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WAIVER OF AUTHORIZATION
ABOUT WAIVER OF AUTHORIZATION
Since the privacy provisions of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) became
effective on April 14, 2003, researchers now need to
take precautions to protect the privacy of individually
identifiable health information, or "protected
health information" ("PHI"). Under the
HIPAA Privacy Rule, some research that was exempt from
informed consent and/or IRB review now requires authorization
for release of PHI or a Waiver of Authorization issued
by an IRB or Privacy Board.
A Covered Entity may use or disclose protected health
information for research, regardless of the source of
funding of the research, provided that:
The CE obtains documentation that an alteration to,
or Waiver of Authorization, as required by §164.508
for use or disclosure of protected health information,
has been approved by either an Institutional Review
Board (IRB), or a Privacy Board that:
- Has members with varying backgrounds and appropriate
professional competency as necessary to review the
effect of the research protocol on the individual's
privacy rights and related interests;
- Includes at least one member who is not affiliated
with the CE, not affiliated with any entity conducting
or sponsoring the research, and not related to any
person who is affiliated with any of such entities;
and
- Does not have any member participating in a review
of any project in which the member has a conflict
of interest.
SUBMITTING A REQUEST FOR
WAIVER OF AUTHORIZATION:
To submit a request for Waiver of Authorization:
1. Provide a protocol or plan for gathering and analyzing
the data. Make sure your study plan includes all these
elements:
- The objective of the research project and background
of study.
- The rationale for the use of the selected subject
population.
- The procedures that will be performed to generate
research data.
- Each element of the data set that will be used in
the research and the rationale for its inclusion in
the data set.
- The anticipated beginning and end dates of the project
(or approximate length of data gathering activities).
- Number of records involved in the project.
Don't leave anything out - it will only delay the
review of your request. If you cannot provide an element
requested on the form, provide an explanation for its
omission.
2. Provide a copy of your data recording tool.
3. The fee for review of your request for Waiver of
Authorization must be included with your submission
material. (For fee schedule, call or e-mail Jim
Saunders. Contact information below).
REVIEW PROCESS:
Your submission will be reviewed for completeness
and, if complete, will be reviewed for Waiver of Authorization
as follows:
Full Board Review:
Complete submissions received by the end of the day
Friday will be reviewed on the following Thursday.
Expedited Review:
If the project qualifies for Expedited Review, as determined
by The Privacy Board staff, review will be completed
within 2 business days.
CRITERIA FOR APPROVAL TO WAIVE
AUTHORIZATION:
A. The use or disclosure of protected health information
involves no more than minimal risk to the individuals;
B. The alteration or waiver will not adversely affect
the privacy rights and the welfare of the individuals;
C. The research could not practicably be conducted without
the alteration or waiver;
D. The research could not practicably be conducted without
access to, and use of, the protected health information;
E. There is an adequate plan to protect the identifiers
from improper use and disclosure;
F. There is an adequate 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; and
G. There are adequate written assurances 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 project, or
for other research for which the use or disclosure of
protected health information would be permitted by regulation);
H. The information to be used/disclosed for the purposes
of the research is the minimum necessary to accomplish
the intended purpose of the use, disclosure, or request.
FEE SCHEDULE
Call or e-mail Jim
Saunders for the fee schedule.
Phone: 781-431-7577
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