Section 3: Removal of organs for scientific purposes.

Any establishment or organisation planning to carry out research requiring the use of an organ removed from a person whose death has been duly confirmed must send the Director General of the Agence de la biomédecine, by registered post with acknowledgement of receipt, a protocol including in particular a description of the research programme and the nature and number of samples envisaged. This protocol is included in a file, the…

The Director General of the Agency will issue an acknowledgement of receipt when the dossier referred to in Article R. 1232-15 is complete and will simultaneously send this dossier to the Minister for Research. If the dossier is incomplete, he will request, by registered letter with acknowledgement of receipt, any additional document or information that he considers necessary, indicating the deadline for providing it.

The Director General of the Agency shall, where appropriate, forward to the Minister for Research, within the two-month time limit laid down in Article R. 1232-18, any information in his possession which is likely to make it possible to assess the need for the sample or the relevance of the research.

Implementation of the protocol may begin on expiry of the two-month period following issue of the acknowledgement of receipt, unless the Minister responsible for research decides to prohibit implementation in application of article L. 1232-3, after the establishment or organisation has been given the opportunity to present its observations within a specified period which may not exceed one month.

The Director General of the Agence de la biomédecine must be informed of any change in the information contained in the file during the implementation of the protocol. The latter will inform the Minister for Research.

The establishment or organisation must be able to provide the following information at any time, at the request of the Minister for Research or the Director General of the Agence de la biomédecine: 1° The number and nature of the organs removed ; 2° The place and date of removal; 3° Any document attesting, in the cases provided for in Articles L. 1232-1 and L. 1232-2, to the absence of…

Implementation of the protocol is suspended or prohibited if the conditions that justified its authorisation are no longer met and after the establishment or organisation has been invited to present its observations. The Minister for Research and the Agence de la biomédecine inform each other of any facts that may justify a decision to suspend or prohibit the implementation of a protocol in application of article L. 1232-3.

Prior to any suspension or prohibition decision, the Minister in charge of research will give formal notice to the establishment or organisation responsible for implementing the protocol to put an end to its failings or to submit its observations within a specified period. The period of suspension may not exceed one year. The Director General of the Agence de la biomédecine is notified of the suspension or prohibition decision.