title: [Research on usual care: Assessing the qualification criteria of the current legal framework].
abstract: OBJECTIVE
  To evaluate the current legal framework pertaining to research on usual care and to check the adequacy of its use in relation to this research.
  
  
  METHODS
  Quantitative and qualitative analyses were performed to evaluate the research on usual care protocols managed by the Department of Clinical Research and Development (DRCD), Assistance Publique - Hôpitaux de Paris (AP-HP), since Law no. 2004-806 of 9 August 2004 relative to public health policy, came into force in 2006.
  
  
  RESULTS
  Fifty-five research projects were analysed. Some projects had diverging qualifications or had been re-qualified (12 projects).
  
  
  CONCLUSIONS
  Misunderstandings of the law by the actors involved in research as well as an overly narrow definition of research on usual care within the law were the main causes of these divergences.
authors.affiliation: AP-HP, hôpital Saint-Louis, département de la recherche clinique et du développement, 75010 Paris, France.
authors.forename: Mihaela
authors.initials: M
authors.lastname: Matei
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Thalabard
authors.forename: Anne
authors.initials: A
authors.lastname: Laude
authors.forename: Christophe
authors.initials: C
authors.lastname: Misse
authors.forename: Olivier
authors.initials: O
authors.lastname: Chassany
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D005602:France; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006302:Health Services Research / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D018579:Patient Selection; D019984:Quality Indicators, Health Care / Q000331:legislation & jurisprudence*; D012107:Research Design / Q000331:legislation & jurisprudence; D011795:Surveys and Questionnaires