Entire Transcript in Adobe Acrobat Format - National Reference ...
Entire Transcript in Adobe Acrobat Format - National Reference ... Entire Transcript in Adobe Acrobat Format - National Reference ...
281 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 E V E N I N G S E S S I O N DR. FLETCHER: Thank you, Mr. Chairman. I was very impressed with Alex's laying out of the issues. I did not disagree with any of it. I was struck with how much Charles McCarthy and I did agree on since we do have different perspectives but I think our main difference is one of political philosophy, if you will, that he wants and expects the success of the body that he envisions, which essentially is the same body that I envision except with the outside advisory committee. His does not have that. He feels that in the real political world a government-wide body with these responsibilities could not succeed without the protection of a powerful secretarial member of the cabinet. I agree with the point that Alex made in his comment on the weakness of the McCarthy proposal is that it does not remove the conflict of interest. I think that the degree of the weakness of the present system, the weakness of the present system that we have, in protection of human subjects is influenced -- I want to choose the right word -- somewhere between moderately and heavily because obviously OPRR's position in the whole scheme of things is not the only problem. IRB's
282 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 are the problem. The lack of available resources within institutions, federal agencies, universities, of persons with expertise to lead this effort is a problem. But I do think that it is -- the conflict of interest and the conflict of missions is a kind of persistent weakness that demoralizes the whole system. I have been aware of it all of my adult life from the time that the solution was invented in the early '70s to have NIH effectively regulating itself. And if you have that kind of central conflict of missions and conflict of interest it is the kind of national commentary on evading the problem. So I would say even in an era of smaller government that leaders in Congress and the American people are interested in better government, to have smaller and better, and there is not an enormous new amount of appropriations to be made in creating a new body and going about doing this right. So I would say that the McCarthy plan is a good one except that it lacks the national advisory committee feature but it is in the wrong location. The location still begs the question and if it is put there it will continue into the next era, the kind of demoralizing effect that has produced such lack of respect, particularly from
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282<br />
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are the problem. The lack of available resources with<strong>in</strong><br />
<strong>in</strong>stitutions, federal agencies, universities, of persons<br />
with expertise to lead this effort is a problem.<br />
But I do th<strong>in</strong>k that it is -- the conflict of<br />
<strong>in</strong>terest and the conflict of missions is a k<strong>in</strong>d of<br />
persistent weakness that demoralizes the whole system. I<br />
have been aware of it all of my adult life from the time<br />
that the solution was <strong>in</strong>vented <strong>in</strong> the early '70s to have<br />
NIH effectively regulat<strong>in</strong>g itself. And if you have that<br />
k<strong>in</strong>d of central conflict of missions and conflict of<br />
<strong>in</strong>terest it is the k<strong>in</strong>d of national commentary on evad<strong>in</strong>g<br />
the problem.<br />
So I would say even <strong>in</strong> an era of smaller<br />
government that leaders <strong>in</strong> Congress and the American people<br />
are <strong>in</strong>terested <strong>in</strong> better government, to have smaller and<br />
better, and there is not an enormous new amount of<br />
appropriations to be made <strong>in</strong> creat<strong>in</strong>g a new body and go<strong>in</strong>g<br />
about do<strong>in</strong>g this right.<br />
So I would say that the McCarthy plan is a good<br />
one except that it lacks the national advisory committee<br />
feature but it is <strong>in</strong> the wrong location. The location<br />
still begs the question and if it is put there it will<br />
cont<strong>in</strong>ue <strong>in</strong>to the next era, the k<strong>in</strong>d of demoraliz<strong>in</strong>g effect<br />
that has produced such lack of respect, particularly from