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23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 those which have some information and are encrypted. There are two distinctions. One, the information, although it may seem to the person who is making the decision at the time is sufficient to make it anonymous may not make it anonymous. Secondly, after the fact a researcher with findings, which he or she regards as important enough, will have information which could be unencrypted. That is a fundamental distinction it seems to me and the whole notion that in certain research you need fire walls or you need one way barriers and the like because you have information which has an encrypted number on it, which if unencrypted, goes directly to an individual suggests that there is a distinction. I do not think that what I have heard thus far explains to me why you want to lump those two together. DR. EMANUEL: I think, Alex, the answer to that question is let's get through the protections we would like and see if, in fact, they collapse or they do not collapse. Right? That, I think, is the rationale that led us to collapsing them because, in fact, the kind of protections you would want, the kind of consent or IRB review that you would want for those two different categories, in fact, collapses them. They would be the same.
24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MR. CAPRON: I read your charts before this meeting. I came to a different conclusion. It does not seem to me that I have the same sense about information being used where a person could have results of great importance to me which they could unencrypt and where there may be a moral obligation to do so in order to give me a warning or conversely where their scientific interest in unencrypting it is very different. To have a sample used in advance seems to me does not fit under your -- the conclusion that you have given about no IRB review, no individual consent, no community consent in the same way as it would with a sample about which there is no individually identified linkage at all possible. Therefore, that is one of the reasons why it seems to me that different policies must be in place. Certainly the policies having to do with whether you could under any circumstances go back through that wall only applies to information for which the identifiers are there. DR. MURRAY: That is not true. At least not in the hands of the researchers. The identifiers might be perhaps in the hands of a trustee of the tissue or even in an additional party, a third or fourth party. MR. CAPRON: If there are no such identifiers you have no basis for going back. You do not need a policy
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MR. CAPRON: I read your charts before this<br />
meet<strong>in</strong>g. I came to a different conclusion.<br />
It does not seem to me that I have the same<br />
sense about <strong>in</strong>formation be<strong>in</strong>g used where a person could<br />
have results of great importance to me which they could<br />
unencrypt and where there may be a moral obligation to do<br />
so <strong>in</strong> order to give me a warn<strong>in</strong>g or conversely where their<br />
scientific <strong>in</strong>terest <strong>in</strong> unencrypt<strong>in</strong>g it is very different.<br />
To have a sample used <strong>in</strong> advance seems to me<br />
does not fit under your -- the conclusion that you have<br />
given about no IRB review, no <strong>in</strong>dividual consent, no<br />
community consent <strong>in</strong> the same way as it would with a sample<br />
about which there is no <strong>in</strong>dividually identified l<strong>in</strong>kage at<br />
all possible. Therefore, that is one of the reasons why it<br />
seems to me that different policies must be <strong>in</strong> place.<br />
Certa<strong>in</strong>ly the policies hav<strong>in</strong>g to do with whether you could<br />
under any circumstances go back through that wall only<br />
applies to <strong>in</strong>formation for which the identifiers are there.<br />
DR. MURRAY: That is not true. At least not <strong>in</strong><br />
the hands of the researchers. The identifiers might be<br />
perhaps <strong>in</strong> the hands of a trustee of the tissue or even <strong>in</strong><br />
an additional party, a third or fourth party.<br />
MR. CAPRON: If there are no such identifiers<br />
you have no basis for go<strong>in</strong>g back. You do not need a policy
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