Title V: Research on the human embryo, human embryonic stem cells and human induced pluripotent stem cells

The Director General of the Agence de la biomédecine may authorise an embryo research protocol, under the conditions laid down in Article L. 2151-5, after obtaining the opinion of the Steering Committee, for a fixed period which may not exceed five years, renewable under the same conditions.

In addition to verifying the conditions set out in Article L. 2151-5, the Agence de la biomédecine assesses the feasibility of the protocol by taking into account the status of the organisation and ensuring the competence of the person in charge of the research team. To this end, it will in particular take into consideration the titles, functions and scientific work of the person in charge of the research. The…

Only the following may obtain authorisation to carry out embryo research: 1° Public health establishments and medical biology laboratories authorised to store embryos pursuant to Article L. 2142-1, and establishments authorised to carry out pre-implantation diagnosis pursuant to Article L. 2131-4 ; 2° Establishments and organisations that have signed an agreement with at least one of the establishments or laboratories mentioned in 1°. This agreement sets out the conditions under…

The provision of prior information and the collection in writing of the free and informed consent of each of the members of the couple or of the unmarried woman provided for in the last paragraph of Article L. 2131-4 and in Articles L. 2141-3 and L. 2141-4, are carried out, in the case of pre-implantation diagnosis, by the practitioner approved in application of article L. 2131-4-2 and, in other cases,…

Embryos may only be delivered to the person responsible for the research mentioned in Article R. 2151-8 by the holder of the authorisation provided for in Article L. 2151-9, by the practitioner approved in application of Article L. 2131-4-2 or by the practitioner working, in accordance with the fifth paragraph of Article L. 2142-1, in an establishment, laboratory or organisation authorised in application of the same article. The person responsible…

The application for authorisation of an embryo research protocol shall be sent to the Director General of the Agence de la biomédecine by any means capable of establishing a date of receipt. This application must be accompanied by a dossier containing all the information required to verify that the legal conditions have been met, the form and content of which are laid down by decision of the Director General of…

Any decision by the Director General to authorise or refuse research and the opinion of the Steering Committee are forwarded simultaneously to the Ministers for Health and Research, who have a period of one month in which to jointly request a re-examination of the application for authorisation, in application of 1° and 2° of III of article L. 2151-5. When a request for re-examination of an authorised protocol is made…

All research authorised under article L. 2151-5 is placed under the direction of a responsible person designated by the application mentioned in article R. 2151-6. The person responsible for the research sends the Director General of the Agence de la biomédecine an annual report. The final report is sent to the Director General as soon as the research has been completed. These reports shall contain, in particular, information relating to…

Any establishment or organisation wishing to modify a substantial element of the protocol authorised under article L. 2151-5 must submit a new application for authorisation. This application is examined under the same conditions as the initial application.

In the event of a breach of the applicable legislative or regulatory provisions or of the requirements laid down in the authorisation, the Director General of the Agence de la biomédecine may give the establishment or body formal notice to put an end to the breaches observed and, where appropriate, to submit its observations within a period set by the Director General. If the measures taken are not such as…