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Compliance

Instructions: Reliance on the IRB of a UT System/TMC Member Institution

Multiple UT campuses, as well as additional sites like UH and Texas Medical Center (TMC) institutions, have signed an IRB Reciprocity Agreement. The participating sites are:

UT Arlington UT Austin UT Dallas UT El Paso UT Permian Basin
UT Rio Grande Valley UT San Antonio UT Tyler UT Southwestern Medical Center UT Health
UT Medical Branch UT Health Science Center San Antonio UT MD Anderson UT Health Science Center Tyler Baylor College of Medicine
Texas Tech University Texas Tech University Health Sciences Center Texas Tech University Health Sciences Center El Paso Angelo State University University of North Texas
University of North Texas Health Science Center Rice University The Methodist Hospital System Texas A&M University 兔子先生

Under this agreement, one of the above institutions may serve as the IRB of record (Reviewing IRB), and one or more other institution(s) (Relying IRBs) can accept the review and approval of the IRB of record.

Here is a brief description of the process required of UH investigators wishing to rely on one of the above sites:

  1. Complete the Addition of a Site Form with the UH investigator鈥檚 information and provide to the UH IRB Office.

  2. The UH IRB will confirm with the IRB at the external site that they will agree to serve as the IRB of record for the project. If so, the UH IRB will provide necessary documents to the reviewing IRB. The UH IRB will also aid in communicating to you any changes needed to the consent and/or assent templates if requested by the reviewing IRB.

  3. Prepare and submit an external IRB submission in ICON. Follow these instructions for completing this submission. Please note that this draft should be started as soon as possible and can remain pending while awaiting the approved documents from the reviewing IRB.

  4. The reviewing site鈥檚 PI must include UH鈥檚 role, team member(s), and any site-specific recruitment materials/consent forms (if applicable) in their IRB protocol. Based on the timing of adding UH as a site, this may be done in the initial protocol or added as an amendment/modification.

  5. The reviewing IRB will conduct its review and issue an approval letter once all items have been addressed by the reviewing site鈥檚 PI.

  6. The PI at the reviewing IRB site will provide the approval letter, protocol, consent forms and assent forms to the UH investigator.

  7. The UH investigator then attaches the approval letter and complete protocol (including recruitment materials, consent documents, etc.) to the external IRB application in ICON.

  8. The UH investigator submits the external IRB protocol to the UH IRB in ICON.

  9. If the submission is complete, the UH IRB office will provide an acknowledgement letter through the ICON system. Once received, UH engagement in the research may begin.

  10. The UH investigator must promptly notify the UH IRB (in most cases using the 鈥淯pdate鈥� activity in ICON) of the following:
    1. Notification that the reviewing IRB site has renewed its approval at continuing review

    2. Any findings by the reviewing IRB of serious or continuing non-compliance (use 鈥淩eport New Information鈥� activity)

    3. Changes of the financial status of study team members that may require review for conflict of interest

    4. Closure of the study