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Existing International Ethical Guidelines for Human Subjects Research: Some Open Questions

Published online by Cambridge University Press:  29 April 2021

Nicholas A. Christakis  and
Morris J. Panner
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Extract

International guidelines regarding ethics, and in particular the ethics of clinical research, are problematic on two broad levels. First, by asserting their universality, “international” guidelines obscure real and legitimate crosscultural differences in ethical expectations. International guidelines seek to make homogeneous something which is not necessarily so. Second, existing guidelines are ambiguous about their objectives and purposes. On the one hand, guidelines are structured as a set of goals, largely aspirational in language and content. But on the other hand, such guidelines also suggest a normative function, providing a set of standards by which to judge and, if appropriate, sanction investigators’ conduct.

These criticisms are not intended to argue that international guidelines are useless. Nor are they intended to question the good faith under which such guidelines are developed. Rather, we wish to suggest that the role of present international guidelines is somewhat more limited than is ordinarily appreciated.

Type
Article
Information
Law, Medicine and Healthcare , Volume 19 , Issue 3-4 , Fall Winter 1991 , pp. 214 - 221
Copyright
Copyright © American Society of Law, Medicine and Ethics 1991

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References

For more details regarding this debate and regarding the social origin of ethical rules, see Christakis, N.A., “Ethics are Local: An Ethnographic Perspective on the Ethical Conduct of Trans-Cultural Clinical Research”, forthcoming, and Christakis, N.A. and Levine, R.J., “Multinational Research”, in Reich, W.T., Encyclopedia of Bioethics (New York: Macmillan, forthcoming, 1992).Google Scholar
United States, Defense Department, “The Nuremberg Code,”: U.S. v. Karl Brandt, Trials of War Criminals before Nuremberg Military Tribunals under Control Law No. 10, (Washington: Government Printing Office, 1947) vol. 2, p. 181–183, hereafter, “Nuremberg Code.”Google Scholar
World Medical Assembly, “Declaration of Helsinki,”: As revised in 1975, available in Levine, R.J., Ethics and Regulation of Clinical Research (New Haven: Yale University Press, 1986).Google Scholar
Christakis, N.A. and Levine, R.J., “Multinational Research”, op. cit. For some specific examples of socio-cultural determinants of bioethical decision-making, see, for example, Levin, B.W., “International Perspectives on Treatment Choice in Neonatal Intensive Care Units”, Social Science and Medicine, 30 (8)(1990):901–912.Google Scholar
Council for International Organizations of Medical Sciences, Proposed International Guidelines for Biomedical Research Involving Human Subjects, (CIOMS: Geneva, 1982), hereafter CIOMS Guidelines.Google Scholar
CIOMS Guidelines, p. 7, emphasis ours.Google Scholar
CIOMS Guidelines, p. 8.Google Scholar
CIOMS Guidelines, p. 26–27.Google Scholar
Community leader consent may be the only alternative—however unsatisfactory by Western standards—to individual consent in many cases where beneficial research is essential. This alternative may not necessarily be ethically incorrect for the society of which the research subject is a member. Western investigators should also appreciate that what appears to them to be coercion may, from the perspective of local inhabitants, represent cooperation and identification with the groups to which the individual belongs. This observation, however, does not relieve Western investigators of the responsibility to avoid coercion arising from their own actions.Google Scholar
CIOMS Guidelines, p. 17.Google Scholar
“Universal Declaration of Human Rights,” G.A. Res. 217A(III), U.N. GAOR Res. 71, U.N. Doc. A/810 (1948), hereafter “Universal Declaration.”Google Scholar
Regarding Nazi medicine, see: Lifton, R.J., The Nazi Doctors: Medical Killing and the Psychology of Genocide, (New York: Basic Books, 1986).Google Scholar
Oppenheim, L., International Law: A Treatise, 2nd ed., 1912, vol. 1, p. 362.Google Scholar
Henkin, L., The Age of Rights, (New York: Columbia University Press, 1990), p. 193.Google Scholar
For example, it is unclear that existing international standards reflect a truly wide-based consensus regarding clinical research, developed, as they were, to reflect largely Western ethical ideals, and unrecognizant, as they are, of real situations in the developing world. Indeed, even when seen from within a Western perspective, existing codes for clinical research ethics often draw heavily from analytic philosophy, ignoring other equally important Western approaches, such as existentialism, communitarianism, and so forth. For some discussion of possible approaches to potentially disparate research ethics, see: Christakis, N.A., “Ethics are Local,”: Op. cit.Google Scholar
See, for example, Steiner, H., “The Youth of Rights (Review of Henkin: The Age of Rights)”, Harvard Law Review 104 (1991): 917.CrossRefGoogle Scholar
See, for example: “The International Covenant on Economic, Social, and Cultural Rights,” G.A. Res. 2200 (XXI), 21 U.N. GAOR Supp. (No. 16), at p. 49, U.N. Doc. A.6316 (1966) (entered into force Jan. 3, 1976); “International Covenant on Civil and Political Rights,” G.A. Res. 2200 (XXI), 21 U.N. GAOR Supp. (No. 16), at p. 52, U.N. Doc. A/6316 (1966) (entered into force Mar. 23, 1976); “International Convention of the Elimination of All Forms of Racial Discrimination,” Dec. 21, 1965, G.A. Res. 2106 A (XX), U.N. Gaor Supp. (No. 14), at p. 47, U.N. Doc. A/6014 (1965); “Convention on the Elimination of All Forms of Discrimination Against Women,” Dec. 18, 1979, G.A. Res. 34/180, 34 U.N. GAOR Supp. (No. 46) at p. 193, U.N. Doc. A/34/46 (1979).Google Scholar
An-Na'im, A.A., “Human Rights in the Muslim World: Socio-Political Conditions and Scriptural Imperatives”, Harvard Human Rights Journal 3(1990): 13–52; Steiner, , op. cit., p. 934.Google Scholar
Steiner, , op. cit., p. 927.Google Scholar
For more detail, see Levine, R.J., “Informed Consent: Some Challenges to the Universal Validity of the Western Model”, paper presented at the XXV CIOMS Round Table Conference, Geneva, 7-9 November 1990, published in this edition of Law, Medicine & Health Care 19:3-4, Fall-Winter, 1991 We have been greatly influenced by Levine's thinking.Google Scholar
Christakis, N.A., “The Ethical Design of an AIDS Vaccine Trial in Africa”, Hastings Center Report, 18(3)(1988): 31–37.CrossRefGoogle Scholar
Barry, M., “Ethical Considerations of Human Investigation in Developing Countries: The AIDS Dilemma”, New England Journal of Medicine, 319(19)(1988): 1083–1086; Hamilton, D.P., “News and Comment—African AIDS: Whose Research Rules?” Science, (October 12, 1990): 199–200. See also: Angell, M., “Ethical Imperialism? Ethics in International Collaborative Clinical Research”, New England Journal of Medicine, 319(16)(1988): 1081–1083.Google Scholar
Hall, A.J., “Public Health Trials in West Africa: Logistics and Ethics”, IRB: A Review of Human Subjects Research, 11(5)(1989): 8–10.Google Scholar
Christakis, N.A. Lynn, L.A. and Castelo, A., “Clinical AIDS Research that Evaluates Cost-Effectiveness in the Developing World”, IRB: A Review of Human Subjects Research, 13(3)(1990): 4–7.Google Scholar
International ethical guidelines for clinical research also serve, as an incidental and implicit goal, to legitimate human experimentation in general and its conduct by physicians in particular; the presumption is that no one other than a doctor may permissibly conduct such research; the medical profession, in a way, arrogated to itself this unique activity.Google Scholar
The original case appears as: Quill, T.E. “Death and Dignity—A Case of Individualized Decision-Making”, New England Journal of Medicine, 324(10)(1991): 691–694.Google Scholar
Such negotiations need not be necessarily based on national boundaries. Such negotiation could also take place within a given country as well as between two countries. See generally: Englehart, H.T., The Foundations of Bioethics, (New York: Oxford University Press, 1986), on the role of “peaceable negotiation” in the resolution of disparate ethical expectations within a community (at pp. 23–65).Google Scholar
In this regard, the question of the composition of international bodies and the ability of alternative voices to be heard is critical. To date, international bodies have tended to mirror the distribution of power within the world. The more powerful, principally Western nations have dominated the debate. Although Western representatives are often commendably sensitive to the concerns of the developing world, this is no substitute for actual participation by those nations themselves.Google Scholar
See: Schacter, X., “The Obligation of the Parties to Give Effect to the Covenant on Civil and Political Rights”, American Journal of International Law, 73 (1979): 462 ff.; Lillich, R.B., “The United States Constitution and International Human Rights Law”, Harvard Human Rights Journal, 3 (1990): 53–82.Google Scholar
Annas, G.J., “Mengele's Birthmark: The Nuremberg Code in United States Courts”, Journal of Contemporary Health Law and Policy, 7 (1991): 17–45; see also Lillich, R.B., “Invoking Human Rights Law in Domestic Courts”, University of Cincinnati Law Review, 54 (1985): 367 ff.Google Scholar
Schacter, , op. cit.Google Scholar
See also Levine, , “Informed Consent: Some Challenges to the Universal Validity of the Western Model”, op. cit., for another set of procedural guidelines.Google Scholar
Many formal methods to ensure fair and open dialogue exist; for example, see: Broome, B.J. and Christakis, A.N., “A Culturally Sensitive Approach to Tribal Governance Issue Management”, International Journal of Intercultural Relations, 12 (1988): 107–123.Google Scholar
Orentlicher, D., “Bearing Witness: The Art and Science of Human Rights Fact Finding”, Harvard Human Rights Journal, 3 (1990): 83–136.Google Scholar