Standards of evidence for institutional review board decision-making

Abstract

A standard of evidence is a rule or norm pertaining to the type or amount of evidence that is required to prove or support a conclusion. Standards of evidence play an important role in institutional review board (IRB) decision-making, but they are not mentioned in the federal research regulations. In this article, I examine IRB standards of evidence from a normative, epistemological perspective and argue that IRBs should rely on empirical evidence for making decisions, but that other sources of evidence, such as intuition, emotion, and rational reflection, can also play an important role in decision-making, because IRB decisions involve an ethical component which is not reducible to science. I also argue that an IRB should approve a study only if it has clear and convincing evidence that the study meets all the approval criteria and other relevant, ethical considerations; and that for studies which expose healthy volunteers to significant risks, an IRB should require that evidence be more than clear and convincing as a condition for approval. Additional empirical research is needed on how IRBs use evidence to make decisions and how standards of evidence influence IRB decision-making at the individual and group level.

Defining institutional review board application quality: critical research gaps and future opportunities

“…Instead, researchers expect IRB review that is supported by clear explanations and regulatory standards. IRBs have historically had a reputation of hiding behind a veil of anonymity, not providing a rationale or justification for their decisions, and seeking arbitrary revisions that fundamentally change the scope of the research (Hamburger, 2004; Klitzman, 2012; Lynch, 2018; Resnik, 2021). While this view of IRBs is gradually shifting, lingering frustration caused by vague IRB directives can strain relationships and cause mistrust between researchers and the IRB, and potentially compromise research compliance as a result.…”

“…Much of the established literature calling for clearer standards of evidence for IRB quality and decision-making make little or no mention of the caliber of the IRB application submitted by the researcher. Resnik (2021) provides a helpful definition: “A standard of evidence for an IRB would be [a] rule or guideline concerning the type or amount of evidence that is needed to make an approval decision” (p. 429). In applying Resnik’s definition, it is clear that the “amount of evidence needed to make an approval decision” lies squarely within the IRB application.…”

“…Throughout the published literature, calls can be found for a greater understanding of quality review within the field of human participant research (Abbott and Grady, 2011; Lynch et al, 2019; McDonald and Cox, 2009; Nicholls et al, 2015; Resnik, 2021; Scherzinger and Bobbert, 2017; Taylor, 2007; Tsan, 2019; Vawter et al, 2004). While this piece is written from a US perspective, a more precise grasp of research quality is a ubiquitous, global need.…”

Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight

“…Even in the absence of comprehensive quality and effectiveness measures, prior AEREO work has emphasized efforts to measure elements relevant to participant outcomes, meaningful board deliberation, and procedures most likely to identify and mitigate risks to participants (Lynch et al, 2020), such as the quality of the consent process, robust assessment of adverse events, and overall participant experience (Lynch et al, 2021). Yet when each HRPP and IRB takes a customized approach to these factors and others, both in the metrics used and the points at which they are collected, it becomes difficult to make comparisons between institutional practices and their impact on IRB quality (Resnik, 2020; Serpico, 2021; Tsan, 2019). For example, consider attempting to evaluate the impact of 2018 changes to the U.S. Common Rule that eliminated the requirement for annual continuing review for some studies.…”

Making Metrics Meaningful: How Human Research Protection Programs Can Efficiently and Effectively Use Their Data

“…. it is likely to include value judgments that are not reducible to scientific data or facts.” 2 In other words, metrics are one piece of the important constellation of factors increasing IRB transparency. The primary focus of this article is to delineate where HRPPs can operationally use metrics and empirical data to support transparency, growth, and success.…”