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How to Conduct a Chart Review
Any individual conducting a retrospective review
of medical charts for publication that does not meet the
criteria detailed in the “Policy for Determination of
Institutional Review Board Review of Case Reports,” implies
research and therefore requires prospective IRB and R&D
Committee approval. The individual must follow
the following procedures:
(1) Write a protocol.
(a) Describe the research question;
(b) Describe what information will be extracted from
the medical record to answer that question;
(c) Describe the risks and benefits of the research
on the subject(s);
(d) Describe how confidentiality will be maintained;
and
(e) Include a code sheet, if applicable.
(2) Complete the following forms,
available from the Research & Development Website:
(a) Proposed Project Questionnaire (PPQ), which provides
background and tracking information to the Research
Service. The PPQ requests an abstract (500 words or
less) with the following headings
(i) Objectives
(ii) Plan
(iii) Methods
(b) Initial Review Questionnaire (IRQ), which allows
the IRB to focus on the details necessary to provide
a thorough review of the project.
(c) Waiver of Informed Consent/Authorization, which
the IRB uses to determine if all applicable regulations
are satisfied.
(3) Submit all of the items in (1) and (2) above to the
Research Service for review by the IRB and R&D Committee.
(4) Once final IRB and R&D Committee approvals are
received, the retrospective review of medical records
may begin.
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