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209 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 other hand one should not be starry eyed, optimistic, as if there is no carry over. It is completely different because we have a lot of experience there and we have no empirical experience in this area. Second, I am not sure I would pose the question as Alex did, which lets you -- I mean, the way Alex posed it was very stark. Either you talk to them and get their prospective consent or you do not and you just do it to them. Those are not the only kinds of protections. I would not -- I mean, if you ask me that question my reaction to the question is you have posed the wrong question. You have posed a false question. DR. CASSELL: Could you elaborate on how? I mean, what is the alternative? DR. EMANUEL: Well, I mean, it seems to me that if you have got -- DR. HOLTZMAN: He wants you to be closer to the mike. DR. EMANUEL: I is coming. (Laughter.) DR. EMANUEL: I mean, first of all, (Laughter.) DR. HOLTZMAN: You better say the right thing. (Laughter.)

210 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: First of all, I mean if -- here, I think, it crucially depends -- I think as Eric was trying tko suggest -- what kind of understanding of that research you have, whether it -- people who are concerned about this group that is going to be experimented on have been involved in the process of planning the experiments. I think those are other substantive protections that, in fact, lower my overall concern for the need to be sure you have got this full-blooded or as close to full-blooded consent as you have. I think there is a trade off here in my own mind between the kinds of protections you have, how sure you are that there is no benefit to the subject, how sure you are that this is greater than minimal risk. Whether, in fact, the research results -- the community of concern thinks that the research results are going to be very important to them. These are lots of things that come into it and it is not just consent. MR. CAPRON: But there certainly are needs for other protections. The question I think we have based upon experience that we have looked at in the psychiatric facilities is the willingness of researchers to (a) describe research or potential benefit that does not seem to be very likely to have any benefit but (b) the question

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other hand one should not be starry eyed, optimistic, as if<br />

there is no carry over. It is completely different because<br />

we have a lot of experience there and we have no empirical<br />

experience <strong>in</strong> this area.<br />

Second, I am not sure I would pose the question<br />

as Alex did, which lets you -- I mean, the way Alex posed<br />

it was very stark. Either you talk to them and get their<br />

prospective consent or you do not and you just do it to<br />

them. Those are not the only k<strong>in</strong>ds of protections. I<br />

would not -- I mean, if you ask me that question my<br />

reaction to the question is you have posed the wrong<br />

question. You have posed a false question.<br />

DR. CASSELL: Could you elaborate on how? I<br />

mean, what is the alternative?<br />

DR. EMANUEL: Well, I mean, it seems to me that<br />

if you have got --<br />

DR. HOLTZMAN: He wants you to be closer to the<br />

mike.<br />

DR. EMANUEL: I is com<strong>in</strong>g.<br />

(Laughter.)<br />

DR. EMANUEL: I mean, first of all,<br />

(Laughter.)<br />

DR. HOLTZMAN: You better say the right th<strong>in</strong>g.<br />

(Laughter.)

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