[The Ethics Committee meeting in Belgium May 7, 2004, on human experimentation].
The European directive 2001/20/EC concerning the performance or clinical trials has been transposed in the Belgian law of May 7, 2004, entitled "Loi relative aux expérimentations sur la personne humaine" (Moniteur belge, May 18, 2004)". The range of the law is larger than those of the directive. Several new elements must be underlined: 1. Any experimentation on a human being may only begin if the promoter received a positive advice from an ethical committee according to the provision of the law. 2. For multicentric assays, a single opinion, identical for all the participating centres must be obtained. This implies a close dialogue between the ethical committees. A central committee is proposed by the industrial promoter. Each clinical trial of a drug must have a unique identification number obtained at the European agency for the evaluation of medicinal products (EMEA). 3. Taking into account the fear of the pharmaceutical industry that some clinical studies could be "delocalized", the authorities accepted to reduce to twenty- eight days (instead of 60) the delay granted to the ethical committee in order to produce their single opinion. 4. The law of May 7, 2004, clearly defines the dispositions related to the protection of the participants. Particular dispositions are foreseen for the protection of minors, incapable adults and patients in emergency. 5. The promoter endorses, even without fault, the responsibility of the damage caused to the participant or his descendants. An insurance covering this risk must be contracted.
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D001530:Belgium; D004992:Ethics, Medical; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans