Slide Presentations

National Institutes of Health
Slide Presentation on the Privacy Rule and Research

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Slide 12:

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Authorizations for Research Must be for a specific research study - Authorization for future, unspecified research is NOT permitted but Authorization may be obtained to permit the use or disclosure of PHI to create or maintain a repository or database. Different from, but may be combined with, informed consent. Review/approval by IRB/Privacy Board NOT needed under Privacy Rule. (But other regulations would require IRB review when combined with informed consent documents.) Must contain “core elements” & “required statements,” and a signed copy must be given to the individual. Research Authorizations need not expire, but this must be stated.