Human Research Protection Program

Forms and Templates

**This page was updated to coincide with eIRB Lite implementation. If you are looking for a form that is not here, contact the HRPP by hrpp@utsouthwestern.edu for assistance in locating the form.**

Instructions for Use of Forms and Templates

  • Always download the forms from the HRPP website to ensure you are using the most current versions.
  • Items with an asterisk* are required.
  • Remaining items should be submitted if applicable to your research. Depending on the nature of your research, some sections of the application will apply to your research, some will not.
  • Review each section to determine applicability to your research, and include the forms appropriate for your study in your eIRB application submission.
  • Completed forms will be uploaded to eIRB
  • Do not convert MS Word documents to PDF to ensure proper version control
  • The HRPP office will ensure the documents are named according to the HRPP Document Naming Requirements and will rename documents if necessary.

Note: where you see --"placeholder only," there is no required template to download. Instead, you should upload the form provided by the sponsor or create your own as applicable.

Checklists:

Use the following Checklists to assist with selection of applicable forms:

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Protocol Forms

Form CodeForm NameComments/Description
A

Investigator Initiated Research Description or 


Simmons Cancer Center Protocol

 At least one of forms (A-A4) must be submitted.
Form A: You may do any of the following:
  • Create your own protocol,
  • Use Simmons Cancer Center Protocol (required for use with all interventional cancer-related clinical trials)
  • Complete and submit the simplified Form A Template

If you submit a Grant Application (A4) you may also be required to submit Form A – Protocol
A1 Repository Research Description
A2 Expanded Access Description (treatment)
A3 Sponsor Protocol --placeholder only 
A4 Grant Application --placeholder only
A5 Study Diagram or Table --placeholder only Include a study table/flow diagram if one is not included in your protocol.

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Local Protocol Application

Form CodeForm NameComments/Description
B *Study Personnel *Required
B1 Training Certificates - Non-Affiliated --placeholder only Include only if non-affiliated personnel are listed on study and covered under UTSW IRB (See Form CC)
C *Population and Recruitment *Required
D Local Data Safety Monitoring Plan Submit if required by IRB (i.e., More than minimal risk), FDA, NIH, other funding agency

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Consent and HIPAA Authorization Documents

English and Spanish templates available for most consent documents. Submit translation Forms Z, Z1, or Z2 as appropriate.

On July 14, 2020, Forms E, E2, E.X, E.X2, E.R, E.R2, E.S and all non-English short forms were updated to remove "Do Not Disclose" from the footer. All edits to translated documents were made to English wording in the footer only and do not affect the translated content of the form.

Form CodeForm NameComments/Description
E.O Phone Script Use this for studies where a waiver of documentation of consent is requested and there are plans to use a consenting process by phone where participants will provide verbal consent. This document may also be used during the recruitment process. 
E Research Consent Combined with HIPAA Combined consent and HIPAA authorization for most research studies.
E2

Spanish Research Consent Combined with HIPAA
E.X Expanded Access Consent (Treatment) Combined with HIPAA Use when investigational drug/device will be used outside of an approved protocol to treat a patient.
E.X2

Spanish Expanded Access Consent (Treatment) Combined with HIPAA
E.M Emergency Use Consent/Single Patient Expanded Access Consent Use this consent form for emergency use of an investigational drug/device or for a single patient expanded access.
E.M2

Spanish Emergency Use Consent
E.H HUD Consent Use for Humanitarian Use Device submissions if descriptive patient brochure is not available or if required by the IRB
E.H2

Spanish HUD Consent
E.I Information Sheet Use for Verbal consent and submit Form G to request a waiver of documentation (waive signature)
E.I2

Spanish Information Sheet
EI.sIRB sIRB Information Sheet Use for studies where external sites will rely on UTSW as the Single IRB (sIRB). Use for Verbal consent and submit Form G to request a waiver of documentation (waive signature)
E.sIRB1

sIRB Consent Part 1 - Master Consent

sIRB Consent Part 1 - Spanish

 Use for studies where external sites will rely on UTSW as the Single IRB (sIRB). The master consent form provides overall information about the study, as it pertains to all participating sites. A separate site-specific consent form must submitted by each enrolling site.
E.sIRB2 sIRB Consent Part 2 - Site-Specific
E.RsIRB1

sIRB Repository Consent Part 1 - Master Consent

sIRB Repository Consent Part 1 - Spanish

 Use for studies where external sites will rely on UTSW as the Single IRB (sIRB) and the study is collecting materials to be deposited into a repository for future research. The master consent form provides overall information about the study, as it pertains to all participating sites. A separate site-specific consent form must submitted by each enrolling site.
E.RsIRB2

sIRB Repository Consent Part 2 - Site-Specific

sIRB Repository Consent Part 2 - Spanish
E.P Pregnant Partner Consent No template(s) available yet.
E.P2 Pregnant Partner Consent Non-English (placeholder only)
E.R. Repository Consent Combined with HIPAA For use with studies collecting materials to be deposited into a repository for future research
E.R2

Spanish Repository Consent Combined with HIPAA
E.S Short Form English Templates available below under "Translated Short Form Consents"
E.S2 Short Form Non-English (placeholder only)
F Stand Alone HIPAA Authorization Use if institution requires a separate HIPAA authorization. Otherwise, use the combined Consent/Authorization (currently accepted at UTSW, TSRH and Children’s Health)
F2 Stand Alone HIPAA Authorization Non-English
Spanish Template
F.CR HIPAA Authorization for Case Report Use if physician requires a HIPAA authorization for a Case Report. 

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Translated Short Form Consents

Translation Certifications

Karen Short Form Translation Certification

Dari and Pashto Short Form Translation Certification

Irdo Short Form Translation Certification

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Waiver and/or Alteration of Consent and/or HIPAA Requests

 

Form CodeForm NameDescription
G Waiver/Alteration of Consent Request Blank request form to be completed for waivers or alterations of consent which situations in G1-G4 do not apply
G1 Waiver of Consent for Chart Review Use this request for Chart Review waivers.
(This form is pre-completed for most requests; edit as necessary).
G2 Waiver of Consent for Recruitment Use this request to Prescreen Records to identify eligible subjects for recruitment.
(This form is pre-completed for most requests; edit as necessary).
G3 Alteration & Waiver of Documentation of Consent Use this request to obtain verbal consent (i.e., phone) to conduct research procedures (e.g., fasting) prior to full consent.
(This form is pre-completed for most requests; edit as necessary).
G4 Exception from Informed Consent (EFIC) Use this request to waive consent for Planned Emergency Research
H Waiver/Alteration of HIPAA Request Use this to request a waiver of HIPAA authorization (Needed any time health information is used and consent will be waived or verbal consent is obtained to use health information)
H1 Request to Use Decedent PHI in Research Use this form to request access to/collection of Protected Health Information about deceased individuals
H.SF Short Form HIPAA Authorization Alteration Use this to request alteration of HIPAA authorization for short form consents (Needed when there is not time to obtain a written HIPAA authorization in the subject’s own language. The PHI to be used is described in the English HIPAA authorization form, which will be read to the subject in his/her language by an interpreter and verbal authorization will be obtained.)

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Advertisements and Data Collection

Form CodeForm NameDescription
E.O1 Email_Letter Template

This template may be used as recruitment material where there are plans to email or send a letter to potential participants. 
I Advertisement --placeholder only

Include all advertisements to be used

J

Data Collection Form --placeholder only

 Include all data collection/case report forms/questionnaires to be used
J1 i2b2 Data Collection Request Form Use this request if you will obtain data from the i2b2 database

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Vulnerable and Special Population Requests

Form CodeForm NameFor Use When:
K Research Involving Children Children will be enrolled at any time during the research (includes chart reviews of children during the record review)
L Research Involving Decisionally Impaired Decisionally impaired subjects will be included at any time during the research (includes chart reviews of decisionally impaired during the record review)
M Research Involving Prisoners Prisoners will be included at any time during the research (includes chart reviews of prisoners during the record review)
N Request to enroll Students/Residents Submit approved form to enroll students, Residents or other trainees to be targeted for inclusion in the research (does not include incidental enrollments)
O Research Involving Pregnant Women Pregnant Women will be included at any time during the research (includes chart reviews of women pregnant during the record review)
O1 Research Involving Pregnant Partners (of research participants) - follow up only Pregnant partners of subjects will be enrolled or followed (includes chart reviews of the pregnant women). If the child’s outcome will be followed, submit Form K as well.
(This form is pre-completed for most requests; edit as necessary).
P International research You will conduct research outside of the United States (this includes chart reviews in other countries)

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Use of Drugs and/or Devices

Form CodeForm NameDescription
Q Placebo in place of SOC  Use if placebo will be used in place of Standard of Care
R Sponsor-Investigator Monitoring plan Use if the PI is the Sponsor Investigator (holds the IND/IDE)
S Package Insert - Approved Product --placeholder only FDA approved labeling for a drug/device
T1 Investigational Drug Brochure --placeholder only Required for investigational drug studies
T2 Investigational Device Manual --placeholder only Required for investigational device studies
TS-AI Research Involving Software Complete this form if your study involves the development of a clinical decision support tool, machine learning, artificial learning, or predictive modeling.
U1 Emergency Use Pre-Request Submit this form via hrpp@utsouthwestern.edu if prior approval is needed to treat a patient with an unapproved drug/device in an Emergency situation (off protocol)
U2 Emergency Use Post Notification Submit this notification via hrpp@utsouthwestern.edu within five days of the Emergency Use of an unapproved drug/device
U3 Certification of Emergency Use Consent Waiver Complete and submit via hrpp@utsouthwestern.edu if informed consent cannot be obtained prior to Emergency Use treatment

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Miscellaneous Forms

Form CodeForm NameDescription
V Deidentification Agreement Use when requesting completely deidentified data from another source to certify the data you receive is deidentified according to HIPAA
W Lead PI Monitoring plan Use if the PI is the lead PI for a multisite study.
X Request for approval from Laser Committee Complete and submit if Lasers will be used in the research
Y1 Non-Human Research Form Submit if ALL data/specimens in the research will be anonymous to investigators AND study is not FDA regulated
Y2 Non-Regulated Research Form Submit for projects not intended as Research (QI, Program Evaluation, case reports, etc.)
Z Translation Request Form Use to request HRPP assistance with translation of documents
Z1 Translation Verification Submit to certify that someone verified the translations (if certificate of translation is not available)
Z2 Certificate of Translation --placeholder only Submit if translation provided by a commercial company
FF Certificate of Confidentiality (CoC) --placeholder only Submit documentation of CoC if available
EE COI Statement - Non-Affiliated Personnel Complete the REDCap form only if non-affiliated personnel are listed on study and covered under UTSW IRB (See Form B1 and Form CC)
EE1 COI Management Plan - Non-UTSW --placeholder only Plan from outside COI committee/office when a COI management plan is required for non-affiliated personnel (not covered by UTSW FWA) on the study. Note: Form CC does not apply here. Examples are THR, sites relying on UTSW, etc.
  Repository CR Supplement Use when submitting a CR to eIRB Lite for a Repository protocol.

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sIRB Forms

Form codeForm NameDescription
AA

Institutional Profile

 Completed by each non-UTSW affiliated site relying on UTSW IRB
AB

Protocol-Specific Document

 Completed by each non-UTSW affiliated site relying on UTSW IRB to provide institution-specific information for each study
AC sIRB Continuing Review Form Annual Continuing Review form completed by each non-UTSW affiliated site relying on UTSW IRB.
BB IRB Authorization Agreement --placeholder only Required when UTSW IRB reviews for another site or relies on another IRB.  Contact Reliance Program team for more information.
CC Individual Investigator Agreement --placeholder only Required to add an individual as study personnel if that person does not work for an assured (federalwide assurance) institution. If they do work for an assured institution, Form BB or their IRB approval will be required.
DD Reliance Request

Complete to:
1) Request to Rely on an External IRB,
2) Request for External Sites to Rely on UTSW IRB,
3) Request a Letter of Support and/or sIRB Review Fee Quote for a grant submission, or
4) Request to Add Non-UTSW Affiliated Personnel to Study
GG sIRB Consent Form Guidance

This guidance includes the specific requirements needed for the UTSW IRB to approve single IRB (sIRB) submissions requiring informed consent and/or HIPAA Authorization.

HH

 sIRB Communication Plan

Single IRB (sIRB) Communication Plan to document key 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. 

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Site-Specific Required Language For Consents

Local context language is UTSW-specific information that needs to be inserted into the consent form template(s) when UTSW agrees to rely on an external IRB. If the Reviewing IRB is named below, select the associated document. Otherwise, select the "UTSW" document. Pre-review of consent forms by UTSW HRPP is not required before submitting to the Reviewing IRB. 

  • Advarra - Effective December 1, 2023, study teams will insert the local context language found in the UTSW document.
  • WCG (for reference purposes only - Complete WCG ICF Checklist and submit with WCG IRB Application effective 11/15/22)
  • WCG ICF Checklist 

 

 

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