IRB Forms & Templates
Please note that the USF IRB is going fully electronic! This means that you must convert active “paper” studies into eIRB by December 31, 2012. You can convert your historical paper studies at the time of continuing review or any time throughout the year. Historical paper studies that are active on December 31, 2012 will be administratively closed by the USF IRB. If you have questions about the process, please call our help desk at 813-974-2880. To register for eIRB, go to https://arc.research.usf.edu/Prod and register online.
Applications for Initial Review must be submitted via eIRB (hardcopy will not be accepted).
Once you have submitted a new Application for Initial Review via eIRB, all subsequent submissions related to that study (amendments, continuing reviews, reportable events) must be made via eIRB.
Training will be available for study teams who converting their existing hardcopy studies over to eIRB. Please visit our What’s New page for additional information. For more information, please contact the HRPP office at (813) 974-5638. For IRB Consent Form Templates, please see the eIRB Consent Form Templates Page
| Medical IRB 01 |
Application for Initial Review, Determination,or ExemptionSubmit via eIRB |
Complete these forms for existing hardcopy studies only: |
| Information Report |
| Modification Request |
Progress Report
Note: The IRB is required to review information about the conduct of the research since the last IRB review; therefore, the PI must submit a Progress Report regardless of whether the study is to continue or be closed. |
Complete these forms for Emergency Use: |
| Notification of Emergency Use of a Test Article Subsequent to Use |
| Notification of Emergency Use of a Test Article Prior to Use |
| Social & Behavioral IRB 02 |
Application for Initial Review, Determination,or ExemptionSubmit via eIRB |
Complete these forms for existing hardcopy studies only: |
| Information Report |
| Modification Request |
Progress Report
Note: The IRB is required to review information about the conduct of the research since the last IRB review; therefore, the PI must submit a Progress Report regardless of whether the study is to continue or be closed. |
| Addenda (for both boards) Do not attach these forms to eIRB submissions. |
|
Addendum 1: Request for Expedited Review  (2008-06-13) |
Addendum 10: Radiation Safety Information (2008-06-13) |
| Addendum 2: Waiver or Alteration of Informed Consent (2008-06-13) |
Addendum 11: Biosafety Information (2008-06-13) |
| Addendum 3: Data & Safety Monitoring (2008-06-13) |
Addendum 12: Biological Specimens (2008-06-13) |
| Addendum 4: Disclosure of Investigator Interests (COI) (2008-06-13) |
Addendum 13: Summary of Research Activities (2008-06-13) |
| Addendum 5: HIPAA - Use, Receipt, or Disclosure of PHI(2008-06-13) |
Addendum 14: AE Progress Report (2008-06-13) |
| Addendum 6: Key Personnel (2009-3-12) |
Addendum 15: Data & Safety Monitoring Progress Report (2008-06-13)
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| Addendum 7: Drugs, Biologics, Devices (2008-06-13) |
Addendum 16: Planned Emergency Medicine Research (2008-06-13) |
| Addendum 8: Pharmacy (2008-06-13) |
Addendum 17: Investigator - Sponsor Responsibilities(2008-06-13) |
| Addendum 9: Lab Information (2008-06-13) |
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Other Forms (for both boards)
- HIPAA Forms - HIPAA Compliance Program
- Informed Consent Templates
- Veterans Administration (VA) Applications and Templates
General Instructions for Hardcopy Forms
- Always download the latest version at the time you will use it.
- 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.
- Specific instructions and submission checklists are posted below each form link.
| Submit IRB Materials to: USF 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 USF Research Park, Tampa, FL |
| Telephone: | (813) 974-5638 |
| Fax: | (813) 974-7091 |
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