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.