WELCOME CHAIR CHILDRESS: Welcome to the subcommittee meeting, the Subcommittee on Human Subjects Research. We had a very productive day yesterday, with a lot of important questions arising about the fine draft report that we've been working with and an indication of a number of areas that we need to do further reflection, in particular clarifying some of the concerns surrounding the category of more than minimal risk, non-potentially beneficial research, where much of our discussion focused. You've seen the agenda for today. The first activity will be looking at the draft report and we will start with the discussion we had yesterday, looking at the recommendations and seeing where we want to go with those. Then at 8:50 we'll spend some time with Gary Ellis, looking at the discussion of minimal risk, the different understandings of minimal risk, since obviously how we understand minimal risks will -- what these recommendations actually mean. That will come in during the course of our discussion of the draft report. Then at the very end of our discussion of the draft report we will talk about next steps, things we need to do to bring this in to something closer to a final version. Also, as part of next steps we need to think about whether we want to meet in L.A. Apparently the Genetics Subcommittee is going to meet in L.A. I don't have strong feelings about whether we meet or not. We may just want to see where we stand at that point and then make a decision about whether to meet. Then we'll have a discussion with Jack Schwartz, who has appeared before us a couple of times before, on the Maryland Attorney General's Working Group involving draft recommendations from that group on decisionally impaired research subjects. And Bill Freeman will give us an update on the survey of Federal agencies. We'll talk after statements by the public. Let me just mention that it would be helpful if members of the public would indicate if they would like to testify at that point so we'll have some idea of how much time will be required. So you can just sign up at the back and indicate to a member of the staff that you would like to testify at that point. Then we'll discuss future Commission research activities and building on the report of Eric Cassell's committee, and then draw some conclusions. Adjournment would be no later than 12:30. I guess I'll probably be surprised if we run until 12:30, although we obviously have a lot of important work to do, particularly on research with decisionally impaired subjects. Any other points to get out before we get down to work? Harriet, do you have any? MS. HYATT-KNORR: Not right now, no. CHAIR CHILDRESS: Okay. MR. CAPRON: Two questions. The first, is whether we need to have some discussion this morning on the question of the Federal office issue that we heard about yesterday, and that the Commission as a whole had a discussion on. We do not have -- document yet. CHAIR CHILDRESS: Right. She hopes to have that by the end of the month, if I recall correctly. MR. CAPRON: Maybe it's premature, but I did have a slight sense that we were all frustrated that we got the issues out. There seems to remain a great deal of consensus, but we need to make the determination of which is the level we want to recommend. CHAIR CHILDRESS: Well, let me raise the question this way, Alex. I think many of us, I suppose, are in a transition period of moving more toward whole Commission work, away from subcommittee work. I think one of the frustrating things about the previous meeting was that we had such a fine discussion with John Fletcher and Charles McCarthy on this particular topic, a discussion that actually would have been very beneficial to the group as a whole. You did a fine job yesterday of giving the background for that and summarizing it. So I don't know. It would certainly be possible to spend a few minutes talking about some quick responses, but it seems to me that would be a discussion that would be very useful for the Commission as a whole to have. MR. CAPRON: I agree with that. I'd like to know how we're going to have a document that will bring together the contact review that we had. I mean, it seems to me that in some way, most logically, this is a chapter of our Federal agency's report. I mean, it is a much more substantive conclusion to that report than simply reporting on restraints and weaknesses of the responses in different agencies. This is taking that picture and saying the conclusion to be drawn is a little different than simply tinkering. CHAIR CHILDRESS: Right. MR. CAPRON: I entirely agree. I wasn't really trying to say that we needed discussion here now, I just wanted to get some sense of how this fits into your time table. I think as far as the subcommittees, I mean, my hope is that the subcommittees are history and when we talk about meeting on these topics from now on we're talking about all of the -- CHAIR CHILDRESS: Good. No. I quite agree with you. I guess the current plan, and we'll talk about this a little more when Bill Freeman reports, would be to finish the report in the area of genetics on tissue samples and to finish the report on decisionally impaired research subjects, and then to finish the report on the Federal agency. So that would give some sense of the timing. As I understand it, that's the time frame. Let me get Eric in and he can really address it better. DR. DUMAS: Well, I see the subcommittee's working on behalf of the whole, so I wouldn't have any objection at all for this subcommittee to make recommendations, specific recommendation, to the body in regard to this issue which I think we can settle and move it off of the agenda. It seems to me that there is a lot of agreement that we need a place to take care of these concerns. So, I feel impatient to get the things we can make decisions on decided. My suggestion would be that we discuss the report, that we make a recommendation to the body as a whole, and that we'll move that part of our business forward. CHAIR CHILDRESS: And I think there is a lot of wisdom in that. The only problem that has come up is that it is often difficult, and we saw this in the discussion yesterday, to recapture the kinds of arguments, and particularly some of the powerful elements attached to them, in the context of the larger discussion after we've had the subcommittee discussion. In this particular area I think we've lost a lot in not having the whole Commission hear those two reports last time. I think we'd be a lot further along. So the question is whether we want to spend the time doing it today or whether, as I think I like the suggestion that we really talk more about a plan for doing it with the larger Commission. Eric? MR. MESLIN: The only thing that I would add, substantively, is just on the organizational front. It would be very useful for us to have Dr. Gonzales' paper in hand, and we should have that within the next, we hope, week or two. Although that is not identical to the McCarthy-Fletcher proposals, complementary as they may be to each other, that was part of the process of gathering some findings that will inform the Commission. I think it will be entirely possible for staff to put together a document that both summarizes where the debate is and, with input from Commissioners, provides a framework for how to resolve this issue and, as you say, get it off the table. It is a fairly important subject and I think we'd like to hear a bit more from the Commissioners at the appropriate time--this might not be it, unless you feel the need to speak up--as to whether it will join the Federal agency's survey as an appendix or a chapter or whether it will be a stand-alone document that will accompany it. So this is something that we can continue to discuss, but it is a high priority subject because, as you say quite rightly, it is something that we can attend to, having heard a good deal of conversation already. CHAIR CHILDRESS: Rachel, sorry. I hadn't noticed that you were here. Did you have anything you wanted to say at the outset? MS. LEVINSON: No. Just let this continue. CHAIR CHILDRESS: Okay. Any further points about this? MR. CAPRON: Well, not a further point, but I'd like to sort of see where we're going on the conclusion. Could you give us a sense then, would it be reasonable to expect that at the March meeting we would have from staff, or the April meeting we would have from staff, a document drawing on the previous discussion, drawing on yesterday's discussion -- in a way, what I was, in a very rough fashion, trying to do orally was to present what seemed to me to be the elements that would go into that, abstracting them, boiling them down from the excellent papers. If the staff has that material -- I'm with Rhetaugh on this, that it doesn't seem as though it should take up a lot more of our time and we ought to move on. But I think that we're at a point on many topics where moving on means having not the oral agreement, which we seem to have, largely, but really on the table the draft document, and we can sign off on that, even if we saw, well, we're going to hold it for a month or two, or three or four, while it goes into some other document which won't be ready until that time. That's fine. We've gotten through that. I just want to get a sense from you, are we saying March, April? MR. MESLIN: I see no reason why it couldn't be available by the March meeting, with two caveats. One, based on your very helpful overview yesterday, I'd hoped you would be able to provide some substantive input into the writing, either by reflecting on some of the documents or offering some proposed solutions for the Commissioners to debate. I think the point of whether or not there is agreement should go not unchallenged. I think there was certainly agreement that something different ought to occur. There was not agreement as to either the exact location or what the administrative arrangements for putting that office into place would be. I think there it would be fruitful to have some further discussion by the Commission. But I think you're entirely right, it could be done by March with input, not just from you but from Alta Charo, who is not here, and had an interest in providing some commentary. MR. CAPRON: Well, Alta, I should say--and I should have made this more clear--and I did discuss this, and I think I was reflecting her views as well. So let's look at the March meeting. What I would personally urge, and maybe we need a straw vote now and maybe only if that draft is there, you could, as the staff, give us the document then with two concluding sections, one of which says the McCarthy-type version, the other says the Fletcher, then we could have the discussions once we have those before us. I would hope that you would vet the idea with it as widely as you think it's appropriate so that, beyond the thoughts of Fletcher and McCarthy, there may be further refinements, there may be issues that are essential to be addressed that they haven't addressed, et cetera. CHAIR CHILDRESS: Yes. Okay. Rhetaugh, do you feel comfortable with this direction? DR. DUMAS: Oh, yes. I'm flexible. CHAIR CHILDRESS: It sounds as though you want it moving forward. DR. DUMAS: Yes. I just think we take too much time -- CHAIR CHILDRESS: We hear you. DR. DUMAS: -- to make decisions around here. But I can't have it my way all the time. CHAIR CHILDRESS: And I'm assuming that you could provide, for example -- I think it would be very helpful if all of us would have a print-out of your -- MR. CAPRON: Yes. I can do that. CHAIR CHILDRESS: That would be helpful. Okay. Anything else we need to talk about regarding our agenda? (No response) CHAIR CHILDRESS: Okay. Let's start with the -- well, let's see. One more thing. Let me note that everyone should receive at the table this morning a copy of the 10 or 12 pages provided by Paul Oppenbaum for insertion, with modifications, the two sections of Chapter 1, and we'll come back to those pages in due course today. Was there anything else we needed to -- (No response) CHAIR CHILDRESS: All right. Jonathan, anything you'd like to say following yesterday's discussion? We will start with the recommendations, pick up where we left off yesterday, and then move to other portions of the draft document.