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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalCriminal Convictionsconvicts1
PoliticalCriminal Convictionsprisoners7
PoliticalIllegal Activitycrime1
PoliticalIllegal Activityillegal1
PoliticalPersecutedpersecuted1
PoliticalProsecutedprosecuted1
Politicalcriminalcriminal19
Politicalnomadnomadic6
Politicalnomadnomads1
Politicalperson under arrestarrested1
Politicalperson under arrestunder arrest2
Politicalpolitical affiliationparty4
Politicalpolitical affiliationpolitical37
Politicalstateless personsnation5
Politicalvulnerablevulnerable20
Politicalvulnerablevulnerability3
HealthCognitive Impairmentcognitive1
HealthDrug Dependencedependence3
HealthDrug Dependencedependency1
HealthDrug Usagedrug76
HealthDrug Usageinfluence31
HealthDrug Usagesubstance8
HealthDrug Usageusage3
HealthHIV/AIDSHIV16
HealthHIV/AIDShiv/aids0
HealthHealthy Peoplehealthy people3
HealthHealthy Peoplehealthy volunteers3
HealthHealthy Peoplevolunteers7
HealthMentally Disableddisabled12
HealthMentally Disabledmentally4
HealthMentally Disableddisability2
HealthMentally Incapacitatedincapable6
HealthMotherhood/Familyfamily16
HealthPhysically Disabledillness5
HealthPhysically Disabledphysically1
HealthPhysically Illsick4
HealthPregnantpregnant15
HealthTerminally Illterminally1
HealthTerminally Illterminal4
Healthaddictionaddicts5
Healthalcoholismalcoholism3
Healthdegenerative conditionsdegenerate1
Healthhospitalized patientshospitalized1
Healthillill10
Healthof childbearing age/fertilefertile2
Healthpatients in emergency situationsemergency situation1
Healthsexually transmitted disasessexually transmitted1
Healthsexually transmitted disasesstd1
Healthstem cellsstem cells4
SocialAccess to Social Goodsnecessities3
SocialAccess to Social Goodsaccess15
SocialAccess to informationaccess to information5
SocialAgeage64
SocialChildchild12
SocialChildchildren62
SocialElderlyelderly2
SocialEthnicityethnic6
SocialFetus/Neonatefetus5
SocialFetus/Neonatefetuses1
SocialFetus/Neonatefoetus1
SocialHomeless Personshomeless2
SocialIncarceratedincarcerated1
SocialIncarceratedliberty1
SocialIncarceratedrestricted4
SocialInfantinfant4
SocialLinguistic Proficiencylanguage27
SocialMarital Statussingle8
SocialMothersmothers4
SocialOccupationjob5
SocialOccupationoccupation1
SocialPolice Officerpolice1
SocialPresence of Coercioncoerced1
SocialProperty Ownershiphome8
SocialProperty Ownershipproperty3
SocialRacial Minorityminority4
SocialRacial Minorityrace1
SocialReligionfaith6
SocialReligionbelief3
SocialReligionreligion10
SocialReligionreligious59
SocialSoldierarmed forces2
SocialSoldierarmy3
SocialSoldiermilitary19
SocialStudentstudent9
SocialThreat of Stigmathreat5
SocialThreat of Stigmastigmatization1
SocialThreat of Violenceviolence3
SocialTrade Union Membershipunion28
SocialUnemploymentunemployed2
SocialUnemploymentunemployment5
SocialVictim of Abuseabuse5
SocialWomenwomen29
SocialYouth/Minorsminor4
SocialYouth/Minorsyouth5
Socialeducationeducation253
Socialeducationeducational97
Socialembryoembryo6
Socialgendergender1
Socialinternational studentinternational student2
Socialparentsparent2
Socialparentsparents7
Socialphilosophical differences/differences of opinionopinion12
Socialphilosophical differences/differences of opinionphilosophy102
Socialsex workersex workers0
EconomicEconomic/Povertypoor10
EconomicEconomic/Povertypoverty11
EconomicEconomic/Povertylow-income1
EconomicEconomic/Povertysocial status2
EconomicFood Insecurityhungry1
General/OtherDependentdependent3
General/OtherDeveloping Countryunderdeveloped1
General/OtherImpaired Autonomyautonomy18
General/OtherManipulablemanipulate2
General/OtherNatural Hazardshazard2
General/OtherOther Countryanother country1
General/OtherPublic Emergencyemergency10
General/OtherRelationship to Authorityauthority12
General/Othercioms guidelinescioms11
General/Otherdeclaration of helsinkihelsinki22
General/Otheroviedooviedo1
General/Otherparticipants in a control groupplacebo4
General/Otherresidents of ecologically unfavorable regionsecologically unfavorable0

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:

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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
...

Searching for indicator under arrest:

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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:

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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:

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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:

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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:

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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
...

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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
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
...

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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.
...

Searching for indicator healthy volunteers:

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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 “poorchildren
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:

(return to top)
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:

(return to top)
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