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

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going to be confusing about why the matrix makes any sense.
DR. EMANUEL: Hold on. That I do not think is
fair to the history of what happened, David. I mean, that
suggests that somehow this is Zeke Emanuel foisting this
and the rest are signing on.
This was a long debate of us trying to reason
through what the protections are and those three, I should
say, are not the three we have today. Let's be clear. We
have two today. Community consultation exists no where in
the Common Rule. We have individual consent and we have
IRB review. We actually added permutations on those in
terms of IRB administrative review, possibly a general
consent as opposed to a specific consent, so we have been
trying -- I think we have been trying to be innovative in
the kind of requirements we are suggesting.
I think this has been a long process of
deliberation, you know, and one of the problems of the
subcommittee framework is the months of trying to think
through and argue through by using examples, you know, the
Physicians Health Study or the Angiogenesis Factor of
Breast Cancer Women, or some of the other studies, the kind
of reasoning that we have collectively come to is hard to,
you know, recapture in a short succinct manner.
I mean, it may be, you know, if we want to