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 Code

Form Name                                         

Comments/Description

A

Investigator Initiated Protocol Form 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 (if required)
  • 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 Protocol Form

A2

Expanded Access Protocol (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.

Local Protocol Application

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

Translation Certification

English and Spanish templates available for most consent documents

Submit translation Forms Z, Z1, or Z2 as appropriate. 

Form Code

Form Name                                             

 Comments/Description

E

Research Consent Combined with HIPAA

Combined consent and HIPAA authorization for most research studies.

E2

Research Consent Combined with HIPAA Spanish

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

Expanded Access Consent (Treatment) Combined with HIPAA Spanish

E.M

Emergency Use Consent

Use when consent can be obtained. If consent cannot be obtained, complete and submit U3.

E.M2

Emergency Use Consent Spanish

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

HUD Consent Spanish

E.I

Information Sheet

Use for Verbal consent and submit Form G to request a waiver of documentation (waive signature)

E.I2

Information Sheet 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

Repository Consent Combined with HIPAA
Spanish

E.S

Short Form English

Other language translations (besides Spanish) will be available soon

E.S2

Short Form Spanish

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

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Translated Short Form Consents

Translation Certification

Language
Albanian French Punjabi
Amharic German Russian
Arabic Greek Simplified Chinese
Armenian Gujarati Somali
Bengali Hebrew Tagalog
Brazilian Portuguese Hindi Thai
Burmese Hungarian Traditional Chinese
Cambodian Italian Turkish
Creole Japanese Urdu
Edo Korean Vietnamese
European Portuguese Nepali Wolof
Farsi Polish Yiddish

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

Form Code

Form Name

Description

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 anytime 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

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 Advertisements and Data Collection

Form Code

Form Name

Description

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 Code

Form Name

For 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 Code

Form Name

Description

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

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 5 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 Code

Form Name

Description

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

Include 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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Reliance Forms

Form Code

Form Name

Description

AA

Local Context Form for Relying on UTSW IRB

Completed by each non-affiliate 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

Intent to Rely (UT System/Texas Universities)

Use when a Texas institution wishes to rely on UTSW or UTSW will rely on another Texas institution.

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