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117 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 research as well and that public confidence must be earned. It is not going to happen. It must be earned. (Slide.) So what are the considerations? We are going to have to establish standards for population studies using archival tissue. We are going to have to protect individuals the best way we can and we are going to have to address the interests of communities when we do population studies. We must provide adequate compensation for those who manage the collections and we have to standardize the management of the collections. I think those things are just essential. (Slide.) I want to talk a little bit about the pathologists because I know they talk a lot so I will talk a little bit about them. They have a fiduciary responsibility with respect to the patient. They acknowledge it and they talk a lot about it, and that is to ensure that what is there is preserved for care, patient care. They have a fiduciary responsibility also to the resource itself and this is where we are breaking new ground where we begin to think of these resources not as belonging to the pathologist but belonging to the research enterprise and that the pathologist is the fiduciary of

118 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 that research enterprise. They become -- in a national system they are not the arbiter of who gets to use the tissue they hold. Now today they are the arbiters of who gets to use the tissue they hold. So I am presenting a radically different approach. But they do deserve adequate compensation for the work they do in serving as fiduciary responsibility to the research enterprise as a whole. I think that the model that we put in place of a neutral third party, the IRB and the tissue bank, is applicable to archival collections as well as perspective collections but the standards for what must be done in a population study or other study when we are using archival tissue is obviously going to be somewhat different than what it might be in a perspective situation. (Slide.) I am going to talk just briefly about standardization and then I think I am done, almost done anyway. Standardization impacts donor participation and I came to this enterprise because people wanted to help the research process. Now that is a limited population. There are populations that are much more skeptical than the population I came from and there are portions of the population that I speak for that are more skeptical than

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research as well and that public confidence must be earned.<br />

It is not go<strong>in</strong>g to happen. It must be earned.<br />

(Slide.)<br />

So what are the considerations? We are go<strong>in</strong>g<br />

to have to establish standards for population studies us<strong>in</strong>g<br />

archival tissue. We are go<strong>in</strong>g to have to protect<br />

<strong>in</strong>dividuals the best way we can and we are go<strong>in</strong>g to have to<br />

address the <strong>in</strong>terests of communities when we do population<br />

studies. We must provide adequate compensation for those<br />

who manage the collections and we have to standardize the<br />

management of the collections. I th<strong>in</strong>k those th<strong>in</strong>gs are<br />

just essential.<br />

(Slide.)<br />

I want to talk a little bit about the<br />

pathologists because I know they talk a lot so I will talk<br />

a little bit about them. They have a fiduciary<br />

responsibility with respect to the patient. They<br />

acknowledge it and they talk a lot about it, and that is to<br />

ensure that what is there is preserved for care, patient<br />

care. They have a fiduciary responsibility also to the<br />

resource itself and this is where we are break<strong>in</strong>g new<br />

ground where we beg<strong>in</strong> to th<strong>in</strong>k of these resources not as<br />

belong<strong>in</strong>g to the pathologist but belong<strong>in</strong>g to the research<br />

enterprise and that the pathologist is the fiduciary of

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