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211 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 of where that trade off comes. And you can have had other people with similar illnesses agreeing and you can even have a legally authorized representative agreeing. Our sense was you should not do something to somebody which has greater than minimal risk and by the design, even the designers would say, it is not designed to do them any benefit and any benefit would be totally adventitious and unexpected without that person having said if the time comes I am willing to be in that kind of an experiment because I, like you, Mr. Researcher, value the outcome of research enough to subject myself in a state in which I am not capable of protecting myself and not capable of indicating that I want to withdraw, and everything else we think of as normal protections that people have I, myself, am willing to take that risk in order to advance science. It is here, unlike -- I mean, I do not know what I feel in the end about all the losses that will -- if we cannot get access to every human tissue without consent -- I mean, you know, I do not know where I come out on that yet. You all will still have to convince me. But I do know what I think about living human beings who cannot protect themselves and are going to be used in greater than minimal research. I do not want it done unless they have
212 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 said it is okay with them. That is just the bottom line on this point. DR. CHILDRESS: Before I turn to Bernie, Trish and Eric, let me just note Harold and Eric Meslin had called my attention to what appears to be an error on 145 under four, "and IRB may approve this category of research only if the potential subject has given informed consent." I think the "and" should be "or." Has actually given advance directive to be consistent with -- MR. CAPRON: It says "or." "Or if incapable has executed an advanced directive," doesn't it? DR. CHILDRESS: On 145? MR. CAPRON: 145, second line -- DR. MESLIN: Second line of four. DR. CHILDRESS: Mine does not. MR. CAPRON: Oh, no. Look at the top of the page. DR. CHILDRESS: I know but -- MR. CAPRON: Oh. Oh, I am sorry. I was looking at the top of the page. DR. CHILDRESS: Look down under number 4. DR. SHAPIRO: Could you read that again? MR. CAPRON That is potentially beneficial. DR. CHILDRESS: That is right. We do not
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NATIONAL BIOETHICS ADVISORY COMMISS
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I N D E X Welcome 1 Report from the
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