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33 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 review and full IRB review there may be categories that segregate out as exempt from IRB review because people have gone through enough studies to realize that these do not really require anything more than, you know, what now I think are termed exemptions under the Common Rule. But I think this discussion to me is valuable in that it makes me realize we need to articulate better the rationale for collapsing down the matrix in final recommendations and also forcing us to rethink are there other kinds of protections that would give us even more permutations for the different boxes. DR. MURRAY: Harold and Larry? DR. SHAPIRO: I have just a simple -- I think it is a pedagogical suggestion. It does not enter into the substance of this argument but I found it helpful and just pass it on. I found it helpful in looking at these various possibilities and matrixes to organize it somewhat differently, which gave me more flexibility in my thinking, namely I would put along the top "possible protections," and they define all the rows. And then -- excuse me, they define the columns. Excuse me. They define the columns. And then down -- but to define the rows are just differences you would want to make, whether you want to use
34 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 the differences you have or additional ones, or add additional ones. And that all will enable you to keep in front of you easily protections on one side type and type of experiment or something on this side. You may or may not find that useful in dealing with this. I have found it useful in my own work now. DR. MURRAY: Thanks. Larry and Steve? DR. MIIKE: I think the purpose of a body such as our's is to get down to the elemental considerations and then it is for others to put permutations on them. So, I mean, I think that is a fundamental reason why I would say that we want a simple model and then you argue about the distinctions between them. So if we start with a matrix that is so complex that nobody can understand what the underlying basic rationale is we will never get anywhere but if you start -- but if you end up where we, as a subcommittee, currently are and then you can argue the permutations around that like Trish and I were doing I think it is clearer to others. Then, finally, I think if I remember my math, the magic number is seven plus or minus two and most people
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review and full IRB review there may be categories that<br />
segregate out as exempt from IRB review because people have<br />
gone through enough studies to realize that these do not<br />
really require anyth<strong>in</strong>g more than, you know, what now I<br />
th<strong>in</strong>k are termed exemptions under the Common Rule. But I<br />
th<strong>in</strong>k this discussion to me is valuable <strong>in</strong> that it makes me<br />
realize we need to articulate better the rationale for<br />
collaps<strong>in</strong>g down the matrix <strong>in</strong> f<strong>in</strong>al recommendations and<br />
also forc<strong>in</strong>g us to reth<strong>in</strong>k are there other k<strong>in</strong>ds of<br />
protections that would give us even more permutations for<br />
the different boxes.<br />
DR. MURRAY: Harold and Larry?<br />
DR. SHAPIRO: I have just a simple -- I th<strong>in</strong>k<br />
it is a pedagogical suggestion. It does not enter <strong>in</strong>to the<br />
substance of this argument but I found it helpful and just<br />
pass it on.<br />
I found it helpful <strong>in</strong> look<strong>in</strong>g at these various<br />
possibilities and matrixes to organize it somewhat<br />
differently, which gave me more flexibility <strong>in</strong> my th<strong>in</strong>k<strong>in</strong>g,<br />
namely I would put along the top "possible protections,"<br />
and they def<strong>in</strong>e all the rows. And then -- excuse me, they<br />
def<strong>in</strong>e the columns. Excuse me. They def<strong>in</strong>e the columns.<br />
And then down -- but to def<strong>in</strong>e the rows are just<br />
differences you would want to make, whether you want to use