Closure

Closure should be requested if research and/or clinical investigation activities with human subjects are no longer ongoing and have stopped. This means that after closure of the research study with the IRB, there is no longer IRB approval to obtain information or biospecimens about a living person through interaction or intervention with the individual, to obtain identifiable private information or identifiable biospecimens about a living person, and/or to use, study, analyze, or generate identifiable private information or identifiable biospecimens about a living person.

No research and/or clinical investigation involving human subjects, including analysis of identifiable private information or identifiable biospecimens, can occur on a study closed by the IRB. 

If a research study is not renewed or closed by the expiration date, further action may be initiated by the IRB or the HRPP Compliance office, such scheduling a site visit for the study.

Closure is required even if the study no longer requires annual renewed approval under the revised Common Rule. Further action may be initiated by the IRB or the HRPP Compliance office, such scheduling a site visit for the study, for studies that do not require annual renewed approval upon failure of the PI to respond to requests regarding the study status.

Requests for closure are made through the Click^TM Research Compliance System.

How to Submit

1. Complete HRP-528 - Template - Closure Report.
2. In Click, open the Study to close.
3. Create a Modification/CR.
4. Complete the Continuing Review submission.
5. Upload the HRP-528 template (Continuing Review / Study Closure Information SmartForm page).
6. Submit the Continuing Review.

For detailed instructions, see the Quick Guide.

Click Templates

• Required: HRP-528 - Template - Closure Report

Available at the Click Templates page.

Click Quick Guides

• How to Close a Study

Available at the Click Quick Guides & Videos page.

More Information

For more information, visit HRPP Manual 8-9, Closure.