Closure

When is IRB approval no longer needed?

The final step in the IRB process is submitting a closure application to end IRB oversight of the project. You should submit a closure application if your project meets all of the following criteria:

• The only on-going research activities are data analysis and/or writing. All interactions, interventions, and data collection with participants have been completed.
• All identifying information has been removed from the data and destroyed, unless participants gave explicit consent for identifiers to be maintained after the research has been completed (such as participants signing an agreement to donate the research records to a public archive). All code keys that link participants’ ID numbers with identifying information have been destroyed.
• The final data disposition procedures have been completed as they were detailed in the consent form and protocol application.

If your project does not meet these criteria (for instance, identifiers have not yet been removed), then you will need to maintain your active IRB approval. (See the continuing review page for more information.)

Closure application review

Closure applications are reviewed through an expedited process regardless of the original level of review. The reviewer will be looking for the following:

• All research activities with human subjects have ended and the project is ready to be closed.
• The numbers of participants you report is consistent with the number of participants the IRB has previously approved you to recruit and the numbers you have indicated in any previous continuing review applications.
• Whether any adverse events or unanticipated problems have occurred during the last approval period.
• Whether the findings from the research have resulted in information that should be reported to participants.

Leaving LUC

If your research is still in progress, but you are leaving the university for another institution, a closure application should be submitted to LUC. Your new institution will need to cover the project and you should reach out to their IRB.

In some cases, an investigator may need to maintain LUC IRB oversight even after they've left the university. This may be the case for students who are graduating but want to continue to work on their dissertation research for publication purposes. In these cases, another member of the LUC research community must take responsibility for the project (such as the faculty sponsor in the case of students or a colleague in the case of faculty). Prior to leaving, the original investigator should submit an amendment application asking for the PI to be changed and explaining the situation.

My project has expired, should I still submit a closure?

Yes, but note that the federal regulations do not allow for grace periods - once an approval period is over that means the study is no longer approved. This applies even if the expiration date was a single day prior.

Once approval has ended, all research must pause. This includes recruitment, data collection, and analysis of study data. If research activities have continued (even unintentionally) past this point, this is considered non-compliance and you will need to explain these circumstances in the closure report.