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26.10.2014 Views

137 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MS. BARR: We made the assumption it was cancer generally. That was what our language was. DR. EMANUEL: But if I turn out to have a negative biopsy, you know, what I have consented to then if you say can be used for similar diseases. Is it cancer or not or is it just benign breast diseases? You have already made certain assumptions that someone who goes in for a breast biopsy you are going to put them in the cancer classification even though if it is negative for them they might have gone far away from the cancer classification and they are now normal. Similarly for many other conditions. I think again the issue is not purely an informatics and money issue. The issue also is we may feel in our ideal notions of what informed consent does that the more we delineate the bigger that piece of paper is the better the consent. My suggestion is the more layers you have we, as ethicists, may feel more comfortable but, in fact, the process may be inhibited. What we need to concentrate on is not have we given 12 boxes as opposed to two boxes but do the people out there have a reasonable sense even if we have not included all the specifics and that is why I -- my own view is not because of the informatics necessarily and

138 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 complication and cost of the pathologist but for the comprehension and the consistency of the people out there and making sure that once it is implemented without draining all 600,000 doctors and X million nurses, we can be reasonably assured that people are going to know what is out there. So my -- I first was against your form, then very for your form, then having tried to do a general form coming to the view that a layered consent is a good idea but probably two layers is the limit you are going to get. MS. BARR: Yes. You know, I think that I probably agree with you about all of that and I think also that we struggled in an earlier edition of a genetics question specifically. DR. EMANUEL: Right. MS. BARR: And took it out. It is not clear to me that if you are going to work on a general consent and you might want to break down into genetic -- germ line genetic research versus other research as the right -- as a way of breaking this down with the two choices and that we might want to beef up the informational brochure about just what that is and what its implications are. We talk about it in a pretty simple way in our informed consent and in the brochure and that was as a result of focus groups which

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MS. BARR: We made the assumption it was cancer<br />

generally. That was what our language was.<br />

DR. EMANUEL: But if I turn out to have a<br />

negative biopsy, you know, what I have consented to then if<br />

you say can be used for similar diseases. Is it cancer or<br />

not or is it just benign breast diseases?<br />

You have already made certa<strong>in</strong> assumptions that<br />

someone who goes <strong>in</strong> for a breast biopsy you are go<strong>in</strong>g to<br />

put them <strong>in</strong> the cancer classification even though if it is<br />

negative for them they might have gone far away from the<br />

cancer classification and they are now normal. Similarly<br />

for many other conditions.<br />

I th<strong>in</strong>k aga<strong>in</strong> the issue is not purely an<br />

<strong>in</strong>formatics and money issue. The issue also is we may feel<br />

<strong>in</strong> our ideal notions of what <strong>in</strong>formed consent does that the<br />

more we del<strong>in</strong>eate the bigger that piece of paper is the<br />

better the consent.<br />

My suggestion is the more layers you have we,<br />

as ethicists, may feel more comfortable but, <strong>in</strong> fact, the<br />

process may be <strong>in</strong>hibited. What we need to concentrate on<br />

is not have we given 12 boxes as opposed to two boxes but<br />

do the people out there have a reasonable sense even if we<br />

have not <strong>in</strong>cluded all the specifics and that is why I -- my<br />

own view is not because of the <strong>in</strong>formatics necessarily and

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