Book I: Health protection for individuals

Research may only be carried out in a place that has the human, material and technical resources appropriate to the research and compatible with the safety requirements of the persons undergoing the research. This location must be authorised for a specific period in the case of research mentioned in 1° of article L. 1121-1 carried out outside healthcare settings, as well as in hospital departments and in any other location…

No research may be carried out on a deceased person in a state of brain death without their consent expressed during their lifetime or through the testimony of their family. However, if the deceased person is a minor, this consent must be expressed by each of the holders of parental authority. If it is impossible to consult one of the holders of parental authority, the research may be carried out…

Research involving the human person and the results thereof, with the exception of those relating to national defence secrets, are entered in a public access register in accordance with rules laid down by decree.

With a view to the application of the provisions of the first paragraph of article L. 1121-11 and article L. 1121-12 and for the research mentioned in 1° of article L. 1121-1 concerning the products mentioned in article L. 5311-1, a national file shall identify persons who are free from any disease and who voluntarily lend themselves to this research, as well as sick persons when the purpose of the…

I.-For the duration of the research referred to in 1° of article L. 1121-1, the sponsor provides free of charge the investigational medicinal products and, where applicable, the ancillary medicinal products and medical devices used to administer them, as well as, for research involving products other than medicinal products, the products which are the subject of the research. II – Non-commercial research is research whose results are not exploited for…

Articles L. 1121-4 and L. 1121-15 do not apply to non-interventional research involving cosmetic or food products where such research is included in a list established by order of the Minister for Health after consultation with the National Agency for Medicinal and Health Products.

The procedures for applying the provisions of this chapter are determined by decree in the Conseil d’Etat, and in particular : 1° The minimum guarantees for the insurance provided for in the third paragraph of Article L. 1121-10 ; 2° The conditions for the authorisation provided for in article L. 1121-13; 3° The conditions for drawing up and publishing the directories provided for in article L. 1121-15.