Single IRB
Single IRB review is a legal arrangement allowing one IRB (Reviewing IRB, IRB of Record, External IRB) to perform the regulatory review of research on behalf of other, engaged institutions (Relying Site, Participating Site, P Site) under a Reliance Agreement. In January 2018, the NIH mandated use of Single IRB for all NIH-sponsored, multi-site protocols. As of January 20, 2020, under the 2018 Final Common Rule, Single IRB is required for all federally-funded, cooperative research protocols conducted or supported by a Common Rule department/agency. The UVM IRB will allow reliance on an External IRB for multicenter, domestic, non-Exempt, human subjects research protocols with federal funding. Information on reliance may be found in Section 13 of the UVM RPO Policies and Procedures page. Below are additional links to instructions, forms, and educational materials regarding Single IRB.
Procedures
At this time, the University of Vermont (UVM) will allow UVM/UVMHN researchers to rely on an External IRB for multicenter, domestic, non-Exempt, human subjects research protocols where the project has federal funding. A Reliance Agreement (also called an IRB Authorization Agreement) is a document signed by two or more institutions engaged in human subjects research that permits a single IRB to review research activities for more than one site. UVM will enter into an individual Reliance Agreement as required, but also has the following Master Reliance Agreements in place. Master Reliance Agreements allow UVM to rely on a single IRB repeatedly without having to renegotiate an agreement for each individual project.
• National Cancer Institute Central IRB (NCI CIRB) – for adult and pediatric oncology protocols
• SMART IRB
• StrokeNet IRB – for StrokeNet protocols
• WCG IRB (formerly Western IRB) – when a UVM Lead Investigator wishes to subcontract single IRB responsibilities
WCG IRB Information
UVM has subcontracted with WCG IRB (formerly Western IRB) for Single IRB services where UVM/UVMHN researchers wish to be the lead site for their federally-funded proposals. Proposals should include the use of WCG IRB as the IRB of Record for the multi-site research activities, and budgets must be developed to include the expense for the use of this commercial IRB. Reference the UVM RPO’s WCG IRB web page for Step-by-Step instructions.
Smart IRB
“SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants.”
Freely available for institutions and investigators, the SMART IRB is not a single IRB that will review collaborative research. It is an integrated, comprehensive platform that offers a Master IRB Reliance Agreement (the SMART IRB Agreement v1 and SMART IRB Agreement v2.0) and a web-based system (SMART IRB’s Online Reliance System) allowing institutions and their investigators to initiate, track, and document study-specific reliance agreements.
NIH FAQs
Visit this link to read some frequently asked questions from the National Institutes of Health:
Secretary’s Advisory Committee on Human Research Protections – Single IRB Points to Consider
Given the increase in the number of sponsors who now require the use of a single institutional review board (IRB) review, many institutions are now challenged with serving as a single IRB for multisite research or relying on another IRB to review its research.
