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Use
of Archived or Banked Tissue
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Basic
Exempt Criteria §46.101b(4)
Research includes
studies of biological specimens that have been banked for research
purposes. Although health information about the individuals who
provided these specimens can be linked to them, researchers cannot
have direct access to their names, or other information that would
allow them to be identified. An
Honest Broker can
be used, however. |
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Specimens
may include tissue, blood, or bodily fluid
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Specimens
were obtained independent of this research project
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Specimens
are archived in a recognized tissue bank
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All specimens and corresponding data are 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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All
specimens are currently in existence
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Additional
Requirements or Considerations
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Tissue
bank or repository must be identified by name, and the IRB number
or a copy of the consent form completed by subjects must be included
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If
specimens were collected as part of another research project,
a copy of the initial consent form must be attached to ensure
that subjects participating in the initial project did not restrict
the use of their sample to that initial project or to certain
types of analyses
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If specimens
are still being collected, the investigators of the proposed
exempt study cannot personally participate in the collection of
those specimens. This issue needs to be addressed explicitly
in the protocol
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Request
for Exempt Review: Use of Archived
or Banked Tissue, Blood, or Bodily Fluid Specimens |
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