Entire Transcript in Adobe Acrobat Format - National Reference ...
Entire Transcript in Adobe Acrobat Format - National Reference ... Entire Transcript in Adobe Acrobat Format - National Reference ...
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
- Page 221 and 222: 218 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 223 and 224: 220 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 225 and 226: 222 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 227 and 228: 224 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 229 and 230: 226 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 231 and 232: 228 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 233 and 234: 230 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 235 and 236: 232 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 237 and 238: 234 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 239 and 240: 236 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 241 and 242: 238 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 243 and 244: 240 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 245 and 246: 242 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 247 and 248: 244 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 249 and 250: 246 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 251 and 252: 248 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 253 and 254: 250 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 255 and 256: 252 1 creativity. 2 3 4 5 6 7 8 9 1
- Page 257 and 258: 254 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 259 and 260: 256 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 261 and 262: 258 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 263 and 264: 260 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 265 and 266: 262 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 267 and 268: 264 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 269 and 270: 266 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 271: 268 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 275 and 276: 272 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 277 and 278: 274 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 279 and 280: 276 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 281 and 282: 278 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 283 and 284: 1 280
- Page 285 and 286: 282 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 287 and 288: 284 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 289 and 290: 286 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 291 and 292: 288 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 293 and 294: 290 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 295 and 296: 292 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 297 and 298: 294 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 299 and 300: 296 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 301 and 302: 298 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 303 and 304: 300 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 305 and 306: 302 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 307 and 308: 304 1 on. 2 3 4 5 6 7 8 9 I think D
- Page 309 and 310: 306 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 311 and 312: 308 1 2 3 4 5 6 7 8 9 10 11 12 (App
269<br />
1<br />
2<br />
3<br />
4<br />
5<br />
6<br />
7<br />
8<br />
9<br />
10<br />
11<br />
12<br />
13<br />
14<br />
15<br />
16<br />
17<br />
18<br />
19<br />
20<br />
21<br />
22<br />
23<br />
24<br />
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