Transferring a Previously Approved Research Protocol to UTA

Transfer of IRB Oversight

After initial approval, the IRB that reviewed the study typically retains oversight until the research is complete. However, certain circumstances, such as a change in institutional affiliation, may require transferring oversight to another IRB. These transfers help maintain compliance with federal regulations and institutional policies while ensuring continuous protection of human subjects.

Key Considerations During the Transfer Process
  • Retention of IRB records, including protocols, approvals, consent templates, minutes, and reports, in accordance with regulatory requirements.
  • Establishing the effective date for the transfer, ideally with overlapping coverage to prevent gaps in approval.
  • Determining the review level the receiving IRB will conduct before assuming oversight.
  • Executing reliance agreements, such as an IRB Authorization Agreement (IAA) or master reliance agreement, when one IRB will oversee multiple engaged institutions.
  • Assessing participant notification needs, such as updating consent materials with new contact information for rights or injury reporting.
  • Informing appropriate officials or parties, including sponsors, funding agencies, and the FDA for IND/IDE studies, of the new IRB of record and effective dates.

How to Coordinate an IRB Protocol Transfer at UTA

1. Consult UTA Office of Regulatory Services Early

Contact UTA Office of Regulatory Services early to discuss the scope of the transfer, timing, and reliance path.

2. Select the Oversight Model

Determine whether the study will require local UTA review or reliance on an external single IRB (sIRB).

  • UTA provides guidance on multi-site research and IRB reliance, including when UTA relies on an external IRB or serves as the reviewing IRB for non-UTA collaborators.
  • Ensure the arrangement meets NIH sIRB policy and Common Rule requirements for cooperative research, as applicable.
3. Prepare and Submit in Mentis
  • For incoming transfers to UTA, submit an Initial IRB Application with the full protocol, current approvals and consents, and any sponsor documents.
  • UTA generally treats transfers like a new submission unless a reliance agreement is established.
  • For reliance requests, whether UTA cedes review or serves as the reviewing IRB, initiate the reliance request according to UTA’s multi-site guidance.
  • Regulatory Services will coordinate the IAA and required documentation.
  • Plan timelines carefully. Review may take 2–8+ weeks depending on volume and study complexity, so submit early to avoid lapses.
4. Align Consent and Participant Communications
  • Update consent, assent, and subject-rights contact information when the IRB of record changes.
  • Provide notices to already-enrolled participants as appropriate.
  • Do not notify currently enrolled participants of a site change or provide updated consents until updated approval or guidance is received from the UTA IRB.
5. Confirm Record Retention and Close-Out at the Original IRB
  • Confirm which office will retain closed-site records and for how long.
  • Ensure records remain accessible for inspection by HHS/OHRP and FDA, when applicable.
6. Complete Regulatory Follow-Through
  • For FDA-regulated studies, sponsors or independent investigators should update IND/IDE filings to reflect the receiving IRB and transfer date.
  • For ClinicalTrials.gov records, verify who is the responsible party after affiliation changes and update the record as necessary.
7. What to Expect After Submission

Once the protocol is submitted to UTA, the UTA IRB will coordinate directly with the transferring institution’s IRB. The new researcher is generally not required to participate in this process unless additional information is requested.

What to Prepare for UTA

Investigator Checklist
  • Mentis protocol number, if already in UTA, or a brief study synopsis if incoming.
  • Funding status and changes, including prime award transfers, new subawards, or Just-in-Time requests.
  • Current subject activities and whether any interventions or consent activities will continue after the transfer.
  • UTA and non-UTA personnel responsibilities, including who is responsible for each activity and where activities will occur.
  • Prior IRB determinations and approved materials, including protocol, consent, assent, parental permission, and recruitment materials.
  • Reliance plan, including who will serve as the reviewing IRB and any draft IAA if known.
  • ClinicalTrials.gov, FDA/IND/IDE, data-use agreement, and material transfer agreement needs. Coordinate with Regulatory Services for institutional agreements.

UTA References and Help