[Biomedical research legislation applicable since 28 August 2006].

The new legislation concerning biomedical research entered into force on 28 August 2006. This legislation, which goes further than the recommendations of European Directive 2001/20/EC, introduces several modifications reinforcing the role of the Comité de Protection des Personnes (Ethics Committee) and the various administrations. The protection of subjects is reinforced by increased control of participants and investigators. Publication of lists of authorized research is designed to strengthen European research. The authors propose a summary of the new legislation to facilitate preparation of protocols.