Applicability of Applicability of principlesprinciples

Reidar K. Lie, MD, PhDReidar K. Lie, MD, PhD

Department of Clinical Bioethics, Department of Clinical Bioethics, NIH and University of Bergen, NIH and University of Bergen,

NorwayNorway

DisclaimerDisclaimer

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

Informed consentInformed consent

Probably the principle of research Probably the principle of research ethics that has received the most ethics that has received the most attentionattention

In the literature a claim that informed In the literature a claim that informed consent is a Western concept and not consent is a Western concept and not applicable in other settingsapplicable in other settings

Issue of VCT in HIV prevention and Issue of VCT in HIV prevention and treatment settingstreatment settings

Relativity of standardRelativity of standard

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

CIOMS 1993CIOMS 1993 All reasonable efforts should be made to obtain the All reasonable efforts should be made to obtain the

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

CIOMS, 2002CIOMS, 2002

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

Reasons for misconceptionReasons for misconception

Principle of informed consent is not Principle of informed consent is not understood properlyunderstood properly

The status of the existing empirical The status of the existing empirical evidence for claimed cultural evidence for claimed cultural differencesdifferences

Confusion of the moral principle of Confusion of the moral principle of informed consent with the need for informed consent with the need for education and persuasioneducation and persuasion– Need to correct misconception of HIV Need to correct misconception of HIV

vaccines, e.g.vaccines, e.g.

Reasons, more fundamentalReasons, more fundamental

Lack of focus on risk-benefit Lack of focus on risk-benefit evaluation of the researchevaluation of the research

False belief that adequately informed False belief that adequately informed consent will protect research consent will protect research participants against harmparticipants against harm

ConclusionConclusion

Debate over informed consent Debate over informed consent demonstrates that there is a need to demonstrates that there is a need to focus on other issues:focus on other issues:– More effective mechanisms of protection More effective mechanisms of protection

against research risksagainst research risks– More effective mechanisms of protection More effective mechanisms of protection

against ‘exploitation’against ‘exploitation’