SMART IRB Agreement

Supporting IRB reliance across the nation

 Proposed Revisions to the SMART IRB Agreement

The proposed revisions to the SMART IRB Agreement are intended to enable the NIH to sign the Agreement. Further explanation is provided in the cover memo and accompanying FAQs below.

In accordance with the terms of the SMART IRB Agreement, all Participating Institutions were provided the opportunity to review and comment on the proposed revisions (termed SMART IRB Agreement v2.0) from April 2, 2020 through June 10, 2020. During this time, we also welcomed feedback from prospective signatory institutions. The comment period is now closed, and the community feedback we received is undergoing review by SMART IRB leadership and representatives from the NIH National Center for Advancing Translational Sciences. Participating Institutions will be notified regarding next steps, including any required actions related to their participation in the SMART IRB Agreement.

Next Steps

  1. Read the SMART IRB Agreement v2.0 Cover Memo (updated 5/11/20) for details on the proposed NIH revisions and the process moving forward.
  2. Review the proposed SMART IRB Agreement v2.0 (updated 5/11/20) and discuss with institution officials and counsel, as appropriate.
  3. Review the accompanying FAQs (updated 5/11/20) and guidance from the NIH regarding Federal COI requirements (posted 5/11/20).

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