What is the SMART IRB Agreement?

What is the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement?

The SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement (the “SMART IRB Agreement” or the “Agreement”) is the IRB authorization agreement or reliance agreement that permits Participating Institutions to cede review of human subjects research to other Participating Institutions’ IRBs. The Agreement sets forth the authorities, roles, and responsibilities of Participating Institutions and their IRBs when ceding or providing IRB review. The Agreement was designed to meet the proposed regulatory requirement in the Common Rule Notice of Proposed Rulemaking (80 Fed. Reg. 53933 (Sept. 8, 2015)) for documentation of the respective compliance responsibilities of institutions and IRBs participating in an IRB reliance relationship, and is in compliance with the 2018 requirements of the final revised Common Rule 45 CFR 46.. The Agreement was developed with the input of over 110 institutions, from 33 states, including many of the 64 funded Clinical Translational Science Award Hubs.