Institutional Review Board Forms

writingphd Completed IRB forms and documents submitted for North Texas Regional Institutional Review Board review and approval must be accompanied with a signed memo from the Principal Investigator (PI) indicating their request. The memo should also include the protocol name and IRB number (if activity or request is post-approval). 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.

IRB Application Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
IRB New Protocol Application  (Full Board Review)
***REVISED***
11/2018 ms word icon
IRB Protocol Synopsis Template ***REVISED*** 11/2018 ms word icon
Exempt Review Application ***REVISED*** 11/2018 ms word icon
Expedited Review Application ***REVISED*** 11/2018 adobe logo
Progress Report ***REVISED*** 11/2018 ms word icon
Sponsored-Initiated Close Out Form ***NEW*** 11/2018 ms word icon
Investigator-Initiated Close Out Form***NEW*** 11/2018 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*** 01/2018 adobe logo
Guidance on ON-SITE SAE reporting     ***REVISED*** 01/2018 adobe logo
Serious Adverse Event Report for SAE’s at Other Sites (OFF-SITE)     ***REVISED*** 01/2018 adobe logo

 

Involving Other IRBs

General Institutional Review Board Forms Version Adobe Acrobat PDF
IRB Authorization Agreement
2018 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*** 11/2018 ms word icon
Single Subject Case Study Form (research involving single subject chart/record review) ***REVISED*** 11/2018 ms word icon
Chart Review Protocol Application (bundles protocol synopsis with IRB application, and Waivers of Informed Consent and HIPAA) ***REVISED*** 11/2018 ms word icon
Protocol Template for Research Involving Materials (data, records) Already Collected ***REVISED*** 11/2018 ms word icon
Protocol Template for Research Involving Human Biological Material ***REVISED*** 11/2018 ms word icon
Protocol Template for Survey Research    ***REVISED*** 11/2018 ms word icon
Application for Change of Key Personnel    ***REVISED*** 01/2018 ms word icon
Waiver of Informed Consent       ***REVISED***  11/2018 ms word icon
Waiver of Documentation of Informed Consent    ***REVISED***  11/2018 ms word icon

HIPAA Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
HIPAA Research Waiver Application ***REVISED***  01/2018 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

 

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 November 15, 2018