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.
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- Request for access to PHI from a Health Care Component within Missouri State
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- 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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