Informed consent in pragmatic trials: results from a survey of trials published 2014–2019

November 15, 2021

IMPACT members recently co-authored an article in the Journal of Medical Ethics, Informed consent in pragmatic trials: results from a survey of trials published 2014–2019, describing reporting of information related to informed consent in reports about pragmatic trials published 2014-2019.

Spencer Hey, PhD, from the Ethics and Regulation Core and Monica Taljaard, PhD, from the Design and Statistics Core were among the authors of the paper, which summarized findings from a review of 1,988 primary trial reports.  The researchers identified the studies as pragmatic using an electronic search filter implemented in MEDLINE and registered in ClinicalTrials.gov.  The authors found a high prevalence of reporting about informed consent, but minimal reporting of justifications for not obtaining consent for those where consent was reportedly waived. There were relatively few reports about use of alternative consent approaches, which the authors suggest may be a  means to facilitate conduct of pragmatic trials while protecting subject autonomy and maintaining public trust.  The authors recommend that editors and peer reviewers require investigators to share Authors conclude by suggesting that editors and peer reviewers require authors to include details about consent in the published trial reports and that justifications for not obtaining consent are required when consent was not obtained.  Read more here.