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Slide Presentations
National Institutes of Health
Slide Presentation on the Privacy Rule and Research
Slide 28:
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Slide 28 |
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Required Documentation of a Waiver or Alteration of Authorization Includes:
- Identity of the approving IRB or Privacy Board.
- Date on which the waiver or alteration was approved.
- A statement that the IRB or Privacy Board has determined that all of the specified criteria for a waiver or an alteration were met.
- A brief description of the PHI for which use or access has been determined by the IRB or Privacy Board to be necessary in connection with the specific research activity.
- A statement that the waiver or alteration was reviewed and approved under either normal or expedited review procedures.
- The required signature of the IRB or Privacy Board chair or the
chair’s designee.
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