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This procedure describes the requirements for obtaining consent from human research subjects participating in research conducted under the auspices of UNC-Chapel Hill.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the creation of a Privacy Rule for identifiable health information. Except as otherwise permitted, the Privacy Rule requires that a human research subject “authorize” the use or disclosure of the human research subject's "protected health information" to be used in research.