The National Institutes of Health recently delayed the effective date of its requirement to designate a single IRB (sIRB) in research involving multiple boards, but NIH officials have lost none of their enthusiasm for the idea.

The effective date of the NIH policy on the use of a single IRB for multisite research has been extended from Sept. 25, 2017, to Jan. 25, 2018.1 A point of clarification on the dates and deadlines: Though the Common Rule does not officially require sIRB review of multisite research until Jan. 20, 2020, the NIH has issued a policy2 “establishing the expectation sIRB review will be used for all NIH-funded multisite studies, unless there is a requirement for local IRB review under federal, state, or tribal law or regulation” by the aforementioned January 2018 deadline, according to a recently published commentary3 by two top NIH administrators.

They present the historical problem of multiple IRB review as a story of redundancy and irksome delay.

“It seemed straightforward on its surface: a minimal-risk study to look at financial incentives for evidence-based treatment of hypertension. In the end, however, it took 27 months and 115 submissions to get through the 17 institutional review boards involved in reviewing this multisite study,”4 wrote Carrie D. Wolinetz, PhD, lead author of the commentary, and acting chief of staff and associate director for science policy at the NIH.

Other egregious examples are cited, suggesting prolonged delays over minor revisions as “clinical trials [are] delayed months as dozens of IRBs bicker over the details of consent.”

There may have been some prior perception that multiple IRBs added appropriate precautions and enhanced patient protection, but the NIH view now seems to be that this entanglement of the review process may actually increase risk by diffusing responsibility and delaying innovation.

Though the measure appears to enjoy general support, some have questioned the wisdom of making it mandatory. However, the NIH concluded that “strong encouragement” would not affect change in an entrenched system.

NIH Q&A

IRB Advisor asked Wolinetz to speak to this and other related issues in a recent interview.

IRB Advisor: Just to clarify, the shift to a single IRB for multiple sites will eventually be mandatory — this is not a recommendation. Can you elaborate a little on the commentary’s point that leaving this as a voluntary policy would not have solved the problems described?

Wolinetz: The pre-2018 Common Rule encouraged the use of single IRBs when their use would result in greater efficiency of review. Furthermore, the FDA has previously issued guidance promoting single IRB review. While the use of sIRBs has grown in recent years, it has not been adopted in widespread fashion, despite the increasing number of multisite studies. In order to assist in accelerating a change in culture and promote harmonized practices, HHS determined that it would be useful to include a requirement for single IRB review in the revised Common Rule.

IRB Advisor: Your commentary cites numerous examples of overlapping and contradictory oversight by multiple IRBs, leading to prolonged and unnecessary delays in research. Can you comment a little on how such a system arose historically?

Wolinetz: In the past, most research projects were conducted at single institutions and each research institution had one or more IRBs to oversee protections for human research participants. However, as the research landscape has changed, many clinical research projects now involve conducting the same protocol at multiple institutions, each of which has its own culture and procedures. The practice of local IRB review in multisite studies has led to increased burden for researchers and delays in the initiation of research.

IRB Advisor: The NIH cancer institute uses an sIRB, and its effectiveness recently was cited at an NIH advisory panel meeting. Is this successful cancer research model an example of what the NIH is hoping to achieve with sIRB oversight?

Wolinetz: The NCI CIRB is one of several models for single IRB review. Another example is the National Center for Advancing Translational Science’s SMART IRB Reliance System. (For more information, visit: https://smartirb.org/.) The aim of the single IRB policy is to help streamline the IRB review process and remove redundant hurdles to the initiation of such studies. The policy will allow research to proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.

IRB Advisor: How would this work in practice — would participating research institutions decide on the lead IRB for a given research project? Could this then shift to other IRBs for other research, even if the same institutions are involved?

Wolinetz: In the NIH application/proposal for research funding, the applicant/offeror is expected to submit a plan describing the use of a single IRB that would be selected to serve as the IRB of record for all study sites. This is done on a project basis, so yes, it is possible that if the same institutions were involved in a different multisite clinical study, they might choose a different IRB of record for that study.

IRB Advisor: Can you elaborate or provide any examples of the commentary’s statement that, “We are also considering ways to supplement support to cover direct costs for the development of costing models, business processes, system changes, and efficient procedures and tools needed to facilitate sIRB review for multisite research, as well as mechanisms for widely distributing those best practices.”

Wolinetz: NIH issued a Notice of Availability of Administrative Supplements for CTSA [Clinical and Translational Science Award] awardees to develop resources to facilitate single IRB review for multisite research. (For more information, visit: http://bit.ly/2fmjdxr.) The notice states that the awards will support “the development of costing models, business processes, system changes, and efficient procedures and tools needed to facilitate sIRB review for multisite research.” NIH will continue to evaluate the need for additional support.

REFERENCES

  1. National Institutes of Health. Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of Single Institutional Review Board for Multi-Site Research. Notice Number: NOT-OD-17-076. June 16, 2017: http://bit.ly/2s9Gzdk.
  2. National Institutes of Health. Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. Accessed Aug. 4, 2016. http://bit.ly/2binuxC.
  3. Wolinetz CD, Collins FS. Single-Minded Research Review: The Common Rule and Single IRB Policy. Amer Jrl Bioethics 2017;17:(7):34-36.
  4. Petersen LA, Simpson K, Sorelle R, et al. How variability in the institutional review board review process affects minimal-risk multisite health services research. Ann Intern Med 2012;156:728–35.