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.

SMART IRB is not an IRB; rather, it is a platform that encompasses a common IRB reliance agreement (the SMART IRB Agreement) and a suite of web-based resources to facilitate single IRB arrangements. Through smartirb.org, institutions can join the SMART IRB Agreement and manage their profiles, and investigators, study team members, and IRB/HRPP staff and administrators can request, track, and document single IRB (sIRB) arrangements for their studies. SMART IRB also provides essential education and flexible tools and resources to support the implementation of single IRB oversight, with a team of ambassadors available to assist in onboarding and implementation.

Launched in 2016, SMART IRB is currently funded by the NIH National Center for Advancing Translational Sciences. 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 and the Office for Human Research Protections (OHRP) Revised Common Rule Cooperative Research Provision, though SMART IRB may be used for any study that is eligible for IRB reliance, regardless of funding source or status. SMART IRB, the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform, is  designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy. Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. Launched in 2016, SMART IRB is currently funded by the NIH Clinical and Translational Science Awards (CTSA) Program, grant number 3UL1TR002541-04S2. 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.

SMART IRB is not an IRB, but 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. Institutions can join the SMART IRB Agreement and manage their institutional profile through the SMART IRB Joinder system. Through smartirb.org, investigators, study team members, and IRB/HRPP administrators and staff can access 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.

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 collaborative effort built upon existing regional networks for IRB reliance to develop a master IRB reliance agreement and SOPs suitable for use across the nation. Since 2016, more than 1000 participating institutions have joined the SMART IRB Agreement, a growing network of CTSA hubs and affiliates, universities, academic medical centers, community hospitals, cancer centers, independent IRB organizations, and more. 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.

Through the years, SMART IRB continued to develop and enhance the technological infrastructure that supports use of the SMART IRB Agreement for single IRB review arrangements. Given the progress made on the Joinder application, Online Reliance System, and SMART IRB website, in May 2021, NCATS made the decision to manage technical updates, development, and maintenance of these tools in-house moving forward, via NCATS Information Technology Resources Branch (ITRB) team. The SMART IRB team retains oversight and day-to-day operations of the SMART IRB Help Desk and website content, in addition to other functions such as the harmonization efforts, the ambassador team, and ongoing education, training, and resource development to support the SMART IRB community and advance collaborative research across the nation.
Funding for SMART IRB was renewed in June 2023, with a focus on broadening participation, improving systems, and continuing to develop and disseminate education and resources that support investigators and institution staff in the implementation of single IRB arrangements for their multisite studies.

For more information, please visit the SMART IRB website.

Last updated
November 14, 2023