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269 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 a common rule in application. (Slide.) The Office for Protection from Research Risk sometimes found itself subject to direct interference within NIH. In 1992 or thereabouts there was an attempt by the Director to intervene and be involved in some fashion with the Gallo investigation that was then going on for research that had gone on, on the AIDS virus in Africa involving also a French collaborator. This was declined by Dr. McCarthy but there was that kind of pressure that existed. Moreover, the NIH Intramural Program dragged its feet in cooperating with OPRR on a number of occasions until it was threatened with a disclosure of its failure to have complied with its own federal policy and the threat included the notion that revelation would be made that a subject had died in a sleep study at NIMH. The death was apparently actually not connected to the researchers it later turned out but that threat was sufficient to get NIH to sign on to its assurance. (Slide.) OPRR is, however, by the description of Dr. McCarthy and Dr. Fletcher dependent on whistleblowers and the press because it does not really have any institutional

270 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 examinations. The Food and Drug Administration by contrast does go out and at least go through a paper trail at institutions. The OPRR, NIH and the other agencies do not. OPRR has a large case load and depends on outside expertise to -- for most of the scientific evaluation of the cases that are brought to its attention and it has difficulty carrying out major investigations. Dr. McCarthy talked not only about the backlog in investigations but also the impediments that it has to act like an investigatory office. (Slide.) To sum up then, the problems revealed by history are first that the Department of HEW and the other agencies or HHS now that sponsors science see research as the primary mission and address human subjects protection only when pushed, usually following a crisis of some sort. Secondly, that no federal agency holds the position of an authority to ensure the adequacy and uniformity of human subjects protection. Indeed, no one knows how much human subjects research is now ongoing with federal sponsorship much less beyond federal sponsorship. The Office for Protection from Research Risks that NIH has the informal role of first among equals among the offices and the different agencies, it has by far the

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a common rule <strong>in</strong> application.<br />

(Slide.)<br />

The Office for Protection from Research Risk<br />

sometimes found itself subject to direct <strong>in</strong>terference<br />

with<strong>in</strong> NIH. In 1992 or thereabouts there was an attempt by<br />

the Director to <strong>in</strong>tervene and be <strong>in</strong>volved <strong>in</strong> some fashion<br />

with the Gallo <strong>in</strong>vestigation that was then go<strong>in</strong>g on for<br />

research that had gone on, on the AIDS virus <strong>in</strong> Africa<br />

<strong>in</strong>volv<strong>in</strong>g also a French collaborator. This was decl<strong>in</strong>ed by<br />

Dr. McCarthy but there was that k<strong>in</strong>d of pressure that<br />

existed.<br />

Moreover, the NIH Intramural Program dragged<br />

its feet <strong>in</strong> cooperat<strong>in</strong>g with OPRR on a number of occasions<br />

until it was threatened with a disclosure of its failure to<br />

have complied with its own federal policy and the threat<br />

<strong>in</strong>cluded the notion that revelation would be made that a<br />

subject had died <strong>in</strong> a sleep study at NIMH. The death was<br />

apparently actually not connected to the researchers it<br />

later turned out but that threat was sufficient to get NIH<br />

to sign on to its assurance.<br />

(Slide.)<br />

OPRR is, however, by the description of Dr.<br />

McCarthy and Dr. Fletcher dependent on whistleblowers and<br />

the press because it does not really have any <strong>in</strong>stitutional

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