The Clinical Research Department of INSERM assists researchers to ensure the feasibility, quality and correct implementation of their research, that regulatory texts are complied with and research participants are protected.

The law on the protection of participants in clinical and health research defines three main roles: (1) participants in the research, (2) the researcher who thought up the project, constructs, implements it and then analyses the findings,(3)the sponsor. To achieve this, as a sponsor INSERM : 

(1)    Evaluates the clinical and health research projects that researchers present to it,

(2)     prepares the necessary documents for submitting the project to the health authorities (Ethical Research Committee and Competent Authorities),

(3)    takes out civil liability insurance to protect and possibly compensate participants in the research, prepares the information documents on the research and consent that all participants in clinical and health research must sign, together with patients’ associations,

(4)     records and possibly declares any adverse events that arise during a research project to the health authorities,

(5)     ensures the proper implementation and quality of the research through regular visits to the investigation sites

The Clinical Research Department has a large experience in clinical research and has an active portfolio of approximately 250  projects with 10 % of international or European studies (76 % of clinical trials other than for health products, 15 % clinical trials on health products, 7% clinical trials on medical devices and 2 % clinical trials on cellular and gene therapy products)

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