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

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not really mean smaller as much as more sharply focused,
such as those concerned with IRB function. And I do not
think we want to see ourselves doing solely the latter,
should IRB's do a new structure for IRB's or new
regulations but we would like to see us doing both these
kinds of -- taking on these kinds of problems.
However, we do have immediate concerns that we
think should at relatively center stage. The first of
these is the Institutional Review Board problem. We
mention it again and again and again. It comes up. We are
dissatisfied. Every one of the problems which we heard in
the testimony on the decisionally impaired subjects also
had a failure of an IRB and a failure primarily because of
lack of education or structural concerns.
So it is very hard for us not to take -- should
this still be the way moral concerns in biomedicine are
handled and, if so, are there changes to be made so we
ought to take on that directly. Also, it seems to be
ideally -- subject ideally suited for the staff level we
have been talking about where the background research can
be done. We can set up studies that might have to be done
and then come in with something which would be a basis on
which to make decent decisions.
There is another question which is in the