Human Research - Expedited Review

In order to qualify for expedited review, the research must be minimal risk and all the research activities must fit within one or more of the categories listed in the Expedited Research Request Form.  Expedited review does not mean a quick review. 

Examples: prospective clinical data and specimens, non-invasive measurements, survey of children. 

NOTE:  Institutional Review is conducted concurrently by UT Health San Antonio through the Office of Clinical  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

Institutional Research Application for Clinical Trials 2

1 Required for non-clinical trials only.  
No CTO clearance necessary.

 

2 Required for clinical trials only.   
Note: If this study is a clinical trial, start with the CTO Portal. CTO will review your application and instruct you when to submit required forms to the IRB. In the meantime, prepare the required forms so they will be ready to submit upon clearance from CTO.

Inst M - Personnel Form*Required for all submissions (except for VA only studies)
UTHSA IRB Application*Required for all submissions
Form B-1 - Expedited Certification Form*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 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 D - Research Consent + AuthorizationSubmit 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 + AuthorizationSubmit 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 + AuthorizationFor studies collecting pregnancy outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant.
Form D-1-PP - Pregnant ConsentSubmit 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 WithdrawalUse 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 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 Drugs and/or Devices - Submit as applicable

 
Form O - Use of a Drug in ResearchSubmit this form if applicable to your research.
Form O-2 - Use of a Placebo in Place of Standard TherapySubmit this form if applicable to your research.
Form P - Use of Investigational Device FormSubmit 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 StorageThis is not an IRB form. Please review if applicable to your research. See the OCR Policy for Drug/Device Storage.

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 D-PP - Pregnant Consent and AuthorizationFor studies collecting pregnancy outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant.
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 CC - Investigator BrochureThis 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 R - Monitoring Participant Safety and Data IntegritySubmit 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) 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.