TRAINING AND RESOURCES IN
RESEARCH ETHICS EVALUATION
FOR AFRICA

Core reference documents | Références principales | Hauptverweise

• WMA Declaration of Helsinki 2008
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• CIOMS International Ethical Guidelines 2002
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• WHO Operational Guidelines for Ethics Committees 2000
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• ICH-GCP 1996
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• Council of Europe Convention on Human Rights and Biomedicine (1997)
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  and its Additional Protocol on Biomedical Research (2004)
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• EU DIRECTIVE 2001/20/EC on Clinical Trials
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• US 45 CFR 46 Protection of Human Subjects - Common Rule
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Other reference documents | Autres références | Andere Verweise

• International Ethical Guidelines for Epidemiological Studies, 2009
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• EDCTP: EDCTP Guidelines on Ethics
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• UNESCO Universal Declaration on Bioethics and Human Rights
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• UNESCO Universal Declaration on the Human Genome and Human Rights
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• UN, the Universal Declaration of Human Rights
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  Canada, Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans, 1998
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• Canada, Canadian Institutes of Health Research, Guidelines for Health Research Involving Aboriginal People
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• The Nuremburg Code, "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.
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• South Africa, Department of Health, Ethics in Health Research: Principles, Structures and Processes, Research Ethics Guidelines, 2004
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• UK, Nuffield Council on Bioethics, The ethics of research related to healthcare in developing countries, 2002.
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• UK, Nuffield Council on Bioethics, The ethics of research related to healthcare in developing countries a guide to the Report
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• UK Wellcome Trust: Research involving people living in developing countries: Position statement and guidance notes for applicants
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• US, Advisory Committee on Human Radiation Experiments, Report
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• US National Institutes of Health (NIH): NIH Grants Policy Statement
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• US, OHRP International Compilation of Human Research Protections
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• US, The Belmont Report
  [EN][FR][DE]

Literature | Littérature | Literatur

• Amdur, R., & Bankert, E. (2007). Institutional review board member handbook (2nd ed.). Sudbury, Mass.: Jones & Bartlett.
• Beecher, Henry, Ethics and Clinical Research, NEJM Vol. 274, Nr. 24, June 16, 1966, p. 1360.
• Caws P., “Committees and consensus: how many heads are better than one?” (1991) 16(4) Journal of Medicine and Philosophy 375.
• Durand, G., Introduction générale à la bioéthique : Histoire, concepts et outils, (Montréal & Paris : FIDES CERF, 1999).
• Emanuel EJ, Lemmens T, Elliot C (2006) Should society allow research ethics boards to be run as for-profit enterprises? PLoS Med 3(7): e309. DOI: 10.1371/journal.pmed.0030309
• Emanuel, Ezekiel J., David Wendler, Jack Killen, Christine Grady, “What Makes Clinical Research in Developing Countries Ethical? The
• Benchmarks of Ethical Research” (2004) JID 189 March 1 pp. 930-937.
• Freedman, B., “Equipoise and the Ethics of Clinical Research” (1987) 317(3) New England Journal of Medicine 141.
• Freedman, B., “Scientific value and validity as requirements for research: a proposed explication IRB: A review of Human Subjects Research 1987; 9(6): 7-10.
• Freedman, B., Fuks A., & Weijer C., “Demarcating research and treatment: a systematic approach for the analysis of the ethics of clinical research” Clinical Research 1992, 40: 653-660.
• Glass, K.C. & Lemmens, T., “Conflict of Interest and Commercialization of Biomedical Research: What is the Role of Research Ethics Review?” in T. Caulfield & B. William-Jones, eds., The Commercialization of Genetic Research : Ethical, Legal and Policy Issues (New York: Kluwer, 1999).
• IJsselmuiden, C., Stephen Matlin, “Why Health Research?” Research for Health: Policy Briefings A series jointly published by Council on Health Research for Development and Global Forum for Health Research (2006)
• J.W. Glazer, “Hospital Ethics Committees: One of Many Centers Responsibility”. Theoretical Medicine, 1989, 10(4): p275-288.
  Jennings, Bruce. “Possibilities of Consensus: Toward Democratic Moral Discourse,” Journal of Medicine and Philosophy (Aug) 1991; 16:4: 447-463.
• Katz, J., ed., Experimentation with Human Beings, New York, Russel Sage Foundation, 1972
• Moreno, Jonathan D. “Consensus, Contracts, and Committees,” Journal of Medicine and Philosophy (Aug) 1991; 16:4: 393-408.
  Moreno, Jonathan D. “Ethics by Committee: The Moral Authority of Consensus,” Journal of Medicine and Philosophy (Nov) 1988; 13:4: 441-431.
• Thompson D., “Understanding financial conflicts of interest” New England Journal of Medicine 1993, Vol 329 (8), 573-576
• Weijer, C. & Miller, P. “When are research risks reasonable in relation to anticipated benefits?” (2004) 10 Nature Medicine 570.
• Williams, John R., Medical Ethics Manual, World Medical Association, 2005

Links | Liens | Links

• WHO, International Clinical Trials Registry Platform (ICTRP)
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• WHO, Ethics and Health, Ethical standards and procedures for research with human beings
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• TRREE website, e-resources
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