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

Published online by Cambridge University Press:  29 April 2021

Extract

This paper presents first an account of informed consent as it is envisioned and ethically grounded in the Western world. Next there is a discussion of why the Western model is unsuitable in much of the remainder of the world where the concept of “person” differs substantially from that of Western societies. This is followed by some comments on the current controversy on whether ethical standards should be regarded as universally applicable or, rather, whether some degree of ethical and cultural relativism is to be regarded as legitimate. After providing preliminary responses to some questions posed by the Conference Programme Committee, the paper concludes with a proposal for a procedural approach to the resolution of problems with informed consent.

Type
Article
Copyright
Copyright © American Society of Law, Medicine and Ethics 1991

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References

Reprinted in Levine, R.J.: Ethics and Regulation of Clinical Research. Urban & Schwarzenberg, Baltimore & Munich, Second Edition, 1986.Google Scholar
The National Commission and the ethical principles are discussed more extensively in Levine, supra note 1.Google Scholar
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.Google Scholar
45 CFR 46.116.Google Scholar
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. 1630.Google Scholar
De Craemer, W., “A Cross-Cultural Perspective on Personhood”, Milbank Memorial Fund Quarterly 61:1934, Winter 1983.CrossRefGoogle Scholar
Angell, M., “Ethical Imperialism? Ethics in International Collaborative Clinical Research”. New England Journal of Medicine 319:10811083, 1988.Google Scholar
Barry, M., “Ethical Considerations of Human Investigation in Developing Countries: The AIDS Dilemma”. New England Journal of Medicine 319:10831086, 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.CrossRefGoogle Scholar
Pappaioanou, M. et al., “The Family of HIV Seroprevalence Studies: Objectives, Methods and Uses of Sentinel Surveillance in the United States”. Public Health Reports 105(2):113119, 1990.Google Scholar
Bayer, R. Lumey, L.H. and Wan, L., “The American, British and Dutch Responses to Unlinked Anonymous HIV Seroprevalence Studies: An International Comparison”. AIDS 4:283290, 1990, reprinted in this issue of Law, Medicine and Health Care, 19:3–4.CrossRefGoogle Scholar
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.Google Scholar
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.Google Scholar
See De Craemer, supra note 6 and Levine, supra note 5.Google Scholar
Hall, A.J., “Public Health Trials in West Africa: Logistics and Ethics”. IRB: A Review of Human Subjects Research 11 (No. 5):810, Sept/Oct 1989. See also Christakis, supra note 8.Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar