IRB Applications and Forms



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Submit Applications Electronically

Effective January 1, 2010 all 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.

Beginning in Spring 2010, study teams will be able to convert existing hardcopy studies over to eIRB. Until then, for existing studies study teams should continue to submit amendments and continuing reviews in hardcopy and reportable events in the AERS.

For more information, please contact the HRPP office at (813) 974-5638 or see the eIRB announcement on the IRB Page.

NOTICE: Failure to provide a continuing or final IRB Progress Report will result in suspension of a PIs 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.

NOTICE: If your Stimulus Package grant (American Recovery and Reinvestment Act of 2009) includes the use of human subjects, animal subjects, or biological agents that require the approval of the USF Biosafety Committee, please print this Cover Page on colored paper (any color is fine) and attach it to your IRB, IACUC, or Biosafety application as your cover sheet. This will assist the Division of Research Integrity and Compliance in identifying and processing your application.

Medical IRB 01

Application for Initial Review, Determination, or Exemption
      Submit via eIRB

Complete these forms for existing hardcopy studies only:

Information Report
      Form (2008-12-10)
      Instructions / Checklist

Modification Request
      Form (2009-4-8)
      Instructions / Checklist

Progress Report
      Form (2009-5-13)
      Instructions / Checklist

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
      Form (2008-12-10)
      Instructions / Checklist

Notification of Emergency Use of a Test Article
      Prior to Use
      Form (2008-12-10)
      Instructions / Checklist

Social & Behavioral IRB 02

Addenda (for both boards)

Do not attach these forms to eIRB submissions.

       Addendum 1: Request for Expedited Review (2008-06-13)

       Addendum 2: Waiver or Alteration of Informed Consent
           (2008-06-13)

       Addendum 3: Data & Safety Monitoring (2008-06-13)

       Addendum 4: Disclosure of Investigator Interests (COI)
           (2008-06-13)

       Addendum 5: HIPAA - Use, Receipt, or Disclosure of PHI
           (2008-06-13)

       Addendum 6: Key Personnel (2009-3-12)

       Addendum 7: Drugs, Biologics, Devices (2008-06-13)

       Addendum 8: Pharmacy (2008-06-13)

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

      Western IRB (WIRB) Forms & Info

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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 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

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 research@research.usf.edu Last updated: January 4, 2010