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37 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 As you say, there is a situation in which it is impossible and another situation in which it will happen, and another in between. So it seems to me that it is not just talking about what the protections are but the reason to lead towards one protection or another is going to vary depending on what you see the risk is. Let me follow this through in another way. I think I am persuaded by your decision as to previously collected samples to collapse those which were collected for clinical reasons and those which were collected for other research purposes, obviously not for the current research because otherwise it would be a prospective study. That is not the intuition I started with and it is not as though every division and every distinction I think of I follow through to suggest we have to show it. The reason being is if you take that risk approach it seems to me it is very likely that the things that would concern people would be the same whether or not their tissue had been taken out as a result of a diagnostic or therapeutic procedure or some unconnected research and that is not the intuition I started with. I should note, however, I think we need to address that with some care because in the first chapter in
38 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 giving the overview you note quite correctly that most people whose samples are among these hundreds of millions that are being stored do not know that those samples are stored because it was not an explicit part of the consent process and it was never focused on. That is not true for people whose samples were taken for research. They at least know samples were taken for research, they do not know about this research, they may not know how long it is stored but at least they know that someone took it to study it. Now that is a distinction. But if we look to the future and say not what I was originally concerned about, sort of the dignitary difference between having something done to a sample you do not even know anyone has versus the other, but what risks you are going to be exposed to. I can understand why you ended up collapsing those. Just to show that I am not totally pigheaded, Tom, I can understand why. But I do immediately when I think about the risks see differences so I will wait and see whether the collapsing that you have done, which apparently has been done as to future samples in different people's view. I mean, Zeke thought you collapsed research
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As you say, there is a situation <strong>in</strong> which it is<br />
impossible and another situation <strong>in</strong> which it will happen,<br />
and another <strong>in</strong> between.<br />
So it seems to me that it is not just talk<strong>in</strong>g<br />
about what the protections are but the reason to lead<br />
towards one protection or another is go<strong>in</strong>g to vary<br />
depend<strong>in</strong>g on what you see the risk is.<br />
Let me follow this through <strong>in</strong> another way. I<br />
th<strong>in</strong>k I am persuaded by your decision as to previously<br />
collected samples to collapse those which were collected<br />
for cl<strong>in</strong>ical reasons and those which were collected for<br />
other research purposes, obviously not for the current<br />
research because otherwise it would be a prospective study.<br />
That is not the <strong>in</strong>tuition I started with and it is not as<br />
though every division and every dist<strong>in</strong>ction I th<strong>in</strong>k of I<br />
follow through to suggest we have to show it.<br />
The reason be<strong>in</strong>g is if you take that risk<br />
approach it seems to me it is very likely that the th<strong>in</strong>gs<br />
that would concern people would be the same whether or not<br />
their tissue had been taken out as a result of a diagnostic<br />
or therapeutic procedure or some unconnected research and<br />
that is not the <strong>in</strong>tuition I started with.<br />
I should note, however, I th<strong>in</strong>k we need to<br />
address that with some care because <strong>in</strong> the first chapter <strong>in</strong>