Applies to: Agreement V3.0 · Reliance System
SMART IRB is a free national platform for single IRB review of multisite human subjects research. It is funded by the National Center for Advancing Translational Sciences (NCATS) at NIH and operated by Harvard Catalyst, and it is open to any institution that meets the eligibility criteria.
SMART IRB has five parts. You will use some or all of them depending on your role.
The SMART IRB Reliance Agreement (Version 3.0). A master reliance agreement that lets Participating Institutions cede IRB review to, or provide IRB review for, one another without negotiating a new agreement for every study. Version 3.0 has been the only version available for new arrangements since March 17, 2025. It sets out who does what when one institution's IRB reviews on behalf of another, and it satisfies the Common Rule's requirement to document reliance responsibilities. Read about the Agreement.
The Reliance System. The web application where your institution joins the Agreement (by e-signing a Joinder Agreement), signs the optional Indemnification Addendum, manages its contacts and profile, and where study teams and IRB offices request, track, and document reliance for individual studies. Sign in · User guides.
Standard Operating Procedures and templates. The SMART IRB SOPs apply by default to every V3.0 arrangement unless the institutions document otherwise. The Implementation Checklist, Letter of Acknowledgment, and Communication Plan are the working documents most institutions use. All of them are in the Resource Library.
Harmonization. Guidance developed by the Harmonization Steering Committee to align single IRB practices across institutions — ancillary reviews, reportable events, local considerations, conflicts of interest, and more. Harmonization.
People. SMART IRB Ambassadors across the country, the SMART IRB team, free SMART Talks, and Boot Camp. Find an Ambassador · SMART Talks · Contact us.
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