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try<strong>in</strong>g to dist<strong>in</strong>guish as I have understood what we were<br />

about here is whether or not you would agree to be <strong>in</strong> a<br />

consent protect that would expose you to greater than<br />

m<strong>in</strong>imal risk and that has to be expla<strong>in</strong>ed with the k<strong>in</strong>d of<br />

th<strong>in</strong>gs that could happen and make it concrete but would not<br />

be designed to benefit you at all.<br />

And that is the determ<strong>in</strong>ation that is so<br />

crucial here because that k<strong>in</strong>d of research is done by<br />

researchers and it should only be done when the person has<br />

said, as the researcher is say<strong>in</strong>g, I value scientific<br />

knowledge enough to go through a process with no prospect<br />

of be<strong>in</strong>g benefitted by it as opposed to with the lure of<br />

some potential therapeutic payoff for me. And that is why<br />

we dist<strong>in</strong>guished it. We do allow a surrogate <strong>in</strong> the<br />

potentially therapeutic because we say there the fact that<br />

you have not gone through this process and have not made<br />

that determ<strong>in</strong>ation ought not to be a total barrier to your<br />

gett<strong>in</strong>g that benefit of the <strong>in</strong>novative treatment or<br />

whatever is be<strong>in</strong>g done here.<br />

But where that is not a prospect what is the<br />

justification for us<strong>in</strong>g the person? It is just pure use of<br />

a person who has not been given the opportunity to say yea<br />

or nay to that. Not everybody can be presumed to be<br />

will<strong>in</strong>g to go through pa<strong>in</strong> and suffer<strong>in</strong>g <strong>in</strong> order to

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