French Public Health Code
In forceI.-Establishments and organisations authorised under article L. 2151-5 or the first paragraph of article L. 2151-9 shall keep a register of the embryos they hold.
This register mentions :
1° The organisation that supplied the embryos and their identification code after anonymisation ;
2° The title of the research protocol;
3° The name of the person responsible for the research or conservation activity;
4° The number of embryos being researched;
5° Where applicable, the number, designation and characteristics of the embryonic stem cell lines obtained in the course of the research;
6° The results of analyses concerning biological markers of infection;
7° The location(s) of the research and storage;
8° The fate of the embryos.
The person responsible for the research or conservation is responsible for keeping this register. It must ensure that the information recorded in this register is accurate and that it is kept in secure conditions to guarantee its integrity and confidentiality.
II - The Biomedicine Agency keeps a national register of embryos included in research protocols and embryonic stem cell lines derived from them, where applicable, as part of this research. It includes in particular:
1° The authorisation numbers and the names of the establishments or organisations authorised to carry out research or to store embryos ;
2° For each authorisation, the information mentioned in 2° to 5° and 7° and 8° of I as well as the identification code of the embryos and embryonic stem cell lines derived from them.
The person responsible for the research or conservation shall, at the time of the annual report provided for in Article R. 2151-8, provide the Director General of the Agence de la biomédecine with the information necessary for the latter to update this national register.
The identification code assigned by the Agency to each embryo, listed in the registers mentioned above, and to each embryonic stem cell line derived from it, guarantees the confidentiality of the identity of the persons at the origin of the embryo mentioned in Article R. 2151-4.
The person responsible for the research must provide the authorisation holder or the practitioner referred to in Article R. 2151-5 with the identification code allocated by the Agency. This code is kept by the authorisation holder or the practitioner referred to in article R. 2151-5 to enable the pseudonymisation to be reversed so that, if necessary, access can be gained to data enabling the persons from whom the embryo originated to be identified, when this is required for a medical or health safety purpose.
