Authorization for human embryonic stem cell research

Embryonic stem cell research protocols are the subject of declarations addressed to the General Management of the Agence de la biomédecine, preferably by electronic means or by registered letter with acknowledgement of receipt, or deposited against receipt, at 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 Director General within 2 months of the date on which the file was declared complete, the research protocol may begin.

Note, however, that the objection period is 4 months when the aim of the research protocol is to differentiate embryonic stem cells into gametes, to obtain in vitro embryonic development models or to insert these cells into an animal embryo for transfer to a female.

The person responsible for the research submits a biennial report to the Director General of the Agency, and sends him or her the final report on the research as soon as it has been completed.

The Agency must be systematically informed by letter of any modification occurring during the implementation of an authorized embryo research protocol.

The Agency's legal department will then indicate whether the change constitutes a substantial modification. In this case, a new authorization application file must be submitted. 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 will need to be provided.

The Agence de la biomédecine (French Biomedicine Agency), following the advice of its Orientation Council, has set up a procedure for the use of new lines within the framework of an authorized research protocol, different from those mentioned in the initial authorization application. Two hypotheses are envisaged:

1. Import of new hESC lines: In this case, they must submit an import authorization application, in accordance with the procedure described above (import of lines by an already-authorized team).

2. Use of embryonic stem cell lines already present on French territory: This scenario concerns lines that have already been the subject of an import authorization issued by the Agency and that have been imported by another team, or lines derived in France from embryos as part of a research protocol, also authorized by the Agency. The use of a new line by a team must be systematically declared in advance to the Agency. This is not a substantial modification procedure.

The declaration (in the form of a letter addressed to the Director General of the Agency) must be accompanied by: a) Imported lines :

• An agreement with the French research team that imported the line the team wishes to use in its project, specifying that the transfer is to be made from one authorized conservation center to another authorized conservation center.

- A document from the supplier organization attesting to its agreement to the transfer of the line;

b) Lines derived in France :

• The code issued by the Agence de la biomédecine to the embryo from which the line was derived;
• An attestation from the person in charge of the MPA center which supplied the embryo that consent has been obtained (and, for frozen embryos, that consent has been confirmed) from both members of the couple or from the surviving member, and the dates and procedures for obtaining consent;

And, if the information is not already known to the Agency (see "List and characteristics of human embryonic stem cell (hESC) lines derived in France"):

• The date and nature of the embryo (fresh or frozen non-transferable, PGD-derived, supernumerary frozen);
• Biological markers for lineage identification (RT-PCR control of nanog, Oct-3/4 and TDGF expression, and flow cytometry control of SSEA-3 and alkaline phostophatase expression);
• Infectious marker results (HIV, HBV, CMV, mycoplasma, etc.);
• Where applicable, the national registry where the line was declared.