Reimagining IRB review to incorporate a clear and convincing standard of evidence

ABSTRACT

This commentary is a critical response to the article written by David Resnik regarding the use of a standard of evidence for Institutional Review Board (IRB) decision making. Resnik suggests that IRBs should not only base decisions on evidence, but that this evidence should be sufficient to ensure a “clear and convincing” standard similar to that used by juries for legal proceedings. We agree that the increased use of evidence to meet this standard would be ideal since this provides clear guidance and could allow for a more transparent IRB review. However, to effectively meet this standard, significant modification would be required for researchers as well as for IRBs’ processes. First, researchers would be required to identify, understand and include appropriate scientific and ethics evidence in support of their protocol. IRB members and IRB professionals would need to discuss the importance, value, and significance of evidence in order to come to a collective decision regarding each protocol. Such responsibilities are justifiable and could bring much needed rigor and transparency to the system but they would require time, training, research, and education. While Resnik’s suggestion seems to incorporate a small change with respect to a standard, in application it would actually require a novel system.

KEYWORDS:

• IRB
• evidence
• standard of evidence
• research ethics on human subjects

Disclosure statement

This commentary discusses the work in an article recently written by David Resnik. Although this commentary was written in a neutral manner, a collegial relationship may unduly influence or perceive to influence the review. We therefore choose to disclose that authors of this review (Elise Smith and Emily E Anderson) have had ongoing conversation with David Resnik regarding his research. Also, Elise Smith was previously a post-doctoral fellow of David Resnik (2016–2019). We have no financial conflict of interests related to this research.

Notes

1. There is a difference in time allocation between different types of IRBs. For example, independent IRBs in which members are paid may have more time to review each protocol. IRBs in academic centers include many volunteers that may not have much time to allocate to the process. However, the time allotment for independent IRBs would still be more limited if compared to a jury that could take days to arrive to a verdict.

Additional information

Funding

Elise Smith is supported in part by the Clinical and Translational Science Award (UL1TR001439) from the National Center for Advancing Translational Sciences, National Institutes of Health.