[Proposal 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-Sérusclat 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.

Objective: Our objective was to create a tool to assist investigators providing patients with the main results of clinical research studies.

Materials And Methods: We first consulted the various participants in biomedical research: ethics committee (CCPPRB), Clinical Investigation Centres (CIC), institutional sponsors, participating patients, plus research protocols and lawyers specialized in forensic medicine.

Conclusion: After analysis of their answers, we worked out the bases of our tool. This tool is tested in an implementation phase.