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215 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 informed consent. I would like to suggest that informed consent is important but we should not try and make things sound as if they are very much like informed consent when they are not. I think the real issue is that it is not that we get consent or not, that we do not want to do things to people that they would not want us to do or they did not even know about and it is just very uncomfortable. If they consent we figure, well, they let us do it so that is okay. But I think there are other degrees of respecting autonomy, many of which I think you have worked into the report. One is failure to assent even if the patient is uninformed has to be respected. I think that is very important and I would say that you actually have to seek affirmative assent. You cannot just say they did not object so we will do it. You have to say is it okay if I draw your blood. I think that is -- you know, we were talking about incremental improvements this morning. I think that is an incremental but substantial improvement over what happens now where you just get the blood drawn because, you know, we want to draw your blood and you do not object. I think the other thing we tend to do is we try to fit everything in some autonomy model even when it does
216 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 not. Most of these decisions for people of questionable capacity really have a lot more to do with what someone else thinks is in their best interest. I think one of the things that I like about this draft that I think we need to sharpen even more is a willingness to say that family members by default, unless shown otherwise, are the natural surrogates to whom we turn for decisions about is it in this patient's best interest to be a research subject. That is a big change. I mean, if we are willing to say that leaving aside the -- it depends on whether it is benefit and risk. But, you know, Alex, to go back to what you always reminded us sort of the history of this. I mean, there is a school of thought that, you know, it was very, you know, cogent, I think, that said, no, that you cannot do anything to a subject without their free and voluntary consent. It goes right back to the Nuremberg code. So that if we are really saying a family member may consent or may give permission under certain circumstances, again that is -- and if we really involve the family members in a meaningful decision as best they can make it, again I think that is an incremental but substantial improvement. As long as I have the floor I am going to just sort of sneak in another point that is unrelated.
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<strong>in</strong>formed consent. I would like to suggest that <strong>in</strong>formed<br />
consent is important but we should not try and make th<strong>in</strong>gs<br />
sound as if they are very much like <strong>in</strong>formed consent when<br />
they are not.<br />
I th<strong>in</strong>k the real issue is that it is not that<br />
we get consent or not, that we do not want to do th<strong>in</strong>gs to<br />
people that they would not want us to do or they did not<br />
even know about and it is just very uncomfortable. If they<br />
consent we figure, well, they let us do it so that is okay.<br />
But I th<strong>in</strong>k there are other degrees of respect<strong>in</strong>g autonomy,<br />
many of which I th<strong>in</strong>k you have worked <strong>in</strong>to the report.<br />
One is failure to assent even if the patient is<br />
un<strong>in</strong>formed has to be respected. I th<strong>in</strong>k that is very<br />
important and I would say that you actually have to seek<br />
affirmative assent. You cannot just say they did not<br />
object so we will do it. You have to say is it okay if I<br />
draw your blood.<br />
I th<strong>in</strong>k that is -- you know, we were talk<strong>in</strong>g<br />
about <strong>in</strong>cremental improvements this morn<strong>in</strong>g. I th<strong>in</strong>k that<br />
is an <strong>in</strong>cremental but substantial improvement over what<br />
happens now where you just get the blood drawn because, you<br />
know, we want to draw your blood and you do not object.<br />
I th<strong>in</strong>k the other th<strong>in</strong>g we tend to do is we try<br />
to fit everyth<strong>in</strong>g <strong>in</strong> some autonomy model even when it does
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