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Instructions: UT System/TMC Member Reliance on UH IRB

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 University of Houston

Under this agreement, one of the above institutions can serve as the IRB of record (Reviewing IRB), and 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 requesting for one of the above sites to rely on UH’s IRB review:

  1. The Addition of a Site Investigator Form must be completed and signed by the relying site investigator and provided to the UH IRB by emailing the UH IRB Office.

  2. The UH IRB office will confirm with the IRB at the relying site that they agree to rely on the UH IRB. If so, the UH IRB will request necessary documents from the IRB at the relying site. The UH IRB will also aid in negotiating any changes needed to the relying site’s consent and/or assent templates if necessary.

  3. Submit your protocol to the UH IRB for approval. Ideally, this is done in the initial application, but can also be added later by the submission of a modification to the protocol.

  4. The UH investigator must include information describing the activities of the relying IRB in the UH protocol (relying site role, team member(s), locations, and any site-specific recruitment materials/consent forms. Please follow these instructions for completing this submission.

  5. The UH IRB conducts its review; once all items have been addressed, an approval letter will be issued.

  6. The UH PI provides the approval letter, protocol, consent forms and assent forms to the relying site PI, who will provide them to their IRB office according to that institution’s procedures.

  7. The UH investigator must promptly notify the relying site investigator upon:

    1. Notification that UH has renewed its approval at continuing review

    2. Any findings by UH of serious or continuing non-compliance

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

    4. Closure of the study

The external site relying on the UH IRB must provide the UH IRB with:

  • Any management plan put in place by the external institution to manage a financial conflict of interest related to the research project. This management plan must be uploaded into the ICON protocol prior to IRB approval of the study (or using the “Create Modification” activity of the interest is acquired during the course of the study).

  • Any unanticipated events involving risk to subjects or others, or other issues of noncompliance. These should be reported to the UH IRB using the “Report New Information” activity in ICON.