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 San Antonio IRB cede review to an external IRB
If there are plans to utilize a single IRB for the review of multiple sites for the first time, contact the Office of Clinical Research (OCR) prior to submitting (210-567-8555 or IRBreliance@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 OCR as noted above): https://smartirb.org/reliance/.
OCR will authorize submission to the external IRB upon review of the submission documents below. Do not submit to the IRB without OCR permission and appropriate deferral documentation. If submitting to NCI CIRB, prior OCR permission is not required.
The following forms should be submitted to IRBreliance@uthscsa.edu:
| Required Forms | |
Institutional Research Application for non-clinical trials 1 OR Institutional Research Application for Clinical Trials 2 | 1 Required for non-clinical trials only.
2 Required for clinical trials only. |
| Inst-M - Personnel form | *Required |
| Form A - Signature Assurance Sheet | *Required Please note: Assure that both the PI and the PI’s chair sign this form or we will not be able to accept the submission. The PI cannot be the same as the chair due to the conflict of interest that presents. |
| Protocol | *Required |
| External IRB approved consent form template (with local contact info/HIPAA in tracked changes) or NCI CIRB boilerplate language (in tracked changes) | *Required |
| IRB approved Communication Plan | *Required for investigator initiated studies unless there is a coordinating center or equivalent |
| Form t-Inst - Institutional Treatment form | *Required only for Treatment Use / Expanded Access of Drug or Device Studies. |
| HIPAA (Health Insurance Portability and Accountability) - Submit as applicable | |
| Form H-UT (English) | for IRBs that do not provide (e.g. NCI IRB) |
| Form H-UT (Spanish) | for IRBs that do not provide (e.g. NCI IRB) |
| Form J - HIPAA Waiver of Authorization | Submit if applicable |
| Advertisements & Data Collection Instruments - Submit as applicable | |
| Form L-1 - Find a Study Recruitment Website | Submit if applicable |
| Form NN - Use of Technology in Research | Submit if applicable |
| Use of Drugs and/or Devices - Submit as applicable | |
| Form O - Drug or Biologic Being Tested in Research | Submit if applicable |
| Form P - Use of an Investigational Device in Research | Submit if applicable |
| Form Inst-H - Local Investigator FDA-Sponsor Form | Submit if applicable |
| Form Inst-G - Pharmacy LOU | Submit if applicable |
| Use of Radiation / Use of Gene Transfer - Submit as applicable | |
| Form Q - Use of Radiation in Human Research Studies | Submit if applicable |
| Form Q-1 - Gene Transfer Therapy in Human Research Studies | Submit if applicable |
| Vulnerable Populations - Submit as applicable | |
| Form Inst-J - Request for Approval Research involving Child Protective Services | Submit if applicable |
| Other Materials - Submit as applicable | |
| Form CC - Investigator Brochure | This is not a template. Submit if applicable. |
| Form X - Protocol Related Conflict of Interest | Submit if applicable |
Additional Guidance Documents:
- SMART IRB Standard Operating Procedures
- Overall PI (and Lead Study Team) Checklist
- PI Checklist, Relying Institution
- SMART IRB Resources
- UTHSA Institutional Profile
- Agreement Implementation Checklist and Documentation Tool
NOTE: An institutional activation letter from UT Health San Antonio 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 OCR.