Book I: Health protection for individuals

The research referred to in 1° of Article L. 1121-1 may only be carried out after a favourable opinion has been obtained from the Committee for the Protection of Individuals referred to in Article L. 1123-1 and authorisation has been obtained from the competent authority referred to in Article L. 1123-12. The request for an opinion from the Committee and the request for authorisation from the competent authority may or…

Pregnant women, women in labour and breast-feeding mothers may only be asked to take part in the research mentioned in 1° or 2° of Article L. 1121-1 under the following conditions: -either the importance of the expected benefit for themselves or for the child is such as to justify the foreseeable risk incurred ; -such research is justified in terms of the expected benefit for other women in the same…

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 are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research may only be asked to take part in research mentioned in 1° or 2° of Article L. 1121-1 under the following conditions…

Minors may be asked to take part in the research referred to in 1° or 2° of Article L. 1121-1 only if research of comparable effectiveness cannot be carried out on adults and under the following conditions: -either the magnitude of the expected benefit for these persons is such as to justify the foreseeable risk incurred ; -such research is justified in terms of the expected benefit for other minors….

Adults under legal protection or unable to give their consent may only be asked to take part in the research mentioned in 1° or 2° of Article L. 1121-1 if research of comparable effectiveness cannot be carried out on another category of the population and under the following conditions: -either the magnitude of the expected benefit for these persons is such as to justify the foreseeable risk incurred ; -such…

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 non-interventional research. By way of derogation, the Personal Data Protection Committee may authorise a person who is not affiliated to a social security scheme or is the beneficiary of such a scheme to take part in the research mentioned in 1° or 2° of article…

If a person likely to assist in a research project mentioned in 1° or 2° of article L. 1121-1 falls into more than one of the categories mentioned in articles L. 1121-5 to L. 1121-8, those of these provisions which provide the most favourable protection for their interests shall apply.

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…