A sIRB (Single Institutional Review Board) is the selected IRB of record that conducts the ethical review for participating sites of the multi-site study. A relying IRB is an IRB designating an agreement to cede review to an external IRB for a particular study.
Request UT Health IRB Review as the sIRB
If there are plans to utilize a single IRB for the review of multiple sites for the first time, contact the IRB staff prior to submitting (210-567-8250 or IRB@uthscsa.edu). This is an important step to ensure that the reviewing IRB and relying sites have standard operating procedures in place to manage the collaboration.
UT Health San Antonio requires the use of the SMART IRB Agreement unless under extenuating circumstances. Verify participating sites signed on to the SMART IRB Agreement here: https://smartirb.org/participating-institutions/
Submit a sIRB request in the SMART IRB platform if using the SMART IRB Agreement (ONLY after consulting with the IRB as noted above): https://smartirb.org/reliance/. Each site should follow their local processes (which may include an institutional or abbreviated IRB application for review). Sites may not defer or provide site specific documents listed below without this information.
Submit the appropriate IRB submission type along with the following documents to IRBmail@uthscsa.edu:
- Communication Plan (Required for investigator initiated studies unless there is a coordinating center or equivalent)
And, for each site:
- Single IRB Protocol Specific Form (Required from each site unless determined otherwise by the IRB)
- Single IRB Institutional Profile – unless already on file
- Agreement Implementation Checklist and Documentation Tool (documents SMART IRB flexibility terms) – unless already on file
- Form K-2 - Intent to Rely Form (to document protocol specific sIRB review under another existing broad agreement other than the SMART IRB agreement)
Additional Guidance Documents:
- Guidance for Serving as IRB of Record
- SMART IRB Standard Operating Procedures
- Overall PI (and Lead Study Team) Checklist
- PI Checklist, Relying Institution
- SMART IRB Resources
NOTE: Institutional Review is conducted concurrently by UT Health San Antonio through the Office of Clinical Research. An institutional activation letter from UTHSA is required prior to beginning your research. Clinical trials must be reviewed and cleared by the Clinical Trials Office (CTO) before the research application can be submitted to the IRB. Does not apply if UT Health San Antonio is not engaged in research activities.
If study sites include affiliated sites (e.g., University Health System and/or South Texas Veterans Health Care System), instructions for Single IRB Review for Multi-Site Research do not apply.