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87 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 a research although there is nothing to say that it could not be attempted in a clinical situation to get some sort of layered approach. It is not really a very complicated thing. It looks complicated and it sounds complicated, and in practice it has not -- we have not had anyone refuse anything or have any problems with it and it has been in effect for a couple of years now. DR. MURRAY: Steve? DR. HOLTZMAN: I would like to just try to focus then if I can on where I think -- I would like to focus if possible on where I think your recommendations are similar to what we have said and where they are different, and maybe try to elicit the differences in thinking. With respect to the prospectively collected samples I believe we are very, very similar in our thinking at least with respect to those which are collected in a research context leaving open whether we think those collected in a clinical context can have such a robust consent process. With respect to the extant samples you have focused on the sample being anonymous or anonymized versus our focus on the research being conducted anonymously or encrypted, what you call identifiable using the ASHG categories.
88 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 You also make a distinction between broadly related research versus any research. We did not make that distinction. We said if research could be done in an anonymous fashion -- let's forget about that for the moment even anonymously -- any research. We did not think that it required that it be broadly related. You have not said -- as I think you have answered the question -- you have not said if it fails to meet these conditions therefore go to a consent process. You have said go to an IRB. All right. Arguably what they would come back with is go to a consent process or maybe something different. Then the last thing that is -- I want to try to understand this and maybe how you are thinking, take something like the large epidemiological studies you support, Framingham, et cetera, et cetera, it is in the nature of those studies that the samples have to be identifiable because they are longitudinal studies. You are continuing to collect information. So that effectively what we proposed or was suggested is that if someone wants to undertake a study using Framingham samples and they are encrypted we could go ahead and do that without individual consent. According to you, your suggestion here, the
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You also make a dist<strong>in</strong>ction between broadly<br />
related research versus any research. We did not make that<br />
dist<strong>in</strong>ction. We said if research could be done <strong>in</strong> an<br />
anonymous fashion -- let's forget about that for the moment<br />
even anonymously -- any research. We did not th<strong>in</strong>k that it<br />
required that it be broadly related.<br />
You have not said -- as I th<strong>in</strong>k you have<br />
answered the question -- you have not said if it fails to<br />
meet these conditions therefore go to a consent process.<br />
You have said go to an IRB. All right. Arguably what they<br />
would come back with is go to a consent process or maybe<br />
someth<strong>in</strong>g different.<br />
Then the last th<strong>in</strong>g that is -- I want to try to<br />
understand this and maybe how you are th<strong>in</strong>k<strong>in</strong>g, take<br />
someth<strong>in</strong>g like the large epidemiological studies you<br />
support, Fram<strong>in</strong>gham, et cetera, et cetera, it is <strong>in</strong> the<br />
nature of those studies that the samples have to be<br />
identifiable because they are longitud<strong>in</strong>al studies. You<br />
are cont<strong>in</strong>u<strong>in</strong>g to collect <strong>in</strong>formation. So that effectively<br />
what we proposed or was suggested is that if someone wants<br />
to undertake a study us<strong>in</strong>g Fram<strong>in</strong>gham samples and they are<br />
encrypted we could go ahead and do that without <strong>in</strong>dividual<br />
consent.<br />
Accord<strong>in</strong>g to you, your suggestion here, the
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