Key Dates

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. 
 

Resources

• NIH Grants Policy Statement
• Just-in-time Information for Grants Involving Human Subjects (Policy implementation website) 

Inquiries

Please direct all inquiries to:

NIH Office of Extramural Research
Email: [email protected]

or

Division of Grants Policy
Email: [email protected]