title: [New legislation about clinical research involving "usual care": reminder of recent problems].
abstract: OBJECTIVE
  The regulatory framework of clinical research in France was recently modified substantially, in part to transpose into French law directive 2001/20/EC of the European Parliament and Council, which concerns only drug trials. The revision also covered research on "human beings" (Public Health L. 2004-806, 2006-450), on biological samples (revision of bioethics, L. 2004-800) and on data (the so-called CNIL act, L. 2004-801). The value of this set of texts (statutes, decrees, and regulations) is that it diversifies and clarifies the different forms of clinical research.
  
  
  METHODS
  This article describes the painful progression of important public health studies, most often with "academic" sponsors.
  
  
  RESULTS
  The 5 studies described here managed to overcome a variety of obstacles posed by the pre-2004 regulations.
  
  
  CONCLUSIONS
  To understand the new provisions, it is useful to recall the difficulties, imprecision and inaptness of the earlier regulations.
authors.affiliation: Service de réanimation médicale, Hôpital Henri Mondor, AP-HP, Université Paris-Val-de-Marne, Créteil. francois.lemaire@hmn.ap-hop-paris.fr
authors.forename: François
authors.initials: F
authors.lastname: Lemaire
authors.forename: Frédérique
authors.initials: F
authors.lastname: Schortgen
authors.forename: Jean
authors.initials: J
authors.lastname: Chastre
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Fagon
authors.forename: Laurent
authors.initials: L
authors.lastname: Brochard
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Lacherade
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Becquemin
authors.forename: Christian
authors.initials: C
authors.lastname: Brun-Buisson
mesh_terms: D001675:Bioethics; D002986:Clinical Trials as Topic / Q000145:classification / Q000941:ethics / Q000331:legislation & jurisprudence*; D005602:France; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D011634:Public Health; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence