Purpose: 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.
Method: 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).
Discussion: 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.
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