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)
***REVISED***
04/2015 ms word icon adobelogo
IRB Protocol Synopsis 05/2006 ms word icon adobelogo
Exempt Review Application 02/2012 ms word icon adobelogo
Expedited Review Application 04/2009 ms word icon adobelogo
Progress Report ***REVISED*** 10/2014 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) 04/2015 adobelogo
Guidance on UNTHSC ON-SITE SAE reporting 02/2014 adobelogo
Serious Adverse Event Report for SAE’s at Other Sites (OFF-SITE) 04/2015 adobelogo
Protocol Violation Reporting Form 02/2014 ms word icon adobelogo

 

Additional IRB Research-Related Forms

General Institutional Review Board Forms Version MS Word Doc Adobe Acrobat PDF
Conflict of Interest (COI) Form ***REVISED*** 05/2015 adobelogo
Existing Database Form (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 (research involving single subject chart/record review) 01/2014 ms word icon
Chart Review Protocol Application (bundles protocol synopsis with IRB application, and Waivers of Informed Consent and HIPAA) 01/2014 ms word icon
Protocol Template for Research Involving Materials (data, records) Already Collected 05/2010 ms word icon
Protocol Template for Research Involving Human Biological Material 09/2010 ms word icon
Protocol Template for Survey Research 10/2010 ms word icon
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 adobelogo

 

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

 08/2014 MS_Word_icon adobelogo
HIPAA Compliance Data Use Agreement (internal use) 04/2009 adobelogo
HIPAA Compliance Data Use Agreement (external use) 04/2009 adobelogo

 

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
Clinical Trial Consent 05/2009 adobelogo
Children Assent / Parent Consent 05/2009 adobelogo
Sample Cover Letter  (used in lieu of Documentation of Informed 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) 10/2010 ms word icon
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 ms word icon
Short Form- Spanish version 09/2009 ms word icon