Fillable HIPAA Waiver Form-REVISED ReaderExtended

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HIPAA Waiver Form-REVISED ReaderExtended

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Tennessee Tech University
Institutional Review Board for the Protection of Human Subjects
Request for
FULL WAIVER of Authorization Requirements
for Protected Health Information
under the HIPAA Privacy Rule
Date of Request:
Name of Principal Investigator:
Name or Title of Project:
This project has been submitted to the TTU IRB for review at the following level (check one):
______ Expedited Review ______ Full Board Review
List and describe the specific PHI for which use or access is needed to carry out the proposed
research (Be specific; attach additional page, if needed):
Briefly explain the necessity, in terms of your research, for access or use of the specific elements of
PHI that you listed above (use additional page if needed):
I confirm that the responses on this request are accurate and complete
__________________________________________________ _________________________
Signature of Principal Investigator Date
Tennessee Tech University
Institutional Review Board for the Protection of Human Subjects
Approval of
FULL WAIVER of Authorization Requirements
for Protected Health Information
under the HIPAA Privacy Rule
The Tennessee Tech Institutional Review Board for the Protection of Human Subjects (IRB) confirms
that the research project referenced in the Request for Full Waiver has been submitted for required
IRB review at the Expedited or Full-Board level.
The IRB confirms that the following requirements for a Full Waiver of Authorization have been met
and documented by the principal investigator:
• The PHI use or disclosure in this project involves no more than minimal risk to the privacy of
individuals whose PHI will be accessed, used, or disclosed.
• The principal investigator has presented to the IRB an adequate plan to protect PHI identifiers
from improper use and disclosure;
• The principal investigator has presented to the IRB an adequate plan to destroy those PHI
identifiers at the earliest opportunity;
• The principal investigator has assured the IRB in writing that the PHI will not be reused or
disclosed to any other person or entity except (a) as required by law, (b) for authorized
oversight of the research study, or (c) for other research for which the use or disclosure of the
PHI is permitted by the Privacy Rule.
• The principal investigator asserts that the research could not practicably be conducted (a)
without the requested waiver, and (b) without access to and use of the PHI.
The covered entity (institution, agency, provider, insurer) is required by law to retain this
documentation of IRB approval of the waiver for at least 6 years from the date the waiver was
obtained, or from the date when it was last in effect, whichever is later.
The IRB for the Protection of Human Subjects hereby APPROVES this Request for Full Waiver of
Authorization for the project referenced above, and under the terms described in this document. The
Request for Full Waiver is considered part of this approval document by reference.
__________________________________________________ _________________________
Signature, Chair, Tennessee Tech IRB Date of Approval
Printed Name: _______________________________________
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HIPAA Waiver Form-REVISED ReaderExtended

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Completed 14 March 2020

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