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

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When asked, they refused to provide material
support for the process of developing the Common Rule,
which eventually ended up in the Office of Science and
Technology Policy, and it has been slow to comply with OPRR
findings and the terms of its own multiple project
assurance.
(Slide.)
So looking at the recommendations we got from
our two principal experts, first McCarthy recommended the
creation of an Office of Research Ethics within the Office
of the Secretary of Health and Human Services to have three
divisions. One concerned with human subjects protection,
which is our focus. And then another with animal,
laboratory animal, protection. And a final one of
Scientific Integrity, another issue which has engaged the
scientific community and the National Academy of Sciences
and so forth in recent years.
(Slide.)
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He also said that the Human Subjects Protection
Division should have at least two branches. The first an
education branch and the second a compliance branch. And
that the office should make an annual report to the
Congress which would include a report on the performance of