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HIPAA PROVISIONS FOR IRB APPLICATION

If your project includes Protected Health Information (PHI), then address the following issues in your IRB application, in addition to all other sections:

HIPAA Plan:

  • Indicate whether the project will involve protected health information (PHI)
  • Describe the procedures that will be used to comply with the HIPAA Policy. 
    • Following are examples of information and forms that will need to be included in the plan.
      • Procedures to be used regarding the Notice of Privacy Practices
      • Authorization for Use and/or Disclosure of PHI
        • Procedures to be used in requesting Authorization for Use and Disclosure of PHI from Individuals, or
        • Procedures to be used in requesting a waiver of Authorization from the IRB; or
        • Statement that only “de-identified” individual health information will be used.
    • Request for access to PHI from a Health Care Component within Missouri State
    • Request for access to PHI from a Covered Entity outside of Missouri State
      • Application to Covered Entity for Access to PHI
      • Approval by Covered Entity enabling access to PHI
    • Plan for using other HIPAA procedures and forms, as applicable.

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