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HIPAA Forms

Listed below are the most frequently used HIPAA and research-related templates, completion and submission of which may be required for IRB review and approval of FSU research that involves the use or disclosure of individuals' Protected Health Information. For each template below, descriptions, links to the form, and instructions are provided.

  • Research Authorization For Use and Disclosure of Protected Health Information (PHI) [RAMP IRB link] [external link]
    • A valid Authorization (HRP-514 - TEMPLATE HIPAA Authorization for Research) will be required as well as signed and dated by each individual (or their personal representative) from whom permission must be requested for use or disclosure of their PHI, where such use or disclosure is not covered by (1) an IRB-approved waiver/alteration or (2) an executed Data Use Agreement for a Limited Data Set.
    • Provide for FSU IRB review and with your RAMP IRB study submission a copy of the Authorization. In RAMP IRB, the copy should be uploaded in the Local Site Documents section of the study workspace, under Other Attachments, using the category "Research Authorization for Use and Disclosure of PHI".
  • Application for Waiver or Alteration of HIPAA Authorization for Use and Disclosure of Protected Health Information [external link]
    • Provide for FSU IRB review and with your RAMP IRB study submission a completed Application for Waiver or Alteration of HIPAA Authorization. In RAMP IRB, the waiver application should be uploaded in the Local Site Documents section of the study workspace, under Other Attachments, using the category "Application for Waiver or Alteration of HIPAA Authorization".
    • HRP-330 WORKSHEET - HIPAA Authorization [RAMP IRB link] and HRP-441 CHECKLIST - HIPAA Waiver of Authorization [RAMP IRB link] (DO NOT PROVIDE the worksheet or checklist with your RAMP IRB study submission; these are provided for reference only). These materials are used only by OHSP and the IRB to document and determine whether to approve of an Application for Waiver or Alteration of Authorization for Use and Disclosure of PHI).
  • Use of Protected Health Information On Decedents [external link]
    • For use or disclosure of PHI when use or disclosure is only for research involving persons who are deceased.
    • Provide for FSU IRB review and with your RAMP IRB study submission a copy of this form. In RAMP IRB, the copy should be uploaded in the Local Site Documents section of the study workspace, under Other Attachments, using the category "Other".
  • Certification for Use of Protected Health Information Preparatory To Research [external link]
    • For use or disclosure of PHI when use or disclosure is solely for the review of PHI to prepare (as opposed to actually conduct) a research protocol; no PHI may be removed from the Covered Entity by the researcher in the course of the researcher's review.
    • Provide for FSU IRB review and with your RAMP IRB study submission a copy of this Certification. In RAMP IRB, the copy should be uploaded in the Local Site Documents section of the study workspace, under Other Attachments, using the category "Other".
  • HIPAA Data Use Agreement (DUA) [RAMP IRB, availability under the IRB, Library and Templates tabs]
    • A FSU IRB application involving use or disclosure for research purposes of a Limited Data Set (LDS) that is comprised of FSU Protected Health Information (PHI) will only be approved upon the execution (signed by all parties) of a DUA; a FSU IRB application involving use or disclosure for research purposes of a LDS comprised of non-FSU PHI may require an executed DUA signed by the non-FSU Covered Entity.
    • A DUA must be routed for Research legal review and approval using the RAMP Agreements module. Refer to the RAMP Agreements Quick Reference [link] for researchers for instructions and information. For assistance completing the RAMP Agreements SmartForm or for technical assistance with RAMP Agreements, email ramp-agreements@fsu.edu. The OHSP or IRB does not manage the RAMP Agreements module. 
    • The executed DUA should be provided for FSU IRB review and with your RAMP IRB study submission or upon request and as directed
  • Revocation of HIPAA Authorization [external link]
    • Provide this form for completion to any individual or their personal representative who indicates that they want to revoke their authorization for use or disclosure of their PHI for research purposes; a revocation request must be honored by the researcher (i.e., use or disclosure of the individual's PHI must cease) and a copy of the revocation retained in study records.

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