Book I: Health protection for individuals

The provisions of Articles 72, 75, 76, 77, 80, 87, 88, 89 and 90 of the aforementioned Regulation (EU) shall apply to the clinical investigations provided for in paragraph 1 of Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.

Clinical investigations in the field of dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Clinical investigations in the field of midwifery may only be carried out under the direction and supervision of a doctor or a midwife. Clinical investigations involving only minimal risks and constraints in the field of nursing may only be carried out under the…

Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not come under the provisions of Article 64 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and persons admitted to a health or social establishment for purposes other than clinical investigation may be asked to lend themselves…

Persons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in clinical investigations which do not involve any risk or constraint. By way of derogation, the Data Protection Committee may authorise a person who is not affiliated to a social security scheme or who is a beneficiary of such a scheme to take part in clinical…

The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the damage is not attributable to his fault or to the fault of any other party involved, without it being possible to invoke the action of a third party or the voluntary withdrawal of the person who…

The clinical investigation 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 such compensation…

For each clinical investigation with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the dossier submitted to the Data Protection Committee and the competent authority must determine whether it is necessary for the person not to be able to participate simultaneously in another clinical investigation and, if so,…

Clinical investigations may only be carried out in a place that has the human, material and technical resources appropriate to the clinical investigation and compatible with the safety requirements of the persons undergoing it. This location must be authorised for this purpose, for a specific period of time, in the case of clinical investigations involving an intervention on a person which is not justified by his/her usual care and which…

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

With a view to the application of the provisions of the first paragraph of article L. 1125-6 and article L. 1125-7, a national register shall be kept of persons who are free of any disease and who voluntarily lend themselves to clinical investigations, as well as sick persons when the purpose of the clinical investigation is unrelated to their pathological condition. However, the Personal Data Protection Committee may decide in…