09/25/2007
Winthrop University
Institutional Review Board
Request for a Waiver of Written HIPAA Authorization
Instructions: To request a waiver of HIPAA authorization requirements, complete this form and attach it to both the electronic and
paper copy of the Request for Review of Research Involving Human Subjects. PHI is an acronym for Protected Health Information
and is used throughout this document.
Principal Researcher: Name & Title:
Name(s) & Title(s) of other members of the Research Team:
Title of Research Study:
Name and Address of the Health Care Provider:
Health Care Provider Contact:
1.
Protected Health Information (PHI): List in detail, the PHI that is to be collected for the research activity
and explain why this health information is the minimum necessary to meet the research objectives:
2.
Identify the source of the PHI (e.g. medical record etc).
3.
Waiver of HIPAA Authorization; Indicate below the reason for the waiver request:
Seeking IRB approval of authorization waiver – Complete Item 4 below (45CFR164.512(i)(1)(i))
The collection of the PHI is solely to prepare a research protocol and the researcher will not remove
any PHI from the Health Care Provider’s premises and the PHI is necessary for the research purpose.
(45CFR164.512(i)(1)(ii))
The use or disclosure being sought is solely for research on the PHI of decedents and the PHI is
necessary for the research purpose. (45CFR164.512(i)(1)(iii))
The researcher has entered into a Data Use Agreement with the Health Care Provider. Attach a copy
of this agreement to the Request for Review of Research Involving Human Subjects.
(45CFR164.514(e))
4
Minimal Risk – respond to the following three elements:
a.
Describe the plan to protect the identifiers from improper use and disclosure:
09/25/2007
b.
Describe the plan to destroy the 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:
c.
Other that the Researcher or Research Team identified above, describe any other individuals or
entities that will have access to, use of or other disclosure of PHI:
I certify that the Protected Health Information 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.
______________________________ _________
_________________________________ ___________
Signature of Researcher
Signature of Faculty Advisor for Student Researcher
Date
Approval of Waiver Request by IRB
_____________________________ __________
Aaron Hartel, Ph.D., Chair
Institutional Review Board
Date
Date