Ethical issues related to clinical research in developing countries: The approach of ANRS, The French Agency For Research On AIDS.
Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrA599)
Kazatchkine M, Hirsch E M. Kazatchkine, ANRS National Agency for AIDS research, 101 rve de tolbiac, 750 13 Paris, France, Tel.: +33 153 946 023, Fax: +33 153 946 001
For the last ten years, the french National Agency for Research on AIDS (ANRS) has conducted a large number of clinical trials in Africa, in partnership with african scientists and clinicians, e.g. in the area of prevention of MTCT and prophylaxis of opportunistic infections. Until now, ANRS has relied exclusively on the opinion of a french ethical committee and on french legal procedures, to decide on the funding of peer-reviewed clinical research projects in developing countries. As our programs expand, ANRS is considering new procedures to deal with ethical issues arising in the context of clinical research in the developing world. These include the following steps: (1) peer-review of the projects by an international panel of experts, including scientists from developing countries; (2) review of the projects by a local ethical committee, whenever it is available; (3) the signed agreement of investigators (from France and from the target country in the South), to an ethical chart stating a number of general ethical principles (many of these) are already stated in documents such as the Helsinki declaration; (4) for those issues for which there is no simple/univoqual answer, the investigators will be asked to write a specific and extended comment in the application form. ANRS is listing 10-20 such issues, including: informed consent, modalities of access to treatment after a trial has been completed, best standard of care. In addition, no project will be funded if it does not show how its objectives and implications have been discussed with public health authorities to fit in the global efforts of the target country in its policy to fight HIV/AIDS. We believe that such a procedure that takes into account the differient answers that may be brought to a given situation in different settings within a generally agreed framework, may help solving the difficult issues associated with the ethics clinical trials in developing countries.
Keywords: AEGIS, Developing Countries, Research, Acquired Immunodeficiency Syndrome, Biomedical Research, Helsinki Declaration, Government Agencies, HIV Infections, Clinical Trials, Informed Consent, Research Support, Research Subjects, Research Design, Africa, France, ethics, economics, methods
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