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293 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 is that when you have problems you have to respond to them. We have very serious problems in the research community and in the academic research community with designing appropriate responses to problems. It is a fundamental problem of professional self-regulation. We have -- it manifests itself both in how the universities respond and also how the federal government responds. Inside universities -- I was at a conference a couple of years ago where an IRB executive secretary was talking about a system they designed on their campus for tracking the publications of researchers on their campuses and then trying to correlate them with IRB approved protocols, which raised a firestorm of protest on campus at the big brother concept. In the arena of research misconduct any time we talk about government regulatory mechanisms and government oversight we can invoke the specter of the science police. The science police are going to try to destroy research as we know it. There is serious resistance to any kind of inspection system. Now it is widely accepted that we could have an inspection system for animal sites but the concept of having inspection for human sits is anathema. And the third issue -- and the third thing --

294 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 is you have education, you have response to problems, and the third thing you need, I think, for a low incidence, high severity problem, is to have penalties for violation because I assure you that many, many people are busy. They have lots to do. And no matter how well meaning they are and no matter how much they believe in theory in the ethical issues if it is demonstrated time and again that there is no penalty for a serious violation people have better ways to spend their time than to fuss with this nonsense. So that is the three things I say. This leads to two issues and I have brought my conclusions. There are resource issues that someone is going to have to grapple with because the current structure does not have enough staff and not enough money, and probably not enough power to engage in either any of the education response to problems and penalties for violation that does not exist presently. And then we have the structural problems and there are, I think, disabling existing structural problems that must not be perpetuated as we move forward into doing better. The first is the structural conflicts of interest identified by Dr. Fletcher and Dr. McCarthy.

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is that when you have problems you have to respond to them.<br />

We have very serious problems <strong>in</strong> the research community and<br />

<strong>in</strong> the academic research community with design<strong>in</strong>g<br />

appropriate responses to problems. It is a fundamental<br />

problem of professional self-regulation. We have -- it<br />

manifests itself both <strong>in</strong> how the universities respond and<br />

also how the federal government responds.<br />

Inside universities -- I was at a conference a<br />

couple of years ago where an IRB executive secretary was<br />

talk<strong>in</strong>g about a system they designed on their campus for<br />

track<strong>in</strong>g the publications of researchers on their campuses<br />

and then try<strong>in</strong>g to correlate them with IRB approved<br />

protocols, which raised a firestorm of protest on campus at<br />

the big brother concept.<br />

In the arena of research misconduct any time we<br />

talk about government regulatory mechanisms and government<br />

oversight we can <strong>in</strong>voke the specter of the science police.<br />

The science police are go<strong>in</strong>g to try to destroy research as<br />

we know it.<br />

There is serious resistance to any k<strong>in</strong>d of<br />

<strong>in</strong>spection system. Now it is widely accepted that we could<br />

have an <strong>in</strong>spection system for animal sites but the concept<br />

of hav<strong>in</strong>g <strong>in</strong>spection for human sits is anathema.<br />

And the third issue -- and the third th<strong>in</strong>g --

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