Guidelines for IRB review of international collaborative medical research: A proposal

Journal of Law, Medicine and Ethics

Volumn 27, Issue 1, 1999, Pages 87-94

  White, Mary Terrell ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ARTICLE; BEHAVIORAL RESEARCH; BIOMEDICAL AND BEHAVIORAL RESEARCH; CASE REPORT; CHINA; COMPLICITY; CONFIDENTIALITY; CONFLICT; CONSENSUS; COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES; CULTURAL ANTHROPOLOGY; DECISION MAKING; DEVELOPING COUNTRY; ETHICS; FINANCIAL MANAGEMENT; GROUP PROCESS; HEALTH CARE ORGANIZATION; HUMAN; HUMAN EXPERIMENT; HUMAN RIGHTS; INFORMED CONSENT; INTERNATIONAL COOPERATION; INTERPERSONAL COMMUNICATION; METHODOLOGY; MISCELLANEOUS NAMED GROUPS; MORALITY; ORGANIZATION AND MANAGEMENT; PATIENT SELECTION; PERSONNEL; POLITICS; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RESEARCH; RESEARCH SUBJECT; RISK; RISK ASSESSMENT; SOCIAL BEHAVIOR; SOCIAL PSYCHOLOGY; SOCIOECONOMICS; STANDARD; TRUST; UNITED STATES; VULNERABLE POPULATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH; COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES;

ACQUIRED IMMUNODEFICIENCY SYNDROME; BEHAVIORAL RESEARCH; CHINA; COMMITTEE MEMBERSHIP; COMPLICITY; CONFIDENTIALITY; CONSENSUS; CONSENT FORMS; CULTURAL DIVERSITY; DECISION MAKING; DEVELOPING COUNTRIES; DISCLOSURE; DISSENT AND DISPUTES; ETHICAL RELATIVISM; ETHICAL REVIEW; ETHICS; ETHICS COMMITTEES; ETHICS COMMITTEES, RESEARCH; FINANCIAL SUPPORT; GROUP PROCESSES; GUIDELINE ADHERENCE; GUIDELINES; HUMAN EXPERIMENTATION; HUMAN RIGHTS; HUMANS; INFORMED CONSENT; INTERNATIONAL COOPERATION; INTERNATIONALITY; MORALS; NEGOTIATING; ORGANIZATION AND ADMINISTRATION; PATIENT SELECTION; PERSONS; POLITICS; REFERENCE STANDARDS; RESEARCH; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUBJECTS; RISK; RISK ASSESSMENT; SOCIAL RESPONSIBILITY; SOCIAL VALUES; SOCIETIES; SOCIOECONOMIC FACTORS; TRUST; UNITED STATES; VULNERABLE POPULATIONS; WESTERN WORLD;

EID: 0033089498     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.1999.tb01440.x     Document Type: Review

References (35)

1. See A.J. Hall, "Public Health Trials in West Africa: Logistics and Ethics," IRB: A Review of Human Subjects Research, 11, no. 5 (1989): 8-10.
2. See M. Barry, "Ethical Considerations of Human Investigation in Developing Countries: The AIDS Dilemma," N. Engl. J. Med., 319 (1988): 1083-86.
3. See H. Varmus and D. Satcher, "Ethical Complexities of Conducting Research in Developing Countries," N. Engl. J. Med., 337 (1997): 1003-05.
4. See Federal Policy for the Protection of Human Subjects; Notices and Rules, 56 Fed. Reg. 28,002-31 (June 18, 1991).
5. See generally, D.J. Rothman, Strangers at the Bedside (New York: Basic Books, 1991).
6. See Regulations on the Protection of Human Subjects, 45 C.F.R. § 46.101(h).
7. See "The Nuremberg Code," in G.J. Annas and M.A. Grodin, eds., The Nazi Doctor and the Nuremberg Code: Human Rights in Human Experimentation (New York: Oxford University Press, 1992): at 2.
8. 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).
9. See Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993) [hereinafter CIOMS Guidelines].
10. See Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993) [hereinafter CIOMS Guidelines].
11. This statement suggests the Chinese were aware that subjects might be apprehensive about the consequences of being identified as carrying the human immunodeficiency virus.
12. See Y.G. Wang, "AIDS Policy and Bioethics: Ethical Dilemmas Facing China in HIV Prevention," Bioethics, 11 (1997): 323-27; B.R. Liu, "Legal Regulations of AIDS Detection and Administration in P.R. China," International Journal of Bioethics, 3 (1992): 25-27; and M.L. McCall, "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.
13. See Y.G. Wang, "AIDS Policy and Bioethics: Ethical Dilemmas Facing China in HIV Prevention," Bioethics, 11 (1997): 323-27; B.R. Liu, "Legal Regulations of AIDS Detection and Administration in P.R. China," International Journal of Bioethics, 3 (1992): 25-27; and M.L. McCall, "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.
14. See Y.G. Wang, "AIDS Policy and Bioethics: Ethical Dilemmas Facing China in HIV Prevention," Bioethics, 11 (1997): 323-27; B.R. Liu, "Legal Regulations of AIDS Detection and Administration in P.R. China," International Journal of Bioethics, 3 (1992): 25-27; and M.L. McCall, "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.
15. See R. Baker, "A Theory of International Bioethics: Multiculturalism, Postmodernism, and the Bankruptcy of Fundamentalism," Kennedy Institute of Ethics Journal, 8 (1998): 201-31.
16. See M. Angell, "Ethical Imperialism?: Ethics in International Collaborative Clinical Research," N. Engl. J. Med., 319 (1988): 1081-83.
17. See B. Barber, "The Ethics of Experimentation with Human Subjects," Scientific American, 234 (1976): 25-31.
18. See P.M. McNeill, C.A. Berglund, and I.W. Webster, "How Much Influence Do Various Members Have Within Research Ethics Committees?," Cambridge Quarterly of Healthcare Ethics, 3 (1994): 522-32; and J. Robertson, "Ten Ways to Improve IRBs," Hastings Center Report, 9, no. 1 (1979): 29-33.
19. See P.M. McNeill, C.A. Berglund, and I.W. Webster, "How Much Influence Do Various Members Have Within Research Ethics Committees?," Cambridge Quarterly of Healthcare Ethics, 3 (1994): 522-32; and J. Robertson, "Ten Ways to Improve IRBs," Hastings Center Report, 9, no. 1 (1979): 29-33.
20. See J.A. Robertson, "Taking Consent Seriously: IRB Intervention in the Consent Process," IRB: A Review of Human Subjects Research, 4, no. 5 (1982): 1-5.
21. See B.H. Gray, R.A. Cooke, and A.S. Tannenbaum, "Research Involving Human Subjects," Science, 201 (1978): 1094-101; and N.A. Christakis, "Should IRBs Monitor Research More Strictly?," IRB: A Review of Human Subjects Research, 10, no. 2 (1988): 8-10.
22. See B.H. Gray, R.A. Cooke, and A.S. Tannenbaum, "Research Involving Human Subjects," Science, 201 (1978): 1094-101; and N.A. Christakis, "Should IRBs Monitor Research More Strictly?," IRB: A Review of Human Subjects Research, 10, no. 2 (1988): 8-10.
23. See Barry, supra note 2; and L. Newton, "Ethical Imperialism and Informed Consent," IRB: A Review of Human Subjects Research, 12, no. 3 (1990): 10-11.
24. See Baker, supra note 12.
25. See R. Baker, "A Theory of International Bioethics: The Negotiable and the Non-Negotiable," Kennedy Institute of Ethics Journal, 8 (1998): 233-73; and N. Christakis, "Ethics are Local: Engaging Cross-Cultural Variation in the Ethics for Clinical Research," Social Science and Medicine, 35 (1992): 1079-91.
26. See R. Baker, "A Theory of International Bioethics: The Negotiable and the Non-Negotiable," Kennedy Institute of Ethics Journal, 8 (1998): 233-73; and N. Christakis, "Ethics are Local: Engaging Cross-Cultural Variation in the Ethics for Clinical Research," Social Science and Medicine, 35 (1992): 1079-91.
27. 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. 22. See World Medical Association, supra note 8; and Angell, supra note 13.
28. I borrow this expression from Baker, supra note 20.
29. 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 E.G. DeRenzo, "Decisionally Impaired Persons in Research: Refining the Proposed Refinements," Journal of Law, Medicine & Ethics, 25 (1997): at 146.
30. 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 E.G. DeRenzo, "Decisionally Impaired Persons in Research: Refining the Proposed Refinements," Journal of Law, Medicine & Ethics, 25 (1997): at 146.
31. See CIOMS Guidelines, supra note 9, Guideline 8, p. 27.
32. See N.A. Christakis and M.J. Panner, "Existing International Ethical Guidelines for Human Subjects Research: Some Open Questions," Law, Medicine & Health Care, 19 (1991): 214-21.
33. See CIOMS Guidelines, supra note 9, Guideline 15, pp. 45-46.
34. 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.
35. See Christakis and Panner, supra note 26.