Waivers and alterations of authorization requirement

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Question:
Waivers and alterations of authorization requirement

Answer:

•Use or disclosure of the PHI involves no more than minimal risk to the privacy of the research subjects, based on the following elements:
oAn adequate plan to protect any data identifiers from improper use and disclosure.
oAn adequate plan to destroy data identifiers at the earliest opportunity consistent with conduct of the research (unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law).
oAdequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted by HIPAA.
oThe research could not practicably be conducted without the PHI.
oThe research could not practicably be conducted without the waiver.

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