[The French IRB Study: Qualification of research by ethics committees]

In France, the "Research investigations involving human subjects" (RIPH), defined in the Public Health Code, are reviewed by "committees for the protection of persons" (CPP) established by law. Other research studies in health are evaluated conducted by "research ethics committees" (CER) that can be established by research institutions (institutes, hospitals, universities, etc.) without a defined legal framework. The qualification of the research as RIPH or "non-RIPH" (RNIPH) determines the evaluation pathway - mandatory legal or extra-legal. Our objective was to describe the performance of CERs and CPPs in qualifying research projects as RIPH or RNIPH, the qualification standard used being the "Guide to the qualification of health research", an Inserm reference published in 2021.

Since the list of CPPs was already known, universities, university hospitals, and learned societies in medical specialties were contacted to find out if they housed a CER. Between 29/01/2024 and 29/02/2024, all documented CPPs and CERs were asked to participate in the study. If accepted, an email was sent to members with an online questionnaire proposing four cases to be qualified, either RIPH or non-RIPH. The cases were taken from the examples provided by the Inserm guide, which also served as a reference for assessing the responses. The analysis of the responses was carried out individually and at the level of each participating committee.

Thirty-five (35) centers, out of the 110 contacted, participated, producing 175 individual responses collected. The number of members per committee was 18 [12-23]. The response rate per committee was 27% [14-47]. Regarding the members' responses, the qualification was consistent with that of the Inserm guide in 79% (138), 62% (108), 66% (116), and 61% (106) of cases. At the committee level, a wide disparity between the different centers was documented, without notable differences between CER and CPP.

A significant heterogeneity in the qualification of research was noted between the different committees, unrelated to the type of structure (CER or CPP). Information and training systems, aimed at all types of committees, should be encouraged to standardize the research qualification step.