[The protection of persons and biomedical research in France. A multicentre study of 10 committees]

OBJECTIVE: Since 1988, any human biomedical research protocol in France must be submitted to a committee for the protection of persons participating in biomedical research programs (Comit?onsultatif de protection des personnes dans la recherche biom?cale (CCPPRB). This study is one of the first to analyse the functioning of the French CCPPRB at the onset of the application in 2004 of a European ruling on drug research, so as to study the pertinence of the opinions and the necessity or not of homogenising committee habits. METHOD: Ten CCPPRB participated in the study. An external observer visited all the centres. Three methodological instruments were used: semi-directive interviews with categories representative of the committee, analysis of the observer's documents and analysis of the discussions during dossier sessions. RESULTS: The habits are heterogenic regarding the crucial definitions represented by biomedical research and the limits of the latter. In half of the committees, the decision to investigate a protocol is taken by the president alone. All the dossiers are studied by one or several reporters, but not always within discussion sessions, hence underlining the need to respect the multidisciplinarity within a CCPPRB. CONCLUSION: These results show the importance of developing training courses for the members of a CCPPRB and the need to consecrate means for these CCPPRB, representing the democratic authority for the analysis of the protocols