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:
For UNTHSC projects (Principal Investigator is UNTHSC personnel), please send all materials to:

UNTHSC Office of Research Compliance

Center for BioHEalth (CBH) – 160

3500 Camp Bowie Blvd, Fort Worth, Texas 76107

For John Peter Smith Projects (Principal Investigator is JPS personnel), please send all materials to:

JPS Health Network

Office of Clinical Research

1500 S. Main Street, Fort Worth, Texas 76104

817-702-3655

 

IRB Application Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
IRB New Protocol Application  (Full Board Review)
***REVISED***
03/2018 ms word icon
IRB Protocol Synopsis Template ***REVISED*** 01/2018 ms word icon
Exempt Review Application ***REVISED*** 01/2018 ms word icon
Expedited Review Application ***REVISED*** 01/2018 adobe logo
Progress Report ***REVISED*** 01/2018 ms word icon
Sponsored-Initiated Close Out Form ***NEW*** 01/2018 ms word icon
Investigator-Initiated Close Out Form***NEW*** 01/2018 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

 

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

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

 

Informed Consent Samples

These are for guidance only. DO NOT cut and paste from samples.

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
Biomedical Consent 05/2009 adobelogo
Public Health Consent 05/2009 adobelogo
Children Assent / Parent Consent  05/2009  adobelogo

 

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

 

We would like to extend our grateful appreciation to Dr. Cardarelli, Dr. Larrañaga, Dr. Anthony, Dr. Dawson and Dr. Mathew, all principal investigators at UNTHSC, for permission to use their informed consent for educational purposes.

This page was last modified on April 19, 2018