Reminder of Requirement for Certification of IRB Approval

NIH would like to remind the extramural research community that NIH requires recipients to submit a certification to NIH that all nonexempt research involving human subjects has been reviewed and approved by an appropriate Institutional Review Board (IRB). The date of final IRB approval (i.e., the date that all protocols in the proposed research application received IRB review and approval) must be submitted to NIH. Note that submitting a pre-approval, interim, or conditional IRB approval date does not satisfy the requirement to submit the final IRB approval date.    

NIH-supported nonexempt research involving human subjects may not be initiated until final IRB approval has been obtained and the final IRB approval date has been provided  to NIH.  

Additional information regarding this requirement is available in the Guide Notice, NOT-OD-26-043.