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

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clinical benefit. My God, that was a misdiagnosis and we
ought to tell the person now that our lab has run a
different study that they were misdiagnosed and that
something went wrong. You suggested that you had worked
out a statement of when the barrier could be breached back.
You did not work it out. I thought you said you had some
criteria.
DR. BARR: We compromised with the IRB's who
felt that -- we compromised with the IRB community in
working on these documents in saying that there needed to
be room for IRB's to make decisions about when there could
be a breach.
MR. CAPRON: Okay.
MS. BARR: Our committee felt very strongly
that that would -- that was not appropriate, that you just
do not go back because it is research, it is not clinical
practice.
MR. CAPRON: I mean I have a sense that your
earlier intuition, which is IRB's need a lot of very firm
guidance on this, is right and whenever we say, "Gee, there
is too much disagreement, we cannot figure it out, we are
going to leave it to the IRB --"
MS. BARR: You are in trouble.
MR. CAPRON: -- that we are in trouble and the