Section 3: Special provisions for research carried out in the context of medically assisted procreation

Research involving the human person carried out in the context of medically assisted procreation means research which complies with the conditions laid down in Title II of Book I of Part One of this Code, subject to the specific provisions of this Section. This research concerns the clinical and biological activities of medically assisted procreation.

Research involving the human person carried out in the context of medically assisted procreation may only be performed if the conditions for access to and performance of medically assisted procreation set out in articles L. 2141-2 to L. 2141-13 are met. In addition, such research may only be carried out in the health establishments, medical biology laboratories and other organisations mentioned in Article L. 2142-1.

When an unmarried couple or woman undergoing medically assisted procreation is asked to take part in research involving the human person carried out in the context of medically assisted procreation, the provision of information and the obtaining of consent are required, pursuant to articles L. 1122-1, L. 1122-1-1 and L. 2141-2 for each of the persons asked to take part.

The period for examining the application for authorisation is set at ninety days from the date of receipt of the complete dossier. This period may be extended by ninety days if the Director General of the Agence nationale de sécurité du médicament et des produits de santé considers that additional information, consultations or specific studies are necessary to enable him to reach a decision.

For any application for authorisation for research involving the human person carried out in the context of medically assisted procreation, the Director General of the Agence nationale de sécurité du médicament et des produits de santé sends a copy of the complete dossier to the Director General of the Agence de la biomédecine for an opinion. The Director General of the Agence de la biomédecine will give his opinion to…

When the research project is carried out in the context of medically assisted procreation, the Data Protection Committee shall call upon the expertise of at least one practitioner mentioned in the fifth paragraph of Article L. 2142-1 and a paediatrician if the Committee does not include such a specialist. These specialists take part in Committee meetings for the purposes of the research in question and in deliberations relating to this…

The time limit for examining an application for a substantial amendment is set at thirty-five days from receipt of all the information required concerning this application. Where the Director General of the National Agency for the Safety of Medicines and Health Products considers that additional information, consultations or specific studies are necessary to enable him to reach a decision on the application, the period provided for in the previous paragraph…

If no response is received by the end of the period for examining the application for authorisation referred to in Article R. 1125-17 , this shall be deemed to constitute rejection. Silence on the expiry of the time limit for examining the application for substantial modification referred to in article R. 1125-20 also constitutes rejection.