Ethical Principles for the Conduct of Human Subject Research: Population-Based Research and Ethics

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Office of Protection from Research Risks, U.S. Public Health Service: Bethesda, Md., April 18, 1979; Levine R.J. , Ethics and Regulation of Clinical Research. Yale University Press: New Haven, 2d ed. 1988.

Nuremberg Code 1947, printed in Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, vol. II (Washington, DC: U.S. Government Printing Office, 1949, at 181–182); World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, revised by the 29th WHA, Tokyo, Japan, 1975, and the 35th WHA in Venice, Italy, 1983. Reprinted in Medical Ethics Declarations. World Medical Journal. 1984; 31:4; World Health Organization and Council for International Organizations of Medical Sciences. Proposed International Guidelines for Biomedical Research Involving Human Subjects. Geneva, 1982.

Law Reform Commission of Canada. Biomedical Experimentation Involving Human Subjects: Working Paper 61. Ottawa, 1989; U.S. Department of Health and Human Services Rules and Regulations, 45 CFR 46C (Revised as of March 8, 1983); French Consel d'Etat. De l'ethique au droit. Paris 1988.

Gostin L. , “Collective and Individual Rights: Towards Resolving the Conflict”. In: Gostin L. (ed), Civil Liberties in Conflict, Routledge: London and New York, 1988.

Levine R.J. , supra note 1 at 52.

Geneva Declaration 1948, amended 1968, reprinted in Medical Ethics Declarations. World Medical Journal 1984;31:3.

Ajayi O.O. , “Taboos and Clinical Research in West Africa”, J. Med. Ethics 1980;6061–63.

The Belmont Report, supra note 1.

Nuremberg Code, supra note 1, first principle.

Declaration of Helsinki, supra note 2, article I, 9.

WHO/CIOMS, supra note 2, at 23–24.

Council of Europe. Recommendation No. R(90)3 Concerning Medical Research on Human Beings (6 Feb. 1990).

Hill G.J. , “Research on humans published in JAMA” (letter). J. Amer. Med. Assn. 1987; 258:1604.

Ekunwe E.O. and Kessel R. , “Informed Consent in the Developing World”, Hastings Cen. Rep. 1984; 14:23–24.

U.S. Department of Health and Human Services, Rules and Regulations, 45 CFR 46, para. 46.116 (Revised as of March 8, 1983). Yet, some highly developed countries expressly reject the concept of informed consent. Sidaway v. Bethlehem Royal Hospital Governors [1985] A.C. 871.

Christakis N.A. , “The Ethical Design of an AIDS Vaccine Trial in Africa”. Hastings Center Rpt. 1988;18:31–37.

Ajayi O.O. , supra note 7; Adityanjee D. , “Informed Consent: Issues Involved for Developing Countries”. Med. Sci. & Law 1986; 26: 305–307; WHO/CIOMS, supra note 2; Levine R.J. , “Validity of Consent Procedures in Technologically Developing Countries. In: Human Experimentation and Medical Ethics,” Bankowski Z. Howard-Jones N. , eds. Geneva: CIOMS, 1982, pp.16–30.

Indian Council of Medical Research. Policy statement on ethical considerations involved in research on human subjects 1980; New Delhi, ICMR.

Hall A.J. , “Public Health Trials in West Africa: Logistics and Ethics”. IRB 1989; 11:8–10.

Henderson , “Assessment of Vaccination Coverage, Vaccination Scar Rates and Small Pox Scarring in Five Areas of West Africa”. Bull. WHO 1973;84:183–194.

Ajayi O.O. , supra note 7.

Adityanjee D. , supra note 17; Ajayi O.O. , supra note 7.

World Health Organization. Criteria for international testing of candidate HIV vaccines, 27 February – 2 March, 1989.

WHO/CIOMS, supra note 2.

WHO/CIOMS, supra note 2, paras. 14–15.

Hall A.J. , supra note 19.

Levine R.J. , supra note 5.

Centre for Human Rights, United Nations. The Rights of Indigenous Peoples. U.N.: Geneva, 1990.

Miller J. , “Towards an International Ethic for Research with Human Beings”. IRB 1988; 10:9–11.

Gostin L. , “The AIDS Litigation Project: A National Review of Court and Human Rights Commission Decisions, Part II: Discrimination”. J. Am. Med. Assn. 1990;263:2086–2093; PANOS Institute. The Third Epidemic: Repercussions of the fear of AIDS. 1990, PANOS, London.

Beauchamp T.L. Childress J. , Principles of Biomedical Ethics. Oxford University Press, New York. 2nd ed. 1983.

Levine R.J. , supra note 5; Kelman H.C. , “Privacy and Research with Human Beings”. J. Soc. Issues 1977; 33:169–195.

Bok S. , “The Limits of Confidentiality”. Hastings Ctr. Rpt. 1983;13:24–31.

Tarasoff v. Board of Regents of California (1976) 17 Cal.3d 452 (Tarasoff II), vacating 13 Cal.3d 117 (Tarasoff I).

Capron A. , “Protection of Research Subjects: Do Special Rules Apply in Epidemiology”. Paper presented at the IEF Conference on Ethics in Epidemiology, June 12–13, 1989, Birmingham, Alabama.

Tabor E. Gerety R.J. Cairns J. Bayley A.C. , “Did HIV and HTLV Originate in Africa?” (letter). JAMA 1990; 264: 691–692.

Gostin L. , “The Future of Public Health Law”. Amer. J. Law & Med. 1987;12:461–490.

WHO, supra note 2.

Christakis N.A. , “Responding to a Pandemic: International Interests in AIDS Control”. Daedalus 1989; 118:113–134.

Gilks F. and Were J.B.O. , “Ethical Imperialism” (letter) N. Engl. J. Med. 1990; 311:100

Angell M. , “Ethical Imperialism? Ethics in International Collaborative Clinical Research”. N. Engl. J. Med. 1990; 319:1081–1083.

Barry M. , “Ethical Considerations of Human Investigation in Developing Countries: The AIDS Dilemma”. N. Engl. J. Med. 1990; 319:1083–1086.