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. 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.
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.
What we're working on
Growing a national IRB reliance network
- 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 October 2020, SMART IRB Agreement v2.0 became available, enabling NIH to join SMART IRB and facilitating collaborations with NIH Intramural Research Program investigators.
- SMART IRB ambassadors are available to answer questions about joining and implementing the SMART IRB Agreement.
Resources and education to support institutions and investigators
- A growing library of resources helps guide reviewing IRBs, relying institutions, and study teams, including standard operating procedures and FAQs, as well as checklists, templates, and guidance.
- The Learning Center for Investigators helps study teams successfully plan for and navigate sIRB review arrangements for their studies.
- The Learning Center for IRB and HRPP Administrators assists IRB and institution staff in managing and addressing challenges related to sIRB arrangements.
- Peer consultations, webinar recordings, and monthly SMART Talks are available to help IRBs and institutions implement single IRB review.
- SMART IRB's Online Reliance System provides an easy way for investigators and institutions to track and document reliance arrangements on a study-by-study basis.
- SMART IRB Joinder allows Participating Institutions to create and manage their Institutional Profile.
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. Coming soon: Recommendations for the Harmonization of Ancillary Reviews and Conflicts of Interest and sIRB Review.
Background & History
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:
- 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.
SMART IRB Leadership
Lee Nadler, MD
Harvard Catalyst | The Harvard Clinical and Translational Science Center
David S. Zielinski, PhD
Director of Regulatory Policy
Barbara Bierer, MD
Regulatory Foundations, Ethics, and Law Program
Nichelle Cobb, PhD
Association for the Accreditation of Human Research Protection Programs
Director, Regulatory Operations
Aaron Kirby, MSc
Director, Regulatory Affairs Operations
Associate Director of Regulatory Affairs Operations
Polly Goodman, CIP
Associate Director, Regulatory Affairs Operations for 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
Questions? We're Here to Help