title: [Not Available].
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.
authors.affiliation: Inserm CIC BT 505, Paris, France; APHP, Groupe Cochin-Pasteur, Paris, France.
authors.forename: Yvette
authors.initials: Y
authors.lastname: Hénin
authors.affiliation: Inserm, Département de Recherche Clinique et Thérapeutique, Paris, France; Inserm, Comité de Qualification Institutionnel, Paris, France.
authors.forename: Bénédicte de
authors.initials: Bd
authors.lastname: Boischevalier
authors.affiliation: Inserm, Mission Inserm Associations, Paris, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Reboul-Salze
authors.affiliation: Inserm CIC 003, CHU, Grenoble, France; CHU, Pharmacologie, Grenoble, France; Université Joseph Fourier, Grenoble, France; Comité de Protection des Personnes Sud-Est V, CHU de Grenoble, Grenoble, France; Comité d'Éthique des CIC de l'Inter Région Rhône Alpes Auvergne, Clermont-Ferrand, France.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Cracowski
authors.affiliation: Comité d'Éthique des CIC de l'Inter Région Rhône Alpes Auvergne, Clermont-Ferrand, France; Inserm CIC 501, Clermont-Ferrand, France; CHU, Centre Pharmacologique Clinique, Clermont-Ferrand, France. Electronic address: cduale@chu-clermontferrand.fr.
authors.forename: Christian
authors.initials: C
authors.lastname: Dualé
keywords: Recherche BioMédicale; biomedical research; clinical research; consentement éclairé; information; informed consent; participant; recherche clinique; redaction; rédaction