Entire Transcript in Adobe Acrobat Format - National Reference ...
Entire Transcript in Adobe Acrobat Format - National Reference ... Entire Transcript in Adobe Acrobat Format - National Reference ...
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
- Page 89 and 90: 86 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 91 and 92: 88 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 93 and 94: 90 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 95 and 96: 92 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 97 and 98: 94 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 99 and 100: 96 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 101 and 102: 98 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 103 and 104: 100 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 105 and 106: 102 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 107 and 108: 104 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 109 and 110: 106 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 111 and 112: 108 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 113 and 114: 110 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 115 and 116: 112 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 117 and 118: 114 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 119 and 120: 116 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 121 and 122: 118 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 123 and 124: 120 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 125 and 126: 122 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 127 and 128: 124 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 129 and 130: 126 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 131 and 132: 128 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 133 and 134: 130 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 135 and 136: 132 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 137 and 138: 134 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 139: 136 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 143 and 144: 140 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 145 and 146: 142 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 147 and 148: 144 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 149 and 150: 146 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 151 and 152: 148 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 153 and 154: 150 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 155 and 156: 152 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 157 and 158: 154 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 159 and 160: 156 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 161 and 162: 158 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 163 and 164: 160 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 165 and 166: 162 1 2 3 4 5 6 We will adjourn now
- Page 167 and 168: 164 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 169 and 170: 166 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 171 and 172: 168 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 173 and 174: 170 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 175 and 176: 172 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 177 and 178: 174 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 179 and 180: 176 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 181 and 182: 178 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 183 and 184: 180 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 185 and 186: 182 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 187 and 188: 184 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 189 and 190: 186 1 2 3 4 5 6 7 8 9 10 11 12 13 1
137<br />
1<br />
2<br />
3<br />
4<br />
5<br />
6<br />
7<br />
8<br />
9<br />
10<br />
11<br />
12<br />
13<br />
14<br />
15<br />
16<br />
17<br />
18<br />
19<br />
20<br />
21<br />
22<br />
23<br />
24<br />
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