Entire Transcript in Adobe Acrobat Format - National Reference ...
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273 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 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
274 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 authority and made analogies to the Nuclear Regulatory Commission and the Office of Governmental Ethics. And the Congress would appropriate funds directly for the NOHSR and the Senate would confirm the Director nominated by the President. The office would have authority to sanction violations of the regulations. (Slide.) And then going beyond the type of the office to oversee government sponsored research Fletcher recommended,in line with David's suggestion and something we are going to hear more about from Tina, I guess, is the extension of the oversight of the office to all human subjects at least as to the basic provision of IRB review and informed voluntary consent. (Slide.) Now we need to look at these recommendations and say what are their strengths and weaknesses. For the McCarthy recommendation the strengths seem to be that lodging this in the office of a major department of the government gives it protection because the Secretary is a powerful figure in the United States Government and the office, therefore, is not standing alone but has the protection of the Secretary. And it would also make
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274<br />
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10<br />
11<br />
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authority and made analogies to the Nuclear Regulatory<br />
Commission and the Office of Governmental Ethics. And the<br />
Congress would appropriate funds directly for the NOHSR and<br />
the Senate would confirm the Director nom<strong>in</strong>ated by the<br />
President.<br />
The office would have authority to sanction<br />
violations of the regulations.<br />
(Slide.)<br />
And then go<strong>in</strong>g beyond the type of the office to<br />
oversee government sponsored research Fletcher<br />
recommended,<strong>in</strong> l<strong>in</strong>e with David's suggestion and someth<strong>in</strong>g<br />
we are go<strong>in</strong>g to hear more about from T<strong>in</strong>a, I guess, is the<br />
extension of the oversight of the office to all human<br />
subjects at least as to the basic provision of IRB review<br />
and <strong>in</strong>formed voluntary consent.<br />
(Slide.)<br />
Now we need to look at these recommendations<br />
and say what are their strengths and weaknesses. For the<br />
McCarthy recommendation the strengths seem to be that<br />
lodg<strong>in</strong>g this <strong>in</strong> the office of a major department of the<br />
government gives it protection because the Secretary is a<br />
powerful figure <strong>in</strong> the United States Government and the<br />
office, therefore, is not stand<strong>in</strong>g alone but has the<br />
protection of the Secretary. And it would also make