Bonnes PratiquesProposition d’un outil de transmission au patient des résultats globaux de la recherche biomédicaleProposal of a Tool for Providing Patients with the Main Results of Clinical Research Studies

Context Clinical research regulations currently undergo major revisions mainly initiated by the European harmonization. Regulations must indeed all be adapted to the contents of directive 2001/20/CE applicable in France on 1 May 2004. One of the four principal modifications of the Huriet-Serusclat law dating from 4 March 2002 relates to the transmission of the main results of research protocols to participating patients. However, no precise directives or information are provided to investigators and sponsors on how to implement this.