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113 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 If you have a limited resource then you have to prioritize how it is used and there has to be conversation with communities of interest about how it is going to be used. The concept we were talking about earlier which is community collaboration or community consultation. Someone has got to do that and there have to be standards for how it will be done. It seems the likely place for that to happen is with the tissue because they get an overview of what is being requested, the timeliness of it and the amount of it. So we have suggested that an IRB affiliated with a tissue banking institution have -- appoint a panel that will do that kind of review. IRB's do not want to be responsible for that panel. When we asked them, "Well, if not you, who?" There was no answer. So I will say to you, "If not them, who?" But clearly that is a very important function in all this. It is a vital function in all this. What needs to be done? Just clear OPRR or NBAC guidelines. Just what I have talked about. Some standardization of documents so researchers do not get approval in one place, then go to the next place and have to change it and then go back to the first place because

114 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 they need consistency in their trial. If they know they are using tissue and we can simplify what has to be done so that they can use the tissue we will have facilitated research. That was our goal. And finally because we are looking at testing in a clinical setting we are doing some pilot testing with NCI of using this consent in the clinical setting. And what we have done with is it is an add on to the general surgical consent and we are doing some pilot testing and presenting it at different times, sometimes in the doctor's office and sometimes unfortunately the night before because that is when it really happens, and trying to get feedback. You should also know that we focused group the documents and as a result of that working with different ethnic communities we got a lot of very good feedback on how to change the documents and it was from that process that we did the informational brochure. (Slide.) A few more solutions. NCI is actually working with professional groups now regarding costs and storage guidelines. That is going to be a long process. NCI and DOD are talking about a national storage system. That is very preliminary. And then we are in a world where there is ongoing attention to informatics, questions of encoding

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they need consistency <strong>in</strong> their trial. If they know they<br />

are us<strong>in</strong>g tissue and we can simplify what has to be done so<br />

that they can use the tissue we will have facilitated<br />

research. That was our goal.<br />

And f<strong>in</strong>ally because we are look<strong>in</strong>g at test<strong>in</strong>g<br />

<strong>in</strong> a cl<strong>in</strong>ical sett<strong>in</strong>g we are do<strong>in</strong>g some pilot test<strong>in</strong>g with<br />

NCI of us<strong>in</strong>g this consent <strong>in</strong> the cl<strong>in</strong>ical sett<strong>in</strong>g. And<br />

what we have done with is it is an add on to the general<br />

surgical consent and we are do<strong>in</strong>g some pilot test<strong>in</strong>g and<br />

present<strong>in</strong>g it at different times, sometimes <strong>in</strong> the doctor's<br />

office and sometimes unfortunately the night before because<br />

that is when it really happens, and try<strong>in</strong>g to get feedback.<br />

You should also know that we focused group the<br />

documents and as a result of that work<strong>in</strong>g with different<br />

ethnic communities we got a lot of very good feedback on<br />

how to change the documents and it was from that process<br />

that we did the <strong>in</strong>formational brochure.<br />

(Slide.)<br />

A few more solutions. NCI is actually work<strong>in</strong>g<br />

with professional groups now regard<strong>in</strong>g costs and storage<br />

guidel<strong>in</strong>es. That is go<strong>in</strong>g to be a long process. NCI and<br />

DOD are talk<strong>in</strong>g about a national storage system. That is<br />

very prelim<strong>in</strong>ary. And then we are <strong>in</strong> a world where there<br />

is ongo<strong>in</strong>g attention to <strong>in</strong>formatics, questions of encod<strong>in</strong>g

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