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National Institutes of Health HIPAA Privacy Rule - Information for Researchers
This website is currently in the process of being updated. For guidance on the HIPAA Privacy Rule in research, please see: https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html
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Slide Presentation on the Privacy Rule and Research

Slide 33:
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EXAMPLE: Transition Provisions

  • A study needs 1000 participants enrolled.
  • 600 enrolled by signing informed consent before April 14, 2003.
  • 400 will enroll after April 14, 2003.
  • How many participants need to give Authorization? 400
  • How many informed consents were transitioned (presuming the informed consent was not nullified by revisions)? 600

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