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bioethics.georgetown.edu
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295 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 second is the insufficient resources issue that there are not enough resources for the current mission in terms of IRB's that do not work well. You have earnest people engaged in an inadequate and insufficient review process. You do not have adequate education of PI's. You have research that just flat out has not been submitted for review because somebody does not conceive that he or she is conducting research. And then you have review systems that do not work very well. The behavioral sciences I think are a perfect example. The third disabling structural -- existing structural problem is the uneven application and the uneven jurisdiction both within federal agencies and then beyond to universities. I think the most likely answer is a different governmental status and structure in budget, single standard, single office, but a single office with some kind of decentralized or distributed system where you have a single standard, a single office, but it works in a distributed way within the agencies along the model that was just discussed. I think there are some very fine models to explore. The Office of Governmental Ethics I think is the prime model worth exploration.

296 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Gratuitously I am going to add a final note, which is that I think that it is your job, in fact, to explore and to try to solve the structural problem and to make a very explicit recommendation about what the structure should be and I hope you will retain really solid experts who understand the political realities to give you advice on this to help you devise a structure that will work, to find the proper niche, to find the proper reach, authority, jurisdiction, the proper budgetary protection, the right clout to get action when needed. I will tell you that from my experience on the Commission on Research Integrity, which I would call mixed, I would say that as you work it is extraordinarily important to think about to whom your report is submitted. Who receives your report and how exactly will it get implemented? What will be done with it? If you make sort of a generic recommendation somebody should think about this and improve the structure you could be looking another two, four, five, six, ten years, never for actually making a difference in how this works. I cannot believe that this number of really busy, really expert people should put in that kind of effort for that kind of result.

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Gratuitously I am go<strong>in</strong>g to add a f<strong>in</strong>al note,<br />

which is that I th<strong>in</strong>k that it is your job, <strong>in</strong> fact, to<br />

explore and to try to solve the structural problem and to<br />

make a very explicit recommendation about what the<br />

structure should be and I hope you will reta<strong>in</strong> really solid<br />

experts who understand the political realities to give you<br />

advice on this to help you devise a structure that will<br />

work, to f<strong>in</strong>d the proper niche, to f<strong>in</strong>d the proper reach,<br />

authority, jurisdiction, the proper budgetary protection,<br />

the right clout to get action when needed.<br />

I will tell you that from my experience on the<br />

Commission on Research Integrity, which I would call mixed,<br />

I would say that as you work it is extraord<strong>in</strong>arily<br />

important to th<strong>in</strong>k about to whom your report is submitted.<br />

Who receives your report and how exactly will it get<br />

implemented?<br />

What will be done with it?<br />

If you make sort of a generic recommendation<br />

somebody should th<strong>in</strong>k about this and improve the structure<br />

you could be look<strong>in</strong>g another two, four, five, six, ten<br />

years, never for actually mak<strong>in</strong>g a difference <strong>in</strong> how this<br />

works. I cannot believe that this number of really busy,<br />

really expert people should put <strong>in</strong> that k<strong>in</strong>d of effort for<br />

that k<strong>in</strong>d of result.

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