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Study Closure

Study closure means formally ending a research protocol when all activities involving human subjects are finished, and you have completed analyzing the data and specimens as described in the IRB-approved protocol.

When can you close your research study?

You can close your research study when all participants have finished their interactions and interventions, and you have completed the planned data analysis. This includes any analysis of identifiable private information or biospecimens as described in your protocol.

All protocol activities must stop once your protocol is closed.

If the Principal Investigator (PI) is leaving the NIH, their study(ies) should be closed before they leave the NIH, unless a new PI is identified, and the protocol is modified.

Closing a study

When you finish all study activities, you can close the study as follows:

  • For studies requiring Continuing Review (CR): Submit the Modification/CR Form in PROTECT before the study's expiration date.
  • For studies not requiring Continuing Review (CR): Submit the Modification/CR Form in PROTECT when all protocol activities and data analyses are complete.

After the study is closed, you may keep any data and specimens in an identifiable format in secure storage. If you (or another person) then want to use these identifiable data/specimens for a new analysis, a secondary research protocol must be submitted to the IRB.