When should an investigator report a study closure to the IRB?
Study closures should be reported to the IRB via a final report in COEUS when the human subjects research, including research that has received an exempt determination, is permanently closed to enrollment, all subjects have completed all protocol related interventions and interactions, and the collection and analysis of private identifiable information is complete.
Reporting that a study has been completed is best practice for several reasons:
- Permits the institution and Drexel University’s HRPP to maintain accurate metrics, appropriately respond to monitoring or audit inquiries or accounting requests relevant to its human subject research portfolio,
- Provides a start date on the record retention timeline required by the FDA, OHRP, HIPAA, and Drexel University’s records retention policy (OGC-4 Records Retention Policy) and records retention schedule [PDF],
- Allows the institution to properly manage and transfer IRB oversight to another IRB when necessary.
The Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA) require IRBs to function under written procedures. These procedures include keeping the IRB informed of study completion and close out to ensure record retention in compliance with 45 CFR 46.115(b) and/or 21 CFR 56.115(b). Additionally, per the FDA [21 CFR 56.108(a)(3)] procedures require ensuring "prompt reporting to the IRB of changes in a research activity." The completion of the study is a change in activity and should be reported to the IRB and the information provided may be used in the evaluation and approval of related studies.
If Drexel investigators are relying on an external IRB, that IRB is responsible for indicating when the site’s IRB approval status has changed. The reliance agreement will typically require the reviewing IRB to inform our site/investigator when changes in the status of our site approval occur, and closing the study with the IRB is a change that is reported. When correspondence from the reviewing IRB has been received indicating the Drexel site has been closed and no longer carries approval by the reviewing IRB, the closure should be submitted via COEUS so that the project’s record may be closed with the Drexel IRB.
The process for submitting a final report is the same as submitting for a continuing review. Reference the COEUS Lite-How to Submit Continuing Reviews (Renewals) [PDF] document for a step-by-step guide with screenshots.
Questions? Email John Roberts, Executive Director, Human Research Protection Program at jtr77@drexel.edu.
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