Any proposed research not qualifying for Exempt status or Expedited review requires a Full Review, in which a majority of IRB members review and vote on the proposal. These typically involve projects that place human subjects at more than minimal risk.
Examples: Clinical trials; Any research use of radiation; Any research use of anesthesia; Any research use of invasive procedures.
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.
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 1 OR | 1 Required for non-clinical trials only.
2 Required for clinical trials only. |
| Inst M - Personnel Form | *Required for all submissions (except for VA only studies) |
| UTHSA IRB Application | *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. Do not use for clinical trials. OR Use the Form CT Clinical Trial Protocol Template Form and Schedule of Events for investigator initiated clinical trials |
| 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. |
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 D - Research Consent + Authorization | Submit this form if applicable to your research. For non-VA studies only. Combined research consent + HIPAA authorization. For research studies contributing to another repository, refer to the informed consent guidance for repositories. For assistance with drafting the Concise Summary, see the available resources. |
| Form D-1 - Research Consent + Authorization | Submit this form if applicable to your research. For VA studies and studies where VA is a site. Note: If study the includes optional components or sub-studies, submit separate Form D-1 for each component/sub-study For research studies contributing to another repository, there must be a separate repository consent form. For assistance with drafting the Concise Summary, see the available resources. |
| Form D-PP - Pregnant Consent + Authorization | For studies collecting pregnancy outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant. |
| Form D-1-PP - Pregnant Consent | Submit this form if applicable to your research. For VA studies and studies where VA is a site. For studies collecting pregnancy outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant. |
| Form D Withdrawal | Use this form for continued follow-up after withdrawal from interventions. |
| Form D-IS (Information Sheet) | Submit this form if applicable to your research. Template to use when developing information sheet. Differs from consent in that it does not contain a signature section. |
| 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 Drugs and/or Devices - Submit as applicable | |
| Form O - Use of a Drug in Research | Submit this form if applicable to your research. |
| Form O-2 - Use of a Placebo in Place of Standard Therapy | Submit this form if applicable to your research. |
| Form P - Use of Investigational Device Form | Submit this form if applicable to your research. May be Exempt from IDE. |
| Local Sponsor-Investigator Monitoring Plan (Form Inst-H) | Submit this form if applicable to your research. |
| Pharmacy LOU (Form Inst-G) | Submit this form if applicable to your research. |
| OCR - Policy for Drug/Device Storage | This is not an IRB form. Please review if applicable to your research. See the OCR Policy for Drug/Device Storage. |
| Form S - Copy of package insert or FDA approved label (PDR reference) | This is not an IRB template. Include this document for drug or device studies with study directed use of FDA approved medication/device for approved medical indication. |
Use of Radiation / Use of Gene Transfer - 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. |
| Form Q-1 - Gene Transfer Therapy in Human Research Studies | Submit this form if applicable to your research. |
| Form EE - Institutional Biosafety 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 D-PP - Pregnant Consent and Authorization | For studies collecting pregnancy outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant. |
| 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 CC - Investigator Brochure | 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 R - Monitoring Participant Safety and Data Integrity | Submit this form if applicable to your research. Complete this form for all studies considered more than minimal risk, where NIH or FDA require a plan, or IRB requested a plan. |
| 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. |