Human Research - Repository or Databank

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 FormSubmit this form if applicable to your research.

Billing / Payment Forms - Submit as applicable

 
Billing GridThis is not an IRB template. Submit if any clinical services are being used to provide conventional patient care or research procedures.
Participant Payment Plan FormSubmit if you plan to pay enrolled subjects.
Study BudgetThis is not an IRB template. Include (if applicable) with your submission.
Clinical Trial AgreementThis is not an IRB template. Include (if applicable) with your submission.

Consent Forms - Submit as applicable

 
Form E - Repository Consent + AuthorizationSubmit 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 ConsentSubmit 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 studySubmit 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 FormThis 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 AuthorizationSubmit this form if applicable to your research. 
Authorization for Use & Release of Individually Identifiable Health Information.
Form H-VA - VA HIPAA AuthorizationSubmit this form if applicable to your research. 
Authorization for Use & Release of Individually Identifiable Health Information.
Form I - HIPAA De-identification Agreement FormSubmit 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 AuthorizationSubmit this form if applicable to your research.
Form J-1 - Assurance for Research on Decedent's InformationSubmit 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 FormSubmit 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 ChecklistSubmit 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 ScriptSubmit this form if applicable to your research.
Form L-1 - Find a Study Recruitment WebsiteSubmit 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 ResearchSubmit 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 EventsThis 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 CommitteeThis is not an IRB template. Include (if applicable) with your submission.
Form II - Radioactive Drug Research CommitteeThis 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 AbilitySubmit this form if applicable to your research.
Form U - Research Involving Pregnant Women, Fetuses, &/or NeonatesSubmit this form if applicable to your research.
Form U - Prefilled for Pregnant PartnersSubmit this form if applicable to your research.
Form V - Research Involving PrisonersSubmit 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 ApplicationThis is not an IRB template. Include (if applicable) with your submission.
Form HH - Mays Cancer Center Review CommitteeThis is not an IRB template. Include (if applicable) with your submission.
Form X - Protocol Related Conflict of Interest (COI) ReportSubmit this form if applicable to your research. 
See HOP Conflicts of Interest in Scholarly, Research, and Clinical ActivityHOP Conflict of Commitment, and HOP Institutional Conflict of Interest Policy as applicable.
Letters of Support or Memorandum of Understanding for Off-site ResearchThis is not an IRB template. Include (if applicable) with your submission.