title: [The adoption of Jardé law modifies the legal framework of clinical research in France].
abstract: The Jardé law is adopted further to the Public Health Act No. 2004-806 which transposed           into French law the Directive 2001/20/EC on clinical trials of medicinal products, made           effective by the implementing Decree 2006-477 of April 26, 2006. The main novelty           introduced by the Jardé law is to unify all "research organized and practiced on human           beings for the development of biological or medical knowledge" and to facilitate its           effective conduct, without however excluding from the scope of the law routine care and           non-interventional research. The favorable opinion of the French Ethical Research           Committee (comité de protection des personnes or "CCP") will now be required before           launching any research on human beings, after validation of the risk/benefit ratio of said           research. Applicable requirements and procedures - including information and consent - are           adapted to each category of clinical research. New provisions are adopted to address           special situations, previously forgotten. Finally, if Ethics committees were up until now           freely chosen, they will, in two years' time, be randomly assigned. Thus, the Jardé law           amends substantially the legal framework of clinical research in France. The question is           whether these new national provisions will be compatible with those from the next revision           of the so called "clinical trials" directive 2001/20/EC. In any case, the Jarde law will           only come into force when all required implementing measures have been adopted.
authors: Cabinet Intuity, Paris, France. anne-catherine.perroy@univ-lille2.fr
authors: Anne-Catherine
authors: AC
authors: Maillols-Perroy
authors: Yves
authors: Y
authors: Tillet
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D005602:France; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007883:Legislation, Medical / Q000941:ethics / Q000639:trends*; D011634:Public Health / Q000941:ethics / Q000331:legislation & jurisprudence*; D012306:Risk; D036302:Therapeutic Human Experimentation