Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium

BMC Medical Ethics

Elise Jacquier¹  Marie-France Mamzer²  Pierre Laurent-Puig³  Cécile Badoual⁴  Anita Burgun⁵ 

[1] Centre de Recherche Des Cordeliers (UMRS 1138), INSERM, Sorbonne Université, Université de Paris, Team ETREs, 75006, Paris, France;Centre de Recherche Des Cordeliers (UMRS 1138), INSERM, Sorbonne Université, Université de Paris, Team ETREs, 75006, Paris, France;Unité Fonctionnelle D’éthique Et Médecine Légale, Hôpital Necker-Enfants Maladies, Paris, France;Centre de Recherche Des Cordeliers (UMRS 1138), Team Personalized Medicine, INSERM, Sorbonne Université, Université de Paris, Pharmacogenomics and Therapeutic Optimization, 75006, Paris, France;Pharmacogénétique Et Oncologie Moléculaire, Hôpital Européen Georges Pompidou, Assistance publique – Hôpitaux de Paris, Paris, France;Centre de Ressources Biologiques, Service d’anatomo-pathologie, Hôpital Européen Georges Pompidou, Assistance publique – Hôpitaux de Paris, Paris, France;Département D’informatique Médicale, de Biostatistique Et de Santé Publique, Hôpital Européen Georges Pompidou, Assistance publique – Hôpitaux de Paris, Paris, France;UMR-S 1138, Centre de Recherche Des Cordeliers, Paris, France;Faculté de Médecine, Université Paris Descartes, Sorbonne Universités, Paris, France;

关键词: Dynamic consent;    Informed consent;    Translational research;    Biobank research;    Patient participation;    Partnership in research;   

DOI  :  10.1186/s12910-021-00592-9

来源: Springer

【 摘 要 】

BackgroundIn the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM’s translational research programs. This review focused on detailing their form, their informational content, and the adequacy of these documents with the international ethical principles and participants’ rights.MethodsInformed consent forms (ICFs) were collected from CARPEM investigators. A content analysis focused on information related to biological samples and data treatment (context of sampling and collect, aims, reuse, consent renewal), including the type of consent. An automatic assessment of the readability of the ICFs were performed with the IT program “Flesch Score”.Results29 ICFs from 25 of 49 studies were analyzed after selection criteria were applied. Three types of consent were identified: 11 broad consents, six specific consents, and two opt-out consents. The Flesch Scores showed that most of the documents were too complex to be fully understood by most of the potential research participants. Most of the biological samples were collected during the healthcare routine, but the information content about secondary use of biological samples varied between ICFs. All documents mentioned personal data treatment but information about their reuse was not standardized in the ICFs.ConclusionsOur review of current IC procedures of CARPEM showed that practices could be improved considering new translational research methods. “Old fashion written ICFs” should be adapted to the translational research approach, to better respect individual rights and international research ethics principles. In this context, theoretically, a digital tool allowing dynamic information and consent of participants, through an electronic interactive platform may be a good way to promote more active participation in research. Nevertheless, its feasibility in the complex environment of biological samples and data research remains to prove. The way of a combination of a broad consent followed by dynamic information may be alternatively tested.

【 授权许可】

CC BY