Institutional Review Board Forms

writingphdCompleted IRB forms are submitted to the Office of Research Compliance (OReC) located in CBH 160. OReC requires documents submitted for IRB review and approval to be accompanied with a signed memo from the principal investigator indicating their request. The memo should also include the protocol name and IRB number. 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.

OReC 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.


IRB Application Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
IRB New Protocol Application  (Full Board Review)  09/2012 MS word- Exempt Application doc Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
IRB Protocol Synopsis 05/2006

MS word- Exempt Application doc

Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf

Exempt Review Application  02/2012 MS word- Exempt Application doc Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Expedited Review Application  04/2009 MS word- Exempt Application doc Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Progress Report  02/2009 MS word- Exempt Application doc Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf

IRB Reportable Events Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
Serious Adverse Event Report for SAE's at UNTHSC (ON-SITE) 02/2014
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Guidance on UNTHSC ON-SITE SAE reporting 02/2014
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Serious Adverse Event Report for SAE's at Other Sites (OFF-SITE) 02/2014
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Protocol Violation Reporting Form 02/2014

MS word- Exempt Application doc

Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf


Additional IRB Research-Related Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
Conflict of Interest (COI) Form  10/2010
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Existing Database Form ***NEW*** (research involving existing data that are publicly available without restriction or require a "responsible use statement") 01/2014 MS word- Exempt Application doc Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf

Single Subject Case Study Form ***NEW***  (research involving single subject chart/record review)

01/2014 MS word- Exempt Application doc
Chart Review Protocol Application **REVISED**(bundles protocol synopsis with IRB application, and Waivers of Informed Consent and HIPAA) 01/2014

MS word- Exempt Application doc


Protocol Template for Research Involving Materials (data, records) Already Collected          05/2010

MS word- Exempt Application doc


Protocol Template for Research Involving Human Biological Material                         09/2010
Protocol Template for Survey Research 10/2010


Application for Change of Key Personnel  02/2013 MS word- Exempt Application doc
Waiver of Informed Consent   09/2009 MS word- Exempt Application doc Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Waiver of Documentation of Informed Consent    09/2009 MS word- Exempt Application doc Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Consent Document Translation Affirmation Form  11/2009

Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf


HIPAA Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
HIPAA Research Waiver   05/2009 MS word- Exempt Application doc
HIPAA Authorization Template   09/2008
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
HIPAA Compliance Data Use Agreement (internal use) 04/2009

Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf

HIPAA Compliance Data Use Agreement (external use) 04/2009
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf

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
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Public Health Consent  05/2009
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Clinical Trial Consent 05/2009 
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf
Children Assent / Parent Consent 05/2009

Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf

Sample Cover Letter  (used in lieu of Documentation of Informed Consent)

05/2009 
Adobe Acrobat- IRB New Protocol Application (Full Board Review) pdf

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)   10/2010

MS word- Exempt Application doc


Research/Consent Statement for On-line Survey   10/2010 MS word- Exempt Application doc

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  09/2009

MS word- Exempt Application doc


Short Form- Spanish version 09/2009

MS word- Exempt Application doc


This page last updated 04th Feb 2014