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

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not only all the agencies within the Department of Health
and Human Services but all other federal departments and
agencies. It would, therefore, have government-wide
authority even though it was lodged in the Office of the
Secretary of HHS.
(Slide.)
And that the Director of the Office of Research
Ethics would submit his or her own statement of personnel
and budget needs to Congress independent of the HHS
submission.
(Slide.)
John Fletcher recommends the creation of a
National Office of Human Subjects Research advised by a
national advisory committee on human subjects research made
up of 11 to 13 people from outside government. This is in
line with the recommendation made by Jay Katz a number of
years ago actually when this commission was being empaneled
when he said, "You do not need the National Bioethics
Advisory Commission, what we need now is a group that would
actually have continuing oversight of the administration of
these rules."
(Slide.)
Fletcher also said that the National Office of
Human Subjects Research would have government-wide