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Guidelines for IRB Review of International Collaborative Medical Research: A Proposal

Published online by Cambridge University Press:  01 January 2021

Mary Terrell White
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Extract

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.

In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 27 , Issue 1 , Spring 1999 , pp. 87 - 94
Copyright
Copyright © American Society of Law, Medicine and Ethics 1999

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References

See Hall, A.J., “Public Health Trials in West Africa: Logistics and Ethics,” IRB: A Review of Human Subjects Research, 11, no. 5 (1989): 8–10.CrossRefGoogle Scholar
See Barry, M., “Ethical Considerations of Human Investigation in Developing Countries: The AIDS Dilemma,” N. Engl. J. Med., 319 (1988): 1083–86.Google Scholar
See Varmus, H. and Satcher, D., “Ethical Complexities of Conducting Research in Developing Countries,” N. Engl. J. Med., 337 (1997): 1003–05.Google Scholar
See Federal Policy for the Protection of Human Subjects; Notices and Rules, 56 Fed. Reg. 28,002–31 (June 18, 1991).Google Scholar
See generally, Rothman, D.J., Strangers at the Bedside (New York: Basic Books, 1991).Google Scholar
See Regulations on the Protection of Human Subjects, 45 C.F.R. § 46.101(h).Google Scholar
See “The Nuremberg Code,” in Annas, G.J. and Grodin, M.A., eds., The Nazi Doctor and the Nuremberg Code: Human Rights in Human Experimentation (New York: Oxford University Press, 1992): at 2.Google Scholar
See World Medical Assembly, “World Medical Association Declaration of Helsinki,” in Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993): at 47–50 (citing 1989 Declaration of Helsinki).Google Scholar
See Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993) [hereinafter CIOMS Guidelines].Google Scholar
This statement suggests the Chinese were aware that subjects might be apprehensive about the consequences of being identified as carrying the human immunodeficiency virus.Google Scholar
See Wang, Y.G., “AIDS Policy and Bioethics: Ethical Dilemmas Facing China in HIV Prevention,” Bioethics, 11 (1997): 323–27; Liu, B.R., “Legal Regulations of AIDS Detection and Administration in P.R. China,” International Journal of Bioethics, 3 (1992): 25–27; and McCall, M.L., “AIDS Quarantine Law in the International Community: Health and Safety Measures or Human Rights Violations?,” Loyola of Los Angeles International and Comparative Law Annual, 15 (1993): 1001–28.Google Scholar
See Baker, R., “A Theory of International Bioethics: Multiculturalism, Postmodernism, and the Bankruptcy of Fundamentalism,” Kennedy Institute of Ethics Journal, 8 (1998): 201–31.Google Scholar
See Angell, M., “Ethical Imperialism?: Ethics in International Collaborative Clinical Research,” N. Engl. J. Med., 319 (1988): 1081–83.CrossRefGoogle Scholar
See Barber, B., “The Ethics of Experimentation with Human Subjects,” Scientific American, 234 (1976): 25–31.CrossRefGoogle Scholar
See McNeill, P.M. Berglund, C.A., and Webster, I.W., “How Much Influence Do Various Members Have Within Research Ethics Committees?,” Cambridge Quarterly of Healthcare Ethics, 3 (1994): 522–32; and Robertson, J., “Ten Ways to Improve IRBs,” Hastings Center Report, 9, no. 1 (1979): 29–33.Google Scholar
See Robertson, J.A., “Taking Consent Seriously: IRB Intervention in the Consent Process,” IRB: A Review of Human Subjects Research, 4, no. 5 (1982): 1–5.Google Scholar
See Gray, B.H. Cooke, R.A., and Tannenbaum, A.S., “Research Involving Human Subjects,” Science, 201 (1978): 1094–101; and Christakis, N.A., “Should IRBs Monitor Research More Strictly?,” IRB: A Review of Human Subjects Research, 10, no. 2 (1988): 8–10.Google Scholar
See Barry, supra note 2; and Newton, L., “Ethical Imperialism and Informed Consent,” IRB: A Review of Human Subjects Research, 12, no. 3 (1990): 10–11.Google Scholar
See Baker, supra note 12.Google Scholar
See Baker, R., “A Theory of International Bioethics: The Negotiable and the Non-Negotiable,” Kennedy Institute of Ethics Journal, 8 (1998): 233–73; and Christakis, N., “Ethics are Local: Engaging Cross-Cultural Variation in the Ethics for Clinical Re-search,” Social Science and Medicine, 35 (1992): 1079–91.Google Scholar
A negotiated ethic has been recommended previously, but not with specific reference to institutional review board (IRB) review. See Baker, supra note 20; and Christakis, supra note 20.Google Scholar
See World Medical Association, supra note 8; and Angell, supra note 13.Google Scholar
I borrow this expression from Baker, supra note 20.Google Scholar
This recommendation is consistent with the CIOMS guidelines. See CIOMS Guidelines, supra note 9, Guidelines 8 & 14. Evan DeRenzo makes a similar suggestion, that advocates for the mentally ill sit on IRBs looking at research with mentally impaired subjects. See DeRenzo, E.G., “Decisionally Impaired Persons in Research: Refining the Proposed Refinements,” Journal of Law, Medicine & Ethics, 25 (1997): at 146.CrossRefGoogle Scholar
See CIOMS Guidelines, supra note 9, Guideline 8, p. 27.Google Scholar
See Christakis, N.A. and Panner, M.J., “Existing International Ethical Guidelines for Human Subjects Research: Some Open Questions,” Law, Medicine & Health Care, 19 (1991): 214–21.CrossRefGoogle Scholar
See CIOMS Guidelines, supra note 9, Guideline 15, pp. 45–46.Google Scholar
Although I have modified them somewhat, the dual roles of the sponsoring and host IRBs are summarized in the CIOMS guidelines. See CIOMS Guidelines, supra note 9, Guideline 15, p. 44.Google Scholar
See Christakis, and Panner, supra note 26.Google Scholar