79C3C34C52B45572883A05D425EB0F82
FERCIT:Ethical Guidelines for Research on Human Subject in Thailand (2007)
http://www.fercit.org/file/Guideline_English_version.pdf
http://leaux.net/URLS/ConvertAPI Text Files/63B27013D2B106C755D87AF136217610.en.txt
Examining the file media/Synopses/63B27013D2B106C755D87AF136217610.html:
This file was generated: 2020-12-01 07:51:51
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
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p.000003: of diverse interests relevant to the body, mind, and cultural security of a person. This is the foundation of
p.000003: the other following principles. Respect for freely given informed consent. This means the subject needs to be
p.000003: fully informed of all aspects of the research without hidden or biased information using an
p.000003: easy-to-understand language for the subjects. The information should cover the details of the procedures,
p.000003: rights, obligations, requirement for informed consent and the freedom of decision making. Also, the subjects have the
p.000003: rights to withdraw their consent any time without giving any reason. In practice, the informed consent may appear in a
p.000003: form of conversation.
p.000003: 2.2.2 Respect for vulnerable persons. Respect for human dignity leads to an ethical requirement for vulnerable
p.000003: people who have inferior or lack physical capacities or have diminished capacities for making a reasonable
p.000003: decision, such as children, pregnant women, psychiatric patients, unconscious patients, and prisoners.
p.000003: These vulnerable people need to be protected from being forced to participate in a research involuntarily. In
p.000003: practice, a special treatment is needed for the protection of their benefits.
p.000003: 2.2.3 Respect for privacy and confidentiality. This principle is fundamental to the respect for human’s
p.000003: dignity found in various cultures, and it helps to protect the security of mind. Therefore, the standards applied
p.000003: for the respect for privacy and confidentiality help to protect the access to, retention of, and distribution of
p.000003: personal information.
p.000003:
p.000003: 2.3 Principle of Beneficence
p.000003: This principle covers the following aspects.
p.000003: 2.3.1 Balancing between risks and benefits; An analysis of risks and benefits being exposed to the subjects is a
p.000003: key ethical issue of research on human subjects. Research ethics for human subjects in modern times requires a
p.000003: balance between potential risks and benefits, with the desired goal being that the benefits must outweigh
p.000003: the risks and that the potential risks are acceptable for the subjects and received prior to review and
p.000003: approval from an ethics committee. The analysis of the risks and benefits affects the welfare and rights of the
...
p.000006: medicine, instruments, or others should be specified.
p.000006:
p.000006: 3.2 Inducement
p.000006: In recruiting the subjects into a study, the ethical principle that should be followed is that the subject should be
p.000006: invited to participate in the study. Please note that the words "invitation" and "volunteer" mean that the potential
p.000006: subjects are informed correctly, and voluntarily participate in the
p.000006:
p.000007: 7
p.000007: study. The information given should include both advantages, disadvantages to be incurred to the subjects themselves,
p.000007: to the community, or just for scientific benefit. The subjects should make their own decisions, not be forced
p.000007: to do so, or induced unduly. The subjects can also withdraw from the study any time. Several aspects of inducement
p.000007: that should receive consideration include:
p.000007: 3.2.1 Payment or compensation either money or other benefits to be given to the subjects should not be
p.000007: too much to induce the subject to decide to participate in the study without carefully considering the risks that may
p.000007: happen in the study;
p.000007: 3.2.2 For a phase I clinical trial usually conducted in normal subjects, the subjects would not obtain
p.000007: direct medical benefits from the study results. Therefore, it is necessary to compensate for travel expenses, loss
p.000007: of work or other payments, as appropriate. On the contrary, for a phase III study, the subjects usually obtain direct
p.000007: benefit from the study.
p.000007: 3.2.3 Enforced participation in a study may happen to institutionalized people, such as soldiers, prisoners, and
p.000007: students who have to obey or cooperate with their corresponding authorities. In recruiting these people into
p.000007: a study, it is necessary that they are informed and are given opportunity to make their own decisions
p.000007: without any interference from the higher authority.
p.000007: 3.2.4 3.2.4 Payment given to investigators by pharmaceutical companies or sponsors in the form of money or
p.000007: other means that are excessive, or payment methods, such as the given payment is based on the number of subjects
p.000007: participating in the trial, may cause deviation in the case that the investigator attempts to recruit as many subjects
p.000007: as possible for their own benefit.
p.000007:
p.000007: 3.3 Privacy and Confidentiality Protection
p.000007: No. 21 of the Declaration of Helsinki B.E. 2543 states, “The right of research subjects to safeguard their integrity
p.000007: must always be respected. Every precaution should be taken to respect the privacy of the subject, the
p.000007: confidentiality of the patient's information, and to minimize the impacts of the study on the subject's
p.000007: physical and mental integrity and on the personality of the subject."
p.000007:
p.000007: 3.3.1 Confidentiality protection
p.000007: (1) The subjects must be informed about their rights to have their personal information protected
p.000007: strictly.
p.000007: (2) During the informed consent discussion, the investigator must inform the subjects in advance of the
...
p.000008: (3) The investigator is allowed to use the data from the patient's medical records only as specified in the research
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
p.000009: conducting research studies in subjects with illegal careers, such as sex workers or illegal drug users.
p.000009: 3.4.10 In the case where a study is conducted on the vulnerable people without direct health benefit to them, the
p.000009: possible risks should not be greater than the minimal risk normally found in a general physical or psychiatric
p.000009: examination, or unless the research ethics committee allows for a greater-than-minimal risk.
p.000009:
p.000010: 10
p.000010: CHAPTER 4
p.000010:
p.000010: CONDUCTING RESEARCH ACCORDING TO THE PRINCIPLE OF BENEFICENCE
p.000010:
p.000010: 4.1 Nature and Scope of Risks and Benefits
p.000010: The principle of beneficence requires that a research study be justified to conduct on humans by an
p.000010: assessment of a favorable risk and benefit ratio. In the context of research involving human subjects, the term "risk"
p.000010: means the possibility to receive harm, whereas the term "benefit" denotes that which gives a positive value to health
p.000010: or well being.
...
Political / Illegal Activity
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p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
p.000009: conducting research studies in subjects with illegal careers, such as sex workers or illegal drug users.
p.000009: 3.4.10 In the case where a study is conducted on the vulnerable people without direct health benefit to them, the
p.000009: possible risks should not be greater than the minimal risk normally found in a general physical or psychiatric
p.000009: examination, or unless the research ethics committee allows for a greater-than-minimal risk.
p.000009:
p.000010: 10
p.000010: CHAPTER 4
p.000010:
p.000010: CONDUCTING RESEARCH ACCORDING TO THE PRINCIPLE OF BENEFICENCE
p.000010:
p.000010: 4.1 Nature and Scope of Risks and Benefits
p.000010: The principle of beneficence requires that a research study be justified to conduct on humans by an
p.000010: assessment of a favorable risk and benefit ratio. In the context of research involving human subjects, the term "risk"
p.000010: means the possibility to receive harm, whereas the term "benefit" denotes that which gives a positive value to health
p.000010: or well being.
p.000010: Please note that benefits do not indicate an opportunity or possibility. By this definition, a benefit is then
p.000010: opposite to a harm. An assessment of a risk and benefit ratio requires the consideration of both
p.000010: probability and the dimension of possible harm and expected benefits.
...
Political / political affiliation
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p.000022: However, research assistants may be allowed when many records are searched.
p.000022:
p.000022: 7.2.2 The ethics committee may approve the search for identified or identifiable data from the records if the
p.000022: following criteria are fulfilled.
p.000022: (1) the informed consent process possibly causes excessive worries to the subjects or reduces the scientific value of
p.000022: the research, whereas the subjects or the relatives
p.000022: or the involved communities do not gain any benefit or the informed consent cannot practically be obtained;
p.000022: (2) the research is conducted by the attending physician of the patients, and the risks are minimal, and the research
p.000022: does not involve any abnormality of the genetics;
p.000022: (3) the public benefit is of high degree for the proposed research topic;
p.000022: (4) the informed consent process possibly causes excessive worries to the subjects or reduces the scientific value of
p.000022: the research, whereas the subjects, the relatives
p.000022: or the involved communities do not gain any benefits or the informed consent cannot practically be obtained because of
p.000022: too many or outdated medical records, or it is difficult to contact for the informed consent; or
p.000022: (5) the public interests from the research prevail over the private interests
p.000022:
p.000022: 7.2.3 When the ethics committee allows the use of coded identifiable data, it should be decided whether a third party
p.000022: should hold the code.
p.000022: 7.2.4 When the research is conducted in a community, it should be guaranteed that the conduct complies completely
p.000022: with the requirements on the research in the community.
p.000022: 7.2.5 When identified or the re-identifiable data are used in research, the ethics committee should ensure that the
p.000022: collection, handling, and storage of the data comply with the principle of rights of personal information. If the data
p.000022: are
p.000022: to be used for purposes other than those specified in the approved protocol, a new protocol should be submitted for
p.000022: ethical review.
p.000022: 7.2.6 If the research involves the linkage of a set of data, the ethics committee may approve the use of the
p.000022: identifier to assure correct linkage. When the
p.000022: linkage is finished, the ethics committee should require that the emerging data be coded or the identifier be removed.
p.000022: 7.2.7 If the identified or identifiable data are used for other purposes in the research or by other people other than
p.000022: those listed in the previously approved protocol, a new protocol needs to be submitted for ethical review.
p.000022: 7.2.8 The information derived from epidemiological research both short- and long-term should be securely kept from the
p.000022: access of unauthorized people.
p.000022: 7.2.9. When screening the data for the statistical analysis and concluding, the investigator should maintain the
p.000022: confidentiality of the research participants.
p.000022: 7.2.10 The research results should not be published in a manner that can identify the individuals participating in the
...
p.000026: for strictly protecting the subject’s privacy and the confidentiality of the data should be implemented.
p.000026: Generally, researchers should be aware of the following important considerations when conducting human genetic
p.000026: research.
p.000026:
p.000026: 7.6.1 Individuals, Families, and Biological Relatives:
p.000026: (1) The investigator should provide the information and obtain the individual informed consent from relevant people.
p.000026: (2) The outcomes of the research are to be disclosed to appropriate persons free of charge (appropriate persons mean
p.000026: the research participants who inform in advance that they need to know the results).
p.000026: (3) Human genetic researches is often conducted in groups of families or
p.000026: in communities that are related to one another, e.g., the study of a family tree
p.000026: or history or the linkage study on the same chromosome. In case that the study causes a conflict between family
p.000026: members, the investigator must take responsibility for solving the problem by communicating and informing
p.000026: correctly and honestly the information regarding the purposes, benefits, and disadvantages of the research to the
p.000026: families in question.
p.000026:
p.000026: 7.6.2 Privacy, Confidentiality, Loss of Benefits, and Risks
p.000026: (1) The investigator and the ethics committee should ensure that the confidentiality and the results of the genetic
p.000026: research be securely kept from unauthorized access by a third party, such as employer or insurance companies.
p.000026: (2) The investigator studying about the family’s or population’s genetics should review the scope of possible
p.000026: physical and mental impact that may happen to the relevant persons, and demonstrate those to the ethics committee.
p.000026:
p.000026: 7.6.3 Genetic Counseling
p.000026: The investigator and the ethics committee should ensure that the research protocols provide correct and appropriate
p.000026: genetic counseling for the potential subjects.
p.000026:
p.000026:
p.000026: 7.6.4 Genetic Alterations
p.000026: A genetic alteration of a human embryonic cell or a human gamete is regarded as a violation of research ethics. The
p.000026: research study on gene alteration then must not be approved, except for gene therapy that may need to be considered on
p.000026: a case by case basis to receive ethical approval for the research.
p.000026:
p.000026: 7.6.5 Eugenic Concern
p.000026: The objectives of the human genetic research are related to improved knowledge and understanding of genetic diseases
p.000026: that may affect human health only, including health care, and not for eugenic purposes. Additionally, attention must
p.000026: be paid to the subjects’ free decision making on the problems that may arise, in particular, for the married couple who
p.000026: needs to make a decision after being informed about a risk imposed upon the intrauterine fetus to develop a disease.
...
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p.000001: (CIOMS), and the Canadian Ethical Conduct for Research involving Humans, etc. The ethical guidelines has been
p.000001: published and distributed since B.E. 2545, and its English version was available in B.E. 2550.
p.000001:
p.000001: 1.2 Need for Research on Human Subjects
p.000001: Research on human subjects is necessary for promoting scientific progress and building a better understanding in
p.000001: order to improve human well-being. Researchers, universities, governments, and private organizations
p.000001: have various reasons for conducting or sponsoring research on human subjects. Such reasons include, for example,
p.000001: alleviating suffering from illness, evaluating social values or scientific theories, eliminating ignorance,
p.000001: analyzing policies, creating better understanding of human behavior and related purposes. In summary, research on
p.000001: human subjects serves three main purposes, i.e.,
p.000001: 1.2.1 To generate a new body of knowledge and new understanding;
p.000001: 1.2.2 To enhance scientific advancement that benefits the research subjects.
p.000001: 1.2.3 Through research, the subjects may gain benefits from the development of new treatment, from new findings
p.000001: for higher living standard, from new discoveries, from writing, speech, and traditional culture, or from
p.000001: satisfaction in improving society;
p.000001:
p.000002: 2
p.000002: 1.2.4 Also, research provides benefits for the society at large or for certain groups of people or has influence
p.000002: on political behavior, which may lead to an improved health policy. The statistical information about the disease
p.000002: incidence may help to improve public health. The information about living conditions and behavior may lead to social
p.000002: development.
p.000002:
p.000002: 1.3 Objectives of the Ethical Guidelines for Research on Human Subjects in
p.000002: Thailand
p.000002: Thailand has established three basic objectives regarding research on humans:
p.000002: 1.3.1 To ensure that the dignity, rights, safety and well-being of subjects participating in research are protected,
p.000002: and the results of the research are credible;
p.000002: 1.3.2 To serve as guidelines for researchers, ethics committees, organizations, institutions, and people
p.000002: who are related to research ethics;
p.000002: 1.3.3 To serve as a basis for an ethics committee to derive a standard operating procedure (SOP) for
p.000002: the review and approval of biomedical research conducted within each institution.
p.000002:
p.000002: 1.4 Related Terms and Definitions
p.000002: 1.4.1 Research on human subjects means a research study, inquiry, interviews in social science, environment and
p.000002: environmental conditions, a clinical trial of pharmaceutical products and medical devices, a study of the nature
p.000002: of disease, the diagnosis of, the treatment of, the health promotion of, and the prevention of a disease related to
p.000002: human or conducted in human. Also, such research includes research studies using information from
p.000002: patient medical records or databases, laboratory specimens, body fluids, human tissues, and studies about
...
p.000003: for the respect for privacy and confidentiality help to protect the access to, retention of, and distribution of
p.000003: personal information.
p.000003:
p.000003: 2.3 Principle of Beneficence
p.000003: This principle covers the following aspects.
p.000003: 2.3.1 Balancing between risks and benefits; An analysis of risks and benefits being exposed to the subjects is a
p.000003: key ethical issue of research on human subjects. Research ethics for human subjects in modern times requires a
p.000003: balance between potential risks and benefits, with the desired goal being that the benefits must outweigh
p.000003: the risks and that the potential risks are acceptable for the subjects and received prior to review and
p.000003: approval from an ethics committee. The analysis of the risks and benefits affects the welfare and rights of the
p.000003: subjects. However, sometimes the estimation of risks and benefits of all aspects of the research is difficult to
p.000003: achieve. Therefore, the key principle of respect for human dignity always requires a proper and reliable
p.000003: research design, especially biomedical or health research, which needs prior research studies conducted in
p.000003: both laboratory and animal models to ensure safety. Moreover, it requires adequate review of the
p.000003: existing knowledge of the proposed research. Although the analysis of risks and benefits may not be
p.000003: obvious in some research areas, such as the political sciences, economics, or
p.000003:
p.000004: 4
p.000004: history (including a personal biography), the risks still remain as the research results may potentially destroy
p.000004: the credit or grace of an organization or individuals.
p.000004: 2.3.2 Minimizing harm; Researchers are required to protect their subjects from all possible harm or to
p.000004: minimize the dangers. The subjects must not be exposed to unnecessary risks. To achieve excellent scientific and
p.000004: social results, it is truly unavoidable to conduct research on human subjects. The subject sample size should then be
p.000004: as small as possible, but still maintaining scientific integrity, i.e., the smallest sample size adequate for a
p.000004: reliable statistical analysis of the results.
p.000004: 2.3.3 Maximizing benefits; The principle of beneficence relies on compassion, which mandates maximal benefits be
p.000004: entitled to others. This principle is actually supportive of the practice of researchers in certain professions,
p.000004: e.g., healthcare providers, psychologists, social workers, and educators. As mentioned above, the aims of
p.000004: research on human subjects are to provide direct benefits to participating subjects and then to others or the
p.000004: society at large, or contribute to scientific progress. Currently, most research is primarily beneficial to
p.000004: society and the progress of science.
p.000004:
p.000004: 2.4 Principle of Justice
p.000004: This principle covers the following aspects.
...
Political / vulnerable
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p.000003: CHAPTER 2
p.000003:
p.000003: ETHICS FOR RESEARCH ON HUMAN SUBJECTS
p.000003:
p.000003: 2.1 General Ethical Principles
p.000003: Three basic ethical principles consist of: First, respect for persons; Second, beneficence;
p.000003: Third, justice
p.000003:
p.000003: 2.2 Principle of Respect for Person
p.000003:
p.000003: The principle covers the following aspects.
p.000003: 2.2.1 Respect for human dignity. This aspect is the heart of research ethics, which provides for the protection
p.000003: of diverse interests relevant to the body, mind, and cultural security of a person. This is the foundation of
p.000003: the other following principles. Respect for freely given informed consent. This means the subject needs to be
p.000003: fully informed of all aspects of the research without hidden or biased information using an
p.000003: easy-to-understand language for the subjects. The information should cover the details of the procedures,
p.000003: rights, obligations, requirement for informed consent and the freedom of decision making. Also, the subjects have the
p.000003: rights to withdraw their consent any time without giving any reason. In practice, the informed consent may appear in a
p.000003: form of conversation.
p.000003: 2.2.2 Respect for vulnerable persons. Respect for human dignity leads to an ethical requirement for vulnerable
p.000003: people who have inferior or lack physical capacities or have diminished capacities for making a reasonable
p.000003: decision, such as children, pregnant women, psychiatric patients, unconscious patients, and prisoners.
p.000003: These vulnerable people need to be protected from being forced to participate in a research involuntarily. In
p.000003: practice, a special treatment is needed for the protection of their benefits.
p.000003: 2.2.3 Respect for privacy and confidentiality. This principle is fundamental to the respect for human’s
p.000003: dignity found in various cultures, and it helps to protect the security of mind. Therefore, the standards applied
p.000003: for the respect for privacy and confidentiality help to protect the access to, retention of, and distribution of
p.000003: personal information.
p.000003:
p.000003: 2.3 Principle of Beneficence
p.000003: This principle covers the following aspects.
p.000003: 2.3.1 Balancing between risks and benefits; An analysis of risks and benefits being exposed to the subjects is a
p.000003: key ethical issue of research on human subjects. Research ethics for human subjects in modern times requires a
p.000003: balance between potential risks and benefits, with the desired goal being that the benefits must outweigh
p.000003: the risks and that the potential risks are acceptable for the subjects and received prior to review and
p.000003: approval from an ethics committee. The analysis of the risks and benefits affects the welfare and rights of the
p.000003: subjects. However, sometimes the estimation of risks and benefits of all aspects of the research is difficult to
...
p.000004: social results, it is truly unavoidable to conduct research on human subjects. The subject sample size should then be
p.000004: as small as possible, but still maintaining scientific integrity, i.e., the smallest sample size adequate for a
p.000004: reliable statistical analysis of the results.
p.000004: 2.3.3 Maximizing benefits; The principle of beneficence relies on compassion, which mandates maximal benefits be
p.000004: entitled to others. This principle is actually supportive of the practice of researchers in certain professions,
p.000004: e.g., healthcare providers, psychologists, social workers, and educators. As mentioned above, the aims of
p.000004: research on human subjects are to provide direct benefits to participating subjects and then to others or the
p.000004: society at large, or contribute to scientific progress. Currently, most research is primarily beneficial to
p.000004: society and the progress of science.
p.000004:
p.000004: 2.4 Principle of Justice
p.000004: This principle covers the following aspects.
p.000004: The principle of justice includes both fairness and equity. In terms of procedural justice, a standardized procedure
p.000004: with a fair and independent review of research protocols is required. Also, justice requires the distribute of both
p.000004: the burdens and the benefits of a research equally, which leads to the consideration that research should not be
p.000004: performed simply to gain scientific progress in vulnerable people who cannot protect their rights and benefits, as has
p.000004: been witnessed in several cases in the past. In addition, the subjects participating in a research study should be
p.000004: entitled to any direct benefits from the research. Justice is then reflected by not neglecting or discriminating
p.000004: against people or groups of people that may benefit from the progress of research.
p.000004:
p.000005: 5
p.000005: CHAPTER 3
p.000005:
p.000005: CONDUCTING RESEARCH ACCORDING TO THE PRINCIPLE OF RESPECT FOR PERSONS
p.000005:
p.000005:
p.000005: 3.1 Informed Consent Process
p.000005: Conducting a research in conformity with international standards requires correct and appropriate informed
p.000005: consent and invitation to be given to subjects. The process is not to force the subjects to participate in the
p.000005: research directly or indirectly without giving them a chance to be informed about the research procedures
p.000005: or without giving any opportunity to make their own decision. Examples are that patients have a
p.000005: dependent relationship with physicians, or that physicians conduct experiments in patients using one or
p.000005: more medicines or new unproven treatment without informing the patients, or that payment or compensation in either
p.000005: money or gifts or the promise to give something beyond necessity is given, or that the instructions or explanation
...
p.000008: in medical records may be given from the hospital director or other authorized persons.
p.000008: (2) The collection of the data from the medical records must receive approval from the ethics committee, and the
p.000008: patient's confidentiality must be strictly protected.
p.000008: (3) The investigator is allowed to use the data from the patient's medical records only as specified in the research
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
p.000009: conducting research studies in subjects with illegal careers, such as sex workers or illegal drug users.
p.000009: 3.4.10 In the case where a study is conducted on the vulnerable people without direct health benefit to them, the
p.000009: possible risks should not be greater than the minimal risk normally found in a general physical or psychiatric
p.000009: examination, or unless the research ethics committee allows for a greater-than-minimal risk.
p.000009:
p.000010: 10
p.000010: CHAPTER 4
p.000010:
p.000010: CONDUCTING RESEARCH ACCORDING TO THE PRINCIPLE OF BENEFICENCE
p.000010:
p.000010: 4.1 Nature and Scope of Risks and Benefits
p.000010: The principle of beneficence requires that a research study be justified to conduct on humans by an
p.000010: assessment of a favorable risk and benefit ratio. In the context of research involving human subjects, the term "risk"
p.000010: means the possibility to receive harm, whereas the term "benefit" denotes that which gives a positive value to health
p.000010: or well being.
p.000010: Please note that benefits do not indicate an opportunity or possibility. By this definition, a benefit is then
p.000010: opposite to a harm. An assessment of a risk and benefit ratio requires the consideration of both
p.000010: probability and the dimension of possible harm and expected benefits.
...
p.000010: large, or special subject groups in a general society. Before initiating the study, an assessment of risks
p.000010: and discomfort that may happen to the subjects compared with the expected benefits is required. Please be aware that
p.000010: the rights, safety, and wellbeing of the subjects must prevail over the benefits to science and society.
p.000010:
p.000010: .
p.000010: 4.2 Systematic Assessment of Risks and Benefits
p.000010: In most cases it is very difficult to precisely assess a risk and benefit ratio. Because of the lack of a quantitative
p.000010: technique for such assessment, it is necessary to conduct the risk and benefit analysis systematically and reasonably
p.000010: as practical as possible. This can be done in practice by collecting and evaluating the data covering all aspects of
p.000010: the research. Other available alternatives should be considered systematically, which would help to evaluate
p.000010: the research precisely and rigorously.
p.000010:
p.000010: 4.3 Basic Guidelines for Justifying a Research Containing the Minimum Elements:
p.000010: 4.3.1 A demonstrated real need exists to conduct a study in human subjects
p.000010: 4.3.2 Brutal or cruel treatments to subjects are completely unjustified.
p.000010: 4.3.3 Risks are minimized as much as possible, but research objective(s) are still achieved
p.000010: 4.3.4 When research involves a significant risk capable of serious damage, special confirmation is needed in
p.000010: justifying the risk.
p.000010: 4.3.5 When a research is conducted in vulnerable people, the rationale and need should be clearly explained and any
p.000010: and all harm avoided.
p.000010:
p.000010: 4.3.6 The relevant risks and benefits are clearly specified and fully provided in the informed consent form.
p.000010:
p.000010: 4.4 Additional Guidelines for Considering Risks and Benefits of a Research Protocol
p.000010: 4.4.1. An ethics committee needs to assess both risks and benefits. A research protocol should maximize benefits and
p.000010: minimize risks or harm.
p.000010: 4.4.2. A research protocol should demonstrate measures used to reduce risks, including preventive measures and
p.000010: immediate treatment measures once harm occurs to a research participant.
p.000010: 4.4.3. If the benefits do not directly go to the subjects, such as new knowledge, a
p.000010:
p.000011: 11
p.000011: rigorous review on the proper and careful design of the research for potential risks is required.
p.000011: 4.4.4. For research conducted in a community, a private sponsor should provide health services to the community, as
p.000011: appropriate. Or in case a clinical drug trial is conducted with the conclusion that the new drugs are more efficacious
p.000011: than or equal to the active control drugs, the sponsors should provide the benefits to the participating subjects in
p.000011: the control group or in all groups by giving them the new drugs for a certain period after the completion of the study.
...
Health / Cognitive Impairment
Searching for indicator impaired:
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p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
...
p.000019: attention to the differences as well, such as
p.000019: (1) A medical device for human use may not be tested previously in animal models such as retractors because of
p.000019: different human and animal anatomies.
p.000019: (2) Certain types of medical devices should not be studied in healthy human subjects because the research procedures
p.000019: and/or the use of the device may impose extremely high risks and harm, but create no benefits to the subjects. For
p.000019: example, the trials using artificial joints, artificial cardiac valves, or a cardiac pace maker.
p.000019: (3) The clinical trial of a new drug is not regarded as a trial with a minimal risk because the mechanism of action
p.000019: may not be clear. As a result, it is impossible to predict possible side effects. On the contrary, the trial using an
p.000019: external medical device, which is known for its mechanism of action, allows us to predict the possible side effects.
p.000019: The trial can be regarded as imposing a minimal risk. Details will be discussed later.
p.000019: (4) A comparative study using a medical device and a placebo or other comparators to evaluate the effectiveness or
p.000019: efficiency of the treatments may not be conducted because ethical justification if the use of that device is the only
p.000019: opportunity for the subject to obtain benefit from the treatment, such as
p.000019: surgery to insert the artificial joint to replace irreversibly impaired joints.
p.000019: In general, a sham surgery in the comparator group is regarded as ethically inappropriate as it can greatly impose
p.000019: risks and harm to the subjects, while it provides no benefits. The sham surgery, however, used
p.000019: in the clinical trial of a medical device may be conducted under certain circumstances of extreme necessity, provided
p.000019: that the risks must be minimized as much as possible and the subject must be given full and correct information before
p.000019: freely deciding to participate in the trial.
p.000019: As mentioned above, in several cases, a medical device that has clear mechanisms of action may be designed by the
p.000019: physician who directly takes care of the patient. In addition a device available on the market may be altered or
p.000019: further developed and used in the treatment for patients unable to access
p.000019: other available treatments. The investigator or the sponsor of this type of trial may get less financial support than
p.000019: that from drug companies in the case of a clinical drug trial. Hence, the design of a clinical study of a medical
p.000019: device to prove its effectiveness, efficiency and safety may be an observational study instead of a randomized
p.000019: controlled trial, which is the standard for a clinical trial of new drugs. The observational study allows for
p.000019: collecting the data completely and completing the follow-up for all patients for a sufficiently long time. This is
p.000019: demonstrated by the study of artificial joints and cardiac valves that are widely recognized.
...
Searching for indicator impairment:
(return to top)
p.000012: the community bears the burdens, or which the community takes the benefits must be in accordance with the
p.000012: principle of distributive justice as well. A common problem of injustice occurring at the community
p.000012: level is exemplified in the case of trials for product development of drugs, vaccines or medical
p.000012: devices that are sponsored by companies or organizations in developed countries. The trials are conducted
p.000012: in developing countries, but after the end of the trials, drugs or vaccines or medical devices under the
p.000012: studies cannot be made beneficial to the participating populations or countries. One of the causes is due to
p.000012: the lack of access to those drugs or vaccines because of their high cost, or the lack of disease or illness for such
p.000012: drugs or vaccines in those communities in developing countries occurs. Thus, the principle must be carefully and
p.000012: thoroughly considered to bring justice to all levels from the individual to the society.
p.000012: However, please be aware that in reviewing research on human subjects based on this principle, deviation
p.000012: from the principle of distributive justice may sometimes happen reasonably as well, but the differences of related
p.000012: factors such as experiences, sex, physical impairment, capacity, and position must be taken into careful and
p.000012: appropriate consideration. This is to serve as criteria for decision making in the case that different
p.000012: treatments are given to individuals, and this consideration should be made on an individual basis.
p.000012:
p.000013: 13
p.000013: CHAPTER 6
p.000013:
p.000013: ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS
p.000013: A research protocol involving human subjects must be subject to review and approval by an ethics committee for
p.000013: research on human subject before initiating a study. Thus, institutions or organizations with established
p.000013: research protocols or investigators have to appoint and authorize the ethics committee to decide about the research
p.000013: protocol. The institution or organization should establish regulations on the appointment of the ethics
p.000013: committee, the submission of a research protocol for ethical review, the criteria for decision making, and the
p.000013: monitoring of the procedures or the results of ongoing studies.
p.000013:
p.000013: 6.1 Operational Guidelines
p.000013: 6.1.1 The institution or organization with investigators or research studies that involve human subjects
p.000013: should establish its own ethics committee or jointly organize it with other institutions or
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000007: minimized to the lowest level. In general, the best way to protect the subject's confidentiality is to remove
p.000007: the subject's identification from all stages of the study, and to control or restrict access to the data.
p.000007: (5) The subjects should be made aware of the investigator's limitations in keeping their confidentiality. An
p.000007: example is when, the investigator has to transfer the subject’s information from the case report forms
p.000007: to the national regulatory authorities or the sponsor. This also includes where a regulatory requirement exists
p.000007: to report certain events, such as communicable disease, child molestation abuse, and child's
p.000007: negligence, directly to the responsible agency. Under these circumstances, the investigator must inform the
p.000007: subjects of the limitations for keeping confidentiality before the subjects participate in the study.
p.000007: (6) The subjects should be made aware of the social impact on them if there would be any leakage of the data.
p.000007: For example, if the subject's participation in the
p.000007:
p.000008: 8
p.000008: studies on AIDS medicines or vaccines is made public, it is risky for the subjects to receive social discrimination.
p.000008: Such risks should be carefully considered in the same manner as those for any treatment risk resulting from
p.000008: drug or vaccine studies.
p.000008: (7) In the case where the ethics committee decides that signing the informed consent form can be
p.000008: waived, the investigator should explore other means to protect the subject's confidentiality.
p.000008:
p.000008: 3.3.2 Confidentiality between physicians and patient subjects
p.000008: The Declaration of Patients' Rights, issued by the four health professional associations and the Ministry of Public
p.000008: Health, states, “Patients have the right to receive strict protection of their own information.” Any disclosure of the
p.000008: patient’s information to anyone who needs the information, such as doctors, nurses, technical scientists, competent
p.000008: authority, or other researchers, can be made only if the patients or their legally acceptable representative gives
p.000008: prior permission.
p.000008:
p.000008: 3.3.3 Data from medical records
p.000008: (1) In practice, it is quite difficult for a researcher who conducts a study using the information from medical
p.000008: records to have a patient's informed consent form kept in each patient's medical record either by having patients
p.000008: sign the form in advance and keeping it in the medical record or by calling for patients to sign later. In this case,
p.000008: therefore, the ethics committee may consider waiving the signing of the informed consent form. However, the evidence
...
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
p.000009: conducting research studies in subjects with illegal careers, such as sex workers or illegal drug users.
p.000009: 3.4.10 In the case where a study is conducted on the vulnerable people without direct health benefit to them, the
p.000009: possible risks should not be greater than the minimal risk normally found in a general physical or psychiatric
p.000009: examination, or unless the research ethics committee allows for a greater-than-minimal risk.
p.000009:
p.000010: 10
p.000010: CHAPTER 4
p.000010:
p.000010: CONDUCTING RESEARCH ACCORDING TO THE PRINCIPLE OF BENEFICENCE
p.000010:
p.000010: 4.1 Nature and Scope of Risks and Benefits
p.000010: The principle of beneficence requires that a research study be justified to conduct on humans by an
p.000010: assessment of a favorable risk and benefit ratio. In the context of research involving human subjects, the term "risk"
p.000010: means the possibility to receive harm, whereas the term "benefit" denotes that which gives a positive value to health
p.000010: or well being.
p.000010: Please note that benefits do not indicate an opportunity or possibility. By this definition, a benefit is then
p.000010: opposite to a harm. An assessment of a risk and benefit ratio requires the consideration of both
p.000010: probability and the dimension of possible harm and expected benefits.
...
p.000010: 4.3.3 Risks are minimized as much as possible, but research objective(s) are still achieved
p.000010: 4.3.4 When research involves a significant risk capable of serious damage, special confirmation is needed in
p.000010: justifying the risk.
p.000010: 4.3.5 When a research is conducted in vulnerable people, the rationale and need should be clearly explained and any
p.000010: and all harm avoided.
p.000010:
p.000010: 4.3.6 The relevant risks and benefits are clearly specified and fully provided in the informed consent form.
p.000010:
p.000010: 4.4 Additional Guidelines for Considering Risks and Benefits of a Research Protocol
p.000010: 4.4.1. An ethics committee needs to assess both risks and benefits. A research protocol should maximize benefits and
p.000010: minimize risks or harm.
p.000010: 4.4.2. A research protocol should demonstrate measures used to reduce risks, including preventive measures and
p.000010: immediate treatment measures once harm occurs to a research participant.
p.000010: 4.4.3. If the benefits do not directly go to the subjects, such as new knowledge, a
p.000010:
p.000011: 11
p.000011: rigorous review on the proper and careful design of the research for potential risks is required.
p.000011: 4.4.4. For research conducted in a community, a private sponsor should provide health services to the community, as
p.000011: appropriate. Or in case a clinical drug trial is conducted with the conclusion that the new drugs are more efficacious
p.000011: than or equal to the active control drugs, the sponsors should provide the benefits to the participating subjects in
p.000011: the control group or in all groups by giving them the new drugs for a certain period after the completion of the study.
p.000011: Research conducted to explore a new indication not previously approved in the product leaflet must be done in
p.000011: comparison with the approved drug.
p.000011: 4.4.5 In case the subjects cannot personally give an informed consent to participate in the study, the risk that may
p.000011: happen must be a minimal risk. Otherwise, research with slightly greater than a minimal risk would be acceptable only
p.000011: if the research's objective(s) are important enough, and the research provides only good effects to the participating
p.000011: subjects.
p.000011:
p.000011: The assessment of risks and benefits will be very useful to the individuals involved in research on human
p.000011: subjects. For the investigator, the assessment helps to check if the research is properly designed. For the ethics
p.000011: committee, it helps to determine if the risks and benefits that may happen to the subjects are justified. And for
p.000011: the research subjects, it helps to decide whether to participate in the research or not.
p.000011:
p.000012: 12
p.000012: CHAPTER 5
p.000012:
p.000012: CONDUCTING RESEARCH ACCORDNG TO THE PRINCIPLE OF JUSTICE
p.000012:
p.000012: The selection of groups of people of communities for research should be based on a fair distribution of
p.000012: burdens and benefits. Exclusion of any people or communities from any research should be justified.
p.000012:
p.000012: According to the Thai Dictionary of the Royal Academy of Thailand B.E. 2542, the word "justice" (or yutti-tham in
...
p.000016: 6.7.5 The investigator should inform the ethics committee where the protocol has been submitted for ethical
p.000016: review as well as the review's outcome.
p.000016:
p.000016: 6.8 Monitoring of a Research
p.000016: 6.8.1 The institution or organization should appoint a committee independent of the ethics committee to monitor the
p.000016: progress of the research.
p.000016: 6.8.2 The purpose of the research monitoring committee is to ensure that the research complies with the
p.000016: proposed procedures specified in the protocol, and that the advice is given to the subject, as appropriate.
p.000016: 6.8.3 The research monitoring committee should establish its own criteria and mechanisms for monitoring the research
p.000016: protocol.
p.000016:
p.000016: 6.9 Termination or Suspension of Research
p.000016: 6.9.1 The ethics committee may withdraw or suspend its approval given to the research so as to protect the rights
p.000016: and welfare of the research participants. This includes when serious adverse effects are reported, or
p.000016: when the conduct of the research does not comply with the protocols approved by the committee.
p.000016: 6.9.2 In case of premature termination of any research protocols made by the investigator, the reasons for the
p.000016: termination must be reported to the ethics committee.
p.000016:
p.000017: 17
p.000017: CHAPTER 7
p.000017: SPECIFIC TYPES OF RESEARCH ON HUMAN SUBJECTS
p.000017:
p.000017: 7.1 CLINICAL DRUG TRIAL
p.000017:
p.000017: A clinical drug trial is a study of drug on either patients or healthy people in order to study the therapeutic or
p.000017: preventive effects of the drug.
p.000017: In general, an investigational drug used in clinical trial falls into one of four categories, namely:
p.000017: (1) new drugs; (2) unregistered drugs in Thailand (3) registered drugs by the national drug authority, but being
p.000017: studied in new doses or indications not previously approved; and (4) locally produced drugs which required efficacy
p.000017: testing.
p.000017:
p.000017: Phases of Clinical Drug Trials
p.000017: For new drugs, adequate evidence derived from animal studies must be available to ensure safety and determine toxicity
p.000017: levels prior to conducting a study in humans.
p.000017:
p.000017: A Clinical Drug Trail Can Be Classified in Four Phases.
p.000017:
p.000017: Phase I
p.000017: This is a first-in-human trial using a new chemical entity that is usually conducted in healthy volunteers to study
p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
p.000017: elderly, or women with childbearing potential. Anesthesia or anticancer drugs should not be used in the healthy
p.000017: volunteers as a result of its high toxicity. In general, the number of the subjects should not exceed 30
p.000017: subjects. Every subject should give written informed consent before participating in the study. The study in
p.000017: this phase is usually an open study without any control group, i.e., both subjects and investigators know
p.000017: the trial drug. Studies in phase I also involve two stages. Stage I studies employ a small dose, i.e., about 1/50 or
p.000017: 1/100 of the dose used successfully in the animal studies. When the results demonstrate safety, the second stage
p.000017: is then followed by gradually escalating the dose. Once the results are satisfactory, phase II studies are
p.000017: conducted.
p.000017: Phase I trials also include the studies done on the patients suffering from a specific disease with no hope from
p.000017: currently available treatments, such as studies in terminally ill cancer patients.
p.000017:
p.000017: Phase II
p.000017: Phase II studies are conducted on patients with the target treatment of the drug that was satisfactorily studied in
p.000017: Phase I. The primary objective of the trial in this phase is to study short- term pharmacological toxicity in
p.000017: details, while the secondary objective is about the drug’s preliminary efficacy. Anesthesia and
p.000017: anticancer drugs are allowed in the Phase II trials. If possible, a trial design should be randomized and be
p.000017: open label. The subjects and investigators may not know whether the drugs received are investigational
p.000017: drugs or comparator drugs. Approximately, 100-200 subjects are employed in Phase II trials. If serious
p.000017: adverse events are reported frequently, the trials should be stopped temporarily. Once the safety is
p.000017: confirmed, a Phase III trial can then be conducted.
p.000017:
p.000017: Phase III
p.000017: Phase III studies are conducted in patients with the target treatment using the new chemical entity being
p.000017: tested successfully in Phase II. The primary and secondary objectives are to evaluate the pharmacological
p.000017: effectiveness and to study short-term toxicity, respectively. The number of the subjects in Phase II
p.000017: trials may be considerably increased to several thousands depending on sample size determination using a
p.000017: statistical method in conjunction with the existing preliminary data. Most Phase III trials involve a comparative
p.000017: control group, which is usually the group receiving no investigational new drugs. In the Phase III
p.000017: trials, control procedures are implemented beginning from subject selection, group randomization, treatment
p.000017: allocation, follow up, and evaluation. The trial in this phase is aimed to increase patient survival or
p.000017: to improve
p.000017:
p.000018: 18
p.000018: patient quality of life. Then, the trial design should be randomized, double blinded, i.e., both the investigators
p.000018: and the subjects do not know what drugs either investigational or comparative are given. When the drug gives
p.000018: the favorable results under the Phase III trials, they are likely authorized for marketing.
p.000018:
p.000018: Phase IV
p.000018: This phase is also called a post marketing surveillance study. The study is done after the drug has been
p.000018: registered, with the objectives being to study the therapeutic uses, any adverse effects, and toxicity of the
p.000018: drug in a larger numbers of patients who have been using the drug for a longer period of time, or to explore
p.000018: additional effectiveness for other indications other than the approved ones. Also, the study in this phase can
p.000018: be done in other population groups that have never been studied.
p.000018:
p.000018: Ethical Considerations on Each Phase of the Clinical Drug Trial
p.000018:
p.000018: 7.1.1 Phase I Clinical Trials
p.000018: (1) The ethics committee should be independent of the trial sponsor, conduct a rigorous review of a research protocol,
p.000018: and continuously monitor the trial.
p.000018: (2) As the trial in this phase is conducted in healthy subjects where the sponsor of new drugs pay for the study, the
p.000018: ethical review should focus on the following aspects:
p.000018: a. the subject sample selection;
p.000018: b. a freely given informed consent process;
p.000018: c. the meaning of the message in the consent form;
p.000018: d. the qualifications of the committee’s members and performance of the ethics committee;
p.000018: e. applicable regulatory requirements (if any).
p.000018: (3) Specific ethical considerations are needed for the review of the drug trial conducted in patients suffering from
p.000018: an illness with no hope from currently available treatments. As the conduct of the trial under this situation may
p.000018: distort the awareness of the patients, the family, and the investigator in weighing the risks and benefits of the
p.000018: trial, and may affect the freely
p.000018: given informed consent and the termination or the withdrawal criteria,
p.000018: therefore, both the investigator and the ethics committee should co-operate and consult each other throughout the
p.000018: course of the trial.
p.000018:
p.000018: 7.1.2 Phase II and Phase III Clinical Trials
p.000018: Generally, the trials in these phases involve the use of a placebo in the control group. Placebos should not be used
p.000018: in a control group if standard treatments are available because the subjects will lose medical benefits from
p.000018: participating in the trial. In addition to a focus on the freely informed consent process, ethical considerations in
p.000018: a placebo-controlled trial should pay attention to an appropriate design so as to maximize the benefits and minimize
p.000018: harms to patients.
p.000018:
p.000018: 7.1.3 Phase IV
p.000018: The trial in this phase is usually conducted in the private practice of physicians who use the drugs already available
p.000018: on the market. Frequently, the sponsor pays the investigator based on the number of patients recruited in order to
p.000018: study the side effects of drugs and to build acceptance in using the drugs among patients and other physicians. This
p.000018: case may impose an obligation to the investigator. Therefore, the investigator and the ethics committee should
p.000018: consider appropriate benefits and payment to be given to the subjects for their participation.
p.000018:
p.000018: 7.1.4 Clinical Trial of Medical Equipment
p.000018: A clinical trial using a medical device for human use, either invasive or non
p.000018:
p.000019: 19
p.000019: invasive, requires similar ethical considerations as clinical drug trials in four phases, in particular the medical
p.000019: device that is to be inserted into the
p.000019: body. In such a case, a specific consideration is required depending on the
p.000019: types of devices. For example, the conduct of a trial using a cardiac pace maker, which is a very expensive device,
p.000019: requires surgery to evaluate its safety and effectiveness. Considerations are also extended to the costs of the
p.000019: surgery and of a patent license requested by the device’s manufacturer.
p.000019: Slight differences between the clinical trials of drugs and devices can be noted. The ethics committee should pay
p.000019: attention to the differences as well, such as
p.000019: (1) A medical device for human use may not be tested previously in animal models such as retractors because of
p.000019: different human and animal anatomies.
p.000019: (2) Certain types of medical devices should not be studied in healthy human subjects because the research procedures
p.000019: and/or the use of the device may impose extremely high risks and harm, but create no benefits to the subjects. For
p.000019: example, the trials using artificial joints, artificial cardiac valves, or a cardiac pace maker.
p.000019: (3) The clinical trial of a new drug is not regarded as a trial with a minimal risk because the mechanism of action
p.000019: may not be clear. As a result, it is impossible to predict possible side effects. On the contrary, the trial using an
p.000019: external medical device, which is known for its mechanism of action, allows us to predict the possible side effects.
p.000019: The trial can be regarded as imposing a minimal risk. Details will be discussed later.
p.000019: (4) A comparative study using a medical device and a placebo or other comparators to evaluate the effectiveness or
p.000019: efficiency of the treatments may not be conducted because ethical justification if the use of that device is the only
p.000019: opportunity for the subject to obtain benefit from the treatment, such as
p.000019: surgery to insert the artificial joint to replace irreversibly impaired joints.
p.000019: In general, a sham surgery in the comparator group is regarded as ethically inappropriate as it can greatly impose
p.000019: risks and harm to the subjects, while it provides no benefits. The sham surgery, however, used
p.000019: in the clinical trial of a medical device may be conducted under certain circumstances of extreme necessity, provided
p.000019: that the risks must be minimized as much as possible and the subject must be given full and correct information before
p.000019: freely deciding to participate in the trial.
p.000019: As mentioned above, in several cases, a medical device that has clear mechanisms of action may be designed by the
p.000019: physician who directly takes care of the patient. In addition a device available on the market may be altered or
p.000019: further developed and used in the treatment for patients unable to access
p.000019: other available treatments. The investigator or the sponsor of this type of trial may get less financial support than
p.000019: that from drug companies in the case of a clinical drug trial. Hence, the design of a clinical study of a medical
p.000019: device to prove its effectiveness, efficiency and safety may be an observational study instead of a randomized
p.000019: controlled trial, which is the standard for a clinical trial of new drugs. The observational study allows for
p.000019: collecting the data completely and completing the follow-up for all patients for a sufficiently long time. This is
p.000019: demonstrated by the study of artificial joints and cardiac valves that are widely recognized.
p.000019: Systematic consideration of research using a medical device may start from the division of the devices into two
p.000019: categories, i.e., devices with minimal risk or non-significant risk and devices with significant risk, by considering
p.000019: the general characteristics and the use of the devices.
p.000019: Medical devices with significant risks are referred to as devices that
p.000019: • risk death upon usage;
p.000019: • risk permanent disability upon usage;
p.000019: • require a surgery or certain drugs to prevent death and/or disability that may be caused by that device.
p.000019:
p.000020: 20
p.000020: The risks related to the use of the devices also include the risks that are caused by the procedures and techniques
...
p.000020: 7.1.5 Research Budget
p.000020: The ethics committee should review the research budget to ensure that the issue of benefits has been taken into
p.000020: account. In general, the sponsor will pay the investigator based on the number of subjects. Payment calculated
p.000020: based on the number of recruited subjects is an ethical issue, because it is possible that the investigator has
p.000020: conflicting thoughts between the payment to be received and the beneficial and appropriate health service to be given
p.000020: to the subject. This is the case in particular when the patient or the subject trusts the investigator.
p.000020: Research conducted in public hospitals or public health care facilities involve expenditures to cover such as
p.000020: laboratory tests, and lump sum fees determined by the institution. The disclosure of the payment and the other budget
p.000020: items helps the ethics committee to evaluate any conflict of interest, and helps the investigator to decide whether to
p.000020: conduct the trial.
p.000020:
p.000020: 7.1.6 Placebo-Controlled Trial
p.000020: It is generally unacceptable to use a placebo in a control group in a trial where standard treatments or medically
p.000020: proven medicines are available, because patients will lose medical benefits entitled to from participating
p.000020: in the clinical trial. However, the use of a placebo in a control group may be allowed in the following cases.
p.000020: (1) no standard drug medically recognized for the treatment of the disease is available;
p.000020: (2) the available drug for the treatment yields uncertain outcomes;
p.000020: (3) the standard drug for the treatment is available, but it causes serious adverse drug reactions or adverse events
p.000020: that the subjects cannot tolerate;
p.000020: (4) the illness to be studied is managed by itself due to a placebo effect;
p.000020:
p.000021: 21
p.000021: (5) the disease to be studied is a minor condition and treating with a placebo causes the only discomfort or the
p.000021: illness is alleviated slowly or negligibly, and causes no serious or irreversible harm to the subjects;
p.000021: (6) compelling scientific and methodological reasons are necessary
p.000021: to use a placebo-controlled group in determining the effectiveness and the safety of a study drug.
p.000021: In addition to the focus on freely informed consent, the ethical consideration of a placebo-controlled trial should
p.000021: focus on an appropriate design to maximize benefits and minimize harm to patients.
p.000021:
p.000021: 7.1.7 Analysis and Distribution of Research Results
p.000021: In most clinical trials, the sponsor has rights as agreed upon for the analysis and interpretation of research results.
p.000021: However, the investigator and the ethics committee should ensure that:
p.000021: (1) The final analysis and interpretation of the research results will rest with the investigator to ensure that the
p.000021: results would be actually complete and accurate.
p.000021: (2) When the trial of Phase I, II and III is required to stop according to the rules, there must be an independent
p.000021: interim analysis. However, prior to
p.000021: implementing the termination rules, it should be identified that either positive
p.000021: or negative long-term effects of the drug may be obscured by either good or bad short term drug effects.
p.000021: (3) The main responsibility of the investigator is to circulate the research findings to the community of
p.000021: investigators. However, it is found that frequently the research results of several trials, in particular the negative
p.000021: results, are not published or distributed. Not only does the case create an inappropriate scientific conduct and
p.000021: produce no actual research results, but also the research results and the resources invested in the research become in
p.000021: vain.
p.000021:
p.000021:
p.000021: 7.2 EPIDEMIOLOGICAL RESEARCH
p.000021:
p.000021: Epidemiological research is an integral part of public health or health service research, which is necessary for the
p.000021: prevention of and the control of diseases or for improving the efficiency and the performance of a health care system.
p.000021: This leads to the improved health of the population. Certain epidemiological research may be required to study in a
p.000021: large population, and thus a multi- center study is needed.
p.000021: The epidemiological research is different from other types of research in that it involves the use and the keeping of
p.000021: medical information and the tissue samples of patients or populations. Then, an ethical consideration is needed
p.000021: for the use of the data or the tissues regardless of whether the data or the tissues would be stored for the
p.000021: purpose of the treatment.
p.000021:
p.000021: Types of Personal Information
p.000021: Epidemiological research involves the use of the following types of data.
p.000021: a. identified data, which are referred to as, for example, name, date of birth, or address, including such a minor
p.000021: details as a zip code that may be used as an identifier;
...
p.000023: 7.3.3 The investigator should conduct only the research that benefits mankind.
p.000023: 7.3.4 The investigator should ensure that the design of the study is suitable to the objectives of the study.
p.000023: 7.3.5 The investigator should fully inform the subjects so that they can freely decide whether to participate in the
p.000023: research.
p.000023: 7.3.6 The investigator should protect the confidentiality and undisclosed names of the subjects.
p.000023: 7.3.7 The investigator should provide for health care to the subject as much as possible.
p.000023: 7.3.8 If the inclusion criteria are sensitive issues, the investigator should carefully conduct the study to avoid
p.000023: the disclosure of the subjects’ identity. The
p.000023: investigators may sometimes conduct the study in a non-targeted population to prevent the members of the community from
p.000023: being aware of what is conducted.
p.000023: 7.3.9 In case the study is conducted using medical records consisting of the confidentiality of patients, only the
p.000023: authorized medical personnel are allowed to access the data in the records, which can identify the patients. The access
p.000023: should be permitted by the highest authority of the institution.
p.000023: 7.3.10 The investigator should provide appropriate payment, benefits, or privileges to the subjects, and ensure that
p.000023: it should not be too much to induce the subjects to participate in the study.
p.000023:
p.000023:
p.000023: 7.4 VACCINE TRIAL
p.000023:
p.000023: The guidelines for conducting clinical drug trials are also applied to vaccine trials.
p.000023: However, the phase of the vaccine study may have additional details as explained below.
p.000023: 7.4.1 Phase I: This is a first-in-human trial to study the safety and biological effects, in particular the
p.000023: immunogenicity of a vaccine. Doses and routes of administration will be studied in this phase, and the trial is
p.000023: conducted in a low risk population.
p.000023: 7.4.2 Phase II: The trial is conducted in a limited number of patients to firstly explore the efficacy of a vaccine.
p.000023: The vaccine trial also serves for preventive purposes. Therefore, the trial involving a preventive vaccine must
p.000023: be conducted in healthy volunteers, while the trial involving a treatment vaccine is done in the patients of
p.000023: targeted disease.
p.000023: 7.4.3 Phase III: The trial in this phase focuses on the effectiveness of a vaccine for disease
p.000023: prevention. More subjects are then needed for the study in this phase (a thousand subjects and up). The trial
p.000023: is usually a multi-center trial, including a control group.
p.000023:
p.000024: 24
p.000024: 7.4.4 Precautions in a vaccine trial where the vaccines are produced from live-attenuated microorganisms should be
p.000024: exercised as the vaccines may cause infection in the subjects, despite its low possibility. Therefore, it is
p.000024: essential to inform the potential subjects in advance about the risk.The subjects in the control group not receiving
...
p.000040: specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the
p.000040: extent stability permits, samples should be retained either until the analyses of the trial data are complete or
p.000040: as required by the applicable regulatory requirement(s), whichever represents the longer retention period.
p.000040:
p.000040: 15. Record Access
p.000040: 15.1 The sponsor should ensure that it is specified in the protocol or other written agreement that
p.000040: the investigator(s)/institution(s) provide direct access to source data/documents for
p.000040: trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.
p.000040: 15.2 The sponsor should verify that each subject has consented, in writing, to direct access to his/her original
p.000040: medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection.
p.000040:
p.000040: 16. Safety Information
p.000040: 16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
p.000040: 16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies)
p.000040: of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's
p.000040: approval/favorable opinion to continue the trial.
p.000040:
p.000041: 41
p.000041: 17. Adverse Drug Reaction Reporting
p.000041: 17.1 The sponsor should expedite the reporting to all concerned
p.000041: investigator(s)/institutions(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of
p.000041: all adverse drug reactions (ADRs) that are both serious and unexpected.
p.000041: 17.2 Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for
p.000041: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
p.000041: 17.3 The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as
p.000041: required by applicable regulatory requirement(s).
p.000041:
p.000041: 18. Monitoring
p.000041: 18.1 Purpose
p.000041: The purposes of trial monitoring are to verify that:
p.000041: (a) The rights and well-being of human subjects are protected.
p.000041: (b) The reported trial data are accurate, complete, and verifiable from source documents.
p.000041: (c) The conduct of the trial is in compliance with the currently approved
p.000041: protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
p.000041:
p.000041: 18.2 Selection and Qualifications of Monitors
p.000041: (a) Monitors should be appointed by the sponsor.
p.000041: (b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge
p.000041: needed to monitor the trial adequately. A monitor’s qualifications should be documented.
p.000041: (c) Monitors should be thoroughly familiar with the investigational product(s), the protocols, written
p.000041: informed consent form and any other written information to be provided to subjects, the sponsor’s
p.000041: SOPs, GCP, and the applicable regulatory requirement(s).
p.000041:
p.000041: 18.3 Extent and Nature of Monitoring
...
p.000006: [ ] The materials are requested to be shipped to Recipient’s investigators/ Laboratory supervisor/ Instructor shown
p.000006: below.
p.000006:
p.000006:
p.000006:
p.000006: FOM SCIENTIST
p.000006:
p.000006:
p.000006: Signature: ............................................
p.000006: Printed Name: .....................................
p.000006: Unit/Dept: ............................................
p.000006: Faculty /
p.000006: Institute…………………………………
p.000006:
p.000006: Date: ...................................................
p.000006:
p.000006: RECIPIENT SCIENTIST
p.000006:
p.000006:
p.000006: Signature: ............................................
p.000006: Printed Name: ......................................
p.000006: Unit/Dept: .............................................
p.000006: Address: ..............................................
p.000006:
p.000006: Date: ...................................................
p.000006:
p.000006:
p.000006: Explanatory Note:
p.000006:
p.000006: [1] Fill the name, address of the Faculty/Institution that provides the materials, for example, Faculty of Medicine,
p.000006: Chiang Mai University 110 Intavaroros Road, Sriphum District,
p.000006: Muang, Chiang Mai 50200, Thailand
p.000006: [2] Fill the brief name of the Faculty/Institution, for example, Faculty of Medicine
p.000006: [3] Fill the name, address of the Faculty/Institution that receives the materials
p.000006:
p.000006: Attachment B is the protocol.
p.000006:
p.000054: 54
p.000054: ANNEX 9
p.000054:
p.000054: LIST OF MEMBERS,
p.000054: THE WORKING GROUP FOR THE DEVELOPMENT OF NATIONAL ETHICAL GUIDELINES FOR RESEARCH IN HUMAN SUBJECTS B.E. 2545-2547
p.000054:
p.000054: 1. Vichai Chokevivat, M.D.
p.000054: Advisor
p.000054: Food and Drug Administration, Ministry of Public Health
p.000054:
p.000054: 2. Professor Anek Areebhak, M.D. Advisor
p.000054: Faculty of Medicine, Chulalongkorn University
p.000054:
p.000054: 3. Somboon Kiatinun, M.D. Chairlady
p.000054: Faculty of Medicine, Thammasart University
p.000054:
p.000054: 4. Professor Manit Sritpramote, M.D. Member
p.000054: Bangkok Medical College, Bangkok Metropolitan Administration
p.000054:
p.000054: 5. Assoc. Prof. Nimit Morakote, Ph.D. Member
p.000054: Associate Dean for Research Affairs, Faculty of Medicine, Chiangmai University
p.000054:
p.000054: 6. Assoc. Prof. Col. Aphornpirom Ketpanya, M.D Member
p.000054: Phramonkutklao Medical College, the Royal Thai Army
p.000054:
p.000054: 7. Assoc. Prof. Rojana Sirisriro, M.D. Member
p.000054: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
p.000054:
p.000054: 8. Suchart Chongprasert, Ph.D. Member
p.000054: Food and Drug Administration, Ministry of Public Health
p.000054:
p.000054: 9. Korakot Juthasmith, M.D. Member
p.000054: Department of Medical Services, Ministry of Public Health
p.000054:
p.000054: 10. Wiwat Rojanapityakorn, M.D. Member
p.000054: Office for International Development of Health Policies
p.000054:
p.000054: 11. Assoc. Prof. Sopit Thammaree Member & Secretary
p.000054: Faculty of Medicine, Chulalongkorn University
p.000054:
p.000055: 55
p.000055: ANNEX 10
p.000055:
p.000055: LIST OF MEMBERS,
p.000055: THE WORKING GROUP FOR REVISING THE ETHICAL GUIDELINESFOR RESEARCH IN HUAMN SUBJECTS IN THAILAND
p.000055: B.E. 2548-2550
p.000055:
p.000055: 1. Somboon Kiatinun, M.D.
p.000055: Chairperson
p.000055: Faculty of Medicine, Thammasart University
p.000055:
p.000055: 2. Vichai Chokevivat, M.D.
p.000055: Member
p.000055: Director General,
p.000055: Department for the Development of Thai and Alternative Medicines, Ministry of Public Health
p.000055:
p.000055: 3. Assoc. Prof. Nimit Morakote, Ph.D. Member
p.000055: Faculty of Medicine, Chiangmai University
p.000055:
p.000055: 4. Assoc. Prof. Major. Gen. Aphornpirom Ketpunya, M.D. Member
p.000055: Department of the Royal Thai Army
p.000055:
p.000055: 5. Assist. Prof. Phanuwat Lertsitthichai, M.D. Member
p.000055: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
p.000055:
p.000055: 6. Assoc. Prof. Sopit Thammaree Member & Secretary
p.000055: Faculty of Medicne, Chulalongkorn University
...
p.000057: September 2-3, 1998 (B.E.2541), Amarin Room, Third Floor, SD Avenue Hotel, Boromracchonani Road, Bangkok.
p.000057:
p.000057: Canada Tri-council Policy Statement. Ethical Conduct for Research Involving Humans,
p.000057: 1998.
p.000057:
p.000057: Code of Federal Regulations Title 45 Part 6 - Protection of Human Subjects (45 CFR 46) Revised June 18, 1991 (Effective
p.000057: August 19, 1991) Edition October 1, 1993.
p.000057:
p.000057: Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical
p.000057: Research Involving Human Subject, (1993 and a draft version 2001).
p.000057:
p.000057: Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Ethical
p.000057: Review of Epidemiological Studies (1991).
p.000057:
p.000057: Kittaporn, D., Ethical Issues in Social Science Research, Handouts for the First Training Workshop on Ethical
p.000057: Guideline in Clinical Research or Experiments Involving Human Subjects, hosted by the Faculty of Medicine,
p.000057: Khonkaen University and the Forum for Ethical Review Committee in Thailand (FERCIT), June 20-22, 2001 (B.E.
p.000057: 2544), Faculty of Medicine, Khonkaen University.
p.000057:
p.000057: European Epidemiology Group, Good Scientific Practice: Proper Conduct of Epidemiological
p.000057: Research.
p.000057:
p.000057: Drug Control Division, Food and Drug Administration, Ministry of Public Health, Thailand,
p.000057: ICH- Good Clinical Practice Guideline (Thai version), July, B.E. 2543.
p.000057:
p.000057: ICH Harmonized Guideline for Good Clinical Practice. London: EMEA, 1998.
p.000057:
p.000057: National Health and Medical Research Council, Australia, National Statement on Ethical conduct in Research
p.000057: Involving Humans, 1999.
p.000057:
p.000057: Office for Human Research Protections (OHRP), Institutional Review Board Guidebook,
...
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p.000001: that Review Biomedical Research, the Council for International Organizations of Medical Science
p.000001: (CIOMS), and the Canadian Ethical Conduct for Research involving Humans, etc. The ethical guidelines has been
p.000001: published and distributed since B.E. 2545, and its English version was available in B.E. 2550.
p.000001:
p.000001: 1.2 Need for Research on Human Subjects
p.000001: Research on human subjects is necessary for promoting scientific progress and building a better understanding in
p.000001: order to improve human well-being. Researchers, universities, governments, and private organizations
p.000001: have various reasons for conducting or sponsoring research on human subjects. Such reasons include, for example,
p.000001: alleviating suffering from illness, evaluating social values or scientific theories, eliminating ignorance,
p.000001: analyzing policies, creating better understanding of human behavior and related purposes. In summary, research on
p.000001: human subjects serves three main purposes, i.e.,
p.000001: 1.2.1 To generate a new body of knowledge and new understanding;
p.000001: 1.2.2 To enhance scientific advancement that benefits the research subjects.
p.000001: 1.2.3 Through research, the subjects may gain benefits from the development of new treatment, from new findings
p.000001: for higher living standard, from new discoveries, from writing, speech, and traditional culture, or from
p.000001: satisfaction in improving society;
p.000001:
p.000002: 2
p.000002: 1.2.4 Also, research provides benefits for the society at large or for certain groups of people or has influence
p.000002: on political behavior, which may lead to an improved health policy. The statistical information about the disease
p.000002: incidence may help to improve public health. The information about living conditions and behavior may lead to social
p.000002: development.
p.000002:
p.000002: 1.3 Objectives of the Ethical Guidelines for Research on Human Subjects in
p.000002: Thailand
p.000002: Thailand has established three basic objectives regarding research on humans:
p.000002: 1.3.1 To ensure that the dignity, rights, safety and well-being of subjects participating in research are protected,
p.000002: and the results of the research are credible;
p.000002: 1.3.2 To serve as guidelines for researchers, ethics committees, organizations, institutions, and people
p.000002: who are related to research ethics;
p.000002: 1.3.3 To serve as a basis for an ethics committee to derive a standard operating procedure (SOP) for
p.000002: the review and approval of biomedical research conducted within each institution.
p.000002:
p.000002: 1.4 Related Terms and Definitions
p.000002: 1.4.1 Research on human subjects means a research study, inquiry, interviews in social science, environment and
p.000002: environmental conditions, a clinical trial of pharmaceutical products and medical devices, a study of the nature
p.000002: of disease, the diagnosis of, the treatment of, the health promotion of, and the prevention of a disease related to
p.000002: human or conducted in human. Also, such research includes research studies using information from
...
p.000027: (1) The investigator involved the storage of the genetic materials in the bank should demonstrate to the ethics
p.000027: committee and to the subjects the operating procedures used for keeping confidentiality, privacy, and retention of the
p.000027: materials as well the data and the research results.
p.000027: (2) The duration of storing the genetics materials should be specified, including the operating procedures for the
p.000027: destruction of the materials upon completing the storage time.
p.000027: (3) The duration of storing the genetics materials should be specified,
p.000027: including the operating procedures for the destruction of the materials upon completing storage time. Uses of the
p.000027: materials for purposes other than those specified in the approved protocol should receive informed consent from the
p.000027: research participants or their heirs. Furthermore, their families are
p.000027: able to contact for the data or for the withdrawal from the research at anytime without any conditions.
p.000027:
p.000027: 7.6.7 Commercial use of genetic data
p.000027: The investigator must specify the commercial benefits that may be derived from the results or the data of the research
p.000027: using human genetics in research protocols to create further awareness in the ethics committee and the subjects.
p.000027:
p.000027:
p.000027: 7.7 RESEARCH ON HUMAN GAMETES, EMBRYO, EMBRYONIC STEM CELL, AND THE FETUS
p.000027:
p.000027: Research using advanced reproductive heath technology influence the practices of research ethics, researcher’s ethics,
p.000027: and people at large. The regulations issued by the Medical Council, by the advice of the Royal College of
p.000027: Obstetrics and Gynecology of Thailand, have already laid down the medical practice guidelines on the
p.000027: standards of services concerning reproduction technology. In addition, in conducting research involving human
p.000027: gametes, embryos, and the fetus, the risks imposed to the embryo or fetus, the informed consent, and the respect for
p.000027: the rights of the embryo and fetus should be considered. The following criteria are recommended.
p.000027:
p.000027: 7.7.1 Research involving human gametes
p.000027: (1) Obtaining the informed consent from the owners of the gametes is required in research using human gametes, which
p.000027: follows the principles and
p.000027: practices applied in other research involving human subjects.
p.000027: (2) The collection of the human gametes from a deceased person is not allowed, as the informed consent from the
p.000027: donor of the gametes cannot be obtained. Any research conducted using commercialized gametes, or
p.000027: inducing artificial cross-fertilization between the human gamete and an animal gamete, is considered unethical.
p.000027:
...
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p.000019: physician who directly takes care of the patient. In addition a device available on the market may be altered or
p.000019: further developed and used in the treatment for patients unable to access
p.000019: other available treatments. The investigator or the sponsor of this type of trial may get less financial support than
p.000019: that from drug companies in the case of a clinical drug trial. Hence, the design of a clinical study of a medical
p.000019: device to prove its effectiveness, efficiency and safety may be an observational study instead of a randomized
p.000019: controlled trial, which is the standard for a clinical trial of new drugs. The observational study allows for
p.000019: collecting the data completely and completing the follow-up for all patients for a sufficiently long time. This is
p.000019: demonstrated by the study of artificial joints and cardiac valves that are widely recognized.
p.000019: Systematic consideration of research using a medical device may start from the division of the devices into two
p.000019: categories, i.e., devices with minimal risk or non-significant risk and devices with significant risk, by considering
p.000019: the general characteristics and the use of the devices.
p.000019: Medical devices with significant risks are referred to as devices that
p.000019: • risk death upon usage;
p.000019: • risk permanent disability upon usage;
p.000019: • require a surgery or certain drugs to prevent death and/or disability that may be caused by that device.
p.000019:
p.000020: 20
p.000020: The risks related to the use of the devices also include the risks that are caused by the procedures and techniques
p.000020: used, for example, the risk caused by a surgery and general anesthesia used in the process of inserting the devices
p.000020: into the body.
p.000020: If the device to be used in research is similar to or has been used under the approved indications as that of the
p.000020: device available on the market, the advantages and disadvantages of the device to be studied in comparison with the
p.000020: available device should be considered.
p.000020: For example, the conduct of a trial using an electrical pacemaker, despite its high risk, inserted into the patient’s
p.000020: body which contains the property and usage not significantly different from those of the available device on the market
p.000020: may be ethically acceptable according to the principle of beneficence (see list of devices with classified risks in the
p.000020: annex).
p.000020: Deciding which type of risk the trial of a medical device or the device itself falls into is the responsibility of the
p.000020: ethics committee. If the committee decides that the trial and the device used impose a minimal risk, the trial of the
p.000020: device should pass ethical clearance according to the principle of beneficence.
p.000020: However, if the committee decides that the clinical trial of a device imposes a high risk, comparison should be made
p.000020: with similar devices available on the market. Just as exemplified previously, if the device to be used in the trial is
p.000020: greatly different from the devices on the market, the trial should be reviewed according to the general ethical
p.000020: principles applied in clinical trials taking into account the specific characteristics of the trial of medical devices
p.000020: explained earlier.
p.000020: Finally, the investigator and the subject should always realize that devices inserted into the human body undergo
p.000020: failure both in short and long term. The failure of the device may result in damage, even death. When such a risk
p.000020: exists, the investigator is responsible for objectively reporting the event to the sponsor, the ethics committee and
p.000020: the subjects.
p.000020:
p.000020: 7.1.5 Research Budget
...
Health / Healthy People
Searching for indicator healthy people:
(return to top)
p.000016: 6.8.1 The institution or organization should appoint a committee independent of the ethics committee to monitor the
p.000016: progress of the research.
p.000016: 6.8.2 The purpose of the research monitoring committee is to ensure that the research complies with the
p.000016: proposed procedures specified in the protocol, and that the advice is given to the subject, as appropriate.
p.000016: 6.8.3 The research monitoring committee should establish its own criteria and mechanisms for monitoring the research
p.000016: protocol.
p.000016:
p.000016: 6.9 Termination or Suspension of Research
p.000016: 6.9.1 The ethics committee may withdraw or suspend its approval given to the research so as to protect the rights
p.000016: and welfare of the research participants. This includes when serious adverse effects are reported, or
p.000016: when the conduct of the research does not comply with the protocols approved by the committee.
p.000016: 6.9.2 In case of premature termination of any research protocols made by the investigator, the reasons for the
p.000016: termination must be reported to the ethics committee.
p.000016:
p.000017: 17
p.000017: CHAPTER 7
p.000017: SPECIFIC TYPES OF RESEARCH ON HUMAN SUBJECTS
p.000017:
p.000017: 7.1 CLINICAL DRUG TRIAL
p.000017:
p.000017: A clinical drug trial is a study of drug on either patients or healthy people in order to study the therapeutic or
p.000017: preventive effects of the drug.
p.000017: In general, an investigational drug used in clinical trial falls into one of four categories, namely:
p.000017: (1) new drugs; (2) unregistered drugs in Thailand (3) registered drugs by the national drug authority, but being
p.000017: studied in new doses or indications not previously approved; and (4) locally produced drugs which required efficacy
p.000017: testing.
p.000017:
p.000017: Phases of Clinical Drug Trials
p.000017: For new drugs, adequate evidence derived from animal studies must be available to ensure safety and determine toxicity
p.000017: levels prior to conducting a study in humans.
p.000017:
p.000017: A Clinical Drug Trail Can Be Classified in Four Phases.
p.000017:
p.000017: Phase I
p.000017: This is a first-in-human trial using a new chemical entity that is usually conducted in healthy volunteers to study
p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
...
Searching for indicator healthy volunteers:
(return to top)
p.000016:
p.000017: 17
p.000017: CHAPTER 7
p.000017: SPECIFIC TYPES OF RESEARCH ON HUMAN SUBJECTS
p.000017:
p.000017: 7.1 CLINICAL DRUG TRIAL
p.000017:
p.000017: A clinical drug trial is a study of drug on either patients or healthy people in order to study the therapeutic or
p.000017: preventive effects of the drug.
p.000017: In general, an investigational drug used in clinical trial falls into one of four categories, namely:
p.000017: (1) new drugs; (2) unregistered drugs in Thailand (3) registered drugs by the national drug authority, but being
p.000017: studied in new doses or indications not previously approved; and (4) locally produced drugs which required efficacy
p.000017: testing.
p.000017:
p.000017: Phases of Clinical Drug Trials
p.000017: For new drugs, adequate evidence derived from animal studies must be available to ensure safety and determine toxicity
p.000017: levels prior to conducting a study in humans.
p.000017:
p.000017: A Clinical Drug Trail Can Be Classified in Four Phases.
p.000017:
p.000017: Phase I
p.000017: This is a first-in-human trial using a new chemical entity that is usually conducted in healthy volunteers to study
p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
p.000017: elderly, or women with childbearing potential. Anesthesia or anticancer drugs should not be used in the healthy
p.000017: volunteers as a result of its high toxicity. In general, the number of the subjects should not exceed 30
p.000017: subjects. Every subject should give written informed consent before participating in the study. The study in
p.000017: this phase is usually an open study without any control group, i.e., both subjects and investigators know
p.000017: the trial drug. Studies in phase I also involve two stages. Stage I studies employ a small dose, i.e., about 1/50 or
p.000017: 1/100 of the dose used successfully in the animal studies. When the results demonstrate safety, the second stage
p.000017: is then followed by gradually escalating the dose. Once the results are satisfactory, phase II studies are
p.000017: conducted.
p.000017: Phase I trials also include the studies done on the patients suffering from a specific disease with no hope from
...
p.000023: investigators may sometimes conduct the study in a non-targeted population to prevent the members of the community from
p.000023: being aware of what is conducted.
p.000023: 7.3.9 In case the study is conducted using medical records consisting of the confidentiality of patients, only the
p.000023: authorized medical personnel are allowed to access the data in the records, which can identify the patients. The access
p.000023: should be permitted by the highest authority of the institution.
p.000023: 7.3.10 The investigator should provide appropriate payment, benefits, or privileges to the subjects, and ensure that
p.000023: it should not be too much to induce the subjects to participate in the study.
p.000023:
p.000023:
p.000023: 7.4 VACCINE TRIAL
p.000023:
p.000023: The guidelines for conducting clinical drug trials are also applied to vaccine trials.
p.000023: However, the phase of the vaccine study may have additional details as explained below.
p.000023: 7.4.1 Phase I: This is a first-in-human trial to study the safety and biological effects, in particular the
p.000023: immunogenicity of a vaccine. Doses and routes of administration will be studied in this phase, and the trial is
p.000023: conducted in a low risk population.
p.000023: 7.4.2 Phase II: The trial is conducted in a limited number of patients to firstly explore the efficacy of a vaccine.
p.000023: The vaccine trial also serves for preventive purposes. Therefore, the trial involving a preventive vaccine must
p.000023: be conducted in healthy volunteers, while the trial involving a treatment vaccine is done in the patients of
p.000023: targeted disease.
p.000023: 7.4.3 Phase III: The trial in this phase focuses on the effectiveness of a vaccine for disease
p.000023: prevention. More subjects are then needed for the study in this phase (a thousand subjects and up). The trial
p.000023: is usually a multi-center trial, including a control group.
p.000023:
p.000024: 24
p.000024: 7.4.4 Precautions in a vaccine trial where the vaccines are produced from live-attenuated microorganisms should be
p.000024: exercised as the vaccines may cause infection in the subjects, despite its low possibility. Therefore, it is
p.000024: essential to inform the potential subjects in advance about the risk.The subjects in the control group not receiving
p.000024: the real vaccine must also be protected from the disease or be informed that they have a chance to contact the disease
p.000024: from the experimental subject group.
p.000024: 7.4.5 In case of a trial using a recombinant DNA vaccine, the adverse effects of which are not yet clear, the
p.000024: investigator has to strictly follow the regulations of the Ministry of Public Health.
p.000024:
p.000024:
p.000024: 7.5 USE OF HUMAN TISSUE SAMPLES
p.000024:
p.000024: Human tissue samples mean anything being taken out or excreted from a human body or a corpse. The tissue samples also
p.000024: include other tissues, blood, secretions, and excretions from all organ systems. The objective of using the tissue
p.000024: samples is for the diagnosis of a disease or for other purposes.
p.000024:
p.000024: The human tissue samples may be obtained by one of the following means.
...
Searching for indicator volunteers:
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p.000001: countries also have attempted to stipulate regulations and guidelines for research on human subjects, and
p.000001: promote the adoption of the regulations/guidelines in developing countries, such as guidelines for manufacturing
p.000001: of pharmaceuticals or patent application. Prior to being accepted for publication or granted a patent,
p.000001: or conduct a scientific research investigation involving human subjects, researchers are required to
p.000001: obtain ethical approval from a recognized ethics committee. In addition, seminars and conferences have been
p.000001: conducted on the ethical principles or guidelines for research in human subjects in both developing and developed
p.000001: countries; the outcomes of which have been several declarations. The most prominent and widely accepted and
p.000001: most commonly referred to is the Declaration of Helsinki of the World Medical Association (WMA), firstly adopted
p.000001: in Helsinki, Finland in B.E. 2507. The Declaration has been regularly amended to keep pace with
p.000001: advanced science, technology and social changes. The last amendment was formulated and adopted in Scotland in B.E.
p.000001: 2543. Later, several declarations concerning the conduct of a research on human subjects have also been
p.000001: adopted. The most essential element of those declarations is to protect the dignity, rights, safety, and well being
p.000001: of human volunteers or research participants.
p.000001: Various institutions at national and international levels are aware of the ethical issues of research on
p.000001: human subjects. As a result, an ethics committee is appointed whose responsibility it is to monitor that the
p.000001: research conducted within the institution adheres to the ethical principles established in the Declaration of
p.000001: Helsinki or other declarations.
p.000001: In Thailand, the Ministry of Public Health in co-operation with nine Faculties of Medicine have organized a series
p.000001: of seminars at the Faculty of Medicine, Chulalongkorn University. This resulted in the establishment of the Forum
p.000001: for Ethical Review Committees in Thailand or FERCIT. The FERCIT aims to develop plans for promoting ethical research on
p.000001: human subjects. A Working Group was then appointed to draft ethical guidelines for research on human subjects, which
p.000001: are intended to serve as national guidelines. The national ethical guidelines were developed
p.000001: considering of the ethical principles that have their origin in several international guidelines, such as the
p.000001: Declaration of Helsinki of the World Medical Association, the WHO Operational Guidelines for Ethics Committees
p.000001: that Review Biomedical Research, the Council for International Organizations of Medical Science
p.000001: (CIOMS), and the Canadian Ethical Conduct for Research involving Humans, etc. The ethical guidelines has been
...
p.000017: (1) new drugs; (2) unregistered drugs in Thailand (3) registered drugs by the national drug authority, but being
p.000017: studied in new doses or indications not previously approved; and (4) locally produced drugs which required efficacy
p.000017: testing.
p.000017:
p.000017: Phases of Clinical Drug Trials
p.000017: For new drugs, adequate evidence derived from animal studies must be available to ensure safety and determine toxicity
p.000017: levels prior to conducting a study in humans.
p.000017:
p.000017: A Clinical Drug Trail Can Be Classified in Four Phases.
p.000017:
p.000017: Phase I
p.000017: This is a first-in-human trial using a new chemical entity that is usually conducted in healthy volunteers to study
p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
p.000017: elderly, or women with childbearing potential. Anesthesia or anticancer drugs should not be used in the healthy
p.000017: volunteers as a result of its high toxicity. In general, the number of the subjects should not exceed 30
p.000017: subjects. Every subject should give written informed consent before participating in the study. The study in
p.000017: this phase is usually an open study without any control group, i.e., both subjects and investigators know
p.000017: the trial drug. Studies in phase I also involve two stages. Stage I studies employ a small dose, i.e., about 1/50 or
p.000017: 1/100 of the dose used successfully in the animal studies. When the results demonstrate safety, the second stage
p.000017: is then followed by gradually escalating the dose. Once the results are satisfactory, phase II studies are
p.000017: conducted.
p.000017: Phase I trials also include the studies done on the patients suffering from a specific disease with no hope from
p.000017: currently available treatments, such as studies in terminally ill cancer patients.
p.000017:
p.000017: Phase II
p.000017: Phase II studies are conducted on patients with the target treatment of the drug that was satisfactorily studied in
p.000017: Phase I. The primary objective of the trial in this phase is to study short- term pharmacological toxicity in
p.000017: details, while the secondary objective is about the drug’s preliminary efficacy. Anesthesia and
p.000017: anticancer drugs are allowed in the Phase II trials. If possible, a trial design should be randomized and be
...
Health / Mentally Disabled
Searching for indicator mentally:
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p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
...
Searching for indicator disability:
(return to top)
p.000019: further developed and used in the treatment for patients unable to access
p.000019: other available treatments. The investigator or the sponsor of this type of trial may get less financial support than
p.000019: that from drug companies in the case of a clinical drug trial. Hence, the design of a clinical study of a medical
p.000019: device to prove its effectiveness, efficiency and safety may be an observational study instead of a randomized
p.000019: controlled trial, which is the standard for a clinical trial of new drugs. The observational study allows for
p.000019: collecting the data completely and completing the follow-up for all patients for a sufficiently long time. This is
p.000019: demonstrated by the study of artificial joints and cardiac valves that are widely recognized.
p.000019: Systematic consideration of research using a medical device may start from the division of the devices into two
p.000019: categories, i.e., devices with minimal risk or non-significant risk and devices with significant risk, by considering
p.000019: the general characteristics and the use of the devices.
p.000019: Medical devices with significant risks are referred to as devices that
p.000019: • risk death upon usage;
p.000019: • risk permanent disability upon usage;
p.000019: • require a surgery or certain drugs to prevent death and/or disability that may be caused by that device.
p.000019:
p.000020: 20
p.000020: The risks related to the use of the devices also include the risks that are caused by the procedures and techniques
p.000020: used, for example, the risk caused by a surgery and general anesthesia used in the process of inserting the devices
p.000020: into the body.
p.000020: If the device to be used in research is similar to or has been used under the approved indications as that of the
p.000020: device available on the market, the advantages and disadvantages of the device to be studied in comparison with the
p.000020: available device should be considered.
p.000020: For example, the conduct of a trial using an electrical pacemaker, despite its high risk, inserted into the patient’s
p.000020: body which contains the property and usage not significantly different from those of the available device on the market
p.000020: may be ethically acceptable according to the principle of beneficence (see list of devices with classified risks in the
p.000020: annex).
p.000020: Deciding which type of risk the trial of a medical device or the device itself falls into is the responsibility of the
p.000020: ethics committee. If the committee decides that the trial and the device used impose a minimal risk, the trial of the
p.000020: device should pass ethical clearance according to the principle of beneficence.
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000010:
p.000010: 4.1 Nature and Scope of Risks and Benefits
p.000010: The principle of beneficence requires that a research study be justified to conduct on humans by an
p.000010: assessment of a favorable risk and benefit ratio. In the context of research involving human subjects, the term "risk"
p.000010: means the possibility to receive harm, whereas the term "benefit" denotes that which gives a positive value to health
p.000010: or well being.
p.000010: Please note that benefits do not indicate an opportunity or possibility. By this definition, a benefit is then
p.000010: opposite to a harm. An assessment of a risk and benefit ratio requires the consideration of both
p.000010: probability and the dimension of possible harm and expected benefits.
p.000010: The common types of harm that occur to subjects include physical harm or injuries or psychological harm.
p.000010: In addition, other harm may be overlooked such as legal, social, and economic impacts. Moreover, the
p.000010: types of the expected benefits may be consistent with the types of potential harm that may happen.
p.000010: Risks and benefits in a research may affect each subject directly, subject's family, and society at
p.000010: large, or special subject groups in a general society. Before initiating the study, an assessment of risks
p.000010: and discomfort that may happen to the subjects compared with the expected benefits is required. Please be aware that
p.000010: the rights, safety, and wellbeing of the subjects must prevail over the benefits to science and society.
p.000010:
p.000010: .
p.000010: 4.2 Systematic Assessment of Risks and Benefits
p.000010: In most cases it is very difficult to precisely assess a risk and benefit ratio. Because of the lack of a quantitative
p.000010: technique for such assessment, it is necessary to conduct the risk and benefit analysis systematically and reasonably
p.000010: as practical as possible. This can be done in practice by collecting and evaluating the data covering all aspects of
p.000010: the research. Other available alternatives should be considered systematically, which would help to evaluate
p.000010: the research precisely and rigorously.
p.000010:
p.000010: 4.3 Basic Guidelines for Justifying a Research Containing the Minimum Elements:
p.000010: 4.3.1 A demonstrated real need exists to conduct a study in human subjects
p.000010: 4.3.2 Brutal or cruel treatments to subjects are completely unjustified.
p.000010: 4.3.3 Risks are minimized as much as possible, but research objective(s) are still achieved
p.000010: 4.3.4 When research involves a significant risk capable of serious damage, special confirmation is needed in
p.000010: justifying the risk.
...
p.000018: additional effectiveness for other indications other than the approved ones. Also, the study in this phase can
p.000018: be done in other population groups that have never been studied.
p.000018:
p.000018: Ethical Considerations on Each Phase of the Clinical Drug Trial
p.000018:
p.000018: 7.1.1 Phase I Clinical Trials
p.000018: (1) The ethics committee should be independent of the trial sponsor, conduct a rigorous review of a research protocol,
p.000018: and continuously monitor the trial.
p.000018: (2) As the trial in this phase is conducted in healthy subjects where the sponsor of new drugs pay for the study, the
p.000018: ethical review should focus on the following aspects:
p.000018: a. the subject sample selection;
p.000018: b. a freely given informed consent process;
p.000018: c. the meaning of the message in the consent form;
p.000018: d. the qualifications of the committee’s members and performance of the ethics committee;
p.000018: e. applicable regulatory requirements (if any).
p.000018: (3) Specific ethical considerations are needed for the review of the drug trial conducted in patients suffering from
p.000018: an illness with no hope from currently available treatments. As the conduct of the trial under this situation may
p.000018: distort the awareness of the patients, the family, and the investigator in weighing the risks and benefits of the
p.000018: trial, and may affect the freely
p.000018: given informed consent and the termination or the withdrawal criteria,
p.000018: therefore, both the investigator and the ethics committee should co-operate and consult each other throughout the
p.000018: course of the trial.
p.000018:
p.000018: 7.1.2 Phase II and Phase III Clinical Trials
p.000018: Generally, the trials in these phases involve the use of a placebo in the control group. Placebos should not be used
p.000018: in a control group if standard treatments are available because the subjects will lose medical benefits from
p.000018: participating in the trial. In addition to a focus on the freely informed consent process, ethical considerations in
p.000018: a placebo-controlled trial should pay attention to an appropriate design so as to maximize the benefits and minimize
p.000018: harms to patients.
p.000018:
p.000018: 7.1.3 Phase IV
p.000018: The trial in this phase is usually conducted in the private practice of physicians who use the drugs already available
p.000018: on the market. Frequently, the sponsor pays the investigator based on the number of patients recruited in order to
p.000018: study the side effects of drugs and to build acceptance in using the drugs among patients and other physicians. This
p.000018: case may impose an obligation to the investigator. Therefore, the investigator and the ethics committee should
...
p.000025: e. the proposal to protect the privacy and confidentiality of the tissue owners;
p.000025: f. the risk that may happen is a minimal risk;
p.000025: g. the relationship between the previously approved protocols and the new protocols;
p.000025: h. the potential commercial benefits or intellectual property;
p.000025: i. the regulatory requirements.
p.000025: (5) A material transfer agreement should be made in case the tissue samples are transferred to other institutions to
p.000025: ensure the consistency with the principle of respect for persons.
p.000025:
p.000025:
p.000025: 7.6 HUMAN GENETIC RESEARCH
p.000025:
p.000025: Human genetic research is the study of genes and their interactions with the surrounding factors that
p.000025: affect the health of individuals and populations. Not only does the research enlarge the body of knowledge
p.000025: that impacts the individual's health, but it may also affects the health of the individuals and their families in the
p.000025: future, which paves the way for protection from genetic diseases.
p.000025: Regarding the ethics in human genetic research, some additional elements are needed to be considered apart from those
p.000025: applied for other research involving human subjects because of the specific nature of this type of research. For
p.000025: example, the co-operation of the subjects and their families is very much needed for genetic research, and the data or
p.000025: the research results collected from one family may not only benefit those who participate in the research, but also
p.000025: those who do not directly join the research, but are the relatives of the subjects involved in the
p.000025: research.
p.000025:
p.000026: 26
p.000026: Therefore, in certain situations, those relatives have to be informed of the data collected from the other related
p.000026: groups for the benefit of their own families’ health care, such as a married couple who pays attention to the health of
p.000026: their unborn baby.
p.000026: In addition, the information generated by the results of the human genetic research may directly impact the
p.000026: subjects, e.g., causing social stigma or discrimination. Therefore, the investigator should be aware of
p.000026: these potential impacts, and should have measures for solving problems that may arise. The procedures
p.000026: for strictly protecting the subject’s privacy and the confidentiality of the data should be implemented.
p.000026: Generally, researchers should be aware of the following important considerations when conducting human genetic
p.000026: research.
p.000026:
p.000026: 7.6.1 Individuals, Families, and Biological Relatives:
p.000026: (1) The investigator should provide the information and obtain the individual informed consent from relevant people.
p.000026: (2) The outcomes of the research are to be disclosed to appropriate persons free of charge (appropriate persons mean
p.000026: the research participants who inform in advance that they need to know the results).
p.000026: (3) Human genetic researches is often conducted in groups of families or
p.000026: in communities that are related to one another, e.g., the study of a family tree
p.000026: or history or the linkage study on the same chromosome. In case that the study causes a conflict between family
p.000026: members, the investigator must take responsibility for solving the problem by communicating and informing
p.000026: correctly and honestly the information regarding the purposes, benefits, and disadvantages of the research to the
p.000026: families in question.
p.000026:
p.000026: 7.6.2 Privacy, Confidentiality, Loss of Benefits, and Risks
p.000026: (1) The investigator and the ethics committee should ensure that the confidentiality and the results of the genetic
p.000026: research be securely kept from unauthorized access by a third party, such as employer or insurance companies.
p.000026: (2) The investigator studying about the family’s or population’s genetics should review the scope of possible
p.000026: physical and mental impact that may happen to the relevant persons, and demonstrate those to the ethics committee.
p.000026:
p.000026: 7.6.3 Genetic Counseling
p.000026: The investigator and the ethics committee should ensure that the research protocols provide correct and appropriate
p.000026: genetic counseling for the potential subjects.
p.000026:
p.000026:
p.000026: 7.6.4 Genetic Alterations
p.000026: A genetic alteration of a human embryonic cell or a human gamete is regarded as a violation of research ethics. The
p.000026: research study on gene alteration then must not be approved, except for gene therapy that may need to be considered on
p.000026: a case by case basis to receive ethical approval for the research.
p.000026:
p.000026: 7.6.5 Eugenic Concern
p.000026: The objectives of the human genetic research are related to improved knowledge and understanding of genetic diseases
p.000026: that may affect human health only, including health care, and not for eugenic purposes. Additionally, attention must
p.000026: be paid to the subjects’ free decision making on the problems that may arise, in particular, for the married couple who
p.000026: needs to make a decision after being informed about a risk imposed upon the intrauterine fetus to develop a disease.
p.000026: The investigator should provide moral support for the married couple who decides to carry on the pregnancy after they
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000001: In Thailand, the Ministry of Public Health in co-operation with nine Faculties of Medicine have organized a series
p.000001: of seminars at the Faculty of Medicine, Chulalongkorn University. This resulted in the establishment of the Forum
p.000001: for Ethical Review Committees in Thailand or FERCIT. The FERCIT aims to develop plans for promoting ethical research on
p.000001: human subjects. A Working Group was then appointed to draft ethical guidelines for research on human subjects, which
p.000001: are intended to serve as national guidelines. The national ethical guidelines were developed
p.000001: considering of the ethical principles that have their origin in several international guidelines, such as the
p.000001: Declaration of Helsinki of the World Medical Association, the WHO Operational Guidelines for Ethics Committees
p.000001: that Review Biomedical Research, the Council for International Organizations of Medical Science
p.000001: (CIOMS), and the Canadian Ethical Conduct for Research involving Humans, etc. The ethical guidelines has been
p.000001: published and distributed since B.E. 2545, and its English version was available in B.E. 2550.
p.000001:
p.000001: 1.2 Need for Research on Human Subjects
p.000001: Research on human subjects is necessary for promoting scientific progress and building a better understanding in
p.000001: order to improve human well-being. Researchers, universities, governments, and private organizations
p.000001: have various reasons for conducting or sponsoring research on human subjects. Such reasons include, for example,
p.000001: alleviating suffering from illness, evaluating social values or scientific theories, eliminating ignorance,
p.000001: analyzing policies, creating better understanding of human behavior and related purposes. In summary, research on
p.000001: human subjects serves three main purposes, i.e.,
p.000001: 1.2.1 To generate a new body of knowledge and new understanding;
p.000001: 1.2.2 To enhance scientific advancement that benefits the research subjects.
p.000001: 1.2.3 Through research, the subjects may gain benefits from the development of new treatment, from new findings
p.000001: for higher living standard, from new discoveries, from writing, speech, and traditional culture, or from
p.000001: satisfaction in improving society;
p.000001:
p.000002: 2
p.000002: 1.2.4 Also, research provides benefits for the society at large or for certain groups of people or has influence
p.000002: on political behavior, which may lead to an improved health policy. The statistical information about the disease
p.000002: incidence may help to improve public health. The information about living conditions and behavior may lead to social
p.000002: development.
p.000002:
p.000002: 1.3 Objectives of the Ethical Guidelines for Research on Human Subjects in
p.000002: Thailand
p.000002: Thailand has established three basic objectives regarding research on humans:
p.000002: 1.3.1 To ensure that the dignity, rights, safety and well-being of subjects participating in research are protected,
p.000002: and the results of the research are credible;
p.000002: 1.3.2 To serve as guidelines for researchers, ethics committees, organizations, institutions, and people
...
p.000012: study. In doing so, the capacities of individuals in the groups or communities who can bear the potential burdens in
p.000012: the study, or the suitability of the individuals to bear further burdens must be considered. Social justice then
p.000012: deals with setting an order or a priority that needs to be considered before enrolling any groups of people into any
p.000012: studies (for example, adult before children, male before female).
p.000012: Likewise, the principle of distributive justice can also be applied at community and country levels, i.e., that which
p.000012: the community bears the burdens, or which the community takes the benefits must be in accordance with the
p.000012: principle of distributive justice as well. A common problem of injustice occurring at the community
p.000012: level is exemplified in the case of trials for product development of drugs, vaccines or medical
p.000012: devices that are sponsored by companies or organizations in developed countries. The trials are conducted
p.000012: in developing countries, but after the end of the trials, drugs or vaccines or medical devices under the
p.000012: studies cannot be made beneficial to the participating populations or countries. One of the causes is due to
p.000012: the lack of access to those drugs or vaccines because of their high cost, or the lack of disease or illness for such
p.000012: drugs or vaccines in those communities in developing countries occurs. Thus, the principle must be carefully and
p.000012: thoroughly considered to bring justice to all levels from the individual to the society.
p.000012: However, please be aware that in reviewing research on human subjects based on this principle, deviation
p.000012: from the principle of distributive justice may sometimes happen reasonably as well, but the differences of related
p.000012: factors such as experiences, sex, physical impairment, capacity, and position must be taken into careful and
p.000012: appropriate consideration. This is to serve as criteria for decision making in the case that different
p.000012: treatments are given to individuals, and this consideration should be made on an individual basis.
p.000012:
p.000013: 13
p.000013: CHAPTER 6
p.000013:
p.000013: ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS
p.000013: A research protocol involving human subjects must be subject to review and approval by an ethics committee for
p.000013: research on human subject before initiating a study. Thus, institutions or organizations with established
p.000013: research protocols or investigators have to appoint and authorize the ethics committee to decide about the research
...
p.000018: drug in a larger numbers of patients who have been using the drug for a longer period of time, or to explore
p.000018: additional effectiveness for other indications other than the approved ones. Also, the study in this phase can
p.000018: be done in other population groups that have never been studied.
p.000018:
p.000018: Ethical Considerations on Each Phase of the Clinical Drug Trial
p.000018:
p.000018: 7.1.1 Phase I Clinical Trials
p.000018: (1) The ethics committee should be independent of the trial sponsor, conduct a rigorous review of a research protocol,
p.000018: and continuously monitor the trial.
p.000018: (2) As the trial in this phase is conducted in healthy subjects where the sponsor of new drugs pay for the study, the
p.000018: ethical review should focus on the following aspects:
p.000018: a. the subject sample selection;
p.000018: b. a freely given informed consent process;
p.000018: c. the meaning of the message in the consent form;
p.000018: d. the qualifications of the committee’s members and performance of the ethics committee;
p.000018: e. applicable regulatory requirements (if any).
p.000018: (3) Specific ethical considerations are needed for the review of the drug trial conducted in patients suffering from
p.000018: an illness with no hope from currently available treatments. As the conduct of the trial under this situation may
p.000018: distort the awareness of the patients, the family, and the investigator in weighing the risks and benefits of the
p.000018: trial, and may affect the freely
p.000018: given informed consent and the termination or the withdrawal criteria,
p.000018: therefore, both the investigator and the ethics committee should co-operate and consult each other throughout the
p.000018: course of the trial.
p.000018:
p.000018: 7.1.2 Phase II and Phase III Clinical Trials
p.000018: Generally, the trials in these phases involve the use of a placebo in the control group. Placebos should not be used
p.000018: in a control group if standard treatments are available because the subjects will lose medical benefits from
p.000018: participating in the trial. In addition to a focus on the freely informed consent process, ethical considerations in
p.000018: a placebo-controlled trial should pay attention to an appropriate design so as to maximize the benefits and minimize
p.000018: harms to patients.
p.000018:
p.000018: 7.1.3 Phase IV
p.000018: The trial in this phase is usually conducted in the private practice of physicians who use the drugs already available
p.000018: on the market. Frequently, the sponsor pays the investigator based on the number of patients recruited in order to
...
p.000020: to the subject. This is the case in particular when the patient or the subject trusts the investigator.
p.000020: Research conducted in public hospitals or public health care facilities involve expenditures to cover such as
p.000020: laboratory tests, and lump sum fees determined by the institution. The disclosure of the payment and the other budget
p.000020: items helps the ethics committee to evaluate any conflict of interest, and helps the investigator to decide whether to
p.000020: conduct the trial.
p.000020:
p.000020: 7.1.6 Placebo-Controlled Trial
p.000020: It is generally unacceptable to use a placebo in a control group in a trial where standard treatments or medically
p.000020: proven medicines are available, because patients will lose medical benefits entitled to from participating
p.000020: in the clinical trial. However, the use of a placebo in a control group may be allowed in the following cases.
p.000020: (1) no standard drug medically recognized for the treatment of the disease is available;
p.000020: (2) the available drug for the treatment yields uncertain outcomes;
p.000020: (3) the standard drug for the treatment is available, but it causes serious adverse drug reactions or adverse events
p.000020: that the subjects cannot tolerate;
p.000020: (4) the illness to be studied is managed by itself due to a placebo effect;
p.000020:
p.000021: 21
p.000021: (5) the disease to be studied is a minor condition and treating with a placebo causes the only discomfort or the
p.000021: illness is alleviated slowly or negligibly, and causes no serious or irreversible harm to the subjects;
p.000021: (6) compelling scientific and methodological reasons are necessary
p.000021: to use a placebo-controlled group in determining the effectiveness and the safety of a study drug.
p.000021: In addition to the focus on freely informed consent, the ethical consideration of a placebo-controlled trial should
p.000021: focus on an appropriate design to maximize benefits and minimize harm to patients.
p.000021:
p.000021: 7.1.7 Analysis and Distribution of Research Results
p.000021: In most clinical trials, the sponsor has rights as agreed upon for the analysis and interpretation of research results.
p.000021: However, the investigator and the ethics committee should ensure that:
p.000021: (1) The final analysis and interpretation of the research results will rest with the investigator to ensure that the
p.000021: results would be actually complete and accurate.
p.000021: (2) When the trial of Phase I, II and III is required to stop according to the rules, there must be an independent
p.000021: interim analysis. However, prior to
p.000021: implementing the termination rules, it should be identified that either positive
p.000021: or negative long-term effects of the drug may be obscured by either good or bad short term drug effects.
...
Health / Pregnant
Searching for indicator pregnant:
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p.000003: 2.2.1 Respect for human dignity. This aspect is the heart of research ethics, which provides for the protection
p.000003: of diverse interests relevant to the body, mind, and cultural security of a person. This is the foundation of
p.000003: the other following principles. Respect for freely given informed consent. This means the subject needs to be
p.000003: fully informed of all aspects of the research without hidden or biased information using an
p.000003: easy-to-understand language for the subjects. The information should cover the details of the procedures,
p.000003: rights, obligations, requirement for informed consent and the freedom of decision making. Also, the subjects have the
p.000003: rights to withdraw their consent any time without giving any reason. In practice, the informed consent may appear in a
p.000003: form of conversation.
p.000003: 2.2.2 Respect for vulnerable persons. Respect for human dignity leads to an ethical requirement for vulnerable
p.000003: people who have inferior or lack physical capacities or have diminished capacities for making a reasonable
p.000003: decision, such as children, pregnant women, psychiatric patients, unconscious patients, and prisoners.
p.000003: These vulnerable people need to be protected from being forced to participate in a research involuntarily. In
p.000003: practice, a special treatment is needed for the protection of their benefits.
p.000003: 2.2.3 Respect for privacy and confidentiality. This principle is fundamental to the respect for human’s
p.000003: dignity found in various cultures, and it helps to protect the security of mind. Therefore, the standards applied
p.000003: for the respect for privacy and confidentiality help to protect the access to, retention of, and distribution of
p.000003: personal information.
p.000003:
p.000003: 2.3 Principle of Beneficence
p.000003: This principle covers the following aspects.
p.000003: 2.3.1 Balancing between risks and benefits; An analysis of risks and benefits being exposed to the subjects is a
p.000003: key ethical issue of research on human subjects. Research ethics for human subjects in modern times requires a
p.000003: balance between potential risks and benefits, with the desired goal being that the benefits must outweigh
p.000003: the risks and that the potential risks are acceptable for the subjects and received prior to review and
...
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
p.000009: conducting research studies in subjects with illegal careers, such as sex workers or illegal drug users.
...
Health / Terminally Ill
Searching for indicator terminally:
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p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
p.000017: elderly, or women with childbearing potential. Anesthesia or anticancer drugs should not be used in the healthy
p.000017: volunteers as a result of its high toxicity. In general, the number of the subjects should not exceed 30
p.000017: subjects. Every subject should give written informed consent before participating in the study. The study in
p.000017: this phase is usually an open study without any control group, i.e., both subjects and investigators know
p.000017: the trial drug. Studies in phase I also involve two stages. Stage I studies employ a small dose, i.e., about 1/50 or
p.000017: 1/100 of the dose used successfully in the animal studies. When the results demonstrate safety, the second stage
p.000017: is then followed by gradually escalating the dose. Once the results are satisfactory, phase II studies are
p.000017: conducted.
p.000017: Phase I trials also include the studies done on the patients suffering from a specific disease with no hope from
p.000017: currently available treatments, such as studies in terminally ill cancer patients.
p.000017:
p.000017: Phase II
p.000017: Phase II studies are conducted on patients with the target treatment of the drug that was satisfactorily studied in
p.000017: Phase I. The primary objective of the trial in this phase is to study short- term pharmacological toxicity in
p.000017: details, while the secondary objective is about the drug’s preliminary efficacy. Anesthesia and
p.000017: anticancer drugs are allowed in the Phase II trials. If possible, a trial design should be randomized and be
p.000017: open label. The subjects and investigators may not know whether the drugs received are investigational
p.000017: drugs or comparator drugs. Approximately, 100-200 subjects are employed in Phase II trials. If serious
p.000017: adverse events are reported frequently, the trials should be stopped temporarily. Once the safety is
p.000017: confirmed, a Phase III trial can then be conducted.
p.000017:
p.000017: Phase III
p.000017: Phase III studies are conducted in patients with the target treatment using the new chemical entity being
p.000017: tested successfully in Phase II. The primary and secondary objectives are to evaluate the pharmacological
p.000017: effectiveness and to study short-term toxicity, respectively. The number of the subjects in Phase II
p.000017: trials may be considerably increased to several thousands depending on sample size determination using a
p.000017: statistical method in conjunction with the existing preliminary data. Most Phase III trials involve a comparative
p.000017: control group, which is usually the group receiving no investigational new drugs. In the Phase III
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000003: of diverse interests relevant to the body, mind, and cultural security of a person. This is the foundation of
p.000003: the other following principles. Respect for freely given informed consent. This means the subject needs to be
p.000003: fully informed of all aspects of the research without hidden or biased information using an
p.000003: easy-to-understand language for the subjects. The information should cover the details of the procedures,
p.000003: rights, obligations, requirement for informed consent and the freedom of decision making. Also, the subjects have the
p.000003: rights to withdraw their consent any time without giving any reason. In practice, the informed consent may appear in a
p.000003: form of conversation.
p.000003: 2.2.2 Respect for vulnerable persons. Respect for human dignity leads to an ethical requirement for vulnerable
p.000003: people who have inferior or lack physical capacities or have diminished capacities for making a reasonable
p.000003: decision, such as children, pregnant women, psychiatric patients, unconscious patients, and prisoners.
p.000003: These vulnerable people need to be protected from being forced to participate in a research involuntarily. In
p.000003: practice, a special treatment is needed for the protection of their benefits.
p.000003: 2.2.3 Respect for privacy and confidentiality. This principle is fundamental to the respect for human’s
p.000003: dignity found in various cultures, and it helps to protect the security of mind. Therefore, the standards applied
p.000003: for the respect for privacy and confidentiality help to protect the access to, retention of, and distribution of
p.000003: personal information.
p.000003:
p.000003: 2.3 Principle of Beneficence
p.000003: This principle covers the following aspects.
p.000003: 2.3.1 Balancing between risks and benefits; An analysis of risks and benefits being exposed to the subjects is a
p.000003: key ethical issue of research on human subjects. Research ethics for human subjects in modern times requires a
p.000003: balance between potential risks and benefits, with the desired goal being that the benefits must outweigh
p.000003: the risks and that the potential risks are acceptable for the subjects and received prior to review and
p.000003: approval from an ethics committee. The analysis of the risks and benefits affects the welfare and rights of the
...
Health / alcoholism
Searching for indicator alcoholism:
(return to top)
p.000008: records to have a patient's informed consent form kept in each patient's medical record either by having patients
p.000008: sign the form in advance and keeping it in the medical record or by calling for patients to sign later. In this case,
p.000008: therefore, the ethics committee may consider waiving the signing of the informed consent form. However, the evidence
p.000008: should be provided to prove that the subjects are informed about the methods for collecting the data. For example, the
p.000008: methods are to be included on the information sheet for patients being hospitalized, or the permission to use the data
p.000008: in medical records may be given from the hospital director or other authorized persons.
p.000008: (2) The collection of the data from the medical records must receive approval from the ethics committee, and the
p.000008: patient's confidentiality must be strictly protected.
p.000008: (3) The investigator is allowed to use the data from the patient's medical records only as specified in the research
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
...
Health / hospitalized patients
Searching for indicator hospitalized:
(return to top)
p.000008: waived, the investigator should explore other means to protect the subject's confidentiality.
p.000008:
p.000008: 3.3.2 Confidentiality between physicians and patient subjects
p.000008: The Declaration of Patients' Rights, issued by the four health professional associations and the Ministry of Public
p.000008: Health, states, “Patients have the right to receive strict protection of their own information.” Any disclosure of the
p.000008: patient’s information to anyone who needs the information, such as doctors, nurses, technical scientists, competent
p.000008: authority, or other researchers, can be made only if the patients or their legally acceptable representative gives
p.000008: prior permission.
p.000008:
p.000008: 3.3.3 Data from medical records
p.000008: (1) In practice, it is quite difficult for a researcher who conducts a study using the information from medical
p.000008: records to have a patient's informed consent form kept in each patient's medical record either by having patients
p.000008: sign the form in advance and keeping it in the medical record or by calling for patients to sign later. In this case,
p.000008: therefore, the ethics committee may consider waiving the signing of the informed consent form. However, the evidence
p.000008: should be provided to prove that the subjects are informed about the methods for collecting the data. For example, the
p.000008: methods are to be included on the information sheet for patients being hospitalized, or the permission to use the data
p.000008: in medical records may be given from the hospital director or other authorized persons.
p.000008: (2) The collection of the data from the medical records must receive approval from the ethics committee, and the
p.000008: patient's confidentiality must be strictly protected.
p.000008: (3) The investigator is allowed to use the data from the patient's medical records only as specified in the research
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
...
Searching for indicator hospitalized patients:
(return to top)
p.000008: patient's confidentiality must be strictly protected.
p.000008: (3) The investigator is allowed to use the data from the patient's medical records only as specified in the research
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
...
Health / ill
Searching for indicator ill:
(return to top)
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
...
p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
p.000017: elderly, or women with childbearing potential. Anesthesia or anticancer drugs should not be used in the healthy
p.000017: volunteers as a result of its high toxicity. In general, the number of the subjects should not exceed 30
p.000017: subjects. Every subject should give written informed consent before participating in the study. The study in
p.000017: this phase is usually an open study without any control group, i.e., both subjects and investigators know
p.000017: the trial drug. Studies in phase I also involve two stages. Stage I studies employ a small dose, i.e., about 1/50 or
p.000017: 1/100 of the dose used successfully in the animal studies. When the results demonstrate safety, the second stage
p.000017: is then followed by gradually escalating the dose. Once the results are satisfactory, phase II studies are
p.000017: conducted.
p.000017: Phase I trials also include the studies done on the patients suffering from a specific disease with no hope from
p.000017: currently available treatments, such as studies in terminally ill cancer patients.
p.000017:
p.000017: Phase II
p.000017: Phase II studies are conducted on patients with the target treatment of the drug that was satisfactorily studied in
p.000017: Phase I. The primary objective of the trial in this phase is to study short- term pharmacological toxicity in
p.000017: details, while the secondary objective is about the drug’s preliminary efficacy. Anesthesia and
p.000017: anticancer drugs are allowed in the Phase II trials. If possible, a trial design should be randomized and be
p.000017: open label. The subjects and investigators may not know whether the drugs received are investigational
p.000017: drugs or comparator drugs. Approximately, 100-200 subjects are employed in Phase II trials. If serious
p.000017: adverse events are reported frequently, the trials should be stopped temporarily. Once the safety is
p.000017: confirmed, a Phase III trial can then be conducted.
p.000017:
p.000017: Phase III
p.000017: Phase III studies are conducted in patients with the target treatment using the new chemical entity being
p.000017: tested successfully in Phase II. The primary and secondary objectives are to evaluate the pharmacological
p.000017: effectiveness and to study short-term toxicity, respectively. The number of the subjects in Phase II
p.000017: trials may be considerably increased to several thousands depending on sample size determination using a
p.000017: statistical method in conjunction with the existing preliminary data. Most Phase III trials involve a comparative
p.000017: control group, which is usually the group receiving no investigational new drugs. In the Phase III
...
Health / stem cells
Searching for indicator stem cells:
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p.000027: and people at large. The regulations issued by the Medical Council, by the advice of the Royal College of
p.000027: Obstetrics and Gynecology of Thailand, have already laid down the medical practice guidelines on the
p.000027: standards of services concerning reproduction technology. In addition, in conducting research involving human
p.000027: gametes, embryos, and the fetus, the risks imposed to the embryo or fetus, the informed consent, and the respect for
p.000027: the rights of the embryo and fetus should be considered. The following criteria are recommended.
p.000027:
p.000027: 7.7.1 Research involving human gametes
p.000027: (1) Obtaining the informed consent from the owners of the gametes is required in research using human gametes, which
p.000027: follows the principles and
p.000027: practices applied in other research involving human subjects.
p.000027: (2) The collection of the human gametes from a deceased person is not allowed, as the informed consent from the
p.000027: donor of the gametes cannot be obtained. Any research conducted using commercialized gametes, or
p.000027: inducing artificial cross-fertilization between the human gamete and an animal gamete, is considered unethical.
p.000027:
p.000027: 7.7.2 Research on human embryos and embryonic stem cells
p.000027: (1) The fertilization of human gamete results in an embryo, and it is unethical to create human embryos merely for
p.000027: research purposes. However, if the research is conducted for the benefit of reproductive health according to the
p.000027: principles and practices mentioned previously, it would be considered ethical.
p.000027: (2) Research on the alteration of human genes or the internal compositions of the human gametes or in the human embryo
p.000027: must not be conducted. When the
p.000027:
p.000028: 28
p.000028: research using an embryo is conducted, and no information about the future problem being likely to happen to the fetus
p.000028: is available, the embryo must not be
p.000028: implanted in the uterus to induce pregnancy. The experiment on the human embryo is allowed within the period of
p.000028: fourteen days after its fertilization.
p.000028: (3) A human cloning research for reproduction is not approved. Also, induced cross- fertilization between the
p.000028: human gamete and an animal gamete is unethical.
p.000028:
p.000028: 7.7.3 Research involving the intrauterine fetus
p.000028: Research designed for the diagnosis or treatment of the intrauterine fetus that suffers from genetic diseases or
p.000028: congenital anomaly could be conducted if the mother has given her consent after being thoroughly informed about the
p.000028: treatment in detail, since the diagnosis or treatment of the fetus cannot be done separately from that of the mother,
p.000028: and both need to be treated simultaneously.
p.000028:
p.000028: 7.7.4 Research involving the use of fetal tissues, placenta and its blood
p.000028: Research that uses fetal tissues must be conducted in accordance with the ethical principles as applied in other human
p.000028: experimentation. The fetus is a human, not merely tissues. Therefore, obtaining the informed consent from the
p.000028: parents, who are considered the legally acceptable representatives of the tissues, is required.
p.000028: The conduct of research using fetal tissues to generate stem cells must adhere to the practice guidelines established
p.000028: in the Medical Council’s Regulation on the Preservation of the Ethics of Medical Profession (NO. 6) B.E. 2545, Section
p.000028: 9 on the Medical Practice of Blood Stem Cell Transplantation from Donors.
p.000028:
p.000029: 29
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: ANNEXES
p.000029:
p.000030: 30
p.000030: ANNEX 1
p.000030:
p.000030: THE MEDICAL COUNCIL'S REGULATION
p.000030: ON RESEARCH STUDIES AND EXPERIMENTS IN HUMAN SUBJECTS
p.000030: B.E. 2525
p.000030:
p.000030: 1. “Research study and experiment in human subjects” refers to a research study and an experiment using a
p.000030: pharmaceutical product or medical devices, or a study of a natural course of a disease, or the diagnosis,
p.000030: treatment, health promotion, and prevention of a disease which is conducted in human subjects. This also includes a
p.000030: research study conducted using the information from medical records and any specimens taken from the human body.
p.000030:
p.000030: “Ethics Committee” refers to a committee or board appointed by an institution, organization, or agency,
p.000030: which is responsible for conducting an ethical review of researches and experiments in human subjects. This is to
p.000030: protect the rights, safety, and well being of the subjects who participate in the research and experiments.
p.000030:
...
p.000030: must adhere to the Ethical Guidelines for Research Studies and Experiments in Human Subjects and the
p.000030: Ethics for Researchers.
p.000030:
p.000031: 31
p.000031: ANNEX 2
p.000031:
p.000031: THE MEDICAL COUNCIL’S REGULATION
p.000031: ON THE PRESERVATION OF THE ETHICS OF MEDICAL PROFESSION B.E. 2545
p.000031:
p.000031: By virtue of Section 21 (3) (ช) and with the approval of the Special Council of Chairman according to Section 25 of
p.000031: the Medical Profession Act BE 2525, which contains some provisions that restrict the rights and freedom of individuals,
p.000031: however, Sections 29 and 50 of the Constitution of the Kingdom of Thailand allow the act according to the
p.000031: provisions of the Act. The Medical Council Committee hereby issues the regulation as follows.
p.000031: 1. This regulation shall be called, “the Medical Council’s Regulation on the Preservation of the Ethics of
p.000031: Medical Profession (No.6) B.E. 2545”
p.000031: 2. The following statements shall be added as Section 9 of the Medical Council’s Regulation on the
p.000031: Preservation of the Ethics of Medical Profession B.E. 2526.
p.000031:
p.000031: “Section 9”
p.000031: Medical Practice involving Blood Stem Cell Transplantation from Donors
p.000031:
p.000031: 1. In this Section
p.000031: “Blood Stem Cell Transplantation” means the medical practice that involves blood stem cell transplantation from bone
p.000031: marrow, blood, or placenta’s blood.
p.000031: “Donors” mean an individual who donates blood stem cells or placenta’s blood for the blood stem cells transplantation
p.000031: to other people.
p.000031:
p.000031: 2. Medical practitioners who conduct the blood stem cell transplantation shall have the following
p.000031: qualifications.
p.000031: (1) being a hematologist or hematological pediatrician who has received a certificate or diploma
p.000031: from the Medical Council; or
p.000031: (2) being either an internist or a pediatrician who has been trained in a blood stem cell transplantation course
p.000031: approved by the Medical Council.
p.000031:
p.000031: 3. Medical practitioners who conduct the blood stem cell transplantation shall have additional qualifications
p.000031: apart from those described in 2 if the donors and the recipients of the stem cells are unrelated donors.
p.000031: (1) having experience in the bone marrow transplantation not less than 2 years; and
p.000031: (2) having been certified by the Subcommittee on Blood Stem Cell Transplantation
p.000031:
p.000031: 4. There shall be a Subcommittee on Blood Stem Cell Transplantation consisting of one
p.000031: representative from the Bone Marrow Transplantation Association of Thailand, one representative from the Hematology
p.000031: Association of Thailand, one representative from the National Blood Center, Thai Red Cross Society, and a total of
p.000031: at least four but not more than five representatives from institutes experienced in bone marrow
p.000031: transplantation with one representative being from each institute, and two members from the Medical Council.
p.000031: The Subcommittee in the first paragraph shall have the following authorities.
p.000031: (1) certify the medical practitioners according to 3.
p.000031: (2) revoke the certification in case the medical practitioners are not qualified or do not comply with the criteria
p.000031: established under this Section
p.000031:
p.000031: 5. The Subcommittee on Blood Stem Cell Transplantation shall grant the certification of the medical practice
p.000031: described in 3 according to the following criteria.
p.000031: (1) the medical practice is done in a clinic where the number of patients under the bone marrow transplantation from
p.000031: brothers and/or sisters with the same HLA not less than ten patients annually;
p.000031: (2) the medical practice is done in clinics which have the following qualifications
p.000031: 2.1 having other medical specialists, e.g.;
p.000031:
p.000032: 32
p.000032: (a) pediatrics and /or internists in cardiology, infectious disease, gastrointestinal disease, kidney disease, and
p.000032: pulmonary disease;
p.000032: (b) surgery;
p.000032: (c) blood bank
p.000032: 2.2 having permanent nurses at the bone marrow transplantation ward at the proportion between nurses and patients not
p.000032: less than 1:3
p.000032: 2.3 other components
p.000032: (a) having a separate room for the treatment of patients with low
p.000032:
p.000032: white blood cells
p.000032:
p.000032:
p.000032: hours
p.000032:
p.000032: (b) having an intensive care unit
p.000032: (c) being able to provide laboratory testing and radiology for 24 hours
p.000032: (d) being able to provide blood and blood component infusion for 24
p.000032:
p.000032: 6. In case the bone marrow or blood stem cell transplantation is to be done where the donors and the recipients
p.000032: are not biological relatives, the National Blood Service Center, Thai Red Cross Society, shall make a donor
p.000032: registration list by establishing the National Stem Cell Donor Program under the supervision of the Medical Council.
p.000032:
p.000032: 7. In blood stem cell transplantation, the medical practitioners who conduct the transplantation shall comply
p.000032: with the following criteria.
p.000032: (1) conduct a physical examination of the donor to check if he/she is healthy, and suitable for donating blood stem
p.000032: cells
p.000032: (2) inform and explain to the donors the possible risks to harm that may occur to the donors both during and after the
p.000032: donation. Once the donors understand and are willing to donate the stem cells, then the donors sign an informed
p.000032: consent form for donating the blood stem cells. The written informed consent form is attached to this regulation.
p.000032: In case the blood stem cell transplantation is done using the blood from the unbiblical cord, the donor or
p.000032: her husband shall sign the informed consent form.
p.000032: (3) written document shall be made to show that no payment is given to the donors of blood stem cells.
p.000032:
p.000032: 8. The medical practitioners who transplant the blood stem cells can store the blood stem cells in
p.000032: the laboratory for future transplantation, as appropriate.
p.000032:
p.000032: 3. This regulation shall come into force when the period of 60 days after the publication date in the Government
p.000032: Gazette has lapsed.
p.000032:
p.000032: It is hereby announced.
p.000032: Given on the Thirtieth Day of April B.E. 2545.
p.000032:
p.000033: 33
p.000033: ANNEX 3
p.000033:
p.000033: THE MEDICAL COUNCIL’S ANNOUCEMENT NO. 21/2545
p.000033: ON THE STANDARDS OF SERVICES INVOLVING REPRODUCTION TECHNOLOGY (NO.2)
p.000033:
p.000033: As the Medical Council had issued the announcement no. 1/2540 dated 22 October B.E. 2540 on establishing the
p.000033: standards of services involving reproduction technology by medical practitioners, it is now time to additionally
p.000033: establish the standards of services to provide for more appropriate protection to service receivers.
p.000033: By virtue of Section 21(1) of the Medical Profession Act B.E. 2525 where the Act contains certain provisions that
p.000033: restrict the rights and freedom of individuals, however, Sections 29 and 50 of the Constitution of the Kingdom of
p.000033: Thailand allow for the act according to the provisions of the Act. The Medical Council then reached its resolution
p.000033: at the 10/2545 meeting dated 11 October
p.000033: B.E. 2545 to issue the announcement as follows.
p.000033: 1. The following statements shall be added as no. 4/1 and no. 4/2 of the Medical Council’s Announcement No.
p.000033: 1/2540 on Standards of Services involving Reproduction Technology dated 22 October 2540 as follows.
p.000033: “No. 4/1 The services involving reproduction technology shall not be conducted in a way of human cloning for
p.000033: reproduction.
...
Health / visual impairment
Searching for indicator blind:
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p.000045: trials that are relevant to the trial.
p.000045: 2.3 Summary of the known and potential risks and benefits, if any, to human subjects.
p.000045: 2.4 Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s).
p.000045: 2.5 A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory
p.000045: requirement(s).
p.000045: 2.6 Description of the population to be studied.
p.000045: 2.7 References to literature and data that are relevant to the trial, and that provide background for the
p.000045: trial.
p.000045:
p.000045:
p.000045:
p.000045: * This part is adopted from the Chapter on Clinical Trial Protocol and Protocol Amendment(s) of the ICH GCP Guidelines,
p.000045: as the Thai version is directly translated from the ICH GCP Guidelines. Re-translating the Thai version back to the
p.000045: English language may cause slight deviation from the original meaning. Therefore, adopting the original English
p.000045: version is made to best preserve the accuracy of the text.
p.000045:
p.000046: 46
p.000046: 3. Trial Objectives and Purpose
p.000046: A detailed description of the objectives and the purpose of the trial.
p.000046:
p.000046: 4. Trial Design
p.000046: The scientific integrity of the trial and the credibility of the data from the trial depend
p.000046: substantially on the trial design. A description of the trial design, should include:
p.000046: 4.1 A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial.
p.000046: 4.2 A description of the type/design of trial to be conducted (e.g. double-blind, placebo- controlled,
p.000046: parallel design) and a schematic diagram of trial design, procedures and stages.
p.000046: 4.3 A description of the measures taken to minimize/avoid bias, including:
p.000046: (a) Randomization.
p.000046: (b) Blinding.
p.000046: 4.4 A description of the trial treatment(s) and the dosage and dosage regimen of the investigational
p.000046: product(s). Also include a description of the dosage form, packaging, and labeling of the investigational
p.000046: product(s).
p.000046: 4.5 The expected duration of subject participation, and a description of the sequence and duration of all trial
p.000046: periods, including follow-up, if any.
p.000046: 4.6 A description of the "stopping rules" or "discontinuation criteria" for individual subjects, parts of trial and
p.000046: entire trial.
p.000046: 4.7 Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s),
p.000046: if any.
p.000046: 4.8 Maintenance of trial treatment randomization codes and procedures for breaking codes.
p.000046: 4.9 The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of
p.000046: data), and to be considered to be source data.
p.000046:
p.000046: 5. Selection and Withdrawal of Subjects
p.000046: 5.1 Subject inclusion criteria.
p.000046: 5.2 Subject exclusion criteria.
p.000046: 5.3 Subject withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and
p.000046: procedures specifying:
p.000046: (a) When and how to withdraw subjects from the trial/ investigational product treatment.
p.000046: (b) The type and timing of the data to be collected for withdrawn subjects.
...
Searching for indicator blinded:
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p.000017: anticancer drugs are allowed in the Phase II trials. If possible, a trial design should be randomized and be
p.000017: open label. The subjects and investigators may not know whether the drugs received are investigational
p.000017: drugs or comparator drugs. Approximately, 100-200 subjects are employed in Phase II trials. If serious
p.000017: adverse events are reported frequently, the trials should be stopped temporarily. Once the safety is
p.000017: confirmed, a Phase III trial can then be conducted.
p.000017:
p.000017: Phase III
p.000017: Phase III studies are conducted in patients with the target treatment using the new chemical entity being
p.000017: tested successfully in Phase II. The primary and secondary objectives are to evaluate the pharmacological
p.000017: effectiveness and to study short-term toxicity, respectively. The number of the subjects in Phase II
p.000017: trials may be considerably increased to several thousands depending on sample size determination using a
p.000017: statistical method in conjunction with the existing preliminary data. Most Phase III trials involve a comparative
p.000017: control group, which is usually the group receiving no investigational new drugs. In the Phase III
p.000017: trials, control procedures are implemented beginning from subject selection, group randomization, treatment
p.000017: allocation, follow up, and evaluation. The trial in this phase is aimed to increase patient survival or
p.000017: to improve
p.000017:
p.000018: 18
p.000018: patient quality of life. Then, the trial design should be randomized, double blinded, i.e., both the investigators
p.000018: and the subjects do not know what drugs either investigational or comparative are given. When the drug gives
p.000018: the favorable results under the Phase III trials, they are likely authorized for marketing.
p.000018:
p.000018: Phase IV
p.000018: This phase is also called a post marketing surveillance study. The study is done after the drug has been
p.000018: registered, with the objectives being to study the therapeutic uses, any adverse effects, and toxicity of the
p.000018: drug in a larger numbers of patients who have been using the drug for a longer period of time, or to explore
p.000018: additional effectiveness for other indications other than the approved ones. Also, the study in this phase can
p.000018: be done in other population groups that have never been studied.
p.000018:
p.000018: Ethical Considerations on Each Phase of the Clinical Drug Trial
p.000018:
p.000018: 7.1.1 Phase I Clinical Trials
p.000018: (1) The ethics committee should be independent of the trial sponsor, conduct a rigorous review of a research protocol,
p.000018: and continuously monitor the trial.
p.000018: (2) As the trial in this phase is conducted in healthy subjects where the sponsor of new drugs pay for the study, the
p.000018: ethical review should focus on the following aspects:
p.000018: a. the subject sample selection;
p.000018: b. a freely given informed consent process;
...
p.000039:
p.000039: 12. Information on Investigational Product(s)
p.000039: 12.1 When planning trials, the sponsor should ensure that sufficient safety and efficacy data from
p.000039: non-clinical studies and/or clinical trials are available to support human exposure by the route, at the dosages, for
p.000039: the duration, and in the trial population to be studied.
p.000039: 12.2 The sponsor should update the Investigator's Brochure as significant new information becomes available (see 7.
p.000039: Investigator's Brochure).
p.000039:
p.000039: 13. Manufacturing, Packaging, Labeling, and Coding Investigational Product(s)
p.000039: 13.1 The sponsor should ensure that the investigational product(s) (including active comparator(s) and
p.000039: placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is
p.000039: manufactured in accordance with any applicable GMP, and is coded and labeled in a manner that protects the blinding, if
p.000039: applicable. In addition, the labeling should comply with applicable regulatory requirement(s).
p.000039: 13.2 The sponsor should determine, the investigational product(s), acceptable storage temperatures, storage
p.000039: conditions (e.g. protection from light), storage times, reconstitution fluids and procedures, and devices for
p.000039: product infusion, if any. The sponsor should inform all involved parties (e.g. monitors, investigators, pharmacists,
p.000039: storage managers) of these determinations.
p.000039: 13.3 The investigational product(s) should be packaged to prevent contamination and unacceptable
p.000039: deterioration during transport and storage.
p.000039: 13.4 In blinded trials, the coding system for the investigational product(s) should include a mechanism that
p.000039: permits rapid identification of the product(s) in case of a medical emergency, but does not permit
p.000039: undetectable breaks of the blinding.
p.000039: 13.5 If significant formulation changes are made in the investigational or comparative product(s) during the
p.000039: course of clinical development, the results of any additional studies of the formulated product(s) (e.g. stability,
p.000039: dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the
p.000039: pharmacokinetic profile of the product
p.000039:
p.000040: 40
p.000040: should be available prior to the use of the new formulation in clinical trials.
p.000040:
p.000040: 14. Supplying and Handling Investigational Product(s)
p.000040: 14.1 The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational
p.000040: product(s).
p.000040: 14.2 The sponsor should not supply an investigator/institution with the investigational product(s) until
p.000040: the sponsor obtains all required documentation (e.g. approval/favorable opinion from IRB/IEC and regulatory
p.000040: authority(ies)).
p.000040: 14.3 The sponsor should ensure that written procedures include instructions that the
p.000040: investigator/institution should follow the handling and storage of investigational product(s) for the trial and
p.000040: documentation thereof. The procedures should address adequate and safe receipt, handling, storage, dispensing,
...
Social / Access to Social Goods
Searching for indicator access:
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p.000003: rights to withdraw their consent any time without giving any reason. In practice, the informed consent may appear in a
p.000003: form of conversation.
p.000003: 2.2.2 Respect for vulnerable persons. Respect for human dignity leads to an ethical requirement for vulnerable
p.000003: people who have inferior or lack physical capacities or have diminished capacities for making a reasonable
p.000003: decision, such as children, pregnant women, psychiatric patients, unconscious patients, and prisoners.
p.000003: These vulnerable people need to be protected from being forced to participate in a research involuntarily. In
p.000003: practice, a special treatment is needed for the protection of their benefits.
p.000003: 2.2.3 Respect for privacy and confidentiality. This principle is fundamental to the respect for human’s
p.000003: dignity found in various cultures, and it helps to protect the security of mind. Therefore, the standards applied
p.000003: for the respect for privacy and confidentiality help to protect the access to, retention of, and distribution of
p.000003: personal information.
p.000003:
p.000003: 2.3 Principle of Beneficence
p.000003: This principle covers the following aspects.
p.000003: 2.3.1 Balancing between risks and benefits; An analysis of risks and benefits being exposed to the subjects is a
p.000003: key ethical issue of research on human subjects. Research ethics for human subjects in modern times requires a
p.000003: balance between potential risks and benefits, with the desired goal being that the benefits must outweigh
p.000003: the risks and that the potential risks are acceptable for the subjects and received prior to review and
p.000003: approval from an ethics committee. The analysis of the risks and benefits affects the welfare and rights of the
p.000003: subjects. However, sometimes the estimation of risks and benefits of all aspects of the research is difficult to
p.000003: achieve. Therefore, the key principle of respect for human dignity always requires a proper and reliable
p.000003: research design, especially biomedical or health research, which needs prior research studies conducted in
p.000003: both laboratory and animal models to ensure safety. Moreover, it requires adequate review of the
p.000003: existing knowledge of the proposed research. Although the analysis of risks and benefits may not be
p.000003: obvious in some research areas, such as the political sciences, economics, or
p.000003:
p.000004: 4
p.000004: history (including a personal biography), the risks still remain as the research results may potentially destroy
...
p.000005: only to protect the research subjects, but also to protect the investigator, the sponsor, and the ethics
p.000005: committee. Therefore, the investigator is responsible for preparing the details of the research
p.000005: procedures and the information sheet by himself/herself. In case the subjects cannot personally give a written
p.000005: informed consent, the informed consent given verbally with an impartial witness should be specified. In
p.000005: addition, it should specify in what case the legal guardian is to be informed and consent granted.
p.000005:
p.000005: 3.1.1 Advice for the preparation of the information sheet and informed consent form
p.000005: The information sheet and the informed consent process to be given for the subject's decision making should contain the
p.000005: following elements:
p.000005: (1) the title of the study;
p.000005: (2) an invitation describing why the subject should participate in the study;
p.000005: (3) the objective(s) and the research procedures that the investigator and the subject have to follow;
p.000005: (4) the duration of the subject's participation in the study;
p.000005: (5) the expected benefits of the study, which may directly benefit the subject, the community, or society, or for
p.000005: gaining scientific knowledge;
p.000005: (6) the plan for access to the products or the treatments that are proven from the research to be safe and
p.000005: effective for the subject or the community after the study;
p.000005: (7) the subject treatment, risks, discomforts, or any inconvenience that may happen to the subject (or others)
p.000005: participating in the study;
p.000005: (8) available alternative products or treatments that may be useful for the subject vis-à-vis the study product or
p.000005: treatment;
p.000005: (9) the scope of confidentiality and protection of the subject's records;
p.000005:
p.000006: 6
p.000006: (10) the disclosure policy for genetic study results at appropriate time;
p.000006: (11) the investigator's responsibilities (if any) in providing the services to the subject;
p.000006: (12) the availability of free medical treatment and care in case of study-related injuries or damages;
p.000006: (13) availability of payment/compensation for damages in the form of either money or other offers for each subject
p.000006: (if any), and the type and quantity of which should be specified;
p.000006: (14) the funding resources, the sponsor and the participating institutions;
p.000006: (15) whether the results of the study will be disclosed to the subject and how;
p.000006: (16) whether the biological materials collected from the study will be destroyed; if not, the details of the storage
p.000006: and the plan for future use should be provided, and whether such a use is limited;
p.000006: (17) whether there would be any products derived from the biological materials collected from the study;
p.000006: (18) whether the subjects or their families or the persons under the subject's supervision will receive any
p.000006: compensation for damage or death resulting from the study;
...
p.000006:
p.000006: 3.1.2 Practical guidelines that should be followed
p.000006: The guidelines below clarify several relevant ethical considerations.
p.000006: (1) Obtaining informed consent is not merely having the subjects or their legally acceptable representatives
p.000006: sign on the consent form. Rather, the process should reflect a good relationship between the investigator and
p.000006: the subjects. The process should provide clear and complete information sufficient for the subjects to make their
p.000006: decisions. The investigator should pay attention to the care and the physical and mental well being of the subjects
p.000006: during the course of the research.
p.000006: (2) The language used should be suitable to the subject's capacity and avoid technical terms;
p.000006: (3) The investigators must ensure that the potential subjects are aware of their participation in the
p.000006: study, and understand clearly the research procedures;
p.000006: (4) According to the principle of beneficence and non-maleficence, the researcher must inform the subjects in
p.000006: advance of any procedures or treatments other than the diagnosis, treatments or prevention that are
p.000006: useful to the subjects. Advantages or disadvantages of participating in the study should be provided so that the
p.000006: subjects can make their own decisions;
p.000006: (5) Upon the completion of the study, whether the subjects are entitled to continuous access to the
p.000006: medicine, instruments, or others should be specified.
p.000006:
p.000006: 3.2 Inducement
p.000006: In recruiting the subjects into a study, the ethical principle that should be followed is that the subject should be
p.000006: invited to participate in the study. Please note that the words "invitation" and "volunteer" mean that the potential
p.000006: subjects are informed correctly, and voluntarily participate in the
p.000006:
p.000007: 7
p.000007: study. The information given should include both advantages, disadvantages to be incurred to the subjects themselves,
p.000007: to the community, or just for scientific benefit. The subjects should make their own decisions, not be forced
p.000007: to do so, or induced unduly. The subjects can also withdraw from the study any time. Several aspects of inducement
p.000007: that should receive consideration include:
p.000007: 3.2.1 Payment or compensation either money or other benefits to be given to the subjects should not be
p.000007: too much to induce the subject to decide to participate in the study without carefully considering the risks that may
p.000007: happen in the study;
p.000007: 3.2.2 For a phase I clinical trial usually conducted in normal subjects, the subjects would not obtain
p.000007: direct medical benefits from the study results. Therefore, it is necessary to compensate for travel expenses, loss
p.000007: of work or other payments, as appropriate. On the contrary, for a phase III study, the subjects usually obtain direct
p.000007: benefit from the study.
p.000007: 3.2.3 Enforced participation in a study may happen to institutionalized people, such as soldiers, prisoners, and
...
p.000007: 3.3 Privacy and Confidentiality Protection
p.000007: No. 21 of the Declaration of Helsinki B.E. 2543 states, “The right of research subjects to safeguard their integrity
p.000007: must always be respected. Every precaution should be taken to respect the privacy of the subject, the
p.000007: confidentiality of the patient's information, and to minimize the impacts of the study on the subject's
p.000007: physical and mental integrity and on the personality of the subject."
p.000007:
p.000007: 3.3.1 Confidentiality protection
p.000007: (1) The subjects must be informed about their rights to have their personal information protected
p.000007: strictly.
p.000007: (2) During the informed consent discussion, the investigator must inform the subjects in advance of the
p.000007: measures used to protect their confidentiality before signing the consent form.
p.000007: (3) The subjects must sign the informed consent form before the information is to be distributed in case the
p.000007: information can cause danger to them.
p.000007: (4) The possible leakage of the research results containing the subject's confidentiality should be
p.000007: minimized to the lowest level. In general, the best way to protect the subject's confidentiality is to remove
p.000007: the subject's identification from all stages of the study, and to control or restrict access to the data.
p.000007: (5) The subjects should be made aware of the investigator's limitations in keeping their confidentiality. An
p.000007: example is when, the investigator has to transfer the subject’s information from the case report forms
p.000007: to the national regulatory authorities or the sponsor. This also includes where a regulatory requirement exists
p.000007: to report certain events, such as communicable disease, child molestation abuse, and child's
p.000007: negligence, directly to the responsible agency. Under these circumstances, the investigator must inform the
p.000007: subjects of the limitations for keeping confidentiality before the subjects participate in the study.
p.000007: (6) The subjects should be made aware of the social impact on them if there would be any leakage of the data.
p.000007: For example, if the subject's participation in the
p.000007:
p.000008: 8
p.000008: studies on AIDS medicines or vaccines is made public, it is risky for the subjects to receive social discrimination.
p.000008: Such risks should be carefully considered in the same manner as those for any treatment risk resulting from
p.000008: drug or vaccine studies.
p.000008: (7) In the case where the ethics committee decides that signing the informed consent form can be
p.000008: waived, the investigator should explore other means to protect the subject's confidentiality.
...
p.000012: that differences must be made among groups of people that should or should not be included into a particular research
p.000012: study. In doing so, the capacities of individuals in the groups or communities who can bear the potential burdens in
p.000012: the study, or the suitability of the individuals to bear further burdens must be considered. Social justice then
p.000012: deals with setting an order or a priority that needs to be considered before enrolling any groups of people into any
p.000012: studies (for example, adult before children, male before female).
p.000012: Likewise, the principle of distributive justice can also be applied at community and country levels, i.e., that which
p.000012: the community bears the burdens, or which the community takes the benefits must be in accordance with the
p.000012: principle of distributive justice as well. A common problem of injustice occurring at the community
p.000012: level is exemplified in the case of trials for product development of drugs, vaccines or medical
p.000012: devices that are sponsored by companies or organizations in developed countries. The trials are conducted
p.000012: in developing countries, but after the end of the trials, drugs or vaccines or medical devices under the
p.000012: studies cannot be made beneficial to the participating populations or countries. One of the causes is due to
p.000012: the lack of access to those drugs or vaccines because of their high cost, or the lack of disease or illness for such
p.000012: drugs or vaccines in those communities in developing countries occurs. Thus, the principle must be carefully and
p.000012: thoroughly considered to bring justice to all levels from the individual to the society.
p.000012: However, please be aware that in reviewing research on human subjects based on this principle, deviation
p.000012: from the principle of distributive justice may sometimes happen reasonably as well, but the differences of related
p.000012: factors such as experiences, sex, physical impairment, capacity, and position must be taken into careful and
p.000012: appropriate consideration. This is to serve as criteria for decision making in the case that different
p.000012: treatments are given to individuals, and this consideration should be made on an individual basis.
p.000012:
p.000013: 13
p.000013: CHAPTER 6
p.000013:
p.000013: ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS
p.000013: A research protocol involving human subjects must be subject to review and approval by an ethics committee for
p.000013: research on human subject before initiating a study. Thus, institutions or organizations with established
p.000013: research protocols or investigators have to appoint and authorize the ethics committee to decide about the research
...
p.000019: may not be clear. As a result, it is impossible to predict possible side effects. On the contrary, the trial using an
p.000019: external medical device, which is known for its mechanism of action, allows us to predict the possible side effects.
p.000019: The trial can be regarded as imposing a minimal risk. Details will be discussed later.
p.000019: (4) A comparative study using a medical device and a placebo or other comparators to evaluate the effectiveness or
p.000019: efficiency of the treatments may not be conducted because ethical justification if the use of that device is the only
p.000019: opportunity for the subject to obtain benefit from the treatment, such as
p.000019: surgery to insert the artificial joint to replace irreversibly impaired joints.
p.000019: In general, a sham surgery in the comparator group is regarded as ethically inappropriate as it can greatly impose
p.000019: risks and harm to the subjects, while it provides no benefits. The sham surgery, however, used
p.000019: in the clinical trial of a medical device may be conducted under certain circumstances of extreme necessity, provided
p.000019: that the risks must be minimized as much as possible and the subject must be given full and correct information before
p.000019: freely deciding to participate in the trial.
p.000019: As mentioned above, in several cases, a medical device that has clear mechanisms of action may be designed by the
p.000019: physician who directly takes care of the patient. In addition a device available on the market may be altered or
p.000019: further developed and used in the treatment for patients unable to access
p.000019: other available treatments. The investigator or the sponsor of this type of trial may get less financial support than
p.000019: that from drug companies in the case of a clinical drug trial. Hence, the design of a clinical study of a medical
p.000019: device to prove its effectiveness, efficiency and safety may be an observational study instead of a randomized
p.000019: controlled trial, which is the standard for a clinical trial of new drugs. The observational study allows for
p.000019: collecting the data completely and completing the follow-up for all patients for a sufficiently long time. This is
p.000019: demonstrated by the study of artificial joints and cardiac valves that are widely recognized.
p.000019: Systematic consideration of research using a medical device may start from the division of the devices into two
p.000019: categories, i.e., devices with minimal risk or non-significant risk and devices with significant risk, by considering
p.000019: the general characteristics and the use of the devices.
p.000019: Medical devices with significant risks are referred to as devices that
p.000019: • risk death upon usage;
p.000019: • risk permanent disability upon usage;
p.000019: • require a surgery or certain drugs to prevent death and/or disability that may be caused by that device.
...
p.000022: (5) the public interests from the research prevail over the private interests
p.000022:
p.000022: 7.2.3 When the ethics committee allows the use of coded identifiable data, it should be decided whether a third party
p.000022: should hold the code.
p.000022: 7.2.4 When the research is conducted in a community, it should be guaranteed that the conduct complies completely
p.000022: with the requirements on the research in the community.
p.000022: 7.2.5 When identified or the re-identifiable data are used in research, the ethics committee should ensure that the
p.000022: collection, handling, and storage of the data comply with the principle of rights of personal information. If the data
p.000022: are
p.000022: to be used for purposes other than those specified in the approved protocol, a new protocol should be submitted for
p.000022: ethical review.
p.000022: 7.2.6 If the research involves the linkage of a set of data, the ethics committee may approve the use of the
p.000022: identifier to assure correct linkage. When the
p.000022: linkage is finished, the ethics committee should require that the emerging data be coded or the identifier be removed.
p.000022: 7.2.7 If the identified or identifiable data are used for other purposes in the research or by other people other than
p.000022: those listed in the previously approved protocol, a new protocol needs to be submitted for ethical review.
p.000022: 7.2.8 The information derived from epidemiological research both short- and long-term should be securely kept from the
p.000022: access of unauthorized people.
p.000022: 7.2.9. When screening the data for the statistical analysis and concluding, the investigator should maintain the
p.000022: confidentiality of the research participants.
p.000022: 7.2.10 The research results should not be published in a manner that can identify the individuals participating in the
p.000022: research and can affect the culture or other sensitivities.
p.000022: 7.2.11 If the emerging new knowledge during the course of the research has clinical implications or indicates the
p.000022: adjustment of the current treatment, the new knowledge should be disclosed to the relevant competent authority. If
p.000022: possible, both the research participants and the attending physician should be informed
p.000022:
p.000023: 23
p.000023: as well.
p.000023:
p.000023: 7.3 SOCIAL SCIENCE RESEARCH
p.000023:
p.000023: Similarly, the ethical principles applied in social science research consist of the principles of respect for person,
p.000023: beneficence, and justice.
p.000023:
p.000023: 7.3.1 The investigator should protect each subject from any physical or mental harm.
p.000023: 7.3.2 The investigator should respect the faith, belief, culture, religion, and basic rights of the subject.
p.000023: 7.3.3 The investigator should conduct only the research that benefits mankind.
p.000023: 7.3.4 The investigator should ensure that the design of the study is suitable to the objectives of the study.
p.000023: 7.3.5 The investigator should fully inform the subjects so that they can freely decide whether to participate in the
p.000023: research.
p.000023: 7.3.6 The investigator should protect the confidentiality and undisclosed names of the subjects.
p.000023: 7.3.7 The investigator should provide for health care to the subject as much as possible.
p.000023: 7.3.8 If the inclusion criteria are sensitive issues, the investigator should carefully conduct the study to avoid
p.000023: the disclosure of the subjects’ identity. The
p.000023: investigators may sometimes conduct the study in a non-targeted population to prevent the members of the community from
p.000023: being aware of what is conducted.
p.000023: 7.3.9 In case the study is conducted using medical records consisting of the confidentiality of patients, only the
p.000023: authorized medical personnel are allowed to access the data in the records, which can identify the patients. The access
p.000023: should be permitted by the highest authority of the institution.
p.000023: 7.3.10 The investigator should provide appropriate payment, benefits, or privileges to the subjects, and ensure that
p.000023: it should not be too much to induce the subjects to participate in the study.
p.000023:
p.000023:
p.000023: 7.4 VACCINE TRIAL
p.000023:
p.000023: The guidelines for conducting clinical drug trials are also applied to vaccine trials.
p.000023: However, the phase of the vaccine study may have additional details as explained below.
p.000023: 7.4.1 Phase I: This is a first-in-human trial to study the safety and biological effects, in particular the
p.000023: immunogenicity of a vaccine. Doses and routes of administration will be studied in this phase, and the trial is
p.000023: conducted in a low risk population.
p.000023: 7.4.2 Phase II: The trial is conducted in a limited number of patients to firstly explore the efficacy of a vaccine.
p.000023: The vaccine trial also serves for preventive purposes. Therefore, the trial involving a preventive vaccine must
p.000023: be conducted in healthy volunteers, while the trial involving a treatment vaccine is done in the patients of
p.000023: targeted disease.
p.000023: 7.4.3 Phase III: The trial in this phase focuses on the effectiveness of a vaccine for disease
p.000023: prevention. More subjects are then needed for the study in this phase (a thousand subjects and up). The trial
p.000023: is usually a multi-center trial, including a control group.
p.000023:
p.000024: 24
...
p.000024: b. taken from the body for treatment, diagnosis, or other objectives (e.g., learning and teaching, organ donation for
p.000024: transplantation;
p.000024: c. taken from either of the aforementioned sources above, and kept under the applicable regulatory requirements,
p.000024: institutional regulations or by
p.000024: the subject’s approval. In this case, the donors of the tissue samples usually do not know the objectives of the use
p.000024: of the samples of future research.
p.000024: In a research protocol that uses human tissue samples, the ethics committee should review it according to the
p.000024: international ethical guidelines at least those as described below.
p.000024:
p.000024: 7.5.1 Prospective studies
p.000024: The investigator should follow the guidelines below.
p.000024: (1) obtain the written informed consent to use the samples from the donor, giver of the tissue samples or from the
p.000024: legal owner of the corpse;
p.000024: (2) provide detailed information to the donor, giver of the tissue samples or legal owner of the corpse about the
p.000024: objectives of the use of the samples in research or the overall research plan. The information sheet should specify
p.000024: the possibility
p.000024: or the plan to use the samples for future research, storage duration of the samples, and the rights of the subject to
p.000024: request for destruction of the samples when the research is complete;
p.000024: (3) collect the samples from the body of the owner by a specialist with correct and appropriate medical practice;
p.000024: (4) utilize the techniques and systems for the storage of the tissue samples that are appropriate and secured from
p.000024: access by unauthorized persons;
p.000024: (5) use the appropriate data recording, storing, and retrieving systems that ensure protection of the confidentiality
p.000024: of the owner of the tissue samples;
p.000024: (6) appoint a personnel staff responsible for the handling and storage of the tissue samples;
p.000024: (7) The institution or organization that allows the use of human tissue samples for research purposes should lay down
p.000024: the guidelines for the conduct of the research using the tissue samples and for the ethnical review and approval of the
p.000024: research protocols. The guidelines should be in compliance with the applicable laws and regulations, and the
p.000024: institutional ethical guidelines should provide detailed procedures and possible conditions for the use of the tissue
p.000024: samples in the research. The guidelines will be used for the investigator to follow when asking for the subject's
p.000024: donation of the tissue samples used in the research, and for the ethics committee to review the protocols taking into
p.000024:
p.000025: 25
p.000025: consideration international ethical principles, i.e., respect for persons, beneficence, and justice;
p.000025: (8) A material transfer agreement should be made in case the tissue samples are transferred to other institutions to
p.000025: ensure consistency with the principle of respect for persons.
p.000025:
p.000025: 7.5.2 Retrospective Studies Using Stored Human Tissue Samples
p.000025: (1) The institution and the ethics committee should established the rules and regulations that determine what
...
p.000026: these potential impacts, and should have measures for solving problems that may arise. The procedures
p.000026: for strictly protecting the subject’s privacy and the confidentiality of the data should be implemented.
p.000026: Generally, researchers should be aware of the following important considerations when conducting human genetic
p.000026: research.
p.000026:
p.000026: 7.6.1 Individuals, Families, and Biological Relatives:
p.000026: (1) The investigator should provide the information and obtain the individual informed consent from relevant people.
p.000026: (2) The outcomes of the research are to be disclosed to appropriate persons free of charge (appropriate persons mean
p.000026: the research participants who inform in advance that they need to know the results).
p.000026: (3) Human genetic researches is often conducted in groups of families or
p.000026: in communities that are related to one another, e.g., the study of a family tree
p.000026: or history or the linkage study on the same chromosome. In case that the study causes a conflict between family
p.000026: members, the investigator must take responsibility for solving the problem by communicating and informing
p.000026: correctly and honestly the information regarding the purposes, benefits, and disadvantages of the research to the
p.000026: families in question.
p.000026:
p.000026: 7.6.2 Privacy, Confidentiality, Loss of Benefits, and Risks
p.000026: (1) The investigator and the ethics committee should ensure that the confidentiality and the results of the genetic
p.000026: research be securely kept from unauthorized access by a third party, such as employer or insurance companies.
p.000026: (2) The investigator studying about the family’s or population’s genetics should review the scope of possible
p.000026: physical and mental impact that may happen to the relevant persons, and demonstrate those to the ethics committee.
p.000026:
p.000026: 7.6.3 Genetic Counseling
p.000026: The investigator and the ethics committee should ensure that the research protocols provide correct and appropriate
p.000026: genetic counseling for the potential subjects.
p.000026:
p.000026:
p.000026: 7.6.4 Genetic Alterations
p.000026: A genetic alteration of a human embryonic cell or a human gamete is regarded as a violation of research ethics. The
p.000026: research study on gene alteration then must not be approved, except for gene therapy that may need to be considered on
p.000026: a case by case basis to receive ethical approval for the research.
p.000026:
p.000026: 7.6.5 Eugenic Concern
p.000026: The objectives of the human genetic research are related to improved knowledge and understanding of genetic diseases
p.000026: that may affect human health only, including health care, and not for eugenic purposes. Additionally, attention must
p.000026: be paid to the subjects’ free decision making on the problems that may arise, in particular, for the married couple who
p.000026: needs to make a decision after being informed about a risk imposed upon the intrauterine fetus to develop a disease.
...
p.000035: THE OFFICE OF NATIONAL RESEARCH COUNCIL OF THAILAND
p.000035:
p.000035: The Office of National Research Council of Thailand has established the following ethical guidelines for researchers.
p.000035:
p.000035: 1. Researchers must be honest and hold moral responsibility in both science and management.
p.000035:
p.000035: 2. Researchers must be aware of the obligation for the conduct of research as agreed with a sponsoring agency and
p.000035: their affiliated institution.
p.000035:
p.000035: 3. Researchers must be knowledgeable in the field of their research.
p.000035:
p.000035: 4. Researchers must be responsible for the subjects used in studies, either living or non-living things.
p.000035:
p.000035: 5. Researchers must pay respect to the dignity and rights of human subjects participating in a research.
p.000035:
p.000035: 6. Researchers must hold freedom of thought without any bias throughout all stages of research.
p.000035:
p.000035: 7. Researchers should utilize their research results in an appropriate manner.
p.000035:
p.000035: 8. Researchers should respect the scientific opinions of other researchers.
p.000035:
p.000035: 9. Researchers should be responsible for society at all levels.
p.000035:
p.000036: 36
p.000036:
p.000036: ANNEX 5
p.000036: ROLES AND RESPONSIBILITIES OF SPONSOR1
p.000036: 1. Quality Assurance and Quality Control
p.000036: 1.1 The sponsor is responsible for implementing and maintaining quality assurance and quality control systems
p.000036: with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in
p.000036: compliance with the protocol, GCP, and the applicable regulatory requirement(s).
p.000036: 1.2 The sponsor is responsible for securing agreement from all involved parties to ensure direct access (see 1.21) to
p.000036: all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor,
p.000036: and inspection by domestic and foreign regulatory authorities.
p.000036: 1.3 Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been
p.000036: processed correctly.
p.000036: 1.4 Agreements, made by the sponsor with the investigator/institution and any other parties involved with the clinical
p.000036: trial, should be in writing, as part of the protocol or in a separate agreement.
p.000036:
p.000036: 2. Contract Research Organization (CRO)
p.000036: 2.1 A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate
p.000036: responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO
p.000036: should implement quality assurance and quality control.
p.000036: 2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.
p.000036: 2.3 Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the
p.000036: sponsor.
p.000036: 2.4 All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial
p.000036: related duties and functions of a sponsor.
p.000036:
p.000036: 3. Medical Expertise
p.000036: The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on
p.000036: trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for
p.000036: this purpose.
p.000036:
p.000036: 4. Trial Design
p.000036: 4.1 The sponsor should utilize qualified individuals (e.g. biostatisticians, clinical
...
p.000036: translated from the ICH GCP Guidelines. Re-translating the Thai version back to the English language may cause slight
p.000036: deviation from the original meaning. Therefore, adopting the original English version is made to best preserve the
p.000036: accuracy of the text.
p.000036:
p.000037: 37
p.000037: 5. Trial Management, Data Handling, and Record Keeping
p.000037: 5.1 The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the
p.000037: trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.
p.000037: 5.2 The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the
p.000037: progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to
p.000037: recommend to the sponsor whether to continue, modify, or stop a trial. The IDMC should have written operating
p.000037: procedures and maintain written records of all its meetings.
p.000037: 5.3 When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should:
p.000037: (a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established
p.000037: requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation).
p.000037: (b) Maintains SOPs for using these systems.
p.000037: (c) Ensure that the systems are designed to permit data changes in such a way that the data changes are documented
p.000037: and that there is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail).
p.000037: (d) Maintain a security system that prevents unauthorized access to the data.
p.000037: (e) Maintain a list of the individuals who are authorized to make data changes (see 4.1.5 and 4.9.3).
p.000037: (f) Maintain adequate backup of the data.
p.000037: (g) Safeguard the blinding, if any (e.g. maintain the blinding during data entry and processing).
p.000037: 5.4 If data are transformed during processing, it should always be possible to compare the original data and
p.000037: observations with the processed data.
p.000037: 5.5 The sponsor should use an unambiguous subject identification code (see 1.58) that allows identification
p.000037: of all the data reported for each subject.
p.000037: 5.6 The sponsor, or other owners of the data, should retain all of the sponsor-specific essential
p.000037: documents pertaining to the trial (see 8. Essential Documents for the Conduct of a Clinical Trial).
p.000037: 5.7 The sponsor should retain all sponsor-specific essential documents in conformance with the applicable
p.000037: regulatory requirement(s) of the country(ies) where the product is approved, and/or where the sponsor intends
p.000037: to apply for approval(s).
p.000037: 5.8 If the sponsor discontinues the clinical development of an investigational product (i.e., for any or all
p.000037: indications, routes of administration, or dosage forms), the sponsor should maintain all sponsor-specific
p.000037: essential documents for at least two years after formal discontinuation or in conformance with the applicable
p.000037: regulatory requirement(s).
p.000037: 5.9 If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all
p.000037: the trial investigators/institutions and all the regulatory authorities.
...
p.000040: documentation thereof. The procedures should address adequate and safe receipt, handling, storage, dispensing,
p.000040: retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor (or
p.000040: alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s)).
p.000040: 14.4 The sponsor should:
p.000040: (a) Ensure timely delivery of investigational product(s) to the investigator(s).
p.000040: (b) Maintain records that document shipment, receipt, disposition, return, and destruction of the
p.000040: investigational product(s) (see 8. Essential Documents for the Conduct of a Clinical Trial).
p.000040: (c) Maintain a system for retrieving investigational products and documenting this retrieval (e.g. for
p.000040: deficient product recall, reclaim after trial completion, expired product reclaim).
p.000040: (d) Maintain a system for the disposition of unused investigational product(s) and for the documentation of this
p.000040: disposition.
p.000040: 14.5 The sponsor should:
p.000040: (a) Take steps to ensure that the investigational product(s) are stable over the period of use.
p.000040: (b) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm
p.000040: specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the
p.000040: extent stability permits, samples should be retained either until the analyses of the trial data are complete or
p.000040: as required by the applicable regulatory requirement(s), whichever represents the longer retention period.
p.000040:
p.000040: 15. Record Access
p.000040: 15.1 The sponsor should ensure that it is specified in the protocol or other written agreement that
p.000040: the investigator(s)/institution(s) provide direct access to source data/documents for
p.000040: trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.
p.000040: 15.2 The sponsor should verify that each subject has consented, in writing, to direct access to his/her original
p.000040: medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection.
p.000040:
p.000040: 16. Safety Information
p.000040: 16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
p.000040: 16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies)
p.000040: of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's
p.000040: approval/favorable opinion to continue the trial.
p.000040:
p.000041: 41
p.000041: 17. Adverse Drug Reaction Reporting
p.000041: 17.1 The sponsor should expedite the reporting to all concerned
p.000041: investigator(s)/institutions(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of
p.000041: all adverse drug reactions (ADRs) that are both serious and unexpected.
p.000041: 17.2 Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for
p.000041: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
p.000041: 17.3 The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as
p.000041: required by applicable regulatory requirement(s).
p.000041:
p.000041: 18. Monitoring
p.000041: 18.1 Purpose
p.000041: The purposes of trial monitoring are to verify that:
...
p.000043:
p.000043: 19.1 Purpose
p.000043: The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality
p.000043: control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable
p.000043: regulatory requirements.
p.000043:
p.000043: 19.2 Selection and Qualification of Auditors
p.000043: (a) The sponsor should appoint individuals, who are independent of the clinical trials/systems, to conduct
p.000043: audits.
p.000043: (b) The sponsor should ensure that the auditors are qualified by training and experience to
p.000043: conduct audits properly. An auditor’s qualifications should be documented.
p.000043:
p.000043: 19.3 Auditing Procedures
p.000043: (a) The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the
p.000043: sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of
p.000043: audit reports.
p.000043: (b) The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to
p.000043: submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the
p.000043: level of risks to the trial subjects, and
p.000043:
p.000044: 44
p.000044: any identified problem(s).
p.000044: (c) The observations and findings of the auditor(s) should be documented.
p.000044: (d) To preserve the independence and value of the audit function, the regulatory authority(ies) should
p.000044: not routinely request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case
p.000044: by case basis when evidence of serious GCP non-compliance exists, or in the course of legal proceedings.
p.000044: (e) When required by applicable law or regulation, the sponsor should provide an audit certificate.
p.000044:
p.000044: 20. Noncompliance
p.000044: 20.1 Noncompliance with the protocols, SOPs, GCP, and/or applicable regulatory requirement(s) by an
p.000044: investigator/institution, or by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure
p.000044: compliance.
p.000044: 20.2 If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an
p.000044: investigator/institution, the sponsor should terminate the investigator's/institution’s
p.000044: participation in the trial. When an investigator's/institution’s participation is terminated because of
p.000044: noncompliance, the sponsor should notify promptly the regulatory authority(ies).
p.000044:
p.000044: 21. Premature Termination or Suspension of a Trial
p.000044: If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions,
p.000044: and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension.
p.000044: The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or
p.000044: suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory
p.000044: requirement(s).
p.000044:
p.000044: 22. Clinical Trial/Study Reports
...
p.000047: 47
p.000047: 6.3 Procedures for monitoring subject compliance.
p.000047:
p.000047: 7. Assessment of Efficacy
p.000047: 7.1 Specification of the efficacy parameters.
p.000047: 7.2 Methods and timing for assessing, recording, and analyzing efficacy parameters.
p.000047:
p.000047: 8. Assessment of Safety
p.000047: 8.1 Specification of safety parameters.
p.000047: 8.2 The methods and timing for assessing, recording, and analyzing safety parameters.
p.000047: 8.3 Procedures for eliciting reports of and for recording and reporting adverse event and inter-current illnesses.
p.000047: 8.4 The type and duration of the follow-up of subjects after adverse events.
p.000047:
p.000047: 9. Statistics
p.000047: 9.1 A description of the statistical methods to be employed, including timing of any planned interim analysis(ses).
p.000047: 9.2 The number of subjects planned to be enrolled. In multi-centre trials, the numbers of enrolled subjects
p.000047: projected for each trial site should be specified. Reason for choice of sample size, including reflections
p.000047: on (or calculations of) the power of the trial and clinical justification.
p.000047: 9.3 The level of significance to be used.
p.000047: 9.4 Criteria for the termination of the trial.
p.000047: 9.5 Procedure for accounting for missing, unused, and spurious data.
p.000047: 9.6 Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s)
p.000047: from the original statistical plan should be described and justified in protocol and/or in the final report, as
p.000047: appropriate).
p.000047: 9.7 The selection of subjects to be included in the analyses (e.g., all randomized subjects, all dosed subjects, all
p.000047: eligible subjects and evaluable subjects).
p.000047:
p.000047: 10. Direct Access to Source Data/Documents
p.000047: The sponsor should ensure that it is specified in the protocol or other written agreement that the
p.000047: investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory
p.000047: inspection(s), providing direct access to source data/documents.
p.000047: 11. Quality Control and Quality Assurance
p.000047:
p.000047: 12. Ethics
p.000047: Description of ethical considerations relating to the trial.
p.000047:
p.000047: 13. Data Handling and Record Keeping
p.000047: 14. Financing and Insurance
p.000047: Financing and insurance if not addressed in a separate agreement.
p.000047:
p.000047: 15. Publication Policy
p.000047: Publication policy, if not addressed in a separate agreement.
p.000047:
p.000047: 16. Supplements
p.000047:
p.000048: 48
p.000048: (NOTE: Since the protocol and the clinical trial/study report are closely related, further relevant
p.000048: information can be found in the ICH Guideline for Structure and Content of Clinical Study Reports.)
p.000048:
p.000049: 49
p.000049: ANNEX 7
p.000049:
p.000049: EXAMPLES OF MEDICAL DEVICES AND INHERENT RISKS
p.000049:
p.000049: Examples of medical devices that may be regarded as being highly risky
p.000049: - Artificial organs or tissues such as artificial cochlear, injectable collagen, all types of artificial joints,
p.000049: artificial lenses, artificial bones, blood vessel stents and internal stents, including for example stents used in the
p.000049: gall bladder duct, or in the urinary tract system,
p.000049: artificial valve, and artificial blood vessels
p.000049: - Devices used for cardiovascular system, such as cardiac pace maker
p.000049: - Cardiopulmonary resuscitation, laser used for dilating clotted blood vessels and devices for cardiopulmonary
p.000049: bypass used in the open heat operation
p.000049: - Devices for stone destruction
p.000049: - Devices for haemodialysis
p.000049: - The intestinal stapler
p.000049: - Absorbable haemostatic agents
p.000049: - Infusion pumps etc.
p.000049:
...
Social / Child
Searching for indicator child:
(return to top)
p.000007: physical and mental integrity and on the personality of the subject."
p.000007:
p.000007: 3.3.1 Confidentiality protection
p.000007: (1) The subjects must be informed about their rights to have their personal information protected
p.000007: strictly.
p.000007: (2) During the informed consent discussion, the investigator must inform the subjects in advance of the
p.000007: measures used to protect their confidentiality before signing the consent form.
p.000007: (3) The subjects must sign the informed consent form before the information is to be distributed in case the
p.000007: information can cause danger to them.
p.000007: (4) The possible leakage of the research results containing the subject's confidentiality should be
p.000007: minimized to the lowest level. In general, the best way to protect the subject's confidentiality is to remove
p.000007: the subject's identification from all stages of the study, and to control or restrict access to the data.
p.000007: (5) The subjects should be made aware of the investigator's limitations in keeping their confidentiality. An
p.000007: example is when, the investigator has to transfer the subject’s information from the case report forms
p.000007: to the national regulatory authorities or the sponsor. This also includes where a regulatory requirement exists
p.000007: to report certain events, such as communicable disease, child molestation abuse, and child's
p.000007: negligence, directly to the responsible agency. Under these circumstances, the investigator must inform the
p.000007: subjects of the limitations for keeping confidentiality before the subjects participate in the study.
p.000007: (6) The subjects should be made aware of the social impact on them if there would be any leakage of the data.
p.000007: For example, if the subject's participation in the
p.000007:
p.000008: 8
p.000008: studies on AIDS medicines or vaccines is made public, it is risky for the subjects to receive social discrimination.
p.000008: Such risks should be carefully considered in the same manner as those for any treatment risk resulting from
p.000008: drug or vaccine studies.
p.000008: (7) In the case where the ethics committee decides that signing the informed consent form can be
p.000008: waived, the investigator should explore other means to protect the subject's confidentiality.
p.000008:
p.000008: 3.3.2 Confidentiality between physicians and patient subjects
p.000008: The Declaration of Patients' Rights, issued by the four health professional associations and the Ministry of Public
p.000008: Health, states, “Patients have the right to receive strict protection of their own information.” Any disclosure of the
p.000008: patient’s information to anyone who needs the information, such as doctors, nurses, technical scientists, competent
...
Searching for indicator children:
(return to top)
p.000003:
p.000003: The principle covers the following aspects.
p.000003: 2.2.1 Respect for human dignity. This aspect is the heart of research ethics, which provides for the protection
p.000003: of diverse interests relevant to the body, mind, and cultural security of a person. This is the foundation of
p.000003: the other following principles. Respect for freely given informed consent. This means the subject needs to be
p.000003: fully informed of all aspects of the research without hidden or biased information using an
p.000003: easy-to-understand language for the subjects. The information should cover the details of the procedures,
p.000003: rights, obligations, requirement for informed consent and the freedom of decision making. Also, the subjects have the
p.000003: rights to withdraw their consent any time without giving any reason. In practice, the informed consent may appear in a
p.000003: form of conversation.
p.000003: 2.2.2 Respect for vulnerable persons. Respect for human dignity leads to an ethical requirement for vulnerable
p.000003: people who have inferior or lack physical capacities or have diminished capacities for making a reasonable
p.000003: decision, such as children, pregnant women, psychiatric patients, unconscious patients, and prisoners.
p.000003: These vulnerable people need to be protected from being forced to participate in a research involuntarily. In
p.000003: practice, a special treatment is needed for the protection of their benefits.
p.000003: 2.2.3 Respect for privacy and confidentiality. This principle is fundamental to the respect for human’s
p.000003: dignity found in various cultures, and it helps to protect the security of mind. Therefore, the standards applied
p.000003: for the respect for privacy and confidentiality help to protect the access to, retention of, and distribution of
p.000003: personal information.
p.000003:
p.000003: 2.3 Principle of Beneficence
p.000003: This principle covers the following aspects.
p.000003: 2.3.1 Balancing between risks and benefits; An analysis of risks and benefits being exposed to the subjects is a
p.000003: key ethical issue of research on human subjects. Research ethics for human subjects in modern times requires a
p.000003: balance between potential risks and benefits, with the desired goal being that the benefits must outweigh
p.000003: the risks and that the potential risks are acceptable for the subjects and received prior to review and
...
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
...
p.000012: is entitled to receive are denied unreasonably, or when the subjects have to bear burdens unreasonably.
p.000012: Since the principle focuses on the distribution of the burdens and the benefits to the subjects
p.000012: participating in a research study, the application of this principle in reviewing research on human subjects is clearly
p.000012: made in the process of subject selection. Fairness must serve for the selection of the research participants in
p.000012: both the practical procedures and the outcomes. The justice in the subject selection is considered in two
p.000012: levels i.e., individual and societal.
p.000012: Regarding the individual justice in the subject selection, the investigator is required to include the
p.000012: subjects based on the criteria with fairness and non-discrimination, i.e., there should be no offering of benefits to a
p.000012: favorite group of people or recruiting those who are not favored into a risky study. The social justice requires
p.000012: that differences must be made among groups of people that should or should not be included into a particular research
p.000012: study. In doing so, the capacities of individuals in the groups or communities who can bear the potential burdens in
p.000012: the study, or the suitability of the individuals to bear further burdens must be considered. Social justice then
p.000012: deals with setting an order or a priority that needs to be considered before enrolling any groups of people into any
p.000012: studies (for example, adult before children, male before female).
p.000012: Likewise, the principle of distributive justice can also be applied at community and country levels, i.e., that which
p.000012: the community bears the burdens, or which the community takes the benefits must be in accordance with the
p.000012: principle of distributive justice as well. A common problem of injustice occurring at the community
p.000012: level is exemplified in the case of trials for product development of drugs, vaccines or medical
p.000012: devices that are sponsored by companies or organizations in developed countries. The trials are conducted
p.000012: in developing countries, but after the end of the trials, drugs or vaccines or medical devices under the
p.000012: studies cannot be made beneficial to the participating populations or countries. One of the causes is due to
p.000012: the lack of access to those drugs or vaccines because of their high cost, or the lack of disease or illness for such
p.000012: drugs or vaccines in those communities in developing countries occurs. Thus, the principle must be carefully and
p.000012: thoroughly considered to bring justice to all levels from the individual to the society.
p.000012: However, please be aware that in reviewing research on human subjects based on this principle, deviation
...
p.000017: preventive effects of the drug.
p.000017: In general, an investigational drug used in clinical trial falls into one of four categories, namely:
p.000017: (1) new drugs; (2) unregistered drugs in Thailand (3) registered drugs by the national drug authority, but being
p.000017: studied in new doses or indications not previously approved; and (4) locally produced drugs which required efficacy
p.000017: testing.
p.000017:
p.000017: Phases of Clinical Drug Trials
p.000017: For new drugs, adequate evidence derived from animal studies must be available to ensure safety and determine toxicity
p.000017: levels prior to conducting a study in humans.
p.000017:
p.000017: A Clinical Drug Trail Can Be Classified in Four Phases.
p.000017:
p.000017: Phase I
p.000017: This is a first-in-human trial using a new chemical entity that is usually conducted in healthy volunteers to study
p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
p.000017: elderly, or women with childbearing potential. Anesthesia or anticancer drugs should not be used in the healthy
p.000017: volunteers as a result of its high toxicity. In general, the number of the subjects should not exceed 30
p.000017: subjects. Every subject should give written informed consent before participating in the study. The study in
p.000017: this phase is usually an open study without any control group, i.e., both subjects and investigators know
p.000017: the trial drug. Studies in phase I also involve two stages. Stage I studies employ a small dose, i.e., about 1/50 or
p.000017: 1/100 of the dose used successfully in the animal studies. When the results demonstrate safety, the second stage
p.000017: is then followed by gradually escalating the dose. Once the results are satisfactory, phase II studies are
p.000017: conducted.
p.000017: Phase I trials also include the studies done on the patients suffering from a specific disease with no hope from
p.000017: currently available treatments, such as studies in terminally ill cancer patients.
p.000017:
p.000017: Phase II
p.000017: Phase II studies are conducted on patients with the target treatment of the drug that was satisfactorily studied in
p.000017: Phase I. The primary objective of the trial in this phase is to study short- term pharmacological toxicity in
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000017: preventive effects of the drug.
p.000017: In general, an investigational drug used in clinical trial falls into one of four categories, namely:
p.000017: (1) new drugs; (2) unregistered drugs in Thailand (3) registered drugs by the national drug authority, but being
p.000017: studied in new doses or indications not previously approved; and (4) locally produced drugs which required efficacy
p.000017: testing.
p.000017:
p.000017: Phases of Clinical Drug Trials
p.000017: For new drugs, adequate evidence derived from animal studies must be available to ensure safety and determine toxicity
p.000017: levels prior to conducting a study in humans.
p.000017:
p.000017: A Clinical Drug Trail Can Be Classified in Four Phases.
p.000017:
p.000017: Phase I
p.000017: This is a first-in-human trial using a new chemical entity that is usually conducted in healthy volunteers to study
p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
p.000017: elderly, or women with childbearing potential. Anesthesia or anticancer drugs should not be used in the healthy
p.000017: volunteers as a result of its high toxicity. In general, the number of the subjects should not exceed 30
p.000017: subjects. Every subject should give written informed consent before participating in the study. The study in
p.000017: this phase is usually an open study without any control group, i.e., both subjects and investigators know
p.000017: the trial drug. Studies in phase I also involve two stages. Stage I studies employ a small dose, i.e., about 1/50 or
p.000017: 1/100 of the dose used successfully in the animal studies. When the results demonstrate safety, the second stage
p.000017: is then followed by gradually escalating the dose. Once the results are satisfactory, phase II studies are
p.000017: conducted.
p.000017: Phase I trials also include the studies done on the patients suffering from a specific disease with no hope from
p.000017: currently available treatments, such as studies in terminally ill cancer patients.
p.000017:
p.000017: Phase II
p.000017: Phase II studies are conducted on patients with the target treatment of the drug that was satisfactorily studied in
p.000017: Phase I. The primary objective of the trial in this phase is to study short- term pharmacological toxicity in
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
p.000009: conducting research studies in subjects with illegal careers, such as sex workers or illegal drug users.
p.000009: 3.4.10 In the case where a study is conducted on the vulnerable people without direct health benefit to them, the
...
p.000026: (2) The investigator studying about the family’s or population’s genetics should review the scope of possible
p.000026: physical and mental impact that may happen to the relevant persons, and demonstrate those to the ethics committee.
p.000026:
p.000026: 7.6.3 Genetic Counseling
p.000026: The investigator and the ethics committee should ensure that the research protocols provide correct and appropriate
p.000026: genetic counseling for the potential subjects.
p.000026:
p.000026:
p.000026: 7.6.4 Genetic Alterations
p.000026: A genetic alteration of a human embryonic cell or a human gamete is regarded as a violation of research ethics. The
p.000026: research study on gene alteration then must not be approved, except for gene therapy that may need to be considered on
p.000026: a case by case basis to receive ethical approval for the research.
p.000026:
p.000026: 7.6.5 Eugenic Concern
p.000026: The objectives of the human genetic research are related to improved knowledge and understanding of genetic diseases
p.000026: that may affect human health only, including health care, and not for eugenic purposes. Additionally, attention must
p.000026: be paid to the subjects’ free decision making on the problems that may arise, in particular, for the married couple who
p.000026: needs to make a decision after being informed about a risk imposed upon the intrauterine fetus to develop a disease.
p.000026: The investigator should provide moral support for the married couple who decides to carry on the pregnancy after they
p.000026: are aware that the fetus would develop a disease.
p.000026:
p.000027: 27
p.000027:
p.000027: 7.6.6 Banking of Genetic Materials
p.000027: Although establishing a bank for collecting genetic materials is expected to be of benefit in the future, it may impose
p.000027: risks to individuals who are the owners of
p.000027: the genetic materials and their families. Therefore, the following guidelines are recommended.
p.000027: (1) The investigator involved the storage of the genetic materials in the bank should demonstrate to the ethics
p.000027: committee and to the subjects the operating procedures used for keeping confidentiality, privacy, and retention of the
p.000027: materials as well the data and the research results.
p.000027: (2) The duration of storing the genetics materials should be specified, including the operating procedures for the
p.000027: destruction of the materials upon completing the storage time.
p.000027: (3) The duration of storing the genetics materials should be specified,
p.000027: including the operating procedures for the destruction of the materials upon completing storage time. Uses of the
p.000027: materials for purposes other than those specified in the approved protocol should receive informed consent from the
p.000027: research participants or their heirs. Furthermore, their families are
p.000027: able to contact for the data or for the withdrawal from the research at anytime without any conditions.
p.000027:
p.000027: 7.6.7 Commercial use of genetic data
p.000027: The investigator must specify the commercial benefits that may be derived from the results or the data of the research
p.000027: using human genetics in research protocols to create further awareness in the ethics committee and the subjects.
p.000027:
p.000027:
p.000027: 7.7 RESEARCH ON HUMAN GAMETES, EMBRYO, EMBRYONIC STEM CELL, AND THE FETUS
p.000027:
p.000027: Research using advanced reproductive heath technology influence the practices of research ethics, researcher’s ethics,
p.000027: and people at large. The regulations issued by the Medical Council, by the advice of the Royal College of
p.000027: Obstetrics and Gynecology of Thailand, have already laid down the medical practice guidelines on the
p.000027: standards of services concerning reproduction technology. In addition, in conducting research involving human
p.000027: gametes, embryos, and the fetus, the risks imposed to the embryo or fetus, the informed consent, and the respect for
p.000027: the rights of the embryo and fetus should be considered. The following criteria are recommended.
p.000027:
p.000027: 7.7.1 Research involving human gametes
p.000027: (1) Obtaining the informed consent from the owners of the gametes is required in research using human gametes, which
p.000027: follows the principles and
p.000027: practices applied in other research involving human subjects.
p.000027: (2) The collection of the human gametes from a deceased person is not allowed, as the informed consent from the
p.000027: donor of the gametes cannot be obtained. Any research conducted using commercialized gametes, or
p.000027: inducing artificial cross-fertilization between the human gamete and an animal gamete, is considered unethical.
p.000027:
p.000027: 7.7.2 Research on human embryos and embryonic stem cells
p.000027: (1) The fertilization of human gamete results in an embryo, and it is unethical to create human embryos merely for
p.000027: research purposes. However, if the research is conducted for the benefit of reproductive health according to the
p.000027: principles and practices mentioned previously, it would be considered ethical.
p.000027: (2) Research on the alteration of human genes or the internal compositions of the human gametes or in the human embryo
p.000027: must not be conducted. When the
p.000027:
p.000028: 28
p.000028: research using an embryo is conducted, and no information about the future problem being likely to happen to the fetus
p.000028: is available, the embryo must not be
p.000028: implanted in the uterus to induce pregnancy. The experiment on the human embryo is allowed within the period of
p.000028: fourteen days after its fertilization.
p.000028: (3) A human cloning research for reproduction is not approved. Also, induced cross- fertilization between the
p.000028: human gamete and an animal gamete is unethical.
p.000028:
p.000028: 7.7.3 Research involving the intrauterine fetus
p.000028: Research designed for the diagnosis or treatment of the intrauterine fetus that suffers from genetic diseases or
p.000028: congenital anomaly could be conducted if the mother has given her consent after being thoroughly informed about the
p.000028: treatment in detail, since the diagnosis or treatment of the fetus cannot be done separately from that of the mother,
p.000028: and both need to be treated simultaneously.
p.000028:
p.000028: 7.7.4 Research involving the use of fetal tissues, placenta and its blood
p.000028: Research that uses fetal tissues must be conducted in accordance with the ethical principles as applied in other human
p.000028: experimentation. The fetus is a human, not merely tissues. Therefore, obtaining the informed consent from the
p.000028: parents, who are considered the legally acceptable representatives of the tissues, is required.
p.000028: The conduct of research using fetal tissues to generate stem cells must adhere to the practice guidelines established
p.000028: in the Medical Council’s Regulation on the Preservation of the Ethics of Medical Profession (NO. 6) B.E. 2545, Section
p.000028: 9 on the Medical Practice of Blood Stem Cell Transplantation from Donors.
p.000028:
p.000029: 29
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: ANNEXES
p.000029:
p.000030: 30
p.000030: ANNEX 1
p.000030:
p.000030: THE MEDICAL COUNCIL'S REGULATION
p.000030: ON RESEARCH STUDIES AND EXPERIMENTS IN HUMAN SUBJECTS
p.000030: B.E. 2525
p.000030:
p.000030: 1. “Research study and experiment in human subjects” refers to a research study and an experiment using a
p.000030: pharmaceutical product or medical devices, or a study of a natural course of a disease, or the diagnosis,
p.000030: treatment, health promotion, and prevention of a disease which is conducted in human subjects. This also includes a
p.000030: research study conducted using the information from medical records and any specimens taken from the human body.
p.000030:
p.000030: “Ethics Committee” refers to a committee or board appointed by an institution, organization, or agency,
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000021: Epidemiological research involves the use of the following types of data.
p.000021: a. identified data, which are referred to as, for example, name, date of birth, or address, including such a minor
p.000021: details as a zip code that may be used as an identifier;
p.000021: b. potentially identifiable, coded, re-identifiable data, which are referred to as the data of the identifier, which
p.000021: has been removed and replaced by a new code that can re-identify the individuals. They are then regarded as
p.000021: “identifiable data.”
p.000021: c. de-identified, not re-identifiable, anonymous data, which are referred to as the data that have been permanently
p.000021: removed from their identifiers, and as a consequence, the data cannot identify any individuals if the existing
p.000021: identifiers are permanently destroyed or the data are collected without any identifiers.
p.000021:
p.000021: 7.2.1 It is required that all epidemiological research be reviewed by an ethics committee, based on international
p.000021: ethical guidelines. In the epidemiological study that needs to use identified or identifiable data, the individual
p.000021: informed
p.000021:
p.000022: 22
p.000022: consent from each subject for his/her participation should be obtained. The ethics committee should ensure that:
p.000022:
p.000022: (1) the research is conducted according to the applicable policy / laws / regulations related to the personal rights,
p.000022: the privacy, and the disclosure of information, etc.
p.000022: (2) searching for medical records or other records or patients’ reports for research purposes should be restricted to
p.000022: only the investigators knowledgeable in the relevant fields or to the attending physicians.
p.000022: However, research assistants may be allowed when many records are searched.
p.000022:
p.000022: 7.2.2 The ethics committee may approve the search for identified or identifiable data from the records if the
p.000022: following criteria are fulfilled.
p.000022: (1) the informed consent process possibly causes excessive worries to the subjects or reduces the scientific value of
p.000022: the research, whereas the subjects or the relatives
p.000022: or the involved communities do not gain any benefit or the informed consent cannot practically be obtained;
p.000022: (2) the research is conducted by the attending physician of the patients, and the risks are minimal, and the research
p.000022: does not involve any abnormality of the genetics;
p.000022: (3) the public benefit is of high degree for the proposed research topic;
p.000022: (4) the informed consent process possibly causes excessive worries to the subjects or reduces the scientific value of
p.000022: the research, whereas the subjects, the relatives
p.000022: or the involved communities do not gain any benefits or the informed consent cannot practically be obtained because of
p.000022: too many or outdated medical records, or it is difficult to contact for the informed consent; or
p.000022: (5) the public interests from the research prevail over the private interests
p.000022:
...
p.000050: proteins expressed by DNA/RNA supplied by ....[2]….., sub-sets of the original MATERIAL, for example, novel
p.000050: plasmids or vectors.
p.000050: Modifications mean substances created by RECIPIENT, which contain or incorporate the MATERIAL (Original
p.000050: Material, Progeny or Unmodified Derivatives).
p.000050: Commercial purposes mean the sale, patenting, obtaining or transferring intellectual property rights or other
p.000050: tangible or intangible rights by sale or license, product development and seeking pre-marketing approval.
p.000050: 3. The MATERIAL covered by this agreement includes:
p.000050: 3.1 All biological materials, living or dead, originated from within the Kingdom of Thailand/or
p.000050: else where as listed in Attachment A
p.000050: 3.2 Any associated know-how, data and information
p.000050: 3.3 Any Progeny, Unmodified Derivatives and Modifications
p.000050: 3.4 Any cells or DNA, molecules replicated or derived there from
p.000050: 4. The RECIPIENT agrees that:
p.000050: 4.1 The MATERIAL is the property of ....[2]….. and is to be used by the RECIPIENT solely for (check only one that
p.000050: applies)
p.000050: [ ] research purposes.
p.000050: [ ] test, reference, bioassay and control (covering only their use within the framework of corresponding official
p.000050: international test, bioassay and control protocols)
p.000050: [ ] training and teaching purposes
p.000050: at the RECIPIENT’ s institution and only under the direction of the RECIPIENT.
p.000050:
p.000050:
p.000050: The research / test to be conducted by the RECIPIENT is restricted to the project/ test described in
p.000050: Attachment B, Entitled, “
p.000050: ”
p.000050: (Principal Investigator / Laboratory Supervisor / Instructor : …………………………………
p.000050: ……………… ……………… ……………………… )
p.000050:
p.000050: 4.2 The MATERIAL will not be used in human subjects or in clinical trials involving human subjects without the written
p.000050: permission of ....[2]…...
p.000050:
p.000051: 51
p.000051: 5. The RECIPIENT agrees not to transfer the MATERIAL to anyone who does not work under his or her direct
p.000051: supervision at the RECIPIENT’ s institution without the prior written consent of
p.000051: ....[2]…... The RECIPIENT shall refer nay request for the MATERIAL to ....[2]…...
p.000051: 6. The RECIPIENT agrees to use the MATERIAL in appropriate containment facilities by fully trained and
p.000051: competent staff.
p.000051: 7. The RECIPIENT will notify....[2]….. of all research results related to the MATERIAL in writing within one year
p.000051: after completion of the research project.
p.000051: 8. The RECIPIENT agrees to acknowledge....[2] as the source of the MATERIAL and data in
p.000051: any and all publications and patent applications based on or relating to the MATERIAL, replicas, or
p.000051: derivatives there of and any research thereon.
p.000051: 9. The RECIPIENT acknowledges that the MATERIAL is or may be the subject of a patent application.
p.000051: Except provided in this agreement, no expressed or implied licenses or other rights are provided to the RECIPIENT under
p.000051: any patents, patent applications, trade secrets or other proprietary rights of ....[2]….., including any altered forms
p.000051: of the MATERIAL made by ....[2]…...
...
Social / Institutionalized
Searching for indicator institutionalized:
(return to top)
p.000006: medicine, instruments, or others should be specified.
p.000006:
p.000006: 3.2 Inducement
p.000006: In recruiting the subjects into a study, the ethical principle that should be followed is that the subject should be
p.000006: invited to participate in the study. Please note that the words "invitation" and "volunteer" mean that the potential
p.000006: subjects are informed correctly, and voluntarily participate in the
p.000006:
p.000007: 7
p.000007: study. The information given should include both advantages, disadvantages to be incurred to the subjects themselves,
p.000007: to the community, or just for scientific benefit. The subjects should make their own decisions, not be forced
p.000007: to do so, or induced unduly. The subjects can also withdraw from the study any time. Several aspects of inducement
p.000007: that should receive consideration include:
p.000007: 3.2.1 Payment or compensation either money or other benefits to be given to the subjects should not be
p.000007: too much to induce the subject to decide to participate in the study without carefully considering the risks that may
p.000007: happen in the study;
p.000007: 3.2.2 For a phase I clinical trial usually conducted in normal subjects, the subjects would not obtain
p.000007: direct medical benefits from the study results. Therefore, it is necessary to compensate for travel expenses, loss
p.000007: of work or other payments, as appropriate. On the contrary, for a phase III study, the subjects usually obtain direct
p.000007: benefit from the study.
p.000007: 3.2.3 Enforced participation in a study may happen to institutionalized people, such as soldiers, prisoners, and
p.000007: students who have to obey or cooperate with their corresponding authorities. In recruiting these people into
p.000007: a study, it is necessary that they are informed and are given opportunity to make their own decisions
p.000007: without any interference from the higher authority.
p.000007: 3.2.4 3.2.4 Payment given to investigators by pharmaceutical companies or sponsors in the form of money or
p.000007: other means that are excessive, or payment methods, such as the given payment is based on the number of subjects
p.000007: participating in the trial, may cause deviation in the case that the investigator attempts to recruit as many subjects
p.000007: as possible for their own benefit.
p.000007:
p.000007: 3.3 Privacy and Confidentiality Protection
p.000007: No. 21 of the Declaration of Helsinki B.E. 2543 states, “The right of research subjects to safeguard their integrity
p.000007: must always be respected. Every precaution should be taken to respect the privacy of the subject, the
p.000007: confidentiality of the patient's information, and to minimize the impacts of the study on the subject's
p.000007: physical and mental integrity and on the personality of the subject."
p.000007:
p.000007: 3.3.1 Confidentiality protection
p.000007: (1) The subjects must be informed about their rights to have their personal information protected
p.000007: strictly.
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000002: in charge of the revision. The process was completed by the Working Group for Revising the Ethical
p.000002: Guidelines, where members of the working group were mainly from the Working Group for the Development of the
p.000002: Ethical Guidelines previously appointed in B.E. 2545. The Chairperson and the Secretary for the two Working Groups
p.000002: remain the same persons. Some new members joined the Working Group for Revising the Ethical Guidelines, Annex 10).
p.000002:
p.000003: 3
p.000003: CHAPTER 2
p.000003:
p.000003: ETHICS FOR RESEARCH ON HUMAN SUBJECTS
p.000003:
p.000003: 2.1 General Ethical Principles
p.000003: Three basic ethical principles consist of: First, respect for persons; Second, beneficence;
p.000003: Third, justice
p.000003:
p.000003: 2.2 Principle of Respect for Person
p.000003:
p.000003: The principle covers the following aspects.
p.000003: 2.2.1 Respect for human dignity. This aspect is the heart of research ethics, which provides for the protection
p.000003: of diverse interests relevant to the body, mind, and cultural security of a person. This is the foundation of
p.000003: the other following principles. Respect for freely given informed consent. This means the subject needs to be
p.000003: fully informed of all aspects of the research without hidden or biased information using an
p.000003: easy-to-understand language for the subjects. The information should cover the details of the procedures,
p.000003: rights, obligations, requirement for informed consent and the freedom of decision making. Also, the subjects have the
p.000003: rights to withdraw their consent any time without giving any reason. In practice, the informed consent may appear in a
p.000003: form of conversation.
p.000003: 2.2.2 Respect for vulnerable persons. Respect for human dignity leads to an ethical requirement for vulnerable
p.000003: people who have inferior or lack physical capacities or have diminished capacities for making a reasonable
p.000003: decision, such as children, pregnant women, psychiatric patients, unconscious patients, and prisoners.
p.000003: These vulnerable people need to be protected from being forced to participate in a research involuntarily. In
p.000003: practice, a special treatment is needed for the protection of their benefits.
p.000003: 2.2.3 Respect for privacy and confidentiality. This principle is fundamental to the respect for human’s
...
p.000004: been witnessed in several cases in the past. In addition, the subjects participating in a research study should be
p.000004: entitled to any direct benefits from the research. Justice is then reflected by not neglecting or discriminating
p.000004: against people or groups of people that may benefit from the progress of research.
p.000004:
p.000005: 5
p.000005: CHAPTER 3
p.000005:
p.000005: CONDUCTING RESEARCH ACCORDING TO THE PRINCIPLE OF RESPECT FOR PERSONS
p.000005:
p.000005:
p.000005: 3.1 Informed Consent Process
p.000005: Conducting a research in conformity with international standards requires correct and appropriate informed
p.000005: consent and invitation to be given to subjects. The process is not to force the subjects to participate in the
p.000005: research directly or indirectly without giving them a chance to be informed about the research procedures
p.000005: or without giving any opportunity to make their own decision. Examples are that patients have a
p.000005: dependent relationship with physicians, or that physicians conduct experiments in patients using one or
p.000005: more medicines or new unproven treatment without informing the patients, or that payment or compensation in either
p.000005: money or gifts or the promise to give something beyond necessity is given, or that the instructions or explanation
p.000005: about research procedures are given in a technical language too difficult for the subjects to understand.
p.000005: In providing information or invitation to potential subjects to participate in a research, it is important to
p.000005: always adhere to the three ethical principles, i.e., respect for persons, beneficence, and justice.
p.000005: In providing the information or invitation for decision making, the investigator may separate the documents into two
p.000005: parts, i.e., the information sheet explaining research procedures, risks, benefits, what the subjects should
p.000005: be aware of in making their decision, and the informed consent form. The two parts can be combined into one, but it
p.000005: should cover the details of both parts. The language used should be suitable for lay persons to understand and cover
p.000005: medical information as appropriate, including legal and financial aspects of the study. The informed consent is not
p.000005: only to protect the research subjects, but also to protect the investigator, the sponsor, and the ethics
p.000005: committee. Therefore, the investigator is responsible for preparing the details of the research
p.000005: procedures and the information sheet by himself/herself. In case the subjects cannot personally give a written
p.000005: informed consent, the informed consent given verbally with an impartial witness should be specified. In
p.000005: addition, it should specify in what case the legal guardian is to be informed and consent granted.
p.000005:
p.000005: 3.1.1 Advice for the preparation of the information sheet and informed consent form
p.000005: The information sheet and the informed consent process to be given for the subject's decision making should contain the
p.000005: following elements:
p.000005: (1) the title of the study;
p.000005: (2) an invitation describing why the subject should participate in the study;
p.000005: (3) the objective(s) and the research procedures that the investigator and the subject have to follow;
p.000005: (4) the duration of the subject's participation in the study;
...
p.000006: (15) whether the results of the study will be disclosed to the subject and how;
p.000006: (16) whether the biological materials collected from the study will be destroyed; if not, the details of the storage
p.000006: and the plan for future use should be provided, and whether such a use is limited;
p.000006: (17) whether there would be any products derived from the biological materials collected from the study;
p.000006: (18) whether the subjects or their families or the persons under the subject's supervision will receive any
p.000006: compensation for damage or death resulting from the study;
p.000006: (19) that the subject has the freedom to deny or withdraw from the study at anytime without losing any benefits, and
p.000006: must not affect standard treatments that the subject is normally entitled to;
p.000006: (20) that the study protocols have been reviewed and approved by the ethics committee for research in human subjects.
p.000006:
p.000006: 3.1.2 Practical guidelines that should be followed
p.000006: The guidelines below clarify several relevant ethical considerations.
p.000006: (1) Obtaining informed consent is not merely having the subjects or their legally acceptable representatives
p.000006: sign on the consent form. Rather, the process should reflect a good relationship between the investigator and
p.000006: the subjects. The process should provide clear and complete information sufficient for the subjects to make their
p.000006: decisions. The investigator should pay attention to the care and the physical and mental well being of the subjects
p.000006: during the course of the research.
p.000006: (2) The language used should be suitable to the subject's capacity and avoid technical terms;
p.000006: (3) The investigators must ensure that the potential subjects are aware of their participation in the
p.000006: study, and understand clearly the research procedures;
p.000006: (4) According to the principle of beneficence and non-maleficence, the researcher must inform the subjects in
p.000006: advance of any procedures or treatments other than the diagnosis, treatments or prevention that are
p.000006: useful to the subjects. Advantages or disadvantages of participating in the study should be provided so that the
p.000006: subjects can make their own decisions;
p.000006: (5) Upon the completion of the study, whether the subjects are entitled to continuous access to the
p.000006: medicine, instruments, or others should be specified.
p.000006:
p.000006: 3.2 Inducement
p.000006: In recruiting the subjects into a study, the ethical principle that should be followed is that the subject should be
p.000006: invited to participate in the study. Please note that the words "invitation" and "volunteer" mean that the potential
p.000006: subjects are informed correctly, and voluntarily participate in the
p.000006:
p.000007: 7
p.000007: study. The information given should include both advantages, disadvantages to be incurred to the subjects themselves,
p.000007: to the community, or just for scientific benefit. The subjects should make their own decisions, not be forced
p.000007: to do so, or induced unduly. The subjects can also withdraw from the study any time. Several aspects of inducement
p.000007: that should receive consideration include:
...
p.000011: 4.4.5 In case the subjects cannot personally give an informed consent to participate in the study, the risk that may
p.000011: happen must be a minimal risk. Otherwise, research with slightly greater than a minimal risk would be acceptable only
p.000011: if the research's objective(s) are important enough, and the research provides only good effects to the participating
p.000011: subjects.
p.000011:
p.000011: The assessment of risks and benefits will be very useful to the individuals involved in research on human
p.000011: subjects. For the investigator, the assessment helps to check if the research is properly designed. For the ethics
p.000011: committee, it helps to determine if the risks and benefits that may happen to the subjects are justified. And for
p.000011: the research subjects, it helps to decide whether to participate in the research or not.
p.000011:
p.000012: 12
p.000012: CHAPTER 5
p.000012:
p.000012: CONDUCTING RESEARCH ACCORDNG TO THE PRINCIPLE OF JUSTICE
p.000012:
p.000012: The selection of groups of people of communities for research should be based on a fair distribution of
p.000012: burdens and benefits. Exclusion of any people or communities from any research should be justified.
p.000012:
p.000012: According to the Thai Dictionary of the Royal Academy of Thailand B.E. 2542, the word "justice" (or yutti-tham in
p.000012: the Thai language) is defined as fairness, legitimacy, or reasonably justified, which is a widely known
p.000012: or often referred to definition. In the context of research on human subjects, however, the term "justice" is
p.000012: referred to as distributive justice, which requires that both burdens and benefits entitled to the subject
p.000012: participating in the research be distributed equally. Therefore, the key questions of this principle are 1) who
p.000012: bears the burdens and 2) who receives the benefits from the research. Injustice then occurs when the benefits that one
p.000012: is entitled to receive are denied unreasonably, or when the subjects have to bear burdens unreasonably.
p.000012: Since the principle focuses on the distribution of the burdens and the benefits to the subjects
p.000012: participating in a research study, the application of this principle in reviewing research on human subjects is clearly
p.000012: made in the process of subject selection. Fairness must serve for the selection of the research participants in
p.000012: both the practical procedures and the outcomes. The justice in the subject selection is considered in two
p.000012: levels i.e., individual and societal.
p.000012: Regarding the individual justice in the subject selection, the investigator is required to include the
p.000012: subjects based on the criteria with fairness and non-discrimination, i.e., there should be no offering of benefits to a
p.000012: favorite group of people or recruiting those who are not favored into a risky study. The social justice requires
...
p.000036: should implement quality assurance and quality control.
p.000036: 2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.
p.000036: 2.3 Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the
p.000036: sponsor.
p.000036: 2.4 All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial
p.000036: related duties and functions of a sponsor.
p.000036:
p.000036: 3. Medical Expertise
p.000036: The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on
p.000036: trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for
p.000036: this purpose.
p.000036:
p.000036: 4. Trial Design
p.000036: 4.1 The sponsor should utilize qualified individuals (e.g. biostatisticians, clinical
p.000036: pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the
p.000036: protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial
p.000036: reports.
p.000036: 4.2 For further guidance: Clinical Trial Protocol and Protocol Amendment(s) (see 6.), the ICH Guideline for
p.000036: Structure and Content of Clinical Study Reports, and other appropriate ICH guidance on trial design, protocol and
p.000036: conduct.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: * This part is adopted from the Chapter on Sponsor of the ICH GCP Guidelines, as the Thai version is directly
p.000036: translated from the ICH GCP Guidelines. Re-translating the Thai version back to the English language may cause slight
p.000036: deviation from the original meaning. Therefore, adopting the original English version is made to best preserve the
p.000036: accuracy of the text.
p.000036:
p.000037: 37
p.000037: 5. Trial Management, Data Handling, and Record Keeping
p.000037: 5.1 The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the
p.000037: trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.
p.000037: 5.2 The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the
p.000037: progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to
p.000037: recommend to the sponsor whether to continue, modify, or stop a trial. The IDMC should have written operating
p.000037: procedures and maintain written records of all its meetings.
p.000037: 5.3 When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should:
p.000037: (a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established
p.000037: requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation).
p.000037: (b) Maintains SOPs for using these systems.
p.000037: (c) Ensure that the systems are designed to permit data changes in such a way that the data changes are documented
p.000037: and that there is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail).
p.000037: (d) Maintain a security system that prevents unauthorized access to the data.
p.000037: (e) Maintain a list of the individuals who are authorized to make data changes (see 4.1.5 and 4.9.3).
...
p.000045: appropriate) for the trial.
p.000045: 1.5 Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and
p.000045: telephone number(s) of the trial site(s).
p.000045: 1.6 Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is
p.000045: responsible for all trial-site related medical (or dental) decisions (if other than investigator).
p.000045: 1.7 Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s)
p.000045: and/or institutions involved in the trial.
p.000045:
p.000045: 2. Background Information
p.000045: 2.1 Name and description of the investigational product(s).
p.000045: 2.2 A summary of findings from non-clinical studies that potentially have clinical significance and from clinical
p.000045: trials that are relevant to the trial.
p.000045: 2.3 Summary of the known and potential risks and benefits, if any, to human subjects.
p.000045: 2.4 Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s).
p.000045: 2.5 A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory
p.000045: requirement(s).
p.000045: 2.6 Description of the population to be studied.
p.000045: 2.7 References to literature and data that are relevant to the trial, and that provide background for the
p.000045: trial.
p.000045:
p.000045:
p.000045:
p.000045: * This part is adopted from the Chapter on Clinical Trial Protocol and Protocol Amendment(s) of the ICH GCP Guidelines,
p.000045: as the Thai version is directly translated from the ICH GCP Guidelines. Re-translating the Thai version back to the
p.000045: English language may cause slight deviation from the original meaning. Therefore, adopting the original English
p.000045: version is made to best preserve the accuracy of the text.
p.000045:
p.000046: 46
p.000046: 3. Trial Objectives and Purpose
p.000046: A detailed description of the objectives and the purpose of the trial.
p.000046:
p.000046: 4. Trial Design
p.000046: The scientific integrity of the trial and the credibility of the data from the trial depend
p.000046: substantially on the trial design. A description of the trial design, should include:
p.000046: 4.1 A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial.
p.000046: 4.2 A description of the type/design of trial to be conducted (e.g. double-blind, placebo- controlled,
p.000046: parallel design) and a schematic diagram of trial design, procedures and stages.
p.000046: 4.3 A description of the measures taken to minimize/avoid bias, including:
p.000046: (a) Randomization.
p.000046: (b) Blinding.
p.000046: 4.4 A description of the trial treatment(s) and the dosage and dosage regimen of the investigational
p.000046: product(s). Also include a description of the dosage form, packaging, and labeling of the investigational
p.000046: product(s).
p.000046: 4.5 The expected duration of subject participation, and a description of the sequence and duration of all trial
p.000046: periods, including follow-up, if any.
p.000046: 4.6 A description of the "stopping rules" or "discontinuation criteria" for individual subjects, parts of trial and
p.000046: entire trial.
...
Social / Marital Status
Searching for indicator married:
(return to top)
p.000025: i. the regulatory requirements.
p.000025: (5) A material transfer agreement should be made in case the tissue samples are transferred to other institutions to
p.000025: ensure the consistency with the principle of respect for persons.
p.000025:
p.000025:
p.000025: 7.6 HUMAN GENETIC RESEARCH
p.000025:
p.000025: Human genetic research is the study of genes and their interactions with the surrounding factors that
p.000025: affect the health of individuals and populations. Not only does the research enlarge the body of knowledge
p.000025: that impacts the individual's health, but it may also affects the health of the individuals and their families in the
p.000025: future, which paves the way for protection from genetic diseases.
p.000025: Regarding the ethics in human genetic research, some additional elements are needed to be considered apart from those
p.000025: applied for other research involving human subjects because of the specific nature of this type of research. For
p.000025: example, the co-operation of the subjects and their families is very much needed for genetic research, and the data or
p.000025: the research results collected from one family may not only benefit those who participate in the research, but also
p.000025: those who do not directly join the research, but are the relatives of the subjects involved in the
p.000025: research.
p.000025:
p.000026: 26
p.000026: Therefore, in certain situations, those relatives have to be informed of the data collected from the other related
p.000026: groups for the benefit of their own families’ health care, such as a married couple who pays attention to the health of
p.000026: their unborn baby.
p.000026: In addition, the information generated by the results of the human genetic research may directly impact the
p.000026: subjects, e.g., causing social stigma or discrimination. Therefore, the investigator should be aware of
p.000026: these potential impacts, and should have measures for solving problems that may arise. The procedures
p.000026: for strictly protecting the subject’s privacy and the confidentiality of the data should be implemented.
p.000026: Generally, researchers should be aware of the following important considerations when conducting human genetic
p.000026: research.
p.000026:
p.000026: 7.6.1 Individuals, Families, and Biological Relatives:
p.000026: (1) The investigator should provide the information and obtain the individual informed consent from relevant people.
p.000026: (2) The outcomes of the research are to be disclosed to appropriate persons free of charge (appropriate persons mean
p.000026: the research participants who inform in advance that they need to know the results).
p.000026: (3) Human genetic researches is often conducted in groups of families or
p.000026: in communities that are related to one another, e.g., the study of a family tree
p.000026: or history or the linkage study on the same chromosome. In case that the study causes a conflict between family
p.000026: members, the investigator must take responsibility for solving the problem by communicating and informing
p.000026: correctly and honestly the information regarding the purposes, benefits, and disadvantages of the research to the
p.000026: families in question.
...
p.000026: research be securely kept from unauthorized access by a third party, such as employer or insurance companies.
p.000026: (2) The investigator studying about the family’s or population’s genetics should review the scope of possible
p.000026: physical and mental impact that may happen to the relevant persons, and demonstrate those to the ethics committee.
p.000026:
p.000026: 7.6.3 Genetic Counseling
p.000026: The investigator and the ethics committee should ensure that the research protocols provide correct and appropriate
p.000026: genetic counseling for the potential subjects.
p.000026:
p.000026:
p.000026: 7.6.4 Genetic Alterations
p.000026: A genetic alteration of a human embryonic cell or a human gamete is regarded as a violation of research ethics. The
p.000026: research study on gene alteration then must not be approved, except for gene therapy that may need to be considered on
p.000026: a case by case basis to receive ethical approval for the research.
p.000026:
p.000026: 7.6.5 Eugenic Concern
p.000026: The objectives of the human genetic research are related to improved knowledge and understanding of genetic diseases
p.000026: that may affect human health only, including health care, and not for eugenic purposes. Additionally, attention must
p.000026: be paid to the subjects’ free decision making on the problems that may arise, in particular, for the married couple who
p.000026: needs to make a decision after being informed about a risk imposed upon the intrauterine fetus to develop a disease.
p.000026: The investigator should provide moral support for the married couple who decides to carry on the pregnancy after they
p.000026: are aware that the fetus would develop a disease.
p.000026:
p.000027: 27
p.000027:
p.000027: 7.6.6 Banking of Genetic Materials
p.000027: Although establishing a bank for collecting genetic materials is expected to be of benefit in the future, it may impose
p.000027: risks to individuals who are the owners of
p.000027: the genetic materials and their families. Therefore, the following guidelines are recommended.
p.000027: (1) The investigator involved the storage of the genetic materials in the bank should demonstrate to the ethics
p.000027: committee and to the subjects the operating procedures used for keeping confidentiality, privacy, and retention of the
p.000027: materials as well the data and the research results.
p.000027: (2) The duration of storing the genetics materials should be specified, including the operating procedures for the
p.000027: destruction of the materials upon completing the storage time.
p.000027: (3) The duration of storing the genetics materials should be specified,
p.000027: including the operating procedures for the destruction of the materials upon completing storage time. Uses of the
p.000027: materials for purposes other than those specified in the approved protocol should receive informed consent from the
p.000027: research participants or their heirs. Furthermore, their families are
p.000027: able to contact for the data or for the withdrawal from the research at anytime without any conditions.
p.000027:
p.000027: 7.6.7 Commercial use of genetic data
p.000027: The investigator must specify the commercial benefits that may be derived from the results or the data of the research
...
p.000033: ON THE STANDARDS OF SERVICES INVOLVING REPRODUCTION TECHNOLOGY (NO.2)
p.000033:
p.000033: As the Medical Council had issued the announcement no. 1/2540 dated 22 October B.E. 2540 on establishing the
p.000033: standards of services involving reproduction technology by medical practitioners, it is now time to additionally
p.000033: establish the standards of services to provide for more appropriate protection to service receivers.
p.000033: By virtue of Section 21(1) of the Medical Profession Act B.E. 2525 where the Act contains certain provisions that
p.000033: restrict the rights and freedom of individuals, however, Sections 29 and 50 of the Constitution of the Kingdom of
p.000033: Thailand allow for the act according to the provisions of the Act. The Medical Council then reached its resolution
p.000033: at the 10/2545 meeting dated 11 October
p.000033: B.E. 2545 to issue the announcement as follows.
p.000033: 1. The following statements shall be added as no. 4/1 and no. 4/2 of the Medical Council’s Announcement No.
p.000033: 1/2540 on Standards of Services involving Reproduction Technology dated 22 October 2540 as follows.
p.000033: “No. 4/1 The services involving reproduction technology shall not be conducted in a way of human cloning for
p.000033: reproduction.
p.000033: No. 4/2 Medical practitioners who are responsible for the services according to (3), or are the providers of the
p.000033: services involving the reproduction technology shall maintain the standard of services that involve the
p.000033: donation of male or female gametes or an embryo to be employed in a reproductive process as follows.
p.000033: (1) In the case a married couple would like to have a baby by having the wife to carry out pregnancy, the medical
p.000033: practitioner may provide the services
p.000033: (a) using the donor's gamete for fertilization either in vivo or in vitro;
p.000033: (b) requesting for donation of an embryo for pregnancy
p.000033: (2) In the case a married couple who wishes to have a baby by having another woman who is not the
p.000033: wife to carry out the pregnancy instead, the medical practitioner shall provide for the services by using only
p.000033: the embryo derived from the fertilization of the gametes of the married couple.
p.000033: (3) Providing the services in (1) and (2) shall adhere to the following conditions.
p.000033: (a) no payment is given to the donor of the gamete in a manner that can be mistaken as selling-buying;
p.000033: (b) no payment is given to the other woman who carries out the pregnancy instead that may be misunderstood as hired
p.000033: pregnancy;
p.000033: (c) the woman who carries out the pregnancy instead must be a biological relative of the couple either the husband or
p.000033: the wife;
p.000033: (d) Pre-implantation genetic diagnosis of an embryo shall be conducted only for diagnosis purposes, as necessary
p.000033: and as appropriate. Such a conduct shall not be made in a way that may be understood as gender selection, and a
p.000033: written informed consent shall be obtained according to the form attached to this regulation.
p.000033: (4) For any services other than the standards established in (1), (2), and (3), the medical practitioners who are
p.000033: responsible for, or are the service providers shall obtain an approval from the Royal College of Obstetrics
p.000033: and Gynecology of Thailand prior to providing all the services."
p.000033:
p.000034: 34
p.000034: 2. This announcement shall come into force since the date next to the publication date in the Royal Gazette.
p.000034:
p.000034: It is hereby announced.
p.000034: Given on the Twentieth Day of June B.E. 2545.
p.000034:
p.000035: 35
p.000035:
p.000035: ANNEX 4
p.000035:
p.000035: THE ETHICAL GUIDELINES FOR RESEARCHERS,
p.000035: THE OFFICE OF NATIONAL RESEARCH COUNCIL OF THAILAND
p.000035:
p.000035: The Office of National Research Council of Thailand has established the following ethical guidelines for researchers.
...
Searching for indicator single:
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p.000015: regulatory requirements mutatis mutandis, but at least for three years.
p.000015:
p.000015: 6.5 Committee Member with a Conflict of Interest
p.000015: 6.5.1 In case one or more members of the committee have a conflict of interest (e.g., being a principal investigator
p.000015: of, or being on a list of investigators of the protocols under review, or being a competitive investigator of
p.000015: similar research areas), those committee members should not participate in the review and approval process.
p.000015: They, however, can provide relevant opinions, and disclose their conflict of interest with the protocols. The
p.000015: committee should respect the rights of the applicant to oppose.
p.000015:
p.000015: 6.6 Review of an Ongoing Research
p.000015: 6.6.1 After the committee has approved the research study, the investigators have to report the progress of the
p.000015: research to the committee at an appropriate interval. For research protocol with high risks, the investigator
p.000015: should report the progress more frequently than a low risk protocol. The applicant should propose to the committee how
p.000015: often he/she will submit a research progress report to the committee from the date of protocol submission for ethical
p.000015: review, but at least once a year.
p.000015: 6.6.2 Upon the termination of the trial protocol for whatever reasons, the investigator should report the summary of
p.000015: the research results to the committee.
p.000015:
p.000015: 6.7 Ethical Review of a Multi-center Trial
p.000015: 6.7.1 A multi-center trial may be referred to as a trial that is conducted in more than one institution or
p.000015: organization by a single or several investigators. It may also be defined as a trial conducted by a group of
p.000015: investigators from different institutions or from jointly collaborating organizations, and as a trial
p.000015: conducted by investigators who later change their original affiliated institution or organization to a new
p.000015: affiliation.
p.000015: 6.7.2 The multi-center protocols submitted to each institution or organization should contain the same details and
p.000015: meaning of the text, and should specify the quality control techniques of the research procedures to ensure that the
p.000015: practices are the same in each institution in order to obtain credible data.
p.000015: 6.7.3 The ethics committee in each institution or organization should be free to decide about the
p.000015: multi-center protocols, the outcome of which may not necessarily be the same as those of the committees in the other
p.000015: institutions. The research protocols should specify what part(s) of the protocol cannot be amended as it may affect
p.000015: the validity of the data and what part(s) can be modified by the committees as it does not affect the data as a whole.
p.000015: However, it is advised that the committee in each institution or organization consult with one another in case of
p.000015: any possible
p.000015:
p.000016: 16
p.000016: different opinions about the main principle so as to reach a clearly agreed upon decision. The investigator
p.000016: should amend the protocols’ minor details as suggested by the committee in his/her institution.
p.000016: 6.7.4. The ethics committee of each institution or organization may accept entirely the decision made by
...
p.000051: provided by ....[2] without warranty of any sort, expressed or
p.000051: implied. ....[2]….. makes no representation the use of the MATERIAL will not infringe any patent or
p.000051: other proprietary right. The RECIPIENT will indemnify ....[2]….. and its employees and hold ....[2] and
p.000051: its employees from any claims or liabilities which may arise as a result of
p.000051: the use of the MATERIAL by the RECIPIENT.
p.000051: 12. The MATERIAL is provided at no cost; however, fee is requested solely for its preparation and distribution cost.
p.000051: The amount shall be indicated in Attachment A
p.000051: 13. The RECIPIENT shall promptly return or destroy all information and the MATERIAL upon demand therefore
p.000051: by ....[2]…...
p.000051: 14. The agreement shall be effective on the date of last signing below, apply to all information and the MATERIAL
p.000051: received from ....[2]….. and terminate on completion of the RECIPIENT’ s current research with the
p.000051: MATERIAL (within……..years after the effective date) unless the parties agree in writing to extend the agreement
p.000051: 15. ....[2]….. and the RECIPIENT shall use their best efforts to settle in a fair and reasonable manner
p.000051: any disputes arising in connection with this Agreement. If such dispute cannot be settled by the parties
p.000051: between themselves, it shall be first submitted to mediation by a mediator chosen jointly by the parties.
p.000051: In the event that mediation does not bring a resolution of the dispute within 30 days, the dispute shall be
p.000051: submitted to arbitration before a single arbitrator pursuant to the Arbitration Rule of Thailand. Any such
p.000051: arbitration will be subject to such rules.
p.000051:
p.000051:
p.000051: Signed for and on behalf of the RECIPIENT Signed for and on behalf of the ....[2]…..
p.000051:
p.000051: Name………………………………… Name………………………………….
p.000051: (…………………………..…..) (.............................................)
p.000051: Position: …………………………….. Position: ...........................................
p.000051:
p.000051: Date…………………………………. Date…………………………………..
p.000051:
p.000052: 52
p.000052: Signature of Witness Signature of Witness
p.000052:
p.000052: Name………………………………… Name…………………………………
p.000052: (..……………………………..) (…………………………..…….) Position : …………………………….
p.000052: Position: ……………………………. Date…………………………………. Date………………………………….
p.000052:
p.000053: 53
p.000053: Attachment A
p.000053: MTA No………..
p.000053: Material Transfer Record
p.000053:
p.000053: ……[1] agrees to transfer the following materials to …[3]… as follows:
p.000053:
p.000053: No. Material Quantity Remark 1
p.000002: 2
p.000003: 3
p.000004: 4
p.000005: 5
p.000006: 6
p.000006:
p.000006: Preparation costs …………..Baht/…………….unit Total Baht
p.000006: Distribution fees Baht
p.000006: [ ] The materials will be picked up on ……/…………/………(Please notify days/weeks in
p.000006: advance.)
p.000006: [ ] The materials are requested to be shipped to Recipient’s investigators/ Laboratory supervisor/ Instructor shown
p.000006: below.
p.000006:
p.000006:
p.000006:
p.000006: FOM SCIENTIST
...
Social / Occupation
Searching for indicator job:
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p.000013: appropriate.
p.000013: 6.1.10 The ethics committee should establish the requirements for protocol submission along with the
p.000013: required documents, such as an application form, the number of copies of a research protocol to be
p.000013: submitted, subject’s information sheet, informed consent form, and case report form, and should thoroughly
p.000013: communicate to personnel or staff within the institution.
p.000013: 6.1.11 The institution or organization by the advice of the ethics committee should develop standard operating
p.000013: procedures (SOPs) and revise them at an appropriate time interval.
p.000013:
p.000014: 14
p.000014: 6.2 Composition of Ethics Committee
p.000014: 6.2.1 The ethics committee should consist of at least five members, both male and female, and with the following
p.000014: qualifications:
p.000014: (1) At least one member should have knowledge and experience in the current research field(s) regularly reviewed
p.000014: by the committee (e.g., medicine, public health, social science, epidemiology, as appropriate) in order to
p.000014: ensure that the proposed research methodology of the protocol can yield the correct result of the research problem, or
p.000014: is scientifically valid;
p.000014: (2) At least one member should be a lawyer or endowed with knowledge of law.
p.000014: (3) At least one member should be independent of the institution or organization, and is an outsider whose current job
p.000014: is not in the field of medicine, science, or law. If possible, that member should be drawn from the community where
p.000014: the institution or organization is located.
p.000014: (4) At least two members should have knowledge or experience in the current practices of patient care, counseling,
p.000014: or treatment to people (e.g., physician, psychiatrist, social worker, and nurse, as appropriate).
p.000014: 6.2.2 The institution or organization should ensure that at least one third of the total committee
p.000014: members are knowledgeable in research ethics or have ever been undergone training about human research ethics.
p.000014: 6.2.3 The institution or organization should make available a list of the committee members showing names and
p.000014: qualifications, dates of appointment and termination from the office upon the request of the investigators or others.
p.000014:
p.000014: 6.3 Appointment of a Member of an Ethics Committee
p.000014: 6.3.1 The institution or organization should establish the composition of the ethics committee, the
p.000014: term of service of the members, and the criteria for selecting the members of the ethics committee, as appropriate.
p.000014: 6.3.2 Each member must be appointed officially as evidenced by a written document. In addition, the member should
p.000014: have a document that assures legal protection in case of legal liability during the course of duty as an ethics
p.000014: committee member.
p.000014:
...
Social / Property Ownership
Searching for indicator property:
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p.000019: categories, i.e., devices with minimal risk or non-significant risk and devices with significant risk, by considering
p.000019: the general characteristics and the use of the devices.
p.000019: Medical devices with significant risks are referred to as devices that
p.000019: • risk death upon usage;
p.000019: • risk permanent disability upon usage;
p.000019: • require a surgery or certain drugs to prevent death and/or disability that may be caused by that device.
p.000019:
p.000020: 20
p.000020: The risks related to the use of the devices also include the risks that are caused by the procedures and techniques
p.000020: used, for example, the risk caused by a surgery and general anesthesia used in the process of inserting the devices
p.000020: into the body.
p.000020: If the device to be used in research is similar to or has been used under the approved indications as that of the
p.000020: device available on the market, the advantages and disadvantages of the device to be studied in comparison with the
p.000020: available device should be considered.
p.000020: For example, the conduct of a trial using an electrical pacemaker, despite its high risk, inserted into the patient’s
p.000020: body which contains the property and usage not significantly different from those of the available device on the market
p.000020: may be ethically acceptable according to the principle of beneficence (see list of devices with classified risks in the
p.000020: annex).
p.000020: Deciding which type of risk the trial of a medical device or the device itself falls into is the responsibility of the
p.000020: ethics committee. If the committee decides that the trial and the device used impose a minimal risk, the trial of the
p.000020: device should pass ethical clearance according to the principle of beneficence.
p.000020: However, if the committee decides that the clinical trial of a device imposes a high risk, comparison should be made
p.000020: with similar devices available on the market. Just as exemplified previously, if the device to be used in the trial is
p.000020: greatly different from the devices on the market, the trial should be reviewed according to the general ethical
p.000020: principles applied in clinical trials taking into account the specific characteristics of the trial of medical devices
p.000020: explained earlier.
p.000020: Finally, the investigator and the subject should always realize that devices inserted into the human body undergo
p.000020: failure both in short and long term. The failure of the device may result in damage, even death. When such a risk
p.000020: exists, the investigator is responsible for objectively reporting the event to the sponsor, the ethics committee and
p.000020: the subjects.
p.000020:
...
p.000025: investigator to search for the patients and contact them for treatment or follow-up;
p.000025: (4) Under certain situations, the ethics committee may agree for the waiver of the informed consent from the tissue
p.000025: owners in using the stored tissue samples for the research by taking into considerations:
p.000025: a. the modes of obtaining the tissue samples (e.g., from pathology storage, blood bank);
p.000025: b. the scope and content of the informed consent given previously by the owner of the samples (if any);
p.000025: c. the reasons behind the waiver of the informed consent by the investigator, including difficulty of obtaining the
p.000025: informed consent;
p.000025: d. the possibility that the process of obtaining the informed consent may violate the privacy of the owners of the
p.000025: tissues, or cause damages to the physical and/or mental health of the donor or to the donor's social status;
p.000025: e. the proposal to protect the privacy and confidentiality of the tissue owners;
p.000025: f. the risk that may happen is a minimal risk;
p.000025: g. the relationship between the previously approved protocols and the new protocols;
p.000025: h. the potential commercial benefits or intellectual property;
p.000025: i. the regulatory requirements.
p.000025: (5) A material transfer agreement should be made in case the tissue samples are transferred to other institutions to
p.000025: ensure the consistency with the principle of respect for persons.
p.000025:
p.000025:
p.000025: 7.6 HUMAN GENETIC RESEARCH
p.000025:
p.000025: Human genetic research is the study of genes and their interactions with the surrounding factors that
p.000025: affect the health of individuals and populations. Not only does the research enlarge the body of knowledge
p.000025: that impacts the individual's health, but it may also affects the health of the individuals and their families in the
p.000025: future, which paves the way for protection from genetic diseases.
p.000025: Regarding the ethics in human genetic research, some additional elements are needed to be considered apart from those
p.000025: applied for other research involving human subjects because of the specific nature of this type of research. For
p.000025: example, the co-operation of the subjects and their families is very much needed for genetic research, and the data or
p.000025: the research results collected from one family may not only benefit those who participate in the research, but also
p.000025: those who do not directly join the research, but are the relatives of the subjects involved in the
p.000025: research.
p.000025:
p.000026: 26
p.000026: Therefore, in certain situations, those relatives have to be informed of the data collected from the other related
p.000026: groups for the benefit of their own families’ health care, such as a married couple who pays attention to the health of
...
p.000049: - Nerve stimulator
p.000049:
p.000050: 50
p.000050: ANNEX 8
p.000050:
p.000050: MODEL TEMPLATE FOR MATERIAL TRANSFER AGREEMENT
p.000050:
p.000050: MTA No…………..
p.000050: 1. The parties to this Agreement are:
p.000050: 1.1 ……[1]……(hereinafter referred to as ....[2] );
p.000050: 1.2 ………[3] (hereinafter referred to as the RECIPIENT) and ;
p.000050: 1.3 The RECIPIENT includes RECIPIENT’s Scientists as well as Principal Investigator / Laboratory Supervisor/
p.000050: Instructor
p.000050:
p.000050: ....[2]….. agrees to provide the RECIPIENT with MATERIAL, as hereinafter defined, for use in accordance with the terms
p.000050: and conditions of this agreement.
p.000050:
p.000050: 2. In this agreement:
p.000050: Material means original material, progeny, and unmodified derivatives.
p.000050: Progeny means unmodified descendant from the MATERIAL, for example, virus from virus, cell from cell, or organism from
p.000050: organism.
p.000050: Unmodified Derivatives mean substances created by RECIPIENT, which constitute an unmodified functional sub-unit or an
p.000050: expression product of the original MATERIAL, such as purified or fractionated sub-sets of the original
p.000050: MATERIAL, sub-clones of unmodified cell lines, monoclonal antibodies secreted by a hybridoma cell line,
p.000050: proteins expressed by DNA/RNA supplied by ....[2]….., sub-sets of the original MATERIAL, for example, novel
p.000050: plasmids or vectors.
p.000050: Modifications mean substances created by RECIPIENT, which contain or incorporate the MATERIAL (Original
p.000050: Material, Progeny or Unmodified Derivatives).
p.000050: Commercial purposes mean the sale, patenting, obtaining or transferring intellectual property rights or other
p.000050: tangible or intangible rights by sale or license, product development and seeking pre-marketing approval.
p.000050: 3. The MATERIAL covered by this agreement includes:
p.000050: 3.1 All biological materials, living or dead, originated from within the Kingdom of Thailand/or
p.000050: else where as listed in Attachment A
p.000050: 3.2 Any associated know-how, data and information
p.000050: 3.3 Any Progeny, Unmodified Derivatives and Modifications
p.000050: 3.4 Any cells or DNA, molecules replicated or derived there from
p.000050: 4. The RECIPIENT agrees that:
p.000050: 4.1 The MATERIAL is the property of ....[2]….. and is to be used by the RECIPIENT solely for (check only one that
p.000050: applies)
p.000050: [ ] research purposes.
p.000050: [ ] test, reference, bioassay and control (covering only their use within the framework of corresponding official
p.000050: international test, bioassay and control protocols)
p.000050: [ ] training and teaching purposes
p.000050: at the RECIPIENT’ s institution and only under the direction of the RECIPIENT.
p.000050:
p.000050:
p.000050: The research / test to be conducted by the RECIPIENT is restricted to the project/ test described in
p.000050: Attachment B, Entitled, “
p.000050: ”
p.000050: (Principal Investigator / Laboratory Supervisor / Instructor : …………………………………
p.000050: ……………… ……………… ……………………… )
p.000050:
p.000050: 4.2 The MATERIAL will not be used in human subjects or in clinical trials involving human subjects without the written
p.000050: permission of ....[2]…...
p.000050:
p.000051: 51
p.000051: 5. The RECIPIENT agrees not to transfer the MATERIAL to anyone who does not work under his or her direct
p.000051: supervision at the RECIPIENT’ s institution without the prior written consent of
p.000051: ....[2]…... The RECIPIENT shall refer nay request for the MATERIAL to ....[2]…...
p.000051: 6. The RECIPIENT agrees to use the MATERIAL in appropriate containment facilities by fully trained and
p.000051: competent staff.
p.000051: 7. The RECIPIENT will notify....[2]….. of all research results related to the MATERIAL in writing within one year
p.000051: after completion of the research project.
p.000051: 8. The RECIPIENT agrees to acknowledge....[2] as the source of the MATERIAL and data in
...
Social / Racial Minority
Searching for indicator racial:
(return to top)
p.000008: should be provided to prove that the subjects are informed about the methods for collecting the data. For example, the
p.000008: methods are to be included on the information sheet for patients being hospitalized, or the permission to use the data
p.000008: in medical records may be given from the hospital director or other authorized persons.
p.000008: (2) The collection of the data from the medical records must receive approval from the ethics committee, and the
p.000008: patient's confidentiality must be strictly protected.
p.000008: (3) The investigator is allowed to use the data from the patient's medical records only as specified in the research
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
...
Social / Religion
Searching for indicator faith:
(return to top)
p.000022: 7.2.7 If the identified or identifiable data are used for other purposes in the research or by other people other than
p.000022: those listed in the previously approved protocol, a new protocol needs to be submitted for ethical review.
p.000022: 7.2.8 The information derived from epidemiological research both short- and long-term should be securely kept from the
p.000022: access of unauthorized people.
p.000022: 7.2.9. When screening the data for the statistical analysis and concluding, the investigator should maintain the
p.000022: confidentiality of the research participants.
p.000022: 7.2.10 The research results should not be published in a manner that can identify the individuals participating in the
p.000022: research and can affect the culture or other sensitivities.
p.000022: 7.2.11 If the emerging new knowledge during the course of the research has clinical implications or indicates the
p.000022: adjustment of the current treatment, the new knowledge should be disclosed to the relevant competent authority. If
p.000022: possible, both the research participants and the attending physician should be informed
p.000022:
p.000023: 23
p.000023: as well.
p.000023:
p.000023: 7.3 SOCIAL SCIENCE RESEARCH
p.000023:
p.000023: Similarly, the ethical principles applied in social science research consist of the principles of respect for person,
p.000023: beneficence, and justice.
p.000023:
p.000023: 7.3.1 The investigator should protect each subject from any physical or mental harm.
p.000023: 7.3.2 The investigator should respect the faith, belief, culture, religion, and basic rights of the subject.
p.000023: 7.3.3 The investigator should conduct only the research that benefits mankind.
p.000023: 7.3.4 The investigator should ensure that the design of the study is suitable to the objectives of the study.
p.000023: 7.3.5 The investigator should fully inform the subjects so that they can freely decide whether to participate in the
p.000023: research.
p.000023: 7.3.6 The investigator should protect the confidentiality and undisclosed names of the subjects.
p.000023: 7.3.7 The investigator should provide for health care to the subject as much as possible.
p.000023: 7.3.8 If the inclusion criteria are sensitive issues, the investigator should carefully conduct the study to avoid
p.000023: the disclosure of the subjects’ identity. The
p.000023: investigators may sometimes conduct the study in a non-targeted population to prevent the members of the community from
p.000023: being aware of what is conducted.
p.000023: 7.3.9 In case the study is conducted using medical records consisting of the confidentiality of patients, only the
p.000023: authorized medical personnel are allowed to access the data in the records, which can identify the patients. The access
p.000023: should be permitted by the highest authority of the institution.
...
p.000050:
p.000051: 51
p.000051: 5. The RECIPIENT agrees not to transfer the MATERIAL to anyone who does not work under his or her direct
p.000051: supervision at the RECIPIENT’ s institution without the prior written consent of
p.000051: ....[2]…... The RECIPIENT shall refer nay request for the MATERIAL to ....[2]…...
p.000051: 6. The RECIPIENT agrees to use the MATERIAL in appropriate containment facilities by fully trained and
p.000051: competent staff.
p.000051: 7. The RECIPIENT will notify....[2]….. of all research results related to the MATERIAL in writing within one year
p.000051: after completion of the research project.
p.000051: 8. The RECIPIENT agrees to acknowledge....[2] as the source of the MATERIAL and data in
p.000051: any and all publications and patent applications based on or relating to the MATERIAL, replicas, or
p.000051: derivatives there of and any research thereon.
p.000051: 9. The RECIPIENT acknowledges that the MATERIAL is or may be the subject of a patent application.
p.000051: Except provided in this agreement, no expressed or implied licenses or other rights are provided to the RECIPIENT under
p.000051: any patents, patent applications, trade secrets or other proprietary rights of ....[2]….., including any altered forms
p.000051: of the MATERIAL made by ....[2]…...
p.000051: In particular, no expressed or implied licenses or other rights are provided to use the MATERIAL,
p.000051: modifications, or any related patents of the MATERIAL for commercial purposes.
p.000051: 10. If the RECIPIENT desires to use or license the MATERIAL or Modifications for commercial purposes.
p.000051: ....[2]….. AGREES, IN ADVANCE OF SUCH USE, TO NEGOTIATE IN GOOD FAITH WITH RECIPIENT TO ESTABLISH THE TERMS
p.000051: OF A COMMERCIAL LICENSE.
p.000051: 11. The RECIPIENT will use the MATERIAL in compliance with all his/her national and
p.000051: international laws and regulations, including Pathogens and Animal Toxins Act B.E.2525 as amended by
p.000051: Pathogens and Animal Toxins Act (No.2) B.E. 2544. The MATERIAL is experimental in nature and it is
p.000051: provided by ....[2] without warranty of any sort, expressed or
p.000051: implied. ....[2]….. makes no representation the use of the MATERIAL will not infringe any patent or
p.000051: other proprietary right. The RECIPIENT will indemnify ....[2]….. and its employees and hold ....[2] and
p.000051: its employees from any claims or liabilities which may arise as a result of
p.000051: the use of the MATERIAL by the RECIPIENT.
p.000051: 12. The MATERIAL is provided at no cost; however, fee is requested solely for its preparation and distribution cost.
p.000051: The amount shall be indicated in Attachment A
p.000051: 13. The RECIPIENT shall promptly return or destroy all information and the MATERIAL upon demand therefore
p.000051: by ....[2]…...
p.000051: 14. The agreement shall be effective on the date of last signing below, apply to all information and the MATERIAL
p.000051: received from ....[2]….. and terminate on completion of the RECIPIENT’ s current research with the
p.000051: MATERIAL (within……..years after the effective date) unless the parties agree in writing to extend the agreement
p.000051: 15. ....[2]….. and the RECIPIENT shall use their best efforts to settle in a fair and reasonable manner
...
Searching for indicator belief:
(return to top)
p.000022: those listed in the previously approved protocol, a new protocol needs to be submitted for ethical review.
p.000022: 7.2.8 The information derived from epidemiological research both short- and long-term should be securely kept from the
p.000022: access of unauthorized people.
p.000022: 7.2.9. When screening the data for the statistical analysis and concluding, the investigator should maintain the
p.000022: confidentiality of the research participants.
p.000022: 7.2.10 The research results should not be published in a manner that can identify the individuals participating in the
p.000022: research and can affect the culture or other sensitivities.
p.000022: 7.2.11 If the emerging new knowledge during the course of the research has clinical implications or indicates the
p.000022: adjustment of the current treatment, the new knowledge should be disclosed to the relevant competent authority. If
p.000022: possible, both the research participants and the attending physician should be informed
p.000022:
p.000023: 23
p.000023: as well.
p.000023:
p.000023: 7.3 SOCIAL SCIENCE RESEARCH
p.000023:
p.000023: Similarly, the ethical principles applied in social science research consist of the principles of respect for person,
p.000023: beneficence, and justice.
p.000023:
p.000023: 7.3.1 The investigator should protect each subject from any physical or mental harm.
p.000023: 7.3.2 The investigator should respect the faith, belief, culture, religion, and basic rights of the subject.
p.000023: 7.3.3 The investigator should conduct only the research that benefits mankind.
p.000023: 7.3.4 The investigator should ensure that the design of the study is suitable to the objectives of the study.
p.000023: 7.3.5 The investigator should fully inform the subjects so that they can freely decide whether to participate in the
p.000023: research.
p.000023: 7.3.6 The investigator should protect the confidentiality and undisclosed names of the subjects.
p.000023: 7.3.7 The investigator should provide for health care to the subject as much as possible.
p.000023: 7.3.8 If the inclusion criteria are sensitive issues, the investigator should carefully conduct the study to avoid
p.000023: the disclosure of the subjects’ identity. The
p.000023: investigators may sometimes conduct the study in a non-targeted population to prevent the members of the community from
p.000023: being aware of what is conducted.
p.000023: 7.3.9 In case the study is conducted using medical records consisting of the confidentiality of patients, only the
p.000023: authorized medical personnel are allowed to access the data in the records, which can identify the patients. The access
p.000023: should be permitted by the highest authority of the institution.
p.000023: 7.3.10 The investigator should provide appropriate payment, benefits, or privileges to the subjects, and ensure that
p.000023: it should not be too much to induce the subjects to participate in the study.
p.000023:
p.000023:
...
Searching for indicator religion:
(return to top)
p.000022: 7.2.8 The information derived from epidemiological research both short- and long-term should be securely kept from the
p.000022: access of unauthorized people.
p.000022: 7.2.9. When screening the data for the statistical analysis and concluding, the investigator should maintain the
p.000022: confidentiality of the research participants.
p.000022: 7.2.10 The research results should not be published in a manner that can identify the individuals participating in the
p.000022: research and can affect the culture or other sensitivities.
p.000022: 7.2.11 If the emerging new knowledge during the course of the research has clinical implications or indicates the
p.000022: adjustment of the current treatment, the new knowledge should be disclosed to the relevant competent authority. If
p.000022: possible, both the research participants and the attending physician should be informed
p.000022:
p.000023: 23
p.000023: as well.
p.000023:
p.000023: 7.3 SOCIAL SCIENCE RESEARCH
p.000023:
p.000023: Similarly, the ethical principles applied in social science research consist of the principles of respect for person,
p.000023: beneficence, and justice.
p.000023:
p.000023: 7.3.1 The investigator should protect each subject from any physical or mental harm.
p.000023: 7.3.2 The investigator should respect the faith, belief, culture, religion, and basic rights of the subject.
p.000023: 7.3.3 The investigator should conduct only the research that benefits mankind.
p.000023: 7.3.4 The investigator should ensure that the design of the study is suitable to the objectives of the study.
p.000023: 7.3.5 The investigator should fully inform the subjects so that they can freely decide whether to participate in the
p.000023: research.
p.000023: 7.3.6 The investigator should protect the confidentiality and undisclosed names of the subjects.
p.000023: 7.3.7 The investigator should provide for health care to the subject as much as possible.
p.000023: 7.3.8 If the inclusion criteria are sensitive issues, the investigator should carefully conduct the study to avoid
p.000023: the disclosure of the subjects’ identity. The
p.000023: investigators may sometimes conduct the study in a non-targeted population to prevent the members of the community from
p.000023: being aware of what is conducted.
p.000023: 7.3.9 In case the study is conducted using medical records consisting of the confidentiality of patients, only the
p.000023: authorized medical personnel are allowed to access the data in the records, which can identify the patients. The access
p.000023: should be permitted by the highest authority of the institution.
p.000023: 7.3.10 The investigator should provide appropriate payment, benefits, or privileges to the subjects, and ensure that
p.000023: it should not be too much to induce the subjects to participate in the study.
p.000023:
p.000023:
p.000023: 7.4 VACCINE TRIAL
p.000023:
...
Social / Threat of Stigma
Searching for indicator stigma:
(return to top)
p.000025:
p.000025:
p.000025: 7.6 HUMAN GENETIC RESEARCH
p.000025:
p.000025: Human genetic research is the study of genes and their interactions with the surrounding factors that
p.000025: affect the health of individuals and populations. Not only does the research enlarge the body of knowledge
p.000025: that impacts the individual's health, but it may also affects the health of the individuals and their families in the
p.000025: future, which paves the way for protection from genetic diseases.
p.000025: Regarding the ethics in human genetic research, some additional elements are needed to be considered apart from those
p.000025: applied for other research involving human subjects because of the specific nature of this type of research. For
p.000025: example, the co-operation of the subjects and their families is very much needed for genetic research, and the data or
p.000025: the research results collected from one family may not only benefit those who participate in the research, but also
p.000025: those who do not directly join the research, but are the relatives of the subjects involved in the
p.000025: research.
p.000025:
p.000026: 26
p.000026: Therefore, in certain situations, those relatives have to be informed of the data collected from the other related
p.000026: groups for the benefit of their own families’ health care, such as a married couple who pays attention to the health of
p.000026: their unborn baby.
p.000026: In addition, the information generated by the results of the human genetic research may directly impact the
p.000026: subjects, e.g., causing social stigma or discrimination. Therefore, the investigator should be aware of
p.000026: these potential impacts, and should have measures for solving problems that may arise. The procedures
p.000026: for strictly protecting the subject’s privacy and the confidentiality of the data should be implemented.
p.000026: Generally, researchers should be aware of the following important considerations when conducting human genetic
p.000026: research.
p.000026:
p.000026: 7.6.1 Individuals, Families, and Biological Relatives:
p.000026: (1) The investigator should provide the information and obtain the individual informed consent from relevant people.
p.000026: (2) The outcomes of the research are to be disclosed to appropriate persons free of charge (appropriate persons mean
p.000026: the research participants who inform in advance that they need to know the results).
p.000026: (3) Human genetic researches is often conducted in groups of families or
p.000026: in communities that are related to one another, e.g., the study of a family tree
p.000026: or history or the linkage study on the same chromosome. In case that the study causes a conflict between family
p.000026: members, the investigator must take responsibility for solving the problem by communicating and informing
p.000026: correctly and honestly the information regarding the purposes, benefits, and disadvantages of the research to the
p.000026: families in question.
p.000026:
p.000026: 7.6.2 Privacy, Confidentiality, Loss of Benefits, and Risks
p.000026: (1) The investigator and the ethics committee should ensure that the confidentiality and the results of the genetic
...
Searching for indicator stigmatization:
(return to top)
p.000008: prior permission.
p.000008:
p.000008: 3.3.3 Data from medical records
p.000008: (1) In practice, it is quite difficult for a researcher who conducts a study using the information from medical
p.000008: records to have a patient's informed consent form kept in each patient's medical record either by having patients
p.000008: sign the form in advance and keeping it in the medical record or by calling for patients to sign later. In this case,
p.000008: therefore, the ethics committee may consider waiving the signing of the informed consent form. However, the evidence
p.000008: should be provided to prove that the subjects are informed about the methods for collecting the data. For example, the
p.000008: methods are to be included on the information sheet for patients being hospitalized, or the permission to use the data
p.000008: in medical records may be given from the hospital director or other authorized persons.
p.000008: (2) The collection of the data from the medical records must receive approval from the ethics committee, and the
p.000008: patient's confidentiality must be strictly protected.
p.000008: (3) The investigator is allowed to use the data from the patient's medical records only as specified in the research
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000007:
p.000007: 3.3.1 Confidentiality protection
p.000007: (1) The subjects must be informed about their rights to have their personal information protected
p.000007: strictly.
p.000007: (2) During the informed consent discussion, the investigator must inform the subjects in advance of the
p.000007: measures used to protect their confidentiality before signing the consent form.
p.000007: (3) The subjects must sign the informed consent form before the information is to be distributed in case the
p.000007: information can cause danger to them.
p.000007: (4) The possible leakage of the research results containing the subject's confidentiality should be
p.000007: minimized to the lowest level. In general, the best way to protect the subject's confidentiality is to remove
p.000007: the subject's identification from all stages of the study, and to control or restrict access to the data.
p.000007: (5) The subjects should be made aware of the investigator's limitations in keeping their confidentiality. An
p.000007: example is when, the investigator has to transfer the subject’s information from the case report forms
p.000007: to the national regulatory authorities or the sponsor. This also includes where a regulatory requirement exists
p.000007: to report certain events, such as communicable disease, child molestation abuse, and child's
p.000007: negligence, directly to the responsible agency. Under these circumstances, the investigator must inform the
p.000007: subjects of the limitations for keeping confidentiality before the subjects participate in the study.
p.000007: (6) The subjects should be made aware of the social impact on them if there would be any leakage of the data.
p.000007: For example, if the subject's participation in the
p.000007:
p.000008: 8
p.000008: studies on AIDS medicines or vaccines is made public, it is risky for the subjects to receive social discrimination.
p.000008: Such risks should be carefully considered in the same manner as those for any treatment risk resulting from
p.000008: drug or vaccine studies.
p.000008: (7) In the case where the ethics committee decides that signing the informed consent form can be
p.000008: waived, the investigator should explore other means to protect the subject's confidentiality.
p.000008:
p.000008: 3.3.2 Confidentiality between physicians and patient subjects
p.000008: The Declaration of Patients' Rights, issued by the four health professional associations and the Ministry of Public
p.000008: Health, states, “Patients have the right to receive strict protection of their own information.” Any disclosure of the
p.000008: patient’s information to anyone who needs the information, such as doctors, nurses, technical scientists, competent
...
Social / Women
Searching for indicator women:
(return to top)
p.000003: of diverse interests relevant to the body, mind, and cultural security of a person. This is the foundation of
p.000003: the other following principles. Respect for freely given informed consent. This means the subject needs to be
p.000003: fully informed of all aspects of the research without hidden or biased information using an
p.000003: easy-to-understand language for the subjects. The information should cover the details of the procedures,
p.000003: rights, obligations, requirement for informed consent and the freedom of decision making. Also, the subjects have the
p.000003: rights to withdraw their consent any time without giving any reason. In practice, the informed consent may appear in a
p.000003: form of conversation.
p.000003: 2.2.2 Respect for vulnerable persons. Respect for human dignity leads to an ethical requirement for vulnerable
p.000003: people who have inferior or lack physical capacities or have diminished capacities for making a reasonable
p.000003: decision, such as children, pregnant women, psychiatric patients, unconscious patients, and prisoners.
p.000003: These vulnerable people need to be protected from being forced to participate in a research involuntarily. In
p.000003: practice, a special treatment is needed for the protection of their benefits.
p.000003: 2.2.3 Respect for privacy and confidentiality. This principle is fundamental to the respect for human’s
p.000003: dignity found in various cultures, and it helps to protect the security of mind. Therefore, the standards applied
p.000003: for the respect for privacy and confidentiality help to protect the access to, retention of, and distribution of
p.000003: personal information.
p.000003:
p.000003: 2.3 Principle of Beneficence
p.000003: This principle covers the following aspects.
p.000003: 2.3.1 Balancing between risks and benefits; An analysis of risks and benefits being exposed to the subjects is a
p.000003: key ethical issue of research on human subjects. Research ethics for human subjects in modern times requires a
p.000003: balance between potential risks and benefits, with the desired goal being that the benefits must outweigh
p.000003: the risks and that the potential risks are acceptable for the subjects and received prior to review and
...
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
p.000009: conducting research studies in subjects with illegal careers, such as sex workers or illegal drug users.
p.000009: 3.4.10 In the case where a study is conducted on the vulnerable people without direct health benefit to them, the
...
p.000017: preventive effects of the drug.
p.000017: In general, an investigational drug used in clinical trial falls into one of four categories, namely:
p.000017: (1) new drugs; (2) unregistered drugs in Thailand (3) registered drugs by the national drug authority, but being
p.000017: studied in new doses or indications not previously approved; and (4) locally produced drugs which required efficacy
p.000017: testing.
p.000017:
p.000017: Phases of Clinical Drug Trials
p.000017: For new drugs, adequate evidence derived from animal studies must be available to ensure safety and determine toxicity
p.000017: levels prior to conducting a study in humans.
p.000017:
p.000017: A Clinical Drug Trail Can Be Classified in Four Phases.
p.000017:
p.000017: Phase I
p.000017: This is a first-in-human trial using a new chemical entity that is usually conducted in healthy volunteers to study
p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
p.000017: elderly, or women with childbearing potential. Anesthesia or anticancer drugs should not be used in the healthy
p.000017: volunteers as a result of its high toxicity. In general, the number of the subjects should not exceed 30
p.000017: subjects. Every subject should give written informed consent before participating in the study. The study in
p.000017: this phase is usually an open study without any control group, i.e., both subjects and investigators know
p.000017: the trial drug. Studies in phase I also involve two stages. Stage I studies employ a small dose, i.e., about 1/50 or
p.000017: 1/100 of the dose used successfully in the animal studies. When the results demonstrate safety, the second stage
p.000017: is then followed by gradually escalating the dose. Once the results are satisfactory, phase II studies are
p.000017: conducted.
p.000017: Phase I trials also include the studies done on the patients suffering from a specific disease with no hope from
p.000017: currently available treatments, such as studies in terminally ill cancer patients.
p.000017:
p.000017: Phase II
p.000017: Phase II studies are conducted on patients with the target treatment of the drug that was satisfactorily studied in
p.000017: Phase I. The primary objective of the trial in this phase is to study short- term pharmacological toxicity in
p.000017: details, while the secondary objective is about the drug’s preliminary efficacy. Anesthesia and
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: The Ethical Guidelines for Research on Human Subject in Thailand, 2007
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Forum for Ethical Review Committees in Thailand
p.000001:
p.000001:
p.000001: Editors
p.000001: Tada Sueblinwong Punkae Mahaisavariya Suthee Panichkul
p.000001:
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p.000001:
p.000001:
p.000001:
p.000001: Disclaimer!
p.000001: The material is prepared from prepublished manuscript. There is minor change of format. Although an effort has been
p.000001: made to verify the content with published version, reader may refer to published version when necessary.
p.000001:
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p.000001:
p.000001: 1
p.000001: CHAPTER 1
p.000001:
p.000001: DEVELOPMENT OF THE ETHICAL GUIDELINES FOR RESEARCH ON HUMAN SUBJECTS IN THAILAND
p.000001:
p.000001:
p.000001: 1.1 Introduction
p.000001: Nowadays, countries around the world, especially developed countries, have established human rights laws
p.000001: covering several aspects, including the law governing the conduct of research on humans or animals. Developed
p.000001: countries also have attempted to stipulate regulations and guidelines for research on human subjects, and
p.000001: promote the adoption of the regulations/guidelines in developing countries, such as guidelines for manufacturing
p.000001: of pharmaceuticals or patent application. Prior to being accepted for publication or granted a patent,
p.000001: or conduct a scientific research investigation involving human subjects, researchers are required to
p.000001: obtain ethical approval from a recognized ethics committee. In addition, seminars and conferences have been
p.000001: conducted on the ethical principles or guidelines for research in human subjects in both developing and developed
p.000001: countries; the outcomes of which have been several declarations. The most prominent and widely accepted and
p.000001: most commonly referred to is the Declaration of Helsinki of the World Medical Association (WMA), firstly adopted
...
p.000015:
p.000015: 6.7 Ethical Review of a Multi-center Trial
p.000015: 6.7.1 A multi-center trial may be referred to as a trial that is conducted in more than one institution or
p.000015: organization by a single or several investigators. It may also be defined as a trial conducted by a group of
p.000015: investigators from different institutions or from jointly collaborating organizations, and as a trial
p.000015: conducted by investigators who later change their original affiliated institution or organization to a new
p.000015: affiliation.
p.000015: 6.7.2 The multi-center protocols submitted to each institution or organization should contain the same details and
p.000015: meaning of the text, and should specify the quality control techniques of the research procedures to ensure that the
p.000015: practices are the same in each institution in order to obtain credible data.
p.000015: 6.7.3 The ethics committee in each institution or organization should be free to decide about the
p.000015: multi-center protocols, the outcome of which may not necessarily be the same as those of the committees in the other
p.000015: institutions. The research protocols should specify what part(s) of the protocol cannot be amended as it may affect
p.000015: the validity of the data and what part(s) can be modified by the committees as it does not affect the data as a whole.
p.000015: However, it is advised that the committee in each institution or organization consult with one another in case of
p.000015: any possible
p.000015:
p.000016: 16
p.000016: different opinions about the main principle so as to reach a clearly agreed upon decision. The investigator
p.000016: should amend the protocols’ minor details as suggested by the committee in his/her institution.
p.000016: 6.7.4. The ethics committee of each institution or organization may accept entirely the decision made by
p.000016: other institutions or organizations, or accept only the scientific aspect, but request minor amendment for
p.000016: the ethical aspect. This is to facilitate an efficient review and approval of the multi-center protocols.
p.000016: 6.7.5 The investigator should inform the ethics committee where the protocol has been submitted for ethical
p.000016: review as well as the review's outcome.
p.000016:
p.000016: 6.8 Monitoring of a Research
p.000016: 6.8.1 The institution or organization should appoint a committee independent of the ethics committee to monitor the
p.000016: progress of the research.
p.000016: 6.8.2 The purpose of the research monitoring committee is to ensure that the research complies with the
p.000016: proposed procedures specified in the protocol, and that the advice is given to the subject, as appropriate.
p.000016: 6.8.3 The research monitoring committee should establish its own criteria and mechanisms for monitoring the research
p.000016: protocol.
p.000016:
p.000016: 6.9 Termination or Suspension of Research
p.000016: 6.9.1 The ethics committee may withdraw or suspend its approval given to the research so as to protect the rights
p.000016: and welfare of the research participants. This includes when serious adverse effects are reported, or
p.000016: when the conduct of the research does not comply with the protocols approved by the committee.
p.000016: 6.9.2 In case of premature termination of any research protocols made by the investigator, the reasons for the
p.000016: termination must be reported to the ethics committee.
p.000016:
p.000017: 17
p.000017: CHAPTER 7
...
p.000020: items helps the ethics committee to evaluate any conflict of interest, and helps the investigator to decide whether to
p.000020: conduct the trial.
p.000020:
p.000020: 7.1.6 Placebo-Controlled Trial
p.000020: It is generally unacceptable to use a placebo in a control group in a trial where standard treatments or medically
p.000020: proven medicines are available, because patients will lose medical benefits entitled to from participating
p.000020: in the clinical trial. However, the use of a placebo in a control group may be allowed in the following cases.
p.000020: (1) no standard drug medically recognized for the treatment of the disease is available;
p.000020: (2) the available drug for the treatment yields uncertain outcomes;
p.000020: (3) the standard drug for the treatment is available, but it causes serious adverse drug reactions or adverse events
p.000020: that the subjects cannot tolerate;
p.000020: (4) the illness to be studied is managed by itself due to a placebo effect;
p.000020:
p.000021: 21
p.000021: (5) the disease to be studied is a minor condition and treating with a placebo causes the only discomfort or the
p.000021: illness is alleviated slowly or negligibly, and causes no serious or irreversible harm to the subjects;
p.000021: (6) compelling scientific and methodological reasons are necessary
p.000021: to use a placebo-controlled group in determining the effectiveness and the safety of a study drug.
p.000021: In addition to the focus on freely informed consent, the ethical consideration of a placebo-controlled trial should
p.000021: focus on an appropriate design to maximize benefits and minimize harm to patients.
p.000021:
p.000021: 7.1.7 Analysis and Distribution of Research Results
p.000021: In most clinical trials, the sponsor has rights as agreed upon for the analysis and interpretation of research results.
p.000021: However, the investigator and the ethics committee should ensure that:
p.000021: (1) The final analysis and interpretation of the research results will rest with the investigator to ensure that the
p.000021: results would be actually complete and accurate.
p.000021: (2) When the trial of Phase I, II and III is required to stop according to the rules, there must be an independent
p.000021: interim analysis. However, prior to
p.000021: implementing the termination rules, it should be identified that either positive
p.000021: or negative long-term effects of the drug may be obscured by either good or bad short term drug effects.
p.000021: (3) The main responsibility of the investigator is to circulate the research findings to the community of
p.000021: investigators. However, it is found that frequently the research results of several trials, in particular the negative
p.000021: results, are not published or distributed. Not only does the case create an inappropriate scientific conduct and
p.000021: produce no actual research results, but also the research results and the resources invested in the research become in
p.000021: vain.
p.000021:
p.000021:
p.000021: 7.2 EPIDEMIOLOGICAL RESEARCH
p.000021:
p.000021: Epidemiological research is an integral part of public health or health service research, which is necessary for the
p.000021: prevention of and the control of diseases or for improving the efficiency and the performance of a health care system.
p.000021: This leads to the improved health of the population. Certain epidemiological research may be required to study in a
p.000021: large population, and thus a multi- center study is needed.
p.000021: The epidemiological research is different from other types of research in that it involves the use and the keeping of
p.000021: medical information and the tissue samples of patients or populations. Then, an ethical consideration is needed
p.000021: for the use of the data or the tissues regardless of whether the data or the tissues would be stored for the
p.000021: purpose of the treatment.
p.000021:
p.000021: Types of Personal Information
p.000021: Epidemiological research involves the use of the following types of data.
p.000021: a. identified data, which are referred to as, for example, name, date of birth, or address, including such a minor
p.000021: details as a zip code that may be used as an identifier;
p.000021: b. potentially identifiable, coded, re-identifiable data, which are referred to as the data of the identifier, which
p.000021: has been removed and replaced by a new code that can re-identify the individuals. They are then regarded as
p.000021: “identifiable data.”
p.000021: c. de-identified, not re-identifiable, anonymous data, which are referred to as the data that have been permanently
p.000021: removed from their identifiers, and as a consequence, the data cannot identify any individuals if the existing
p.000021: identifiers are permanently destroyed or the data are collected without any identifiers.
p.000021:
p.000021: 7.2.1 It is required that all epidemiological research be reviewed by an ethics committee, based on international
p.000021: ethical guidelines. In the epidemiological study that needs to use identified or identifiable data, the individual
p.000021: informed
p.000021:
p.000022: 22
p.000022: consent from each subject for his/her participation should be obtained. The ethics committee should ensure that:
p.000022:
p.000022: (1) the research is conducted according to the applicable policy / laws / regulations related to the personal rights,
p.000022: the privacy, and the disclosure of information, etc.
p.000022: (2) searching for medical records or other records or patients’ reports for research purposes should be restricted to
p.000022: only the investigators knowledgeable in the relevant fields or to the attending physicians.
p.000022: However, research assistants may be allowed when many records are searched.
p.000022:
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000027: Although establishing a bank for collecting genetic materials is expected to be of benefit in the future, it may impose
p.000027: risks to individuals who are the owners of
p.000027: the genetic materials and their families. Therefore, the following guidelines are recommended.
p.000027: (1) The investigator involved the storage of the genetic materials in the bank should demonstrate to the ethics
p.000027: committee and to the subjects the operating procedures used for keeping confidentiality, privacy, and retention of the
p.000027: materials as well the data and the research results.
p.000027: (2) The duration of storing the genetics materials should be specified, including the operating procedures for the
p.000027: destruction of the materials upon completing the storage time.
p.000027: (3) The duration of storing the genetics materials should be specified,
p.000027: including the operating procedures for the destruction of the materials upon completing storage time. Uses of the
p.000027: materials for purposes other than those specified in the approved protocol should receive informed consent from the
p.000027: research participants or their heirs. Furthermore, their families are
p.000027: able to contact for the data or for the withdrawal from the research at anytime without any conditions.
p.000027:
p.000027: 7.6.7 Commercial use of genetic data
p.000027: The investigator must specify the commercial benefits that may be derived from the results or the data of the research
p.000027: using human genetics in research protocols to create further awareness in the ethics committee and the subjects.
p.000027:
p.000027:
p.000027: 7.7 RESEARCH ON HUMAN GAMETES, EMBRYO, EMBRYONIC STEM CELL, AND THE FETUS
p.000027:
p.000027: Research using advanced reproductive heath technology influence the practices of research ethics, researcher’s ethics,
p.000027: and people at large. The regulations issued by the Medical Council, by the advice of the Royal College of
p.000027: Obstetrics and Gynecology of Thailand, have already laid down the medical practice guidelines on the
p.000027: standards of services concerning reproduction technology. In addition, in conducting research involving human
p.000027: gametes, embryos, and the fetus, the risks imposed to the embryo or fetus, the informed consent, and the respect for
p.000027: the rights of the embryo and fetus should be considered. The following criteria are recommended.
p.000027:
p.000027: 7.7.1 Research involving human gametes
p.000027: (1) Obtaining the informed consent from the owners of the gametes is required in research using human gametes, which
p.000027: follows the principles and
p.000027: practices applied in other research involving human subjects.
p.000027: (2) The collection of the human gametes from a deceased person is not allowed, as the informed consent from the
p.000027: donor of the gametes cannot be obtained. Any research conducted using commercialized gametes, or
p.000027: inducing artificial cross-fertilization between the human gamete and an animal gamete, is considered unethical.
p.000027:
p.000027: 7.7.2 Research on human embryos and embryonic stem cells
p.000027: (1) The fertilization of human gamete results in an embryo, and it is unethical to create human embryos merely for
p.000027: research purposes. However, if the research is conducted for the benefit of reproductive health according to the
p.000027: principles and practices mentioned previously, it would be considered ethical.
p.000027: (2) Research on the alteration of human genes or the internal compositions of the human gametes or in the human embryo
p.000027: must not be conducted. When the
p.000027:
p.000028: 28
p.000028: research using an embryo is conducted, and no information about the future problem being likely to happen to the fetus
p.000028: is available, the embryo must not be
p.000028: implanted in the uterus to induce pregnancy. The experiment on the human embryo is allowed within the period of
p.000028: fourteen days after its fertilization.
p.000028: (3) A human cloning research for reproduction is not approved. Also, induced cross- fertilization between the
p.000028: human gamete and an animal gamete is unethical.
p.000028:
p.000028: 7.7.3 Research involving the intrauterine fetus
p.000028: Research designed for the diagnosis or treatment of the intrauterine fetus that suffers from genetic diseases or
p.000028: congenital anomaly could be conducted if the mother has given her consent after being thoroughly informed about the
p.000028: treatment in detail, since the diagnosis or treatment of the fetus cannot be done separately from that of the mother,
p.000028: and both need to be treated simultaneously.
p.000028:
p.000028: 7.7.4 Research involving the use of fetal tissues, placenta and its blood
p.000028: Research that uses fetal tissues must be conducted in accordance with the ethical principles as applied in other human
p.000028: experimentation. The fetus is a human, not merely tissues. Therefore, obtaining the informed consent from the
p.000028: parents, who are considered the legally acceptable representatives of the tissues, is required.
p.000028: The conduct of research using fetal tissues to generate stem cells must adhere to the practice guidelines established
...
p.000032: Given on the Thirtieth Day of April B.E. 2545.
p.000032:
p.000033: 33
p.000033: ANNEX 3
p.000033:
p.000033: THE MEDICAL COUNCIL’S ANNOUCEMENT NO. 21/2545
p.000033: ON THE STANDARDS OF SERVICES INVOLVING REPRODUCTION TECHNOLOGY (NO.2)
p.000033:
p.000033: As the Medical Council had issued the announcement no. 1/2540 dated 22 October B.E. 2540 on establishing the
p.000033: standards of services involving reproduction technology by medical practitioners, it is now time to additionally
p.000033: establish the standards of services to provide for more appropriate protection to service receivers.
p.000033: By virtue of Section 21(1) of the Medical Profession Act B.E. 2525 where the Act contains certain provisions that
p.000033: restrict the rights and freedom of individuals, however, Sections 29 and 50 of the Constitution of the Kingdom of
p.000033: Thailand allow for the act according to the provisions of the Act. The Medical Council then reached its resolution
p.000033: at the 10/2545 meeting dated 11 October
p.000033: B.E. 2545 to issue the announcement as follows.
p.000033: 1. The following statements shall be added as no. 4/1 and no. 4/2 of the Medical Council’s Announcement No.
p.000033: 1/2540 on Standards of Services involving Reproduction Technology dated 22 October 2540 as follows.
p.000033: “No. 4/1 The services involving reproduction technology shall not be conducted in a way of human cloning for
p.000033: reproduction.
p.000033: No. 4/2 Medical practitioners who are responsible for the services according to (3), or are the providers of the
p.000033: services involving the reproduction technology shall maintain the standard of services that involve the
p.000033: donation of male or female gametes or an embryo to be employed in a reproductive process as follows.
p.000033: (1) In the case a married couple would like to have a baby by having the wife to carry out pregnancy, the medical
p.000033: practitioner may provide the services
p.000033: (a) using the donor's gamete for fertilization either in vivo or in vitro;
p.000033: (b) requesting for donation of an embryo for pregnancy
p.000033: (2) In the case a married couple who wishes to have a baby by having another woman who is not the
p.000033: wife to carry out the pregnancy instead, the medical practitioner shall provide for the services by using only
p.000033: the embryo derived from the fertilization of the gametes of the married couple.
p.000033: (3) Providing the services in (1) and (2) shall adhere to the following conditions.
p.000033: (a) no payment is given to the donor of the gamete in a manner that can be mistaken as selling-buying;
p.000033: (b) no payment is given to the other woman who carries out the pregnancy instead that may be misunderstood as hired
p.000033: pregnancy;
p.000033: (c) the woman who carries out the pregnancy instead must be a biological relative of the couple either the husband or
p.000033: the wife;
p.000033: (d) Pre-implantation genetic diagnosis of an embryo shall be conducted only for diagnosis purposes, as necessary
p.000033: and as appropriate. Such a conduct shall not be made in a way that may be understood as gender selection, and a
p.000033: written informed consent shall be obtained according to the form attached to this regulation.
p.000033: (4) For any services other than the standards established in (1), (2), and (3), the medical practitioners who are
p.000033: responsible for, or are the service providers shall obtain an approval from the Royal College of Obstetrics
p.000033: and Gynecology of Thailand prior to providing all the services."
p.000033:
p.000034: 34
p.000034: 2. This announcement shall come into force since the date next to the publication date in the Royal Gazette.
p.000034:
p.000034: It is hereby announced.
p.000034: Given on the Twentieth Day of June B.E. 2545.
p.000034:
p.000035: 35
p.000035:
p.000035: ANNEX 4
p.000035:
p.000035: THE ETHICAL GUIDELINES FOR RESEARCHERS,
p.000035: THE OFFICE OF NATIONAL RESEARCH COUNCIL OF THAILAND
p.000035:
p.000035: The Office of National Research Council of Thailand has established the following ethical guidelines for researchers.
p.000035:
p.000035: 1. Researchers must be honest and hold moral responsibility in both science and management.
p.000035:
p.000035: 2. Researchers must be aware of the obligation for the conduct of research as agreed with a sponsoring agency and
p.000035: their affiliated institution.
p.000035:
p.000035: 3. Researchers must be knowledgeable in the field of their research.
p.000035:
p.000035: 4. Researchers must be responsible for the subjects used in studies, either living or non-living things.
p.000035:
...
Social / employees
Searching for indicator employees:
(return to top)
p.000051: any and all publications and patent applications based on or relating to the MATERIAL, replicas, or
p.000051: derivatives there of and any research thereon.
p.000051: 9. The RECIPIENT acknowledges that the MATERIAL is or may be the subject of a patent application.
p.000051: Except provided in this agreement, no expressed or implied licenses or other rights are provided to the RECIPIENT under
p.000051: any patents, patent applications, trade secrets or other proprietary rights of ....[2]….., including any altered forms
p.000051: of the MATERIAL made by ....[2]…...
p.000051: In particular, no expressed or implied licenses or other rights are provided to use the MATERIAL,
p.000051: modifications, or any related patents of the MATERIAL for commercial purposes.
p.000051: 10. If the RECIPIENT desires to use or license the MATERIAL or Modifications for commercial purposes.
p.000051: ....[2]….. AGREES, IN ADVANCE OF SUCH USE, TO NEGOTIATE IN GOOD FAITH WITH RECIPIENT TO ESTABLISH THE TERMS
p.000051: OF A COMMERCIAL LICENSE.
p.000051: 11. The RECIPIENT will use the MATERIAL in compliance with all his/her national and
p.000051: international laws and regulations, including Pathogens and Animal Toxins Act B.E.2525 as amended by
p.000051: Pathogens and Animal Toxins Act (No.2) B.E. 2544. The MATERIAL is experimental in nature and it is
p.000051: provided by ....[2] without warranty of any sort, expressed or
p.000051: implied. ....[2]….. makes no representation the use of the MATERIAL will not infringe any patent or
p.000051: other proprietary right. The RECIPIENT will indemnify ....[2]….. and its employees and hold ....[2] and
p.000051: its employees from any claims or liabilities which may arise as a result of
p.000051: the use of the MATERIAL by the RECIPIENT.
p.000051: 12. The MATERIAL is provided at no cost; however, fee is requested solely for its preparation and distribution cost.
p.000051: The amount shall be indicated in Attachment A
p.000051: 13. The RECIPIENT shall promptly return or destroy all information and the MATERIAL upon demand therefore
p.000051: by ....[2]…...
p.000051: 14. The agreement shall be effective on the date of last signing below, apply to all information and the MATERIAL
p.000051: received from ....[2]….. and terminate on completion of the RECIPIENT’ s current research with the
p.000051: MATERIAL (within……..years after the effective date) unless the parties agree in writing to extend the agreement
p.000051: 15. ....[2]….. and the RECIPIENT shall use their best efforts to settle in a fair and reasonable manner
p.000051: any disputes arising in connection with this Agreement. If such dispute cannot be settled by the parties
p.000051: between themselves, it shall be first submitted to mediation by a mediator chosen jointly by the parties.
p.000051: In the event that mediation does not bring a resolution of the dispute within 30 days, the dispute shall be
p.000051: submitted to arbitration before a single arbitrator pursuant to the Arbitration Rule of Thailand. Any such
p.000051: arbitration will be subject to such rules.
p.000051:
p.000051:
p.000051: Signed for and on behalf of the RECIPIENT Signed for and on behalf of the ....[2]…..
p.000051:
p.000051: Name………………………………… Name………………………………….
p.000051: (…………………………..…..) (.............................................)
...
Social / gender
Searching for indicator gender:
(return to top)
p.000033: (1) In the case a married couple would like to have a baby by having the wife to carry out pregnancy, the medical
p.000033: practitioner may provide the services
p.000033: (a) using the donor's gamete for fertilization either in vivo or in vitro;
p.000033: (b) requesting for donation of an embryo for pregnancy
p.000033: (2) In the case a married couple who wishes to have a baby by having another woman who is not the
p.000033: wife to carry out the pregnancy instead, the medical practitioner shall provide for the services by using only
p.000033: the embryo derived from the fertilization of the gametes of the married couple.
p.000033: (3) Providing the services in (1) and (2) shall adhere to the following conditions.
p.000033: (a) no payment is given to the donor of the gamete in a manner that can be mistaken as selling-buying;
p.000033: (b) no payment is given to the other woman who carries out the pregnancy instead that may be misunderstood as hired
p.000033: pregnancy;
p.000033: (c) the woman who carries out the pregnancy instead must be a biological relative of the couple either the husband or
p.000033: the wife;
p.000033: (d) Pre-implantation genetic diagnosis of an embryo shall be conducted only for diagnosis purposes, as necessary
p.000033: and as appropriate. Such a conduct shall not be made in a way that may be understood as gender selection, and a
p.000033: written informed consent shall be obtained according to the form attached to this regulation.
p.000033: (4) For any services other than the standards established in (1), (2), and (3), the medical practitioners who are
p.000033: responsible for, or are the service providers shall obtain an approval from the Royal College of Obstetrics
p.000033: and Gynecology of Thailand prior to providing all the services."
p.000033:
p.000034: 34
p.000034: 2. This announcement shall come into force since the date next to the publication date in the Royal Gazette.
p.000034:
p.000034: It is hereby announced.
p.000034: Given on the Twentieth Day of June B.E. 2545.
p.000034:
p.000035: 35
p.000035:
p.000035: ANNEX 4
p.000035:
p.000035: THE ETHICAL GUIDELINES FOR RESEARCHERS,
p.000035: THE OFFICE OF NATIONAL RESEARCH COUNCIL OF THAILAND
p.000035:
p.000035: The Office of National Research Council of Thailand has established the following ethical guidelines for researchers.
p.000035:
p.000035: 1. Researchers must be honest and hold moral responsibility in both science and management.
p.000035:
p.000035: 2. Researchers must be aware of the obligation for the conduct of research as agreed with a sponsoring agency and
p.000035: their affiliated institution.
p.000035:
p.000035: 3. Researchers must be knowledgeable in the field of their research.
p.000035:
p.000035: 4. Researchers must be responsible for the subjects used in studies, either living or non-living things.
p.000035:
p.000035: 5. Researchers must pay respect to the dignity and rights of human subjects participating in a research.
p.000035:
p.000035: 6. Researchers must hold freedom of thought without any bias throughout all stages of research.
p.000035:
p.000035: 7. Researchers should utilize their research results in an appropriate manner.
...
Social / parents
Searching for indicator parents:
(return to top)
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
p.000009: conducting research studies in subjects with illegal careers, such as sex workers or illegal drug users.
p.000009: 3.4.10 In the case where a study is conducted on the vulnerable people without direct health benefit to them, the
p.000009: possible risks should not be greater than the minimal risk normally found in a general physical or psychiatric
p.000009: examination, or unless the research ethics committee allows for a greater-than-minimal risk.
p.000009:
p.000010: 10
p.000010: CHAPTER 4
p.000010:
p.000010: CONDUCTING RESEARCH ACCORDING TO THE PRINCIPLE OF BENEFICENCE
p.000010:
p.000010: 4.1 Nature and Scope of Risks and Benefits
...
p.000028: is available, the embryo must not be
p.000028: implanted in the uterus to induce pregnancy. The experiment on the human embryo is allowed within the period of
p.000028: fourteen days after its fertilization.
p.000028: (3) A human cloning research for reproduction is not approved. Also, induced cross- fertilization between the
p.000028: human gamete and an animal gamete is unethical.
p.000028:
p.000028: 7.7.3 Research involving the intrauterine fetus
p.000028: Research designed for the diagnosis or treatment of the intrauterine fetus that suffers from genetic diseases or
p.000028: congenital anomaly could be conducted if the mother has given her consent after being thoroughly informed about the
p.000028: treatment in detail, since the diagnosis or treatment of the fetus cannot be done separately from that of the mother,
p.000028: and both need to be treated simultaneously.
p.000028:
p.000028: 7.7.4 Research involving the use of fetal tissues, placenta and its blood
p.000028: Research that uses fetal tissues must be conducted in accordance with the ethical principles as applied in other human
p.000028: experimentation. The fetus is a human, not merely tissues. Therefore, obtaining the informed consent from the
p.000028: parents, who are considered the legally acceptable representatives of the tissues, is required.
p.000028: The conduct of research using fetal tissues to generate stem cells must adhere to the practice guidelines established
p.000028: in the Medical Council’s Regulation on the Preservation of the Ethics of Medical Profession (NO. 6) B.E. 2545, Section
p.000028: 9 on the Medical Practice of Blood Stem Cell Transplantation from Donors.
p.000028:
p.000029: 29
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: ANNEXES
p.000029:
p.000030: 30
p.000030: ANNEX 1
p.000030:
p.000030: THE MEDICAL COUNCIL'S REGULATION
p.000030: ON RESEARCH STUDIES AND EXPERIMENTS IN HUMAN SUBJECTS
p.000030: B.E. 2525
p.000030:
p.000030: 1. “Research study and experiment in human subjects” refers to a research study and an experiment using a
p.000030: pharmaceutical product or medical devices, or a study of a natural course of a disease, or the diagnosis,
p.000030: treatment, health promotion, and prevention of a disease which is conducted in human subjects. This also includes a
p.000030: research study conducted using the information from medical records and any specimens taken from the human body.
p.000030:
p.000030: “Ethics Committee” refers to a committee or board appointed by an institution, organization, or agency,
p.000030: which is responsible for conducting an ethical review of researches and experiments in human subjects. This is to
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000008: patient's confidentiality must be strictly protected.
p.000008: (3) The investigator is allowed to use the data from the patient's medical records only as specified in the research
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
p.000008: reached, may cause risks to community, society, races or minors such as stigmatization, injustice or discrimination..
p.000008: An example is research results showing that certain groups of people may be subjected to alcoholism at a greater
p.000008: rate. The investigator must take steps to protect the confidentiality of these groups of people both during study and
p.000008: at the end of the study, including all related published articles. The ethics committee should review the impacts that
p.000008: may happen to groups of people, especially in a research study about ethinic and racial groups. Individual informed
p.000008: consent as well as community permission should be obtained.
p.000008:
p.000008: 3.4 Research Studies in Vulnerable Subjects
p.000008: Vulnerable groups of people are those who need to depend on others, and are unable to express their opinion freely or
p.000008: to make their own decisions. These include hospitalized patients, prisoners, children, the mentally impaired,
p.000008: critically ill patients, psychotic patients, pregnant women, and the economically disadvantaged. They are
p.000008: easily taken advantage of. As a consequence, the protection of vulnerable groups of people is of prime
p.000008: importance. Investigators should not select these groups of people simply because of easy management or convenience for
p.000008:
p.000009: 9
p.000009: the conduct of a research study due to their economic or health constraints. However, if a valid need exists to
p.000009: conduct a study on these people, some recommendations should be followed.
p.000009:
p.000009: 3.4.1 An irrefutable rationale for conducting research in these population groups should be clearly explained in the
p.000009: protocols.
p.000009: 3.4.2 Precautions against possible physical and mental harm should be exercised especially when the study
p.000009: is conducted on children.
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
...
p.000014: current international ethical guidelines taking into account local or national laws, religions, traditions, and
p.000014: cultures.
p.000014: 6.4.2 The institution or organization and the ethics committee should establish the regulations or
p.000014: operating guidelines for committee meetings, such as the frequency of the meetings, announced dates of the meetings,
p.000014: timeframe for protocol review, quorum requirements, decision- making procedures, channels of communicating the
p.000014: decision, complaint process, reviewing fee (if any), protection of confidentiality of the protocols, and prevention of
p.000014: possible conflicts of interests.
p.000014: 6.4.3 In case the ethics committee cannot reach a definite decision on any scientific aspects, the
p.000014: committee may seek for other expert's opinions. However, it must ensure that the experts have no conflicts
p.000014: of interest with the research protocols, and that the experts can maintain the confidentiality of the protocols.
p.000014: Otherwise, the ethics committee may forward the protocols to a scientific committee or an epidemiology committee or to
p.000014: other committees within the institution or organization, asking for their opinions before conducting the ethical
p.000014: review.
p.000014: 6.4.4. The ethics committee may communicate its decision upon the protocol review to the investigators in four
p.000014: categories namely:
p.000014: (1) approval/favorable opinion;
p.000014: (2) approval after the investigator amends or modifies the protocol or clarifies points according to the committee's
p.000014: suggestions;
p.000014:
p.000015: 15
p.000015: (3) the investigator needs to amend the protocol as suggested by the committee and resubmits it for the
p.000015: next review meeting, or the review is postponed for temporarily;
p.000015: (4) disapproval/negative opinion.
p.000015: The ethics committee is required to provide an explanation for its disapproval decisions so that the investigator can
p.000015: clarify and request the committee to review its decision.
p.000015: 6.4.5. The ethics committee should establish a system along with procedures for an expedited review of the
p.000015: research protocols that imposes a minimal risk, or of protocol amendment with no additional risk. The committee
p.000015: should also establish the criteria for what research protocols could fit the expedited review.
p.000015: 6.4.6 The ethics committee should determine the types of protocols that can be conducted with no ethical review
p.000015: submission.
p.000015: 6.4.7 The ethics committee should establish the conditions whereby the informed consent discussion and/or signing a
p.000015: consent form can be waived.
p.000015: 6.4.8 The ethics committee should implement an efficient system for recording minutes and archiving to allow for an
p.000015: audit upon request and receive prior permission from the head of the institution or organization or
p.000015: from a competent authority. The duration for document storage should be in accordance with the applicable
p.000015: regulatory requirements mutatis mutandis, but at least for three years.
p.000015:
...
p.000037: ICH region or until at least two years have elapsed since the formal discontinuation of clinical development of the
p.000037: investigational
p.000037:
p.000038: 38
p.000038: product. These documents should be retained for a longer period however if required by the applicable regulatory
p.000038: requirement(s) or if needed by the sponsor.
p.000038: 5.12 The sponsor should inform the investigator(s)/institution(s) in writing of the need for record retention and
p.000038: should notify the investigator(s)/institution(s) in writing when the trial related records are no longer needed.
p.000038:
p.000038: 6. Investigator Selection
p.000038: 6.1 The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator
p.000038: should be qualified by training and experience and should have adequate resources (see 4.1, 4.2) to properly
p.000038: conduct the trial for which the investigator is selected. If organization of a coordinating committee and/or selection
p.000038: of coordinating investigator(s) are to be utilized in multi-centre trials, their organization and/or selection
p.000038: are the sponsor's responsibility.
p.000038: 6.2 Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should
p.000038: provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator's Brochure, and should
p.000038: provide sufficient time for the investigator/institution to review the protocol and the information provided.
p.000038: 6.3 The sponsor should obtain the investigator's/institution's agreement:
p.000038: (a) to conduct the trial in compliance with GCP, with the applicable regulatory requirement(s) (see 4.1.3),
p.000038: and with the protocol agreed to by the sponsor and given approval/favorable opinion by the IRB/IEC (see 4.5.1);
p.000038: (b) to comply with procedures for data recording/reporting;
p.000038: (c) to permit monitoring, auditing and inspection (see 4.1.4) and
p.000038: (d) to retain the trial related essential documents until the sponsor informs the investigator/institution
p.000038: these documents are no longer needed (see 4.9.4 and 5.5.12).
p.000038: The sponsor and the investigator/institution should sign the protocols, or an alternative document, to
p.000038: confirm this agreement.
p.000038:
p.000038: 7. Allocation of Responsibilities
p.000038: Prior to initiating a trial, the sponsor should define, establish, and allocate all trial-related duties and
p.000038: functions.
p.000038:
p.000038: 8. Compensation to Subjects and Investigators
p.000038: 8.1 If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should
p.000038: indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial,
p.000038: except for claims that arise from malpractice and/or negligence.
p.000038: 8.2 The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event
p.000038: of trial-related injuries in accordance with the applicable regulatory requirement(s).
p.000038: 8.3 When trial subjects receive compensation, the method and manner of compensation should comply with
p.000038: applicable regulatory requirement(s).
p.000038:
p.000038: 9. Financing
p.000038: The financial aspects of the trial should be documented in an agreement between the sponsor and the
p.000038: investigator/institution.
p.000038:
p.000038: 10. Notification/Submission to Regulatory Authority(ies)
p.000038: Before initiating the clinical trial(s), the sponsor (or the sponsor and the investigator, if required by
p.000038: the applicable regulatory requirement(s)) should submit any required application(s) to
p.000038:
p.000039: 39
p.000039: the appropriate authority(ies) for review, acceptance, and/or permission (as required by the applicable
p.000039: regulatory requirement(s)) to begin the trial(s). Any notification/submission should be dated and contain
p.000039: sufficient information to identify the protocol.
p.000039:
p.000039: 11. Confirmation of Review by IRB/IEC
p.000039: 11.1 The sponsor should obtain from the investigator/institution:
p.000039: (a) The name and address of the investigator's/institution’s IRB/IEC.
p.000039: (b) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws
p.000039: and regulations.
p.000039: (c) Documented IRB/IEC approval/favorable opinion and, if requested by the sponsor, a current copy of the protocols,
p.000039: written informed consent form(s) and any other written information to be provided to subjects, subject recruiting
p.000039: procedures, and documents related to payments and compensation available to the subjects, and any other
p.000039: documents that the IRB/IEC may have requested.
p.000039: 11.2 If the IRB/IEC conditions its approval/favorable opinion upon change(s) in any aspect of the trial, such as
p.000039: modification(s) of the protocol, written informed consent form and any other written information to be provided to
p.000039: subjects, and/or other procedures, the sponsor should obtain from the investigator/institution a copy of the
p.000039: modification(s) made and the date approval/favorable opinion was given by the IRB/IEC.
p.000039: 11.3 The sponsor should obtain from the investigator/institution documentation and dates of any IRB/IEC
p.000039: re-approvals/re-evaluations with favorable opinion, and of any withdrawals or suspensions of approval/favorable
p.000039: opinion.
p.000039:
p.000039: 12. Information on Investigational Product(s)
p.000039: 12.1 When planning trials, the sponsor should ensure that sufficient safety and efficacy data from
p.000039: non-clinical studies and/or clinical trials are available to support human exposure by the route, at the dosages, for
p.000039: the duration, and in the trial population to be studied.
p.000039: 12.2 The sponsor should update the Investigator's Brochure as significant new information becomes available (see 7.
p.000039: Investigator's Brochure).
p.000039:
p.000039: 13. Manufacturing, Packaging, Labeling, and Coding Investigational Product(s)
p.000039: 13.1 The sponsor should ensure that the investigational product(s) (including active comparator(s) and
p.000039: placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is
p.000039: manufactured in accordance with any applicable GMP, and is coded and labeled in a manner that protects the blinding, if
p.000039: applicable. In addition, the labeling should comply with applicable regulatory requirement(s).
p.000039: 13.2 The sponsor should determine, the investigational product(s), acceptable storage temperatures, storage
p.000039: conditions (e.g. protection from light), storage times, reconstitution fluids and procedures, and devices for
p.000039: product infusion, if any. The sponsor should inform all involved parties (e.g. monitors, investigators, pharmacists,
p.000039: storage managers) of these determinations.
p.000039: 13.3 The investigational product(s) should be packaged to prevent contamination and unacceptable
p.000039: deterioration during transport and storage.
p.000039: 13.4 In blinded trials, the coding system for the investigational product(s) should include a mechanism that
p.000039: permits rapid identification of the product(s) in case of a medical emergency, but does not permit
p.000039: undetectable breaks of the blinding.
p.000039: 13.5 If significant formulation changes are made in the investigational or comparative product(s) during the
p.000039: course of clinical development, the results of any additional studies of the formulated product(s) (e.g. stability,
p.000039: dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the
p.000039: pharmacokinetic profile of the product
p.000039:
p.000040: 40
p.000040: should be available prior to the use of the new formulation in clinical trials.
p.000040:
p.000040: 14. Supplying and Handling Investigational Product(s)
p.000040: 14.1 The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational
p.000040: product(s).
p.000040: 14.2 The sponsor should not supply an investigator/institution with the investigational product(s) until
p.000040: the sponsor obtains all required documentation (e.g. approval/favorable opinion from IRB/IEC and regulatory
p.000040: authority(ies)).
p.000040: 14.3 The sponsor should ensure that written procedures include instructions that the
p.000040: investigator/institution should follow the handling and storage of investigational product(s) for the trial and
p.000040: documentation thereof. The procedures should address adequate and safe receipt, handling, storage, dispensing,
p.000040: retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor (or
p.000040: alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s)).
p.000040: 14.4 The sponsor should:
p.000040: (a) Ensure timely delivery of investigational product(s) to the investigator(s).
p.000040: (b) Maintain records that document shipment, receipt, disposition, return, and destruction of the
p.000040: investigational product(s) (see 8. Essential Documents for the Conduct of a Clinical Trial).
p.000040: (c) Maintain a system for retrieving investigational products and documenting this retrieval (e.g. for
p.000040: deficient product recall, reclaim after trial completion, expired product reclaim).
p.000040: (d) Maintain a system for the disposition of unused investigational product(s) and for the documentation of this
p.000040: disposition.
p.000040: 14.5 The sponsor should:
p.000040: (a) Take steps to ensure that the investigational product(s) are stable over the period of use.
p.000040: (b) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm
p.000040: specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the
p.000040: extent stability permits, samples should be retained either until the analyses of the trial data are complete or
p.000040: as required by the applicable regulatory requirement(s), whichever represents the longer retention period.
p.000040:
p.000040: 15. Record Access
p.000040: 15.1 The sponsor should ensure that it is specified in the protocol or other written agreement that
p.000040: the investigator(s)/institution(s) provide direct access to source data/documents for
p.000040: trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.
p.000040: 15.2 The sponsor should verify that each subject has consented, in writing, to direct access to his/her original
p.000040: medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection.
p.000040:
p.000040: 16. Safety Information
p.000040: 16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
p.000040: 16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies)
p.000040: of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's
p.000040: approval/favorable opinion to continue the trial.
p.000040:
p.000041: 41
p.000041: 17. Adverse Drug Reaction Reporting
p.000041: 17.1 The sponsor should expedite the reporting to all concerned
p.000041: investigator(s)/institutions(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of
p.000041: all adverse drug reactions (ADRs) that are both serious and unexpected.
p.000041: 17.2 Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for
p.000041: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
p.000041: 17.3 The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as
p.000041: required by applicable regulatory requirement(s).
p.000041:
p.000041: 18. Monitoring
p.000041: 18.1 Purpose
p.000041: The purposes of trial monitoring are to verify that:
p.000041: (a) The rights and well-being of human subjects are protected.
p.000041: (b) The reported trial data are accurate, complete, and verifiable from source documents.
p.000041: (c) The conduct of the trial is in compliance with the currently approved
p.000041: protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
p.000041:
p.000041: 18.2 Selection and Qualifications of Monitors
p.000041: (a) Monitors should be appointed by the sponsor.
p.000041: (b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge
...
p.000044:
p.000044: 21. Premature Termination or Suspension of a Trial
p.000044: If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions,
p.000044: and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension.
p.000044: The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or
p.000044: suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory
p.000044: requirement(s).
p.000044:
p.000044: 22. Clinical Trial/Study Reports
p.000044: Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are
p.000044: prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s). The
p.000044: sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the
p.000044: ICH Guideline for Structure and Content of Clinical Study Reports. (NOTE: The ICH Guideline for Structure
p.000044: and Content of Clinical Study Reports specifies that abbreviated study reports may be acceptable in certain cases.)
p.000044:
p.000044: 23. Multi-centre Trials
p.000044: For multi-centre trials, the sponsor should ensure that:
p.000044: 23.1 All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if
p.000044: required, by the regulatory authority(ies), and given approval/favorable opinion by the IRB/IEC.
p.000044: 23.2 The CRFs are designed to capture the required data at all multi-centre trial sites. For those investigators who
p.000044: are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional
p.000044: data.
p.000044: 23.3 The responsibilities of coordinating investigator(s) and the other participating investigators
p.000044: are documented prior to the start of the trial.
p.000044: 23.4 All investigators are given instructions on following the protocol, on complying with a uniform set of
p.000044: standards for the assessment of clinical and laboratory findings, and on completing the CRFs.
p.000044: 23.5 Communication between investigators is facilitated.
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045: ANNEX 6
p.000045: CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)2
p.000045:
p.000045: The contents of a trial protocol should generally include the following topics. However, site specific information
p.000045: may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the
p.000045: information listed below may be contained in other protocol referenced documents, such as an Investigator’s
p.000045: Brochure.
p.000045:
p.000045: 1. General Information
p.000045: 1.1 Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment
p.000045: number(s) and date(s).
p.000045: 1.2 Name and address of the sponsor and monitor (if other than the sponsor).
p.000045: 1.3 Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the
p.000045: sponsor.
p.000045: 1.4 Name, title, address, and telephone number(s) of the sponsor's medical expert (or dentist when
p.000045: appropriate) for the trial.
...
Social / sex worker
Searching for indicator sex workers:
(return to top)
p.000009: 3.4.3 The research procedures used in the study should be appropriate for the specific groups of these people.
p.000009: 3.4.4 In a study involving pregnant women, adequate information on the safety and impacts to the fetus
p.000009: should beprovided.
p.000009: 3.4.5 In a study involving minors, psychiatric patients, or the incompetent, the informed consent should be
p.000009: obtained from their parents, or guardians or legal representatives.
p.000009: 3.4.6 It should be ensured that parents, guardians, or legally acceptable representatives
p.000009: are fully informed about the study.
p.000009: 3.4.7 The rights of the minors and the economically disadvantaged should be respected for making
p.000009: their voluntary decisions.
p.000009: 3.4.8 It should be shown that the research participants have freedom in voluntarily participating in
p.000009: a research study, including for example a research study conducted on prisoners, inmates, and refugees.
p.000009: 3.4.9 Precautions against harm and protection of confidentiality should be strictly exercised when
p.000009: conducting research studies in subjects with illegal careers, such as sex workers or illegal drug users.
p.000009: 3.4.10 In the case where a study is conducted on the vulnerable people without direct health benefit to them, the
p.000009: possible risks should not be greater than the minimal risk normally found in a general physical or psychiatric
p.000009: examination, or unless the research ethics committee allows for a greater-than-minimal risk.
p.000009:
p.000010: 10
p.000010: CHAPTER 4
p.000010:
p.000010: CONDUCTING RESEARCH ACCORDING TO THE PRINCIPLE OF BENEFICENCE
p.000010:
p.000010: 4.1 Nature and Scope of Risks and Benefits
p.000010: The principle of beneficence requires that a research study be justified to conduct on humans by an
p.000010: assessment of a favorable risk and benefit ratio. In the context of research involving human subjects, the term "risk"
p.000010: means the possibility to receive harm, whereas the term "benefit" denotes that which gives a positive value to health
p.000010: or well being.
p.000010: Please note that benefits do not indicate an opportunity or possibility. By this definition, a benefit is then
p.000010: opposite to a harm. An assessment of a risk and benefit ratio requires the consideration of both
...
Economic / Economic/Poverty
Searching for indicator social status:
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p.000025: patient’s disease, the physician should make the best attempt to maintain the confidentiality of the patient. When
p.000025: research
p.000025: is conducted using stored tissue samples, searching for the patients or the patients’ information should be done as
p.000025: little as possible and only as necessary for achieving the research objectives only.
p.000025: (3) If the results of the research may affect the health of patients, the ethics committee may require the
p.000025: investigator to search for the patients and contact them for treatment or follow-up;
p.000025: (4) Under certain situations, the ethics committee may agree for the waiver of the informed consent from the tissue
p.000025: owners in using the stored tissue samples for the research by taking into considerations:
p.000025: a. the modes of obtaining the tissue samples (e.g., from pathology storage, blood bank);
p.000025: b. the scope and content of the informed consent given previously by the owner of the samples (if any);
p.000025: c. the reasons behind the waiver of the informed consent by the investigator, including difficulty of obtaining the
p.000025: informed consent;
p.000025: d. the possibility that the process of obtaining the informed consent may violate the privacy of the owners of the
p.000025: tissues, or cause damages to the physical and/or mental health of the donor or to the donor's social status;
p.000025: e. the proposal to protect the privacy and confidentiality of the tissue owners;
p.000025: f. the risk that may happen is a minimal risk;
p.000025: g. the relationship between the previously approved protocols and the new protocols;
p.000025: h. the potential commercial benefits or intellectual property;
p.000025: i. the regulatory requirements.
p.000025: (5) A material transfer agreement should be made in case the tissue samples are transferred to other institutions to
p.000025: ensure the consistency with the principle of respect for persons.
p.000025:
p.000025:
p.000025: 7.6 HUMAN GENETIC RESEARCH
p.000025:
p.000025: Human genetic research is the study of genes and their interactions with the surrounding factors that
p.000025: affect the health of individuals and populations. Not only does the research enlarge the body of knowledge
p.000025: that impacts the individual's health, but it may also affects the health of the individuals and their families in the
p.000025: future, which paves the way for protection from genetic diseases.
p.000025: Regarding the ethics in human genetic research, some additional elements are needed to be considered apart from those
p.000025: applied for other research involving human subjects because of the specific nature of this type of research. For
p.000025: example, the co-operation of the subjects and their families is very much needed for genetic research, and the data or
...
General/Other / Dependent
Searching for indicator dependent:
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p.000004: with a fair and independent review of research protocols is required. Also, justice requires the distribute of both
p.000004: the burdens and the benefits of a research equally, which leads to the consideration that research should not be
p.000004: performed simply to gain scientific progress in vulnerable people who cannot protect their rights and benefits, as has
p.000004: been witnessed in several cases in the past. In addition, the subjects participating in a research study should be
p.000004: entitled to any direct benefits from the research. Justice is then reflected by not neglecting or discriminating
p.000004: against people or groups of people that may benefit from the progress of research.
p.000004:
p.000005: 5
p.000005: CHAPTER 3
p.000005:
p.000005: CONDUCTING RESEARCH ACCORDING TO THE PRINCIPLE OF RESPECT FOR PERSONS
p.000005:
p.000005:
p.000005: 3.1 Informed Consent Process
p.000005: Conducting a research in conformity with international standards requires correct and appropriate informed
p.000005: consent and invitation to be given to subjects. The process is not to force the subjects to participate in the
p.000005: research directly or indirectly without giving them a chance to be informed about the research procedures
p.000005: or without giving any opportunity to make their own decision. Examples are that patients have a
p.000005: dependent relationship with physicians, or that physicians conduct experiments in patients using one or
p.000005: more medicines or new unproven treatment without informing the patients, or that payment or compensation in either
p.000005: money or gifts or the promise to give something beyond necessity is given, or that the instructions or explanation
p.000005: about research procedures are given in a technical language too difficult for the subjects to understand.
p.000005: In providing information or invitation to potential subjects to participate in a research, it is important to
p.000005: always adhere to the three ethical principles, i.e., respect for persons, beneficence, and justice.
p.000005: In providing the information or invitation for decision making, the investigator may separate the documents into two
p.000005: parts, i.e., the information sheet explaining research procedures, risks, benefits, what the subjects should
p.000005: be aware of in making their decision, and the informed consent form. The two parts can be combined into one, but it
p.000005: should cover the details of both parts. The language used should be suitable for lay persons to understand and cover
p.000005: medical information as appropriate, including legal and financial aspects of the study. The informed consent is not
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
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p.000003: Third, justice
p.000003:
p.000003: 2.2 Principle of Respect for Person
p.000003:
p.000003: The principle covers the following aspects.
p.000003: 2.2.1 Respect for human dignity. This aspect is the heart of research ethics, which provides for the protection
p.000003: of diverse interests relevant to the body, mind, and cultural security of a person. This is the foundation of
p.000003: the other following principles. Respect for freely given informed consent. This means the subject needs to be
p.000003: fully informed of all aspects of the research without hidden or biased information using an
p.000003: easy-to-understand language for the subjects. The information should cover the details of the procedures,
p.000003: rights, obligations, requirement for informed consent and the freedom of decision making. Also, the subjects have the
p.000003: rights to withdraw their consent any time without giving any reason. In practice, the informed consent may appear in a
p.000003: form of conversation.
p.000003: 2.2.2 Respect for vulnerable persons. Respect for human dignity leads to an ethical requirement for vulnerable
p.000003: people who have inferior or lack physical capacities or have diminished capacities for making a reasonable
p.000003: decision, such as children, pregnant women, psychiatric patients, unconscious patients, and prisoners.
p.000003: These vulnerable people need to be protected from being forced to participate in a research involuntarily. In
p.000003: practice, a special treatment is needed for the protection of their benefits.
p.000003: 2.2.3 Respect for privacy and confidentiality. This principle is fundamental to the respect for human’s
p.000003: dignity found in various cultures, and it helps to protect the security of mind. Therefore, the standards applied
p.000003: for the respect for privacy and confidentiality help to protect the access to, retention of, and distribution of
p.000003: personal information.
p.000003:
p.000003: 2.3 Principle of Beneficence
p.000003: This principle covers the following aspects.
p.000003: 2.3.1 Balancing between risks and benefits; An analysis of risks and benefits being exposed to the subjects is a
p.000003: key ethical issue of research on human subjects. Research ethics for human subjects in modern times requires a
p.000003: balance between potential risks and benefits, with the desired goal being that the benefits must outweigh
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000039: the duration, and in the trial population to be studied.
p.000039: 12.2 The sponsor should update the Investigator's Brochure as significant new information becomes available (see 7.
p.000039: Investigator's Brochure).
p.000039:
p.000039: 13. Manufacturing, Packaging, Labeling, and Coding Investigational Product(s)
p.000039: 13.1 The sponsor should ensure that the investigational product(s) (including active comparator(s) and
p.000039: placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is
p.000039: manufactured in accordance with any applicable GMP, and is coded and labeled in a manner that protects the blinding, if
p.000039: applicable. In addition, the labeling should comply with applicable regulatory requirement(s).
p.000039: 13.2 The sponsor should determine, the investigational product(s), acceptable storage temperatures, storage
p.000039: conditions (e.g. protection from light), storage times, reconstitution fluids and procedures, and devices for
p.000039: product infusion, if any. The sponsor should inform all involved parties (e.g. monitors, investigators, pharmacists,
p.000039: storage managers) of these determinations.
p.000039: 13.3 The investigational product(s) should be packaged to prevent contamination and unacceptable
p.000039: deterioration during transport and storage.
p.000039: 13.4 In blinded trials, the coding system for the investigational product(s) should include a mechanism that
p.000039: permits rapid identification of the product(s) in case of a medical emergency, but does not permit
p.000039: undetectable breaks of the blinding.
p.000039: 13.5 If significant formulation changes are made in the investigational or comparative product(s) during the
p.000039: course of clinical development, the results of any additional studies of the formulated product(s) (e.g. stability,
p.000039: dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the
p.000039: pharmacokinetic profile of the product
p.000039:
p.000040: 40
p.000040: should be available prior to the use of the new formulation in clinical trials.
p.000040:
p.000040: 14. Supplying and Handling Investigational Product(s)
p.000040: 14.1 The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational
p.000040: product(s).
p.000040: 14.2 The sponsor should not supply an investigator/institution with the investigational product(s) until
p.000040: the sponsor obtains all required documentation (e.g. approval/favorable opinion from IRB/IEC and regulatory
p.000040: authority(ies)).
p.000040: 14.3 The sponsor should ensure that written procedures include instructions that the
p.000040: investigator/institution should follow the handling and storage of investigational product(s) for the trial and
p.000040: documentation thereof. The procedures should address adequate and safe receipt, handling, storage, dispensing,
p.000040: retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor (or
p.000040: alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s)).
p.000040: 14.4 The sponsor should:
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000006: subjects are informed correctly, and voluntarily participate in the
p.000006:
p.000007: 7
p.000007: study. The information given should include both advantages, disadvantages to be incurred to the subjects themselves,
p.000007: to the community, or just for scientific benefit. The subjects should make their own decisions, not be forced
p.000007: to do so, or induced unduly. The subjects can also withdraw from the study any time. Several aspects of inducement
p.000007: that should receive consideration include:
p.000007: 3.2.1 Payment or compensation either money or other benefits to be given to the subjects should not be
p.000007: too much to induce the subject to decide to participate in the study without carefully considering the risks that may
p.000007: happen in the study;
p.000007: 3.2.2 For a phase I clinical trial usually conducted in normal subjects, the subjects would not obtain
p.000007: direct medical benefits from the study results. Therefore, it is necessary to compensate for travel expenses, loss
p.000007: of work or other payments, as appropriate. On the contrary, for a phase III study, the subjects usually obtain direct
p.000007: benefit from the study.
p.000007: 3.2.3 Enforced participation in a study may happen to institutionalized people, such as soldiers, prisoners, and
p.000007: students who have to obey or cooperate with their corresponding authorities. In recruiting these people into
p.000007: a study, it is necessary that they are informed and are given opportunity to make their own decisions
p.000007: without any interference from the higher authority.
p.000007: 3.2.4 3.2.4 Payment given to investigators by pharmaceutical companies or sponsors in the form of money or
p.000007: other means that are excessive, or payment methods, such as the given payment is based on the number of subjects
p.000007: participating in the trial, may cause deviation in the case that the investigator attempts to recruit as many subjects
p.000007: as possible for their own benefit.
p.000007:
p.000007: 3.3 Privacy and Confidentiality Protection
p.000007: No. 21 of the Declaration of Helsinki B.E. 2543 states, “The right of research subjects to safeguard their integrity
p.000007: must always be respected. Every precaution should be taken to respect the privacy of the subject, the
p.000007: confidentiality of the patient's information, and to minimize the impacts of the study on the subject's
p.000007: physical and mental integrity and on the personality of the subject."
p.000007:
p.000007: 3.3.1 Confidentiality protection
p.000007: (1) The subjects must be informed about their rights to have their personal information protected
p.000007: strictly.
p.000007: (2) During the informed consent discussion, the investigator must inform the subjects in advance of the
p.000007: measures used to protect their confidentiality before signing the consent form.
p.000007: (3) The subjects must sign the informed consent form before the information is to be distributed in case the
p.000007: information can cause danger to them.
...
p.000007: negligence, directly to the responsible agency. Under these circumstances, the investigator must inform the
p.000007: subjects of the limitations for keeping confidentiality before the subjects participate in the study.
p.000007: (6) The subjects should be made aware of the social impact on them if there would be any leakage of the data.
p.000007: For example, if the subject's participation in the
p.000007:
p.000008: 8
p.000008: studies on AIDS medicines or vaccines is made public, it is risky for the subjects to receive social discrimination.
p.000008: Such risks should be carefully considered in the same manner as those for any treatment risk resulting from
p.000008: drug or vaccine studies.
p.000008: (7) In the case where the ethics committee decides that signing the informed consent form can be
p.000008: waived, the investigator should explore other means to protect the subject's confidentiality.
p.000008:
p.000008: 3.3.2 Confidentiality between physicians and patient subjects
p.000008: The Declaration of Patients' Rights, issued by the four health professional associations and the Ministry of Public
p.000008: Health, states, “Patients have the right to receive strict protection of their own information.” Any disclosure of the
p.000008: patient’s information to anyone who needs the information, such as doctors, nurses, technical scientists, competent
p.000008: authority, or other researchers, can be made only if the patients or their legally acceptable representative gives
p.000008: prior permission.
p.000008:
p.000008: 3.3.3 Data from medical records
p.000008: (1) In practice, it is quite difficult for a researcher who conducts a study using the information from medical
p.000008: records to have a patient's informed consent form kept in each patient's medical record either by having patients
p.000008: sign the form in advance and keeping it in the medical record or by calling for patients to sign later. In this case,
p.000008: therefore, the ethics committee may consider waiving the signing of the informed consent form. However, the evidence
p.000008: should be provided to prove that the subjects are informed about the methods for collecting the data. For example, the
p.000008: methods are to be included on the information sheet for patients being hospitalized, or the permission to use the data
p.000008: in medical records may be given from the hospital director or other authorized persons.
p.000008: (2) The collection of the data from the medical records must receive approval from the ethics committee, and the
p.000008: patient's confidentiality must be strictly protected.
p.000008: (3) The investigator is allowed to use the data from the patient's medical records only as specified in the research
p.000008: protocol.
p.000008:
p.000008: 3.3.4 Risks to Groups of People
p.000008: Research results from certain fields such as epidemiology, genetics, and the social sciences, whatever conclusions are
...
p.000013: parties.
p.000013: 6.1.2 Upon the establishment of the ethics committee, the institution or organization has to determine the committee's
p.000013: scope of responsibilities, relation with the investigators both inside and outside the institution. Also, the
p.000013: mechanism for reporting the summary of the committee's performance and a member's term of holding office should
p.000013: be established.
p.000013: 6.1.3 The institution or organization should provide for the ethics committee adequate resources, including
p.000013: stationery supplies, facilities, clerical personnel, training opportunity, and payment/honorarium (if any) so
p.000013: that it can function efficiently.
p.000013: 6.1.4 The institution or organization (alone or in collaboration with other institutions) should provide for legal
p.000013: liability protection for the ethics committee.
p.000013: 6.1.5 The institution or organization not having its own ethics committee should arrange for a written agreement with
p.000013: other institutions or organizations having their own ethics committees so that the institution can have its personnel
p.000013: to serve as the committee members and share legal and other liabilities, as appropriate.
p.000013: 6.1.6 The institution or organization should appoint the ethics committee by its highest authority.
p.000013: However, the number of the sub-committees under the ethics committee may vary based upon the workload for protocol
p.000013: review so that the committee can function efficiently.
p.000013: 6.1.7 The main function of the ethics committee is to protect the rights and well-being of the research participants,
p.000013: whereas the key role of each member of the committee is to independently decide if the protocols provide for adequate
p.000013: protection of the rights and welfare of the research participants.
p.000013: 6.1.8 The ethics committee should advise the affiliated institution or organization concerning a
p.000013: system for ethical training to be given to the investigators within the institution.
p.000013: 6.1.9 The ethics committee in cooperation with its institution or organization should establish a database
p.000013: of experts, both inside and outside the institution/organization, who can provide their advice on
p.000013: specific issues to the ethics committee. An honorarium paid for the experts should be determined, as
p.000013: appropriate.
p.000013: 6.1.10 The ethics committee should establish the requirements for protocol submission along with the
p.000013: required documents, such as an application form, the number of copies of a research protocol to be
...
p.000015: next review meeting, or the review is postponed for temporarily;
p.000015: (4) disapproval/negative opinion.
p.000015: The ethics committee is required to provide an explanation for its disapproval decisions so that the investigator can
p.000015: clarify and request the committee to review its decision.
p.000015: 6.4.5. The ethics committee should establish a system along with procedures for an expedited review of the
p.000015: research protocols that imposes a minimal risk, or of protocol amendment with no additional risk. The committee
p.000015: should also establish the criteria for what research protocols could fit the expedited review.
p.000015: 6.4.6 The ethics committee should determine the types of protocols that can be conducted with no ethical review
p.000015: submission.
p.000015: 6.4.7 The ethics committee should establish the conditions whereby the informed consent discussion and/or signing a
p.000015: consent form can be waived.
p.000015: 6.4.8 The ethics committee should implement an efficient system for recording minutes and archiving to allow for an
p.000015: audit upon request and receive prior permission from the head of the institution or organization or
p.000015: from a competent authority. The duration for document storage should be in accordance with the applicable
p.000015: regulatory requirements mutatis mutandis, but at least for three years.
p.000015:
p.000015: 6.5 Committee Member with a Conflict of Interest
p.000015: 6.5.1 In case one or more members of the committee have a conflict of interest (e.g., being a principal investigator
p.000015: of, or being on a list of investigators of the protocols under review, or being a competitive investigator of
p.000015: similar research areas), those committee members should not participate in the review and approval process.
p.000015: They, however, can provide relevant opinions, and disclose their conflict of interest with the protocols. The
p.000015: committee should respect the rights of the applicant to oppose.
p.000015:
p.000015: 6.6 Review of an Ongoing Research
p.000015: 6.6.1 After the committee has approved the research study, the investigators have to report the progress of the
p.000015: research to the committee at an appropriate interval. For research protocol with high risks, the investigator
p.000015: should report the progress more frequently than a low risk protocol. The applicant should propose to the committee how
p.000015: often he/she will submit a research progress report to the committee from the date of protocol submission for ethical
p.000015: review, but at least once a year.
p.000015: 6.6.2 Upon the termination of the trial protocol for whatever reasons, the investigator should report the summary of
p.000015: the research results to the committee.
p.000015:
p.000015: 6.7 Ethical Review of a Multi-center Trial
p.000015: 6.7.1 A multi-center trial may be referred to as a trial that is conducted in more than one institution or
...
p.000016: protocol.
p.000016:
p.000016: 6.9 Termination or Suspension of Research
p.000016: 6.9.1 The ethics committee may withdraw or suspend its approval given to the research so as to protect the rights
p.000016: and welfare of the research participants. This includes when serious adverse effects are reported, or
p.000016: when the conduct of the research does not comply with the protocols approved by the committee.
p.000016: 6.9.2 In case of premature termination of any research protocols made by the investigator, the reasons for the
p.000016: termination must be reported to the ethics committee.
p.000016:
p.000017: 17
p.000017: CHAPTER 7
p.000017: SPECIFIC TYPES OF RESEARCH ON HUMAN SUBJECTS
p.000017:
p.000017: 7.1 CLINICAL DRUG TRIAL
p.000017:
p.000017: A clinical drug trial is a study of drug on either patients or healthy people in order to study the therapeutic or
p.000017: preventive effects of the drug.
p.000017: In general, an investigational drug used in clinical trial falls into one of four categories, namely:
p.000017: (1) new drugs; (2) unregistered drugs in Thailand (3) registered drugs by the national drug authority, but being
p.000017: studied in new doses or indications not previously approved; and (4) locally produced drugs which required efficacy
p.000017: testing.
p.000017:
p.000017: Phases of Clinical Drug Trials
p.000017: For new drugs, adequate evidence derived from animal studies must be available to ensure safety and determine toxicity
p.000017: levels prior to conducting a study in humans.
p.000017:
p.000017: A Clinical Drug Trail Can Be Classified in Four Phases.
p.000017:
p.000017: Phase I
p.000017: This is a first-in-human trial using a new chemical entity that is usually conducted in healthy volunteers to study
p.000017: acute toxicity that is associated with the dose range of the drug. Because of drug side effects, the study
p.000017: should be conducted in well-equipped facilities in the hospital, and should not be conducted on children, the
p.000017: elderly, or women with childbearing potential. Anesthesia or anticancer drugs should not be used in the healthy
p.000017: volunteers as a result of its high toxicity. In general, the number of the subjects should not exceed 30
p.000017: subjects. Every subject should give written informed consent before participating in the study. The study in
...
p.000022: collection, handling, and storage of the data comply with the principle of rights of personal information. If the data
p.000022: are
p.000022: to be used for purposes other than those specified in the approved protocol, a new protocol should be submitted for
p.000022: ethical review.
p.000022: 7.2.6 If the research involves the linkage of a set of data, the ethics committee may approve the use of the
p.000022: identifier to assure correct linkage. When the
p.000022: linkage is finished, the ethics committee should require that the emerging data be coded or the identifier be removed.
p.000022: 7.2.7 If the identified or identifiable data are used for other purposes in the research or by other people other than
p.000022: those listed in the previously approved protocol, a new protocol needs to be submitted for ethical review.
p.000022: 7.2.8 The information derived from epidemiological research both short- and long-term should be securely kept from the
p.000022: access of unauthorized people.
p.000022: 7.2.9. When screening the data for the statistical analysis and concluding, the investigator should maintain the
p.000022: confidentiality of the research participants.
p.000022: 7.2.10 The research results should not be published in a manner that can identify the individuals participating in the
p.000022: research and can affect the culture or other sensitivities.
p.000022: 7.2.11 If the emerging new knowledge during the course of the research has clinical implications or indicates the
p.000022: adjustment of the current treatment, the new knowledge should be disclosed to the relevant competent authority. If
p.000022: possible, both the research participants and the attending physician should be informed
p.000022:
p.000023: 23
p.000023: as well.
p.000023:
p.000023: 7.3 SOCIAL SCIENCE RESEARCH
p.000023:
p.000023: Similarly, the ethical principles applied in social science research consist of the principles of respect for person,
p.000023: beneficence, and justice.
p.000023:
p.000023: 7.3.1 The investigator should protect each subject from any physical or mental harm.
p.000023: 7.3.2 The investigator should respect the faith, belief, culture, religion, and basic rights of the subject.
p.000023: 7.3.3 The investigator should conduct only the research that benefits mankind.
p.000023: 7.3.4 The investigator should ensure that the design of the study is suitable to the objectives of the study.
p.000023: 7.3.5 The investigator should fully inform the subjects so that they can freely decide whether to participate in the
p.000023: research.
p.000023: 7.3.6 The investigator should protect the confidentiality and undisclosed names of the subjects.
p.000023: 7.3.7 The investigator should provide for health care to the subject as much as possible.
p.000023: 7.3.8 If the inclusion criteria are sensitive issues, the investigator should carefully conduct the study to avoid
p.000023: the disclosure of the subjects’ identity. The
p.000023: investigators may sometimes conduct the study in a non-targeted population to prevent the members of the community from
p.000023: being aware of what is conducted.
p.000023: 7.3.9 In case the study is conducted using medical records consisting of the confidentiality of patients, only the
p.000023: authorized medical personnel are allowed to access the data in the records, which can identify the patients. The access
p.000023: should be permitted by the highest authority of the institution.
p.000023: 7.3.10 The investigator should provide appropriate payment, benefits, or privileges to the subjects, and ensure that
p.000023: it should not be too much to induce the subjects to participate in the study.
p.000023:
p.000023:
p.000023: 7.4 VACCINE TRIAL
p.000023:
p.000023: The guidelines for conducting clinical drug trials are also applied to vaccine trials.
p.000023: However, the phase of the vaccine study may have additional details as explained below.
p.000023: 7.4.1 Phase I: This is a first-in-human trial to study the safety and biological effects, in particular the
p.000023: immunogenicity of a vaccine. Doses and routes of administration will be studied in this phase, and the trial is
p.000023: conducted in a low risk population.
p.000023: 7.4.2 Phase II: The trial is conducted in a limited number of patients to firstly explore the efficacy of a vaccine.
p.000023: The vaccine trial also serves for preventive purposes. Therefore, the trial involving a preventive vaccine must
p.000023: be conducted in healthy volunteers, while the trial involving a treatment vaccine is done in the patients of
p.000023: targeted disease.
p.000023: 7.4.3 Phase III: The trial in this phase focuses on the effectiveness of a vaccine for disease
p.000023: prevention. More subjects are then needed for the study in this phase (a thousand subjects and up). The trial
p.000023: is usually a multi-center trial, including a control group.
p.000023:
p.000024: 24
p.000024: 7.4.4 Precautions in a vaccine trial where the vaccines are produced from live-attenuated microorganisms should be
...
p.000037: (f) Maintain adequate backup of the data.
p.000037: (g) Safeguard the blinding, if any (e.g. maintain the blinding during data entry and processing).
p.000037: 5.4 If data are transformed during processing, it should always be possible to compare the original data and
p.000037: observations with the processed data.
p.000037: 5.5 The sponsor should use an unambiguous subject identification code (see 1.58) that allows identification
p.000037: of all the data reported for each subject.
p.000037: 5.6 The sponsor, or other owners of the data, should retain all of the sponsor-specific essential
p.000037: documents pertaining to the trial (see 8. Essential Documents for the Conduct of a Clinical Trial).
p.000037: 5.7 The sponsor should retain all sponsor-specific essential documents in conformance with the applicable
p.000037: regulatory requirement(s) of the country(ies) where the product is approved, and/or where the sponsor intends
p.000037: to apply for approval(s).
p.000037: 5.8 If the sponsor discontinues the clinical development of an investigational product (i.e., for any or all
p.000037: indications, routes of administration, or dosage forms), the sponsor should maintain all sponsor-specific
p.000037: essential documents for at least two years after formal discontinuation or in conformance with the applicable
p.000037: regulatory requirement(s).
p.000037: 5.9 If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all
p.000037: the trial investigators/institutions and all the regulatory authorities.
p.000037: 5.10 Any transfer of ownership of the data should be reported to the appropriate authority(ies), as
p.000037: required by the applicable regulatory requirement(s).
p.000037: 5.11 The sponsor specific essential documents should be retained until at least two years after the last approval of
p.000037: a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an
p.000037: ICH region or until at least two years have elapsed since the formal discontinuation of clinical development of the
p.000037: investigational
p.000037:
p.000038: 38
p.000038: product. These documents should be retained for a longer period however if required by the applicable regulatory
p.000038: requirement(s) or if needed by the sponsor.
p.000038: 5.12 The sponsor should inform the investigator(s)/institution(s) in writing of the need for record retention and
p.000038: should notify the investigator(s)/institution(s) in writing when the trial related records are no longer needed.
p.000038:
p.000038: 6. Investigator Selection
p.000038: 6.1 The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator
p.000038: should be qualified by training and experience and should have adequate resources (see 4.1, 4.2) to properly
p.000038: conduct the trial for which the investigator is selected. If organization of a coordinating committee and/or selection
p.000038: of coordinating investigator(s) are to be utilized in multi-centre trials, their organization and/or selection
p.000038: are the sponsor's responsibility.
p.000038: 6.2 Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should
p.000038: provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator's Brochure, and should
p.000038: provide sufficient time for the investigator/institution to review the protocol and the information provided.
...
p.000038: (b) to comply with procedures for data recording/reporting;
p.000038: (c) to permit monitoring, auditing and inspection (see 4.1.4) and
p.000038: (d) to retain the trial related essential documents until the sponsor informs the investigator/institution
p.000038: these documents are no longer needed (see 4.9.4 and 5.5.12).
p.000038: The sponsor and the investigator/institution should sign the protocols, or an alternative document, to
p.000038: confirm this agreement.
p.000038:
p.000038: 7. Allocation of Responsibilities
p.000038: Prior to initiating a trial, the sponsor should define, establish, and allocate all trial-related duties and
p.000038: functions.
p.000038:
p.000038: 8. Compensation to Subjects and Investigators
p.000038: 8.1 If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should
p.000038: indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial,
p.000038: except for claims that arise from malpractice and/or negligence.
p.000038: 8.2 The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event
p.000038: of trial-related injuries in accordance with the applicable regulatory requirement(s).
p.000038: 8.3 When trial subjects receive compensation, the method and manner of compensation should comply with
p.000038: applicable regulatory requirement(s).
p.000038:
p.000038: 9. Financing
p.000038: The financial aspects of the trial should be documented in an agreement between the sponsor and the
p.000038: investigator/institution.
p.000038:
p.000038: 10. Notification/Submission to Regulatory Authority(ies)
p.000038: Before initiating the clinical trial(s), the sponsor (or the sponsor and the investigator, if required by
p.000038: the applicable regulatory requirement(s)) should submit any required application(s) to
p.000038:
p.000039: 39
p.000039: the appropriate authority(ies) for review, acceptance, and/or permission (as required by the applicable
p.000039: regulatory requirement(s)) to begin the trial(s). Any notification/submission should be dated and contain
p.000039: sufficient information to identify the protocol.
p.000039:
p.000039: 11. Confirmation of Review by IRB/IEC
p.000039: 11.1 The sponsor should obtain from the investigator/institution:
p.000039: (a) The name and address of the investigator's/institution’s IRB/IEC.
p.000039: (b) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws
p.000039: and regulations.
p.000039: (c) Documented IRB/IEC approval/favorable opinion and, if requested by the sponsor, a current copy of the protocols,
p.000039: written informed consent form(s) and any other written information to be provided to subjects, subject recruiting
p.000039: procedures, and documents related to payments and compensation available to the subjects, and any other
p.000039: documents that the IRB/IEC may have requested.
p.000039: 11.2 If the IRB/IEC conditions its approval/favorable opinion upon change(s) in any aspect of the trial, such as
p.000039: modification(s) of the protocol, written informed consent form and any other written information to be provided to
p.000039: subjects, and/or other procedures, the sponsor should obtain from the investigator/institution a copy of the
p.000039: modification(s) made and the date approval/favorable opinion was given by the IRB/IEC.
p.000039: 11.3 The sponsor should obtain from the investigator/institution documentation and dates of any IRB/IEC
...
p.000039: product infusion, if any. The sponsor should inform all involved parties (e.g. monitors, investigators, pharmacists,
p.000039: storage managers) of these determinations.
p.000039: 13.3 The investigational product(s) should be packaged to prevent contamination and unacceptable
p.000039: deterioration during transport and storage.
p.000039: 13.4 In blinded trials, the coding system for the investigational product(s) should include a mechanism that
p.000039: permits rapid identification of the product(s) in case of a medical emergency, but does not permit
p.000039: undetectable breaks of the blinding.
p.000039: 13.5 If significant formulation changes are made in the investigational or comparative product(s) during the
p.000039: course of clinical development, the results of any additional studies of the formulated product(s) (e.g. stability,
p.000039: dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the
p.000039: pharmacokinetic profile of the product
p.000039:
p.000040: 40
p.000040: should be available prior to the use of the new formulation in clinical trials.
p.000040:
p.000040: 14. Supplying and Handling Investigational Product(s)
p.000040: 14.1 The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational
p.000040: product(s).
p.000040: 14.2 The sponsor should not supply an investigator/institution with the investigational product(s) until
p.000040: the sponsor obtains all required documentation (e.g. approval/favorable opinion from IRB/IEC and regulatory
p.000040: authority(ies)).
p.000040: 14.3 The sponsor should ensure that written procedures include instructions that the
p.000040: investigator/institution should follow the handling and storage of investigational product(s) for the trial and
p.000040: documentation thereof. The procedures should address adequate and safe receipt, handling, storage, dispensing,
p.000040: retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor (or
p.000040: alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s)).
p.000040: 14.4 The sponsor should:
p.000040: (a) Ensure timely delivery of investigational product(s) to the investigator(s).
p.000040: (b) Maintain records that document shipment, receipt, disposition, return, and destruction of the
p.000040: investigational product(s) (see 8. Essential Documents for the Conduct of a Clinical Trial).
p.000040: (c) Maintain a system for retrieving investigational products and documenting this retrieval (e.g. for
p.000040: deficient product recall, reclaim after trial completion, expired product reclaim).
p.000040: (d) Maintain a system for the disposition of unused investigational product(s) and for the documentation of this
p.000040: disposition.
p.000040: 14.5 The sponsor should:
p.000040: (a) Take steps to ensure that the investigational product(s) are stable over the period of use.
p.000040: (b) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm
p.000040: specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the
p.000040: extent stability permits, samples should be retained either until the analyses of the trial data are complete or
p.000040: as required by the applicable regulatory requirement(s), whichever represents the longer retention period.
p.000040:
p.000040: 15. Record Access
p.000040: 15.1 The sponsor should ensure that it is specified in the protocol or other written agreement that
p.000040: the investigator(s)/institution(s) provide direct access to source data/documents for
p.000040: trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.
p.000040: 15.2 The sponsor should verify that each subject has consented, in writing, to direct access to his/her original
p.000040: medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection.
p.000040:
p.000040: 16. Safety Information
p.000040: 16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
p.000040: 16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies)
p.000040: of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's
p.000040: approval/favorable opinion to continue the trial.
p.000040:
p.000041: 41
p.000041: 17. Adverse Drug Reaction Reporting
p.000041: 17.1 The sponsor should expedite the reporting to all concerned
p.000041: investigator(s)/institutions(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of
p.000041: all adverse drug reactions (ADRs) that are both serious and unexpected.
p.000041: 17.2 Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for
p.000041: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
p.000041: 17.3 The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as
p.000041: required by applicable regulatory requirement(s).
p.000041:
p.000041: 18. Monitoring
p.000041: 18.1 Purpose
p.000041: The purposes of trial monitoring are to verify that:
p.000041: (a) The rights and well-being of human subjects are protected.
p.000041: (b) The reported trial data are accurate, complete, and verifiable from source documents.
p.000041: (c) The conduct of the trial is in compliance with the currently approved
p.000041: protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
p.000041:
p.000041: 18.2 Selection and Qualifications of Monitors
p.000041: (a) Monitors should be appointed by the sponsor.
p.000041: (b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge
p.000041: needed to monitor the trial adequately. A monitor’s qualifications should be documented.
p.000041: (c) Monitors should be thoroughly familiar with the investigational product(s), the protocols, written
p.000041: informed consent form and any other written information to be provided to subjects, the sponsor’s
p.000041: SOPs, GCP, and the applicable regulatory requirement(s).
p.000041:
p.000041: 18.3 Extent and Nature of Monitoring
p.000041: The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the appropriate
p.000041: extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on
p.000041: considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial. In
p.000041: general there is a need for on-site monitoring, before, during, and after the trial; however in exceptional
...
p.000043: sponsor’s designated representative.
p.000043:
p.000043: 19. Audit
p.000043: If or when sponsors perform audits, as part of implementing quality assurance, they should consider:
p.000043:
p.000043: 19.1 Purpose
p.000043: The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality
p.000043: control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable
p.000043: regulatory requirements.
p.000043:
p.000043: 19.2 Selection and Qualification of Auditors
p.000043: (a) The sponsor should appoint individuals, who are independent of the clinical trials/systems, to conduct
p.000043: audits.
p.000043: (b) The sponsor should ensure that the auditors are qualified by training and experience to
p.000043: conduct audits properly. An auditor’s qualifications should be documented.
p.000043:
p.000043: 19.3 Auditing Procedures
p.000043: (a) The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the
p.000043: sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of
p.000043: audit reports.
p.000043: (b) The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to
p.000043: submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the
p.000043: level of risks to the trial subjects, and
p.000043:
p.000044: 44
p.000044: any identified problem(s).
p.000044: (c) The observations and findings of the auditor(s) should be documented.
p.000044: (d) To preserve the independence and value of the audit function, the regulatory authority(ies) should
p.000044: not routinely request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case
p.000044: by case basis when evidence of serious GCP non-compliance exists, or in the course of legal proceedings.
p.000044: (e) When required by applicable law or regulation, the sponsor should provide an audit certificate.
p.000044:
p.000044: 20. Noncompliance
p.000044: 20.1 Noncompliance with the protocols, SOPs, GCP, and/or applicable regulatory requirement(s) by an
p.000044: investigator/institution, or by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure
p.000044: compliance.
p.000044: 20.2 If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an
p.000044: investigator/institution, the sponsor should terminate the investigator's/institution’s
p.000044: participation in the trial. When an investigator's/institution’s participation is terminated because of
p.000044: noncompliance, the sponsor should notify promptly the regulatory authority(ies).
p.000044:
p.000044: 21. Premature Termination or Suspension of a Trial
p.000044: If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions,
p.000044: and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension.
p.000044: The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or
p.000044: suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory
p.000044: requirement(s).
p.000044:
p.000044: 22. Clinical Trial/Study Reports
p.000044: Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are
p.000044: prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s). The
p.000044: sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the
p.000044: ICH Guideline for Structure and Content of Clinical Study Reports. (NOTE: The ICH Guideline for Structure
p.000044: and Content of Clinical Study Reports specifies that abbreviated study reports may be acceptable in certain cases.)
p.000044:
p.000044: 23. Multi-centre Trials
p.000044: For multi-centre trials, the sponsor should ensure that:
p.000044: 23.1 All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if
p.000044: required, by the regulatory authority(ies), and given approval/favorable opinion by the IRB/IEC.
p.000044: 23.2 The CRFs are designed to capture the required data at all multi-centre trial sites. For those investigators who
p.000044: are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional
p.000044: data.
p.000044: 23.3 The responsibilities of coordinating investigator(s) and the other participating investigators
p.000044: are documented prior to the start of the trial.
p.000044: 23.4 All investigators are given instructions on following the protocol, on complying with a uniform set of
p.000044: standards for the assessment of clinical and laboratory findings, and on completing the CRFs.
p.000044: 23.5 Communication between investigators is facilitated.
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045: ANNEX 6
p.000045: CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)2
p.000045:
p.000045: The contents of a trial protocol should generally include the following topics. However, site specific information
p.000045: may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the
p.000045: information listed below may be contained in other protocol referenced documents, such as an Investigator’s
p.000045: Brochure.
p.000045:
p.000045: 1. General Information
p.000045: 1.1 Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment
p.000045: number(s) and date(s).
p.000045: 1.2 Name and address of the sponsor and monitor (if other than the sponsor).
p.000045: 1.3 Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the
p.000045: sponsor.
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000001: of human volunteers or research participants.
p.000001: Various institutions at national and international levels are aware of the ethical issues of research on
p.000001: human subjects. As a result, an ethics committee is appointed whose responsibility it is to monitor that the
p.000001: research conducted within the institution adheres to the ethical principles established in the Declaration of
p.000001: Helsinki or other declarations.
p.000001: In Thailand, the Ministry of Public Health in co-operation with nine Faculties of Medicine have organized a series
p.000001: of seminars at the Faculty of Medicine, Chulalongkorn University. This resulted in the establishment of the Forum
p.000001: for Ethical Review Committees in Thailand or FERCIT. The FERCIT aims to develop plans for promoting ethical research on
p.000001: human subjects. A Working Group was then appointed to draft ethical guidelines for research on human subjects, which
p.000001: are intended to serve as national guidelines. The national ethical guidelines were developed
p.000001: considering of the ethical principles that have their origin in several international guidelines, such as the
p.000001: Declaration of Helsinki of the World Medical Association, the WHO Operational Guidelines for Ethics Committees
p.000001: that Review Biomedical Research, the Council for International Organizations of Medical Science
p.000001: (CIOMS), and the Canadian Ethical Conduct for Research involving Humans, etc. The ethical guidelines has been
p.000001: published and distributed since B.E. 2545, and its English version was available in B.E. 2550.
p.000001:
p.000001: 1.2 Need for Research on Human Subjects
p.000001: Research on human subjects is necessary for promoting scientific progress and building a better understanding in
p.000001: order to improve human well-being. Researchers, universities, governments, and private organizations
p.000001: have various reasons for conducting or sponsoring research on human subjects. Such reasons include, for example,
p.000001: alleviating suffering from illness, evaluating social values or scientific theories, eliminating ignorance,
p.000001: analyzing policies, creating better understanding of human behavior and related purposes. In summary, research on
p.000001: human subjects serves three main purposes, i.e.,
p.000001: 1.2.1 To generate a new body of knowledge and new understanding;
p.000001: 1.2.2 To enhance scientific advancement that benefits the research subjects.
p.000001: 1.2.3 Through research, the subjects may gain benefits from the development of new treatment, from new findings
p.000001: for higher living standard, from new discoveries, from writing, speech, and traditional culture, or from
p.000001: satisfaction in improving society;
p.000001:
p.000002: 2
p.000002: 1.2.4 Also, research provides benefits for the society at large or for certain groups of people or has influence
p.000002: on political behavior, which may lead to an improved health policy. The statistical information about the disease
...
p.000056:
p.000056: 17. Sopit Thammaree,MSc (Pharm.). Member & Secretary
p.000056:
p.000057: 57
p.000057: BIBLOGRAPHY
p.000057:
p.000057: Bioethics and Advanced Biomedical Research: Draft, Bioethical Issues and Guidelines on Modern Biomedical Research
p.000057: Involving Humans, Thai National Health Foundation and National Center for Genetic Engineering and Biotechnology,
p.000057: 2003,(Thai)
p.000057:
p.000057: Singhaneti, B., Fundamental Principles of Rights, Freedom, and Dignity of Humans according to the
p.000057: Constitution of the Kingdom of Thailand, Vinyuchon, B.E. 2543 (2000), p. 231 (Thai).
p.000057:
p.000057: Office of National Research Council, Ministry of Science, Technology, and Environment,
p.000057: The Ethical Guideline for Researcher, National Research Council, B.E. 2541 (1998) (Thai).
p.000057:
p.000057: Institute for Population and Social Research, Mahidol University, Handouts of the “Ethics in Human Research” Workshop,
p.000057: September 2-3, 1998 (B.E.2541), Amarin Room, Third Floor, SD Avenue Hotel, Boromracchonani Road, Bangkok.
p.000057:
p.000057: Canada Tri-council Policy Statement. Ethical Conduct for Research Involving Humans,
p.000057: 1998.
p.000057:
p.000057: Code of Federal Regulations Title 45 Part 6 - Protection of Human Subjects (45 CFR 46) Revised June 18, 1991 (Effective
p.000057: August 19, 1991) Edition October 1, 1993.
p.000057:
p.000057: Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical
p.000057: Research Involving Human Subject, (1993 and a draft version 2001).
p.000057:
p.000057: Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Ethical
p.000057: Review of Epidemiological Studies (1991).
p.000057:
p.000057: Kittaporn, D., Ethical Issues in Social Science Research, Handouts for the First Training Workshop on Ethical
p.000057: Guideline in Clinical Research or Experiments Involving Human Subjects, hosted by the Faculty of Medicine,
p.000057: Khonkaen University and the Forum for Ethical Review Committee in Thailand (FERCIT), June 20-22, 2001 (B.E.
p.000057: 2544), Faculty of Medicine, Khonkaen University.
p.000057:
p.000057: European Epidemiology Group, Good Scientific Practice: Proper Conduct of Epidemiological
p.000057: Research.
p.000057:
p.000057: Drug Control Division, Food and Drug Administration, Ministry of Public Health, Thailand,
p.000057: ICH- Good Clinical Practice Guideline (Thai version), July, B.E. 2543.
p.000057:
p.000057: ICH Harmonized Guideline for Good Clinical Practice. London: EMEA, 1998.
p.000057:
p.000057: National Health and Medical Research Council, Australia, National Statement on Ethical conduct in Research
p.000057: Involving Humans, 1999.
p.000057:
p.000057: Office for Human Research Protections (OHRP), Institutional Review Board Guidebook,
...
General/Other / common rule
Searching for indicator 45XcfrX46:
(return to top)
p.000056: Member
p.000056:
p.000056: 14. Suwat Lertsukprasert, M.D.
p.000056: Member
p.000056:
p.000056: 15. Nimit Morakote, Ph.D.
p.000056: Member
p.000056:
p.000056: 16. Aphornpirom Ketpunya, M.D. Member
p.000056:
p.000056: 17. Sopit Thammaree,MSc (Pharm.). Member & Secretary
p.000056:
p.000057: 57
p.000057: BIBLOGRAPHY
p.000057:
p.000057: Bioethics and Advanced Biomedical Research: Draft, Bioethical Issues and Guidelines on Modern Biomedical Research
p.000057: Involving Humans, Thai National Health Foundation and National Center for Genetic Engineering and Biotechnology,
p.000057: 2003,(Thai)
p.000057:
p.000057: Singhaneti, B., Fundamental Principles of Rights, Freedom, and Dignity of Humans according to the
p.000057: Constitution of the Kingdom of Thailand, Vinyuchon, B.E. 2543 (2000), p. 231 (Thai).
p.000057:
p.000057: Office of National Research Council, Ministry of Science, Technology, and Environment,
p.000057: The Ethical Guideline for Researcher, National Research Council, B.E. 2541 (1998) (Thai).
p.000057:
p.000057: Institute for Population and Social Research, Mahidol University, Handouts of the “Ethics in Human Research” Workshop,
p.000057: September 2-3, 1998 (B.E.2541), Amarin Room, Third Floor, SD Avenue Hotel, Boromracchonani Road, Bangkok.
p.000057:
p.000057: Canada Tri-council Policy Statement. Ethical Conduct for Research Involving Humans,
p.000057: 1998.
p.000057:
p.000057: Code of Federal Regulations Title 45 Part 6 - Protection of Human Subjects (45 CFR 46) Revised June 18, 1991 (Effective
p.000057: August 19, 1991) Edition October 1, 1993.
p.000057:
p.000057: Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical
p.000057: Research Involving Human Subject, (1993 and a draft version 2001).
p.000057:
p.000057: Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Ethical
p.000057: Review of Epidemiological Studies (1991).
p.000057:
p.000057: Kittaporn, D., Ethical Issues in Social Science Research, Handouts for the First Training Workshop on Ethical
p.000057: Guideline in Clinical Research or Experiments Involving Human Subjects, hosted by the Faculty of Medicine,
p.000057: Khonkaen University and the Forum for Ethical Review Committee in Thailand (FERCIT), June 20-22, 2001 (B.E.
p.000057: 2544), Faculty of Medicine, Khonkaen University.
p.000057:
p.000057: European Epidemiology Group, Good Scientific Practice: Proper Conduct of Epidemiological
p.000057: Research.
p.000057:
p.000057: Drug Control Division, Food and Drug Administration, Ministry of Public Health, Thailand,
p.000057: ICH- Good Clinical Practice Guideline (Thai version), July, B.E. 2543.
p.000057:
p.000057: ICH Harmonized Guideline for Good Clinical Practice. London: EMEA, 1998.
p.000057:
p.000057: National Health and Medical Research Council, Australia, National Statement on Ethical conduct in Research
p.000057: Involving Humans, 1999.
p.000057:
p.000057: Office for Human Research Protections (OHRP), Institutional Review Board Guidebook,
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000001: made to verify the content with published version, reader may refer to published version when necessary.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 1
p.000001: CHAPTER 1
p.000001:
p.000001: DEVELOPMENT OF THE ETHICAL GUIDELINES FOR RESEARCH ON HUMAN SUBJECTS IN THAILAND
p.000001:
p.000001:
p.000001: 1.1 Introduction
p.000001: Nowadays, countries around the world, especially developed countries, have established human rights laws
p.000001: covering several aspects, including the law governing the conduct of research on humans or animals. Developed
p.000001: countries also have attempted to stipulate regulations and guidelines for research on human subjects, and
p.000001: promote the adoption of the regulations/guidelines in developing countries, such as guidelines for manufacturing
p.000001: of pharmaceuticals or patent application. Prior to being accepted for publication or granted a patent,
p.000001: or conduct a scientific research investigation involving human subjects, researchers are required to
p.000001: obtain ethical approval from a recognized ethics committee. In addition, seminars and conferences have been
p.000001: conducted on the ethical principles or guidelines for research in human subjects in both developing and developed
p.000001: countries; the outcomes of which have been several declarations. The most prominent and widely accepted and
p.000001: most commonly referred to is the Declaration of Helsinki of the World Medical Association (WMA), firstly adopted
p.000001: in Helsinki, Finland in B.E. 2507. The Declaration has been regularly amended to keep pace with
p.000001: advanced science, technology and social changes. The last amendment was formulated and adopted in Scotland in B.E.
p.000001: 2543. Later, several declarations concerning the conduct of a research on human subjects have also been
p.000001: adopted. The most essential element of those declarations is to protect the dignity, rights, safety, and well being
p.000001: of human volunteers or research participants.
p.000001: Various institutions at national and international levels are aware of the ethical issues of research on
p.000001: human subjects. As a result, an ethics committee is appointed whose responsibility it is to monitor that the
p.000001: research conducted within the institution adheres to the ethical principles established in the Declaration of
p.000001: Helsinki or other declarations.
p.000001: In Thailand, the Ministry of Public Health in co-operation with nine Faculties of Medicine have organized a series
p.000001: of seminars at the Faculty of Medicine, Chulalongkorn University. This resulted in the establishment of the Forum
p.000001: for Ethical Review Committees in Thailand or FERCIT. The FERCIT aims to develop plans for promoting ethical research on
p.000001: human subjects. A Working Group was then appointed to draft ethical guidelines for research on human subjects, which
p.000001: are intended to serve as national guidelines. The national ethical guidelines were developed
p.000001: considering of the ethical principles that have their origin in several international guidelines, such as the
p.000001: Declaration of Helsinki of the World Medical Association, the WHO Operational Guidelines for Ethics Committees
p.000001: that Review Biomedical Research, the Council for International Organizations of Medical Science
p.000001: (CIOMS), and the Canadian Ethical Conduct for Research involving Humans, etc. The ethical guidelines has been
p.000001: published and distributed since B.E. 2545, and its English version was available in B.E. 2550.
p.000001:
p.000001: 1.2 Need for Research on Human Subjects
p.000001: Research on human subjects is necessary for promoting scientific progress and building a better understanding in
p.000001: order to improve human well-being. Researchers, universities, governments, and private organizations
p.000001: have various reasons for conducting or sponsoring research on human subjects. Such reasons include, for example,
p.000001: alleviating suffering from illness, evaluating social values or scientific theories, eliminating ignorance,
p.000001: analyzing policies, creating better understanding of human behavior and related purposes. In summary, research on
p.000001: human subjects serves three main purposes, i.e.,
p.000001: 1.2.1 To generate a new body of knowledge and new understanding;
p.000001: 1.2.2 To enhance scientific advancement that benefits the research subjects.
p.000001: 1.2.3 Through research, the subjects may gain benefits from the development of new treatment, from new findings
p.000001: for higher living standard, from new discoveries, from writing, speech, and traditional culture, or from
p.000001: satisfaction in improving society;
p.000001:
p.000002: 2
...
p.000002: human or conducted in human. Also, such research includes research studies using information from
p.000002: patient medical records or databases, laboratory specimens, body fluids, human tissues, and studies about
p.000002: the physiology, biochemistry, pathology, responses to treatment in physique, biochemistry, psychology of
p.000002: normal subjects and patients. These research projects are collectively called biomedical research.
p.000002:
p.000002: 1.4.2 Ethics Committee or Research Ethics Committee means a committee appointed by an institution,
p.000002: organization, or agency whose responsibility is to review the ethical aspects of research studies and
p.000002: experiments on human subjects so that the rights, safety, and well-being of research subjects are
p.000002: protected. The ethics committee has been defined in the Medical Council's Regulation on the Preservation of
p.000002: Ethics of the Medical Profession (No. 5) B.E. 2545, Section 6. The ethics committee is also called differently, for
p.000002: example an Ethics Committee for Research on Human Subjects.
p.000002:
p.000002: 1.4.3 Ethical Guidelines for Research on Human Subjects means ethical guidelines or criteria
p.000002: related to research studies or experiments on human subjects, for example, the Declaration of Helsinki and
p.000002: other ethical guidelines established by each institution.
p.000002:
p.000002: 1.5 Revision of the Ethical Guidelines for Research on Human Subjects in Thailand
p.000002: Thanks to rapid advances in science and technology, the first version of the Ethical
p.000002: Guidelines, published in B.E. 2545, could not cover or keep pace with contemporary issues. It is therefore necessary
p.000002: to revise the first Ethical Guidelines. The Medical Council of Thailand as a regulatory body has assigned the
p.000002: Sub-committee on the Promotion of the National Ethical Guidelines for Research on Human Subjects to be
p.000002: in charge of the revision. The process was completed by the Working Group for Revising the Ethical
p.000002: Guidelines, where members of the working group were mainly from the Working Group for the Development of the
p.000002: Ethical Guidelines previously appointed in B.E. 2545. The Chairperson and the Secretary for the two Working Groups
p.000002: remain the same persons. Some new members joined the Working Group for Revising the Ethical Guidelines, Annex 10).
p.000002:
p.000003: 3
p.000003: CHAPTER 2
p.000003:
p.000003: ETHICS FOR RESEARCH ON HUMAN SUBJECTS
p.000003:
p.000003: 2.1 General Ethical Principles
p.000003: Three basic ethical principles consist of: First, respect for persons; Second, beneficence;
p.000003: Third, justice
p.000003:
p.000003: 2.2 Principle of Respect for Person
p.000003:
p.000003: The principle covers the following aspects.
p.000003: 2.2.1 Respect for human dignity. This aspect is the heart of research ethics, which provides for the protection
...
p.000007: too much to induce the subject to decide to participate in the study without carefully considering the risks that may
p.000007: happen in the study;
p.000007: 3.2.2 For a phase I clinical trial usually conducted in normal subjects, the subjects would not obtain
p.000007: direct medical benefits from the study results. Therefore, it is necessary to compensate for travel expenses, loss
p.000007: of work or other payments, as appropriate. On the contrary, for a phase III study, the subjects usually obtain direct
p.000007: benefit from the study.
p.000007: 3.2.3 Enforced participation in a study may happen to institutionalized people, such as soldiers, prisoners, and
p.000007: students who have to obey or cooperate with their corresponding authorities. In recruiting these people into
p.000007: a study, it is necessary that they are informed and are given opportunity to make their own decisions
p.000007: without any interference from the higher authority.
p.000007: 3.2.4 3.2.4 Payment given to investigators by pharmaceutical companies or sponsors in the form of money or
p.000007: other means that are excessive, or payment methods, such as the given payment is based on the number of subjects
p.000007: participating in the trial, may cause deviation in the case that the investigator attempts to recruit as many subjects
p.000007: as possible for their own benefit.
p.000007:
p.000007: 3.3 Privacy and Confidentiality Protection
p.000007: No. 21 of the Declaration of Helsinki B.E. 2543 states, “The right of research subjects to safeguard their integrity
p.000007: must always be respected. Every precaution should be taken to respect the privacy of the subject, the
p.000007: confidentiality of the patient's information, and to minimize the impacts of the study on the subject's
p.000007: physical and mental integrity and on the personality of the subject."
p.000007:
p.000007: 3.3.1 Confidentiality protection
p.000007: (1) The subjects must be informed about their rights to have their personal information protected
p.000007: strictly.
p.000007: (2) During the informed consent discussion, the investigator must inform the subjects in advance of the
p.000007: measures used to protect their confidentiality before signing the consent form.
p.000007: (3) The subjects must sign the informed consent form before the information is to be distributed in case the
p.000007: information can cause danger to them.
p.000007: (4) The possible leakage of the research results containing the subject's confidentiality should be
p.000007: minimized to the lowest level. In general, the best way to protect the subject's confidentiality is to remove
p.000007: the subject's identification from all stages of the study, and to control or restrict access to the data.
p.000007: (5) The subjects should be made aware of the investigator's limitations in keeping their confidentiality. An
...
p.000028: 9 on the Medical Practice of Blood Stem Cell Transplantation from Donors.
p.000028:
p.000029: 29
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: ANNEXES
p.000029:
p.000030: 30
p.000030: ANNEX 1
p.000030:
p.000030: THE MEDICAL COUNCIL'S REGULATION
p.000030: ON RESEARCH STUDIES AND EXPERIMENTS IN HUMAN SUBJECTS
p.000030: B.E. 2525
p.000030:
p.000030: 1. “Research study and experiment in human subjects” refers to a research study and an experiment using a
p.000030: pharmaceutical product or medical devices, or a study of a natural course of a disease, or the diagnosis,
p.000030: treatment, health promotion, and prevention of a disease which is conducted in human subjects. This also includes a
p.000030: research study conducted using the information from medical records and any specimens taken from the human body.
p.000030:
p.000030: “Ethics Committee” refers to a committee or board appointed by an institution, organization, or agency,
p.000030: which is responsible for conducting an ethical review of researches and experiments in human subjects. This is to
p.000030: protect the rights, safety, and well being of the subjects who participate in the research and experiments.
p.000030:
p.000030: “Ethical Guidelines for Research Studies and Experiments in Human Subjects” refer to ethical guidelines
p.000030: or ethical principles for research and experiments in human subjects, such as the Declaration of Helsinki and
p.000030: any ethical guidelines for a research study in human subjects established by an institution.
p.000030:
p.000030: “Ethics for Researchers,” refers to the Ethical Guidelines of the National Research Council of
p.000030: Thailand.
p.000030:
p.000030: 2. Medical practitioners who conduct research or experiment in human subjects must obtain informed consent from
p.000030: potential subjects, and ready to protect the subjects from any harm that occurs from the experiment.
p.000030:
p.000030: 3. Medical practitioners must treat the subjects in the same manner that they treat a patient during the
p.000030: course of the medical practice as applied mutatis mutandis by Section 3 of the Council’s Regulations.
p.000030:
p.000030: 4. Medical practitioners must be responsible for the dangers and damage that happen to the subjects in the
p.000030: experiment and such dangers or damage are not due to the subjects’ mistakes.
p.000030:
p.000030: 5. Medical practitioners who conduct or participate in research studies or experiments in human subjects can
p.000030: initiate the research studies only if the research or experimental proposals have been reviewed and approved by an
p.000030: ethics committee.
p.000030:
p.000030: 6. Medical practitioners who conduct or participate in research studies or experiments in human subjects
p.000030: must adhere to the Ethical Guidelines for Research Studies and Experiments in Human Subjects and the
p.000030: Ethics for Researchers.
p.000030:
...
General/Other / participants in a control group
Searching for indicator control group:
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p.000010: justifying the risk.
p.000010: 4.3.5 When a research is conducted in vulnerable people, the rationale and need should be clearly explained and any
p.000010: and all harm avoided.
p.000010:
p.000010: 4.3.6 The relevant risks and benefits are clearly specified and fully provided in the informed consent form.
p.000010:
p.000010: 4.4 Additional Guidelines for Considering Risks and Benefits of a Research Protocol
p.000010: 4.4.1. An ethics committee needs to assess both risks and benefits. A research protocol should maximize benefits and
p.000010: minimize risks or harm.
p.000010: 4.4.2. A research protocol should demonstrate measures used to reduce risks, including preventive measures and
p.000010: immediate treatment measures once harm occurs to a research participant.
p.000010: 4.4.3. If the benefits do not directly go to the subjects, such as new knowledge, a
p.000010:
p.000011: 11
p.000011: rigorous review on the proper and careful design of the research for potential risks is required.
p.000011: 4.4.4. For research conducted in a community, a private sponsor should provide health services to the community, as
p.000011: appropriate. Or in case a clinical drug trial is conducted with the conclusion that the new drugs are more efficacious
p.000011: than or equal to the active control drugs, the sponsors should provide the benefits to the participating subjects in
p.000011: the control group or in all groups by giving them the new drugs for a certain period after the completion of the study.
p.000011: Research conducted to explore a new indication not previously approved in the product leaflet must be done in
p.000011: comparison with the approved drug.
p.000011: 4.4.5 In case the subjects cannot personally give an informed consent to participate in the study, the risk that may
p.000011: happen must be a minimal risk. Otherwise, research with slightly greater than a minimal risk would be acceptable only
p.000011: if the research's objective(s) are important enough, and the research provides only good effects to the participating
p.000011: subjects.
p.000011:
p.000011: The assessment of risks and benefits will be very useful to the individuals involved in research on human
p.000011: subjects. For the investigator, the assessment helps to check if the research is properly designed. For the ethics
p.000011: committee, it helps to determine if the risks and benefits that may happen to the subjects are justified. And for
p.000011: the research subjects, it helps to decide whether to participate in the research or not.
p.000011:
p.000012: 12
p.000012: CHAPTER 5
p.000012:
p.000012: CONDUCTING RESEARCH ACCORDNG TO THE PRINCIPLE OF JUSTICE
p.000012:
p.000012: The selection of groups of people of communities for research should be based on a fair distribution of
p.000012: burdens and benefits. Exclusion of any people or communities from any research should be justified.
...
p.000018: (2) As the trial in this phase is conducted in healthy subjects where the sponsor of new drugs pay for the study, the
p.000018: ethical review should focus on the following aspects:
p.000018: a. the subject sample selection;
p.000018: b. a freely given informed consent process;
p.000018: c. the meaning of the message in the consent form;
p.000018: d. the qualifications of the committee’s members and performance of the ethics committee;
p.000018: e. applicable regulatory requirements (if any).
p.000018: (3) Specific ethical considerations are needed for the review of the drug trial conducted in patients suffering from
p.000018: an illness with no hope from currently available treatments. As the conduct of the trial under this situation may
p.000018: distort the awareness of the patients, the family, and the investigator in weighing the risks and benefits of the
p.000018: trial, and may affect the freely
p.000018: given informed consent and the termination or the withdrawal criteria,
p.000018: therefore, both the investigator and the ethics committee should co-operate and consult each other throughout the
p.000018: course of the trial.
p.000018:
p.000018: 7.1.2 Phase II and Phase III Clinical Trials
p.000018: Generally, the trials in these phases involve the use of a placebo in the control group. Placebos should not be used
p.000018: in a control group if standard treatments are available because the subjects will lose medical benefits from
p.000018: participating in the trial. In addition to a focus on the freely informed consent process, ethical considerations in
p.000018: a placebo-controlled trial should pay attention to an appropriate design so as to maximize the benefits and minimize
p.000018: harms to patients.
p.000018:
p.000018: 7.1.3 Phase IV
p.000018: The trial in this phase is usually conducted in the private practice of physicians who use the drugs already available
p.000018: on the market. Frequently, the sponsor pays the investigator based on the number of patients recruited in order to
p.000018: study the side effects of drugs and to build acceptance in using the drugs among patients and other physicians. This
p.000018: case may impose an obligation to the investigator. Therefore, the investigator and the ethics committee should
p.000018: consider appropriate benefits and payment to be given to the subjects for their participation.
p.000018:
p.000018: 7.1.4 Clinical Trial of Medical Equipment
p.000018: A clinical trial using a medical device for human use, either invasive or non
p.000018:
p.000019: 19
p.000019: invasive, requires similar ethical considerations as clinical drug trials in four phases, in particular the medical
p.000019: device that is to be inserted into the
p.000019: body. In such a case, a specific consideration is required depending on the
p.000019: types of devices. For example, the conduct of a trial using a cardiac pace maker, which is a very expensive device,
...
p.000020: exists, the investigator is responsible for objectively reporting the event to the sponsor, the ethics committee and
p.000020: the subjects.
p.000020:
p.000020: 7.1.5 Research Budget
p.000020: The ethics committee should review the research budget to ensure that the issue of benefits has been taken into
p.000020: account. In general, the sponsor will pay the investigator based on the number of subjects. Payment calculated
p.000020: based on the number of recruited subjects is an ethical issue, because it is possible that the investigator has
p.000020: conflicting thoughts between the payment to be received and the beneficial and appropriate health service to be given
p.000020: to the subject. This is the case in particular when the patient or the subject trusts the investigator.
p.000020: Research conducted in public hospitals or public health care facilities involve expenditures to cover such as
p.000020: laboratory tests, and lump sum fees determined by the institution. The disclosure of the payment and the other budget
p.000020: items helps the ethics committee to evaluate any conflict of interest, and helps the investigator to decide whether to
p.000020: conduct the trial.
p.000020:
p.000020: 7.1.6 Placebo-Controlled Trial
p.000020: It is generally unacceptable to use a placebo in a control group in a trial where standard treatments or medically
p.000020: proven medicines are available, because patients will lose medical benefits entitled to from participating
p.000020: in the clinical trial. However, the use of a placebo in a control group may be allowed in the following cases.
p.000020: (1) no standard drug medically recognized for the treatment of the disease is available;
p.000020: (2) the available drug for the treatment yields uncertain outcomes;
p.000020: (3) the standard drug for the treatment is available, but it causes serious adverse drug reactions or adverse events
p.000020: that the subjects cannot tolerate;
p.000020: (4) the illness to be studied is managed by itself due to a placebo effect;
p.000020:
p.000021: 21
p.000021: (5) the disease to be studied is a minor condition and treating with a placebo causes the only discomfort or the
p.000021: illness is alleviated slowly or negligibly, and causes no serious or irreversible harm to the subjects;
p.000021: (6) compelling scientific and methodological reasons are necessary
p.000021: to use a placebo-controlled group in determining the effectiveness and the safety of a study drug.
...
p.000023: should be permitted by the highest authority of the institution.
p.000023: 7.3.10 The investigator should provide appropriate payment, benefits, or privileges to the subjects, and ensure that
p.000023: it should not be too much to induce the subjects to participate in the study.
p.000023:
p.000023:
p.000023: 7.4 VACCINE TRIAL
p.000023:
p.000023: The guidelines for conducting clinical drug trials are also applied to vaccine trials.
p.000023: However, the phase of the vaccine study may have additional details as explained below.
p.000023: 7.4.1 Phase I: This is a first-in-human trial to study the safety and biological effects, in particular the
p.000023: immunogenicity of a vaccine. Doses and routes of administration will be studied in this phase, and the trial is
p.000023: conducted in a low risk population.
p.000023: 7.4.2 Phase II: The trial is conducted in a limited number of patients to firstly explore the efficacy of a vaccine.
p.000023: The vaccine trial also serves for preventive purposes. Therefore, the trial involving a preventive vaccine must
p.000023: be conducted in healthy volunteers, while the trial involving a treatment vaccine is done in the patients of
p.000023: targeted disease.
p.000023: 7.4.3 Phase III: The trial in this phase focuses on the effectiveness of a vaccine for disease
p.000023: prevention. More subjects are then needed for the study in this phase (a thousand subjects and up). The trial
p.000023: is usually a multi-center trial, including a control group.
p.000023:
p.000024: 24
p.000024: 7.4.4 Precautions in a vaccine trial where the vaccines are produced from live-attenuated microorganisms should be
p.000024: exercised as the vaccines may cause infection in the subjects, despite its low possibility. Therefore, it is
p.000024: essential to inform the potential subjects in advance about the risk.The subjects in the control group not receiving
p.000024: the real vaccine must also be protected from the disease or be informed that they have a chance to contact the disease
p.000024: from the experimental subject group.
p.000024: 7.4.5 In case of a trial using a recombinant DNA vaccine, the adverse effects of which are not yet clear, the
p.000024: investigator has to strictly follow the regulations of the Ministry of Public Health.
p.000024:
p.000024:
p.000024: 7.5 USE OF HUMAN TISSUE SAMPLES
p.000024:
p.000024: Human tissue samples mean anything being taken out or excreted from a human body or a corpse. The tissue samples also
p.000024: include other tissues, blood, secretions, and excretions from all organ systems. The objective of using the tissue
p.000024: samples is for the diagnosis of a disease or for other purposes.
p.000024:
p.000024: The human tissue samples may be obtained by one of the following means.
p.000024: a. taken directly from the body of the subject for research use where the donors of the tissues give their informed
p.000024: consent;
p.000024: b. taken from the body for treatment, diagnosis, or other objectives (e.g., learning and teaching, organ donation for
p.000024: transplantation;
p.000024: c. taken from either of the aforementioned sources above, and kept under the applicable regulatory requirements,
p.000024: institutional regulations or by
p.000024: the subject’s approval. In this case, the donors of the tissue samples usually do not know the objectives of the use
p.000024: of the samples of future research.
p.000024: In a research protocol that uses human tissue samples, the ethics committee should review it according to the
p.000024: international ethical guidelines at least those as described below.
p.000024:
p.000024: 7.5.1 Prospective studies
...
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p.000018: and continuously monitor the trial.
p.000018: (2) As the trial in this phase is conducted in healthy subjects where the sponsor of new drugs pay for the study, the
p.000018: ethical review should focus on the following aspects:
p.000018: a. the subject sample selection;
p.000018: b. a freely given informed consent process;
p.000018: c. the meaning of the message in the consent form;
p.000018: d. the qualifications of the committee’s members and performance of the ethics committee;
p.000018: e. applicable regulatory requirements (if any).
p.000018: (3) Specific ethical considerations are needed for the review of the drug trial conducted in patients suffering from
p.000018: an illness with no hope from currently available treatments. As the conduct of the trial under this situation may
p.000018: distort the awareness of the patients, the family, and the investigator in weighing the risks and benefits of the
p.000018: trial, and may affect the freely
p.000018: given informed consent and the termination or the withdrawal criteria,
p.000018: therefore, both the investigator and the ethics committee should co-operate and consult each other throughout the
p.000018: course of the trial.
p.000018:
p.000018: 7.1.2 Phase II and Phase III Clinical Trials
p.000018: Generally, the trials in these phases involve the use of a placebo in the control group. Placebos should not be used
p.000018: in a control group if standard treatments are available because the subjects will lose medical benefits from
p.000018: participating in the trial. In addition to a focus on the freely informed consent process, ethical considerations in
p.000018: a placebo-controlled trial should pay attention to an appropriate design so as to maximize the benefits and minimize
p.000018: harms to patients.
p.000018:
p.000018: 7.1.3 Phase IV
p.000018: The trial in this phase is usually conducted in the private practice of physicians who use the drugs already available
p.000018: on the market. Frequently, the sponsor pays the investigator based on the number of patients recruited in order to
p.000018: study the side effects of drugs and to build acceptance in using the drugs among patients and other physicians. This
p.000018: case may impose an obligation to the investigator. Therefore, the investigator and the ethics committee should
p.000018: consider appropriate benefits and payment to be given to the subjects for their participation.
p.000018:
p.000018: 7.1.4 Clinical Trial of Medical Equipment
p.000018: A clinical trial using a medical device for human use, either invasive or non
p.000018:
p.000019: 19
p.000019: invasive, requires similar ethical considerations as clinical drug trials in four phases, in particular the medical
p.000019: device that is to be inserted into the
p.000019: body. In such a case, a specific consideration is required depending on the
p.000019: types of devices. For example, the conduct of a trial using a cardiac pace maker, which is a very expensive device,
p.000019: requires surgery to evaluate its safety and effectiveness. Considerations are also extended to the costs of the
p.000019: surgery and of a patent license requested by the device’s manufacturer.
p.000019: Slight differences between the clinical trials of drugs and devices can be noted. The ethics committee should pay
p.000019: attention to the differences as well, such as
p.000019: (1) A medical device for human use may not be tested previously in animal models such as retractors because of
p.000019: different human and animal anatomies.
p.000019: (2) Certain types of medical devices should not be studied in healthy human subjects because the research procedures
p.000019: and/or the use of the device may impose extremely high risks and harm, but create no benefits to the subjects. For
p.000019: example, the trials using artificial joints, artificial cardiac valves, or a cardiac pace maker.
p.000019: (3) The clinical trial of a new drug is not regarded as a trial with a minimal risk because the mechanism of action
p.000019: may not be clear. As a result, it is impossible to predict possible side effects. On the contrary, the trial using an
p.000019: external medical device, which is known for its mechanism of action, allows us to predict the possible side effects.
p.000019: The trial can be regarded as imposing a minimal risk. Details will be discussed later.
p.000019: (4) A comparative study using a medical device and a placebo or other comparators to evaluate the effectiveness or
p.000019: efficiency of the treatments may not be conducted because ethical justification if the use of that device is the only
p.000019: opportunity for the subject to obtain benefit from the treatment, such as
p.000019: surgery to insert the artificial joint to replace irreversibly impaired joints.
p.000019: In general, a sham surgery in the comparator group is regarded as ethically inappropriate as it can greatly impose
p.000019: risks and harm to the subjects, while it provides no benefits. The sham surgery, however, used
p.000019: in the clinical trial of a medical device may be conducted under certain circumstances of extreme necessity, provided
p.000019: that the risks must be minimized as much as possible and the subject must be given full and correct information before
p.000019: freely deciding to participate in the trial.
p.000019: As mentioned above, in several cases, a medical device that has clear mechanisms of action may be designed by the
p.000019: physician who directly takes care of the patient. In addition a device available on the market may be altered or
p.000019: further developed and used in the treatment for patients unable to access
p.000019: other available treatments. The investigator or the sponsor of this type of trial may get less financial support than
p.000019: that from drug companies in the case of a clinical drug trial. Hence, the design of a clinical study of a medical
p.000019: device to prove its effectiveness, efficiency and safety may be an observational study instead of a randomized
...
p.000020: principles applied in clinical trials taking into account the specific characteristics of the trial of medical devices
p.000020: explained earlier.
p.000020: Finally, the investigator and the subject should always realize that devices inserted into the human body undergo
p.000020: failure both in short and long term. The failure of the device may result in damage, even death. When such a risk
p.000020: exists, the investigator is responsible for objectively reporting the event to the sponsor, the ethics committee and
p.000020: the subjects.
p.000020:
p.000020: 7.1.5 Research Budget
p.000020: The ethics committee should review the research budget to ensure that the issue of benefits has been taken into
p.000020: account. In general, the sponsor will pay the investigator based on the number of subjects. Payment calculated
p.000020: based on the number of recruited subjects is an ethical issue, because it is possible that the investigator has
p.000020: conflicting thoughts between the payment to be received and the beneficial and appropriate health service to be given
p.000020: to the subject. This is the case in particular when the patient or the subject trusts the investigator.
p.000020: Research conducted in public hospitals or public health care facilities involve expenditures to cover such as
p.000020: laboratory tests, and lump sum fees determined by the institution. The disclosure of the payment and the other budget
p.000020: items helps the ethics committee to evaluate any conflict of interest, and helps the investigator to decide whether to
p.000020: conduct the trial.
p.000020:
p.000020: 7.1.6 Placebo-Controlled Trial
p.000020: It is generally unacceptable to use a placebo in a control group in a trial where standard treatments or medically
p.000020: proven medicines are available, because patients will lose medical benefits entitled to from participating
p.000020: in the clinical trial. However, the use of a placebo in a control group may be allowed in the following cases.
p.000020: (1) no standard drug medically recognized for the treatment of the disease is available;
p.000020: (2) the available drug for the treatment yields uncertain outcomes;
p.000020: (3) the standard drug for the treatment is available, but it causes serious adverse drug reactions or adverse events
p.000020: that the subjects cannot tolerate;
p.000020: (4) the illness to be studied is managed by itself due to a placebo effect;
p.000020:
p.000021: 21
p.000021: (5) the disease to be studied is a minor condition and treating with a placebo causes the only discomfort or the
p.000021: illness is alleviated slowly or negligibly, and causes no serious or irreversible harm to the subjects;
p.000021: (6) compelling scientific and methodological reasons are necessary
p.000021: to use a placebo-controlled group in determining the effectiveness and the safety of a study drug.
p.000021: In addition to the focus on freely informed consent, the ethical consideration of a placebo-controlled trial should
p.000021: focus on an appropriate design to maximize benefits and minimize harm to patients.
p.000021:
p.000021: 7.1.7 Analysis and Distribution of Research Results
p.000021: In most clinical trials, the sponsor has rights as agreed upon for the analysis and interpretation of research results.
p.000021: However, the investigator and the ethics committee should ensure that:
p.000021: (1) The final analysis and interpretation of the research results will rest with the investigator to ensure that the
p.000021: results would be actually complete and accurate.
p.000021: (2) When the trial of Phase I, II and III is required to stop according to the rules, there must be an independent
p.000021: interim analysis. However, prior to
p.000021: implementing the termination rules, it should be identified that either positive
p.000021: or negative long-term effects of the drug may be obscured by either good or bad short term drug effects.
p.000021: (3) The main responsibility of the investigator is to circulate the research findings to the community of
p.000021: investigators. However, it is found that frequently the research results of several trials, in particular the negative
p.000021: results, are not published or distributed. Not only does the case create an inappropriate scientific conduct and
p.000021: produce no actual research results, but also the research results and the resources invested in the research become in
p.000021: vain.
p.000021:
p.000021:
p.000021: 7.2 EPIDEMIOLOGICAL RESEARCH
p.000021:
p.000021: Epidemiological research is an integral part of public health or health service research, which is necessary for the
...
p.000039: documents that the IRB/IEC may have requested.
p.000039: 11.2 If the IRB/IEC conditions its approval/favorable opinion upon change(s) in any aspect of the trial, such as
p.000039: modification(s) of the protocol, written informed consent form and any other written information to be provided to
p.000039: subjects, and/or other procedures, the sponsor should obtain from the investigator/institution a copy of the
p.000039: modification(s) made and the date approval/favorable opinion was given by the IRB/IEC.
p.000039: 11.3 The sponsor should obtain from the investigator/institution documentation and dates of any IRB/IEC
p.000039: re-approvals/re-evaluations with favorable opinion, and of any withdrawals or suspensions of approval/favorable
p.000039: opinion.
p.000039:
p.000039: 12. Information on Investigational Product(s)
p.000039: 12.1 When planning trials, the sponsor should ensure that sufficient safety and efficacy data from
p.000039: non-clinical studies and/or clinical trials are available to support human exposure by the route, at the dosages, for
p.000039: the duration, and in the trial population to be studied.
p.000039: 12.2 The sponsor should update the Investigator's Brochure as significant new information becomes available (see 7.
p.000039: Investigator's Brochure).
p.000039:
p.000039: 13. Manufacturing, Packaging, Labeling, and Coding Investigational Product(s)
p.000039: 13.1 The sponsor should ensure that the investigational product(s) (including active comparator(s) and
p.000039: placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is
p.000039: manufactured in accordance with any applicable GMP, and is coded and labeled in a manner that protects the blinding, if
p.000039: applicable. In addition, the labeling should comply with applicable regulatory requirement(s).
p.000039: 13.2 The sponsor should determine, the investigational product(s), acceptable storage temperatures, storage
p.000039: conditions (e.g. protection from light), storage times, reconstitution fluids and procedures, and devices for
p.000039: product infusion, if any. The sponsor should inform all involved parties (e.g. monitors, investigators, pharmacists,
p.000039: storage managers) of these determinations.
p.000039: 13.3 The investigational product(s) should be packaged to prevent contamination and unacceptable
p.000039: deterioration during transport and storage.
p.000039: 13.4 In blinded trials, the coding system for the investigational product(s) should include a mechanism that
p.000039: permits rapid identification of the product(s) in case of a medical emergency, but does not permit
p.000039: undetectable breaks of the blinding.
p.000039: 13.5 If significant formulation changes are made in the investigational or comparative product(s) during the
p.000039: course of clinical development, the results of any additional studies of the formulated product(s) (e.g. stability,
p.000039: dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the
p.000039: pharmacokinetic profile of the product
p.000039:
p.000040: 40
p.000040: should be available prior to the use of the new formulation in clinical trials.
...
p.000045: trials that are relevant to the trial.
p.000045: 2.3 Summary of the known and potential risks and benefits, if any, to human subjects.
p.000045: 2.4 Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s).
p.000045: 2.5 A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory
p.000045: requirement(s).
p.000045: 2.6 Description of the population to be studied.
p.000045: 2.7 References to literature and data that are relevant to the trial, and that provide background for the
p.000045: trial.
p.000045:
p.000045:
p.000045:
p.000045: * This part is adopted from the Chapter on Clinical Trial Protocol and Protocol Amendment(s) of the ICH GCP Guidelines,
p.000045: as the Thai version is directly translated from the ICH GCP Guidelines. Re-translating the Thai version back to the
p.000045: English language may cause slight deviation from the original meaning. Therefore, adopting the original English
p.000045: version is made to best preserve the accuracy of the text.
p.000045:
p.000046: 46
p.000046: 3. Trial Objectives and Purpose
p.000046: A detailed description of the objectives and the purpose of the trial.
p.000046:
p.000046: 4. Trial Design
p.000046: The scientific integrity of the trial and the credibility of the data from the trial depend
p.000046: substantially on the trial design. A description of the trial design, should include:
p.000046: 4.1 A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial.
p.000046: 4.2 A description of the type/design of trial to be conducted (e.g. double-blind, placebo- controlled,
p.000046: parallel design) and a schematic diagram of trial design, procedures and stages.
p.000046: 4.3 A description of the measures taken to minimize/avoid bias, including:
p.000046: (a) Randomization.
p.000046: (b) Blinding.
p.000046: 4.4 A description of the trial treatment(s) and the dosage and dosage regimen of the investigational
p.000046: product(s). Also include a description of the dosage form, packaging, and labeling of the investigational
p.000046: product(s).
p.000046: 4.5 The expected duration of subject participation, and a description of the sequence and duration of all trial
p.000046: periods, including follow-up, if any.
p.000046: 4.6 A description of the "stopping rules" or "discontinuation criteria" for individual subjects, parts of trial and
p.000046: entire trial.
p.000046: 4.7 Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s),
p.000046: if any.
p.000046: 4.8 Maintenance of trial treatment randomization codes and procedures for breaking codes.
p.000046: 4.9 The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of
p.000046: data), and to be considered to be source data.
p.000046:
p.000046: 5. Selection and Withdrawal of Subjects
p.000046: 5.1 Subject inclusion criteria.
p.000046: 5.2 Subject exclusion criteria.
p.000046: 5.3 Subject withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and
p.000046: procedures specifying:
p.000046: (a) When and how to withdraw subjects from the trial/ investigational product treatment.
p.000046: (b) The type and timing of the data to be collected for withdrawn subjects.
p.000046: (c) Whether and how subjects are to be replaced.
p.000046: (d) The follow-up for subjects withdrawn from investigational product treatment/trial treatment.
p.000046:
p.000046: 6. Treatment of Subjects
p.000046: 6.1 The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the
p.000046: dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the
p.000046: follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the
p.000046: trial.
p.000046: 6.2 Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during
p.000046: the trial.
p.000046:
p.000047: 47
p.000047: 6.3 Procedures for monitoring subject compliance.
p.000047:
p.000047: 7. Assessment of Efficacy
p.000047: 7.1 Specification of the efficacy parameters.
p.000047: 7.2 Methods and timing for assessing, recording, and analyzing efficacy parameters.
p.000047:
p.000047: 8. Assessment of Safety
...
General/Other / tri-council policy statement
Searching for indicator tri-council:
(return to top)
p.000056:
p.000056: 9. Piyatat Tasanawiwat, M.D.
p.000056: Member
p.000056:
p.000056: 10. Hatern Thintara, M.D.
p.000056: Member
p.000056:
p.000056: 11. Pakorn Siriyong, M.D.
p.000056: Member
p.000056:
p.000056: 12. Yotee Thongpenyai, M.D.
p.000056: Member
p.000056:
p.000056: 13. Phanuwat Lertsitthichai, M.D.
p.000056: Member
p.000056:
p.000056: 14. Suwat Lertsukprasert, M.D.
p.000056: Member
p.000056:
p.000056: 15. Nimit Morakote, Ph.D.
p.000056: Member
p.000056:
p.000056: 16. Aphornpirom Ketpunya, M.D. Member
p.000056:
p.000056: 17. Sopit Thammaree,MSc (Pharm.). Member & Secretary
p.000056:
p.000057: 57
p.000057: BIBLOGRAPHY
p.000057:
p.000057: Bioethics and Advanced Biomedical Research: Draft, Bioethical Issues and Guidelines on Modern Biomedical Research
p.000057: Involving Humans, Thai National Health Foundation and National Center for Genetic Engineering and Biotechnology,
p.000057: 2003,(Thai)
p.000057:
p.000057: Singhaneti, B., Fundamental Principles of Rights, Freedom, and Dignity of Humans according to the
p.000057: Constitution of the Kingdom of Thailand, Vinyuchon, B.E. 2543 (2000), p. 231 (Thai).
p.000057:
p.000057: Office of National Research Council, Ministry of Science, Technology, and Environment,
p.000057: The Ethical Guideline for Researcher, National Research Council, B.E. 2541 (1998) (Thai).
p.000057:
p.000057: Institute for Population and Social Research, Mahidol University, Handouts of the “Ethics in Human Research” Workshop,
p.000057: September 2-3, 1998 (B.E.2541), Amarin Room, Third Floor, SD Avenue Hotel, Boromracchonani Road, Bangkok.
p.000057:
p.000057: Canada Tri-council Policy Statement. Ethical Conduct for Research Involving Humans,
p.000057: 1998.
p.000057:
p.000057: Code of Federal Regulations Title 45 Part 6 - Protection of Human Subjects (45 CFR 46) Revised June 18, 1991 (Effective
p.000057: August 19, 1991) Edition October 1, 1993.
p.000057:
p.000057: Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical
p.000057: Research Involving Human Subject, (1993 and a draft version 2001).
p.000057:
p.000057: Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Ethical
p.000057: Review of Epidemiological Studies (1991).
p.000057:
p.000057: Kittaporn, D., Ethical Issues in Social Science Research, Handouts for the First Training Workshop on Ethical
p.000057: Guideline in Clinical Research or Experiments Involving Human Subjects, hosted by the Faculty of Medicine,
p.000057: Khonkaen University and the Forum for Ethical Review Committee in Thailand (FERCIT), June 20-22, 2001 (B.E.
p.000057: 2544), Faculty of Medicine, Khonkaen University.
p.000057:
p.000057: European Epidemiology Group, Good Scientific Practice: Proper Conduct of Epidemiological
p.000057: Research.
p.000057:
p.000057: Drug Control Division, Food and Drug Administration, Ministry of Public Health, Thailand,
p.000057: ICH- Good Clinical Practice Guideline (Thai version), July, B.E. 2543.
p.000057:
p.000057: ICH Harmonized Guideline for Good Clinical Practice. London: EMEA, 1998.
p.000057:
...
Orphaned Trigger Words
p.000024: (5) use the appropriate data recording, storing, and retrieving systems that ensure protection of the confidentiality
p.000024: of the owner of the tissue samples;
p.000024: (6) appoint a personnel staff responsible for the handling and storage of the tissue samples;
p.000024: (7) The institution or organization that allows the use of human tissue samples for research purposes should lay down
p.000024: the guidelines for the conduct of the research using the tissue samples and for the ethnical review and approval of the
p.000024: research protocols. The guidelines should be in compliance with the applicable laws and regulations, and the
p.000024: institutional ethical guidelines should provide detailed procedures and possible conditions for the use of the tissue
p.000024: samples in the research. The guidelines will be used for the investigator to follow when asking for the subject's
p.000024: donation of the tissue samples used in the research, and for the ethics committee to review the protocols taking into
p.000024:
p.000025: 25
p.000025: consideration international ethical principles, i.e., respect for persons, beneficence, and justice;
p.000025: (8) A material transfer agreement should be made in case the tissue samples are transferred to other institutions to
p.000025: ensure consistency with the principle of respect for persons.
p.000025:
p.000025: 7.5.2 Retrospective Studies Using Stored Human Tissue Samples
p.000025: (1) The institution and the ethics committee should established the rules and regulations that determine what
p.000025: circumstances the investigator can waive the informed consent from the owner of the tissue samples so as to use the
p.000025: stored samples for research;
p.000025: (2) Whenever a physician has received a human tissue sample for purposes of the treatment or diagnosis of the
p.000025: patient’s disease, the physician should make the best attempt to maintain the confidentiality of the patient. When
p.000025: research
p.000025: is conducted using stored tissue samples, searching for the patients or the patients’ information should be done as
p.000025: little as possible and only as necessary for achieving the research objectives only.
p.000025: (3) If the results of the research may affect the health of patients, the ethics committee may require the
p.000025: investigator to search for the patients and contact them for treatment or follow-up;
p.000025: (4) Under certain situations, the ethics committee may agree for the waiver of the informed consent from the tissue
p.000025: owners in using the stored tissue samples for the research by taking into considerations:
p.000025: a. the modes of obtaining the tissue samples (e.g., from pathology storage, blood bank);
p.000025: b. the scope and content of the informed consent given previously by the owner of the samples (if any);
p.000025: c. the reasons behind the waiver of the informed consent by the investigator, including difficulty of obtaining the
p.000025: informed consent;
p.000025: d. the possibility that the process of obtaining the informed consent may violate the privacy of the owners of the
...
p.000041:
p.000041: 18.4 Monitor's Responsibilities
p.000041: The monitor(s) in accordance with the sponsor’s requirements should ensure that the trial is conducted and documented
p.000041: properly by carrying out the following activities when relevant and necessary to the trial and the trial site:
p.000041: (a) Acting as the main line of communication between the sponsor and the investigator.
p.000041: (b) Verifying that the investigator has adequate qualifications and resources (see 4.1, 4.2, 5.6) and remain adequate
p.000041: throughout the trial period, and that facilities, including laboratories, equipment, and staff, are adequate to safely
p.000041: and properly conduct the trial and remain adequate throughout the trial period.
p.000041:
p.000042: 42
p.000042: (c) Verifying, for the investigational product(s):
p.000042: • That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial.
p.000042: • That the investigational product(s) are supplied only to subjects who are eligible to receive it and at the protocol
p.000042: specified dose(s).
p.000042: • That subjects are provided with necessary instruction on properly using, handling, storing, and returning
p.000042: the investigational product(s).
p.000042: • That the receipt, use, and return of the investigational product(s) at the trial sites are controlled
p.000042: and documented adequately.
p.000042: • That the disposition of unused investigational product(s) at the trial sites complies with applicable
p.000042: regulatory requirement(s) and is in accordance with the sponsor.
p.000042: (d) Verifying that the investigator follows the approved protocol and all approved amendment(s), if any.
p.000042: (e) Verifying that written informed consent was obtained before each subject's participation in the
p.000042: trial.
p.000042: (f) Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all
p.000042: trial supplies needed to conduct the trial properly and to comply with the applicable regulatory
p.000042: requirement(s).
p.000042: (g) Ensuring that the investigator and the investigator's trial staff are adequately informed about the
p.000042: trial.
p.000042: (h) Verifying that the investigator and the investigator's trial staff are performing the specified trial
p.000042: functions, in accordance with the protocols and any other written agreement between the sponsor and
p.000042: the investigator/institution, and have not delegated these functions to unauthorized individuals.
p.000042: (i) Verifying that the investigator is enrolling only eligible subjects.
p.000042: (j) Reporting the subject recruitment rate.
p.000042: (k) Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained.
p.000042: (l) Verifying that the investigator provides all the required reports, notifications, applications, and
p.000042: submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial.
p.000042: (m) Checking the accuracy and completeness of the CRF entries, source documents and other trial-related records
p.000042: against each other. The monitor specifically should verify that:
p.000042: • The data required by the protocol are reported accurately on the CRFs and are consistent with the source documents.
p.000042: • Any dose and/or therapy modifications are well documented for each of the trial subjects.
p.000042: • Adverse events, concomitant medications and inter-current illnesses are reported in accordance with
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| 45XcfrX46 | common rule |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| alcoholism | alcoholism |
| authority | Relationship to Authority |
| belief | Religion |
| blind | visual impairment |
| blinded | visual impairment |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| control group | participants in a control group |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| drug | Drug Usage |
| elderly | Elderly |
| embryo | embryo |
| emergency | Public Emergency |
| employees | employees |
| faith | Religion |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| gender | gender |
| healthy people | Healthy People |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| hospitalized | hospitalized patients |
| hospitalized patients | hospitalized patients |
| ill | ill |
| illegal | Illegal Activity |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| influence | Drug Usage |
| institutionalized | Institutionalized |
| job | Occupation |
| language | Linguistic Proficiency |
| married | Marital Status |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| party | political affiliation |
| placebo | participants in a control group |
| political | political affiliation |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| racial | Racial Minority |
| religion | Religion |
| restricted | Incarcerated |
| sex workers | sex worker |
| single | Marital Status |
| social status | Economic/Poverty |
| stem cells | stem cells |
| stigma | Threat of Stigma |
| stigmatization | Threat of Stigma |
| terminally | Terminally Ill |
| tri-council | tri-council policy statement |
| unconscious | Unconscious People |
| usage | Drug Usage |
| volunteers | Healthy People |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| belief | ['faith', 'religion'] |
| blind | ['blinded'] |
| blinded | ['blind'] |
| child | ['children'] |
| children | ['child'] |
| control group | ['placebo'] |
| disability | ['mentally'] |
| drug | ['influence', 'usage'] |
| faith | ['belief', 'religion'] |
| healthy people | ['healthyXvolunteers', 'volunteers'] |
| healthy volunteers | ['healthyXpeople', 'volunteers'] |
| hospitalized | ['hospitalizedXpatients'] |
| hospitalized patients | ['hospitalized'] |
| impaired | ['impairment'] |
| impairment | ['impaired'] |
| influence | ['drug', 'usage'] |
| married | ['single'] |
| mentally | ['disability'] |
| party | ['political'] |
| placebo | ['controlXgroup'] |
| political | ['party'] |
| religion | ['faith', 'belief'] |
| single | ['married'] |
| stigma | ['stigmatization'] |
| stigmatization | ['stigma'] |
| usage | ['drug', 'influence'] |
| volunteers | ['healthyXpeople', 'healthyXvolunteers'] |
Trigger Words
capacity
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input