How the Agreement is amended

Applies to: Agreement V3.0 (§8.6)

The Agreement can be amended, and Version 3.0 is the most recent example: a significant amendment developed with two public comment periods before taking effect in March 2025.

What the Agreement says (§8.6). The SMART IRB Executive Coordinating Committee may periodically propose and issue amendments to, or updated versions of, the Agreement and the Indemnification Addendum under SMART IRB's published policies. Any material change is opened for written comment, and every Participating Institution is entitled to review and comment. An institution continues in the amended Agreement without further action unless the change is significant enough to require new Joinders — in which case SMART IRB publishes a transition plan, and prior versions may remain in effect for ongoing activities (as happened with V1.0/V2.0 arrangements after the V3.0 launch).

SMART IRB's process for a material amendment

1. SMART IRB posts the proposed amendment language at smartirb.org.
2. All Participating Institutions — Points of Contact and Institutional Officials — are notified and given at least 30 days to comment.
3. SMART IRB considers all feedback and posts any revised draft.
4. Participating Institutions are notified of the revisions and given at least 15 more days to comment before the amendment is finalized.
5. If an alternative proposal from the comment period is adopted instead, the updated version goes back through the same steps.

Will we have to sign again? Only if SMART IRB determines the change is significant enough to require re-execution. Version 3.0 required a new Joinder because it was not compatible with earlier versions.

If your institution cannot accept an amendment, it may terminate its participation under §7.2.1.2 and the SOP on ending participation. See Terminating your institution's participation.

See also - What's new in Version 3.0 - Terminating your institution's participation