Authorization for research on human induced pluripotent stem cells

Research protocols involving iPS cells, the purpose of which is to differentiate them into gametes, to obtain in vitro embryonic development models, or to insert these cells into an animal embryo with the aim of transferring it to a female, must be declared to the Director General of the Agence de la biomédecine, preferably by electronic means or by registered letter with acknowledgement of receipt, or by hand-delivery against receipt, to the following address:

juridique@biomedecine.fr

Agence de la biomédecine - Direction juridique - 1 avenue du Stade de France

93212 Saint-Denis La Plaine Cedex

After checking the admissibility of the declaration file, the Agency acknowledges receipt. If the required documents or information are missing, the Agency sets a deadline by which they must be supplied.

In the absence of opposition from the Directorate General within 4 months of the date on which the file was declared complete, the research protocol may begin.

The person responsible for the research sends the Agency's General Manager a report every two years, and the final report as soon as it has been completed.

The Agency must be systematically informed by letter of any modification made during the implementation of the research protocol.

The Agency's Legal Department will then indicate whether the change constitutes a substantial modification. In this case, a new declaration must be filed. It will then be examined according to the same procedure as the initial application (see above).

If this is not the case, only the technical information required by the Agence de la biomédecine to keep files up to date should be provided.

The Agence de la biomédecine has set up a system to ensure the traceability of differentiated cells that authorized research teams may be able to obtain from human embryonic stem cells.