Mandating Evidence-Based Informed Consent Practices: A Critical Engagement with IRB Leader Focus Group Findings

Evidence-based informed consent practices-such as writing in plain language, formatting for readability, and assessing understanding using validated instruments-are underutilized in research practice. Yet the Common Rule does not specifically require the use of evidence-based informed consent practices. In this paper, we explore the wisdom of mandating evidence-based informed consent practices either at the institutional or federal level. In the first part, we share findings from a series of six focus groups with leaders of institutional review boards (IRBs) about mandating evidence-based informed consent practice. In general, IRB leaders had positive views toward plain language and optimal document formatting but were skeptical about validated assessments of participant comprehension of consent information. They generally opposed federal and institutional mandates, preferring an educational approach to promoting evidence-based informed consent practices. In the second part of the paper, we draw upon data from several of our studies and the literature to defend the conclusion that IRBs should experiment with mandates for evidence-based informed consent practices. We accept that federal regulations may be insufficiently flexible. However, educational efforts alone have not sufficed and are not likely to increase adoption of evidence-based informed consent practices. We believe institutional mandates will not actually lead to greater delays in review of research protocols or investigator burden if rolled out with sufficient guidance and resources, which are readily available.