Committee for the Protection of Persons

¹ Centre Hospitalier de Versailles, Le Chesnay, France
² Pierre Fabre Médicaments, Boulogne, France
³ Agence française de sécurité sanitaire des produits de santé (Afssaps), Saint-Denis, France

Abstract

The transposition into French law of Directive 2001/20/CE, which relates to good clinical practice in the conduction of trials on drugs for human use, has required the modification of certain provisions that concern the protection of persons participating in biomedical research, in particular those provisions concerning the conditions for the authorisation of biomedical research. Declaration to the competent authorities now comes prior to authorisation and, henceforth, the prior opinion of a Committee for the Protection of Persons (CPP) must be expressly favourable in order for a trial to be undertaken. Proposals are put forward by this Round Table in order to promote the stability and professionalism of the CPPs.