Aide à la rédaction du document écrit destiné à l'information du participant à la Recherche BioMédicale et à l'attestation de son consentement éclairé

Abstract

Since the full implementation in France of the European Directive 2001/20/EC about biomedical research, a written information form must be given to any participant in research, who must give in return his/her written consent. The written and consent form must be validated by a referent ethics committees prior to the research, but guidelines for the redaction of such document are missing. Thus, the investigators who are often in charge of the redaction could be helped by a tutorial that may consider the legal aspects, the rights of the participant and the quality of information. For this, a group from the French network of the clinical investigation centres--directed by the Inserm--worked on a tutorial which is presented here. This tutorial has been built stepwise, with review of the literature, enquiry within the French clinical investigation centres, primary redaction, internal validation, and final validation by external experts versed in the field of ethics for biomedical research.