IRB Protocol Closure or PI Transfer Upon Departure from UTA
If you are leaving UTA, you cannot remain PI on an active IRB protocol. Before your departure date, you must either:
- Close the IRB protocol, or
- Transfer PI responsibility to an eligible UTA investigator.
UTA IRB does not allow protocols to remain open without a UTA‑affiliated PI.
Confirm the study is eligible for closure You may still be writing manuscripts or storing data after closure, as long as no additional analysis of identifiable data occurs.
How to close the protocol in Mentis Steps:
- Log in to Mentis: https://mentis.uta.edu
- Open the approved protocol
- Select Create Modification
- In Section Three, choose “Other”
- State clearly:
- Submit the modification
Alternative: Email closure request
If Mentis access is limited (common during off‑boarding), you may email: regulatoryservices@uta.edu
Include:
- IRB protocol number
- Study title
- PI name
- Statement that the study is complete and should be closed
- Your UTA departure date
IRB staff can close some protocols on behalf of the PI.
After closure
- You will receive a notification of closure by email
- This starts the research record retention clock
- No further human subjects research activities are permitted under that protocol.
- Identify a UTA‑eligible faculty/staff PI
- Submit a Modification in Mentis to change PI (and submit all required change of PI documentation)
- The new PI must accept responsibility before you leave
Important reminders when leaving UTA
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You cannot take the UTA IRB approval with you to another institution
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If you want to continue the research elsewhere:
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Close the UTA protocol or
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Obtain approval at the new institution’s IRB
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Data/specimen sharing or transfer must comply with the original consent and may require IRB consultation.
Data and Specimen Transfer
1. Who Owns the Data and Specimens:
- Research data and biological specimens belong to the responsible institution, not the individual investigator.
- Even when a principal investigator (PI) moves, institutional permission is required before anything can be transferred.
Why this matters: This ensures compliance with sponsor obligations, regulatory requirements (IRB/HIPAA), and intellectual property protections.
To move research data to a new institution:- Permission is required from the responsible institution (UTA).
- The UTA IRB must review and approve:
- The purpose of the data transfer
- Whether the consent allows a transfer
- A formal legal agreement between institutions is mandatory.
- Most consent forms do not explicitly mention data transfer, so IRB review is essential.
- The new institution must agree to protect confidentiality and intellectual property.
- The original data remain with the responsible institution.
- This allows compliance with:
- Sponsor requirements
- FDA regulations
- Data retention policies
- The departing PI may take copies, but must:
- Leave originals in good order
- Coordinate with the institution
3. Transfer of Human Biological Specimens
Types of Specimens Covered
- Body fluids (blood, urine, stool)
- Tissues and cells
- DNA/RNA and other cellular components
- Biorepository samples
- Leftover samples from prior or ongoing studies
Required Agreements
A Material Transfer Agreement (MTA) is required before samples can be moved.
The MTA:
- Confirms institutional ownership of samples
- Defines permitted research uses
- Identifies who may use the samples
- Includes liability and indemnification terms
- Prohibits attempts to identify donors
Important:
If samples include associated subject data, those data must be handled according to the research data transfer rules described above (IRB review, DUA, consent/HIPAA considerations).
Practical Implications for Investigators