IRB Protocol Closure or PI Transfer Upon Departure from UTA

If you are leaving UTA, you cannot remain the Principal Investigator (PI) on an active IRB protocol. Before your departure date, you must:

  1. Close the IRB protocol.
  2. Transfer PI responsibility to an eligible UTA investigator.

Note: UTA IRB does not allow protocols to remain open without a UTA-affiliated PI.

Option A: Close the IRB protocol (most common when leaving UTA)

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
  1. Log in to Mentis.
  2. Open the approved protocol.
  3. Select Create Modification.
  4. In Section Three, choose Other.
  5. Enter the following statement:
    • "This protocol is completed and should be closed."
  6. Submit the modification.

IRB staff will confirm and process the closure.

Alternative: Email a Closure Request

If Mentis access is limited (common during off-boarding), you may email regulatoryservices@uta.edu.

Include the following:

  • IRB protocol number
  • Study title
  • PI name
  • A 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.

Option B: Transfer the protocol to another UTA PI (instead of closing)

If the Research Will Continue at UTA
  • Identify a UTA-eligible faculty or staff member to serve as the new Principal Investigator (PI).
  • Submit a Modification in Mentis to change the PI and include all required Change of PI documentation.
  • The new PI must accept responsibility for the protocol before your departure from UTA.

Important: If no eligible UTA PI is identified, the protocol must be closed.

Important Reminders When Leaving UTA
  • You cannot take the UTA IRB approval with you to another institution.
  • If you want to continue the research elsewhere:
    • Close the UTA protocol, or
    • Obtain approval from the new institution's IRB.
  • Data and 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.

2. Transferring Research Data

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 permits the transfer.
  • A formal legal agreement between institutions is required.
  • Most consent forms do not explicitly address 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 supports compliance with:
    • Sponsor requirements.
    • FDA regulations.
    • Data retention policies.
  • The departing PI may take copies but must:
    • Leave the original records 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 requirements described above, including IRB review, DUA, and consent/HIPAA considerations.

Practical Implications for Investigators
  • Data and specimen transfers are not automatic when changing institutions.
  • Multiple approvals may be required:
    • Institutional authorization.
    • IRB review.
    • Legal agreements (DUA and MTA).
  • Planning should begin months in advance to avoid disruptions to research.