Title II: Research involving the human person

The sponsor is responsible for compensation for the harmful consequences of research involving the human person for the person who undergoes the research and for those of his successors in title, unless he can prove that the damage is not attributable to his fault or to that of any other party involved, without the possibility of invoking the action of a third party or the voluntary withdrawal of the person…

Research involving the human person does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, where applicable, compensation for constraints suffered paid by the promoter. The total amount of compensation that a person may receive in any one year is limited to a maximum set by the Minister for Health. The payment of…

For each piece of research mentioned in 1° or 2° of Article L. 1121-1, the dossier submitted to the Committee for the Protection of Individuals and, where applicable, to the competent authority, shall determine whether it is necessary for the person not to be able to participate simultaneously in another piece of research and, where applicable, shall set a period of exclusion during which the person taking part in the…

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.