Title II: Research involving the human person

Prior to the performance of research involving the human person, information is provided to the person participating in the research by the investigator or by a doctor representing the investigator. Where the investigator is a qualified person, this information is provided by the investigator or by another qualified person representing the investigator. In particular, the information covers : 1° The objective, methodology and duration of the research ; 2° The…

No research mentioned in 1° of Article L. 1121-1 may be carried out on a person without their free and informed consent, obtained in writing, after they have been given the information provided for in Article L. 1122-1. Where it is impossible for the person concerned to express their consent in writing, it may be attested by the trusted support person provided for in Article L. 1111-6, by a family…

The sponsor may ask the person undergoing research to give informed consent at the time when he or she is required to agree to his or her data being used in subsequent research exclusively for scientific purposes. The person may withdraw their consent to this subsequent use or exercise their right to object at any time.

In the case of research involving the human person to be carried out in emergency situations where it is not possible to obtain the prior consent of the person who will be subjected to the research, where such consent is required, the protocol submitted for the opinion of the committee referred to in Article L. 1123-1 may stipulate that the consent of this person is not sought and that only…

In the case of research involving the human person mentioned in 2° of Article L. 1121-1 , the methodological requirements of which are not compatible with obtaining consent under the conditions provided for in the second paragraph of Article L. 1122-1-1, the protocol submitted for the opinion of the relevant personal data protection committee may provide that consent is not sought and that the information provided for in Article L….

I.- Unemancipated minors, protected adults or adults who are unable to express their consent and who are not the subject of a legal protection measure shall, when their participation in research involving the human person is envisaged, receive the information provided for in Article L. 1122-1 adapted to their capacity for understanding, both from the investigator and from the persons, bodies or authorities responsible for assisting them, representing them or…