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. SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS) and 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
Enabling collaborative research using single IRB review
  • Providing a roadmap for institutions to comply with the NIH single IRB policy
  • A growing library of resources includes standard operating procedures, FAQs, and guidance
  • Reliance System (beta launching May 4 2017) will provide an easy way for investigators and institutions to track and document reliance decisions on a study-by-study basis
Harmonizing across the nation
  • A blue-ribbon committee is convening to support and encourage collaborative harmonization of best practices, policies and procedures for implementing single IRB review of multisite research.

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 is Funded by the NIH Clinical and Translational Science Awards (CTSA) Program through grant number UL1TR001102-04S1.

Ambassadors

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
Co-Investigator
Alan Green, MD
Principal Investigator
Dartmouth Synergy Clinical and Translational Science Institute
Co-Investigator
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 Reliance
Sabune Winkler, JD
Director
Regulatory Foundations, Ethics, and Law Program
Harvard Catalyst
Chief Regulatory Operations Officer for Implementation
Nichelle Cobb, PhD
Director
Health Sciences IRB Office
University of Wisconsin-Madison
Chief Informatics Officer
Douglas MacFadden, MS
Chief Informatics Officer
Harvard Catalyst