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HIPAA
The HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule imposes requirements on certain investigators and research organizations who qualify as "covered entities" to obtain permission before using or disclosing individually identifiable health information (Protected Health Information, or PHI). Before an investigator who is also a covered entity can use PHI in the course of research, including certain recruitment activities and retrospective chart reviews, the investigator must obtain the participant’s written permission to use and disclose the participant’s PHI.
HIPAA Authorizations
The HIPAA Privacy Rule expressly allows for a HIPAA authorization to be combined with any other type of written permission for the same research study, including an informed consent form. The Quorum Board will review HIPAA authorization language that is included within a consent form, but Quorum will not review standalone HIPAA authorizations.
HIPAA Waivers
In lieu of obtaining valid HIPAA authorizations from each research participant,
the HIPAA Privacy Rule allows an investigator to apply to a "Privacy Board" or
to an institutional review board for a waiver or partial waiver of the HIPAA authorization
requirement. In order for the Quorum Board to approve a HIPAA waiver request, the
investigator must submit adequate information to allow the Board to determine
that:
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The use and/or disclosure of the PHI sought will involve no more than a minimal
risk to the privacy of individuals;
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The plan to protect individuals' identifiers from improper use and disclosure
is adequate;
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The plan to destroy the identifiers at the earliest opportunity consistent with
conduct of the research is adequate, or the health or research justification
for retaining the identifiers is adequate, or retention of the identifiers is
required by law;
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The written assurances are adequate 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 study or for other research for which the
use or disclosure of PHI would be permitted by state and federal laws,
including the HIPAA Privacy Rule;
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The research could not practicably be conducted without the waiver; and
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The research could not practicably be conducted without access to and use of
the PHI.
Quorum is available to review applications from investigators who seek
such HIPAA waivers and partial waivers. Please submit a
Request for Complete Waiver of Authorization when a covered
investigator or research organization seeks permission to access PHI for
research or to develop a recruitment database.
If a covered investigator or research organization desires to access PHI for
the sole purpose of recruiting individuals to participate in a particular
clinical investigation, please submit a
Request for Partial Waiver of Authorization for Research Recruitment Purposes.
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