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 are essential to maintain compliance with federal regulations and institutional policies while ensuring continuous protection of human subjects.
Key considerations during the transfer process include:
  • Retention of IRB records (protocols, approvals, consent templates, minutes, 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 (IRB Authorization Agreement/IAA or master reliance) 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 (sponsors, funding agencies, 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 to scope the transfer, timing, and reliance path.
2. Select the oversight model (local UTA review vs. reliance on an external sIRB):
  • UTA has guidance on Multi‑site Research & IRB Reliance (when UTA relies on an external IRB or serves as 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 (UTA’s IRB submission system):
  • For incoming transfers to UTA: submit an Initial IRB Application with the full protocol, current approvals/consents, and any sponsor documents; UTA treats transfers like a new submission unless a reliance is established.
  • For reliance (UTA cedes or serves): initiate the reliance request per UTA’s multi‑site guidance; Regulatory Services will coordinate the IAA and required documentation.
  • Plan timelines: UTA posts current queue volumes and advises 2–8+ weeks depending on volume and study complexity—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 them with updated consents until updated approval or guidance is received from the UTA IRB.
5. Record retention and close‑out at the original IRB:
  • Confirm which office retains closed‑site records and for how long; ensure access for inspection (HHS/OHRP and FDA).
6. Regulatory follow‑through:
  • For FDA‑regulated studies, sponsors/independent investigators update IND/IDE filings to reflect the receiving IRB and transfer date. [fda.gov]
  • For ClinicalTrials.gov records, verify who is the responsible party after affiliation changes and update as necessary (UTA provides CT.gov guidance).
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, and the new researcher is generally not required to participate in this process.
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 (prime award transfers, new subawards, Just‑In‑Time requests).
  • Current subject activities and whether any interventions/consent will continue after the transfer.
  • UTA vs. non‑UTA personnel and site responsibilities (who does what, where).
  • Prior IRB determinations and approved materials (protocol, consent/assent/parental permission, recruitment).
  • Reliance plan (who will be reviewing IRB; draft IAA if known). [
  • ClinicalTrials.gov, FDA/IND/IDE, and data‑use/MTA needs (coordinate with Regulatory Services for institutional agreements). [resources.uta.edu]
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