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.
SMART IRB is not an IRB; rather, it's a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB's Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements. Investigators and their study teams, together with institutional and HRPP/IRB offices, use the SMART IRB platform to initiate single IRB review of a study. SMART IRB also provides a gateway to essential education as well as flexible tools and resources designed to support the adoption and implementation of single IRB review for a range of studies.
Launched in 2016, SMART IRB is currently funded by the NIH Clinical and Translational Science Awards (CTSA) Program, grant number UL1TR002541-01S1. The platform serves as a roadmap for institutions to implement The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board for Multisite Research effective January 2018, though SMART IRB may be used for any study that is eligible for IRB reliance, regardless of funding source or status.
In September 2014, NCATS funded a collaborative effort to develop a master IRB reliance agreement and standard operating procedures (SOPs) that could be adopted by institutions across the U.S. This process culminated in the development of the SMART IRB Agreement and SOPs.
In 2016, NCATS initiated the official launch of SMART IRB, which at this stage, focused on encouraging the adoption of the SMART IRB Agreement and enabling IRB reliance on a national scale. This first phase, through April 2018, was led by Harvard Catalyst, University of Wisconsin-Madison ICTR, and Dartmouth Synergy, with the support of ambassadors from CTSAs across the U.S.
During this first phase:
In July 2018, with renewed support and commitment from NCATS, the SMART IRB team accelerated efforts to grow the SMART IRB network, support and train institutional representatives and study teams in the implementation of single IRB review, and promote harmonization across the nation.
Questions? We're Here to Help
SMART IRB ambassadors are available to assist institutions in joining and implementing the SMART IRB Agreement