IRB Applications and Forms



Office of Research > Research Integrity & Compliance > IRB > IRB Applications & Forms

General Instructions

Always download the latest version at the time you will use it. Previous version will not be accepted after February 13, 2007.
Forms must be typed (word processor). Handwritten submissions will not be accepted.
Please provide complete answers to every question. If an item is not applicable, please type "NA" and briefly explain why it is not applicable.
Incomplete or handwritten submissions will be closed 30 days after notification.
Before printing forms, check page layout: most forms are in landscape format.
For all supporting documents (protocol, informed consent, addenda, etc.), highlight any revisions made.

Submit IRB Materials to: USF Division of Research Integrity and Compliance
	On-Campus Mail:	MDC35
	Regular Mail:	12901 Bruce B. Downs Blvd., MDC35 Tampa, FL 33612
	Hand Delivery:	3702 Spectrum Blvd., Suite 155 MAP USF Research Park, Tampa, FL
	Telephone: Fax:	(813) 974-9343 (813) 974-5618

Failure to provide a continuing or final IRB Progress Report will result in suspension of a Principal Investigator's ability to submit new IRB Applications. For research that has expired, a final IRB Progress Report must be submitted before any new IRB Submission will be accepted.

Medical IRB 01

      Application for Initial Review (2008-06-13) – New!

      Determination Form (2007-07-01) – New!

      Application for Exempt Certification (2008-03-12) – New!

      Information Report (2006-11-13)

      Modification Request (2008-03-12) – New!

      Notification of Emergency Use of a Test Article
           - Subsequent to Use (2006-11-13)

      Notification of Pending Emergency Use of a Test Article
           - Prior to Use (2006-11-13)

      Progress Report (2007-07-01) – New!

The IRB is required to review information about the conduct of the research since the last IRB review. This is accomplished by the PI completing a Progress Report. This report is required whether the study is to continue or the PI is reporting on the what occurred during the last review period, before closing the study. The Progress Report replaces the Continuation and Final Review forms.

Social & Behavioral IRB 02

      Application for Initial Review (2007-07-01) – New!

      Determination Form (2007-07-01) – New!

      Application for Exempt Certification (2008-03-12) – New!

      Information Report (2006-11-13)

      Modification Request (2008-03-12) – New!

      Progress Report (2007-07-01) – New!

The IRB is required to review information about the conduct of the research since the last IRB review. This is accomplished by the PI completing a Progress Report. This report is required whether the study is to continue or the PI is reporting on the what occurred during the last review period, before closing the study. The Progress Report replaces the Continuation and Final Review forms.

Addenda (for both boards)

       Addendum 1: Request for Expedited Review (2006-01-06)

       Addendum 2: Waiver or Alteration of Informed Consent
           (2007-07-01) – New!

       Addendum 3: Data & Safety Monitoring (2006-11-13)

       Addendum 4: Disclosure of Investigator Interests (COI)
           (2006-11-13)

       Addendum 5: HIPAA - Use, Receipt, or Disclosure of PHI
           (2006-11-13)

       Addendum 6: Key Personnel (2006-11-13)

       Addendum 7: Drugs, Biologics, Devices (2006-11-13)

       Addendum 8: Pharmacy (2006-11-13)

       Addendum 9: Lab Information (2006-11-13)

       Addendum 10: Radiation Safety Information (2006-11-13)

       Addendum 11: Biosafety Information (2006-11-13)

       Addendum 12: Biological Specimens (2006-11-13)

       Addendum 13: Summary of Research Activities (2007-07-01) – New!

       Addendum 14: AE Progress Report (2007-07-01) – New!

       Addendum 15: Data & Safety Monitoring Progress Report (2006-11-13)

       Addendum 16: Planned Emergency Medicine Research
           (2007-08-01) – New!

       Addendum 17: Investigator - Sponsor Responsibilities
           (2008-06-13) – New!

Other Forms (for both boards)

      Adverse Events Reporting System (AERS) — login
           [More Information about AERS]

      Conflict of Interest Forms
           - Financial Relationships Disclosure Form
           - Conflict of Interest in Research Program

      HIPAA Forms - HIPAA Compliance Program

      Informed Consent Templates

      Investigator Responsibilities Certification

      Veterans Administration (VA) Applications and Templates

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Division of Research Integrity & Compliance
Mail: 12901 Bruce B. Downs Blvd, MDC35, Tampa, FL 33612-4799 Phone: (813) 974-5638 Fax: (813) 974-5618

Direct questions or comments about this Web site to jarnaldi@research.usf.edu Last updated: July 17, 2008