Criteria for Approval, Continued — Risks, Benefits and the Second Criterion

As we work our way through a review of the criteria for approval, please keep in mind that these criteria should guide our study reviews and the drafting of contingencies sent back to study teams.

The second criterion for approval is “Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result.”

IRBs, in considering this criterion, are to consider only those risks and benefits that may result from the research (and not those from interventions subjects would receive even if they don’t enroll in the study). IRBs also is not to consider possible long-range effects of applying knowledge gained in the research, such as how the research might impact future public policy.

Chapter 3-11 in the Institutional Review Board Member Handbook (everybody gets one when they join the IRB; please contact the IRB office if you need a copy) provides some guidance about how to evaluate whether research risks are reasonable relative to potential benefits. The authors state that physicians may offer enrollment in a study to their patients when the therapeutic procedures in a clinical trial are consistent with competent medical care. These procedures must meet the ethical standard of clinical equipoise, which exists when there is honest, professional disagreement among experts as to the preferred treatment.

When a study involves only nontherapeutic procedures or interventions, IRBs must determine that risks are minimized consistent with sound research design, and reasonable in relationship to the knowledge that may be gained.

The IRB meeting is a good venue in which to discuss questions of risks versus benefits. The diversity of opinions represented in the membership may prompt discussions of potential risks and benefits reviewers may not think of individually.

Source for this item: Institutional Review Board Member Handbook, by Robert Amdur and Elizabeth A. Bankert