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59 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. MURRAY: Zeke, can I make just one point that would go for all of the -- particularly the ones collected in terms of clinical care? DR. EMANUEL: Right. DR. MURRAY: Whether previously or now. If there is on the record that a person did not want their tissue used for research that preempts any possible use. We do not -- we did not specifically note that in this table but that should be noted. DR. EMANUEL: The other thing to note is that we heard from Bartha Knopers that in Europe or at least in the Netherlands they were going to a presumed consent with an opt out. For our reasons we had thought and discussed why that might not be good and it might encourage sloppy record keeping if you could not identify a record and other reasons. So I think, in general, we are moving to having the general consent process and we had thought through some of the problems and difficulties because we had heard from some of the people in our mini-hearings about the fact that they do not remember even signing a consent form and they felt coerced, et cetera. Now without going through each of the boxes, I mean we can again try to discuss --
60 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MR. CAPRON: How does the general differ from the present situation? That is to say -- you know, the assumption is when I went into the hospital last year I signed a consent form that allowed general use of tissues. I mean, there was some language that was not brought to my attention but it was there. Is that what you are thinking about? DR. EMANUEL: No. MR. CAPRON: You are thinking about something that goes well beyond that. In practical effect -- DR. EMANUEL: Let's say -- let's be clear. One of the reasons we are not going to full informed consent is because in many circumstances when you collect your tissue you -- MR. CAPRON: You do not know what the study will be. DR. EMANUEL: We have no idea what the study -- and we do not want to tie hands today for studies that might -- we might want to do fifty years from now or whatever. So the issue is what kind of consent can you have? Is signing a piece of paper where there is one obscure line -- and actually some of us have looked at some of those lines. They are not nearly as good as you would like them to be currently. So one issue is to make that
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MR. CAPRON: How does the general differ from<br />
the present situation? That is to say -- you know, the<br />
assumption is when I went <strong>in</strong>to the hospital last year I<br />
signed a consent form that allowed general use of tissues.<br />
I mean, there was some language that was not brought to my<br />
attention but it was there.<br />
Is that what you are th<strong>in</strong>k<strong>in</strong>g about?<br />
DR. EMANUEL: No.<br />
MR. CAPRON: You are th<strong>in</strong>k<strong>in</strong>g about someth<strong>in</strong>g<br />
that goes well beyond that. In practical effect --<br />
DR. EMANUEL: Let's say -- let's be clear. One<br />
of the reasons we are not go<strong>in</strong>g to full <strong>in</strong>formed consent is<br />
because <strong>in</strong> many circumstances when you collect your tissue<br />
you --<br />
MR. CAPRON: You do not know what the study<br />
will be.<br />
DR. EMANUEL: We have no idea what the study --<br />
and we do not want to tie hands today for studies that<br />
might -- we might want to do fifty years from now or<br />
whatever. So the issue is what k<strong>in</strong>d of consent can you<br />
have? Is sign<strong>in</strong>g a piece of paper where there is one<br />
obscure l<strong>in</strong>e -- and actually some of us have looked at some<br />
of those l<strong>in</strong>es. They are not nearly as good as you would<br />
like them to be currently. So one issue is to make that