The Principal Investigator may close out the protocol when all the following are complete:

• Recruitment and enrollment
• Subject follow up
• Data collection
• Data analysis of identifiable data, records, or specimens (i.e. use or access to subject identifiable data is no longer necessary)

Data Analysis

Maintaining identifiable private data/specimens, without using, studying, or analyzing such information/specimens is not human subjects research. If all other human subjects activities have been completed but identifiable private data/specimens will simply be maintained (as described in the IRB-approved protocol), then IRB review and approval is no longer necessary and the study may be closed. When analysis of identifiable data/specimens is complete and the only remaining activities are write-up of results and storage of the data/specimens, the study may be closed even if the research team retains identifiers and/or a key linking identifiers to coded data/specimens. If enrollment and data/specimen collection are complete, and the research team has stripped the data/specimens of identifiers, the study can be closed even if data/specimen analysis continues.

Secondary Analysis of Existing Data/Specimens

Study teams must consult with the IRB office prior to use of data or specimens from a closed research study if the original investigators seek to use the data/specimens to investigate new research questions/topics OR if other investigators wish to use those data/specimens to study a new research question or topic, as this may constitute new human subjects research requiring IRB exemption or approval.

Data Sharing

If a study team plans on sharing data or specimens with individuals or entities not previously described in the IRB application, the study team must consult with the IRB office to ensure that the conditions under which the IRB approved the collection and use of the data/specimens are met.

The investigator should notify the IRB that they have completed an approved IRB study through the electronic submission system via the submission of a Closure Report. In Mentis, please begin a modification for the protocol to be closed. Then, in Section Three, choose Other and write that this protocol is completed and should be closed. IRB Staff will reach out to you to confirm you wish to close this protocol.

Alternatively, researchers may send an email to RegulatoryServices@uta.edu to notify IRB Staff of a study’s closure, and IRB Staff may be able to close out specific studies on behalf of the Principal Investigator.

Once a closure is officially documented in the electronic submission system and a notice has been sent to the Principal Investigator via email, this starts the clock for the required research record retention period following study closure. This period may be three years or longer, depending on funding agency requirements, whichever is longer.