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Existing
Data, Documents, or Records
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|
Basic
Exempt Criteria §46.101b(4)
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| Research
is most commonly conducted on data derived from patients' medical
records, but other research or clinical records may also be accessed
under this exemption. Although investigators can review those records
(if they have a legitimate right to access those records), they
cannot record any private identifiable information from these records.
An Honest Broker
can be used, however. |
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All
data are currently in existence
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|
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All information
is publically available, OR
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All
information is recorded anonymously, OR
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|
Data are
recorded in such a way that researchers cannot identify subjects.
Two acceptable strategies for this de-identification exist:
- Identifiable
data are de-identified by an appropriate software program OR
- The de-identification
of data is carried out by a person who is independent of the
research (i.e., an independent "honest
broker") and who has been identified by name in the protocol,
and has completed the "honest broker" certification form. Information
linking the assigned code numbers to the subjects’ identity
(if applicable) is maintained solely by the independent “honest
broker”
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Additional
Requirements or Considerations
|
|
x
|
A
copy of the data extraction form or a list of variables to-be-studied
must be submitted with the IRB application |
|
x
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Investigator’s
right to access records (including medical records) must be documented
in protocol |
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Request for
Exempt Review: Existing Data, Documents,
or Record
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|
