[Clinical trials in developing countries: who should define ethics?].
Many clinical trials have proved much more difficult to implement in developing countries than in the Northern countries if not totally impossible. Should we therefore just observe this situation and approve a "double ethical standard"? Clinical trials in developing countries are also a means for volunteers to have access to medical care, therefore how could the process of informed consent keep its significance? In this context, should the participation in clinical trials be restricted or even stopped? If so, we would thus justify the superiority of an international duty of charity compared with the right of autonomy of these populations. This theoretical analysis cannot be precisely justified. On the contrary, it reveals that while informed consent, international organisations and guidelines have the tendency to play a major role in this debate, local ethics committee are too absent although they represent the more relevant and legitimate discussion partners in this dilemma.
Faculté de médecine, Département de recherche éthique, Université Paris-Sud-XI, France.
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D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D003906:Developing Countries; D028744:Ethics Committees, Research / Q000592:standards; D032984:Ethics, Research; D019983:Guideline Adherence; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics*; D006806:Human Rights; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D007390:International Agencies / Q000941:ethics / Q000592:standards; D009042:Motivation; D026684:Personal Autonomy; D035842:Research Subjects / Q000523:psychology; D012959:Socioeconomic Factors