title: Partnering with patients in translational oncology research: ethical approach.
abstract: The research program CARPEM (cancer research and personalized medicine) brings together the expertise of researchers and hospital-based oncologists to develop translational research in the context of personalized or "precision" medicine for cancer. There is recognition that patient involvement can help to take into account their needs and priorities in the development of this emerging practice but there is currently no consensus about how this can be achieved. In this study, we developed an empirical ethical research action aiming to improve patient representatives' involvement in the development of the translational research program together with health professionals. The aim is to promote common understanding and sharing of knowledge between all parties and to establish a long-term partnership integrating patient's expectations.
  
  
  
  Two distinct committees were settled in CARPEM: an "Expert Committee", gathering healthcare and research professionals, and a "Patient Committee", gathering patients and patient representatives. A multidisciplinary team trained in medical ethics research ensured communication between the two committees as well as analysis of discussions, minutes and outputs from all stakeholders.
  
  
  
  The results highlight the efficiency of the transfer of knowledge between interested parties. Patient representatives and professionals were able to identify new ethical challenges and co-elaborate new procedures to gather information and consent forms for adapting to practices and recommendations developed during the process. Moreover, included patient representatives became full partners and participated in the transfer of knowledge to the public via conferences and publications.
  
  
  
  Empirical ethical research based on a patient-centered approach could help in establishing a fair model for coordination and support actions during cancer research, striking a balance between the regulatory framework, researcher needs and patient expectations. Our approach addresses the concept of translational ethics as a way to handle the main remaining gap between combining care and research activities in the medical pathway and the existing framework.
authors.affiliation: Laboratoire d'Ethique Médicale et Médecine Légale EA4569, Faculté de Médecine, Université Paris Descartes, 45 rue des Saints-Pères, 75006, Paris, France. marie-france.mamzer@parisdescartes.fr.|Unité fonctionnelle d'éthique et médecine légale, Hôpital Necker-Enfants malades, Assistance publique-Hôpitaux de Paris, 75015, Paris, France. marie-france.mamzer@parisdescartes.fr.
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Mamzer
authors.affiliation: Laboratoire d'Ethique Médicale et Médecine Légale EA4569, Faculté de Médecine, Université Paris Descartes, 45 rue des Saints-Pères, 75006, Paris, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Duchange
authors.affiliation: Laboratoire d'Ethique Médicale et Médecine Légale EA4569, Faculté de Médecine, Université Paris Descartes, 45 rue des Saints-Pères, 75006, Paris, France.
authors.forename: Sylviane
authors.initials: S
authors.lastname: Darquy
authors.affiliation: Independent patient representative, Paris, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Marvanne
authors.affiliation: Collectif Interassociatif Sur la Santé (CISS), 75007, Paris, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Rambaud
authors.affiliation: Cancercontribution.fr, Paris, France.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Marsico
authors.affiliation: Patients & Web, Paris, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Cerisey
authors.affiliation: Laboratoire d'Ethique Médicale et Médecine Légale EA4569, Faculté de Médecine, Université Paris Descartes, 45 rue des Saints-Pères, 75006, Paris, France.|Soins de support, Service de cancérologie, Hôpital Européen Georges Pompidou, Assistance publique-Hôpitaux de Paris, 75015, Paris, France.
authors.forename: Florian
authors.initials: F
authors.lastname: Scotté
authors.affiliation: Département d'informatique médicale, de biostatistique et de santé publique, Hôpital Européen Georges Pompidou, Assistance publique-Hôpitaux de Paris, 75015, Paris, France.|UMR-S 1138, Centre de recherche des Cordeliers, 75006, Paris, France.|Faculté de médecine Paris Descartes, Sorbonne universités, Paris, France.
authors.forename: Anita
authors.initials: A
authors.lastname: Burgun
authors.affiliation: Centre de Ressources biologiques, Service d'anatomo-pathologie, Hôpital Européen Georges Pompidou, Assistance publique-Hôpitaux de Paris, 75015, Paris, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Badoual
authors.affiliation: Inserm UMR-S 1147, Université Paris Descartes, 75006, Paris, France.|Service de Biochimie Pharmacogénétique et Oncologie Moléculaire, Hôpital Européen Georges Pompidou, Assistance publique-Hôpitaux de Paris, 75015, Paris, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Laurent-Puig
authors.affiliation: Laboratoire d'Ethique Médicale et Médecine Légale EA4569, Faculté de Médecine, Université Paris Descartes, 45 rue des Saints-Pères, 75006, Paris, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Hervé
mesh_terms: D003142:Communication; D032962:Consent Forms; D017041:Ethics Committees; D017408:Guidelines as Topic; D006801:Humans; D051188:Knowledge Bases; D008495:Medical Oncology / Q000941:ethics*; D009154:Mutation / Q000235:genetics; D009369:Neoplasms / Q000235:genetics; D057285:Precision Medicine; D057170:Translational Research, Biomedical / Q000941:ethics*
keywords: Medical ethics; Patient-centered approach; Personalized medicine; Translational ethics; Translational research