How the Agreement changes

Yes, the Agreement can be amended — Version 3.0 is itself a significant amendment, developed with community comment (November 2023 – February 2024 and November 2024-December 2024) before taking effect in March 2025.

Who is notified

When SMART IRB administration proposes any material Agreement amendment they will seek input from Participating Institutions during the drafting process, as follows:

• The proposed draft amendment language will be posted at SMARTIRB.org.
• All Participating Institutions (including Points of Contacts and Institutional Officials) will be notified of the proposed amendment language and provided at least a 30-day comment period.
• All feedback will be considered.
• A revised draft of the amendment language, if any, will be posted at SMARTIRB.org.
• All Participating Institutions (including Points of Contact and Institutional Officials) will be notified of any updates to the proposed amendment language and provided at least a 15-day comment period prior to the amendment being finalized.

If alternative proposals received during the feedback process are determined to be preferable to the originally proposed amendment, the updated version will be communicated back to the appropriate individuals, following the steps above.

Does my institution have to sign again?

It depends on the nature of the change. It will be determined, on an amendment-by-amendment basis, whether Participating Institutions must re-execute the Joinder Agreement.

In cases where a Participating Institution is unable to accept the terms of the amended Agreement, the institution may terminate its participation in SMART IRB, as described in the SMART IRB Standard Operating Procedure for "Ending Site Participation in SMART IRB or Specific Research."