Etude sur 10 ans de 622 avis non favorables rendus par 19 comités consultatifs de protection des personnes se prêtant à la recherche biomédicale (CCPPRB)

Few protocols (1.3% of the total number of files) are rejected on the basis of scientific and ethical criteria. Traceability is a significant problem, which obstructed the study of lost protocols and amendments. For protocols not covered by the law, the committees already work in accordance with the European directive recommending the exclusion of studies consisting only of routine medical procedures.