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 icon adobelogo
IRB Protocol Synopsis 05/2006

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Exempt Review Application  02/2012 ms word icon adobelogo
Expedited Review Application  04/2009 ms word icon adobelogo
Progress Report  02/2009 ms word icon adobelogo

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
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Guidance on UNTHSC ON-SITE SAE reporting 02/2014
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Serious Adverse Event Report for SAE's at Other Sites (OFF-SITE) 02/2014
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Protocol Violation Reporting Form 02/2014

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Additional IRB Research-Related Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
Conflict of Interest (COI) Form  10/2010
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Existing Database Form ***NEW*** (research involving existing data that are publicly available without restriction or require a "responsible use statement") 01/2014 ms word icon adobelogo

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

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

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

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

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Application for Change of Key Personnel  02/2013 ms word icon
Waiver of Informed Consent   09/2009 ms word icon adobelogo
Waiver of Documentation of Informed Consent    09/2009 ms word icon adobelogo
Consent Document Translation Affirmation Form  11/2009

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HIPAA Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
HIPAA Research Waiver   05/2009 ms word icon

***NEW***

HIPAA Authorization Template 

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HIPAA Compliance Data Use Agreement (internal use) 04/2009

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HIPAA Compliance Data Use Agreement (external use) 04/2009
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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
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Public Health Consent  05/2009
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Clinical Trial Consent 05/2009 
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Children Assent / Parent Consent 05/2009

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

05/2009 
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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

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Research/Consent Statement for On-line Survey   10/2010 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  09/2009

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Short Form- Spanish version 09/2009

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This page last updated 22nd Sep 2014