title: [Ethical and juridical context of the facial allotransplant].
abstract: Every french medical research, notably the ones regarding the facial allotransplant, is supposed to respect the code of professional conduct. Nevertheless, these researches have to be conducted in a specific ethical and juridical environment that is important to know. The French national ethics advisory committee for life sciences and health (CCNE) has the duty to give advices on the ethical problems raised by the progress of knowledge in the fields of biology, medicine and health and to publish guidelines on these subjects. The Biomedicine Agency (Agence de la biomédecine) is a state health agency that has replaced the French agency for transplants (EFG) for all the duties of this state agency. Its authorization is mandatory. The French agency for sanitary safety in health products (Afssaps) warrants, through its missions of sanitary protection, the efficacy, the quality and the good use of all human health products, notably the organs and the tissues from human origin. From now on, the CPPs (Ethics committees enforced by the bioethical law in 2004) replace the former CCPPRBs (Ethics committees enforced by the Huriet-Sérusclat law in 1988). They are the protagonists of the new biomedical research framework. All human research on allotransplantation undertaken is from now on, subject to the prior and jointly favorable opinion of a CPP and authorization by Afssaps. The Clinical research hospital program (PHRC) allows the monetary support of these researches providing they respect the ethical guidelines and the law.
authors.affiliation: Service de Chirurgie Plastique, Reconstructrice et Esthétique, CHU Henri-Mondor, 51, avenue du Maréchal-de-Lattre-de-Tassigny, 94010 Créteil cedex, France. jean-paul.meningaud@hmn.aphp.fr
authors.forename: J-P
authors.initials: JP
authors.lastname: Meningaud
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D054445:Facial Transplantation / Q000941:ethics* / Q000331:legislation & jurisprudence*; D005602:France; D006801:Humans