[Does clinical research provide any "direct individual benefit"?].
The European Commission and Parliament have promulgated a directive on clinical research (2001/20/CE) in April 2001. Its provisions have to be incorporated in all national laws by May 2004. Accordingly, the French " loi Huriet " (a law passed in 1988 organizing clinical research in France) had to be revised. During the process, it appeared that a key issue was the suppression of a distinction made by this law between research with and without " direct individual benefit ", a French specificity, as the directive recommends rather the assessment of the risk/benefit ratio. In order to harmonize the French legislation with the other European laws, and to suppress a set of provisions which have been repeatedly attacked during the last ten years, the French members of parliament have voted on October 2003 a new law which, among other important modifications, suppress that distinction.
Service de réanimation médicale, Hôpital Henri-Mondor, 51, avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France. francois.lemaire@hmn.ap-hop-paris.fr
François
F
Lemaire
D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans