|
Retrospective
Medical Record Review
|
|
Basic
Exempt Criteria {§46.101b(4)
|
| Research
studies involving the retrospective review, collection and analysis
of medical record information are descriptive studies that ordinarily
seek to evaluate relationships between one or more biomedical, treatment,
and/or demographic variables and one or more outcome measures in
patients. Data may include a wide range of information from the
medical record (e.g., results of lab tests, nursing and physician
notes, summary reports - including intake and discharge summaries
and consultant reports, raw data from electrophysiological or imaging
tests, etc.). Because this research involves medical records, compliance
with the HIPAA Privacy Rule (46 CFR Part 160; Part 164 (subparts
A,E) ) is required.
The University
of Pittsburgh IRB recognizes three somewhat different pathways
for conducting these studies, depending on (a) whether the investigator
recording information has patient care responsibilities, and (b)
whether identifiable information will be recorded. Note that in
the latter case, investigators who wish to record identifiable
information must request a waiver
of informed consent/HIPAA authorization. This is NOT an exempt
application.
Click for
more detailed guidance
on retrospective medical record reviews at UPMC/Pitt, along
with our responses to Frequently
Asked Questions.
|
| A.
Recording of Medical Information, Without Identifiers, By or Under
the Oversight Of a Principal Investigator
Who Would Normally Have Access to this Information by Virtue of
His/Her Patient Care Responsibilities: |
|
An investigator
may personally review medical records and abstract relevant data
from the medical records if ALL of the following conditions are
met:
|
|
|
All
medical records to be accessed for study are currently in existence
at the time of the IRB submission. |
|
|
The
desired medical record data is recorded by the investigator in
such a way that the respective patients cannot be identified (i.e.,
by the investigator or others) either directly, or indirectly
via linkage codes assigned to the data. This means that the investigator
cannot link names, social security numbers, or any other patient
identifiers to the data set. As a consequence, the resulting research
data set is necessarily completely anonymous. For that reason,
once the information has been extracted from the medical record,
it will not be possible for the investigator to go back to the
medical record and add other patient-specific information to this
research dataset.
|
|
|
The principal
investigator (P.I.) of the research study has legitimate access
to the desired medical information insofar as he or she is a UPMC
staff member and/or has been granted UPMC privileges and provides
related care (i.e., related to the information desired) to the
patients, or is in the position to provide related care (including
treatment, and/or diagnostic services) to the patients.
For example,
any health professional providing patient care to a particular
set of patients (e.g., all patients treated in the Emergency Department;
all patients with aphasia; all patients undergoing CT scans),
would ordinarily have access to the related medical record information
of those patients as part of his or her current or future job
responsibilities, and hence would be in a position to serve as
the P.I. of a research study involving a retrospective review
of those medical records (regardless of whether he or she actually
provided direct care to those particular patients).
Note that
the University IRB will not approve a retrospective medical record
research study if the medical record information desired is not
in some way related to the patient care responsibilities of the
listed P.I.
|
|
This
application also requires a request for a waiver of HIPAA authorization;
such a request is incorporated into the exempt application form.
|
|
|
|
|
B. Recording
of Medical Information, Without Identifiers, By a
Principal Investigator Who Does not have Patient Care Responsibilities
|
|
If the P.I.
of the retrospective research study does not provide related care,
or is not in the position to provide related care, to the patients
whose medical records are being accessed, it is recommended that
the investigator utilize the services of a University IRB certified
honest broker system. The honest broker accesses the desired
medical record information on behalf of the P.I. and provides
the P.I. with an appropriately de-identified data set - either
a completely de-identified data set ("HIPAA Safe-Harbor")
or a data set that includes patient-specific dates and/or geographical
information ("Limited Data Set"). Use of an IRB-certified
honest broker system ensures compliance with both the Federal
Policy and HIPAA Privacy Rule regulations since no identifiable
medical record information is being obtained or used directly
by the investigators. Hence a waiver of the requirement for informed
consent and/or HIPAA authorization is not necessary. In addition,
there is no requirement that all of the desired medical record
information must be in existence at the time of IRB submission.
That is, the honest broker can assign a code number to the data
given to the investigator provided that the investigator does
not have access to the information linking this code number to
the identities of the respective patients. Using this code number,
the investigator can request, through the honest broker, additional
medical information corresponding to a given patient. From an
IRB perspective, this type of application (where all data are
not currently available for study) would meet criteria for 'no
human subjects' involvement (45 CFR 46.102.f).
|
|
|
Request
for Exempt Review: Medical
Record Review Using Certified Honest Broker
|
| * |
|
|
FAQ
Document |
|
|
Guidance
on Retrospective Medical Review Document
|
|
|
|
