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21 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 prospective so it does not make any sense to me not to collapse them. DR. EMANUEL: Well, I think the way to understand that is to work through each of the boxes as the subcommittee did and the rationale for them. Let me emphasize what I think are the -- and I would hope that my fellow commissioners would again -- the three path breaking, I think, distinctions we have made. One is between the previously collected samples and the samples collected after the report's recommendations. The second is that the evaluation, the ethical evaluation, should be based on the use of the tissue, not on the manner of collection or storage of the tissue, because what we are interested in, and the reasons we have worries is the harms that result and that depends upon being able to identify a specific result with a specific person, and that recognition that some research conducted on individually anonymous -- in an individually anonymous manner may nevertheless have sufficient sociodemographic information to adversely affect communities. MR. CAPRON: Could you pause now because -- DR. EMANUEL: Well, let -- MR. CAPRON: -- because you think you have responded --
22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 DR. EMANUEL: I want to -- can I -- (Slide.) To put this a little bit in a framework the current system, the Common Rule, recognizes only two categories. All right. It has nothing to say about the rest of this. This is really the reason we are here and looking at it because it is solid on all these other boxes. Now, I do not want to -- I do not know if the commission wants me to potentially jump ahead and suggest what the recommendations were or should we just leave that? DR. MURRAY: I think we should go ahead. DR. EMANUEL: Does that sound -- DR. MURRAY: Does anybody want to comment at this stage? MR. CAPRON: Yes. DR. MURRAY: To respond to Alex -- well, but I think -- okay. MR. CAPRON: May I -- DR. MURRAY: Go ahead, Alex, have your say. MR. CAPRON: Well, thank you. I agree entirely with the notion of the focus being not on the way samples are stored but on how they are used. It seems to me that there is a self-evident distinction between a sample which has no identifiers and
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the prospective so it does not make any sense to me not to<br />
collapse them.<br />
DR. EMANUEL: Well, I th<strong>in</strong>k the way to<br />
understand that is to work through each of the boxes as the<br />
subcommittee did and the rationale for them. Let me<br />
emphasize what I th<strong>in</strong>k are the -- and I would hope that my<br />
fellow commissioners would aga<strong>in</strong> -- the three path<br />
break<strong>in</strong>g, I th<strong>in</strong>k, dist<strong>in</strong>ctions we have made. One is<br />
between the previously collected samples and the samples<br />
collected after the report's recommendations.<br />
The second is that the evaluation, the ethical<br />
evaluation, should be based on the use of the tissue, not<br />
on the manner of collection or storage of the tissue,<br />
because what we are <strong>in</strong>terested <strong>in</strong>, and the reasons we have<br />
worries is the harms that result and that depends upon<br />
be<strong>in</strong>g able to identify a specific result with a specific<br />
person, and that recognition that some research conducted<br />
on <strong>in</strong>dividually anonymous -- <strong>in</strong> an <strong>in</strong>dividually anonymous<br />
manner may nevertheless have sufficient sociodemographic<br />
<strong>in</strong>formation to adversely affect communities.<br />
MR. CAPRON: Could you pause now because --<br />
DR. EMANUEL: Well, let --<br />
MR. CAPRON: -- because you th<strong>in</strong>k you have<br />
responded --