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. In accordance with the terms of the SMART IRB Agreement, all Participating Institutions now have the opportunity to review and comment on the proposed revisions (termed SMART IRB Agreement v2.0). We also welcome further feedback from prospective signatory institutions.

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 new guidance from the NIH regarding Federal COI requirements (posted 5/11/20); we will update the FAQs as additional questions come in.
  4. Provide Feedback. Deadline Extended: SMART IRB Agreement v2.0 will be open for comment through June 8, 2020.

Questions? Contact us.

Learn more about NIH’s proposed revisions, as well as the process for submitting comments and next steps by viewing our April SMART Talk: 2-part session: NIH Proposed Updates to the SMART IRB Agreement & sIRB Considerations in the Context of COVID-19.

Thank you for attending to this during the pandemic, as we know you have so many important responsibilities to attend to at this time.

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