Completing clinical research protocols for Institutional Review Boards advice request: a support document ; Document d’aide à la rédaction de protocoles de Recherche Impliquant la Personne Humaine (RIPH) pour solliciter l’avis du Comité de Protection des Personnes (CPP)

Background: since year 2012, with the “Jarde” law, any scientific research on human subject (RIPH) must obtain an Institutional Review Board (CPP) advice before being initiated. This last regulatory requirement places into difficulties many students and PhD supervisors who may not be used to complete such clinical research protocols CPP advice requests. Objectives: the primary objective was to create a local support document to help completing clinical research protocols advice requests. The secondary objective was to list, between December 2018 and May 2019, any already existing support documents within every General Medicine departments (DMG) of French Medicine universities. Method: every General Medicine department has been contacted by e-mail to list existing support documents. Then, a local help document has been drawn up based on the “Haute Autorité de Santé (HAS)” method to create a recommendation. Results: 34 departments have been contacted, 17 answered. 14 already have a support structure for PhD students, but only 3 of them have a specific support document for research protocols. A first version of a local support document has been written and reviewed. After review and commentaries analysis, it has been modified including all the relevant elements from the General Medicine departments. Conclusion: it will probably be necessary to update this document with all the future remarks of the users and the law’s evolutions. Others support documents may already exist but there is no available information about them. However, the process to create this document increases its validity. Furthermore, this support document could be used not only by medicine students but also by any university student who could have to complete such regulatory requirement. ; Contexte : avec la loi Jardé de 2012, toute Recherche Impliquant la Personne Humaine (RIPH) requiert, avant de débuter, l’avis favorable d’un Comité de Protection des Personnes (CPP). Cette nouvelle disposition réglementaire met en difficulté les chercheurs peu ...