Elise Jacquier1, Pierre Laurent-Puig2,3, Cécile Badoual4, Anita Burgun5,6,7, Marie-France Mamzer8,9. 1. Centre de Recherche Des Cordeliers (UMRS 1138), INSERM, Sorbonne Université, Université de Paris, Team ETREs, 75006, Paris, France. elise.jacquier@etu.u-paris.fr. 2. Centre de Recherche Des Cordeliers (UMRS 1138), Team Personalized Medicine, INSERM, Sorbonne Université, Université de Paris, Pharmacogenomics and Therapeutic Optimization, 75006, Paris, France. 3. Pharmacogénétique Et Oncologie Moléculaire, Hôpital Européen Georges Pompidou, Assistance publique - Hôpitaux de Paris, Paris, France. 4. Centre de Ressources Biologiques, Service d'anatomo-pathologie, Hôpital Européen Georges Pompidou, Assistance publique - Hôpitaux de Paris, Paris, France. 5. Département D'informatique Médicale, de Biostatistique Et de Santé Publique, Hôpital Européen Georges Pompidou, Assistance publique - Hôpitaux de Paris, Paris, France. 6. UMR-S 1138, Centre de Recherche Des Cordeliers, Paris, France. 7. Faculté de Médecine, Université Paris Descartes, Sorbonne Universités, Paris, France. 8. Centre de Recherche Des Cordeliers (UMRS 1138), INSERM, Sorbonne Université, Université de Paris, Team ETREs, 75006, Paris, France. 9. Unité Fonctionnelle D'éthique Et Médecine Légale, Hôpital Necker-Enfants Maladies, Paris, France.
Abstract
BACKGROUND: In 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. METHODS: Informed 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". RESULTS: 29 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. CONCLUSIONS: Our 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.
BACKGROUND: In 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. METHODS: Informed 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". RESULTS: 29 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. CONCLUSIONS: Our 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.
Entities:
Keywords:
Biobank research; Dynamic consent; Informed consent; Partnership in research; Patient participation; Translational research
Authors: Christopher A Harle; Elizabeth H Golembiewski; Kiarash P Rahmanian; Janice L Krieger; Dorothy Hagmajer; Arch G Mainous; Ray E Moseley Journal: J Am Med Inform Assoc Date: 2018-03-01 Impact factor: 4.497
Authors: Kapil Chalil Madathil; Reshmi Koikkara; Jihad Obeid; Joel S Greenstein; Iain C Sanderson; Katrina Fryar; Jay Moskowitz; Anand K Gramopadhye Journal: Int J Med Inform Date: 2013-06-10 Impact factor: 4.046