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• You must submit all required study closure materials via NIH electronic IRB system using the Modification/Continuing Review (CR) form.
• Unless a new Principal Investigator (PI) is named, a study must be closed if the current PI is leaving the NIH.
• Once the protocol is closed, all research activities will cease.
• Once the study is closed, any analyses using the identifiable private information or identifiable biospecimens from the study, will require prospective IRB review and approval.

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Unless the study is being prematurely closed or is being terminated by the IRB, for non-exempt human subjects research, the research study will be closed when all subjects have completed research interactions, and interventions and primary data analysis is complete. This includes analysis of identifiable private information or identifiable biospecimens, consistent with the analyses described in your protocol. The PI must also provide assurance to the IRB that the maintenance and future use of specimens will be consistent with the plan described in the protocol and with the informed consent(s). 

What happens when studies are closed because all study activities are complete?

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• Studies for which CR is required: Submit the Study Closure Submission Modification/CR Form no later than the expiration date of the study.
• Studies for which CR is not a requirement: Submit the Study Closure Submission Modification/CR Form when all human subjects research activities are complete.

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