Title II: Research involving the human person

Subject to the provisions of this chapter, the provisions of chapters III, V and VI of this title apply respectively to research involving the human person, clinical investigations and performance studies which are classified as a national defence secret within the meaning ofarticle 413-9 of the Criminal Code and which are carried out for protection purposes. Such research, clinical investigations and performance studies are referred to as “research, clinical investigations…

I.- For research, clinical investigations or performance studies involving national defence secrets, the sponsor submits the project for the opinion of a specific committee for the protection of individuals, called the “Defence and National Security Committee for the Protection of Individuals”, approved by the Prime Minister on the proposal of the Minister for Defence and after obtaining the opinion of the Minister for Health. The Prime Minister alone is competent…

When the authority designated in article L. 1123-12 or in II of articles L. 1125-1 and L. 1126-1 does not have agents with the level of clearance required for national defence confidentiality, given the level of classification of the research involving the human person, the clinical investigation or the performance study that is envisaged, the competent authority, within the meaning of this article, is the Prime Minister.

Any substantial modification at the initiative of the sponsor of a research project, clinical investigation or performance study covered by national defence confidentiality must obtain, prior to its implementation, a favourable opinion from the Defence and National Security Committee for the Protection of Individuals mentioned in I of Article L. 1123-16 and, in the case of research mentioned in 1° of article L. 1121-1, clinical investigations mentioned in II of…

For research, clinical investigations or performance studies covered by national defence confidentiality, the sponsor must notify the competent authority of all relevant information relating to the safety of the research, clinical investigation or performance study. Where such research, clinical investigations or performance studies involve persons who have no medical condition and who voluntarily undergo such research, clinical investigations or performance studies, the sponsor shall also notify the Minister for Defence.

The procedures for applying this chapter are defined, unless otherwise provided, by decree in the Conseil d’Etat, in particular : 1° The conditions for approval, funding, operation and appointment of the members of the Committee for the Protection of Individuals – Defence and National Security, as well as the nature of the information that must be communicated to it by the sponsor and on which it is required to give…