Research Bioethics in the Ugandan Context II: Procedural and Substantive Reform

Uganda National Council on Science and Technology, Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda sec. II.A [Guidelines] (Kampala: Author, 1998).

Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO), International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: Authors, 1993).

CIOMS, International Guidelines for Ethical Review of Epidemiological Studies (Geneva: Author, 1991).

Chap. 4, par. 2; Mukholi D. , A Complete Guide to Uganda's Fourth Constitution: History, Politics, and the Law (Kampala: Fountain Publishers, 1995).

Guidelines, supra note 1 at sec. II.E.

CIOMS, supra note 2.

Guidelines, supra note 1 at sec. I.C.

Joint United Nations Programme on HIV/AIDS, Report on the Global HIV/AIDS Epidemic (Geneva: World Health Organization, June 1998): 64–72.

Kunstatdler P. , “Medical Ethics in Cross-Cultural and Multi-Cultural Perspectives,” Social Science and Medicine, 14B (1980): 289–296.

Loue S. Okello D. , and Kawuma M. , “Research Bioethics in the Ugandan Context: A Program Summary,” Journal of Law, Medicine & Ethics, 24 (1996): 47–53; Loue S. Okello D. & Kawuma M. , “Bioethics and AIDS Research in Uganda,” [letter], AIDS, 10 (1996B): 932–933.

Caldwell J.C. Orubuloye I.O. , and Caldwell P. , “Under-reaction to AIDS in SubSaharan Africa,” in Orubuloye I.O. , eds., Sexual Networking and AIDS in SubSaharan Africa: Behavioral Research and the Social Context (Canberra: Australian National University, 1994): 217–234.

Obbo C. , “Women, Children, and a ‘Living Wage,’” in Hansen H.B. and Twaddle M. , eds., Changing Uganda (London: James Currey, 1991): 98–111; Center for International Health Information, Uganda: Country Health Profile (Arlington, Virginia: Author, 1995); Loue Okello , and Kawuma , supra note 10.

Mukama K.J. , “Recent Developments in the Language Situation and Prospects for the Future”, in Hansen and Twaddle , supra note 12, at 334–350; Mutibwa P. , Uganda Since Independence: A Story of Unfulfilled Hopes (Kampala: Fountain Publishers, 1992); Doornbos M. , Not All the King's Men: Inequality as a Political Instrument in Ankole, Uganda (The Hague: Mouton, 1978): 8–11.

Mutibwa , supra note 13; Bond G.C. and Vincent J. , “Living on the Edge: Changing Social Structures in the Context of AIDS,” in Hansen and Twaddle , supra note 12, at 113–129.

Nzita R. and Niwampa M. , Peoples and Cultures of Uganda, 2nd ed. (Kampala: Fountain Publishers, 1995).

Mutibwa , supra note 13.

Guidelines , supra note 1, at sec. III.B.

21 C.F.R. Parts 50,56,312 (1996); 45 C.F.R. Part 46 (1995).

CIOMS and WHO, supra note 2.

CIOMS, supra note 3.

Reprinted in Annas G.J. and Grodin M.A. , The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation (New York: Oxford University Press, 1992): 2.

Guidelines supra note 1, at sec. IV.A.

Loue Okello , and Kawuma , supra note 10.

Mutibwa , supra note 13; Bond and Vincent , supra note 14.

Guidelines, supra note 1, at sec. IV.A.

Macklin R. and Page A. , “Informed Consent: Proposed Findings and Recommendations,” Draft prepared for the National Bioethics Advisory Commission, (October 12, 1999), Finding 7, at page 4.

Id., Finding 9, at page 4.

Id., Recommendation 7, at page 4.

Id., Recommendation 9, at page 4.

World Medical Association, Declaration of Helsinki (Ferney-Voltaire, 1964, revised 1974, 1983, 1989, and 1996).

CIOMS, supra note 2.

21 C.F.R. Parts 50, 56, 312 (1996); 45 C.F.R. Part 46 (1995).

Bennett J.C. , “Inclusion of Women in Clinical Trials—Policies for Population Subgroups,” N. Engl. J. Med., 329 (1993): 288–291; Merkatz R.B. Temple R. Sobel S. Women in Clinical Trials of New Drugs—A Change in Food and Drug Administration New Policy,” N. Engl. J. Med., 329 (1993): 292–286.

Guidelines, supra note 1, at sec. IV.B.

Barton T. and Wamai G. , Equity and Vulnerability: A Situation Analysis of Women, Adolescents, and Children in Uganda (Kampala: Uganda National Council for Children, 1994).

Nzita and Niwampa , supra note 15.

Wallman S. , Kampala Women Getting By: Wellbeing in the Time of AIDS (London: James Currey, 1996).

21 C.F.R. Parts 50, 56, 312 (1996); 45 C.F.R. Part 46 (1995).

Guidelines, supra note 1, at sec. IV.C.

45 C.F.R. § 46.409(a)(1)(1998); Guidelines, supra note 1 at sec. IV.C.1.

45 C.F.R. § 46.409(a)(1998).

Guidelines, supra note 1, at sec. IV.C.1).

45 C.F.R. §§ 46.606, −.407, −.409 (1998).

45 C.F.R. § 46.409(b)(1998).

Guidelines, supra note 1, at sec. IV.C.4.

Joint United Nations Programme on HIV/AIDS, supra note 8.

Supra note 21.

CIOMS, supra note 2.

21 C.F.R. Parts 50, 56, 312 (1996); 45 C.F.R. Part 46 (1995).

Guidelines, supra note 1, at sec. IV.D.(2).

Id. at sec. IV.D.

Id. at sec. IV.F.(2).

Advisory Committee on Human Radiation Experiments, The Human Radiation Experiments: Final Report of the Advisory Committee on Human Radiation Experiments (New York: Oxford University Press, 1996).

Guidelines, supra note 1, at sec. IV.E.(3).

Pirouet L. , “Refugees In and From Uganda in the Post-Independence Period,” in Hansen H.B. and Twaddle M. , eds., Uganda Now: Between Decay and Development (London: James Currey, 1988), pp. 239–253; Tumwine H. , “Bunibugyo Displaced Reject Rwandese Camps,” Sunday Vision, June 29, 1997, p. 1 at col. 1

Guidelines, supra note 1, at sec. IV.G.

Guidelines, supra note 1, at sec. V.C.(3).

Bayer R. , “The Debate Over Maternal-Fetal HIV Transmission Prevention trials in Africa, Asia and the Caribbean: Racist Exploitation or Exploitation of Racism,” American Journal of Public Health, 88 (1998): 567–570; Cohen J. , “Ethics of AZT Studies in Poorer Countries Attacked,” Science, 276 (May 16, 1997): 1022; Angell M. , “The Ethics of Clinical Research in the Third World,” N. Engl. J. Med., 337 (1997): 847–849; Gambia Government/Medical Research Council Joint Ethical Committee, “Ethical Issues Facing Medical Research in Developing Countries,” Lancet, 351 (1998): 286–287; Lurie P. and Wolfe S.M. , “Unethical Trials of Interventions to Reduce Perinatal Transmission of Human Immunodeficiency Virus in Developing Countries,” N. Engl. J. Med., 337 (1997): 853–856; Varmus H. and Satcher P. , “Ethical Complexities of Conducting Research in Developing Countries,” N. Engl. J. Med., 337 (1997): 1003–1005.

World Medical Association, supra note 27, at Art. II, par. 3.

Perley S. , “The Nuremberg Code: An International Overview,” in Annas G.J. and Grodin M.A. , eds. The Nazi Doctors and the Nuremberg Code: Human Rights and Human Experimentation 149–173, 157 (New York: Oxford University Press, 1992).

Lie R.K. , “Ethics of Placebo-Controlled Trials in Developing Countries,” Bioethics, 12 (1998): 307–311.

World Bank, World Development Report: Investing in Health (New York: Oxford University Press, 1993).

See Levine R.J. , “The 'Best Proven Therapeutic Method” Standard in Clinical Trials in Technologically Developing Countries,” Journal of Clinical Ethics, 9 (1998): 167–172, 170.

Guidelines, supra note 1, at sec. V.D.(3).

Guidelines, supra note 1, at sec. V.D.(4)

Supra note 2, at Guideline 15.

Del Rio C. , “Is Ethical Research Feasible in Developed and Developing Countries,” Bioethics 12 (1998): 328–330.

Guidelines, supra note 1, at sec. V.D.(6).

45 C.F.R.§ 46.116 (1998); 21 C.F.R. § 50.25(a)(6)(1998).

Lederer S. E. and Grodin M.A. , “Historical Overview: Pediatric Experimentation,” in Grodin M.A. and Glantz L.H. , eds., Children As Research Subjects: Science, Ethics, & Law (New York: Oxford University Press, 1994): 3–25.