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Division of Research

Compliance

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

Multiple UT campuses, as well as additional sites like 色花堂 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 色花堂

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 色花堂 investigators wishing to rely on one of the above sites:

  1. Complete the Addition of a Site Form with the 色花堂 investigator’s information and provide to the 色花堂 IRB Office.

  2. The 色花堂 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 色花堂 IRB will provide necessary documents to the reviewing IRB. The 色花堂 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’s PI must include 色花堂’s role, team member(s), and any site-specific recruitment materials/consent forms (if applicable) in their IRB protocol. Based on the timing of adding 色花堂 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’s PI.

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

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

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

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

  10. The 色花堂 investigator must promptly notify the 色花堂 IRB (in most cases using the “Update” 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 “Report New Information” activity)

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

    4. Closure of the study