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New Requirement for CR supplement form and study closure memo

Starting on April 1, 2026, the NIH IRB will require a supplement form to be completed and attached to the continuing review (CR) form in PROTECT. This expectation applies to all IRB-approved studies involving prospective informed consent (IFC) of participants, including studies currently in follow-up or data analysis.

The CR form in the legacy IRB system, iRIS, in use prior to January 2023, provided more detail about the status of the study and about enrolled participants. The use of this supplement will restore critical information about study status and risk and should streamline communication and reduce delays in the IRB review process. In addition, when closing a study, a closure memo will now be required to be uploaded in PROTECT.

How do I complete this task?

  • Continuing Review (CR) - For studies that involve prospective IFC of participants, the CR supplement form must be completed and uploaded as an attachment in section 6 “Attach supporting documents” in PROTECT.
    • Continuing Review Supplement can be found in PROTECT in the IRB Library under Templates tab
  • Study Closure – For all closure submissions in PROTECT, the closure memo must be completed and uploaded as an attachment in section 6 “Attach supporting documents”.
    • Closure Memo can befound in PROTECT in the IRB Library under Templates tab

What happens if the supplement or memo is not attached to the CR?

Those CRs submitted to the IRB prior to 4/1/26 that do not have a CR supplement or closure memo will not require one unless the IRB has questions and needs more information in order to conduct its review.

New CRs submitted to the IRB on or after 4/1/26 will require the supplement or closure memo depending on the type of submission being submitted. Submissions that do not include the required supplement or closure memo will be returned without review.

Questions?