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is it go<strong>in</strong>g to do it? I mean, basically what you have<br />

described is <strong>in</strong>formed consent. I do not see how it is<br />

anyth<strong>in</strong>g different than <strong>in</strong>formed consent. An advance<br />

directive --<br />

MS. BACKLAR: I tell you what is advance about<br />

it.<br />

DR. CHILDRESS: It may be an improvement --<br />

MS. BACKLAR: The advance part of it is <strong>in</strong> a<br />

sense the person is prepar<strong>in</strong>g <strong>in</strong> case they lose capacity<br />

and at a time that they lose -- they should lose capacity<br />

for decision mak<strong>in</strong>g if they are <strong>in</strong> the research protocol,<br />

which might <strong>in</strong>volve com<strong>in</strong>g off medications or various<br />

th<strong>in</strong>gs, that for sure they have with them a surrogate and<br />

an outside provider. So <strong>in</strong> a sense that is the advance<br />

part of it.<br />

While they have capacity to make decisions for<br />

themselves they will.<br />

DR. CHILDRESS: But we could simply require<br />

those mechanisms without connect<strong>in</strong>g it with the notion of<br />

an advance directive.<br />

DR. EMANUEL: I also might mention that does<br />

not apply well to the dementia category, which at least<br />

from a numerical standpo<strong>in</strong>t --<br />

MS. BACKLAR: I understand that.

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