Studies involving the creation of local biorepository, data repository or registry, or collection of data and/or specimens to be sent and stored at another (non-UTHSCSA) repository.
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. Does not apply if UT Health San Antonio is not engaged in research activities.
Submit the following forms to IRBmail@uthscsa.edu for IRB review and approval:
Required Forms for Initial Submission | |
| Institutional Research Application for non-clinical trials | *Required for all submissions |
| Inst M - Personnel Form | *Required for all submissions (except for VA only studies) |
| UTHSA IRB Application | *Required for all submissions |
| Form C-1 - Local Repository Description | *Required for all submissions |
| Protocol | *Required for all submissions Include the sponsor's protocol with your submission OR Use the Form BC Protocol Template Form if you do not have a sponsor's protocol. |
| Form A - Signature Assurance Sheet | *Required for all submissions 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. How to digitally sign Adobe forms. |
Expedited Review - Submit if requesting an expedited review | |
| Form B-1 - Expedited Certification Form | Submit this form if applicable to your research. |
Billing / Payment Forms - Submit as applicable | |
| Billing Grid | This is not an IRB template. Submit if any clinical services are being used to provide conventional patient care or research procedures. |
| Participant Payment Plan Form | Submit if you plan to pay enrolled subjects. |
| Study Budget | This is not an IRB template. Include (if applicable) with your submission. |
| Clinical Trial Agreement | This is not an IRB template. Include (if applicable) with your submission. |
Consent Forms - Submit as applicable | |
| Form E - Repository Consent + Authorization | Submit this form if applicable to your research. For non-VA studies only. Combined research consent + HIPAA authorization. For assistance with drafting the Concise Summary, see the available resources. |
| Form E-1 - Repository Consent | Submit this form if applicable to your research. For VA studies and studies where VA is a site. Submit a Form H-VA to VA to the R&D Office—see below in the HIPAA Section. For assistance with drafting the Concise Summary, see the available resources. |
| Form F (BLANK Template) | Submit this form if applicable to your research. This is a BLANK template for one of the following: (1) Alteration to Consent (not all required elements of consent will be presented) (2) Waiver of Informed Consent Process (When consent is not obtained) (3) Waiver of Documentation of Informed Consent Process (consent will be obtained but a signature will not). |
| Form F - SAMPLE waiver of consent for Chart Review study | Submit this form if applicable to your research. This is PRE-POPULATED form which contains acceptable template wording when requesting a waiver of consent to complete a chart review study. |
| Form G - Model Consent Form | This is not an IRB template. Include (if applicable) with your submission. |
HIPAA (Health Insurance Portability and Accountability) - Submit as applicable | |
| Form H-UT - UT HIPAA Authorization | Submit this form if applicable to your research. Authorization for Use & Release of Individually Identifiable Health Information. |
| Form H-VA - VA HIPAA Authorization | Submit this form if applicable to your research. Authorization for Use & Release of Individually Identifiable Health Information. |
| Form I - HIPAA De-identification Agreement Form | Submit this form if applicable to your research. Complete Form I if a covered entity will remove the identifiers. The de-identified data or specimens will be released to the PI from a covered entity. |
| Form J - HIPAA Waiver of Authorization | Submit this form if applicable to your research. |
| Form J-1 - Assurance for Research on Decedent's Information | Submit this form if applicable to your research. Form J-1 - This document is used to notify the IRB that an investigator plans to use or disclosure PHI of decedents (deceased persons); to assure the IRB that it is being requested solely for the purpose of research on the PHI of decedents for the Research Project described; and to assure the IRB that it is necessary for conduct of this Research Project. The researcher agrees that upon request by UTHSCSA or affiliated institution’s Covered Component from whom the PHI is sought, he/she will provide documentation establishing that the Individual’s(s’) whose PHI is/are being requested is/are deceased. |
Collaboration - Submit as applicable | |
| Form K-2 - Intent to Rely Form | Submit this form if applicable to your research. This form is used to document centralized IRB review under a Broad or Reciprocal agreement. This form helps to ensure any outstanding concerns or requirements by the Deferring Site are addressed before the study is approved by the Reviewing IRB. |
| Greater Plains Collaborative Reliance Checklist | Submit this form if applicable to your research. Use this form when you are collaborating with researchers from an Institution that is part of the Greater Plains Collaborative Reciprocity Agreement. This form will need to be filled out by the relying institution. |
Advertisements & Data Collection Instruments - Submit as applicable | |
| Form L - Proposed advertisement(s) | This is not an IRB template. Include the proposed advertisements (any type for recruiting) (if applicable) with your submission. See Guidelines for Advertising |
| Form L - Phone Script | Submit this form if applicable to your research. |
| Form L-1 - Find a Study Recruitment Website | Submit this form if applicable to your research. Complete if you wish the study to be posted on the Find a Study website. |
| Form M - Proposed data collection instrument(s) | This is not an IRB template. Include the proposed data collection instrument(s) [used to record data (i.e., CRF, Excel spreadsheet, survey, questionnaire)] (if applicable) with your submission. |
| Form NN - Use of Technology in Research | Submit this form if applicable to your research. |
| Form NN - Use of Technology in Research (Redcap) | Submit this form if applicable to your research. This is a PRE-POPULATED form for eConsent using UTHSA Redcap. |
| Schedule of Events | This is not an IRB template. Include (if applicable) with your submission. |
Use of Radiation - Submit as applicable | |
| Form Q - Use of Radiation in Human Research (Radiation Exposure Worksheet) | Submit this form if applicable to your research. |
| Form GG - Radiation Safety Committee | This is not an IRB template. Include (if applicable) with your submission. |
| Form II - Radioactive Drug Research Committee | This is not an IRB template. Include (if applicable) with your submission. |
Vulnerable Populations - Submit as applicable | |
| Form T - Inclusion of Adults with Impaired Decision-Making Ability | Submit this form if applicable to your research. |
| Form U - Research Involving Pregnant Women, Fetuses, &/or Neonates | Submit this form if applicable to your research. |
| Form U - Prefilled for Pregnant Partners | Submit this form if applicable to your research. |
| Form V - Research Involving Prisoners | Submit this form if applicable to your research. |
| Form W - Research Involving Children, Healthy Neonates, and/or Neonates (Viability not in question) | Submit this form if applicable to your research. |
| Texas Department of Family and Protective Services Request for Approval (Form Inst-J) | Submit this form if applicable to your research. For research involving Child Protective Services |
Other Materials - Submit as applicable | |
| Form AA - Grant Application | This is not an IRB template. Include (if applicable) with your submission. |
| Form HH - Mays Cancer Center Review Committee | This is not an IRB template. Include (if applicable) with your submission. |
| Form X - Protocol Related Conflict of Interest (COI) Report | Submit this form if applicable to your research. See HOP Conflicts of Interest in Scholarly, Research, and Clinical Activity, HOP Conflict of Commitment, and HOP Institutional Conflict of Interest Policy as applicable. |
| Letters of Support or Memorandum of Understanding for Off-site Research | This is not an IRB template. Include (if applicable) with your submission. |