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Institutional
Review Board: Committee on the Use of Human Subjects
February 4, 2003
Dear Investigator:
RE: Request for IRB Approval for Chart Review
Retrospective chart review as a research methodology poses no more than
minimal risk to subjects. Nonetheless, there is the possibility of a
breach of confidentiality and as you are aware, privacy is a sensitive
as well as legal issue at the current time. HIPAA regulations also require
that we be protective of people's personal health information. In light
of these concerns, the IRB is now requiring the following for all retrospective
chart review studies:
1. A formal protocol with a statement of purpose, hypotheses
or study question. This should be submitted on the Expedited
Review Form.
2. On page 4 of the form, item #4, please include a detailed
description of measures taken to protect confidentiality of data. Specify
that data collection forms will be coded and not contain any personal
identification; that the masterlist which links the subject's identity
to the code will be maintained in a secure location; specify who has
access to the list; that the list will be destroyed at the completion
of the research.
3. Please attach a copy of the data collection tool you intend
to use (Item 7, page 5 of form). If you are collecting any information
which does not specifically address the study question, please add an
explanation as to why the information is being recorded.
4. When applicable, please include a request for waiver of consent
to participate in research and waiver of authorization to disclose and
use Protected Health Information (PHI). Include the following justification:
a. the research involves no more than minimal risk to subjects;
b. the waiver will not adversely affect the rights and welfare of the
subjects;
c. the research could not practicably be carried out without the waiver
(cite protocol-specific reason);
d. the research could not practicably be carried out without use of
the PHI;
e. written assurance that the PHI will not be reused or disclosed to
a third party, except as specified by the Privacy Rule.
5. Prior to submitting an application, the investigator (including
student researchers) should provide evidence of at least initial training
for protection of human subjects in research. This requirement may be
met by completing the computer-based program found
on our website.
Please call if we may assist you in any way. Thank you for your cooperation.
Sincerely,
Ina M. Friedman, MSN, NP-C, CIM
Chair
Committee on Use of Human Subjects
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