Reasonableness as the Key to Defining, Measuring, and Improving IRB Quality

Abstract: Institutional Review Boards (IRBs) play a critical role in the research ecosystem but meaningful measures of their quality are lacking, a challenge that has been recognized for decades but remains unresolved. The difficulty of evaluating IRB quality has led to insufficient measures - compliance, review speed, and investigator satisfaction - that in turn have led to an “audit culture” in which these metrics substitute for and distort the ethical goals of research review and oversight. The result is that IRBs may inappropriately impede research or fail to adequately protect participants. In this panel presentation, we will introduce a novel model of “IRB Reasonableness” that aims to refocus IRBs on protecting participants and facilitating ethical research by developing new measures of IRB quality and tools to support high performance on those measures. We will first describe concerns arising from current approaches to assessing IRB quality; explain the concept of IRB Reasonableness, drawing on the distinction between rules and standards and analogies to other decisionmakers; and advance the argument that IRBs offer a type of procedural protection. The panel will then turn to describing several “Pillars of IRB Quality” that can serve as the initial essential elements of IRB Reasonableness, including (1) engagement with both research communities and investigators; (2) expertise of IRB members, staff, and consultants; (3) meaningful deliberation between IRB members across a range of perspectives and experience; and (4) use of precedent to promote consistency and clarify challenging research ethics principles through case-based reasoning.

Keywords: IRB quality, reasonableness, audit culture