About Us
Providing a roadmap for single IRB review
Overview
SMART IRB is designed to harmonize and streamline the IRB review process, while ensuring a high level of protection for research participants.
The SMART IRB Platform
What is SMART IRB?
SMART IRB is not an IRB; rather, it is a free platform offering a roadmap for single IRB (sIRB) review: The SMART IRB Reliance Agreement, the Reliance System, and essential tools, resources, and training to facilitate sIRB oversight.
Who is it for?
SMART IRB supports all who engage in human subjects research, including IRB/HRPP administrators and staff, investigators, and study teams. Our 1,300+ Participating Institutions include universities, academic medical centers, community hospitals, commercial/independent IRBs, federal agencies, and more.
How does it work?
Through smartirb.org, Participating Institutions and study teams can coordinate reliance arrangements and access education, expertise, and flexible resources to support a wide range of studies.
What We’re Working on
Building an expansive IRB reliance network
- SMART IRB Reliance Agreement Version 3.0 was developed with substantial community input to enable more institutions and federal agencies to join SMART IRB. As of March 17, 2025, all new institutions will join SMART IRB Reliance Agreement V3.0 and Participating Institutions must join V3.0 to initiate any new reliance arrangements.
- To date, more than 1300 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.
- SMART IRB Ambassadors are available to share their single IRB expertise and assist institutions in 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.
- The Learning Center for Investigators & Study Teams helps study teams successfully plan for and navigate sIRB review arrangements for their studies.
- The Learning Center for IRB/HRPP Staff & Institutions assists IRB administrators and institution staff in managing and addressing challenges related to sIRB arrangements.
- SMART IRB’s new and improved Reliance System allows institutions to join SMART IRB Agreement V3.0 and manage their institutional listing and profile and provides an easy way for investigators and institutions to coordinate, track, and document reliance arrangements.
- Monthly online SMART Talks provide real-world perspectives, lessons learned, and first-hand advice on a range of sIRB issues.
- The annual Single IRB Boot Camp: A How-to Guide with SMART IRB provides IRB/HRPP personnel new to sIRB arrangements with remote training on successful implementation of the sIRB model.
- The annual SMART IRB Symposium: Enhanced Training in Single IRB Review is a remote workshop for IRB/HRPP professionals who are experienced in the sIRB process, addressing challenges in managing sIRB oversight for a range of protocols.
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.
- Recommendations, best practices, and templates developed by content experts and informed by community review and input are freely available to support alignment of processes and procedures across institutions.
Leadership
Barbara Bierer, MD
Principal Investigator and Program Director
Program Director, Regulatory Foundations, Ethics, and Law Program, Harvard Catalyst
Nichelle Cobb, PhD
Senior Advisor
Association for the Accreditation of Human Research Protection Programs
Aaron Kirby, MSc
Director, Regulatory Affairs Operations
Director, Regulatory Affairs Operations, Harvard Catalyst
Polly Goodman, CIP
Senior Associate Director, Regulatory Affairs Operations
Senior Associate Director, Regulatory Affairs Operations, SMART IRB, Harvard Catalyst
Jeremy Lavigne, MA, CIP
Senior Officer, Regulatory Affairs Operations
Senior Officer, SMART IRB, Harvard Catalyst
Jonathan M. Green, MD MBA
Program Director, Strategic Initiatives
Director, Office of Human Subjects Research Protections, National Institutes of Health
Michael Linke, PhD, CIP
Program Director, Education
Chair, University of Cincinnati IRB and StrokeNet Central IRB; Adjunct Professor of Internal Medicine, University of Cincinnati
Background & History
March 2025
The Future of Single IRB
SMART IRB Reliance Agreement Version 3.0 launched on March 17, 2025, along with an updated SMARTIRB.org and a new SMART IRB Reliance System. The new Agreement broadens participation to additional federal agencies, provides greater harmonization with the Revised Common Rule, and is responsive to sIRB research community feedback over the past 8+ years. The new system integrates and enhances the functionality of the previous Joinder and Online Reliance Systems, allowing institutions to join SMART IRB Reliance Agreement V3.0 and manage their listing and profile, and providing a central home for investigators and institutions to coordinate and track single IRB arrangements for their studies, with improved flexibility in editing, adding sites, user permissions, and more.
December 2024
Under Construction: New Agreement, Website, and System
Following the closing of a second review and comment period, the SMART IRB Team worked to address community feedback, finalize SMART IRB Reliance Agreement V3.0, and prepare for the implementation of this necessary revision to the SMART IRB Reliance Agreement, including the launch of a new website and system.
November 2023
Toward Broader Participation and Utilization
Between November 2023 and February 2024, a draft SMART IRB Reliance Agreement Version 3.0 was posted for an initial review and comment period to obtain feedback from Participating Institutions and stakeholders on the proposed revisions. The initial draft of SMART IRB Reliance Agreement V3.0 incorporated community feedback obtained over several years, with the aim of allowing more institutions and federal agencies to join SMART IRB, and to be responsive to regulatory changes outlined in the Revised Common Rule.
June 2023
Renewed Funding Continues Growth and Platform Enhancements
Funding for SMART IRB was renewed by NCATS 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.
May 2021
NCATS Takes Over Technical Updates and Developments
NCATS shifted management of technical updates, development, and maintenance of SMART IRB’s IT systems in-house, to their Information Technology Resources Branch (ITRB). The SMART IRB team retains oversight and day-to-day operations of the 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.
October 2020
NIH becomes the 800th SMART IRB Participating Institution
Revisions to the SMART IRB Agreement enabled the NIH to join as a Participating Institution, facilitating 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.
July 2018
Growing the SMART IRB Network
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 sIRB review and promote harmonization.
July 2016
Official Launch of SMART IRB
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..
September 2014
Collaborative Effort Funded
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., culminating in the development of the SMART IRB Agreement and SOPs.
Join SMART IRB
Join the platform to harmonize and streamline IRB review for multisite studies, while ensuring a high level of protection for research participants.
