The Biomedical research administration cell ensures the administrative and ethical support of UNIACT as the NeuroSpin investigation facility for research involving human subjects (French RIPH regulatory framework). Under the supervision of the medical director, it is headed by an expert in biomedical research ethics and regulations, assisted by a specialized clinical research nurse in NeuroSpin and a research assistant for the Service Hospitalier Frederic-Joliot.

The cell provides regulatory and ethical assistance to the principal investigators and scientific managers from the design, grant application, IRB (Institutional Review Board) submission of their studies to the long-term management of their data. It works in tight collaboration with the legal department of the CEA (data protection officer, lawyers, ...) and assist the director of the Clinical Trials Committee of the CEA Fundamental Research Division which decides on CEA sponsorship for biomedical research studies after appropriate strategical, ethical and regulatory review. It maintains close contact with the IRB and the ANSM for any question concerning CEA-sponsored studies.

A STRATEGIC EXTERNAL ACTIVITY

The cell manager carries out external activities essential to the credibility and sustainability of the expertise of the Biomedical research administration cell, such as the full membership of a Parisian IRB, of the Pasteur

Institute animal ethics committee, of the French federation of research ethics committees, and the presidency of the research ethics committee of the Université Paris-Saclay.