NIH Reminder: IRB Approval Certification Required Before Award

NIH Policy Notices

Published February 18th, 2026

Detected March 13th, 2026

Summary

The National Institutes of Health (NIH) issued a notice reminding the extramural research community that certification of Institutional Review Board (IRB) approval is required before award for nonexempt human subjects research. Funds cannot be used for such research without this certification, which must be the date of final IRB approval, not pending or expired.

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What changed

This NIH Notice serves as a reminder that applicants proposing nonexempt human subjects research must provide certification of final Institutional Review Board (IRB) approval before an award can be made. NIH will not permit funds to be used for such research if this certification, in the form of the final IRB approval date, has not been submitted and accepted. This requirement is rooted in 45 CFR Part 46 and the NIH Grants Policy Statement, emphasizing that research involving human subjects cannot commence under NIH support prior to obtaining IRB approval and submitting the final approval date.

Compliance officers for institutions receiving NIH funding must ensure that all grant applications involving nonexempt human subjects research include the correct final IRB approval date. Failure to do so may result in awards being issued with restrictions preventing any human subjects research until the certification is obtained, or potentially, the inability to use awarded funds for the research. Organizations should proactively manage their IRB review timelines to align with grant application submission and award processes, as ICOs may require earlier submission or impose restrictions at their discretion.

What to do next

Ensure all grant applications for nonexempt human subjects research include the final IRB approval date.
Verify that IRB approval is final and not pending or expired before submission.
Review internal processes to ensure timely IRB review and certification submission to meet NIH award requirements.

Penalties

NIH will not allow any funds to be used by recipients for nonexempt human subjects research where certification via final IRB approval date has not been provided. Awards may be issued with restrictions preventing human subjects research until certification is obtained.

Source document (simplified)

Reminder of Requirement for Certification of IRB Approval Notice Number: NOT-OD-26-043

Key Dates

Release Date: February 18, 2026

Related Announcements

January 11, 2019 - Removal of the Requirement for Institutional Review Board Review of NIH Grant Applications and Contract Proposals Related to Research. See Notice NOT-OD-19-055.

March 30, 2012 - Notice of Requirement for Electronic Submission of Just-in-time Information and Related Business Process Changes Beginning April 20, 2012. See Notice NOT-OD-12-101.

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

This Notice is to remind the extramural research community that NIH requires certification that all nonexempt human subjects research has been reviewed and approved by an appropriate Institutional Review Board (IRB). Applicants must submit the date of final IRB approval, which is the date that all protocols in the proposed research application received IRB review and approval (i.e., the date of the last protocol approval). Submission of pending (e.g., conditional, pre-approval, interim) or expired IRB approval dates is not acceptable. NIH will not allow any funds to be used by recipients for nonexempt human subjects research where certification via final IRB approval date has not been provided to the funding Institutes, Centers, and Offices (ICO).

Information for NIH Grant Applicants

45 CFR Part 46 and the NIH GPS sections 2.5.1 and 4.1.15.2 require applicants proposing nonexempt human subjects research to provide certification to NIH that an appropriate IRB has reviewed and approved the proposed research in the form of the final IRB approval date. Certification of IRB approval may be filed at any time before award in accord with Just-in-Time procedures, unless required earlier by the ICO. Under no circumstances may NIH-supported nonexempt research involving human subjects be initiated prior to obtaining IRB approval and providing the final IRB approval date to NIH. At ICO discretion, NIH may issue an award with a restriction in the Notice of Award so that no human subjects research may be conducted under the award until the certification of IRB review and approval has been obtained and accepted by NIH.

Applicant organizations should consider these requirements when deciding when to initiate IRB review for applications that may receive NIH funding.

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