Office of the Institutional Review Board

All (A - Z) Forms

 

Form Instructions/Information

Amendment to Human Use Protocol

Used for modifications/amendments. See Amendment page.

Communication Plan This tool is key to documenting communication roles, such as submitting initial and continuing reviews, amendments, and reportable events to the Reviewing IRB; providing conflict of interest management plans to the Reviewing IRB; and providing IRB-approved documents and communicating Reviewing IRB determinations to relying site study teams and is required to be submitted to the UTHSA IRB. See SMART IRB and Statewide Agreements.

Consent Short Form

Submit an amendment to request IRB approval to utilize a SHORT FORM consent process for potential subjects or LARs that are non-English speaking and there is not enough time to obtain a translation. The English version is provided here to be translated in the appropriate language.

Emergency ID Card (Sample)

This is a sample of an emergency ID card.
Emergency Use of Investigational Drugs Biologics or Devices - Consent Template See Emergency Use page for guidance.
Emergency Use - Certification from Independent Physician See Emergency Use page for guidance.
Emergency Use - IRB Notification Form See Emergency Use page for guidance.
Emergency Use - Drug Checklist See Emergency Use page for guidance.
Emergency Use - Device Checklist See Emergency Use page for guidance.
Exception Request Form See Exception page for guidance. Refer to the Modifications and Amendments Policy and Procedure
Form A-1 - Multipurpose Signature Assurance Sheet Should be submitted with all forms required after approval (amendments, progress reports). How to digitally sign Adobe forms.

Form A - Signature Assurance Sheet Required for initial submission. How to digitally sign Adobe forms.
Form B-1 - Expedited Certification Form To be used for new human research study reviewed by the IRB using an expedited procedure.
Form B-3 - Exempt Research Request - General Information Sheet See Exempt page for guidance.
Form BC - Protocol Template Form Use this template form if you do not have a sponsor's protocol.
Do not use for clinical trials - instead use the Form CT - Clinical Trial template.
Form C-1 - Local Repository Description See Repository page for guidance.
Form CT - Clinical Trial Protocol Template Form Use the Form CT template for investigator initiated clinical trials.

Form D - Research Consent + Authorization

For non-VA studies only.
Combined research consent + HIPAA authorization.
For research studies contributing to another repository, refer to the informed consent instructions for repositories.
Form D-1 - VA Research Consent + Authorization For VA studies and studies where VA is a site.
For research studies contributing to another repository, refer to the informed consent instructions for repositories.

Form D-IS - Information Sheet

Template to use when developing information sheet. Differs from consent in that it does not contain a signature section.
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 D Withdrawal Use this form for continued follow-up after withdrawal from interventions.
Form E - Repository Consent + Authorization For non-VA studies only.
Form E-1 - VA Repository Consent + Authorization For VA studies and studies where VA is a site.

Form F - BLANK Template

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 - Chart Review Study

This is PRE-POPULATED sample form which contains acceptable template wording when requesting a waiver of consent to complete a chart review study.
Form F - EFIC Exception from Informed Consent.

Form F - Recruitment

For studies approved prior to 1/21/2019. This is PRE-POPULATED sample form which contains acceptable template wording when requesting a waiver of consent to identify eligible subjects for recruitment.
Form F - Waiver of documentation of consent for research procedures prior to full consent For studies approved prior to 1/21/2019. This is PRE-POPULATED sample form which contains acceptable template wording when requesting an alteration and waiver of signature to obtain abbreviated verbal consent for procedures completed prior to full informed consent (e.g. request subject to answer screening questions or attend screening visit in fasting state). Include the Form L – Phone Script in the submission.
Form H-1 Translation Certification Form To be turned in with translated consent form. Pertains to subjects from any foreign culture.
Form H-UT - UT HIPAA Authorization Authorization for Use & Release of Individually Identifiable Health Information.
Form I - HIPAA De-identification Agreement Form 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 Inst-F - Investigational Drug Information Record VA form 10-9012
Form Inst-G - Pharmacy Letter of Understanding (LOU) To be used for transferring investigational drug/device between institutions.
Form Inst-H - Local Sponsor-Investigator Monitoring Plan To be used if a local investigator is listed as the sponsor on an FDA issued IND or IDE.
Form Inst-J - Research Involving Child Protective Services
Texas Department of Family and Protective Services Request for Approval
Form Inst-M - Personnel Form Used to list research team members by name.
Form J - HIPAA Waiver of Authorization Use this form to request access to identifiable health information without prior written permission from the subject.
Form J-1 - Assurance for Research on Decedent's Information This form 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.
Form K-2 - Intent to Rely Form This form should be completed 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.
Form L - Phone Script The phone script is used with Form F - Alteration and waiver of documentation of consent.
Form L-1 - Find a Study Recruitment Website Complete if you wish the study to be posted on the Find a Study website.
Form NN - Use of Technology in Research Used by the IRB to assist with determinations appropriate for use of electronic informed consent and mobile application.
Form O - Use of a Drug in Research

A drug or biologic being tested in research

Form O-2 - Use of a Placebo in Place of Standard Therapy

To be used if a placebo will be used in place of standard therapy

Form P - Use of Investigational Device Form May be Exempt from IDE. Including Humanitarian Use Device.
Form Q - Use of Radiation in Human Research Radiation Exposure Worksheet
Form Q-1 - Gene Transfer Therapy in Human Research Studies To be used for studies involving the deliberate transfer of DNA, or DNA or RNA derived from recombinant DNA (human gene transfer).
Form R - Monitoring Participant Safety and Data Integrity

Used for Data and Safety Monitoring Plan.

Form T - Inclusion of Adults with Impaired Decision-Making Ability

For research involving adults with impaired decision-making ability.

Form tA - Signature Assurance Sheet For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.
Form tB - General Information Sheet For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.
Form tB-2 - Study Personnel List For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.

Form tC - Research Description

For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.
Form tD - Research Consent For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.

Form tO - Investigational New Drug

For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.
Form tO-1 - Approved Drug Unapproved Use For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.
Form tP - Investigational Device For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.
Form U - Research Involving Pregnant Women, Fetuses, &/or Neonates

To be used for human subjects research involving these specific populations.

Form U - Pregnant Women, Neonates, Fetuses- describing Follow up only To be used for Follow-up only.
Form V - Research Involving Prisoners

To be used for human subjects research involving these specific populations.

Form W - Research Involving Children, Healthy Neonates, and/or Neonates (Viability not in question) To be used for human subjects research involving these specific populations. Includes assent waiver request, waiver of parental permission.
Form X - Protocol Related Conflict of Interest (COI) Report See HOP Conflicts of Interest in Scholarly, Research, and Clinical Activity, HOP Conflict of Commitment, and HOP Institutional Conflict of Interest Policy as applicable.
Greater Plains Collaborative Reliance Checklist Use this form when you are collaborating with researchers from an Institution that is part of the Greater Plains Collaborative (GPC) Reciprocity Agreement. This form will need to be completed by the relying institution.

Inactivation Request Form

Final Report form.

Individual Investigator Agreement

One Non-Affiliated Investigator, One Study. For Researchers not affiliated with UT Health San Antonio.

Individual Investigator Agreement (modified for multiple investigators)

Multiple Non-Affiliated Investigators, One Study. For Researchers not affiliated with UT Health San Antonio.
  • Signed Part A for each non-affiliated investigator
  • Signed Part B for each study listing all non-affiliated investigators

Institutional B - Participant Payment Plan Form

To be used if you plan to pay enrolled subjects.
Institutional Research Application for non-clinical trials This form to be used for non-clinical trials only
Non-Human Research, Request for Review See Non-Human Research page for guidance.
Non-Regulated Research Project, Request for Review See Non-Regulated Research page for guidance.

Progress Report Form

Used for continuing review. See Progress Report page.

Progress Report Form for Repository

Used for continuing review. See Progress Report page.

Progress Report Form-HDE

Used for continuing review. See Progress Report page.

Prompt Report Form

Use the Prompt Report form to report adverse events, non-adverse events, UPIRSOs, noncompliance. See Guidance and Policy documents.
Re-Activation form Use this form if you wish to request to re-initiate a research study. The IRB will review the document and decide on a case by case basis whether the study can be re-initiated.
Schedule of Events Use the Schedule of Events for investigator initiated clinical trials.
Single IRB Institutional Profile A reviewing IRB POC may use this survey to obtain key local context information from relying institutions. See SMART IRB page.
Single IRB Protocol Specific Form This survey will aid in obtaining key information from relying site study teams to determine whether particular regulatory or institutional requirements should be communicated to the Reviewing IRB. See SMART IRB page.
SMART IRB Agreement Implementation Checklist and Documentation Tool This form is used to document which options institutions will implement as part of the Ceded Review. See SMART IRB page.
Tracking Log for Events and Problems Use for UPIRSO and Events and Problems Not Requiring Prompt Reporting. For use when pre-existing tracking system capable of producing reports is not available.

Tracking Log for Protocol Deviations

Use this log to document all protocol deviations and track any subsequent reports to the IRB.
Transfer Research Data Form Request to Transfer Research Data, Tangible Research Property or Equipment When Leaving the University
UTHSA Institutional Profile To be used with potential reviewing IRBs/potential relying IRBs.
UTHSA IRB Application UTHSCSA IRB Application

   

 

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