79C3C34C52B45572883A05D425EB0F82
Research involving Human Participants in Developing Societies
https://mrc.ukri.org/publications/browse/research-involving-human-participants-in-developing-societies/
http://leaux.net/URLS/ConvertAPI Text Files/E9B1D440C293AD897E187551C5F3F8C6.en.txt
Examining the file media/Synopses/E9B1D440C293AD897E187551C5F3F8C6.html:
This file was generated: 2021-01-08 21:29:13
| 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
Health / HIV/AIDS
Searching for indicator HIV:
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p.000002: participants. Particular restrictions and safeguards are required when this is not possible (eg, emergency situations,
p.000002: mentally incapacitated individuals, children).
p.000002: 5. There must be neither inducement nor coercion to
p.000002: participate. However, for certain types of research without a therapeutic component participants may be recompensed for
p.000002: their expense, time, and inconvenience.
p.000002: 6. The research should be done only with the approval of an appropriate independent research ethics body, in
p.000002: addition to which the MRC always considers the ethical propriety of the proposals.
p.000002:
p.000003: 3
p.000003:
p.000003: Research involving human participants in developing societies
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p.000003:
p.000003:
p.000003: 7. Information about identifiable individuals derived from the research must be regarded as confidential, and
p.000003: appropriate safeguards must be in place governing access to such information by others.
p.000003: 8. The research must conform to all relevant legal requirements.
p.000003: In addition, investigators are expected to follow other MRC guidance as appropriate:
p.000003: • MRC policy on antiretroviral therapy (ART) for people infected with HIV and involved in research in developing
p.000003: countries: general guidance notes for consideration, 2002.
p.000003: • MRC guidelines for good clinical practice in clinical trials, 1998, which are based on the principles of the
p.000003: International Conference on Harmonisation harmonised tripartite guideline, Good Clinical Practice: Consolidated
p.000003: Guideline, 1997.
p.000003: • Personal information in medical research, 2000.
p.000003: • Human tissue and biological samples for use in research, 2001.
p.000003: • Cluster randomised trials: methodological and ethical considerations, 2002.
p.000003: • Health technology assessment in surgery, 2003.
p.000003: • MRC interim guidance on ethics of research involving human material derived from the nervous system, 2003.
p.000003:
p.000003:
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p.000004: 4
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p.000004: Research involving human participants in developing societies
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p.000004: Specific considerations
p.000004: Over and above these general principles, the conduct of MRC- sponsored research in developing societies should follow
p.000004: the specific guidance listed below.
p.000004: 1. Organisations from developed countries should not normally support research, in pursuit of their own goals,
p.000004: involving people in developing societies if that research could be carried out reasonably well in a developed
p.000004: community.
p.000004: 2. Special care must be taken to ensure that the social and economic characteristics of the developing society,
...
Health / Mentally Disabled
Searching for indicator mentally:
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p.000001: agreement on important areas of guidance.
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p.000002: 2
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p.000002: Research involving human participants in developing societies
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p.000002: General principles
p.000002: The MRC's key ethical principles, outlined in Responsibility in Investigations on Human Participants and Material and
p.000002: on Personal Information, 1992, apply to research conducted in developing societies:
p.000002: 1. The research must be of potential scientific or practical value: it must address an important question, and
p.000002: be feasible and well-designed.The scientific rationale for conducting the research must be sound.
p.000002: 2. The research must use the minimum number of human participants consistent with the objectives of the study,
p.000002: without compromising the integrity and validity of the research.
p.000002: 3. The potential and known risks of the research, as well as its potential benefits to the participants or
p.000002: others, must be considered by both participants and investigators.
p.000002: 4. The research must whenever possible be done only with the full and informed consent of the individual
p.000002: participants. Particular restrictions and safeguards are required when this is not possible (eg, emergency situations,
p.000002: mentally incapacitated individuals, children).
p.000002: 5. There must be neither inducement nor coercion to
p.000002: participate. However, for certain types of research without a therapeutic component participants may be recompensed for
p.000002: their expense, time, and inconvenience.
p.000002: 6. The research should be done only with the approval of an appropriate independent research ethics body, in
p.000002: addition to which the MRC always considers the ethical propriety of the proposals.
p.000002:
p.000003: 3
p.000003:
p.000003: Research involving human participants in developing societies
p.000003:
p.000003:
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p.000003:
p.000003: 7. Information about identifiable individuals derived from the research must be regarded as confidential, and
p.000003: appropriate safeguards must be in place governing access to such information by others.
p.000003: 8. The research must conform to all relevant legal requirements.
p.000003: In addition, investigators are expected to follow other MRC guidance as appropriate:
p.000003: • MRC policy on antiretroviral therapy (ART) for people infected with HIV and involved in research in developing
p.000003: countries: general guidance notes for consideration, 2002.
p.000003: • MRC guidelines for good clinical practice in clinical trials, 1998, which are based on the principles of the
...
Health / Motherhood/Family
Searching for indicator family:
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p.000005: is required to judge the ethical acceptability of the research in accordance with the customs and traditions of the
p.000005: community concerned. As with research conducted in developed societies, the local ethics committee members should
p.000005: include lay people qualified to represent the cultural and moral values of their community as well as professionals.The
p.000005: committee should be chaired by someone entirely independent of the research and have at least one other independent
p.000005: member.
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p.000006: 6
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p.000006: Research involving human participants in developing societies
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p.000006: 8. Special care should be taken to obtain genuine informed consent from participants, including the use of
p.000006: reliable intermediaries as appropriate to ensure that the implications of participation are fully understood. In
p.000006: particular, all prospective participants must fully understand that their
p.000006: participation is entirely voluntary and that they are free to refuse to participate or withdraw at any time without
p.000006: loss of any entitlement. Although there is no substitute for individual consent, the cultural need for the potential
p.000006: participant to consult a senior family member or community leader should be respected, and in some cases this person
p.000006: may need to be consulted first. A permanent personalised record of consent should be retained, although this need not
p.000006: necessarily be in the form of a signature.
p.000006: 9. There should be discussion in advance with relevant parties in the developing society about the plans for
p.000006: research and about dissemination of results to study participants and local people. In anticipation of any beneficial
p.000006: results of research with a therapeutic component, the discussion should include how the product/intervention being
p.000006: evaluated might be made available locally after the study.
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p.000007: 7
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p.000007: Research involving human participants in developing societies
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p.000007: Further reading
p.000007: 1. World Medical Association (WMA). World Medical Association Declaration of Helsinki: ethical principles for
p.000007: medical research involving human subjects. As adopted by the 52nd WMA General Assembly, 2000, with note of
p.000007: clarification on paragraph 29 added 2002.
p.000007: 2. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health
p.000007: Organization (WHO). International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS,
p.000007: 2002.
...
Social / Access to Social Goods
Searching for indicator access:
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p.000002: without compromising the integrity and validity of the research.
p.000002: 3. The potential and known risks of the research, as well as its potential benefits to the participants or
p.000002: others, must be considered by both participants and investigators.
p.000002: 4. The research must whenever possible be done only with the full and informed consent of the individual
p.000002: participants. Particular restrictions and safeguards are required when this is not possible (eg, emergency situations,
p.000002: mentally incapacitated individuals, children).
p.000002: 5. There must be neither inducement nor coercion to
p.000002: participate. However, for certain types of research without a therapeutic component participants may be recompensed for
p.000002: their expense, time, and inconvenience.
p.000002: 6. The research should be done only with the approval of an appropriate independent research ethics body, in
p.000002: addition to which the MRC always considers the ethical propriety of the proposals.
p.000002:
p.000003: 3
p.000003:
p.000003: Research involving human participants in developing societies
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 7. Information about identifiable individuals derived from the research must be regarded as confidential, and
p.000003: appropriate safeguards must be in place governing access to such information by others.
p.000003: 8. The research must conform to all relevant legal requirements.
p.000003: In addition, investigators are expected to follow other MRC guidance as appropriate:
p.000003: • MRC policy on antiretroviral therapy (ART) for people infected with HIV and involved in research in developing
p.000003: countries: general guidance notes for consideration, 2002.
p.000003: • MRC guidelines for good clinical practice in clinical trials, 1998, which are based on the principles of the
p.000003: International Conference on Harmonisation harmonised tripartite guideline, Good Clinical Practice: Consolidated
p.000003: Guideline, 1997.
p.000003: • Personal information in medical research, 2000.
p.000003: • Human tissue and biological samples for use in research, 2001.
p.000003: • Cluster randomised trials: methodological and ethical considerations, 2002.
p.000003: • Health technology assessment in surgery, 2003.
p.000003: • MRC interim guidance on ethics of research involving human material derived from the nervous system, 2003.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Research involving human participants in developing societies
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Specific considerations
p.000004: Over and above these general principles, the conduct of MRC- sponsored research in developing societies should follow
p.000004: the specific guidance listed below.
p.000004: 1. Organisations from developed countries should not normally support research, in pursuit of their own goals,
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Social / Child
Searching for indicator children:
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p.000001:
p.000001:
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p.000002: 2
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p.000002: Research involving human participants in developing societies
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: General principles
p.000002: The MRC's key ethical principles, outlined in Responsibility in Investigations on Human Participants and Material and
p.000002: on Personal Information, 1992, apply to research conducted in developing societies:
p.000002: 1. The research must be of potential scientific or practical value: it must address an important question, and
p.000002: be feasible and well-designed.The scientific rationale for conducting the research must be sound.
p.000002: 2. The research must use the minimum number of human participants consistent with the objectives of the study,
p.000002: without compromising the integrity and validity of the research.
p.000002: 3. The potential and known risks of the research, as well as its potential benefits to the participants or
p.000002: others, must be considered by both participants and investigators.
p.000002: 4. The research must whenever possible be done only with the full and informed consent of the individual
p.000002: participants. Particular restrictions and safeguards are required when this is not possible (eg, emergency situations,
p.000002: mentally incapacitated individuals, children).
p.000002: 5. There must be neither inducement nor coercion to
p.000002: participate. However, for certain types of research without a therapeutic component participants may be recompensed for
p.000002: their expense, time, and inconvenience.
p.000002: 6. The research should be done only with the approval of an appropriate independent research ethics body, in
p.000002: addition to which the MRC always considers the ethical propriety of the proposals.
p.000002:
p.000003: 3
p.000003:
p.000003: Research involving human participants in developing societies
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 7. Information about identifiable individuals derived from the research must be regarded as confidential, and
p.000003: appropriate safeguards must be in place governing access to such information by others.
p.000003: 8. The research must conform to all relevant legal requirements.
p.000003: In addition, investigators are expected to follow other MRC guidance as appropriate:
p.000003: • MRC policy on antiretroviral therapy (ART) for people infected with HIV and involved in research in developing
p.000003: countries: general guidance notes for consideration, 2002.
p.000003: • MRC guidelines for good clinical practice in clinical trials, 1998, which are based on the principles of the
p.000003: International Conference on Harmonisation harmonised tripartite guideline, Good Clinical Practice: Consolidated
p.000003: Guideline, 1997.
p.000003: • Personal information in medical research, 2000.
...
Social / philosophical differences/differences of opinion
Searching for indicator difference of opinion:
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p.000002: 2
p.000003: 3
p.000005: 5
p.000008: 8
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p.000001: 1
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p.000001: Research involving human participants in developing societies
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p.000001: Introduction
p.000001: The MRC expects all researchers that it funds to follow these guidelines when their research involves developing
p.000001: societies.We hope that other researchers and those reviewing or supervising research will also find them helpful. The
p.000001: guidance given here is brief; we encourage readers to consult the key sources of further information listed on page
p.000001: eight. Although there is some difference of opinion in the published sources, there is also a large measure of
p.000001: agreement on important areas of guidance.
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p.000002: 2
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p.000002: Research involving human participants in developing societies
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: General principles
p.000002: The MRC's key ethical principles, outlined in Responsibility in Investigations on Human Participants and Material and
p.000002: on Personal Information, 1992, apply to research conducted in developing societies:
p.000002: 1. The research must be of potential scientific or practical value: it must address an important question, and
p.000002: be feasible and well-designed.The scientific rationale for conducting the research must be sound.
p.000002: 2. The research must use the minimum number of human participants consistent with the objectives of the study,
p.000002: without compromising the integrity and validity of the research.
p.000002: 3. The potential and known risks of the research, as well as its potential benefits to the participants or
p.000002: others, must be considered by both participants and investigators.
p.000002: 4. The research must whenever possible be done only with the full and informed consent of the individual
p.000002: participants. Particular restrictions and safeguards are required when this is not possible (eg, emergency situations,
...
Searching for indicator opinion:
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p.000006: evaluated might be made available locally after the study.
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p.000007: 7
p.000007:
p.000007: Research involving human participants in developing societies
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Further reading
p.000007: 1. World Medical Association (WMA). World Medical Association Declaration of Helsinki: ethical principles for
p.000007: medical research involving human subjects. As adopted by the 52nd WMA General Assembly, 2000, with note of
p.000007: clarification on paragraph 29 added 2002.
p.000007: 2. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health
p.000007: Organization (WHO). International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS,
p.000007: 2002.
p.000007: 3. Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries. London:
p.000007: Nuffield Council on Bioethics, 2002.
p.000007: 4. Council of Europe Steering Committee on Bioethics. Additional protocol to the Convention on Human Rights and
p.000007: Biomedicine, on biomedical research. Strasbourg: Council of Europe, 2004.
p.000007: 5. European Group on Ethics in Science and New Technologies to the European Commission. Opinion Nr 17 on ethical
p.000007: aspects of clinical research in developing countries. Luxembourg: Office for Official Publications of the European
p.000007: Communities, 2003/04.
p.000007: 6. European Council and European Parliament. Directive 2001/20/EC of the European Parliament and the Council on
p.000007: the approximation of the laws, regulations and administrative provisions of the Member States relating to
p.000007: implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, April
p.000007: 2001, adopted by Member States 2003, to be applied with effect from May 2004.
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p.000008: 8
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p.000008: Medical Research Council
p.000008: 20 Park Crescent London W1B 1AL
p.000008: tel: 020 7636 5422 fax: 020 7436 6179
p.000008: www.mrc.ac.uk
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Economic / Economic/Poverty
Searching for indicator poor:
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p.000003: countries: general guidance notes for consideration, 2002.
p.000003: • MRC guidelines for good clinical practice in clinical trials, 1998, which are based on the principles of the
p.000003: International Conference on Harmonisation harmonised tripartite guideline, Good Clinical Practice: Consolidated
p.000003: Guideline, 1997.
p.000003: • Personal information in medical research, 2000.
p.000003: • Human tissue and biological samples for use in research, 2001.
p.000003: • Cluster randomised trials: methodological and ethical considerations, 2002.
p.000003: • Health technology assessment in surgery, 2003.
p.000003: • MRC interim guidance on ethics of research involving human material derived from the nervous system, 2003.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Research involving human participants in developing societies
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Specific considerations
p.000004: Over and above these general principles, the conduct of MRC- sponsored research in developing societies should follow
p.000004: the specific guidance listed below.
p.000004: 1. Organisations from developed countries should not normally support research, in pursuit of their own goals,
p.000004: involving people in developing societies if that research could be carried out reasonably well in a developed
p.000004: community.
p.000004: 2. Special care must be taken to ensure that the social and economic characteristics of the developing society,
p.000004: or poor communications, do not diminish the researchers' respect for the rights and interests of the people involved,
p.000004: or the community as a whole.
p.000004: 3. The reason for undertaking the research will usually be its relevance to the health/healthcare needs of the
p.000004: community in which it is carried out, either in the short-term or long-term.
p.000004: 4. Research on topics without a therapeutic component needs especially careful scrutiny, taking account of the
p.000004: balance of risks and benefits to participants in the particular circumstances and setting of the study.
p.000004: 5. When setting the standard of care, the MRC follows the recommendation of the Nuffield Council on Bioethics,
p.000004: 2002:
p.000004: "For the control group in a particular research study… wherever appropriate participants in the control group should be
p.000004: offered a universal standard of care for the disease being studied. Where it is not appropriate to offer a universal
p.000004: standard of care, the minimum standard of care
p.000005: 5
p.000005:
p.000005: Research involving human participants in developing societies
p.000005:
p.000005:
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p.000005: that should be offered to the control group is the best intervention available for that disease as part of the national
p.000005: public health system."
p.000005: The fact that a treatment tested in a trial may not currently be affordable to the local population should not in
p.000005: itself necessarily be a reason to preclude the study on ethical grounds, but the information given to patients should
p.000005: set out the position unequivocally. In research on public health
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General/Other / Incapacitated
Searching for indicator incapacitated:
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p.000001: agreement on important areas of guidance.
p.000001:
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p.000002: 2
p.000002:
p.000002: Research involving human participants in developing societies
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: General principles
p.000002: The MRC's key ethical principles, outlined in Responsibility in Investigations on Human Participants and Material and
p.000002: on Personal Information, 1992, apply to research conducted in developing societies:
p.000002: 1. The research must be of potential scientific or practical value: it must address an important question, and
p.000002: be feasible and well-designed.The scientific rationale for conducting the research must be sound.
p.000002: 2. The research must use the minimum number of human participants consistent with the objectives of the study,
p.000002: without compromising the integrity and validity of the research.
p.000002: 3. The potential and known risks of the research, as well as its potential benefits to the participants or
p.000002: others, must be considered by both participants and investigators.
p.000002: 4. The research must whenever possible be done only with the full and informed consent of the individual
p.000002: participants. Particular restrictions and safeguards are required when this is not possible (eg, emergency situations,
p.000002: mentally incapacitated individuals, children).
p.000002: 5. There must be neither inducement nor coercion to
p.000002: participate. However, for certain types of research without a therapeutic component participants may be recompensed for
p.000002: their expense, time, and inconvenience.
p.000002: 6. The research should be done only with the approval of an appropriate independent research ethics body, in
p.000002: addition to which the MRC always considers the ethical propriety of the proposals.
p.000002:
p.000003: 3
p.000003:
p.000003: Research involving human participants in developing societies
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 7. Information about identifiable individuals derived from the research must be regarded as confidential, and
p.000003: appropriate safeguards must be in place governing access to such information by others.
p.000003: 8. The research must conform to all relevant legal requirements.
p.000003: In addition, investigators are expected to follow other MRC guidance as appropriate:
p.000003: • MRC policy on antiretroviral therapy (ART) for people infected with HIV and involved in research in developing
p.000003: countries: general guidance notes for consideration, 2002.
p.000003: • MRC guidelines for good clinical practice in clinical trials, 1998, which are based on the principles of the
p.000003: International Conference on Harmonisation harmonised tripartite guideline, Good Clinical Practice: Consolidated
p.000003: Guideline, 1997.
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000001: eight. Although there is some difference of opinion in the published sources, there is also a large measure of
p.000001: agreement on important areas of guidance.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: Research involving human participants in developing societies
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: General principles
p.000002: The MRC's key ethical principles, outlined in Responsibility in Investigations on Human Participants and Material and
p.000002: on Personal Information, 1992, apply to research conducted in developing societies:
p.000002: 1. The research must be of potential scientific or practical value: it must address an important question, and
p.000002: be feasible and well-designed.The scientific rationale for conducting the research must be sound.
p.000002: 2. The research must use the minimum number of human participants consistent with the objectives of the study,
p.000002: without compromising the integrity and validity of the research.
p.000002: 3. The potential and known risks of the research, as well as its potential benefits to the participants or
p.000002: others, must be considered by both participants and investigators.
p.000002: 4. The research must whenever possible be done only with the full and informed consent of the individual
p.000002: participants. Particular restrictions and safeguards are required when this is not possible (eg, emergency situations,
p.000002: mentally incapacitated individuals, children).
p.000002: 5. There must be neither inducement nor coercion to
p.000002: participate. However, for certain types of research without a therapeutic component participants may be recompensed for
p.000002: their expense, time, and inconvenience.
p.000002: 6. The research should be done only with the approval of an appropriate independent research ethics body, in
p.000002: addition to which the MRC always considers the ethical propriety of the proposals.
p.000002:
p.000003: 3
p.000003:
p.000003: Research involving human participants in developing societies
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 7. Information about identifiable individuals derived from the research must be regarded as confidential, and
p.000003: appropriate safeguards must be in place governing access to such information by others.
p.000003: 8. The research must conform to all relevant legal requirements.
p.000003: In addition, investigators are expected to follow other MRC guidance as appropriate:
p.000003: • MRC policy on antiretroviral therapy (ART) for people infected with HIV and involved in research in developing
p.000003: countries: general guidance notes for consideration, 2002.
p.000003: • MRC guidelines for good clinical practice in clinical trials, 1998, which are based on the principles of the
...
General/Other / cioms guidelines
Searching for indicator cioms:
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p.000006: participant to consult a senior family member or community leader should be respected, and in some cases this person
p.000006: may need to be consulted first. A permanent personalised record of consent should be retained, although this need not
p.000006: necessarily be in the form of a signature.
p.000006: 9. There should be discussion in advance with relevant parties in the developing society about the plans for
p.000006: research and about dissemination of results to study participants and local people. In anticipation of any beneficial
p.000006: results of research with a therapeutic component, the discussion should include how the product/intervention being
p.000006: evaluated might be made available locally after the study.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Research involving human participants in developing societies
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Further reading
p.000007: 1. World Medical Association (WMA). World Medical Association Declaration of Helsinki: ethical principles for
p.000007: medical research involving human subjects. As adopted by the 52nd WMA General Assembly, 2000, with note of
p.000007: clarification on paragraph 29 added 2002.
p.000007: 2. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health
p.000007: Organization (WHO). International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS,
p.000007: 2002.
p.000007: 3. Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries. London:
p.000007: Nuffield Council on Bioethics, 2002.
p.000007: 4. Council of Europe Steering Committee on Bioethics. Additional protocol to the Convention on Human Rights and
p.000007: Biomedicine, on biomedical research. Strasbourg: Council of Europe, 2004.
p.000007: 5. European Group on Ethics in Science and New Technologies to the European Commission. Opinion Nr 17 on ethical
p.000007: aspects of clinical research in developing countries. Luxembourg: Office for Official Publications of the European
p.000007: Communities, 2003/04.
p.000007: 6. European Council and European Parliament. Directive 2001/20/EC of the European Parliament and the Council on
p.000007: the approximation of the laws, regulations and administrative provisions of the Member States relating to
p.000007: implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, April
p.000007: 2001, adopted by Member States 2003, to be applied with effect from May 2004.
p.000007:
p.000008: 8
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Medical Research Council
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000006: particular, all prospective participants must fully understand that their
p.000006: participation is entirely voluntary and that they are free to refuse to participate or withdraw at any time without
p.000006: loss of any entitlement. Although there is no substitute for individual consent, the cultural need for the potential
p.000006: participant to consult a senior family member or community leader should be respected, and in some cases this person
p.000006: may need to be consulted first. A permanent personalised record of consent should be retained, although this need not
p.000006: necessarily be in the form of a signature.
p.000006: 9. There should be discussion in advance with relevant parties in the developing society about the plans for
p.000006: research and about dissemination of results to study participants and local people. In anticipation of any beneficial
p.000006: results of research with a therapeutic component, the discussion should include how the product/intervention being
p.000006: evaluated might be made available locally after the study.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Research involving human participants in developing societies
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Further reading
p.000007: 1. World Medical Association (WMA). World Medical Association Declaration of Helsinki: ethical principles for
p.000007: medical research involving human subjects. As adopted by the 52nd WMA General Assembly, 2000, with note of
p.000007: clarification on paragraph 29 added 2002.
p.000007: 2. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health
p.000007: Organization (WHO). International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS,
p.000007: 2002.
p.000007: 3. Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries. London:
p.000007: Nuffield Council on Bioethics, 2002.
p.000007: 4. Council of Europe Steering Committee on Bioethics. Additional protocol to the Convention on Human Rights and
p.000007: Biomedicine, on biomedical research. Strasbourg: Council of Europe, 2004.
p.000007: 5. European Group on Ethics in Science and New Technologies to the European Commission. Opinion Nr 17 on ethical
p.000007: aspects of clinical research in developing countries. Luxembourg: Office for Official Publications of the European
p.000007: Communities, 2003/04.
p.000007: 6. European Council and European Parliament. Directive 2001/20/EC of the European Parliament and the Council on
p.000007: the approximation of the laws, regulations and administrative provisions of the Member States relating to
p.000007: implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, April
...
General/Other / participants in a control group
Searching for indicator control group:
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p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Research involving human participants in developing societies
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Specific considerations
p.000004: Over and above these general principles, the conduct of MRC- sponsored research in developing societies should follow
p.000004: the specific guidance listed below.
p.000004: 1. Organisations from developed countries should not normally support research, in pursuit of their own goals,
p.000004: involving people in developing societies if that research could be carried out reasonably well in a developed
p.000004: community.
p.000004: 2. Special care must be taken to ensure that the social and economic characteristics of the developing society,
p.000004: or poor communications, do not diminish the researchers' respect for the rights and interests of the people involved,
p.000004: or the community as a whole.
p.000004: 3. The reason for undertaking the research will usually be its relevance to the health/healthcare needs of the
p.000004: community in which it is carried out, either in the short-term or long-term.
p.000004: 4. Research on topics without a therapeutic component needs especially careful scrutiny, taking account of the
p.000004: balance of risks and benefits to participants in the particular circumstances and setting of the study.
p.000004: 5. When setting the standard of care, the MRC follows the recommendation of the Nuffield Council on Bioethics,
p.000004: 2002:
p.000004: "For the control group in a particular research study… wherever appropriate participants in the control group should be
p.000004: offered a universal standard of care for the disease being studied. Where it is not appropriate to offer a universal
p.000004: standard of care, the minimum standard of care
p.000005: 5
p.000005:
p.000005: Research involving human participants in developing societies
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: that should be offered to the control group is the best intervention available for that disease as part of the national
p.000005: public health system."
p.000005: The fact that a treatment tested in a trial may not currently be affordable to the local population should not in
p.000005: itself necessarily be a reason to preclude the study on ethical grounds, but the information given to patients should
p.000005: set out the position unequivocally. In research on public health
p.000005: interventions to benefit a host country, the use of locally practicable standards of care may be required.
p.000005: 6. With respect to placebo-controlled trials, the MRC follows the recommendation of the Council for
p.000005: International Organizations of Medical Sciences, 2002, that placebo may be used:
p.000005: "…when use of an established effective intervention as comparator would not yield scientifically reliable results and
p.000005: use of placebo would not add any risk of serious or irreversible harm."
p.000005: 7. Ethics review should take place in the UK and in the host country. Local ethics review of research proposals
p.000005: is required to judge the ethical acceptability of the research in accordance with the customs and traditions of the
p.000005: community concerned. As with research conducted in developed societies, the local ethics committee members should
...
Searching for indicator placebo:
(return to top)
p.000004: 4. Research on topics without a therapeutic component needs especially careful scrutiny, taking account of the
p.000004: balance of risks and benefits to participants in the particular circumstances and setting of the study.
p.000004: 5. When setting the standard of care, the MRC follows the recommendation of the Nuffield Council on Bioethics,
p.000004: 2002:
p.000004: "For the control group in a particular research study… wherever appropriate participants in the control group should be
p.000004: offered a universal standard of care for the disease being studied. Where it is not appropriate to offer a universal
p.000004: standard of care, the minimum standard of care
p.000005: 5
p.000005:
p.000005: Research involving human participants in developing societies
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: that should be offered to the control group is the best intervention available for that disease as part of the national
p.000005: public health system."
p.000005: The fact that a treatment tested in a trial may not currently be affordable to the local population should not in
p.000005: itself necessarily be a reason to preclude the study on ethical grounds, but the information given to patients should
p.000005: set out the position unequivocally. In research on public health
p.000005: interventions to benefit a host country, the use of locally practicable standards of care may be required.
p.000005: 6. With respect to placebo-controlled trials, the MRC follows the recommendation of the Council for
p.000005: International Organizations of Medical Sciences, 2002, that placebo may be used:
p.000005: "…when use of an established effective intervention as comparator would not yield scientifically reliable results and
p.000005: use of placebo would not add any risk of serious or irreversible harm."
p.000005: 7. Ethics review should take place in the UK and in the host country. Local ethics review of research proposals
p.000005: is required to judge the ethical acceptability of the research in accordance with the customs and traditions of the
p.000005: community concerned. As with research conducted in developed societies, the local ethics committee members should
p.000005: include lay people qualified to represent the cultural and moral values of their community as well as professionals.The
p.000005: committee should be chaired by someone entirely independent of the research and have at least one other independent
p.000005: member.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: Research involving human participants in developing societies
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 8. Special care should be taken to obtain genuine informed consent from participants, including the use of
p.000006: reliable intermediaries as appropriate to ensure that the implications of participation are fully understood. In
p.000006: particular, all prospective participants must fully understand that their
p.000006: participation is entirely voluntary and that they are free to refuse to participate or withdraw at any time without
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| children | Child |
| cioms | cioms guidelines |
| control group | participants in a control group |
| difference of opinion | philosophical differences/differences of opinion |
| emergency | Public Emergency |
| family | Motherhood/Family |
| helsinki | declaration of helsinki |
| incapacitated | Incapacitated |
| mentally | Mentally Disabled |
| opinion | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| poor | Economic/Poverty |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| control group | ['placebo'] |
| difference of opinion | ['opinion'] |
| opinion | ['differenceXofXopinion'] |
| placebo | ['controlXgroup'] |
Trigger Words
coercion
consent
cultural
developing
ethics
harm
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input