1. Applicability of principles Reidar K. Lie, MD, PhD Department of Clinical Bioethics, NIH and University of Bergen, Norway

2. Disclaimer The opinions expressed are the author’s own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, or Department of Health and Human Services The opinions expressed are the author’s own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, or Department of Health and Human Services

3. Informed consent Probably the principle of research ethics that has received the most attention Probably the principle of research ethics that has received the most attention In the literature a claim that informed consent is a Western concept and not applicable in other settings In the literature a claim that informed consent is a Western concept and not applicable in other settings Issue of VCT in HIV prevention and treatment settings Issue of VCT in HIV prevention and treatment settings

4. Relativity of standard This brief survey of descriptions of relationships between health professionals in three cultures leads me to conclude that the informed consent standards of the Declaration of Helsinki are not universally valid … they do not reflect adequately the views held in these cultures of the nature of the person in his or her relationship to society… Robert Levine, 1992 This brief survey of descriptions of relationships between health professionals in three cultures leads me to conclude that the informed consent standards of the Declaration of Helsinki are not universally valid … they do not reflect adequately the views held in these cultures of the nature of the person in his or her relationship to society… Robert Levine, 1992

5. CIOMS 1993 All reasonable efforts should be made to obtain the informed consent of each prospective subject according to the standards specified in Guidelines 1 to 3, to that the rights of prospective subjects are respected ensure. For example, when because of communication difficulties investigators cannot make prospective subjects sufficiently aware of the implications of participation to give adequately informed consent, the decision of each prospective subject on whether to consent should be elicited through a reliable intermediary such as a trusted community leader. In some cases other mechanisms, approved by an ethical review committee, may be more suitable. All reasonable efforts should be made to obtain the informed consent of each prospective subject according to the standards specified in Guidelines 1 to 3, to that the rights of prospective subjects are respected ensure. For example, when because of communication difficulties investigators cannot make prospective subjects sufficiently aware of the implications of participation to give adequately informed consent, the decision of each prospective subject on whether to consent should be elicited through a reliable intermediary such as a trusted community leader. In some cases other mechanisms, approved by an ethical review committee, may be more suitable.

6. CIOMS, 2002 In some cultures an investigator may enter a community to conduct research or approach prospective subjects for their individual consent only after obtaining permission from a community leader, a council of elders, or another designated authority. Such customs must be respected. In no case, however, may the permission of a community leader or other authority substitute for individual informed consent. In some cultures an investigator may enter a community to conduct research or approach prospective subjects for their individual consent only after obtaining permission from a community leader, a council of elders, or another designated authority. Such customs must be respected. In no case, however, may the permission of a community leader or other authority substitute for individual informed consent.

7. Reasons for misconception Principle of informed consent is not understood properly Principle of informed consent is not understood properly The status of the existing empirical evidence for claimed cultural differences The status of the existing empirical evidence for claimed cultural differences Confusion of the moral principle of informed consent with the need for education and persuasion Confusion of the moral principle of informed consent with the need for education and persuasion –Need to correct misconception of HIV vaccines, e.g.

8. Reasons, more fundamental Lack of focus on risk-benefit evaluation of the research Lack of focus on risk-benefit evaluation of the research False belief that adequately informed consent will protect research participants against harm False belief that adequately informed consent will protect research participants against harm

9. Conclusion Debate over informed consent demonstrates that there is a need to focus on other issues: Debate over informed consent demonstrates that there is a need to focus on other issues: –More effective mechanisms of protection against research risks –More effective mechanisms of protection against ‘exploitation’