French Public Health Code
In forceI.- In compliance with the requirements set out in Article L. 1211-2, any person of legal age who agrees to the removal or collection of tissues or cells shall receive, prior to consenting to the donation or not objecting to the use of these tissues or cells when they have been removed during surgery carried out in his or her interest, information on the purposes, procedures and consequences of this removal or collection.
This information is given by a member of the retrieval team who is trained and able to convey it in a clear and appropriate manner.
This information covers :
1° The nature and purpose of the donation for therapeutic purposes, in particular its potential benefits for the recipient ;
2° The possible risks incurred by the donor and, where applicable, the foreseeable physical and psychological consequences of the donation as well as its possible repercussions on the donor's personal, family and professional life and the possible need for follow-up after the donation;
3° The need to carry out medical biology tests, in particular to screen for certain transmissible infectious diseases, and the possibility of being kept informed of the results;
4° The need to assess the donor's state of health during a medical interview and a clinical examination;
5° The need to take and store biological samples for biovigilance purposes and their possible use for scientific purposes, or for the production or testing of in vitro diagnostic medical devices, or for the quality control of medical biology examinations, or as part of expert assessments and technical controls carried out by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products);
6° The protection of personal data concerning the donor and, in the case of unrelated donations, the anonymous nature of the donation with regard to recipients.
II - Subject to the specific provisions applicable to donors of haematopoietic cells collected from bone marrow or peripheral blood mentioned in article R. 1241-4, and the specific provisions relating to adult donors who are the subject of a legal protection measure with representation relating to the person who must express their consent under the conditions mentioned in article L. 1241-4, the donor's consent or non-opposition is collected in writing by a member of the collection team. The original of the document expressing this consent or non-opposition is kept in the donor's medical file and a copy is sent to the establishment authorised in application of article L. 1243-2.
