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

BMC Medical Ethics 22 (1):1-13 (2021)
  Copy   BIBTEX

Abstract

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.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 92,923

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Biobanks--When is Re-consent Necessary?K. S. Steinsbekk & B. Solberg - 2011 - Public Health Ethics 4 (3):236-250.
Informed Consent: Is it Sacrosanct?Alison Assiter - 2005 - Research Ethics 1 (3):77-83.
Broadening consent--and diluting ethics?B. Hofmann - 2009 - Journal of Medical Ethics 35 (2):125-129.
The Right to Withdraw Consent to Research on Biobank Samples.Gert Helgesson & Linus Johnsson - 2005 - Medicine, Health Care and Philosophy 8 (3):315-321.
The consent problem within DNA biobanks.Darren Shickle - 2006 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 37 (3):503-519.
Can informed consent to research be adapted to risk?Danielle Bromwich & Annette Rid - 2015 - Journal of Medical Ethics 41 (7):521-528.

Analytics

Added to PP
2021-03-03

Downloads
10 (#1,218,872)

6 months
5 (#707,850)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

References found in this work

View all 7 references / Add more references