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National Institutes of Health HIPAA Privacy Rule - Information for Researchers
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Slide 32:
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Option 6: “Grandfathered” Research Permissions

  • Grandfathered-in under the Transition Provisions if, BEFORE April 14, 2003, covered entity obtains:
    • Participant’s informed consent,
    • Waiver by an IRB of informed consent (unless informed consent sought after compliance date), or
    • Authorization or other express legal permission to use or disclose PHI for research.
    • Grandfathering ends when any change made after compliance date makes prior permission invalid.

Department of Health and Human Services National Institutes of Health USAGov The HIPAA Privacy Rule