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Glossary

SMART IRB Agreement

Supporting IRB reliance across the nation

Proposed SMART IRB Reliance Agreement Version 3.0

Over the past several years, SMART IRB leadership has been working with the SMART IRB Harmonization Steering Committee, the National Center for Advancing Translational Sciences (NCATS) and other federal agency representatives, and members of the SMART IRB community to discuss possible changes to the current SMART IRB Agreement.

The proposed SMART IRB Reliance Agreement Version 3.0 is a significant amendment of the current SMART IRB Agreement. These changes are intended to:

  • address feedback from current and potential Participating Institutions
  • fully reflect changes to IRB review requirements in the 2018 Common Rule; and
  • allow additional federal agencies to participate in the agreement.

All current Participating Institutions and stakeholders, as well as prospective signatories, were provided opportunity to comment on SMART IRB Reliance Agreement Version 3.0 between November 15, 2023 and February 15, 2024. The comment period is now closed, and the community feedback we received is undergoing review. Once finalized, Version 3.0 will replace Versions 2.0 and 1.0. Participating Institutions will be notified regarding next steps, including any required actions related to their participation in the SMART IRB Agreement.

Learn More

  1. Read the SMART IRB Reliance Agreement Version 3.0 Cover Memo.
  2. Review SMART IRB Reliance Agreement Version 3.0 along with the Executive Summary of Key Changes and discuss with institution officials and counsel, as appropriate (see: SMART IRB Reliance Agreement Version 3.0 with tracked changes as compared to v2.0).
  3. Review the FAQs on the Comment and Transition Process.
  4. Watch the SMART Talk: Introducing SMART IRB Reliance Agreement v3.0. This session provides an orientation to the proposed updates and why they are being put forward. [Download Slides]

For questions about the proposed amendment, please contact an ambassador or email help@smartirb.org.

Background

SMART IRB Agreement Version 1 (including versions 1.1. and 1.2) was available for sign on from September 5, 2016 – September 30, 2020, at which point SMART IRB Agreement Version 2.0 became available. SMART IRB Agreement v1 and v2.0 were compatible, which means that Participating Institutions were not required to sign SMART IRB Agreement Version 2.0. Once a final version of SMART IRB Reliance Agreement Version 3.0 is issued for execution (joinder), all current Participating Institutions will need to execute (join) the final SMART IRB Reliance Agreement Version 3.0 in order to continue participation.

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 Current Agreement

(updated October 1, 2020)

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

Review 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.