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What responsibilities do clinical researchers have under the HIPAA Privacy Rule?

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What responsibilities do clinical researchers have under the HIPAA Privacy Rule?

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The HIPAA Privacy Rule requires: • Providing mandated information to research subjects about their privacy rights and how PHI can be used. • Informing subjects about the right to access and amend their PHI. • Adopting clear and systematic privacy and database security procedures. • Designating an individual to be responsible for seeing that the privacy procedures are adopted and followed. • Securing records containing individually identifiable health information so that they are not readily available to those who do not need to see them.

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