by Raffaella Hart, MSHS, CIP - Vice President, IRB and IBC Services at BRANY
The requirement and expectation for use of a single Institutional Review Board (sIRB) for multi-site research has arrived. The National Institutes of Health (NIH) has firmly established the expectation that sIRBs will be used to review multi-site research. In its final policy on this topic, effective September 25, 2017, NIH explained that proposals for domestic, multi-site, non-exempt human subjects research should include plans for use of a sIRB. On January 19, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued the final rule to update the regulations that protect human subjects (45 CFR 46, Subpart A – referred to as the “Common Rule”), which included a new requirement for sIRB review for multi-site research (with exceptions permitted and a three-year effective date of January 20, 2020).For many institutionally-based human research protection programs (HRPPs), managing single IRB review for all their multi-site studies will be a big challenge, whether they are intended to serve as the sIRB or rely on a sIRB. Accommodating varying sIRB review models may require some retooling of existing policies and procedures; educating investigators, IRB members, and staff; and adaptable thinking.
Preparing for sIRB Review
There are many existing models of single (or “centralized”) IRB review from which one can learn. Organizations that have experience with relying upon or serving as a single IRB for multi-site research can think about the processes they have established and how to scale them up for the anticipated increase in research proposals using sIRB review. For organizations that have limited experience in this area, adaptation and education will be necessary.
Relying on a sIRB
Relying on another entity to provide IRB review for research does not absolve the local organization from its research oversight obligations and other regulatory responsibilities (for example, conflict of interest reporting or institutional biosafety review).
Before relying on a sIRB, the local organization should identify what it needs to know about the research from the local researcher and the sIRB, and determine how to obtain and incorporate that information into its current research oversight framework. With an anticipated increase in requests to rely on a sIRB, the organization should take a few things into consideration:
Additional resources that may be needed
How and when non-IRB review-related organizational requirements will be reconciled
How post-approval monitoring will be accomplished, and
- How problems that may arise with the conduct or review of the research will be handled
Serving as a sIRB
Serving as the sIRB of record for external organizations can be a challenge for an organization. The sIRB should take into consideration:
What information the sIRB needs to substantively evaluate applications from researchers external to the sIRB’s organization (for example, local context or local laws or expertise for the study topic)
If the sIRB organizational systems are capable of managing submissions and records for IRB review of multiple sites for the same study in a meaningful way
How will IRB review of modifications and continuing review be accomplished and communicated to external sites
If a problem arises at an external site, to what extent will the sIRB intervene
How will reporting be managed (reporting to federal regulatory authorities or institutional reporting for noncompliance), and
What additional resources, if any, are needed to conduct the IRB review (for example, additional staffing and IRB meeting time)
Communication is Key
The key to facilitating sIRB review among local and external sites is communication. All parties involved in the sIRB arrangement need to know what is expected of them, how to effectively communicate with one another, and what to do when a problem arises. The goal is to achieve IRB review and oversight that reduces redundancy and variation, improves efficiency, and keeps stakeholders and key parties well-informed.
IRB Authorization Agreements
To facilitate communication, it is important to develop a rapport that affords the opportunity to clearly establish expectations and to get questions answered. IRB authorization agreements, also called reliance agreements, can be an initial key communication tool for the local site and the external IRB. Agreements should clearly specify the responsibilities of the organization providing sIRB review and the site relying on the sIRB. Negotiating these agreements provides a catalyst for dialogue and a chance to build a successful sIRB relationship.
IRB administrators need to take inventory of their organization’s policies and standard operating procedures (SOPs); develop SOPs to help investigators, IRB staff, and IRB members successfully navigate sIRB review; and consider any additional education and training needs.
About the Author
Raffaella Hart is the Vice President of IRB and IBC Services. She is a Certified IRB Professional (CIP) and has been involved in research administration for more than 15 years. She and her team also facilitate BRANY’s IBC Services and COI review services.
CITI Program sIRB Training
CITI Program has three new modules that researchers and IRB administrators may utilize to review relevant issues when determining whether to serve as a sIRB or rely on an external sIRB. View our Human Subjects Research page or our IRB Administration course for more information.
Single Institutional Review Board (sIRB) Use and Administration: When Relying on a sIRB
Single Institutional Review Board (sIRB) Use and Administration: When Serving on a sIRB of Record
Single Institutional Review Board (sIRB) Use and Administration: Authorization Agreements
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