title: [General and ethical considerations for the informed consent process: Guidelines from the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC)].
abstract: Informed consent is not restricted to clinical research and must be applied to high-risk care such as hematopoietic stem cell transplantation. If standardized informed consent might improve inequalities in medical practices between different transplantation centers, it is strongly recommended that it be adapted with an honest dialogue between physicians and patients and physicians and donors. In an attempt to harmonize clinical practices among French hematopoietic stem cell transplantation centers, the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) held its sixth annual workshop series in September 2015 in Lille. This event brought together practitioners from across the country. The purpose of this paper is to highlight the French law concerning patients' rights and ethical practices for an informed consent process to be applied to care or research.
authors.affiliation: EFS Bretagne, unité de thérapie cellulaire, rue Pierre-Jean-Gineste, 35016 Rennes, France.
authors.forename: Jean-Baptiste
authors.initials: JB
authors.lastname: Thibert
authors.affiliation: Assistance publique-Hôpitaux de Paris, hôpital Saint-Antoine, service d'hématologie clinique et thérapie cellulaire, 184, rue du Faubourg-St-Antoine, 75012 Paris, France.
authors.forename: Alice
authors.initials: A
authors.lastname: Polomeni
authors.affiliation: CHU de Lille, université Lille 2, LIRIC Inserm U995, 59000 Lille, France.
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Yakoub-Agha
authors.affiliation: CHU Dupuytren, université de Limoges, service d'hématologie clinique et de thérapie cellulaire, UMR CNRS 7276, 2, avenue ML-King, 87032 Limoges cedex, France. Electronic address: dominique.bordessoule@chu-limoges.fr.
authors.forename: Dominique
authors.initials: D
authors.lastname: Bordessoule
mesh_terms: D026688:Bioethical Issues; D016026:Bone Marrow Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence; D064987:Cell- and Tissue-Based Therapy / Q000941:ethics; D003142:Communication; D003245:Consensus Statements as Topic; D005602:France; D018380:Hematopoietic Stem Cell Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D010817:Physician-Patient Relations / Q000941:ethics; D012955:Societies, Medical; D014019:Tissue Donors / Q000941:ethics / Q000331:legislation & jurisprudence
keywords: Consentement éclairé; Donor and patient rights; Droits des patients et donneurs; Ethics; Greffe de cellules souches hématopoïétiques; Informed consent; Stem cell transplantation; Éthique