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275 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 absolutely clear that sitting at the head of HHS that office has authority over all divisions of the Public Health Service, which ORR struggles to exercise today. The weakness is that it does not fully remove the conflict of interest because it leaves the office within a department which is the major sponsor of research by the government and it compromises the independence of that person because being a part of the Office of the Secretary, whatever independence one may have, is somewhat dependent on the forbearance of the Secretary who may not be happy with everything the office is suggesting. It creates the problem of a department having an office which then has oversight over sister departments and agencies. (Slide.) Looking at the Fletcher recommendations, the strength is that clearly this office would be independent of the research sponsors and it would benefit from an outside board which would bring not only expertise but visibility to the subject. It would not be just a group of government employees. They would be responding to and seek the advice of outsiders who would have the ability to raise the issue publicly under the Federal Advisory Committees Act.
276 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 The weaknesses are that, you know, we clearly need White House and/or -- probably and as well as or -- real sponsorship. If the White House is not interested in protecting this office and if a committee of Congress or certain members of the committee do not regard it as an important function that they want to protect and ensure its independence, a small office like this will not have independence. The press alone cannot ensure the independence of an office like this. Furthermore, absent some current human subjects scandal it may be difficult to create a new agency in our present smaller government era. (Slide.) Having said this I also want to suggest for our discussion that there is certain things we can focus on and other things that we can exclude. The central objective I hope we could agree on would be to create a body with authority and ability to get the job done. Although OPRR is the major human subjects protection body today, its performance need not be the focus of any report. Indeed, I would suggest it would be inappropriate to focus in on OPRR. The concern is with structural problems, some of which affect OPRR's operations, some effect its location, and likewise the location of comparable offices in either
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276<br />
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The weaknesses are that, you know, we clearly<br />
need White House and/or -- probably and as well as or --<br />
real sponsorship. If the White House is not <strong>in</strong>terested <strong>in</strong><br />
protect<strong>in</strong>g this office and if a committee of Congress or<br />
certa<strong>in</strong> members of the committee do not regard it as an<br />
important function that they want to protect and ensure its<br />
<strong>in</strong>dependence, a small office like this will not have<br />
<strong>in</strong>dependence. The press alone cannot ensure the<br />
<strong>in</strong>dependence of an office like this.<br />
Furthermore, absent some current human subjects<br />
scandal it may be difficult to create a new agency <strong>in</strong> our<br />
present smaller government era.<br />
(Slide.)<br />
Hav<strong>in</strong>g said this I also want to suggest for our<br />
discussion that there is certa<strong>in</strong> th<strong>in</strong>gs we can focus on and<br />
other th<strong>in</strong>gs that we can exclude. The central objective I<br />
hope we could agree on would be to create a body with<br />
authority and ability to get the job done. Although OPRR<br />
is the major human subjects protection body today, its<br />
performance need not be the focus of any report. Indeed, I<br />
would suggest it would be <strong>in</strong>appropriate to focus <strong>in</strong> on<br />
OPRR. The concern is with structural problems, some of<br />
which affect OPRR's operations, some effect its location,<br />
and likewise the location of comparable offices <strong>in</strong> either