Participating Institutions
including all CTSA hubs

SMART IRB Agreement

Supporting IRB reliance across the nation

Now Available: SMART IRB Agreement v2.0

SMART IRB Agreement v2.0 incorporates revisions to the original SMART IRB Agreement that enable the NIH to participate in the Agreement. Further explanation of these changes and of the implications for Participating Institutions are provided in the cover memo and accompanying FAQs below.

As of October 1, 2020, any new institutions will sign the Joinder Agreement for SMART IRB Agreement v2.0. Current Participating Institutions may sign the updated Agreement to facilitate collaborations with NIH Intramural Research Program (IRP) investigators. The Participating Institutions list indicates the version(s) of the Agreement that each institution has signed.

Learn More

  1. Read the SMART IRB Agreement v2.0 Cover Memo for details on the revisions.
  2. Review the SMART IRB Agreement v2.0 and discuss with institution officials and counsel, as appropriate (see SMART IRB Agreement v2.0 with tracked changes).
  3. Review the accompanying FAQs and guidance from the NIH regarding Federal COI requirements.


In the spring of 2020, Participating Institutions and prospective signatories were provided the opportunity to review and comment on proposed revisions to enable NIH to sign the SMART IRB Agreement. SMART IRB leadership and representatives from the NIH National Center for Advancing Translational Sciences reviewed and incorporated feedback from the community and finalized SMART IRB Agreement v2.0 on October 1, 2020.

SMART IRB Agreement Version 1 (including versions 1.1. and 1.2) was available for sign on from September 5, 2016 – September 30, 2020. SMART IRB Agreement v1 is compatible with Version 2.0, which means that Participating Institutions are not required to sign SMART IRB Agreement Version 2.0. While Participating Institutions must be on v2.0 in order to use the SMART IRB Agreement to enact a reliance with NIH, institutions do not need to be on 2.0 to enact reliance arrangements with other non-NIH Participating Institutions; for further details, please reference these FAQs.

Questions? Contact us.

For IRBs and Institutions

The SMART IRB Agreement:

  • Enables reliance on a study-by-study basis
  • Clearly defines roles and responsibilities
  • Eliminates the need to sign reliance agreements for each study

Once you've joined SMART IRB, you may use the Agreement to support collaborations among Participating Institutions.

Learn more about how it works, or join now.

For Investigators

The SMART IRB Agreement:

  • Reduces hurdles for multisite collaborations
  • Supports small and large studies, regardless of funding
  • Helps you obtain trial results faster

Investigators from Participating Institutions can use the SMART IRB Online Reliance System to request reliance arrangements for their studies.

Learn more about how SMART IRB can support your collaborations

Review the Current Agreement

(updated October 1, 2020)

Before joining SMART IRB, review the current agreement with institution officials and counsel.

Review the Current Agreement

Do not sign the sample Joinder Agreement.

Note: SMART IRB Agreement Version 1 is compatible with Version 2.0; Participating Institutions that have signed v1 are not required to sign SMART IRB Agreement Version 2.0.

sIRB Learning Center:

Videos and Resources

Visit the Learning Center for IRB/HRPP Administrators to learn more about the SMART IRB Agreement, watch past webinars, and access on-demand tools and guidance to help you navigate the Single IRB process.

Join our mailing list to be notified of upcoming learning opportunities.