The First Criterion for IRB Approval of Research — A Refresher

When participating in those lively, and sometimes lengthy, discussions at IRB meetings, it can be easy to forget that IRB approval is based on on just a handful of criteria. Upcoming IRB Members Blog items will provide a refresher of these criteria. These criteria should underpin all the contingencies the IRB sends back to investigators. Keeping these requirements in mind when reviewing research improves the consistency of our reviews and minimizes the chances of the IRB straying too far afield in its contingencies.

The first criterion:

(1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

The second part of this criterion is fairly straightforward, particularly at an academic medical center like ours where we see many studies involving experimental medical treatments. The advantages of incorporating standard of care procedures into research whenever possible are clear — it minimizes risk and inconvenience to participants, can reduce costs by reducing the number of research-only procedures to be done, and limits demands on the institution’s resources.

This criterion’s first part leads us to the debate over how closely the IRB should evaluate study design and scientific quality. While some have argued that the IRB should concern itself with ethics rather than study design, it would be impossible for the IRB to evaluate this criterion without considering study design and overall scientific quality. From the Institutional Review Board Member Handbook (that’s the little gray book each IRB member receives when joining the board; please contact the IRB office if you need a copy):

If revising the study design will meaningfully decrease the risk to subjects without a major compromise in the persuasiveness of the study results, the IRB should not approve the protocol. When a study involving risk is set up to ask a question that is not important or has already been answered by previous research, the risk/benefit ratio is likely to be unfavorable.

Like so many things in research, the answer to the question of how deeply the IRB should delve into study design and procedures is, “It depends.” The IRB sees many studies where the risks to subjects are low (many of these are handled by expedited review), and even if the study design is less than optimal, the IRB may not feel a change in the design will have an important impact on the risk/benefit ratio.

Sources for this item: Institutional Review Board Member Handbook, by Robert Amdur and Elizabeth A. Bankert; Jan. 14, 2014 webinar titled Keeping Your Eye on the Ball: How and Why to Keep the IRB Focused First and Foremost on the Regulatory Approval Criteria, presented by Jonathan M. Green, MD, and Jeffrey A. Cooper, MD, MMM.