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It is no secret that there has been conspicuous lack of enthusiasm in some corners for the switch to a single IRB overseeing studies with multiple sites, which takes effect next year with the new Common Rule.
How did we get here? To answer this question, researchers reviewed the public comments submitted on the proposal for single-IRB review. They reviewed hundreds of comments on the question when it was originally broached in 2011 and then again in the 2015 Notice of Proposed Rulemaking.
“Our analysis indicates that support for the single‐IRB mandate was limited,” they reported. “The most common argument against the proposed mandate came from those concerned with the loss of site‐specific IRB review of the protocol for a multisite study to address issues relevant to local context.”
Although the water appears to be well under the bridge on this, we asked for comment from lead author Holly Taylor, PhD, MPH, a professor in the Berman Institute of Bioethics at Johns Hopkins University in Baltimore.
IRB Advisor: In reviewing the public comments submitted to the original and revised proposal for mandated single‐IRB (sIRB) review, you found a surprising lack of support for this concept. Can you comment on why there was some concern of replacing one “inefficient system” with another one?
Taylor: On the latter question, the concern is that — at least in the short-term — institutions will need to continue all the ancillary reviews conducted by their HRPPs [human research protection programs] and create new systems to manage becoming a sIRB or rely on another IRB. There seems to be consensus that the current system has inefficiencies, but not evidence that moving to the sIRB will relieve HRPPs of administrative activities.
IRB Advisor: Can you elaborate on the concern by many that use of a single IRB for a multisite study might diminish the local context of the research? Was there a concern that the results would be of less value to local researchers and research subjects?
Taylor: My sense was that the concern is about losing information that may be unique to the local setting in which the research will be conducted. I don’t think this is a concern for the average multisite clinical trial where a condition or disease is the primary eligibility criteria (e.g., large oncology trial) that draw patients from a wide geographic area around the institution recruiting subjects.
The concern is about trials that will be conducted in a local community around the institution where there may be some local knowledge relevant to the recruitment of subjects that an IRB in another city or state would not be aware of. That said, in these cases the sIRB would likely realize that soliciting local input would be important and may be an exception to the general rule where local input is less important.
IRB Advisor: You and colleagues note that the “the new policy is essentially an unfunded mandate for an IRB to assume additional administrative responsibilities.” Do you anticipate some reluctance to take on the single-IRB role and ensuing costs?
Taylor: That is hard to say. I think it will be hardest for smaller institutions with a smaller research “footprint” to find the resources needed.
1. Taylor HA, Ehrhardt, Ervin AM. Public Comments on the Proposed Common Rule Mandate for Single IRB Review of Multisite Research. Ethics Hum Res. 2019 Jan;41(1):15-21. doi: 10.1002/eahr.500002.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, Physician Editor Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.