Human Investigation Committee
2013
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Is it research?
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If yes, does it involve human subjects?
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If yes, can it be exempt?
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If no, will a Request for Approval of Medical
Record Review be the appropriate form to
submit?
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Research: ‘a clinical investigation or a
systematic investigation, including research
and development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge’.
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Quality Improvement activities
Activities preparatory to research e.g.
reviewing records to determine whether there
is a sufficient pool of subjects
Case studies
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Human subject: A living individual (1) about
whom an investigator (whether professional
or student) conducting research obtains
either (a) data through intervention or
interaction with the individual; or (b)
identifiable private information; or (2) who is
or becomes a participant in research
involving drugs or devices, either as a
recipient of a test article or as a control.
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Research on decedents
Note: A Waiver of HIPAA Authorization may still
be needed (contact the HIPAA Privacy Officer)

A search of medical records involves looking
at identifiable data
◦ Medical records contain highly personal information
◦ Protections for confidentiality are important
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For the researcher, the exemption means that
the project has to be initially reviewed by the
IRB but it does not need subsequent annual
reviews (but any changes to the project do!)
Certain types of research projects can be
eligible for a determination of exempt status
by the IRB:
1) presenting minimal risk
2) meeting one of the federal categories

45 CFR 46.101(b)(4)Research involving the
collection or study of existing data,
documents, records, pathological specimens,
or diagnostic specimens, if these sources are
publicly available or if the information is
recorded by the investigator in such a manner
that subjects cannot be identified, directly or
through identifiers linked to the subjects.
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All the data or the specimens have to be
existing at the time you request exemption
You can’t record identifiers
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A HIPAA waiver will be required if you don’t
have a direct healthcare relationship to the
potential subjects.
If this relates to an investigational drug or
device, the study cannot be exempt, per FDA
regulations.

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You are going to search a medical records
database for all subjects who had an allergic
response to an anesthetic used in the OR
from January 2011 through December 2011.
You are going to record only:
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Their gender
Their age
Their treatment
The type of surgery
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Retrospective = On the shelf
Prospective = medical records have not been
created at the time of approval of the request
Note:
Only retrospective chart review can be exempt
Prospective medical records may require a consent
from subjects
◦ Consent from Subjects/HIPAA Authorization will
be needed unless:
 The research poses no greater than minimal risk
to subjects AND
 The waiver does not adversely affect subjects’
rights and welfare AND
 It is impracticable to obtain the subjects consent
and authorization for use or disclosure of the PHI
without the waiver.

The Request for Approval of Medical Record Review
form (100 FR 7) should be used for non-exempt
research projects involving medical record reviews
only, and where there are NO plans to:
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contact subjects for follow-up,
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create a data archive for future research.
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http://www.yale.edu/hrpp/formstemplates/biomedical.html
http://www.yale.edu/hrpp/resources/docs/1
00FR7MRR_application8-24-12.doc
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Check our website:
http://www.yale.edu/hrpp/index.html
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Call the HRPP main number: 785-4688
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Or email us at hrpp@yale.edu
Thank you!