in
p.000293: 1993). Presently, the following documents form the legislative basis in healthcare:
p.000293: - Constitution of Republic of Tajikistan (RT) (1994)
p.000293: - RT law “On AIDS Prevention” (No 904; 23 of December 1993)
p.000293: - RT law “On Donorship of Blood and its Components” (No 901; 23 December 1993)
p.000293: - RT law “On the State Sanitary Inspection” (No 987; 20 of July 1994)
p.000293: - RT law “On the Protection of Population Health” (No 419; 15 of May 1997)
p.000293: - RT Labour Code (1997).
p.000293: - Family Code (1997).
p.000293: - RT law “On Narcotic Drugs, Psychotropic and Precursors” (No 874, 10 of December 1999)
p.000293: - RT law “On Pharmaceutical Products and Pharmaceutical Activity” (No 39; 6 of August 2001)
p.000293: - RT law “On Psychiatric Care” (No 90, 2 of December 2000)
p.000293: - RT law “On Reproductive Health and Reproductive Rights” (No 72; 2 of December 2002)
p.000293: - RT law “On Private Medical Practice” (No 60; 3 of December 2000)
p.000293: - RT law “On Salt Iodination” (No 85; 2 of December 2002)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Tropical
p.000293: Diseases (Malaria) in Republic of Tajikistan in 1997-2005” (No 342, 4 of December 1997)
p.000293: - Decree of the RT Government “On the Approval of the National Programme for the Control of Viral
p.000293: Hepatitis “B” in Tajikistan in 2000- 2007” (No 100; 11 of March 2000)
p.000293:
p.000294: 294
p.000294:
p.000295: 295
p.000295:
p.000295: - Decree of the RT Government “On the Approval of the Concept of Healthcare Reformation in Republic of Tajikistan”
p.000295: (No 94; 4 of March 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Prevention and Control of
p.000295: HIV/AIDS/STD in Republic of Tajikistan in the Period to 2007” (No 475; 27 of November 2002)
p.000295: - Decree of the RT Government “On the RT Strategy for Preventing the Menace of AIDS Spreading for the Period of
p.000295: 2002-2005” (No 389; 1 of October 2002)
p.000295: - Decree of the RT Government “On the Approval of the RT Strategy for the Protection of Population Health in the Period
p.000295: to 2010” (No 436; 5 of November 2002)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for Tuberculosis Control for the
p.000295: Period 2003-2010” (№ 524; 31 of December 2002)
p.000295: - Decree of the RT Government “On Family Medicine” (2000)
p.000295: - Decree of the RT Government “On the Approval of the National Programme for the Development of a Healthy
p.000295: Life-Style in the Period to 2010 (No84; 3 of March 2003)
p.000295: The problem of protection of research subjects’ health and rights is reflected in strategic documents
p.000295: “The RT Strategy for the Protection of the Population Health in the Period to 2010”, “The RT Strategy
p.000295: of Reducing Poverty (2002)” and “The RT Strategy of Achieving Goals of the Development of the Millennium”. The
p.000295: documents aim at reducing mortality of children under 5 years of age by 2/3 and mortality of mothers by ¾; at improving
p.000295: access to the service of reproductive health, at preventing HIV/ AIDS spreading and at eliminating sex discrimination
p.000295: in the field of primary and secondary education. To ensure the national demographic policy, the Government approved
p.000295: and adopted the programme “The Concept of RT State Demographic Policy for the Period 2003-2015” (2002).
p.000295: The independent Tajikistan with its scientific potential in healthcare has reached a new, international level of
p.000295: science development, and therefore it is necessary to carry out ethical review of biomedical research in compliance
p.000295: with international regulations. The controlling body is the Committee on Medical Ethics (CME) at the RT Health
p.000295: Ministry. In its activity, the CME is guided by the Constitution of Republic Tajikistan. Documents regulating the
p.000295: CME practice comply with international legal standards and RT laws. The CME forms a part of the Forum for Ethics
p.000295: Committees in the Commonwealth of Independent States. The CME is to review and monitor scientific research in medicine
p.000295: and the compliance with ethical regulations to protect right and dignity of a research subject. Presently, the RT
p.000295: Government is considering the law “On the Protection of Human Rights and Dignity in Biomedical Research”
p.000295: based on the IPA CIS model Law “On the Protection of Human Rights and Dignity in Biomedical Research in CIS”.
p.000295:
p.000295: 3.9.3 Education in Bioethics
p.000295:
p.000295: In Tajikistan biomedical ethics is considered as a interdisciplinary field of knowledge analyzing moral problems of
p.000295: human attitude to living organisms. However meanwhile we do not have either a system of organizational and legal
p.000295: support or objective conditions for a proper development of bioethics. This implies an insufficient propagation of
p.000295: scientific knowledge and juridical culture both in medical community and public at large. Another factor is scarce
p.000295: technical equipment for biomedical research, though much is being done to improve the situation.
p.000295: In the XXI century, the reform of healthcare in Tajikistan is inseparably linked with scientific studies in the fields
p.000295: where the issues of bioethics are of vital importance. In western countries, bioethics is an advanced educational
p.000295: discipline. In the last decade some CIS countries, such as Russia, Ukraine, etc. have been introducing courses on
p.000295: bioethics into the syllabus of medical, philosophical and sociological faculties.
p.000295: At the Tajikistan Medical University ethics is taught within a Course on Ethics and Deontology at the Department of
p.000295: Philosophy. Education in ethics for undergraduate medical students helps them to develop their moral and ethical
p.000295: outlook and to make an appropriate and just decision when conducting a medical research. Unfortunately today
p.000295: bioethics as a special discipline is not included into the system of education in Tajikistan.
p.000295: Introduction of a course on biomedical ethics into the course of higher educational institutions in RT is the demand of
p.000295: the times as Tajikistan has taken the path of democratic development of the juridical civil state where reforms cover
p.000295: the total sphere of education for the purpose of forming a new outlook in professional training.
p.000295:
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p.000296:
p.000297: 297
p.000297:
p.000297: Humanities are essential components of professional training of a future physician as they enhance moral development
p.000297: and mutual understanding. We share the opinion that bioethics is a subject of interdisciplinary
p.000297: communication, and, with regard to medicine, it should be taught at institutes of higher medical education as moral and
p.000297: ethical knowledge used in patient- physician communication.
p.000297: Bioethics in CT is developing in several directions: education (medical, pedagogical, social, and economic);
p.000297: legislative regulation and establishment of ethics committees. Considering WHO recommendations (1994) on the
p.000297: introduction of a course on bioethics into the syllabi of medical educational institutions all over the world, and
p.000297: the necessity to work out and study moral and legal regulation and to implement into healthcare
p.000297: practice new biomedical technologies, it is essential to introduce into the practice of undergraduate and
p.000297: postgraduate education a systematic training of CT medical professionals in biomedical ethics. To achieve this
p.000297: goal, it is necessary to introduce into the State Standard of Higher Medical Education of RT the discipline “Biomedical
p.000297: Ethics” and to develop a programme of a general and special course. Already at the stage of master training and
p.000297: postgraduate studies, it is necessary to introduce a programme on ethical and legal problems of each medical specialty.
p.000297: One of the key elements here concerns ethical aspects of planning and conducting biomedical research, approbating and
p.000297: implementing new technologies. It is essential to develop a firm ethical position with regard to biomedical
p.000297: research, to introduce teaching programmes covering basic ethical principles for investigators and to
p.000297: establish a system of local ethics committees that review biomedical research.
p.000297: In the process of the formation of the Republican Committee on Medical Ethics (RCME) a seminar organized by a
p.000297: representative from J.Hopkins University (Baltimore, USA) was held in Dushanbe (2004) to train future RCME members.
p.000297: On completing the seminar, the students took exams and received certificates. In 2004 we also accomplished a
p.000297: project within the framework of a LIGP/ACTR/ACCELS Programme of the American Council for International Education and
p.000297: Culture at the Department of States.
p.000297: During the last two years from one to three professionals annually have attended courses on ethical review
p.000297: held in Almaty (Kazakhstan) at the Higher School of Public Healthcare.
p.000297: The implementation of European standards in CT and a new model of the teaching process require a cardinal change
p.000297: and structuring of all teaching programmes in compliance with the principles of the Bologna educational
p.000297: system.
p.000297:
p.000297: 3.9.4. The System of Ethical Review
p.000297:
p.000297: The current international system of a public and state control of safeguarding rights, dignity and autonomy
p.000297: of human subjects participating in biomedical research, and of compliance with universal ethical principles of
p.000297: biomedical research involving human subjects, implies the creation of independent public institutions – ethics
p.000297: committees.
p.000297: Ethics committees are analytical, consultative and monitoring units of various composition and status. They have to
p.000297: work out moral regulations for biomedical research, to carry out ethical review and give recommendations in case of
p.000297: conflicts arising in biomedical research or in medical practice. The Committee on Medical Ethics (CME) at the Health
p.000297: Ministry of Tajikistan performs these functions. To undergo ethical review, investigators should submit research
p.000297: proposals and their supporting documents to the CME secretary. Ethical review of biomedical research is carried
p.000297: out at the CME meeting in compliance with adopted regulations. The CME members may make positive, conditional (with
p.000297: clear suggestions for revision) and negative (in case of potential harm to research subjects’ rights and dignity)
p.000297: decisions on applications for the ethical review. They may monitor the compliance with ethical regulations throughout
p.000297: the research.
p.000297: Another significant aspect of the creation and development of the ethical review system is the review of
p.000297: dissertation works. There is an agreement between the Russian Federation and Tajikistan according to which
p.000297: certification and approval of candidate and doctoral dissertations is performed by the Expert Council for Medicine
p.000297: at the Higher Certifying Commission of the Ministry of Education of the Russian Federation. According to the
p.000297: Bulletin of the Higher Certifying Commission “On the Procedure of Biomedical Research Involving Human Subjects”
p.000297: (No 3, 2002), the Expert Council for Medicine emphasized that the chairpersons of dissertation councils should review
p.000297: both registered and new methods of diagnostics and treatment with regard to their compliance with
p.000297:
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p.000298:
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p.000299:
p.000299: international and Russian legislation on biomedical research involving human subjects.
p.000299: When planning clinical research within the framework of a dissertation work investigators should follow regulating
p.000299: documents of the health ministries of Tajikistan and the Russian Federation and obtain a written informed
p.000299: consent from research subjects or their legal representatives. The research project should be approved by the CME at
p.000299: the Health ministry of Tajikistan. Dissertation councils may only accept dissertations for review if they meet the
p.000299: abovementioned requirements.
p.000299: Though the CME at the Health Ministry of CT has been partially equipped with technical facilities, there
p.000299: are, unfortunately, a number of administrative and technical problems caused by the lack of a real financial
p.000299: support. This is the reason why the CME members cannot receive their education abroad, except participation
p.000299: in international conferences held by the FECCIS. Besides, we need funds to organize specialized seminars and courses
p.000299: for training members of regional and local ECs. There are serious financial problems concerning the publication of
p.000299: methodical materials.
p.000299: There is a pressing need to introduce a course on medical ethics into syllabi of institutes of higher medical
p.000299: education and medical colleges. Currently, a methodical manual on the principles of ethical review for
p.000299: undergraduate and post-graduate students is in active preparation.
p.000299: In 2003-2004, a group of physicians from the Republican Oncological Centre implemented a six-month educational
p.000299: project “The Initiative for the Protection of Patients’ Rights in Tajikistan”. The physicians found that,
p.000299: unfortunately, medical professionals lack knowledge on legislation referring to patient’s rights. The project’s
p.000299: objective was to conduct 20 educational seminars on ethical aspects of the patient—physician communication and
p.000299: mechanisms for safeguarding patients’ rights for physicians of healthcare institutions in Dushanbe and five other
p.000299: regions (Rudaki, Gissar, Tursun- Zade, Varzob and Vahdat). Unfortunately, medical professionals showed a low level
p.000299: of knowledge referring to patients’ rights. Thus, 50% of responding physicians in Dushanbe and about 100% of physicians
p.000299: in the regions did not have a proper knowledge on the relevant legislation. A survey revealed frequent cases of the
p.000299: violation of patients’ rights on different levels of medical and social services (50% of physicians
p.000299: mentioned healthcare institutions, 20% - institutions of social service, 30% - public authorities).
p.000299: Only 2% of respondents mentioned that patients might defend their rights via public institutions. According to the
p.000299: survey data, all physicians (100%) believe that medical secrecy implies non-disclosure of a diagnosis and that
p.000299: information on a patient’s health should be concealed from him/her, which conflicts with the Declaration of
p.000299: Patients’ Rights. However the majority of respondents gave correct answers to questions about the
p.000299: physician’s responsibility for a patient’s health if the patient refuses to follow medical prescriptions or regimen. As
p.000299: to legitimization of euthanasia in Tajikistan, 95% of respondents gave negative answers. The survey results show that
p.000299: the development of a mechanism for safeguarding patient’ rights should be in the centre of all healthcare reforms in
p.000299: Tajikistan. To develop the ethical review system, it is necessary to raise the level of professional ethical knowledge
...
p.000301: population and sanitary measures.
p.000301: Chepurovski, O.N.Teziakov, A.I.Smidovich et al.) tended to develop a new system of public healthcare based on
p.000301: democratic principles, equity, creative approach and with the emphasis on preventive medicine. Like V.V.Veresaev42,
p.000301: they were against an abnormal system of private medical practice that made physicians to live on those rubles and
p.000301: kopecks they received from their patients, and to live better they should wish to have more patients. In short,
p.000301: there was a conflict with ethical principles and morals – to build up one’s well-being on illnesses and sufferings of
p.000301: others.
p.000301: There were attempts to oppose those abnormal tendencies, and one of them was adoption of “The Code of Medical
p.000301: Ethics” proposed by the Society of Uman Physicians.
p.000301: In the Soviet period medical ethics used the best of what had been accumulated by preceding generations.
p.000301: All graduates from medical institutes took The Oath of the Soviet Physician that outlined main ethical principles.
p.000301: However in medicine, as in other fields, ethics principles were often marked with dogmatism which depreciated their
p.000301: role.
p.000301: At the beginning of the 1990s the process of establishing bioethics committees began in Ukraine. It was
p.000301: stimulated by the joint international projects with scientists from the USA and west European countries. In 1998 the
p.000301: National Committee on Bioethics at the National Academy of Sciences was established on UNESCO’s recommendation. In 2001
p.000301: it was transformed into the Commission for Bioethics at the Ukrainian Cabinet. Later, in the end of 2005, its
p.000301: activity was suspended. The Committee at the National Academy of Sciences became the central national
p.000301: organization again. Within this period two National Congresses with foreign participants were held in 2001 and 2004 as
p.000301: well as a number of international seminars and symposia on different aspects of bioethics, particularly on
p.000301: implementation of standard operational procedures for ethical review. Presently the third Congress is in active
p.000301: preparation.
p.000301: The Commission prepared for the Supreme Soviet recommendations on ratification of Convention on Human Rights and
p.000301: Biomedicine adopted by the Council of Europe and signed by Ukraine. In cooperation with the Ministry of Justice much
p.000301: work was done on comparing our legislation with main statements of every article of the Convention. It turned
p.000301: out that the existing
p.000301:
p.000301: 42 V.V. Veresaev (1867 – 1945) – a famous physician and writer, the author of “Notes of a Doctor”
p.000301:
p.000302: 302
p.000302:
p.000303: 303
p.000303:
p.000303: Ukraine legislation for the most part correspond to the Convention, and there are but some statements to be harmonized.
p.000303: This issue was discussed at the bilateral meeting in Strasbourg (2002). After that the Commission initiated the process
p.000303: of ratification. Currently the process is in its completion stage. After the ratification the Convention of the Council
p.000303: of Europe will have the force of law.
p.000303: Today commissions and committees on bioethics are actively working at the National Academy of Sciences, Ukrainian
p.000303: Academy of Medical Sciences and all medical universities, at research institutes and other biomedical
p.000303: institutions. Presently there are about 100 bioethics committe es and commissions functioning on
p.000303: different levels. Their work is particularly active in the Crimea, Lvov, Odessa and Kharkov. The main task of
p.000303: commissions and committees on bioethics is to promote ethical principles in all spheres of their institutions’ activity
p.000303: and perform ethical review of research projects. In the institutes of higher education they have to participate in
p.000303: teaching bioethics.
p.000303: Now we are facing a new stage: each committee or commission functioning at the local level should be
p.000303: accredited by the central institution and continuously provided with all relevant information. For this purpose we need
p.000303: to develop the system of accreditation and to establish the information centre. These are the principal directions of
p.000303: our current active work.
p.000303: Over the last two years the Supreme Certifying Commission of Ukraine have been carrying out ethical review of all
p.000303: dissertations in medicine and biology.
p.000303: We have established an effective cooperation with the Division on Bioethics at the Council of Europe. Within
p.000303: this period two bilateral meetings in Strasbourg and Kiev were held with the participation of authoritative
p.000303: experts Anna Maclaren (United Kingdom) and Maria Louisa Labat (France). Preparation for the Convention ratification
p.000303: and problems relating to the use of stemXcells were on the agenda. That was not only mutual exchange of
p.000303: information but also the search of adequate decisions. All participants agreed that fundamental research should go on
p.000303: the use of stemXcells should go on and that too much of advertising and commercialization discredits the whole thing.
p.000303: The third bilateral meeting is to be held in the end of 2007.
p.000303: The greatest achievement, however, is that bioethics gradually enters into the life of scientific laboratories and
p.000303: institutes as well as into syllabi of medical universities. Ethical review of new research projects has become a
p.000303: routine practice.
p.000303: 3.10.2. Legal Regulations
p.000303:
p.000303: The protection of human rights in biomedical research is a particularly important field requiring a special
p.000303: legislative approach. In Ukraine legislation there is a number of general and special acts setting both general
p.000303: principles concerning the protection of human rights in biomedical research and detailed statements regulating the
p.000303: order of conducting those.
p.000303: The Constitution of Ukraine (1966) is the main law proclaiming the priority of the individual, his/her life and health,
p.000303: dignity, honour, personal inviolability and safety, protection of human rights and freedoms (Art. 3). The Constitution
p.000303: states the principle of freedom and equality with regard to human rights and dignity (Art. 21); non-admission of
p.000303: discrimination (Art. 24); person’s inalienable right to life (Art. 27); everyone’s right to respect of his/her dignity,
p.000303: (Art. 28). Article 28 states in particular: “No person shall be subjected to medical, scientific or other experiments
p.000303: without his or her free consent”. Article 32 states that the collection, storage, use and dissemination of confidential
p.000303: information about a person without his or her consent shall not be permitted. The Constitution declares that everyone
p.000303: has the right to health protection, medical care and medical insurance (Art. 49); and that everyone has the right to an
p.000303: environment that is safe for life and health is guaranteed the right of free accessXtoXinformation about the
p.000303: environmental situation, the quality of food and consumer goods (Art. 50). Thus, The Constitution secures the
p.000303: fundamental human rights with regard to biomedical research.
p.000303: Another important document is “Basic Legislation on Public Health Service in Ukraine “. This law adopted in
p.000303: 1992 is continuously revised and amended. It sets general healthcare principles and those concerning
p.000303: biomedical research, defines state and public responsibility for the health level and preservation of the Ukraine gene
p.000303: pool.
p.000303: The “Basic Legislation” contains statements on professional standards. It stipulates that only those
p.000303: who have an appropriate education and qualification meeting uniform qualification requirements may take up medical and
...
p.000305: Human Rights and Biomedicine, should be taken into consideration as an increasingly determining factor in proportion to
p.000305: his or her age and degree of maturity (Convention, Art. 6) is not included into Ukrainian legislation. Neither is the
p.000305: item that adults who according to law do not have capacity to consent shall as far as possible take part in the
p.000305: decision-making procedure. However, there is a similar rule about informed consent to the application of new methods or
p.000305: pharmaceutical products concerning minors from 15 to 18 years of age and individuals with a limited capacity to consent
p.000305: (Art. 44.2 of Basic Legislation).
p.000305: The right to withdraw consent is not clearly stated either in the law or in the majority of other special
p.000305: laws but the Ukrainian law “On Pharmaceutical Products” (Art. 8). According to this law, a volunteer or the person’s
p.000305: legal representative can freely withdraw his or her consent to participate in clinical trials.
p.000305: There is no regulation relating to medical interventions for the benefit of the health of the person concerned
p.000305: in emergency situations when the appropriate informed consent cannot be obtained. For this case we need a legal
p.000305: norm stating that the previously expressed wishes relating to a medical intervention by a patient who is not, at the
p.000305: time of the intervention, in a condition to express his or her wishes should be taken into account.
p.000305: The law “On Pharmaceutical Products” states the necessity to obtain a written consent from a potential subject of a
p.000305: clinical trial or from his or her legal representative (Art. 8). This additional measure is connected with the danger
p.000305: of abuse and infringement of human rights.
p.000305: The right to information is closely related to the concept of informed consent. Recognition of this right is
p.000305: particularly essential for former soviet republics with their traditional paternalistic approach to physician-patient
p.000305: relationship. The transition to the concept of cooperation signifies the respect for the patient’s will, for his or her
p.000305: dignity and free choice. This is especially important for the sphere of biomedical research involving human subjects.
p.000305: The general rule is fixed in Ukrainian legislation – in Basic Legislation and in special laws. However,
p.000305: Basic Legislation says nothing about the confidentiality of private information, and corresponding
p.000305: statements can
p.000305:
p.000306: 306
p.000306:
p.000307: 307
p.000307:
p.000307: be found only in the Ukrainian laws “On Prevention of AIDS Disease and Social Protection of Population” (Art. 8) and
p.000307: “On Providing Psychiatric Care” where only the patient or his/her legal representative have the right to private
p.000307: information.
p.000307: The Ukrainian law “On Prohibition of Reproductive Human Cloning” is restricted to the sphere defined in the law title
p.000307: and does not regulate in any way embryo cloning “for therapeutic purposes”. It only prohibits importing cloned human
p.000307: embryos into Ukraine and exporting them from the country.
p.000307: Apart from abovementioned laws, there are many other legislative acts regulating, one way or another, issues relating
p.000307: to biomedical experiments. These are Ukrainian laws “On Scientific and Scientific/Technical Expertise”, “On Ensuring
p.000307: Sanitary and Epidemiologic Well-Being of the Population”, “On Healthcare”, “On Protection of People from
p.000307: Ionizing Radiation”, “On Measures against Tuberculosis”, “On Implantation of Pace-makers”, “On the Animal World” and
p.000307: “On Veterinary Medicine” and a number of other laws and Decrees of the Ukrainian Cabinet of Ministers,
p.000307: President’s Decrees and orders of the Ministry of Health. Noteworthy is the order of the Ukrainian Ministry of Health
p.000307: No 66 on February 2006 “On Rules of Conducting Clinical Trials of Pharmaceutical Products and Reviewing
p.000307: Materials of Clinical Trials”.
p.000307: With all this considerable number of regulating documents, there is no legislation in the sphere of human
p.000307: genome with regard to both general and specific principles. Almost unregulated is one of the most significant bioethics
p.000307: fields - in vitro research on embryos. Article 19 of the law “On Transplantation of Organs and Other Anatomical
p.000307: Materials” stipulates that it may be possible to use fetal material for transplantation, while issues relating to
p.000307: research on embryos and creation of human embryos for research purposes are not regulated.
p.000307: One of stimulating events that should facilitate the process of legal regulation in the sphere of biomedical
p.000307: research was signing of Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the
p.000307: Application of Biology and Medicine: Convention on Human Rights and Biomedicine in March 2002. This implied
p.000307: assuming political obligations to introduce relevant norms into national legislation (signing and ratification of an
p.000307: additional Protocol on biomedical research is meanwhile a more remote perspective). Today, on the instructions of the
p.000307: Cabinet on
p.000307: the necessity to ratify the Convention efforts are underway towards the development of a relevant legal and
p.000307: normative basis. There was an attempt to adopt a complex law on human rights and biomedicine by analogy with the
p.000307: Convention but the institutions where the draft law was submitted for consideration decided that it required an
p.000307: essential revision.
p.000307:
p.000307: 3.10.3. Education in Bioethics
p.000307:
p.000307: There are 17 institutes of higher medical education of the 4th level of accreditation (undergraduate level) and 3
p.000307: institutes for postgraduate training located in 14 provinces of Ukraine.
p.000307: Starting from 1990s some bioethics problems began to appear in the course of undergraduate and postgraduate training of
p.000307: medical professionals, biologists, social workers and veterinaries, and eventually special training modules and courses
p.000307: in bioethics have been designed.
p.000307: In 2004 the Ministry of Health approved an elective course in bioethics for students of the 5th year at medical
p.000307: universities and institutes of the 4th level of accreditation. The course consists of lectures (10 academic hours),
p.000307: practical seminars (17 academic hours) and students’ individual work (54 academic hours)
p.000307: Although the elective course in bioethics was adopted as a special course for institutes of higher
p.000307: medical education, today bioethics in Ukraine is usually taught not as a separate course but as a
p.000307: fragment of compulsory courses in philosophy of science and medicine, ethics, ethics and deontology of social
p.000307: work, valeology et al. The list of topics and number of hours depend on different teachers and their views on
p.000307: bioethics and the place it has in their courses.
p.000307: Bioethics is also taught at medical institutions for postgraduate training, at universities and polytechnic institutes,
p.000307: at veterinary academies and other institutes of higher education in Kiev, Lvov, Kharkov, Odessa, Vinnitsa and other
p.000307: Ukrainian cities.
p.000307: Thus the Department of Philosophy at National Medical Academy for Postgraduate Studies named after P.L.Shupik was one
p.000307: of the first in Ukraine to introduce in 2000 a compulsory course “Bioethics as Modern Medical Ethics” (12 hours) for
p.000307: postgraduate students. Bioethics is also included into some other courses offered by the Academy: “Sociocultural,
p.000307: Ethical and
p.000307:
p.000308: 308
p.000308:
p.000309: 309
p.000309:
p.000309: Deontological Aspects of Physician’s Activity” (18 h) for clinical residents; “Philosophy of Medicine” (36 h) for
p.000309: PhD students and PhD candidates; “Organization and Performance of Ethical Review of Biomedical Research” (36 h) for
p.000309: physicians and members of ethics committees at research institutes and institutes of higher medical education in
p.000309: Ukraine.
p.000309: A considerable experience in teaching bioethics has been accumulated at National Medical University named
p.000309: after A.A.Bogomolets and at Ukrainian Medical College (Kiev). A programme on experimental studies of bioethics
p.000309: basic principles was launched in 2000 at Ukrainian Medical College at National Medical University named
p.000309: after A.A.Bogomolets and has been successfully functioning since then. Within the framework of teaching
p.000309: seminar the following activities are carried out during every academic year:
p.000309: • Individual work – analysis of actual bioethical problems and situations; assistance in the preparation of
p.000309: a computer presentation; report presentation and a follow-up discussion;
p.000309: • Regular public open lectures by leading Ukrainian and Russian scientists on actual ethical problems
p.000309: relating to biomedical technologies;
p.000309: • Visiting teaching seminars on the basis of the Institute of Experimental and Theoretical Biophysics at the Russian
p.000309: Academy of Sciences (town of Pushchino, Russia)
p.000309: In Kiev compulsory courses in bioethics are also taught at the National Technical University (Department of
p.000309: Political Sciences, Sociology and Social Work), Academy of Labour and Social Relations (Department of
p.000309: Practical Psychology and Social Work), T. Schevchenko National University (Faculties of Ethics and Aesthetics,
p.000309: Biochemistry and Science Methodology), at the National Agrarian University et al.
p.000309: In the western region of Ukraine bioethics is taught in the context of fundamental principles of
p.000309: Christian moral (Ivano-Frankovsk Medical Academy, Lvov Theological Academy, Lvov State Academy of Veterinary
p.000309: Medicine named by S.Z.Gzhitsky, Lvov State Medical University named after D. Galitsky, The Western Branch of
p.000309: Interregional Academy of Personnel Management et al.). Thus Lvov Medical University offers an elective
p.000309: course in bioethics for students in the 3rd year at every faculty. There are also seminars (16 h) for
p.000309: physicians and teaching staff held at the Department of Healthcare Organization and Management. To provide the
p.000309: teaching process with methodical materials, The Training and Methodical Centre for Bioethics was established at the
p.000309: University.
p.000309: Institutes of higher education in Kharkov became methodical centres of teaching bioethics in the Eastearn Ukraine.
p.000309: Since 2004 the Department of Valeology at the Faculty of Philosophy of Kharkov National University named after
p.000309: V.Karazin has been offering a special course “Bioethics as the Ethics of Health” (90 hours). The course
p.000309: was designed for students of the 2nd year who are trained as teachers in valeology. At all faculties of Kharkov
p.000309: Medical University bioethics is taught as an elective seminar course. Kharkov Zoo-Veterinary Academy has a
p.000309: noteworthy experience of teaching bioethics based on the use of alternative methods of studying anatomy and physiology
p.000309: of human beings and animals.
p.000309: At Vinnitsa National Medical University named after N.I. Pirogov bioethics is taught to students of the 3rd
p.000309: year (Faculty of Dentistry, 27h) and to students of the 5th year (Faculty of Pharmacology, 54 h). Both courses end with
p.000309: a test. Bioethics is also taught at institutes of higher education in Dnepropetrovsk, Zaporozhye, Lugansk, Odessa,
p.000309: Poltava, Sumy et al.
p.000309: Different public associations play an essential role in distribution of bioethical knowledge - such as
p.000309: All-Ukraine Public Organization “Ukraine Association on Bioethics”; Kiev Ecological and Cultural Centre; Kharkov
p.000309: Regional Society for Animal Protection and others. Due to their efforts a number of foreign materials were translated
p.000309: into Ukrainian language, books and manuals on teaching bioethics were written to be used in Ukrainian
p.000309: universities and institutes.
p.000309: The existing experience of teaching bioethics at Ukrainian institutes of higher education allows us to draw the
p.000309: following conclusions.
p.000309: The introduction of courses in bioethics in Ukraine, as in other post- soviet countries, is complicated by the fact
p.000309: that for a long time scientists and teachers had no opportunity to study foreign materials on the subject. The lack of
p.000309: home studies in the field of bioethics and the lack of comprehensive knowledge on theoretical, methodological,
p.000309: historical and cultural contexts of the development of bioethical discourse affects negatively the level and quality of
p.000309: teaching bioethics.
p.000309: On the other hand, in Ukraine, as in other European countries, there is a tendency of teaching bioethics as an
p.000309: applied biomedical ethics of a narrow professional character. At UNESCO seminar on problems of
p.000309:
p.000310: 310
p.000310:
p.000311: 311
p.000311:
p.000311: teaching bioethics in East European countries (Moscow, January 2005) it was mentioned that 70% of those who teach
p.000311: bioethics are physicians with a classical medical education. Thus, the majority of bioethics teachers have not studied
p.000311: ethics as an independent or philosophical discipline, which certainly affects the general tendency of education in
p.000311: bioethics and interpretation of basic bioethics problems.
p.000311: Currently there is an urgent need to teach bioethics as a special form of worldview, as an interdisciplinary science
p.000311: uniting separate fields of natural sciences and humanities. Bioethics should be considered and studied as
p.000311: global ethics (knowledge of humanity global problems and ways how to resolve those) and as a field involving
p.000311: different cultural traditions.
p.000311: Today opportunities for education in the field bioethics and Good Clinical Practice on the international level
p.000311: for specialists from Ukraine are restricted to separate training courses and seminars (including conferences,
p.000311: symposiums or congresses on bioethics and clinical research) held by public organizations, institutes of higher
p.000311: medical education, research institutes, National Academy of Sciences, National Academy of Medical Sciences and State
p.000311: Pharmacological centre of Ukraine.
p.000311: We do not have a system of education in GCP principles. The only course for training members of ethics committees
p.000311: “Organization and Performance of Ethical Review of Biomedical research” (36 h) was designed and adopted at the
p.000311: Department of Philosophy of National Academy for Postgraduate Training named after P.L.Shupik (Kiev).
p.000311: Over last 5 years several PhD dissertations in specialties “science philosophy” and “public management”
p.000311: directly related to medical and ecological ethics have been defended.
p.000311: Nowadays teaching bioethics as an academic discipline requires the combination of instrumental principles,
p.000311: approaches and standards of natural sciences with theoretical models and principles of humanities.
p.000311: Although teaching bioethics as a separate discipline has begun only 5-6 years ago, a high level of higher
p.000311: medical and humanitarian education, highly professional teachers, a sufficient number of libraries, internet
p.000311: offer a favorable opportunity for a further development of education in bioethics. Teaching bioethics as
p.000311: a compulsory discipline at medical, biological and humanitarian institutions of higher education will facilitate
p.000311: not only humanization but also algorithmization of specialists’ thought,
p.000311: democratization of professional activity, interdisciplinary integration of theoretical and practical knowledge as
p.000311: well as improving of teaching process as a whole.
p.000311:
p.000311: References
p.000311: 1 Vekovshina S.V., Kulichenko V.L. Bioethics: Origins and [Theoretical] Grounds (A Philosophical
p.000311: and Methodological Analysis) Kiev, 2002 (in Russian).
...
p.000313: academicians in the fields of biology, medicine, philosophy, as well as representatives of Ministry of
p.000313: Health, Ministry of Environmental Safety, Ministry of Education and Science, Ministry of Justice and of Academy of
p.000313: Medical Sciences and Academy of Agrarian Sciences were invited to take part in the work of the Committee.
p.000313: In 2002 Bioethics Committee at the Presidium of Academy of Medical Sciences of Ukraine was established. In cooperation
p.000313: with Ministry of Health it developed model regulations for medical ethics committees at scientific and medical
p.000313: institutions in line with modern international requirements. During these years a number of public organizations
p.000313: having a concern in bioethics have emerged, and the implementation of the system of ethical review for biomedical
p.000313: research has begun on a large scale.
p.000313: Today we have the following system of ethical review. Firstly, there are different laws and by-laws regulating
p.000313: biomedical research. The order of conducting clinical trials of pharmaceutical products and reviewing materials of
p.000313: clinical trials has been developed in compliance with the Articles 7 and 8 of the Ukrainian Law “On Pharmaceutical
p.000313: Products”43 and in line with requirements of the Directive 2001/20/EC of the European Parliament and of the
p.000313: Council EC ICH GCP44 and Declaration of Helsinki45. It was approved by the Order of the Ministry of health
p.000313: of Ukraine No 6646. The responsibility for reviewing documentation on clinical drug trials rests with the State
p.000313: Pharmacological Centre of the Ukrainian Ministry of Health.
p.000313: General principles of conducting clinical trials:
p.000313: • According to the sponsor’s choice, clinical trials are mostly conducted at specialized medical
p.000313: institutions the list of which is submitted by the Centre in accordance with established procedure and approved by the
p.000313: Ministry of Health.
p.000313: • All clinical trials are conducted in compliance with ethical principles set by Helsinki Declaration, and on the
p.000313: condition that the basic requirements relating to the protection of research subjects (patients or healthyXvolunteers)
p.000313: are observed. Clinical trials may only be conducted if the expected benefit justifies the risk.
p.000313: • All clinical trials are conducted only after a compulsory review of trial protocol by ethics committees
...
p.000315: also becoming a routine practice. In 2005 a compulsory ethical review of dissertation works in medicine,
p.000315: biology and veterinary medicine. The continuously growing amount of
p.000315: 47 www.pharma-Centre.kiev.ua/clinic/programm.doc
p.000315:
p.000316: 316
p.000316:
p.000317: 317
p.000317:
p.000317: work performed by ethics committees/commissions makes us think about the necessity of financing this work.
p.000317: New demands on the quality of ethical review require improving the work of existing local ethics committees. It
p.000317: is necessary to organize a continuing education of ethics committees members and to develop legal regulation of
p.000317: operation and interaction of committees at different levels.
p.000317:
p.000317: 3.10.5. Perspectives and Forms of International Cooperation
p.000317:
p.000317: World tendencies of bioethics development have an essential influence on its development in Ukraine. First local ethics
p.000317: committees in Ukraine were established in 1992. They were approved at the Board Meeting of the Ukrainian Ministry of
p.000317: Health, and thus became legitimate to carry out ethical review of scientific projects. This idea can be
p.000317: illustrated with two large international projects. The Institute of Pediatrics, Obstetrics and Gynecology of the
p.000317: Ukraine Academy of Medical Sciences participated in an international multicentre epidemiological study “Mother
p.000317: and Child”, and the Institute of Occupational Medicine of the Ukrainian Academy of Medical Sciences in cooperation
p.000317: with colleagues from USA conducted an ophthalmologic research in rescuers who had participated in the elimination of
p.000317: the Chernobyl accident. Both projects were carried out in cooperation with the University of Illinois and
p.000317: Columbia University (USA). Within the framework of the projects the teaching staff of universities provided a basic
p.000317: training in bioethics for Ukrainian medical specialists involved in the projects.
p.000317: Since 1998 Ukraine cooperates with different UN organizations including UNESCO that has initiated
p.000317: establishing the National Committee on Bioethics in Ukraine. In 1998 the Committee on Bioethics was established at the
p.000317: Presidium of the Ukraine National Academy of Sciences that had been functioning as a national agency till 2001. After
p.000317: the First National Congress on Bioethics with many participants from abroad (Kiev, 2001) the Commission on Bioethics at
p.000317: the Ukrainian Cabinet of Ministers was established. From the very beginning of its activity, the Commission established
p.000317: contacts with UNESCO, WHO, bioethics organizations at Council of Europe, European Parliament and European Union, in CIS
p.000317: countries, USA, Canada, Belgium, England and other countries. Our activity attracted attention of Vatican and
p.000317: of representatives of other confessions. Members of the Commission on Bioethics and other experts are
p.000317: taking part as delegates, participants and guests in different international congresses, conferences,
p.000317: seminars and working groups relating to bioethics.
p.000317: Ukraine is actively participating in conducting clinical trials of pharmaceutical products in the
p.000317: framework of multicentre international research. The National Pharmacological Centre of the Ukraine Ministry of
p.000317: Health, in cooperation with WHO, organizes clinical trials according GCP regulations in which compliance with
p.000317: bioethics principles is one of the cardinal elements.
p.000317: In the framework of national congresses, conferences and bilateral working groups with participants
p.000317: from Ukraine and the European Parliament joint seminars and workshops are held. Thus in March 2006,
p.000317: with the support of the Revival Foundation, in the framework of the Project “East-East: Partnership Beyond Borders” an
p.000317: international seminar was held where problems of standardization of rules for ethical review and ethics
p.000317: committees practice were considered with a particular emphasis on the issue of compliance with GCP
p.000317: requirements. Representatives from Latvia, Lithuania, Moldova, Estonia, the European Council and the GCP Alliance-
p.000317: Europe took part in the seminar. The seminar was held in the format of SIDCER “Recognition Programme” in
p.000317: the CIS. Such events are a unique experience for many countries of CIS, East and Central Europe.
p.000317: There is a continuing multilateral cooperation with FECCIS, with international unions of bioethics-related
p.000317: organizations of USA (PRIM&R), of Baltic countries and countries of Central Europe (2001-2007). This
p.000317: cooperation intensifies information exchange, structure development and training specialists in bioethics. In the
p.000317: framework of this work, information networks of bioethics committees at all levels is developing in countries
p.000317: of Central and East Europe. The main fields of cooperation are training in bioethics, ethics in the practice of
p.000317: scientific research and the development of the structure of ethics committees and organizations so as to improve the
p.000317: practice of ethical review.
p.000317: The practice of ethical review and an ethical follow-up procedure for research projects conducted in cooperation with
p.000317: the USA shows itself in the implementation of joint projects. The development of this practice ensures a high quality
p.000317: of ethical review of international projects which later is extended
p.000317:
p.000318: 318
p.000318:
p.000319: 319
p.000319:
p.000319: to the national level. Thus in 2005 the Ethics Committee of the Occupational Medicine at the Ukraine Academy of Medical
p.000319: Sciences was registered at the Office for Human Research Protection at the USA Government and received the Federalwide
p.000319: Assurance FWA00007871. Several local committees in Ukraine also have international registration numbers.
p.000319: Since November 1995 when Ukraine became a permanent member of the Council of Europe, a Ukraine representative has been
p.000319: working actively at the Steering Committee on Bioethics in Strasbourg (France). In the framework of this activity
p.000319: Ukraine participated in the development of international documents including the revised text of the “Convention
p.000319: of Human Rights and Biomedicine” (Oviedo, 1997). In 2004 the representative of Ukraine was elected to the Board of the
p.000319: Steering Committee on Bioethics as a Committee Reporter on the activity of Ethics Committees at medical research
p.000319: institutions. Two seminars on topical ethical problems in transplantology and cell therapy were held in Ukraine with
p.000319: the assistance and participation of CE experts. The representative of Ukraine takes part as a reporter in the
p.000319: educational project of the CE on implementation of CE documents on bioethics in the countries of the former Soviet
p.000319: Union. Currently, in the framework of the Steering Committee on Bioethics at the CE, Ukraine participates in the
p.000319: development of guidelines for a fetus and embryo protection and in the design of a protocol relating to genetic
p.000319: testing.
p.000319: International Seminar “Development of the Recommendations on Application of Standard Operational Procedures
p.000319: for Ethical Review of Biomedical Research” was held in the framework of the Second National Congress on Bioethics
p.000319: (Kiev, 2004) organized in cooperation with FECCIS and UNESCO. Experts and participants from CIS, Baltic States, the USA
p.000319: and Japan attended the Seminar.
p.000319: The main objective of the seminar was to discuss ways and methods of implementing Standard Operational Procedures
p.000319: into the practice of ethical evaluation of biomedical research in the countries of the former Soviet Union
p.000319: and neighbouring Baltic countries and countries of Eastern Europe. High ethical standards and requirements outlined in
p.000319: this document should be implemented into the practice of local ethics committees. At the same time we should consider
p.000319: specific local features of a particular region. Therefore we have to focus our attention on issues of interaction
p.000319: between regional, national and local ethics committees. Another important problem
...
p.000321: 4. Bioethics Manual. / Ed. P.V. Lopatin. М., 2005. 240 p. (in Russian)
p.000321: 5. Medical Ethics Manual. Translated from English. /Ed. Yu.M.
p.000321: Lopukhin, B.G.Yudin. М., 2004. 400 p. (in Russian)
p.000321: 6. http://www.bioethics.union.edu
p.000321: 3.11 REPUBLIC oF UzBEKIStAn (M.S. Abdullakhodjaeva)
p.000321:
p.000321: 3.11.1. Historical and Cultural Background
p.000321:
p.000321: The history of bioethics in Uzbekistan roots back to interpretations of ethical teachings in pre-Islamic tradition and
p.000321: in the Koran.
p.000321: Syncretism of the oriental philosophical tradition gave rise to a term that has no analogues in European culture –
p.000321: “adab” and “adabnoma” – a teaching describing the due behaviour of a well-brought-up person. The term combines the
p.000321: general education, the theory of ethics and norms of a polite behaviour. Both in a strictly scientific sense and by
p.000321: birth terms “ethics” and “adabnoma” are not identical; they differ in the approach to the study of ethics, in
p.000321: argumentation and in the focus of their attention (general abstract principles and/or a code of behaviour). Central
p.000321: Asian codes of behaviour “Kobusnoma” by Unsurmaol Kaykovus, the treatise “On Ethics” by Ibn Sina, “Four
p.000321: Conversations” be Arusi Samarkandi, “The Oriental Code of Decencies” by Sadyk Kashgari and many other works are
p.000321: fundamental methodological sources of Uzbek model of bioethics. Adabnoma, rather than Islam, provided a
p.000321: basis for the development of research ethics and medical practice in pre-Soviet time. Thus, distinctive features
p.000321: of national historical and cultural, philosophical and methodological sources of biomedical ethics in
p.000321: Uzbekistan are the pedagogical orientation and a pronounced didactic character. Such were traditions, norms
p.000321: and values of Zoroastrism and Islam and achievements in medicine and philosophy of the Moslem (Arabic)
p.000321: Renaissance, creative heritage of Central Asian thinkers and physicians Abu Ali Ibn Sina, Abu Abdullah
p.000321: Khorezmi, Abu Nasr Mohammed al-Farabi, Abu Raihan Beruni and other prominent figures representing Islamic
p.000321: philosophical and religious thought (Al Kindi, Abu Hamida Gazali, Ibn Rushda, Abu Bakra Ar-Razi). However,
p.000321: nowadays syncretism of oriental philosophy reveals itself in the fact that modern Uzbek philosophers and physicians do
p.000321: not make a clear distinction between secular and religious argumentation. Sacred texts have traditionally been a source
p.000321: of philosophical thought for Uzbek investigators. Western scientists usually state their positions. The Western
p.000321: bio[medical] ethics distinguishes between biomedical ethics based on religious teachings and secular biomedical ethics
p.000321:
p.000322: 322
p.000322:
p.000323: 323
p.000323:
p.000323: that uses ethical argumentation as such. Sacred texts offer a comprehensive collection of thoughts, and one may find in
p.000323: them confirmation from “above” of nearly any statement.
p.000323: Moslem teaching has developed special canons of the attitude to patients and disabled persons that, to a large
p.000323: extent, formed the basis for patient-physician relationship. First of all, Al Bukhari’s khadises remind Moslems
p.000323: that the Prophet suffered severely, and therefore, who, if not Him, knows better what it means to be ill and suffer
p.000323: (Abu Abdullah Muhammad ibn Ismoil al-Bukhoriy. Khadis. Al-jomi’ ac-cokhikh 4. Ishornali tiuplam. Tashkent, Komuslar
p.000323: bosh takhririiati, 1992. B. 3 – in Uzbek). Everything that befalls human beings is of God’s will. To visit the sick,
p.000323: even infants, is a duty of each Moslem. It is a tradition not to ask about the disease or name the disease aloud; one
p.000323: should ask about the general state of health and use euphemisms in telling the diagnosis: “that very illness”, “caught
p.000323: some cold”, “a bad illness”, etc. There are many variants. This is a kind of medical secrecy observed by persons in the
p.000323: patient’s environment. In the end of the visit the physician should say some words of support, to express his firm
p.000323: belief that the patient will recover, even if the physician knows that it is hardly possible. Moslems should support
p.000323: all disabled people and have mercy to ugly persons, because they are what they are of God’s will. To care for the
p.000323: disabled is the duty of all relatives and people from the community.
p.000323: Patients too have their duties. They have to bear their suffering as much as they can, not to grumble or fall into
p.000323: despair, to suppress one’s moans, not to ask for death. If a Moslem anticipates his death he should pay his debts,
p.000323: make his will and directions concerning funerals, beg everyone’s forgiveness and to repent of his sins
p.000323: (Sadyk-i-Kashgari M. Oriental Code of Decencies. Adab-ul-Salikhyn. Tashkent, 1992, pp. 35-37; in Uzbek). The precept
p.000323: “Thou should not ask for your death” suggests a direct answer to the question what Islamic teaching says about
p.000323: euthanasia. The person’s right to euthanasia, both active and passive still remains a topic of heated debates. Islam
p.000323: may not approve of either kind of euthanasia, as it is nothing but a conscious murder of a human being (even if he/she
p.000323: has a terminal illness) committed by another person, particularly by a physician. If the patient has a terminal
p.000323: illness, the physician’s duty is to relieve his/her suffering with various analgesics and to render moral support
p.000323: in the face of impending death, so that the patient would leave this world as a sensible person who
p.000323: completed all his/her earthy tasks, bid farewell to his/her relatives and repented before the Almighty Allah.
p.000323: Abu Ali Ibn Sina (980-1037) expressed his attitude to euthanasia in his “Biography” wrote that a
p.000323: seriously ill person consciously “broke the regimen for the last time”, which hastened his death. Here
p.000323: we have to mention his views on medical and ethical problems of dying and natural death. These views expand the scope
p.000323: of modern bioethics, which allows us to retransmit from the past entire strata of knowledge about the physician’s duty
p.000323: and search of new ways for applying ethics when it is necessary to care for a dying patient, to form behaviour
p.000323: standards in seriously ill patients, to safeguard their rights for a good death and to maintain their faith in
p.000323: spiritual and moral immortality of human soul.
p.000323: In the light of the aforesaid, Ibn Sina’s treatise “Illumination” that is not widely known among researches is of a
p.000323: particular interest. The treatise adds to concepts of natural death presented in “Canon”. In modern terms, the treatise
p.000323: suggests that the philosophy of death ensues logically from a moral comprehension of life. Ibn Sina offers a systemic
p.000323: substantiation of the natural death from the viewpoint of the right to a good death and in the light of the theory that
p.000323: death means “the return” to an origin. This idea was developed in many works, particularly in works by Ilya Mechnikov
p.000323: (1845- 1916) who attempted to explain the concept of “the instinct of natural death” from the viewpoint of biology and
p.000323: psychophysiology.
p.000323: With regard to ethical principles, “Canon of medical Science” is a literary source containing elements of
p.000323: bioethics. It differs from its antiquity analogues in the attempt to characterize medicine not only as a system of
p.000323: medical and biological knowledge, but also as a canon of spiritual and ethical basis of the entire medical science
p.000323: (“Avicenna and the ethics of science and technology today”. Division of Science and Technology Ethics, UNESCO, France,
p.000323: 2006, p. 1-16). There were many reasons why “Canon” excited much interest in different historical periods including the
p.000323: European Renaissance. However, there are no doubts that in “Canon of Medical Science” a human being for the first time
p.000323: becomes not merely a subject of an anatomical or physiological research but a person. It is noteworthy that the “Canon”
p.000323: is really permeated with humanistic ideas. It has a powerful spiritual and moral potential for the development of
p.000323: medical science the subject of which is not just a human being but also his/her life style with all the variety of
p.000323: cultural,
p.000323:
p.000324: 324
p.000324:
p.000325: 325
p.000325:
p.000325: legal, religious and other features. According to Ibn Sina, it is essential to humanize the process of bringing up
p.000325: healthyXpeople and to find the ways for maintaining and developing spiritual harmony throughout a person’s life.
p.000325: Ethical views of Ibn Sina are still topical nowadays. He saw a physician as a patient’s friend, tutor and helper.
p.000325: To fulfill this noble mission, the physician, apart from professional knowledge and experience, should have many
p.000325: positive qualities – mercy, respect for human dignity, readiness to self-sacrifice in a patient’s interests,
p.000325: etc.
p.000325: When analyzing Ibn Sina’s ethical precepts we should note that those were in line with Hippocrates’s teaching. Ibn Sina
p.000325: wrote: “The physician should read Hippocrates’s precepts so as to be able to show honesty and frankness when treating
p.000325: patients. He should keep his clothes clean, be neat and perfumed. When he visits a patient he should be amiable, and
p.000325: cheerful, and witty so that he could cheer the ill person, because support offered by the physician multiplies the
p.000325: strength of natural warmth”. He was tireless in calling upon physicians to develop their general and special knowledge,
p.000325: to exchange professional experience and travel. In those times, travels served to extend scientific contacts. In the
p.000325: Middle Ages, there were many charlatan “healers” and even physicians deceiving their patients. Reasons for that Ibn
p.000325: Sina saw in a poor medical training, as physicians were not taught to see in each person his/her unique world of
p.000325: his/her experience, sufferings and hopes. “Treat the person, not the disease” – that was his motto.
p.000325: Ibn Sina’s views on childhood are noteworthy. “Canon of Medical Science” states that child’s life and health
p.000325: should be objects of care, protection and a special regimen from the moment of conception, not just from the moment of
p.000325: birth. A newborn baby needs a wet nurse with a stable nervous system. Games are essential, as all educational
p.000325: and formative processes, starting from very early years, should proceed from games. One may not punish a child, as
p.000325: the task of a tutor and physician if to protect the child’s soul, to facilitate the development of the feeling of
p.000325: self-respect. It is particularly important to prohibit any punishment for children under age of five, i.e. at the age
p.000325: when a child does not realize the meaning of his/her actions. Abu Ali Ibn Sina believed that, irrespective of state and
p.000325: public benefits, a child should receive a good intellectual, moral and ethical education in the family and at school.
p.000325: In his works, Ali Abu Ibn Sina gave much attention to school education. Kind and well-educated teachers may only
p.000325: teach at school,
p.000325: where children are brought up and educated until the age of fourteen. A teacher should know well the subject
p.000325: he teaches; he should follow the moral principles and be an honest, loving and courageous person.
p.000325: In the system of Ibn Sina’s ethical views, a concept of mizaj implying the necessity of an entirely individual approach
p.000325: to each individual, irrespective of the person’s age of health condition and considering a unique combination of
p.000325: qualities on the individual and his/her living and working conditions.
p.000325: The knowledge of human nature and temperament is the basis of a physician’s strategy when maintaining a
p.000325: proper level of health, and, if need be, planning the therapy. A comprehensive study of the “Canon” helps us to tell a
p.000325: sanguine person from a phlegmatic one or a choleric person from a melancholy one, and to mark out characteristic
p.000325: biotypes. If we translate it into the language of modern bioethics, we can see clearly the logical construct of
p.000325: Hippocrates, Galen and Avicenna; treat not a disease but a person, and not just a person but also a biotype
p.000325: whose psychological responses are subordinate to its biological nature (mizaj), or temperament. Ages later Ivan
p.000325: Pavlov mentioned the biotypological approach used widely by Ibn Sina as a fruitful one, revealing “fundamental
p.000325: features” of human nature.
p.000325: Thus, “Canon of Medical Science” written in the times of the Oriental Renaissance, and very popular during the European
p.000325: Renaissance, nowadays, if profoundly studied, can contribute essentially to the theory of bioethics, and humanize
p.000325: modern medicine and healthcare. Fundamental ethical ideas of “Canon of Medical Science” uniting medicine and a worthy
p.000325: life in the philosophy of health are still topical nowadays. Moreover, it outruns, in many respects, our
p.000325: ideas on medical ethics. Indeed, Ibn Sina’s attempts to link problems of medicine with the mode of life and to create
p.000325: conditions for maintaining spiritual harmony throughout a person’s life are particularly significant nowadays.
p.000325: According Ibn Sina’s precepts, the physician should do not only his/her professional duties but also his/her moral duty
p.000325: (Kasymov
p.000325: A.I. Ethical Views of Abu Ali Ibn Sina (Avicenna). In: “Bioethics in Uzbekistan – Clinical, Philosophical
p.000325: and Legal Aspects.” Tashkent, 2006, pp. 57-62).
p.000325: In 2003, the Islamic Republic of Iran and UNESCO instituted the Avicenna prize for the development of modern
p.000325: bioethics in science. The role of Avicenna in the development of current bioethical views runs all through the book
p.000325: “Avicenna and the Ethics of Science Technology Today” published
p.000325:
p.000326: 326
p.000326:
p.000327: 327
p.000327:
p.000327: by UNESCO in 2006. Avicenna’s life and works invite us to think about the ethics of science. (“Avicenna and the Ethics
p.000327: of Science and Technology Today”. UNESCO, France, 2006, pp.1-18).
p.000327: The Moslem etiquette of attitude to the patient has been and is certainly influencing the content of professional
p.000327: ethics of Uzbekistan physicians. However, a transformation of the socio-economic development model that
p.000327: began after Uzbekistan had declared its independence in 1991, and, as a consequence, commercialization of
p.000327: medicine, resulted in a too rapid and radical transition to the principles of informed consent. In particularly
p.000327: difficult cases, Uzbekistan physicians prefer an indirect informing – they inform not the patient but his/her
p.000327: relatives. Physicians in countries with the domination of Roman Catholicism act in a similar way.
p.000327: Indeed, we find Moslem views on certain dilemmas of modern biomedical ethics have much in common with
p.000327: views of other orthodox religions. Islam having undergone many trials by the Soviet atheism and political extremism
p.000327: provides an ideological foundation for the development of bioethical values. However, it would be incorrect
p.000327: merely to reduce Uzbekistan ethical norms to Islamic ones. Uzbekistan is a secular state, and Islam adherents form
p.000327: but one of society segments, and religious norms are but one of the components of biomedical ethics in Uzbekistan. Many
p.000327: ethical and medical rules of social life exist not only in form of religious dogmas but also as traditions, rituals and
p.000327: folklore, which helps to observe the norms across generations.
p.000327: Biomedical ethics in Uzbekistan is open to world tendencies, such as globalization and westernization that have a
p.000327: strong impact on Uzbekistan science. Achievements in the field of informed consent, reproductive behaviour,
p.000327: etc. prove the response to world tendencies. The protection of universal human values, as well as traditional values is
p.000327: a key issue of the contemporary medical ethics in Uzbekistan.
p.000327: Thus, the Uzbekistan model of biomedical ethics is at the stage of intensive development. The intensity
p.000327: of research development in this field is predetermined by ethical tendencies in Uzbekistan education and
p.000327: philosophy existing throughout the history of Uzbekistan (Zagyrtdinove
p.000327: F.B. Peculiarities of Biomedical Ethics in Uzbekistan. In: “”Bioethics in Uzbekistan – Clinical, Philosophical
p.000327: and Legal Aspects.” Tashkent, 2006, pp. pp. 122-128).
p.000327: 3.11.2. Legal Regulations
p.000327:
p.000327: The State plays a key role in safeguarding social and economic rights of its citizens, and therefore
p.000327: the State social policy should be directed at maintaining social health, which is described by three groups of
p.000327: characteristics: 1) population health (physical, mental and social); 2) intellectual potential and the level of
p.000327: professional knowledge; 3) spiritual and moral values.
p.000327: To maintain and improve population health and to raise a healthy generation, the Ministry of Public
p.000327: Health of the Republic of Uzbekistan undertakes a considerable work on reforming healthcare based on a number of
p.000327: principles and with a special attention to:
p.000327: • the observance of constitutional rights to receive a qualified medical care and
p.000327: • the principle of an equitable access to medical service.
p.000327: Issues relating to social relations in medicine are regulated by the Constitution of the Republic of
p.000327: Uzbekistan (Art. 24, 26, 40, 43; 1922) and by laws directed to the protection of citizens’ rights in medicine.
p.000327: 1. “On the State Control” (3 of July 1992; revised editions: 6 of May 1995; 15 of April 1999; 31 of August 2000);
p.000327: 2. “On the Protection of Consumers’ Rights” (26 of April 1996; revised edition: 5 of April 2002);
p.000327: 3. “On the Protection of Citizens’ Health” (29 of August 1997);
p.000327: 4. “On Drugs and Pharmaceutical Activity” (25 of April 1997);
p.000327: 5. “On Narcotic and Psychoactive Drugs (19 of August 1999; revised edition: 15 of December 2000);
p.000327: 6. “On the Prevention of Diseases Caused by HIV” (19 of August 1999);
p.000327: 7. “On Providing Psychiatric Care” (31 of August 2000);
p.000327: 8. “Radiation Safety” (2001);
p.000327: 9. “On the Protection of Population from Tuberculosis” (11 of May 2001);
p.000327: 10. “On Donor Blood and Its Components” (12 of August 2002).
p.000327: Constitution of the Republic of Uzbekistan states that every citizen has the right to a qualified medical care (Art.
p.000327: 40).
p.000327:
p.000328: 328
p.000328:
p.000329: 329
p.000329:
p.000329: The law “On Protection of Citizens’ Health” adopted in 1996 sets out relevant principles of health protection and
p.000329: guarantees medical care for the citizens. In other words, the State safeguards citizens’ rights to the protection of
p.000329: health, stimulates the development of a healthy mode of life and regulates
p.000329:
p.000329: aid;
p.000329: - confidentiality with regard to information about applying for medical
p.000329:
p.000329: - voluntary consent to a medical intervention or refusal of it;
p.000329: - receiving information about his/her rights and responsibilities and his/
p.000329:
p.000329: the activity of state structures, national enterprises, institutions and public unions in the field of healthcare
p.000329: (Kolesnikova L. Some Legal Aspects of Regulating Physician--Patient Relationship. Materials of the First National
p.000329: Congress on Bioethics with International Participation. Tashkent, 2005, pp. 58-59; Kolesnikova L. Relations of Doctor
p.000329: and Patient in the Light of Laws in Force in Uzbekistan: Clinical, Philosophical and Legal Aspects. Tashkent, 2006, pp.
p.000329: 129-135).
p.000329: Article 3 of the Law defines main principles of citizens’ health protection:
p.000329: - observance of human rights in the field of health protection;
p.000329: - availability of medical care for all social strata;
p.000329: - the priority of preventive measures;
p.000329: - social protection of citizens in cases of health loss;
p.000329: - the unity of medical science and practice.
p.000329: According to Article 13 of the Law, “…the State ensures the protection against discrimination irrespective of a disease
p.000329: the citizen has. Appropriate sanctions should be applied in the event of infringement of the provisions contained in
p.000329: this Article”.
p.000329: Nevertheless, in current practice of physician—patient relationship there are cases of marginalization and
p.000329: stigmatization, which shows itself in relation to most vulnerable social groups – drug and alcohol addicts, sex
p.000329: workers, etc. In the event of diagnosing an “improper disease” (venereal diseases, AIDS) a patient is labeled as
p.000329: “shameful”. A suspicious attitude of medical staff to patients with such a diagnosis infringes patients’ rights, which
p.000329: affects their moral and psychological state and, consequently, has a negative impact on the treatment efficiency.
p.000329: According to Article 24 of the Law, the patient has the right to:
p.000329: - respectful and humane attitude of medical staff;
p.000329: - choice of a physician;
p.000329: - medical aid (examination, treatment, etc.) provided in compliance with relevant sanitary requirements;
p.000329: - consultation by a medical specialist on the patient’s request;
p.000329: her health condition;
p.000329: - compensation in the event of a damage to his/her health;
p.000329: - access to a lawyer or another representative for the protection of his/ her rights.
p.000329: In case of infringement of a patient’s rights, his/her legal representative may make a complaint to any instance.
p.000329: Article 34 of the law “On the Protection of Citizens’ Health” permits to conduct biomedical research involving human
p.000329: subjects at state institutions after laboratory experiments and with informed consent from a research
p.000329: participant.
p.000329: To protect patients’rights and dignity,Article 25 prohibits propagandizing, including information in mass media,
p.000329: methods of prevention, diagnostics and treatment, as well as pharmaceutical products unless they undergo trials.
p.000329: The law “On Protection of Citizens’ Health” is closely linked with the law of the Republic of Uzbekistan “On Protection
p.000329: of Consumers’ Rights”. The title reflects the essence of the law – to protect consumers of any services (general,
p.000329: community, trade services, etc.) including medical ones. According to the Law, “a consumer is a citizen (natural
p.000329: person) who purchases, orders or has an intention to purchase or order goods or a service for personal use or a private
p.000329: non-profit household”.
p.000329: A consumer of medical services is a patient having certain rights defined by the Law. It is difficult
p.000329: enough to put a patient on the same level as the consumer of general, community or trade services. To provide a
p.000329: comprehensive protection of a patient’s rights a special law is needed, however, in the absence of such a
p.000329: law, provisions of the law “On Protection of Consumers’ Rights” are applied.
p.000329: It is noteworthy that in the events of a damage to a patient’s life and health the guilty part (medical professionals)
p.000329: are liable to criminal prosecution or to disciplinary or financial sanctions as prescribed by Articles 989 and 1022 of
p.000329: the Civil Code of the Republic of Uzbekistan. According to the Articles mentioned, the person who has suffered undue
p.000329: harm and/or moral damage
p.000329:
p.000330: 330
p.000330:
p.000331: 331
p.000331:
p.000331: resulting from an intervention is entitled to fair financial compensation estimated according to the
p.000331: conditions and procedures prescribed by law.
p.000331: Currently, there are but single instances of suits brought by patients or their relatives against medical institutions.
p.000331: Uzbekistan has little experience in considering such complaints at court, because citizens are not properly informed
p.000331: about their rights. The lack of knowledge in this field negatively affects physician-patient relationships and the
p.000331: treatment efficiency. It is physicians’ professional duty to know patients’ and physicians’ rights and
p.000331: responsibilities. Incidentally, while the patient may be ignorant of his rights and responsibilities relating to
p.000331: medical care, the physician usually has this knowledge but intentionally conceals it from the patient,
p.000331: which is a disadvantage to both the patient and the physician.
p.000331: To involve medical professionals in educational activity aiming at informing patients about their rights, as
p.000331: well as physicians’ rights is one of urgent tasks for the healthcare system of Uzbekistan. .
p.000331: Ethical norms considering special features in relationship with patients from various age and social groups should have
p.000331: a significant place in the system regulating medical activity, particularly the rule of confidentiality relating to
p.000331: information obtained from the patient. This rule applies to adults (capable), minors (incapable or partially
p.000331: capable) and to persons with restricted capabilities who need a constant care.
p.000331: Ethical principles are essential in providing medical care to patients with sexuallyXtransmitted diseases. A
p.000331: more tolerant attitude of the society and law-enforcement bodies to patients from risk groups (sex workers,
...
p.000333: 1. Declaration of Helsinki
p.000333: 2. Universal Declaration on Human Rights (1948)
p.000333: 3. The Universal Declaration on the Human Genome and Human Rights (1997)
p.000333: 4. Monaco Declaration (18 of July 2001),
p.000333: 5. International Declaration on Human Genetic Data (adopted by UNESCO General Assembly; 16 of Octobe, 2003
p.000333: 6. Universal Declaration on Bioethics and Human Rights (UNESCO, 2005)
p.000333: 7. United Nations Declaration on Human Cloning (8 of March 2005)
p.000333: 8. ECOSOS Resolution “Genetic privacy and non-discrimination” (21 of July 2004)
p.000333: 9. Resolutions of ECOSOS Commission for Human Rights:
p.000333: - Human Rights and Bioethics (25 of April 2003);
p.000333: - Principles of biomedical ethics with regard to the role of medical professionals, particularly
p.000333: physicians, in the protection of prisoners or persons underXarrest against tortures and other cruel, inhuman or
p.000333: disgracing attitude and punishment (18 of December 1982);
p.000333: - Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of
p.000333: Mankind (10 of November 1975).
p.000333: In its activity the National Ethics Committee (NEC) of the Republic of Uzbekistan at the Ministry of Public Health of
p.000333: Uzbekistan uses also other international documents, such as
p.000333: 1. Final Act of the International Conference on Healthcare (New-York, 22 July 1946)
p.000333: 2. The Nuremberg Code (1947)
p.000333: 3. Universal Declaration on Human Rights 1948
p.000333: 4. Declaration of Helsinki (WHO, 1964, 2002)
p.000333: 5. European Agreement on Providing Medical Assistance to Persons Temporarily Residing in Other [Member] (Geneva, 17
p.000333: of October 1980)
p.000333: 6. Convention on Biological (Rio de Janeiro, 5 of June 1992)
p.000333: 7. Budapest Summit Decisions. Human Dimension (Budapest, 1994)
p.000333: 8. Agreement on Collaboration in Public Health Protection (Minsk, 26 of June 1992)
p.000333: 9. The Charter of Social Rights and Guarantees to the Citizens of Independent States (approved by the
p.000333: Inter-parliamentary Assembly of the Commonwealth of Independent States, 29 of October 1994)
p.000333: 10. Convention on Human Rights and Biomedicine (Council of Europe, 1996)
p.000333: 11. Note for Guidance on Good Clinical Practice (ICH, 1996)
p.000333: 12. WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
p.000333: 13. Model Law of IPA CIS “On the Protection of Human Rights and Dignity in Biomedical Research in the CIS” (2005)
p.000333: 14. International Ethical guidelines for Biomedical research Involving Human Subjects (WHO/CIOMS, 13 of June 1993/2003)
p.000333: 15. Report of the International Bioethics Committee on the Possibility of Elaborating a Universal Instrument on
p.000333: Bioethics (13 of June 2003)
p.000333: 16. UNESCO Programme on Bioethics: Priorities and Perspectives (17 of October 1999)
p.000333: 17. Implementation of the Universal Declaration on the Human. Genome and Human Rights (17 of November
p.000333: 1999)
p.000333: A number of national laws of the Republic of Uzbekistan relating to the implementation of international agreements in
p.000333: healthcare imply a possibility of a joint regulation by the national Uzbekistan legislation and international norms.
p.000333: Article 1 of the Law “on the Protection of Citizen’s Health” (No 265-I; 29 of August 1996) states that “if
p.000333: an international agreement sets out rules others than those in the national legislation, norms of the international
p.000333: agreement are applied”.
p.000333: Substantiation of certain approaches to resolving bioethics problems is nowadays in the centre of political,
p.000333: philosophical and religious investigations that are to offer guiding lines in our rapidly changing world. Thus, the
p.000333: necessity to consider existing religious moral norms and cultural traditions in making decisions on key bioethical
p.000333: problems was discussed at the International Congress of Bioethics (Teheran, 2005). For the independent the
p.000333: Republic of Uzbekistan this issue is particularly topical. Despite the secular character of Uzbekistan, many residents
p.000333: are practicing Islam and other religions. The clause on the liberty of conscience in the Constitution of the
p.000333: Republic of Uzbekistan reflects the respect for the feelings of believers in our country, and therefore specific
p.000333: features of religious thinking are to be considered in
p.000333:
p.000334: 334
p.000334:
p.000335: 335
p.000335:
p.000335: adopting the Code of the Republic of Uzbekistan on Bioethical Problems (Mukhamedova Z.M. Islamic Bioethics in
p.000335: Historical Context. In: “Materials of the First National Congress on Bioethics”, Tashkent, 2005, pp. 98-100).
p.000335: It is necessary to note that nowadays there is a number of ethical codes interpreting teachings of the Koran and Sunnah
p.000335: with regard to complicated medical and biological problems. Thus, there are the Islamic Code of Medical
p.000335: Ethics48 and Islamic Bioethics49 correlating their statements with the Islam teachings: the Koran, Shariat and
p.000335: Hasid.50 These Codes are used in Kuwait, Egypt, Saudi Arabia, Iran, Pakistan and in other countries with Moslem
p.000335: communities (Canada, USA et al.). These documents pave the way to the development of ethical and religious regulations
p.000335: for biomedicine in Uzbekistan.
p.000335: Despite measures taken in our country, there remain problems relating to the protection of human rights in healthcare.
p.000335: Monitoring surveys carried out by the Ombudsman of the Republic of Uzbekistan showed that citizens apply to different
p.000335: state structures not only because of a poor material and technical basis of healthcare institutions or lack of
p.000335: pharmaceuticals, but also because the violation of patients’ rights to information about their diseases and
p.000335: methods of their treatment. The majority of patients, particularly in rural areas, do not have any knowledge on
p.000335: their rights, as healthcare institutions have not established procedures for providing relevant information. Mostly,
p.000335: patients are informed of their responsibilities and regulations the patient has to observe at a healthcare institution.
p.000335: Violation patients’ rights frequently result also from a low level of legal knowledge in medical professionals. The
p.000335: analysis of complaints submitted
p.000335: 48 The Islamic code of medical ethics. World Med J 1982, Kuwait Document, Islamic Code of Medical Ethics,
p.000335: International Organization of Islamic Medicine, 1981, Proposed Medical Research Projects, edited by: Abdul Jawad M. As
p.000335: Sawai, Commission on Scientific Signs of Qur,an and Sunnah, 1992.
p.000335: 49 Abdallah S. Daar, A.Binsumeit Al Khitamy. Bioethics for clinicians: 21. Islamic bioethics CMAJ 2001; 164(1):60-3
p.000335: 50 Hathout H. Why an Islamic perspective? In: El-Gindy AR, editor. Health policy, ethics and human values:
p.000335: Islamic perspective. Kuwait: Islamic Organization of Medical Sciences; 1995. p. 81- 5.;Hamdani DH. Canadian
p.000335: Muslims on the eve of the twenty-first century. J Muslim Minority Affairs 1999; 19(2):197-209.
p.000335: to various state structures with regard to violation of citizens’ rights in healthcare show that conditions
p.000335: causing violation of citizens’ rights in this sphere are determined by a number of factors, such as:
p.000335: 1. imperfection of legislation referring to medical practice;
p.000335: 2. a low level of implementing normative and legal documents regulating the practice of healthcare system;
p.000335: 3. an inadequate level of citizens’ awareness of their rights and responsibilities in medicine.
p.000335: All abovementioned problems are the object of bioethics – a new field of knowledge rapidly developing all over the
p.000335: world for working out ways and methods for resolving problem situations in healthcare and in the sphere of new
p.000335: medical technologies. To improve the situation, the Republic of Uzbekistan worked out a draft law on medical
p.000335: practice.
p.000335: When designing the law attention has been paid to the following issues:
p.000335: 1. Modern medicine is a high-tech field; a rapid development of new biotechnologies, new treatment methods is
p.000335: continuously expanding ways of medical intervention in human body. Therefore, an individual needs new mechanisms of
p.000335: protection in the sphere of medicine, because a person’s health, life and dignity depend on them.
p.000335: 2. Issues concerning an appropriate quality of medical assistance, its availability, social justice, equality and
p.000335: non-discrimination in healthcare are also essential.
p.000335: 3. It is necessary to create a model of patient—physician relationship that would imply cooperation and dialogue
p.000335: between two parties equal in rights based on the respect for a person’s autonomy.
p.000335: 4. A patient has certain rights the violation of which entails not only moral but also judicial responsibility.
p.000335: Appropriate sanctions should be applied to a physician in the event of a damage done to a patient that resulted from
p.000335: unqualified and careless actions.
p.000335: 5. In setting out principles of medical practice, we have to think not only about an individual’s rights and freedoms
p.000335: but also about his/her dignity and integrity. The concept of human integrity covers an individual’s genetic structures,
p.000335: intellect and psyche. Any medical intervention is only possible with a voluntary and informed consent obtained from a
p.000335: person.
p.000335: 6. A necessary condition for a medical intervention is a patient’s voluntary and informed consent. A
p.000335: voluntary consent implies that it has been
p.000335:
p.000336: 336
p.000336:
p.000337: 337
p.000337:
p.000337: obtained without deception, concealing information or pressure. Consent is informed when it is given by a person who
p.000337: has been informed, in a plain and understandable language, about the purpose and nature of the suggested intervention,
p.000337: its possible risks and alternative treatment methods.
p.000337: 7. It is necessary to define in national legislation the status of embryos at different stages of their
p.000337: development. The lack of legal regulation here opens up opportunities for their commercial use or for a groundless
p.000337: accusation of physicians studying embryos. We need laws on human reproduction, human genetic structures,
p.000337: confidentiality of information obtained in genetic testing, etc.
p.000337: 8. Any restrictions of rights and freedoms of a patient with socially dangerous diseases may only be introduced in
p.000337: compliance with laws, but not following subordinate legislation adopted by healthcare bodies.
p.000337: 9. To improve legislation referring to healthcare, it is essential to remove merely declarative norms having
p.000337: no mechanisms or procedures for their implementation. The lack of mechanisms and procedures for a practical
p.000337: implementation of legal regulations results in violation of patients’ rights, an insufficient level of healthcare
p.000337: system efficiency, and, consequently, lowers patients’ trust in healthcare reforms carried out by the State.
p.000337: In the light of the above said, the draft project of the Law “On Medical Practice” has been designed. Chapter III of
p.000337: the Law (Articles 29-50) defines patients’ rights and responsibilities:
p.000337: • Article 29 sets out provisions for implementing patients’ rights;
p.000337: • Article 30 declares patients’ right to life;
p.000337: • Article 31 states patients’ right to non-discrimination;
p.000337: • Article 32 states patients’ right to a free choice;
p.000337: • Article 33 ensures patients’ safety in the field of healthcare;
p.000337: • Article 34 protects patients’ right to physical integrity with regard to medical interventions;
p.000337: • Article 35 ensures patients’ rights to religious freedom;
p.000337: • Article 36 states patients’ rights to pain relief;
p.000337: • Article 37 prohibits any measures putting pressure on patients for behavioural reasons;
p.000337: • Article 38 sets out patients’ right to participate in planning and conducting a treatment;
p.000337: • Article 39 states the right to receive medical information;
p.000337: • Article 40 sets out the right to introduce changes and amendments into medical information;
p.000337: • Article 41 ensures personal immunity when providing medical assistance;
p.000337: • Article 42 sets out the rule of informed consent;
p.000337: • Article 43 states patients’ right to refuse medical treatment;
p.000337: • Article 44 ensures patients’ right to receive a necessary medical care and its availability;
p.000337: • Article 45 states patients’ right to receive all necessary types and forms of medical care;
p.000337: • Article 46 sets out the right to medical care for non-residents of the Republic of Uzbekistan;
p.000337: • Article 47 ensures the right to medical care for residents of the Republic of Uzbekistan staying in the
p.000337: territory of other countries.
p.000337: The draft project of the Law includes provisions referring to the protection of patients’ rights in medical
p.000337: research. Thus, Article 48 states that any biomedical research involving human subjects may only be carried out after
p.000337: the person concerned has given consent to it, and the research project has been approved by the National Ethics
p.000337: Committee (NEC).
p.000337: When designing a research involving human subjects the physician should weigh thoroughly predictable risks to
p.000337: cause harm against potential benefit of the research.
p.000337: Biomedical research or a clinical trial may only be carried out after the person concerned has given free
p.000337: and informed consent to it based on information provided by the investigator.
p.000337: Physician-investigator should safeguard the patient’s right to withdraw his/her consent to participate in a research at
p.000337: any time and for any reason.
p.000337: This draft project of the law has been submitted to the Legislative Chamber of Uzbekistan Parliament; it
p.000337: has been discussed, and will be adopted in 2007.
p.000337: Alongside the patients’ rights, the Law “On Medical Practice” implies patients’ responsibilities. Thus, Article 47
p.000337: states that the patient should
p.000337: - to show tact and respect towards medical professionals;
p.000337: - to give comprehensive information necessary for the diagnostics and treatment of a disease;
p.000337:
p.000338: 338
p.000338:
p.000339: 339
p.000339:
p.000339: - to follow the physician’s prescriptions after having given consent to a medical intervention;
p.000339: - to comply with the routine of the healthcare institution;
p.000339: - to collaborate with the physician in the process of treatment;
p.000339: - to inform the physician without delay about a change in his/her health condition in the process of diagnostics and
p.000339: treatment;
p.000339: - to apply to the physician immediately if there is a suspicion of a disease or a disease posing hazard of a wide
p.000339: spreading;
p.000339: - to avoid any actions that may infringe other patients’ rights.
p.000339: It is essential to include into the draft project of the Law provisions on the physician’s rights and responsibilities
p.000339: that enhance the rapport with the patient, as both the patient and the physician become partners having reciprocal
p.000339: rights and responsibilities, and the right for one party, is the responsibility of another one.
p.000339: The Law “On Medical Practice” will facilitate the regulation of independent ethical review and safeguard the
p.000339: protection of rights and dignity of Uzbekistan citizens in biomedical trials.
p.000339: Legislative measures undertaken in Uzbekistan will be able to protect individuals, the society and humankind as a
p.000339: whole against undesirable or sometimes harmful consequences from the implementation of new biomedical
p.000339: technologies.
p.000339:
p.000339: 3.11.3. Education in Bioethics
p.000339:
p.000339: Problems of teaching bioethics arouse much discussion at all international forums on bioethics.
p.000339: According to UNESCO Ethics Education Programme (EEP), for the biennium 2004-2005 the activities in the area of ethics
p.000339: teaching have primarily focused on East and Central Europe. During 2006-2007 priority has been given to
p.000339: South-East Europe and part of the Arab region (Gulf region).
p.000339: To facilitate the development of new relations in Uzbekistan healthcare that would more adequately comply with
p.000339: current political and social conditions, all Uzbekistan institutes of higher medical institutions and
p.000339: universities (faculties of law, philosophy and biology) introduced regular courses on bioethics into the syllabi
p.000339: of undergraduate and postgraduate education.
p.000339: According to the State Standard of Education, at institutes of higher medical education bioethics is taught at two
p.000339: levels: 1st level --”Introduction to Bioethics” and 2nd level – “Biomedical ethics” for senior students (3rd year).
p.000339: In 1998, Tashkent Medical Academy (TMA) included the study of basic bioethical problems in the baccalaureate programme
p.000339: on social sciences and humanities. Since 2002 TMA is offering modules on bioethics for magistracy residents; in 2003
p.000339: the Faculty of Post-Graduate Education at the Tashkent Medical Academy included topics on bioethics into the
p.000339: programme for post-graduate education, and since 2004 bioethics is taught as an elective course.
p.000339: The Chair of Philosophy has designed a programme on bioethics and published a manual “Introduction to Bioethics”
p.000339: in Russian and Uzbek (2004). In 2005, an anonymous questionnaire on key bioethical problems was offered to medical
p.000339: students of the second year to assess the level of their training and the system of their values and general worldview
p.000339: [1].
p.000339: In the second year students study philosophical and legal aspects of bioethics. The course consists of
p.000339: lectures (10 hours) and seminars (10 hours).
p.000339: In the third year, bioethics is taught at all faculties (general medicine, dentistry, pediatrics, biomedicine, etc.).
p.000339: The course aims at raising the level of education in biomedical ethics and the professional level of future physicians.
p.000339: Their knowledge of bioethics will help them to avoid deontological and professional mistakes and to make decisions in
p.000339: difficult situations.
p.000339: The working group of the NEC in collaboration with the TMA professionals teaching bioethics has designed a
p.000339: programme on biomedical ethics for baccalaureate students. The course consists of five lectures (10 hours), 8
p.000339: seminars (17 hours) and 54 hours are given to individual work. The course ends up with a test.
p.000339: Themes vary depending on the course. The syllabus on bioethics covers the following topics: categorical issues of
p.000339: bioethics as a science (relation of the concepts “bioethics”, “biomedical ethics”, “medical ethics”, “ecological
p.000339: ethics”, “research ethics”; subject and tasks of bioethics; theory, principles and methods of biomedical ethics, etc.);
p.000339: international legislation on bioethics; history of medical ethics (including issues of spiritual development
p.000339: and
p.000339:
p.000340: 340
p.000340:
p.000341: 341
p.000341:
p.000341: education, of life and death reflected in works by scientists of different times and peoples; secular and religious
p.000341: aspects of modern biomedical ethics; specific features of biomedical ethics in Islamic countries and
p.000341: Zoroastrian medicine), etc. In addition to that, students should study the Constitution of the Republic of Uzbekistan
p.000341: (1992), as well as laws and normative documents regulating public relations in healthcare. All cardinal problems of
p.000341: theoretical and applied bioethics are considered including ethical problems in clinical trials and biomedical research
p.000341: involving human subjects and animals. Specific ethical problems associated with students’ specialization are also
p.000341: considered.
p.000341: The NEC of the Republic of Uzbekistan is carrying on an essential work on the development of a regular education in
p.000341: bioethics and on training home specialists in the field of modern bioethics.
p.000341: Since 2000, members of the NEC and of regional and local ethics committees have participated in training
p.000341: seminars on bioethics (2001 – Saint- Petersburg, Russia; 2001 – Kiev, Ukraine; 2002 – Almaty, Kazakhstan; 2003
p.000341: – Saint-Petersburg, Russia and Tashkent, Uzbekistan; 2004 – Kiev, Ukraine and Baku, Azerbaijan; 2005 – Yerevan,
p.000341: Armenia; Almaty, Kazakhstan and Tashkent, Uzbekistan; 2006 – Tashkent, Uzbekistan). Training seminars were organized by
p.000341: the Forum for Ethics in the Commonwealth of Independent States, US National Healthcare Union and American Centers for
p.000341: Disease Control and Prevention (CDCP) in collaboration with UNDP (World Bank/WHO), IPA CIS, EFGCP, UNESCO, EC
p.000341: and other international and national organizations. Training seminar on research ethics for members of NEC and local
p.000341: ECs of Uzbekistan that was held in Tashkent, Uzbekistan was conducted in the framework of SIDCER “Recognition
p.000341: Programme”. Within this seminar there were a training courses “Standard Operational Procedures” and “Human
p.000341: Subject Protection”. The training seminars covered the following issues:
p.000341: - The role of ethical review in biomedical research;
p.000341: - The role of SOPs in conducting ethical review, establishing ECs, choosing independent consultants and
p.000341: confidentiality agreement.
p.000341: The teaching programmes on ethics for EC members and programmes on GCP for postgraduate education were discussed at the
p.000341: seminars (C.Jankw, Austria) as well as Fogarty Programme (B.Yudin, Russia):
p.000341: - the procedure of establishing an EC and EC meetings;
p.000341: - legislative basis for the ethical review of biomedical research;
p.000341: - the procedure of obtaining informed consent.
p.000341: There were also training seminars for EC members from countries of Central Asia. Tashkent hosted training seminars
p.000341: “Principles of Ethics in Biomedical Research”(CDCP, 2003), “Principles of Conducting Ethical Review and
p.000341: Obtaining Informed Consent” (CDCP, 2005).
p.000341: In addition to training EC members, NEC of the Republic of Uzbekistan provides assistance in educating students and
p.000341: physicians with regard to the protection of human rights and dignity in modern medicine and biology. The
p.000341: introduction of a course on bioethics pursues the following goals: 1) to provide new knowledge; 2) to develop practical
p.000341: abilities; 3) to develop a conscious need for moral development [2].
p.000341: Recognizing the necessity of training professionals with a high level of proficiency, we shall use the following three
p.000341: variants of a course programme designed in the framework of the project “Bioethics for CIS Countries” (the head of the
p.000341: Project – B.G.Yudin):
p.000341: - Short-term course for investigators and EC members (held in Tashkent, 2005);
p.000341: - A programme for bioethics teachers;
p.000341: - A programme for training professionals with a high level of proficiency in bioethics.
p.000341: The introduction of a course on bioethics into syllabi of institutes of higher medical institutions in
p.000341: Uzbekistan meets the demands of the time and is connected with reformation processes in health care and education
p.000341: aiming at humanization and development of a new worldview in the context of the National model of training
p.000341: professionals and building a democratic and jural civil society.
p.000341:
p.000341: References
p.000341: 1. Atakhanov Sh.E., Mukhamedova Z.M. On the Necessity to Introduce the Course on Bioethics into the Higher Education.
p.000341: In: Materials of the First National Congress on Bioethics of the Republic of Uzbekistan. Tashkent, 2005, pp. 88-89 (in
p.000341: Russian).
p.000341: 2. Nazhmetdinova D.K., Mukhamedova Z.M. Problems of Bioethics in the Context of Moral Components of
p.000341: Medical Knowledge of Future Physicians. In: Materials of the First National Congress on Bioethics of the Republic of
p.000341: Uzbekistan. Tashkent, 2005, pp. 100-103 (in Russian).
p.000341:
p.000342: 342
p.000342:
p.000343: 343
p.000343:
p.000343: 3. Rustamova M.T. Ethical Education of Medical Students and its Role in the Protection of Patients’ Rights. In:
p.000343: Materials of the First National Congress on Bioethics of the Republic of Uzbekistan. Tashkent, 2005, pp. 105-106
p.000343: (in Russian).
p.000343: 4. Abdullakhodjaeva M.S., Mukhamedova Z.M., Rustamova M.T.. Avicenna and the ethics of science and
p.000343: technology today. In: Ethics of science and technology Exploration of the frontiers of science and ethics. UNESCO,
p.000343: France, 2006.
p.000343: 5. Zagrytdinova F. On Biomedical Ethical Problems. Tashkent, 2005, p. 131 (in Russian).
p.000343: 6. Mukhamedova Z.M. Introduction in Bioethics. Tashkent, 2004, p. 110 (in Russian).
p.000343: 7. Mukhamedova Z.M. Bioethics. Tashkent, 2006, p. 148.
p.000343: 8. Zagrytdinova F. Ethics: A Manual. Tashkent, 2005, p. 134.
p.000343:
p.000343: 3.11.4. The System of Ethical Review
p.000343:
p.000343: A rapid development of biology, pharmaceutical industry and new biotechnologies for diseases diagnostics,
p.000343: treatment and prevention required the review of clinical efficiency of new and generic pharmaceutical products and put
p.000343: in the forefront the necessity to protect human rights in biomedical research involving human subjects.
p.000343: The establishment of national, regional and local ECs facilitated a wide implementation of ethical review of
p.000343: biomedical research performed in Uzbekistan in compliance with international ethical principles and WHO Operational
p.000343: Guidelines for Ethics Committees that Review Biomedical Research (2000).
p.000343: The necessity to establish EC for conducting ethical review of clinical trials (CT) emerged in Uzbekistan in the
p.000343: end of the nineteenth. It was connected with involvement of Uzbekistan in international scientific projects, which
p.000343: implied conducting an ethical review in conformity with international ethical norms. Another important reason was the
p.000343: establishment of the State Registration of Pharmaceutical Products and Medical Facilities. Presently, the NEC conducts
p.000343: ethical review of CT of home and foreign pharmaceutical products and multi-centre research. From the very beginning the
p.000343: NEC has been conducted ethical review of biomedical research involving human
p.000343: subjects. The NEC controls the procedure of obtaining informed consent and other ethical aspects including the
p.000343: safety of research participants’ insurance and monitors the process of medical research to check the risks of the
p.000343: research. The NEC also controls educational programmes on bioethics in institutes of higher education, training
p.000343: seminars and conferences on bioethics and publications in medical journals and mass media. It is responsible for a
p.000343: prompt notification of authorized bodies in the case of any unexpected adverse effects that are hazardous to research
p.000343: participants or other persons associated with the research, in the event of any serious violation of ethical norms or
p.000343: in the case of the suspension/termination of a research involving human subjects that was previously approved by the
p.000343: NEC and conducted in Uzbekistan or with the participation of Uzbekistan.
p.000343: In 2000, the minister of public health approved the document Regulations for the National Ethics Committee at the
p.000343: Medical Scientific Council of the Ministry of Public Health of the Republic of Uzbekistan”. The Regulations define the
p.000343: tasks, responsibilities and rights of the Committee, as well as its structure and procedures.
p.000343: In 2003, the document was revised. It included a wider range of tasks, a more detailed description of the NEC
p.000343: organization activity, procedures, rights and responsibilities (in particular, a new clause “Responsibilities
p.000343: of Investigators and Research Directors” was added). The NEC is an independent institution created on a
p.000343: voluntary basis at the Ministry of Public Health for the protection of human rights, health and safety in biomedical
p.000343: research. Currently, the Regulations for the NEC (adopted on June 20, 2005) are in full compliance with relevant
p.000343: international principles and norms.
p.000343: In connection with the completion of establishing local ECs throughout the Republic of Uzbekistan, and to improve their
p.000343: activity, a new and more comprehensive version of the Regulations for local ECs was discussed and adopted at
p.000343: the First National Congress on Bioethics with international participation. The Regulations state that local ECs
p.000343: are created under the aegis of the NEC at patient care institutions and research institutes in form of a public unit
p.000343: that is not registered as a juridical person. Local ECs are responsible for monitoring biomedical research approved by
p.000343: the NEC at the site of the research with regard to compliance with the review procedures, obtaining informed consent
p.000343: from the research subjects, research safety (serious adverse effects, inadequate reaction) and notifying
p.000343: NEC if the
p.000343:
p.000344: 344
p.000344:
p.000345: 345
p.000345:
p.000345: research should be terminated because of complications arising in the course of the biomedical research). Local ECs
p.000345: describe the results of their activity in form of an annual report that are archived and retained at local
p.000345: ECs. Operational procedures and rules relating to documenting and archiving should ensure confidentiality of
p.000345: local ECs performance. At the same time the activity of ECs at all levels should be open to the society, which is
p.000345: stated in relevant documents. Information about ECs members, work schedule and decisions may not be confidential.
p.000345: Thus, Republic of Uzbekistan created a multilevel system for ethical review of biomedical research. In compliance with
p.000345: WHO recommendations the NEC members are leading Uzbekistan scientists with experience in various fields of medical
p.000345: and other sciences (biology, law, genetics, philosophy) and representatives of religious and public institutions,
p.000345: ombudsmen and a representative of the National Centre for Human Rights. Regional and local ECs established at regional
p.000345: centers (Samarkand, Bukhara, Andijan, Nukus) and large clinical sites at institutes of higher medical education and
p.000345: research institutes are also headed by eminent Uzbekistan scientists.
p.000345: The NEC reviews international research projects involving human subjects and makes its decisions about the
p.000345: project. The NEC of Republic Uzbekistan has been registered at American Centers for Information Disease Control
p.000345: (Atlanta) and American Centers for Disease Control and Prevention (NAMRO-3, Cairo).
p.000345: The NEC functions in conformity with Standard Operational Procedures (SOPs) designed in the process of a regular work.
p.000345: According to the NEC procedures, the documents should be reviewed within 7-30 days (expedited or regular review). Since
p.000345: the time of its establishment, the NEC has reviewed over 320 various projects including joint international
p.000345: research projects, research projects designed by Uzbekistan scientists and dissertations based on biomedical research
p.000345: involving human subjects.
p.000345: The NEC review also projects of clinical trials of pharmaceutical products, of medical equipment and other products for
p.000345: medical needs. Usually research projects meet ethical requirements, and the NEC makes positive decisions. Sometimes,
p.000345: however, there are cases when the NEC declines a project. This usually concerns clinical trials of a non-registered
p.000345: pharmaceutical product or of a new rout of a known drug administration when there is no approval by the Pharmacological
p.000345: Committee or the drug is hazardous to a patient’s
p.000345: health. Negative decisions are also made if the risk of complications or adverse effects is very high. The
p.000345: main criterion for an objective and reliable judgment about efficiency and safety of a pharmaceutical product
p.000345: is a clinical trial that ensures the safety of its participants. The Pharmacological Committee established in 1992
p.000345: at the Central Department for Control of Pharmaceutical Products and Medical Equipment within the Ministry
p.000345: of Public Health of the Republic of Uzbekistan conducts a scientific review of research projects. Acknowledging the
p.000345: importance of ethical review for a biomedical research the Pharmacological Committee closely collaborates with the NEC,
p.000345: which is very helpful with regard to such ethical problems as the protection of rights and interests of CT subjects. To
p.000345: obtain the permission for a CT the relevant documents are first submitted to the Pharmacological Committee that
p.000345: conducts its own review, and only after approval by the Committee the documents may be submitted to the
p.000345: NEC for the ethical review. Chairpersons of local ECs representing institutions that are planning to conduct
p.000345: clinical trials are present at the NEC meetings.
p.000345: In the period from 1992 to 2005 inclusive, the Pharmacological Committee reviewed 910 clinical trials of
p.000345: pharmaceutical products (312 of those were from domestic and 598 from foreign manufacturers) belonging to various
p.000345: pharmaco-logical groups. Starting from 2001 the number of clinical trials has increased, which is mainly
p.000345: connected with new requirements relating to the registration of pharmaceutical products. It is noteworthy,
p.000345: that starting from 2001 all clinical trials have been conducted according to uniform guidelines complying
p.000345: with GCP for both domestic and foreign manufacturers. Clinical trials have been carried out at more than 60 medical
p.000345: institutions authorized by the Ministry of Public Health. During that period, 25 pharmaceutical products from both
p.000345: domestic and foreign manufacturers have been declined because of their low efficiency and/or expressed adverse effects.
p.000345: The first experience in actual application of ethical principles strictly according to GCP was gained in multicentre
p.000345: trials organized by large foreign pharmaceutical firms.
p.000345: To safeguard the protection of CT subjects, all documents relating to preclinical trials of toxicity and
p.000345: pharmaceutical activity of both new and generic pharmaceutical products should be most thoroughly studied
p.000345: and analyzed. Preclinical trials are conducted according to “Guidelines on
p.000345:
p.000346: 346
p.000346:
p.000347: 347
p.000347:
p.000347: Preclinical Trials of Pharmaceutical Products Safety” stating that placebo is used only to study pharmaceutical
p.000347: products for adjuvant therapy in patients with a mild or medium degree of a disease. Besides, there are
p.000347: special conditions for research participants from vulnerable groups.
p.000347: In 2001 paragraphs referring to CT ethics were included into the “Guidelines for Conducting Clinical Trials
p.000347: of Pharmaceutical Products and Expertise of Trial Materials”. Now, apart from the research Protocol and individual
p.000347: registration form, documentation submitted by the applicant to the NEC should include written informed consent forms
p.000347: signed by potential trial participants.
p.000347: The NEC activity in the sphere of implementing ethical principles into medical science and healthcare enhanced the
p.000347: quality of patient—physician relationship and of medical services provided by healthcare institutions. This
p.000347: also served to reduce the number of complaints from patients.
p.000347: The NEC coordinates its activity with the Centre of Science and Technology. The latter considers applied,
p.000347: fundamental and innovation grant projects relating to biomedical research after they were approved by the NEC.
p.000347: The NEC collaborates with the Higher Certifying Commission at the Cabinet of the Republic of Uzbekistan. According
p.000347: to the petition of the NEC Medical Council “On the Necessity to Conduct Ethical Review of Dissertation
p.000347: Works Involving Patients or Volunteers as Research Subjects” (Protocol No 25, 2002) the Commission considers
p.000347: dissertation works only after the NEC permission to carry out the research (including biomedical research with animals)
p.000347: was obtained.
p.000347: The NEC participated in the organization of the First National Congress on Bioethics with international participation
p.000347: (2005) and a scientific conference “Ethical Aspects of New Biotechnologies in Biology and Medicine” (2006). It
p.000347: facilitated the publication of the Conference papers and of a book “Bioethics in Uzbekistan. Clinical, Philosophical
p.000347: and Legal Aspects” (2006).
p.000347: At the First National Congress four trends in bioethics were discussed:
p.000347: - ethical problems in science;
p.000347: - legal aspects of bioethics;
p.000347: - bioethics and education;
p.000347: - bioethics and the environment.
p.000347: A special attention was given to ethical aspects of new biotechnologies, patient-physician relationships in various
p.000347: fields of healthcare (pediatrics, neonatology, surgery, neurosurgery, emergency care, neurology, psychiatry) and
p.000347: bioethical education.
p.000347: The Congress adopted a Resolution that will facilitate the development of bioethics in Uzbekistan.
p.000347: The main tasks of the Congress were to promote legislation with regard to the protection of human rights and
p.000347: dignity in biomedical research involving human subjects; to outline the strategy for developing the activity of the NEC
p.000347: in the field of bioethics; to discuss educational programmes on bioethics for students of higher educational
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| access to information | Access to information |
| addicts | addiction |
| age | Age |
| alcoholism | alcoholism |
| another country | Other Country |
| armed forces | Soldier |
| army | Soldier |
| arrested | person under arrest |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belief | Religion |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| coerced | Presence of Coercion |
| cognitive | Cognitive Impairment |
| convicts | Criminal Convictions |
| crime | Illegal Activity |
| criminal | criminal |
| degenerate | degenerative conditions |
| dependence | Drug Dependence |
| dependency | Drug Dependence |
| dependent | Dependent |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| ecologically unfavorable | residents of ecologically unfavorable regions |
| education | education |
| educational | education |
| elderly | Elderly |
| embryo | embryo |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| ethnic | Ethnicity |
| faith | Religion |
| family | Motherhood/Family |
| fertile | of childbearing age/fertile |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| foetus | Fetus/Neonate |
| gender | gender |
| hazard | Natural Hazards |
| healthy people | Healthy People |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| hiv/aids | HIV/AIDS |
| home | Property Ownership |
| homeless | Homeless Persons |
| hospitalized | hospitalized patients |
| hungry | Food Insecurity |
| ill | ill |
| illegal | Illegal Activity |
| illness | Physically Disabled |
| incapable | Mentally Incapacitated |
| incarcerated | Incarcerated |
| infant | Infant |
| influence | Drug Usage |
| international student | international student |
| job | Occupation |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| low-income | Economic/Poverty |
| manipulate | Manipulable |
| mentally | Mentally Disabled |
| military | Soldier |
| minor | Youth/Minors |
| minority | Racial Minority |
| mothers | Mothers |
| nation | stateless persons |
| necessities | Access to Social Goods |
| nomadic | nomad |
| nomads | nomad |
| occupation | Occupation |
| opinion | philosophical differences/differences of opinion |
| oviedo | oviedo |
| parent | parents |
| parents | parents |
| party | political affiliation |
| persecuted | Persecuted |
| philosophy | philosophical differences/differences of opinion |
| physically | Physically Disabled |
| placebo | participants in a control group |
| police | Police Officer |
| political | political affiliation |
| poor | Economic/Poverty |
| poverty | Economic/Poverty |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| prosecuted | Prosecuted |
| race | Racial Minority |
| religion | Religion |
| religious | Religion |
| restricted | Incarcerated |
| sex workers | sex worker |
| sexually transmitted | sexually transmitted disases |
| sick | Physically Ill |
| single | Marital Status |
| social status | Economic/Poverty |
| std | sexually transmitted disases |
| stem cells | stem cells |
| stigmatization | Threat of Stigma |
| student | Student |
| substance | Drug Usage |
| terminal | Terminally Ill |
| terminally | Terminally Ill |
| threat | Threat of Stigma |
| under arrest | person under arrest |
| underdeveloped | Developing Country |
| unemployed | Unemployment |
| unemployment | Unemployment |
| union | Trade Union Membership |
| usage | Drug Usage |
| violence | Threat of Violence |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| HIV | ['hiv/aids'] |
| access | ['necessities'] |
| armed forces | ['army', 'military'] |
| army | ['armedXforces', 'military'] |
| arrested | ['underXarrest'] |
| belief | ['faith', 'religion', 'religious'] |
| child | ['children'] |
| children | ['child'] |
| convicts | ['prisoners'] |
| crime | ['illegal'] |
| dependence | ['dependency'] |
| dependency | ['dependence'] |
| disability | ['disabled', 'mentally'] |
| disabled | ['mentally', 'disability'] |
| drug | ['influence', 'substance', 'usage'] |
| education | ['educational'] |
| educational | ['education'] |
| faith | ['belief', 'religion', 'religious'] |
| fetus | ['fetuses', 'foetus'] |
| fetuses | ['fetus', 'foetus'] |
| foetus | ['fetus', 'fetuses'] |
| healthy people | ['healthyXvolunteers', 'volunteers'] |
| healthy volunteers | ['healthyXpeople', 'volunteers'] |
| hiv/aids | ['HIV'] |
| home | ['property'] |
| illegal | ['crime'] |
| illness | ['physically'] |
| incarcerated | ['liberty', 'restricted'] |
| influence | ['drug', 'substance', 'usage'] |
| job | ['occupation'] |
| liberty | ['incarcerated', 'restricted'] |
| low-income | ['poor', 'poverty', 'socialXstatus'] |
| mentally | ['disabled', 'disability'] |
| military | ['armedXforces', 'army'] |
| minor | ['youth'] |
| minority | ['race'] |
| necessities | ['access'] |
| nomadic | ['nomads'] |
| nomads | ['nomadic'] |
| occupation | ['job'] |
| opinion | ['philosophy'] |
| parent | ['parents'] |
| parents | ['parent'] |
| party | ['political'] |
| philosophy | ['opinion'] |
| physically | ['illness'] |
| political | ['party'] |
| poor | ['poverty', 'low-income', 'socialXstatus'] |
| poverty | ['poor', 'low-income', 'socialXstatus'] |
| prisoners | ['convicts'] |
| property | ['home'] |
| race | ['minority'] |
| religion | ['faith', 'belief', 'religious'] |
| religious | ['faith', 'belief', 'religion'] |
| restricted | ['incarcerated', 'liberty'] |
| sexually transmitted | ['std'] |
| social status | ['poor', 'poverty', 'low-income'] |
| std | ['sexuallyXtransmitted'] |
| stigmatization | ['threat'] |
| substance | ['drug', 'influence', 'usage'] |
| terminal | ['terminally'] |
| terminally | ['terminal'] |
| threat | ['stigmatization'] |
| under arrest | ['arrested'] |
| unemployed | ['unemployment'] |
| unemployment | ['unemployed'] |
| usage | ['drug', 'influence', 'substance'] |
| volunteers | ['healthyXpeople', 'healthyXvolunteers'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
| youth | ['minor'] |
Trigger Words
capacity
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
self-determination
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input