Title II: Research involving the human person

Research organised and carried out on human beings with a view to developing biological or medical knowledge is authorised under the conditions set out in this Book and is hereinafter referred to as “research involving the human person”. There are three categories of research involving the human person: 1° Interventional research involving an intervention on a person that is not justified by the person’s usual care; 2° Interventional research involving…

No research involving the human person may be carried out : – if it is not based on the latest scientific knowledge and on sufficient pre-clinical experimentation ; – if the foreseeable risk incurred by the persons who take part in the research is out of all proportion to the anticipated benefit for these persons or the interest of this research; – if its aim is not to extend scientific…

Research may only be carried out under the following conditions: – under the direction and supervision of a doctor with appropriate experience ; – in material and technical conditions appropriate to the research and compatible with the requirements of scientific rigour and the safety of the persons undergoing the research. In the human behavioural sciences, a qualified person, together with the investigator, may direct the research. Research in the field…

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.