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Eurecnet - National Information: France

National Information: France

Short description of RECs system

There are 39 Ethics Committees in France. These Committees of Protection of Persons (Comités de Protection des Personnes, CPP) divide up into 7 regions all over the country. There are 5 to 6 CPPs per region (except for the Ile de France region around Paris which has 10 Committees) and they are all competent for the whole region. In addition, each committee has a national competence. According to the law of public health (Loi de Santé Publique, 2004) and the bioethics law (Loi de Bioethique, 2004-2011) the Ethics Committees are responsible for decisions concerning interventional studies, standard of care studies, medical and other health products and further research areas (such as genetics or physiology).

All committees are independent in matters of their procedures for appointing members, in their requirements for memberships and in sources of funding (Ministry of Health). Each committee is composed of 28 persons (14 members and 14 deputies) from a wide range of disciplines, such as biomedicine, ethics, social sciences, psychology and law. There are two groups in all committees: one medical college and one non-medical college. The medical college (7 members) is composed of 4 persons qualified in biomedical research, 1 general practitioner, 1 hospital pharmacist and 1 nurse. Whereas, the non-medical college (7 members) is composed of 1 person specialized in ethics, 1 psychologist, 2 lawyers, 1 social worker and 2 patients. The members of each committee generally meet once per month. The committees usually plan their meetings 6 to 12 months in advance and make the meetings dates available on their website.

Organisation

The Ethics Committees’ competences range from ethical, scientific and methodological considerations (e.g. the protection of trial subjects, the protection of human rights, dignity and wellbeing of persons, benefits and risks ratio, the quality of research facilities, qualification and suitability of investigators, subject information and informed consent and the recruitment procedure).

The Competent Authority (CA) is responsible for the pharmaceutical conformity and quality of drugs, the security and safety of drugs, the security and conformity of methods and practices and the general security of subjects. In addition, the CA takes care of the exchange of information and the transfer of RECs opinions and CA authorizations.

Clinical trial sponsors have to submit their protocols both to the relevant regional Ethics Committee (CPP), and to the competent authority. These submissions can be either simultaneous or one after the other. The authorisation to conduct a trial requires both the Ethics Committee (CPP) approval and the Competent Authority (CA) authorization.

The chair of the Ethics Committee (CPP) designates two rapporteurs, one of each college, and all proposals are reviewed by biostatistician. Each committee reviews 5 or 6 clinical trials forms and about 20 substantial amendments by meeting. Of course, the committee’s opinions must be justified. The sponsors can demand a re-examination of their protocols once. In case of a negative opinion the Ministry of Health may assign another committee.

National Level

Besides the regional Ethics Committees there is also one National Consultative Ethics Committee (Comité consultatif national d'éthique, CCNE). France was the first country to create such a Committee. Its intended role is to single out issues arising out of progress in the life sciences and make public statements and recommendations. The issues of medically assisted procreation and experiments on humans were the first to be addressed by the CCNE. But its scope of investigation soon extended to other topics, such as research on human embryos, access to genetic information and the concept of consent. The National Committee (CCNE) has 40 members and its chair is appointed by the President of France.

Networking between RECs

The Ethics Committees (CCP) and the National Commission for Vocational Certification (Commission Nationale de la Certification Professionnelle, CNCP) assemble at an annual meeting and exchange information and current discussions. There is no official national program for committees’ training, however, the regional Ethics Committees organize training sessions for their members and there are training and information meetings available for committee members, academic sponsors, investigators and patients.

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