Need for greater transparency in documenting informed consent

Need for greater transparency in documenting informed consent
Commentary
Peter Tugwell, J. Andre Knottnerus
Journal of Clinical Epidemiology, May 2019; 109 pp v–vii
Abstract
Kotz et al. in a Commentary [1] call for a re-examination of patient consent in randomised clinical trials. Although informing potential participants about the aims and procedures of a trial is mandatory when seeking their consent, current practice in obtaining informed consent appears to have been shaped the legal duty of disclosure; consent is seen as an action, concluded by signing a form. In line with this administrative attitude toward informed consent, the procedure is standardly reported in a research article. However, there is evidence that the exact information that is given to potential participants is often not understood by them. This is unacceptable, so the authors argue that details about informed consent procedures of randomized controlled trials should be reported transparently with the essential features of the information for participants summarized in the methods section of a trial report and that the full, original participant information letter is published as supplementary material.