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

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examinations. The Food and Drug Administration by contrast
does go out and at least go through a paper trail at
institutions. The OPRR, NIH and the other agencies do not.
OPRR has a large case load and depends on
outside expertise to -- for most of the scientific
evaluation of the cases that are brought to its attention
and it has difficulty carrying out major investigations.
Dr. McCarthy talked not only about the backlog in
investigations but also the impediments that it has to act
like an investigatory office.
(Slide.)
To sum up then, the problems revealed by
history are first that the Department of HEW and the other
agencies or HHS now that sponsors science see research as
the primary mission and address human subjects protection
only when pushed, usually following a crisis of some sort.
Secondly, that no federal agency holds the
position of an authority to ensure the adequacy and
uniformity of human subjects protection. Indeed, no one
knows how much human subjects research is now ongoing with
federal sponsorship much less beyond federal sponsorship.
The Office for Protection from Research Risks
that NIH has the informal role of first among equals among
the offices and the different agencies, it has by far the