Entire Transcript in Adobe Acrobat Format - National Reference ...
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277 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 departments. The concern is with all federal agencies and just looking at OPRR would wrongly focus us on NIH. (Slide.) Also, our present mode of operation, and all the concerns that have been raised about the assurance process and the adequacy of IRB's, need not figure as a topic for us in this report. We have committed ourselves to the notion that that is a topic that needs to be studied. Were there to be such an office, either at the secretarial level or as an independent agency, certainly it would be appropriate for that office then to take on this responsibility and maybe continue the present format and maybe modify it. But our satisfaction with or questions about, or our dissatisfaction with the current method of assurances, and the use of IRB's is not something we have to determine and I think should not really be a subject of debate while we are deciding do we need a government-wide agency and/or any of these models the ones that we should follow. I think that would be a distraction. (Slide.) Likewise, if we believe that the office should have government-wide jurisdiction we might -- and yet we are unable to see or unable to develop private enthusiasm
278 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 for bringing their research under such an office we might say, "Let's see if it works on the government-wide basis and then as a later issue that office could go to the Congress, assuming that Glenn bill does not already pass, and say there really are issues with privately funded research and the best way to ensure that is conducted in an appropriate way is to bring it under this office. Finally, one point I did not put up here but I think is obvious, when one talks about this office I think it is best not to use the elocution that we used occasionally at first, which was "elevating OPRR to." Both for the reason I do not think we should solely focus on OPRR but it is very likely that just as the departments have their own ethics offices now to deal with the conflict of interest and so forth administratively within their office or agency, and yet there is a government-wide office of governmental ethics it is very likely that we need a governmental-wide policy setting, rule interpreting and maybe investigating body, and an agency by agency ability to work with their own grantees and their own researchers to get how the rules apply and the process of giving the grants and so forth. All that remains. It very well may mean that only a small part of
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278<br />
1<br />
2<br />
3<br />
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5<br />
6<br />
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8<br />
9<br />
10<br />
11<br />
12<br />
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for br<strong>in</strong>g<strong>in</strong>g their research under such an office we might<br />
say, "Let's see if it works on the government-wide basis<br />
and then as a later issue that office could go to the<br />
Congress, assum<strong>in</strong>g that Glenn bill does not already pass,<br />
and say there really are issues with privately funded<br />
research and the best way to ensure that is conducted <strong>in</strong> an<br />
appropriate way is to br<strong>in</strong>g it under this office.<br />
F<strong>in</strong>ally, one po<strong>in</strong>t I did not put up here but I<br />
th<strong>in</strong>k is obvious, when one talks about this office I th<strong>in</strong>k<br />
it is best not to use the elocution that we used<br />
occasionally at first, which was "elevat<strong>in</strong>g OPRR to."<br />
Both for the reason I do not th<strong>in</strong>k we should<br />
solely focus on OPRR but it is very likely that just as the<br />
departments have their own ethics offices now to deal with<br />
the conflict of <strong>in</strong>terest and so forth adm<strong>in</strong>istratively<br />
with<strong>in</strong> their office or agency, and yet there is a<br />
government-wide office of governmental ethics it is very<br />
likely that we need a governmental-wide policy sett<strong>in</strong>g,<br />
rule <strong>in</strong>terpret<strong>in</strong>g and maybe <strong>in</strong>vestigat<strong>in</strong>g body, and an<br />
agency by agency ability to work with their own grantees<br />
and their own researchers to get how the rules apply and<br />
the process of giv<strong>in</strong>g the grants and so forth. All that<br />
rema<strong>in</strong>s.<br />
It very well may mean that only a small part of