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.
Growing a national IRB reliance network
To date, more than 1100 Participating Institutions have joined the SMART IRB Agreement, a growing network that includes Clinical and Translational Science Awards (CTSA) hubs and affiliates, universities, academic medical centers, community hospitals, cancer centers, independent IRB organizations, NIH and more.,
- Proposed SMART IRB Reliance Agreement Version 3.0 was posted for review and comment from November 15, 2023 - February 15, 2024; comments are currently under review.
- SMART IRB ambassadors are available to answer questions about joining and implementing the SMART IRB Agreement.
Training and resources and education to support institutions and investigators
An evolving library of resources provides standard operating procedures, FAQs, checklists, templates, guidance and more.The Learning Center for Investigators helps study teams plan for and navigate sIRB review, and The Learning Center for IRB and HRPP Administrators assists IRB and institution staff in managing and addressing challenges related to sIRB arrangements.
- Monthly online SMART Talks provide real-world perspectives, lessons learned, and first-hand advice around a range of sIRB issues.
- Annually, SMART Talks provides IRB and HRPP personnel new to sIRB arrangements with remote training on successful implementation of the sIRB model.
- The SMART IRB Symposium: Enhanced Training in Single IRB Review is a remote workshop for HRPP/IRB professionals who are experienced in the sIRB process, addressing challenges in managing sIRB oversight for a range of protocols.
- With NCATS Information Technology Resources Branch (ITRB), the SMART IRB team is developing a new, improved, and integrated system to request, track, and document reliance arrangements and manage institutional profiles, all in one place. This system will bring together the functionality of the Online Reliance System and the SMART IRB Joinder platform, while introducing exciting new features and workflow enhancements.
Harmonizing implementation of single IRB review across the nation
The Harmonization Steering Committee and its working groups develop tools to support and encourage collaborative harmonization of best practices, policies, and procedures.
- Harmonized documents include: include: Fees and Costing Models under NIH sIRB Policy, Institution v. IRB Responsibilities Guidance, Institutional Profile, a Protocol-specific Document, Reportable Events Recommendations, Responsibilities Associated with the Review of Study Personnel, the Single IRB Continuing Review Process; Post-Approval Auditing for Studies Subject to Single IRB Review, Recommendations for the Harmonization of Ancillary Reviews, Conflicts of Interest Review Processes for sIRB Review; in process: Recommendations for the Harmonization of Local Considerations; Guidance on Reliance for Exemption Determinations.
In September 2014, NCATS funded a collaborative effort to develop a common 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:
- More than 400 institutions joined SMART IRB's reliance network.
- SMART IRB ambassadors and peer consultants assisted institutions as they adopted and prepared to implement the SMART IRB Agreement.
- The SMART IRB team developed and disseminated a robust library of resources for study teams, reviewing IRBs, and relying institutions to implement single IRB review.
- A recurring webinar series led by SMART IRB team members offered support and guidance for participating institutions and their investigators.
- Early adopters from across the U.S. helped guide feature development of the Online Reliance System during the system's beta phase (May 2017-January 2018).
- The Online Reliance System officially launched in January 2018, providing a centralized system to request, track, and document reliance arrangements.
- The Harmonization Steering Committee and its working groups developed and finalized its first set of harmonized documents following consideration of feedback received during a public review and comment period.
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. A key part of these efforts involved incorporating revisions to the SMART IRB Agreement to enable the NIH to participate in the Agreement and to facilitate collaborations with NIH Intramural Research Program investigators. NIH signed the joinder to SMART IRB Agreement v2.0 in October 2020, becoming the 800th SMART IRB Participating Institution.
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.
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SMART IRB Leadership
Principal Investigator and Program Director
Barbara Bierer, MD
Regulatory Foundations, Ethics, and Law Program
Nichelle Cobb, PhD
Association for the Accreditation of Human Research Protection Programs
Director, Regulatory Affairs Operations
Aaron Kirby, MSc
Director, Regulatory Affairs Operations
Senior Associate Director, Regulatory Affairs Operations
Polly Goodman, CIP
Senior Associate Director, Regulatory Affairs Operations, SMART IRB
Senior Officer, Regulatory Affairs Operations
Jeremy Lavigne, MA, CIP
Senior Officer, SMART IRB
Program Director, Strategic Initiatives
Jonathan M. Green, MD MBA
Director, Office of Human Subjects Research Protections, National Institutes of Health
Program Director, Education
Michael Linke, PhD, CIP
Chair, University of Cincinnati IRB and StrokeNet Central IRB; Adjunct Professor of Internal Medicine, University of Cincinnati
SMART IRB ambassadors are available to assist institutions in joining and implementing the SMART IRB Agreement