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

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departments. The concern is with all federal agencies and
just looking at OPRR would wrongly focus us on NIH.
(Slide.)
Also, our present mode of operation, and all
the concerns that have been raised about the assurance
process and the adequacy of IRB's, need not figure as a
topic for us in this report. We have committed ourselves
to the notion that that is a topic that needs to be
studied. Were there to be such an office, either at the
secretarial level or as an independent agency, certainly it
would be appropriate for that office then to take on this
responsibility and maybe continue the present format and
maybe modify it.
But our satisfaction with or questions about,
or our dissatisfaction with the current method of
assurances, and the use of IRB's is not something we have
to determine and I think should not really be a subject of
debate while we are deciding do we need a government-wide
agency and/or any of these models the ones that we should
follow. I think that would be a distraction.
(Slide.)
Likewise, if we believe that the office should
have government-wide jurisdiction we might -- and yet we
are unable to see or unable to develop private enthusiasm