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183 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 -- there has been a change of heart amongst some of the members or you just want a clarification? DR. SHAPIRO: No, there has not. Even if we wanted to be, we could not be, but I do not think -- my sense is no. I did not interpret the comments Eric made that way. I interpreted them as the question of whether we should be suggesting regulation to whoever the regulatory bodies are but that is how I interpret what Eric was saying. DR. BRITO: Okay. In terms of the specific topics I want to say that they all sound very apropos obviously but it would be very ambitious to tackle them all. One of the ones that is very focused that I think we should tackle right now and has been raised before is the research being done by this country in other countries, particularly pharmaceuticals particularly with the HIV studies because I think there is a lot of room there where we could contribute both pro and con and reasons for placebo and not placebo, et cetera. I think that is something we could tackle in a short amount of time and do a reasonably good job. Then the education I think is also very important to do because I think there is a lot of misconceptions about suggestions we make or other bodies
184 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 make particularly from the media and I think that is where we should start with the educational process. And then the behavioral research. We had mentioned before, and I do not know if that has just been lost somewhere, about addressing the issue of research with children or involving children. I think this is where maybe we could tie it in particularly because I think there is a lot of problems with behavioral research lacking in children for various reasons so I think that is where we may be able to tie that in if we decide not to address that specifically at this point. DR. SHAPIRO: Thank you. Jim? DR. CHILDRESS: I very much like the list of immediate concerns and I think I would also note that several of these the Humans Subjects Subcommittee has raised at different points as important for us to cover. I would also mention that a few of these may have a higher status than this indicates. For instance, gene patenting, as I recall, was one of the things we were asked to look at by -- perhaps even in our charter. DR. BRITO: The President, yes. DR. CHILDRESS: Certainly the -- I think one of the documents that established us. So one question would
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183<br />
1<br />
2<br />
3<br />
4<br />
5<br />
6<br />
7<br />
8<br />
9<br />
10<br />
11<br />
12<br />
13<br />
14<br />
15<br />
16<br />
17<br />
18<br />
19<br />
20<br />
21<br />
22<br />
23<br />
24<br />
-- there has been a change of heart amongst some of the<br />
members or you just want a clarification?<br />
DR. SHAPIRO: No, there has not. Even if we<br />
wanted to be, we could not be, but I do not th<strong>in</strong>k -- my<br />
sense is no. I did not <strong>in</strong>terpret the comments Eric made<br />
that way. I <strong>in</strong>terpreted them as the question of whether we<br />
should be suggest<strong>in</strong>g regulation to whoever the regulatory<br />
bodies are but that is how I <strong>in</strong>terpret what Eric was<br />
say<strong>in</strong>g.<br />
DR. BRITO: Okay.<br />
In terms of the specific topics I want to say<br />
that they all sound very apropos obviously but it would be<br />
very ambitious to tackle them all. One of the ones that is<br />
very focused that I th<strong>in</strong>k we should tackle right now and<br />
has been raised before is the research be<strong>in</strong>g done by this<br />
country <strong>in</strong> other countries, particularly pharmaceuticals<br />
particularly with the HIV studies because I th<strong>in</strong>k there is<br />
a lot of room there where we could contribute both pro and<br />
con and reasons for placebo and not placebo, et cetera. I<br />
th<strong>in</strong>k that is someth<strong>in</strong>g we could tackle <strong>in</strong> a short amount<br />
of time and do a reasonably good job.<br />
Then the education I th<strong>in</strong>k is also very<br />
important to do because I th<strong>in</strong>k there is a lot of<br />
misconceptions about suggestions we make or other bodies
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