Entire Transcript in Adobe Acrobat Format - National Reference ...

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then looking at a new -- not actually genetic test but a
new kind of test to make predictions about who would have
recurrence or who would die from their disease.
They took 104 samples completely anonymous -- I
mean, to the researcher anonymous but obviously to the
pathologist who drew them out and wanted to correlate
clinical information with the tissue sample. So that is a
paradogmatic case, I would think, of that box. There was
no interest in identifying ethnic groups or racial groups
or other groups.
Okay. So the question is these women did not
consent to this research when they came in for their
biopsy. They may have signed a general consent that their
samples because it is a teaching hospital would be used for
education and research purposes. So what kind of risk do
they face and what kind of protections do we want to put
into place was the question.
In the boxes you can see the recommendations
that we are suggesting, that the IRB -- I mean, it should
be said that under current proposal, under current Common
Rule guidelines no IRB review for this necessary and no
consent necessary. At least that is our interpretation of
the guidelines.
MR. CAPRON: Could you explain one aspect of