How does the ethical review process work in France and which are the designated ethics committees?
Clinical trials of medical devices and in vitro diagnostic medical devices are subject to a parallel authorisation from the National Security Agency of Medicines and Health Products ( ANSM ), especially when they relate to medical devices without CE marking, or medical devices which already have EC marking but used in a new indication (different from that of the CE marking) or when the clinical trials of the device require the undertaking of examinations solely related to the trial and when such examinations pose a significant risk; and the accountable Committee for the Protection of Persons (CPP) established at many locations throughout France.
Clinical trials on medical devices are intended to substantiate the performance and safety of the product in accordance with the requirements of the respective european Directive.
CPP gives its opinion on the conditions of validity of the research , particularly with regard to :
- the protection of persons , including the protection of participants;
- adequacy , completeness and intelligibility to provide written and the procedure for obtaining informed consent and the justification for the research on persons incapable of giving informed consent information;
- the possibility of a period of reflection necessity;
- the possible need to include in the protocol, a ban on participating simultaneously in another search or a period of exclusion;
- the relevance of the research , the adequacy of the assessment of the anticipated benefits and risks and the merits of the conclusions;
- the balance between the objectives and the means employed ;
qualifications of the investigator .
- the amounts and the terms of compensation of participants;
procedures for recruitment of participants.
The required CPP application form specifying the content of the respective dossier is provided in the following link. Submission is made to the specific CPP listed below that is accountable for the French Principal Investigator with an electronic copy to the ANSM.
Formulaire 1 – Demande d’autorisation auprès de l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) et de demande d’avis du comité de protection des personnes (CPP) pour une recherche biomédicale portant sur un dispositif médical (30/07/2013)
In parallel, another application for study approval is made to the French Agence nationale de sécurité du médicament et des produits de santé (ANSM). This application is provided below listing the content requirements of the dossier, which is sub:mitted in electronic fashion.
Identification of French Ethics Committees (CPPs)