Home > Organ and tissue donation and transplantation > Declaration of collection for scientific purposes (from deceased persons or fetuses resulting from IG)

Declaration of collection for scientific purposes (from deceased persons or fetuses resulting from IG)

Published on 12 May 2025

Approvals / Authorizations

    Any organization wishing to carry out research requiring the removal of organs, tissues or cells from a deceased person, or the removal of embryonic or foetal tissues or cells following termination of pregnancy, must submit a dossier to the Director General of the Agence de la biomédecine, the form and content of which are laid down by decree, including the protocol for such removal.

    On receipt, the Agency has 2 months in which to examine the application. During this period, the Legal Department, in conjunction with the Agency's Medical and Scientific Department, ensures that the proposed samples are feasible, without prejudice to samples for therapeutic purposes. It also ensures compliance with procedures for verifying the absence of donor opposition (deceased donation) or consent (termination of pregnancy).

    • If the file is complete, the Agency's Director General issues an acknowledgement of receipt and simultaneously sends the file to the Minister responsible for research.
    • If the file is incomplete, the Director General of the Agency requests, by registered letter with acknowledgement of receipt, any additional documents or information she considers necessary, indicating the deadline for providing them.

    Two months after the date of issue of the acknowledgement of receipt indicating that the dossier is complete, the protocol may begin, unless the Minister in charge of research decides to prohibit it. Any modification of the elements included in the dossier during the implementation of the protocol must be brought to the attention of the Director General of the Agency, who will inform the Minister in charge of research.

    As the legislator has provided for a declaratory system for scientific sampling protocols , the Agency does not issue any official notification or favorable opinion.

    Concerning the removal of organs, tissues or cells from a person whose death has been duly confirmed

    This type of donation requires specific organization, and it is up to the research team to contact the various players involved in setting up the file.

    1. Hospital organ procurementcoordination, which identifies donors, interviews relatives, organizes organ and tissue procurement, and provides logistical support to procurement teams. It is imperative that the research team contact the coordinator of the establishment where it wishes to carry out the retrieval to explain its project and ensure its participation. In addition to the file, the forms for approaching relatives, providing information and monitoring the samples, which are intended for hospital coordinators, must be completed;
    2. The regional department of the Agence de la biomédecine (SRA), in charge of the operational organization of the samples, in liaison with the hospital coordinator;
    3. The harvesting team, which will be contacted by the SRA to carry out the harvesting once a donor has been identified.

    It should be noted that each year, the Agency will send the coordinator a summary sheet to monitor the progress of the project and the number of samples taken.

    At the end of the project, the research team is asked to present the results obtained to the members of the hospital sampling coordination committee.

    Files and forms to be completed and submitted

    For further information, please send your questions by e-mail to nicolas.chatauret@biomedecine.fr

    Applications should be sent by registered post with acknowledgement of receipt to:Agence de la biomédecine Direction Juridique 1, avenue du stade de France 93212 Saint Denis La Plaine CedexOR by e-mail to the address shown on the 1st page of the application.

    Share