Protocol Directors have the responsibility of informing the IRB when a protocol has been completed. Protocol Directors may close a human research subjects protocol when all of the following conditions are met:
- Recruitment and enrollment of participants has been completed
- All activities and interventions with all participants have been completed
- Analysis of identifiable data is complete
- Data has been fully deidentified (e.g., identifiable information such as with names, emails, and audio have been destroyed) even when participants have agreed for their identifiable data (videos, audio) to be maintained indefinitely except: In cases where participants agreed for information to be made public (for instance, using their real name in publications, or participating in an art intervention where their photographs will be displayed, etc.).
- If identifiers remain on the data, researchers must request continuing review
- There is no additional research beyond the original intent planned for these data
When you should NOT close:
- If data analysis involving identifiable information is still ongoing
- If you or any team members/study personnel are still accessing identifiable private information or biospecimens
- If the study is still recruiting or conducting interventions
Once a protocol is closed, it cannot be reopened.
Also, once your protocol is closed, any associated HIPAA authorizations become invalid and access to medical records must stop immediately. This is true regardless of whether the HIPAA authorization is embedded in the study consent form or was given as an additional form, since that access is part of the research activities.
How to close a protocol in Kuali:
1. Log in to your Kuali IRB Dashboard and click on the title of the protocol you want to close. If there are any outstanding actions such as a pending Amendment or Renewal, you will not be able to close the protocol until that action is resolved. Please be aware that once you close the protocol you will not be able to duplicate it or re-open it. If you have any questions regarding what closing out a protocol means for your study, please review this guidance or contact our office.
2. Once you open the desired protocol, the sidebar on the far-right side will provide you available actions. Click on Request Close (in the past this action was called Final Report) to initiate this action.
3. Clicking on Request Close will open the request along with a copy of the entirety of the approved protocol. Section 1 of the Close Request will ask the researcher whether the research activities described in the approved protocol ever occurred. If the researcher chooses “No” then the researcher can then immediately submit the Close Request.
4. On the other hand, if the answer is “Yes,” the form will display relevant questions that should be answered before submission of the Close Request.
5. Once all the questions have been answered you will be able to submit the Close Request. Clicking Submit will cause the Kuali system to validate that all the required questions have been answered. If there are unanswered questions, the system will alert you. If the Close Request passes the validation, the request will be submitted for IRB review. The Close Request will be reviewed and if all is in order the protocol will be closed within 3 business days. You will receive an automated message from Kuali when the protocol is officially closed.
View our Kuali Protocols - IRB User Guide (PDF) for instructions on submitting close requests.