The Director General of the Agence de la biomédecine shall forward to the Minister for Research, within the time limit laid down in Article R. 1232-18, as necessary, any information revealing that the planned research is of such a nature as to call into question compliance with ethical principles, the need for the removal or the relevance of the 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 nature of the tissues or cells removed and the number of samples taken ; 2° The place and date of removal; 3° Any document attesting to the existence of written consent from persons who have…
In the cases provided for in Article L. 1241-5, the Minister for Research may suspend or prohibit implementation of the protocol under the conditions described in Articles R. 1232-18 and R. 1232-22. The decision to suspend or prohibit is communicated to the Director General of the Agence de la biomédecine.
For the application of the provisions of this chapter, samples taken in the context of biomedical research as defined in Article L. 1121-1 shall be regarded as samples taken for therapeutic purposes.
The authorisation to take tissue samples for therapeutic purposes from a deceased person is issued, suspended or withdrawn under the same conditions as those laid down in article R. 1233-2 and articles R. 1233-4 to R. 1233-6 and R. 1233-11.
To be authorised to take tissue samples for therapeutic purposes from a deceased person, health establishments must : 1° Demonstrate that their organisation and operating conditions are such that retrieval operations can be carried out satisfactorily; 2° Appoint a medical coordinator for the retrieval activity, after consultation with the establishment’s medical advisory body, and one or, where appropriate, hospital coordinators, nurses; the list of these persons is communicated to the…
Health establishments authorised to carry out tissue sampling shall take the necessary steps to ensure that all documents relating to the sampling referred to in the rules of good tissue sampling practice provided for in article L. 1245-6 are kept.
Each year, health establishments authorised to carry out tissue retrieval send the Director General of the Regional Health Agency and the Director General of the Biomedicine Agency the information required to assess their activity, in accordance with the procedures specified by order of the Minister for Health, issued after consultation with the Director General of the Biomedicine Agency.
The health establishments mentioned in the third paragraph of article L. 1233-1, which are not authorised to retrieve tissues, define the terms and conditions of their participation in a retrieval network by means of an agreement with the establishments authorised to carry out such retrievals. These agreements are forwarded to the Director General of the Agence de la biomédecine.
Inspections carried out in application of articles L. 1421-1 and L. 5313-1 in establishments authorised to retrieve tissues are carried out at least every two years.
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75001, Paris France
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