Update: Revised SMART IRB Reliance Agreement Version 3.0
The revised SMART IRB Reliance Agreement Version 3.0 incorporates a number of substantive changes based on comments received during the initial review period, with the goal of enabling more parties to join. This revised draft was available for a second review period, which closed December 13, 2024. Comments received are currently under review, and Participating Institutions will be notified regarding next steps.
Additional information on revised SMART IRB Reliance Agreement Version 3.0 can be found below.
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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.
Over the past several years, SMART IRB leadership has worked 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 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. During this initial comment period, we received 250 unique comments from 54 different institutions. Working with the SMART IRB Harmonization Steering Committee, NCATS and other federal agency representatives, and members of the SMART IRB community, we considered all comments and made a number of substantive changes to the draft agreement with the goal to enable more parties to join. These changes have been incorporated into the revised SMART IRB Reliance Agreement Version 3.0, which was available for a second review period from November 13, 2024 – December 13, 2024.
Questions? Contact us.
For IRBs and Institutions
The SMART IRB Agreement:
- Enables reliance on a study-by-study basis, as well as documenting multiple reliances either between institutions, or for consortiums or other groups of studies.
- 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
(updated October 1, 2020)
Before joining SMART IRB, review the current agreement with institution officials and counsel.
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.
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.
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