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Bulletin du Cancer

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Guidelines for the collection, conservation and use of human biological samples in the field of cancer Volume 93, supplement 5, Août 2006

Authors
Institut National du Cancer (French National Cancer Institute), 52, avenue André-Morizet, 92513 Boulogne-Billancourt Cedex, Assistance Publique-Hôpitaux de Paris, 3, avenue Victoria, 75004 Paris, Université Paris 7 – Denis Diderot, 92, avenue de France, 75013 Paris

Human biosample resources represent one of the most essential resources for research programs in the field of cancer, either for identification of new characterisation criteria for diagnosis, prognosis, response to treatments or for research of new targeted treatments. These resources will also be more and more directly used in clinical practice for the benefit of the patients. A workgroup set up by the National Cancer Institute (INCa) defined a « Charter » made up of five rules of good practice for the attention of the people in charge of human biologic resource centers and of associated research programs. This Charter represents a recommendation from INCa, and will ease the set-up of multi-centric and partnership, national or international research programs, according to French laws and patients’interests. The processing of the Charter has been based upon analysis of legal texts applied by a group of legal experts and upon a « consensus » regarding the Charter’s rules with hospital representatives, researchers and drug manufacturers. The Charter has been checked by scientific bodies, institutional organisations, and related legal and ethic authorities. The main recommendations of the « Charter » are as follows : 1. The preservation of a remainder of biologic material for the benefit of clinical patients ; 2. Information for all patients and checking that no opposition exists for using the samples for Research ; 3. The preservation of documents in the medical file of the patient ; 4. The principle of systematic research partnership each time a sample has to be transferred to another laboratory, and the refusal of transfers without any partnership ; 5. The absolute need to respect all protection rules of personal information regarding clinical data associated to samples. These recommendations are given with explanations, and whenever possible with practical tools which make their application easier.