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.
Highlights
In the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases
Translational research has been recently described as a process that starts “from the bedside, goes to the bench of scientists, and comes back to the bedside” [5]: patients donate their biological samples and data for research, scientists use them for various types of basic science research, and the research findings can result in new clinical therapeutics and new healthcare policies for patients [3, 6]
Collecting informed consent documents In October 2017, all Cancer Research for Personalized Medicine (CARPEM) investigators listed in a 5-years activity report about the activities of CARPEM were asked by email to provide the informed consent forms from studies they had started between 2012 and 2017
Summary
In the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. Innovative studies are dependent upon infrastructures, such as biobanks and data repositories, in which biological samples and healthcare data are collected and can be used for various exvivo non-interventional phases of translational research. The duration of the storage should better be unlimited and sharing data and samples at a local, national, or international level has become essential [5, 8,9,10]. In this specific context, biological samples and data are at the heart of the health research. As biological samples are valuable only if they are coupled with associated data, they raise similar issues to those concerning data treatment [13]
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