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Categories of Review

Introduction to Categories of IRB Review Exempt Review Expedited Review Full Board Review Continuing Review-Progress Report Protocol Amendments and Modifications

Guidance or "How-to-pages"

What is Human Subject Research?Designing Research Protocols IRB Protocol Synopsis Designing Research-Supporting Documents Consenting Non-English Speaking Subjects IRB Application Submission IRB Reportable Events Data Storage and Security HIPAA Regulations Regulation on Human Subject Research

Other Key Information and Guidelines

Informed Consent-HIPAA Guidelines OPHS-IRB Question and Answer NIH Pre-review IRB Membership Roster-FWA version

Forms

IRB Forms IRB Meetings IRB Review Schedule

Training for UNTHSC Human Subject Researchers

Training Requirements Training Policy CITI FAQs CITI Course

Resources

On-line Resources OPHS and IRB Contacts Research Glossary

University of North Texas Health Science Center at Fort Worth

INSTITUTIONAL REVIEW BOARD FORMS

Completed IRB forms are submitted to the Office for the Protection of Human Subjects (OPHS) located in CBH 160. OPHS 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.

General Institutional Review Board Forms	Version	MS Word doc	Adobe Acrobat pdf
IRB Application Forms
IRB New Protocol Application (Full Board Review)	06/2006
Exempt Review Application since 09/09	09/2009
Expedited Review Application	04/2009
Progress Report	02/2009
IRB Reportable Events Forms
Serious Adverse Event Report for SAE's at UNTHSC (ON-SITE)	04/2009
Guidance on UNTHSC ON-SITE SAE reporting	06/2009
Serious Adverse Event Report for SAE's at Other Sites (OFF-SITE)	04/2009
Protocol Violation Reporting Form since Nov 2009	10/09
Additional IRB Research-Related Forms
Conflict of Interest (COI) Form	05/2006
Application for Change of Key Personnel	10/2009
Waiver of Informed Consent since Sept 2009	09/2009
Waiver of Documentation of Informed Consent since Sept 2009	09/2009
Consent Document Translation Affirmation Form since Nov 2009	11/2009
HIPAA Forms
HIPAA Research Waiver	04/2009
HIPAA Authorization Template	09/2008
HIPAA Compliance Data Use Agreement (internal use)	04/2009
HIPAA Compliance Data Use Agreement (external use)	04/2009
Informed Consent Samples These are for guidance only. DO NOT cut and paste from samples.
Biomedical Consentsince 05/09	05/2009
Public Health Consentsince 05/09	05/2009
Clinical Trial Consentsince 05/09	05/2009
Children Assent / Parent Consent since 05/09	05/2009
Sample Cover Letter (used in lieu of Informed Consent)since 05/09	05/2009
Short Form Templates Informed Consent for Use with Non-English Speaking Subjects
Short Form- English version since 09/09	09/2009
Short Form- Spanish version since 09/09	09/2009

OPHS 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.