Institutional Review Board Forms

writingphdCompleted IRB forms and documents submitted for North Texas Regional Institutional Review Board review and approval must be submitted in IRBNet. Additionally, the Principal Investigator (PI) must electronically sign the IRBNet package before submitting to the IRB for review. An IRB number will be generated for new protocols upon initial submission / review. Documents should be submitted in a timely manner for proper review and approval.

Your computer must have Microsoft Word and/or Adobe Acrobat to access and read the following forms, samples and templates. If you need to download Adobe Acrobat, please follow this link.

Important Note:

  • Please submit all documents in IRBNet by selecting “Create New Project” in the left-hand navigation bar.
  • Please note the following:
    • THE PRINCIPAL INVESTIGATOR MUST HAVE FULL ACCESS TO THE IRBNET PROTOCOL PACKAGE IN ORDER FOR IT TO BE REVIEWED BY THE IRB.
    • Please be sure to use a very descriptive file name for each document submitted as a pdf or word.doc file. Example: “MMSE scale” is much better than “Scale 1”. . . “Recruiting flyer” is better than “Ad 1”, and so forth.
    • Refer to the “Read Me First” document located in IRBNet under “Forms and Templates” for more guidance.
  • For Progress Reports/Continuing Reviews:
    • Please submit all documents in IRBNet by entering the project you wish to update through “My Projects.” Then select “Create a New Package” in the left-hand navigation bar.

*As a general reminder, Full Board submissions MUST be received by CLOSE OF BUSINESS (5:00 PM CT) on the day of the submission deadline in order to be considered for the upcoming IRB Meeting.*

 

IRBNet Guidance Materials

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
IRBNet User Manual 08/2019 adobe logo
IRB Guidance for IRBNet Wizard Application Form for New Protocols (see IRBNET for the electronic application form) 04/2019 adobe logo

IRB Application Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
IRB Protocol Synopsis Template ***REVISED*** 11/2018 ms word icon
Site-Specific Protocol Information for Sponsored Clinical Trials 04/2019 ms word icon
Continuing Review/Progress Report ***REVISED*** 11/2019 ms word icon
Sponsored-Initiated Close Out Form ***NEW*** 11/2019 ms word icon
Investigator-Initiated Close Out Form***NEW*** 11/2019 ms word icon

 

IRB Reportable Events Forms

General Institutional Review Board Forms Version Adobe Acrobat PDF MS Word Doc
Serious Adverse Event Report for SAE’s  at UNTHSC or JPS (ON-SITE)    ***REVISED*** 11/2019 adobe logo
Guidance on ON-SITE SAE reporting     ***REVISED*** 12/2019 adobe logo
Serious Adverse Event Report for SAE’s at Other Sites (OFF-SITE)     ***REVISED*** 11/2019 adobe logo

 

Involving Other IRBs

General Institutional Review Board Forms Version Adobe Acrobat PDF
IRB Authorization Agreement
2019 adobe logo
SMART IRB Agreement Template 2018 adobe logo

 

Additional IRB Research-Related Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
Conflict of Interest (COI) Form ***REVISED*** 01/2018 adobelogo
Existing Database Form (research involving existing data that are publicly available without restriction or require a “responsible use statement”)  ***REVISED*** 11/2019 ms word icon
Chart Review Protocol Application (bundles protocol synopsis with IRB application, and Waivers of Informed Consent and HIPAA) ***REVISED*** 11/2019 ms word icon
Protocol Template for Research Involving Materials (data, records) Already Collected ***REVISED*** 10/2019 ms word icon
Protocol Template for Research Involving Human Biological Material ***REVISED*** 11/2019 ms word icon
Protocol Template for Survey Research    ***REVISED*** 11/2019 ms word icon
Application for Change of Key Personnel    ***REVISED*** 01/2018 ms word icon
Waiver of Informed Consent       ***REVISED***  01/2019 ms word icon
Waiver of Documentation of Informed Consent    ***REVISED***  01/2019 ms word icon

HIPAA Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
HIPAA Research Waiver Application ***REVISED***  01/2019 ms word icon
HIPAA Authorization Template ***REVISED***  01/2018 MS_Word_icon

 

Consent Templates

 

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
Study Consent Cover Letter (in lieu of Documentation of Informed Consent)  ***REVISED***  01/2018 ms word icon
Research/Consent Statement for On-line Survey ***REVISED*** 01/2018 ms word icon
Templates for “Key Information” Section of Informed Consent Document 04/2019 ms word icon

 

Short Form Templates

Informed Consent for Use with Non-English Speaking Subjects

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
Short Form- English version ***REVISED*** 02/2018 ms word icon
Short Form- Spanish version ***REVISED*** 02/2018 ms word icon

 

This page was last modified on December 10, 2019