Setting up of a Clinical Research Centers Ethics Committee in Rhone-Alpes-Auvergne District

Objective. French law on biomedical research does not apply to non-interventional researches. A favourable advice of an IRB (Institutional Review Board) is required. This article describes the setting up of a Clinical Research Centers Ethics Committee. Methods. The Clinical Research Centers Ethics Committee (CRCEC) was created in November, 2006. To guarantee a better objectivity Grenoble's projects are reviewed in Clermont-Ferrand board and conversely. Recommendations are given according to the compliance of research with laws and regulations in effect in France. Results. Twenty eight projects were submitted to the CRCEC during a 18 months period, mainly observation studies in a hospital setting. Four projects were redirected towards a formal French Ethic Committees (CPP) submission. Requests of modifications concerned a lack of information relative to data confidentiality. Conclusion. This committee is useful but its voluntary and "unofficial" nature questions about its perpetuation. We suggest that non interventional research be submitted to official CPP.