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  6. Appendix C

Compliance

Instructions: UT System/TMC Member Reliance on IRB

Multiple UT campuses, as well as additional sites like 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 91破解版

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 investigators requesting for one of the above sites to rely on 鈥檚 IRB review:

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

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

  3. Submit your protocol to the 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 investigator must include information describing the activities of the relying IRB in the 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 IRB conducts its review; once all items have been addressed, an approval letter will be issued.

  6. The 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鈥檚 procedures.

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

    1. Notification that  has renewed its approval at continuing review

    2. Any findings by 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 IRB must provide the 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 鈥淐reate Modification鈥� 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 IRB using the 鈥淩eport New Information鈥� activity in ICON.