Will the Privacy Rule affect informed consent documents for clinical research involving intervention or interaction with subjects (clinical trials, survey studies)?

Yes. The Privacy Rule specifies additional elements that must be included in getting permission from a subject to participate in clinical research. Current regulations already require that a consent document address how confidentiality will be protected.

The Privacy Rule imposes more specific requirements for authorization to use identifiable health information. In addition to informed consent, investigators must now obtain specific written authorization for use and disclosure of a subject's protected information. Authorization language is required if investigators plan to access existing health information as part of the research and/or for any use or disclosure of health information that is generated during the course of the research.

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