Entire Transcript in Adobe Acrobat Format - National Reference ...
Entire Transcript in Adobe Acrobat Format - National Reference ... Entire Transcript in Adobe Acrobat Format - National Reference ...
127 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 variation you are going to get among IRB's from those that really have thought about this very well and really go through a very careful process to those for whom the issues just do not emerge and so they easily approve it or disapprove it is going to be extreme. I am very worried and I hope that -- this is to my fellow commissioners -- I hope that we in looking at it will think about what kinds of guidance that would be because that breaching the barrier and going back for "what are good reasons" is an essential issue on this anonymizable or identifiable, or whatever the phrase that we end up using, encrypted information. But I have those other three points if you could -- I think you took notes on them. MS. BARR: I did. Let me try and go backwards. On paying for the code, I basically come from a world that says you usually do not get the whole pie and that is because I come from a very political world. That was my prior activist sort of training. And so what I have learned is that you set -- sometimes move in incremental steps. And faced with a very large problem and a desire to move the process forward what our group did was locate two areas of grave concern in terms of facilitating research with research.
128 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 One was lack of standardization and guidance for IRB's and the other was the consent process. And so we did the work we did to address those problems. In doing that work we wanted to give the donor as much freedom to code as possible but it seemed that at the state of technology and the world we were entering where they did not even give consent it would be a very good step forward to insist on consent and then at least offer choice. As a community gets used to simple choices then perhaps we can add more complex choices as our informatics become more sophisticated. In an ideal world would I be standing arguing for really sophisticated coding? Absolutely. But in a world in which there was going to be significant resistance from clinicians who are not researchers and who had a resource that researchers were going to want to use we made a judgment. Now if this group believes that the research community itself can get enough tissue for research purposes specifically designated for research purposes without going to the clinicians in the world, that is an interesting point. It does mean that participants like me, who may have her biopsy in a local hospital, never get to participate in the enterprise. So am I willing to trade
- Page 79 and 80: 76 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 81 and 82: 78 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 83 and 84: 80 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 85 and 86: 82 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- Page 87 and 88: 84 1 2 3 4 5 6 7 8 9 10 11 12 13 14
- 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: 126 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 and 140: 136 1 2 3 4 5 6 7 8 9 10 11 12 13 1
- Page 141 and 142: 138 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
127<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 />
variation you are go<strong>in</strong>g to get among IRB's from those that<br />
really have thought about this very well and really go<br />
through a very careful process to those for whom the issues<br />
just do not emerge and so they easily approve it or<br />
disapprove it is go<strong>in</strong>g to be extreme. I am very worried<br />
and I hope that -- this is to my fellow commissioners -- I<br />
hope that we <strong>in</strong> look<strong>in</strong>g at it will th<strong>in</strong>k about what k<strong>in</strong>ds<br />
of guidance that would be because that breach<strong>in</strong>g the<br />
barrier and go<strong>in</strong>g back for "what are good reasons" is an<br />
essential issue on this anonymizable or identifiable, or<br />
whatever the phrase that we end up us<strong>in</strong>g, encrypted<br />
<strong>in</strong>formation.<br />
But I have those other three po<strong>in</strong>ts if you<br />
could -- I th<strong>in</strong>k you took notes on them.<br />
MS. BARR: I did. Let me try and go backwards.<br />
On pay<strong>in</strong>g for the code, I basically come from a world that<br />
says you usually do not get the whole pie and that is<br />
because I come from a very political world. That was my<br />
prior activist sort of tra<strong>in</strong><strong>in</strong>g. And so what I have<br />
learned is that you set -- sometimes move <strong>in</strong> <strong>in</strong>cremental<br />
steps. And faced with a very large problem and a desire to<br />
move the process forward what our group did was locate two<br />
areas of grave concern <strong>in</strong> terms of facilitat<strong>in</strong>g research<br />
with research.