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

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But there are two subsidiary issues which we
are not fully addressing now but which are essential.
(Slide.)
The first is how well are IRB's actually
following the rules that are set forth. The second is how
well are subjects being protected. Now those are not the
same thing obviously. The IRB's can be doing a great job
of following the rules and subjects could still not be well
protected if the rules were not effective in protecting
them. We recognize both of these as topics we want to
address but we have not yet fully developed a plan of how
we are going to go about that.
(Slide.)
In looking at the federal agency report so far
we have seen certain problems. First, there has been an
uneven execution of the responsibility to protect subjects
among agencies. Second, there is a variation in the amount
of attention that agencies give. Third, there has been
wide variation in the application of the rules. Indeed, in
even understanding questions like what is research, what is
exempt. Some of the agencies have looked at things that
seemed to us to be research and said, "No, they are not
research. We do not have to have IRB's review them."
(Slide.)