Informed Consent: Some Challenges to the Universal Validity of the Western Model

Reprinted in Levine R.J. : Ethics and Regulation of Clinical Research. Urban & Schwarzenberg, Baltimore & Munich, Second Edition, 1986.

The National Commission and the ethical principles are discussed more extensively in Levine, supra note 1.

Statement from the consultation on criteria for international testing of candidate HIV vaccines. World Health Organization, Global Programme on AIDS, Geneva, 27 February-2 March, 1989.

45 CFR 46.116.

Levine R.J. , “Validity of Consent Procedures in Technologically Developing Countries. In: Human Experimentation and Medical Ethics. Ed. by Bankowski Z. and Howard-Jones N. , Council for International Organizations of Medical Sciences, Geneva, 1982, pp. 16–30.

De Craemer W. , “A Cross-Cultural Perspective on Personhood”, Milbank Memorial Fund Quarterly 61:19–34, Winter 1983.

Angell M. , “Ethical Imperialism? Ethics in International Collaborative Clinical Research”. New England Journal of Medicine 319:1081–1083, 1988.

Barry M. , “Ethical Considerations of Human Investigation in Developing Countries: The AIDS Dilemma”. New England Journal of Medicine 319:1083–1086, 1988; Christakis N.A. , “Responding to a Pandemic: International Interests in AIDS Control”. Daedalus 118 No. 2):113–114, 1989; and Christakis N.A. , “Ethical Design of an AIDS Vaccine Trial in Africa”. Hastings Center Report 18 (No. 3):31–37, June/July, 1988.

Pappaioanou M. , “The Family of HIV Seroprevalence Studies: Objectives, Methods and Uses of Sentinel Surveillance in the United States”. Public Health Reports 105(2):113–119, 1990.

Bayer R. Lumey L.H. and Wan L. , “The American, British and Dutch Responses to Unlinked Anonymous HIV Seroprevalence Studies: An International Comparison”. AIDS 4:283–290, 1990, reprinted in this issue of Law, Medicine and Health Care, 19:3–4.

Windom R.E. , Assistant Secretary for Health, policy on informing those tested about HIV serostatus, letter to PHS agency heads, Washington, DC, May 9, 1988.

Proposed International Guidelines for Biomedical Research Involving Human Subjects, A Joint Project of the World Health Organization and the Council for International Organizations of Medical Sciences, CIOMS, Geneva, 1982.

See De Craemer, supra note 6 and Levine, supra note 5.

Hall A.J. , “Public Health Trials in West Africa: Logistics and Ethics”. IRB: A Review of Human Subjects Research 11 (No. 5):8–10, Sept/Oct 1989. See also Christakis, supra note 8.

Levine R.J. and Mariner W.K. , “Proposed Guidelines for International Testing of Vaccines and Drugs Against HIV Infection and AIDS”, prepared at the request of WHO, Global Programme on AIDS and submitted January 5, 1990.

Such recognition could be accomplished by incorporating these elements and standards in the planned revision of the WHO/CIOMS Proposed International Guidelines. This, of course, would be appropriate only after due deliberation and modification as necessary.

There are other matters that the ethical review system in the initiating country will be less capable of reviewing than will that in the host country. For examples, considerations of privacy and confidentiality and equitable selection of subjects require a high degree of familiarity with the customs of the community in which the research is to be conducted. Such matters are beyond the scope of the present discussion.