About Us

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. Launched in 2016, SMART IRB is funded by the NIH Clinical and Translational Science Awards (CTSA) Program, grant number UL1TR001102-04S1. The platform is intended to serve 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.

What we've been working on

Helping institutions join SMART IRB
  • Nearly 300 institutions joined SMART IRB in the first year, including all CTSA hubs, and the SMART IRB family continues to grow - see the full list of Participating Institutions.
  • SMART IRB ambassadors are available to answer questions and share the simple steps for joining
Enabling collaborative research using single IRB review
  • SMART IRB provides a roadmap for institutions to comply with the NIH single IRB policy
  • A growing library of resources includes standard operating procedures and FAQs to guide use of the Agreement, as well as checklists, templates, and guidance for reviewing IRBs, relying institutions, and study teams.
  • Peer consultations and regularly scheduled webinars are available to help IRBs and institutions implement single IRB review
  • Online Reliance System provides an easy way for investigators and institutions to track and document reliance arrangements on a study-by-study basis.
  • Early adopters from institutions throughout the U.S. helped guide feature development during the Online Reliance System's beta phase (May 2017-January 2018). The system fully launched in 2018 and new features will continue to be implemented in response to user feedback.
Harmonizing across the nation
  • The Harmonization Steering Committee and its working groups have come together to support and encourage collaborative harmonization of best practices, policies, and procedures for implementing single IRB review of multisite research. Learn more about harmonization.

Background & History

SMART IRB began as a project called IRBrely, which was led by Dartmouth Synergy and funded by NCATS from September 2014 through April 2016. This collaborative effort built upon existing regional networks for IRB reliance to develop a master IRB reliance agreement and standard operating procedures (SOPs) suitable for use across the nation.

In July 2016, NCATS funded the next phase of work to enable IRB reliance on a national scale. This project is led by Harvard Catalyst, University of Wisconsin-Madison ICTR, and Dartmouth Synergy.


SMART IRB ambassadors are knowledgeable in the processes and practicalities of IRB reliance and are available to assist institutions in joining and implementing the SMART IRB Agreement. Learn more

Questions?  We're Here to Help

SMART IRB Leadership

Principal Investigator
Lee Nadler, MD
Principal Investigator
Harvard Catalyst | The Harvard Clinical and Translational Science Center
Alan Green, MD
Principal Investigator
Dartmouth Synergy Clinical and Translational Science Institute
Marc Drezner, MD
Principal Investigator
UW Institute for Clinical and Translational Research
University of Wisconsin-Madison
Executive Director
Laura Weisel, MBA
Executive Director
Harvard Catalyst
Director of Regulatory Policy
Barbara Bierer, MD
Program Leader
Regulatory Foundations, Ethics, and Law Program
Harvard Catalyst
Chief Regulatory Operations Officer for Implementation
Nichelle Cobb, PhD
Health Sciences IRB Office
University of Wisconsin-Madison
Chief Informatics Officer
Douglas MacFadden, MS
Chief Informatics Officer
Harvard Catalyst

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