Chapter III: Personal data protection committees and competent authority

The Minister for Health approves one or, as required, several personal protection committees for a fixed period. Their members are appointed by the Director General of the Regional Health Agency for the region in which the committee is based. The committees are completely independent in the performance of their duties. They have legal personality under public law. The committees are funded by the State.

I. – A National Commission for Research Involving the Human Person, responsible for coordinating, harmonising and evaluating the practices of the Committees for the Protection of Individuals, has been set up under the authority of the Minister for Health. Each year, it submits recommendations to the Minister for Health concerning the consequences, in terms of healthcare organisation, of research whose results are of major interest for public health. The National…

The committees are composed in such a way as to guarantee their independence and the diversity of their expertise in the field of research involving the human person and with regard to ethical, social, psychological and legal issues. They shall include representatives of approved patient or health system user associations designated under the provisions of article L. 1114-1.

The members of the Committees, the persons called upon to collaborate in their work, and the agents covered by the general statute of civil servants or the general statute of military personnel who are in possession of such information are required, under the conditions and subject to the penalties laid down in articles 226-13 and 226-14 of the French Penal Code, to keep secret any information which may come to…

The Minister for Health may withdraw the approval of a committee if the conditions of independence, composition or operation required to carry out its mission in the best possible conditions are no longer met.

I.- Before carrying out research involving the human person, the sponsor submits the project for the opinion of a personal data protection committee designated at random from among the available committees and having the necessary competence to examine the project, under the conditions set out in article L. 1123-14. It may only request one opinion per research project. In the event of an unfavourable opinion from the committee, the sponsor…

I.- The committee gives its opinion on the conditions for the validity of the research, particularly with regard to : -the protection of individuals, in particular the protection of participants ; the adequacy, completeness and intelligibility of the written information to be provided, as well as the procedure to be followed for obtaining informed consent, and the justification for research on persons incapable of giving informed consent or, where applicable,…

Any sponsor based in France who plans to carry out research involving the human person in a non-EU country may submit its project to a committee for the protection of individuals. The Committee for the Protection of Individuals gives its opinion on the conditions for the validity of the research with regard to article L. 1121-2 and I of article L. 1123-7.

When the National Agency for the Safety of Medicines and Health Products, the High Authority for Health, the Minister for Health or the European Medicines Agency refers a non-interventional research project involving a medicinal product which has been granted a marketing authorisation to the Committee for the Protection of Individuals for an opinion, it shall give the opinion referred to in Article L. 1123-7 solely with regard to the requirements…

No one may carry out any research mentioned in 1° of Article L. 1121-1 without authorisation from the competent authority issued within a period set by regulation. If the competent authority informs the sponsor in a letter, stating the reasons, that it has objections to the implementation of the research, the sponsor may modify the content of its research project and submit this new request to the competent authority. This…