[Study over 10 years of 622 protocols receiving unfavourable reports from 19 research ethics committees].

Objective: The aim of this study was to analyse the nature of applications and the criteria for their negative evaluation by 19 ethics committees for the protection of human subjects participating in biomedical research, the French CCPPRB.

Methodology: The committees distinguished between negative opinions that were given from the start of the applications or after amendments were made, and between lost protocols (no answer within more than 1 year) or protocols that were outside of the framework of the Huriet-Sérusclat law. The opinions were analysed by an independent observer over a period of 10 years.

Results: 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.