DISCUSSION CONTINUES ON RESEARCH WITH DECISIONALLY IMPAIRED SUBJECTS: DRAFT REPORT CHAIR CHILDRESS: Okay. Let's get started again. Okay. Jonathan wants to say something. DR. MORENO: Just very briefly. I just spoke a few minutes ago to a relevant section of the report that speaks to attempting to array examples of minimal and greater than minimal risk, is not on pages in the 90s, it's in the 70s. It starts on page 73 and goes on for about 8 or 10 pages. CHAIR CHILDRESS: Let's pick up our discussion and see if there's anything else you want to say about minimal risk. We've noted that the problems, the difficulties, in defining it and specifying it. What I would urge people to do, since this does play a crucial role in the document as you have it, is actually to look over those pages very, very carefully and let's do some e-mail exchanges. I mean, let's really now pick up along the lines of the cloning report, movement toward modifying this in a way that can get us to a final draft. Those who feel particularly strongly about things, let's come forward with proposed language and let's move it. Now, connected with that, I see Laurie and Jonathan had a conversation over the break about interpretation of benefit. We do concentrate on the risk side in our discussions, but obviously the benefit side is also important, where we are talking about the probability and magnitude of benefit parallel to the probability and magnitude of harm or discomfort. So let's have a few comments about that since I think their discussion, as I understood it, was potentially instructive, potentially beneficial to our group. Laurie or Jonathan? MS. FLYNN: Well, the comment that I made was, I continue to have real reservations about the structure that was laid out here in terms of greater than minimal risk with no potential benefit, in part, because my understanding of the concept of potential benefit is pretty direct, pretty immediate, and pretty readily and likely to happen for the individual who is the subject of research. That's what I thought our text was saying and that's my understanding of potential direct therapeutic benefit. Jonathan, I think, has a view that is different and appears to feel that the definition may be somewhat more elastic and more broadly applied in the real world than the way I'm seeing it. I think it's useful for us to understand, how is that term defined, what is meant by potential benefit to the patient? I think we really had no conversation, no inputs from the research community or others, as to how that term of art is used when IRBs make decisions. CHAIR CHILDRESS: Okay. DR. MORENO: Laurie has expressed, in essence, what I said to her during the break. Namely that, without endorsing this view, my experience as an IRB member is that the notion of potentiality is, indeed, quite elastic and that investigators are given a relatively large amount of leeway in identifying what could conceivably be of benefit to the subject, including even simply a closer monitoring of the subject. In the experience with the early HIV studies, for example, this was a very common point that was made by investigators, that potentiality of benefit for subjects could include simply getting better health care. That gives rise to other issues about access to health care and so forth, but we're putting those aside for a moment. So what I was saying to Laurie was that, perhaps in practice, more kinds of studies can be captured by the concept of potential benefit than one might at first think or one might think is philosophically ideal. CHAIR CHILDRESS: Jonathan, since I don't have the document fully memorized at this point, I can't remember how well we do it in the document. DR. MORENO: Probably not as well as we ought to do, because the document does try to walk the straight and narrow philosophical line that potential benefit ought to be -- a relatively compelling case ought to be made for potential benefit for the subject. But what I was saying was that, in practice, the way this washes out in the real world is that there is more breadth given to the concept than is done in the textbooks. CHAIR CHILDRESS: Could you take as a task to elaborate in appropriate places on that and we'll have further discussion on it. Other points to be made? Let me, before we -- two other things should be mentioned about minimal risk. One, is the FDA has a statement on minimal risk and that sheet will be provided and circulated. So it will be sent to the NBAC office and then will be circulated to us. Then, second, but we won't pick this up until Alex comes back in, there's also a research project under way at NBAC in looking at the literature of trials involving decision impaired subjects to determine, here again with the uncertainties about definition, those that involve more than minimal risk, and then with an effort to look at some of the consent forms related to those research projects. So we'll want to say more about that, and both those points are connected with minimal risk. DR. CASSELL: On the issue of benefits yesterday when we were having that argument back and forth, there is a benefit to people to be treated as though they were normal persons, to be allowed to do what normal persons do. To be altruistic. One of the things that normal persons do is to be altruistic, and that that is a benefit. However, I do not want you to think that I think that's a benefit under the terms usually meant by benefit versus risk. The benefits we mean are direct, usually therapeutic benefits, not the benefits of belonging to humankind. DR. MORENO: No. But what we're -- and what concerned Laurie was not the notion of directness, but the notion of potentiality. That is the issue that was of great concern to Laurie, and how the likelihood of benefits that might accrue to being in a study -- if there's 100 percent likelihood of feeling altruistic, I suppose, though I agree with you, that's not what I would, as a professor of medical ethics, consider to be a direct benefit of being in a study. What Laurie was concerned about was the likelihood that this diagnostic test or this therapeutic intervention that was being examined would be of direct benefit to me as a subject. CHAIR CHILDRESS: I thought it went beyond that, that this might well produce something that would be of benefit to me as a subject and not simply limited to -- if we go the direction you're going in, Jonathan, it seems to me then that brings it much more clearly under what we would ordinarily think about using as traditional language, that we've gone beyond the therapeutic trials. But I would take it that Laurie is looking at the review that, even in what we tend to think about as non-therapeutic trials, a possibility of developing something that would be beneficial should be included on the benefits side. Laurie, am I misunderstanding? DR. MORENO: That's an accurate description of her thinking, just to be clear. What I was saying was that in the real world my experience is that much of what you and I sitting around an academic seminar table might think of as non-therapeutic is often construed as having benefit, not just the psychological benefits, but being observed by good doctors and nurses as part of the study might accrue to your well-being -- your medical well-being. MS. FLYNN: Again, I was focusing on many of the kinds of basic neuroscience studies that are not intended or designed to provide immediate therapeutic benefit that are looking at the underlying etiology and process of disorder. There's no immediate likelihood that my clinical condition, if I am a subject, is going to be enhanced. So I would agree with all of these discussions through the very narrow definition of benefit. DR. MORENO: By the way, also in the real world I'm sure you've all seen on consent forms -- often one sees a consent form as a statement. One of the benefits to you for being in this study is being more closely monitored, having your condition more closely monitored. Many people would consider that to be a potential benefit. CHAIR CHILDRESS: As we approach this and think about the revision of the document, one has to worry about excessive elasticity at this point. Diane, then Trish. DR. DUMAS: But knowing about that elasticity just increases my resolve that people for whom the risk is conceived to be greater than minimal should not be included in research projects. There's another point here, too. That is -- DR. MORENO: Just to be clear, you mean, should not be included in research projects without their consent or -- DR. DUMAS: Without their consent. DR. MORENO: -- without some analogous process. DR. DUMAS: Without their consent. DR. MORENO: Would you permit legally authorized representatives to make -- DR. DUMAS: Yes. There would be exceptions. Yes, of course. But I think a general rule -- DR. MORENO: Because that's the framework right now. DR. DUMAS: The general rule is that people should be informed about the research. We should make every effort to make sure that they understand what they're consenting to in that process. Now, if there is some reason why that can't be obtained through the regular process, then the conditions under which there would be exceptions should be defined. But there is also a mention in the document about benefits accruing not only to that individual, but to the population. I don't know whether we want to deal with that or not. If the benefit is to the population for which the person belongs, are we interpreting that to be a benefit to the individual? I think that distinction needs to be made. DR. MORENO: I think we're quite clear that that is not considered to be a benefit to the individual. DR. DUMAS: As long as we're talking about potential or likelihood, I'm comfortable. I don't think we can promise anything more. CHAIR CHILDRESS: Diane, then Trish. DR. SCOTT-JONES: I was just trying to look in the draft, Jonathan, to look back and review where you talked about benefit and what it means. I am just trying to see how far we're going to go with this notion of quantitative judgments because we're sort of suggesting somehow that you balance the benefits against the risk and that you have some favorable ratio of benefits to risks. I don't know if we want to do more in that regard than we've already done, and I'm not sure that that was the point of the comment that maybe there are more benefits than we've acknowledged in most research projects. Is that the point, so that somehow the benefits side will have more points on it in relation to the risk side; is that the thrust of the comments? CHAIR CHILDRESS: Well, first of all, we've just not looked at the benefits side. If we're going to include the benefit/risk ratio in the determination we at least need to say something about it. But, second, there was also a question about -- DR. SCOTT-JONES: There's quite a lot of it. CHAIR CHILDRESS: That is in our discussion. DR. DUMAS: Oh. Okay. CHAIR CHILDRESS: Our discussion is focused only on the risk part. Then there's the question about whether it can be defined narrowly or broadly. But I think -- either risk or benefit, it can't be purely quantitative because there is the qualitative element that enters in in even defining something as a harm or discomfort, et cetera. So it's going to be much more complicated, even if there is a quantitative sign. CHAIR CHILDRESS: Trish, then Rhetaugh. I'm sorry. Diane, first. Sorry. DR. SCOTT-JONES: I was just going to say, here is already at least acknowledgement of persons saying that there are indirect benefits, such as diversion from routine, the opportunity to meet with other people, to feel useful and helpful, greater access provided to professional care and support. I think we've done a lot already to acknowledge these. CHAIR CHILDRESS: Well, the point was, not in our discussion. DR. SCOTT-JONES: Oh. Okay. CHAIR CHILDRESS: Our discussion here. What we need to do is identify, since we don't have a lot of time, areas that we want to go back and now look at the report and make sure that the report does what we want it to do, and then Alex and Eric can just come in. Then really take a Dali-like approach to this, namely, over and through e-mail and faxes over the next several weeks, really push forward areas where we want to make the kind of revisions so that we can come up with a draft that we can really go through very carefully and see whether that reflects what we, as a subcommittee and as a Commission, want to hold. I have Trish, and then Rhetaugh. PROFESSOR BACKLAR: I want to back up -- very important when we go to this. We know there's potential benefits, just as we know there's risk of harm. There is that balance going on there. I also want to reiterate the subjective aspects of these personal benefits are hard to quantify. The other thing which I really actually believe we have in the report, that some of these benefits which Laurie is alluding to come about because the actual care for many of these people is inadequate. Some people come into these protocols in order to get something they just don't get outside, just like people do who have AIDS. There are all kinds of research protocols going on with different diseases where this occurs. CHAIR CHILDRESS: We'll take Rhetaugh's comment, then we'll turn to the issue I raised about the research project on minimal risk research that the NBAC staff is conducting. DR. DUMAS: What I'd like to do is share with the group what I've said to some individuals, and that is that we need to give greater attention to issues of the characteristics or the constellation of IRBs because you can't quantify the factors that are important to consider. Ultimately, the people who sit on the IRBs will have to make judgments. We need to think very carefully about, as best we can, how those boards should be constellated to get the kind of judgments that we believe that they need to make. CHAIR CHILDRESS: Alex, if you'll make your comment, we want to then talk about the research. MR. CAPRON: Yes. I want to follow up directly on what Rhetaugh just said, because I was just having a conversation with Gary Ellis and I think it would be useful for Jonathan to take a look at the language about the special composition IRBs when they're dealing with research having to do with prisoners because, as Rhetaugh has emphasized, particularly when we're dealing with these vague standards, membership is going to be important. Without having to get into the whole subject of how adequate IRBs overall are and what their composition is and their education, certainly an emphasis on a membership that would have a representative of the relevant patient populations that would be perhaps more heavily balanced towards lay people and outsiders rather than fellow researchers and physicians, or physician researchers -- for this, would be a way of giving us some comfort that the process beyond the consent issue, which is so difficult for us, is adequate to the particular needs of this population where we have a history. I want to just put on the table something. After our last meeting, I was sent a consent form for one of the studies of people who testified. I thought the testimony had been very interesting in emphasizing the quality of the consent process, and so forth. The consent form didn't come up to that standard. I wrote the investigator asking for some clarification because I was afraid I was misunderstanding what was represented in the form. The staff is now engaged in the project of looking at studies in this area that seek to involve more than minimal risk and where there are questions about the subjects being exposed to risk without real consent, and so forth. We'll be following up to try to get some more consent forms to see whether they could usefully address that aspect of the issue, because I agree with what many people have said about the importance of consent here. We all recognize that the consent form is not equivalent to the consent, but certainly a consent form which itself has problems is not likely to be well remedied by aspects of many undefined -- about that. I mean, that's what the UCLA people said. Well, yes, the form was no good, but we had a conversation in which all this came out. I think that the concern about the membership of the IRB is one way of addressing that because I think the more disinterested IRB would have looked at the form that I saw and said, wait a second, what does this mean, why are we saying this, is this accurate, is this conveying what's really at issue here? So perhaps we can address it and perhaps you could get some ideas from other areas of the regulations that already specify special make-up. DR. MORENO: Could I just -- I want to make sure that I have good guidance right now from committee members. Alex, are you suggesting that I should draft further recommendations to the effect that not only the discretionary authority that the IRB now has to add consultants and other members for specific studies involving vulnerable or special populations, but that those ought to be required for certain kinds of studies? MR. CAPRON: Yes. DR. MORENO: Okay. I just want to predict that people will raise questions about the impact of that requirement on the capacity of institutions to do studies with these populations. I can hear some folks whispering in my ear, perhaps not in this room, that the analogy to prison studies would constitute a significant drag on the ability to do research with these populations. Now, as a draftsperson I'm only pointing this out to you. I'm trying to anticipate an issue that this will -- MR. CAPRON: All protections of human subjects are a drag on the ability to do research. DR. MORENO: Yes. But when we're talking about prison research we're talking about a relatively high threshold, as you know better than I. That is, again, something that this body needs to consider. I'd be happy to draft the language -- MR. CAPRON: Why don't you draft something and we'll consider it when we have a draft. DR. MORENO: Okay. MS. FLYNN: Let me just ask a question, because I feel very strongly about this. And I appreciate very much your comments, Rhetaugh and Alex. My organization several years ago drafted a policy that specifically requests guidance to IRBs who do review a great deal of psychiatric research, that they have as members of the IRB no fewer than two representatives of the subject population and that IRBs who do not routinely review this research have an affirmative obligation to bring on as consultants not only experts who are physicians and researchers, but those who represent the community who are the subject population. I guess I'm not clear what the burden is. DR. MORENO: That language that you just used doesn't vary greatly at all from what is currently at the discretion of the IRB. What I heard Alex suggesting was that something along these lines, some proportion of the IRB, not only membership, but a further question is, should they actually be present for the discussion of that study. Very often these folks, as we all know, don't show up. By these folks, I mean, community members have a hard time attending, very often. So it's not only a matter of having them as members on a piece of paper, but also having them actually sign off on the study. MS. FLYNN: Yes. Yes. Yes. Absolutely. DR. MORENO: Okay. That helps me. DR. DUMAS: I feel very strongly that our best bet for getting change is through the IRB. If people in our communities don't show up at IRBs, we need to understand why. In some communities they do and they are very active. It's not comfortable for the scientists. Most often, the groups have more scientists than other members. So if you've got one community member and they feel overwhelmed at not having a voice, I can see why they don't come. But we need to change that. Well, I don't think I need to say anything more about that because the assumption in the past has been that the IRB is a scientific evaluative committee so it should be comprised of people who are involved in research and who have a commitment to the development of science. I think that that is only partially true, that it should also include people who have some interest in the general welfare of those who are being involved in this process. CHAIR CHILDRESS: Okay. Let me Eric to come in. Alex has to leave shortly, right? Would you like to comment on the research project? MR. MESLIN: Sure. I'll just be brief about this and tell you where we are. A couple of stand-back are with us now and we can benefit from any input that the commissioners have. Following the last meeting when Alex had expressed some interest in staff pursuing this we engaged in a number of search strategies, inductive search strategies, designed to identify those projects published in the peer review literature that seemed to meet this generalized concern of studies that involved greater than minimal risk for which not only the consent form or consent process might be an interesting indicator of whether or not protection was adequate, but also more substantively whether or not the research design itself raised any particular ethical questions. So what we are now in the process of doing--and it's a very intermediate process, there's nothing to present to you today--is we've identified probably several hundred abstracts that seem to meet this general threshold of concern. We would love to hear maybe a bit more comment from commissioners as to what they would really like to see, because the next step in this process is to contact the investigators, identified obviously by authorship on the papers, and ask whether they wouldn't be prepared to share with us a copy of both protocol and consent form. This will serve a couple of, I think, very useful purposes. One, since this isn't an investigation into unethical practices but merely an effort to understand what the nature of this research activity is, it would, I think, meet our public obligation at the very least, but it would meet, I think, the more substantive obligation to understand just what is going on. Now, we realize that the publication of a study is not identical with our ability to understand all of the nuances of what goes on in the preparation of a protocol and how consent forms in the process might be carried out. At this point, that is what our strategy is and we would hope to be able to complete a summative, if not formative, analysis of that within the next few weeks. CHAIR CHILDRESS: Any comments on that? (No response) CHAIR CHILDRESS: One other thing, before Alex leaves, I'd love for us to decide, and that is whether we want to meet in February. MR. CAPRON: Well, I'm not clear from yesterday's discussion we didn't come away with the impression that, if we're dealing with a topic in Los Angeles the next meeting, we ought to all be dealing with that. So if the Tissues Report is in a position where it ought to be discussed, I would hope we don't have Tissues or Genetic Subcommittee meetings in which the rest of us would then come in and be presented again with something which would require, for Genetic Subcommittee people, to go over that ground again and either feel frustrated that we're all so naive and unsophisticated or that they've gone off in a direction which others are not happy with. Likewise, I would hope we don't go much further on this report. We had some good feedback from the other commissioners yesterday and it helped to make clear for us areas where the report needs to be worked on. But from now on in, aren't we thinking that we're going to be meeting as a committee of the Commission instead as of a couple of subcommittees? If so, Eric, Jim, I mean, it's really a matter of saying, how much are we going to have from our various work products that are ready for further discussion to be mailed out two weeks from now, which is really what you're talking about if you're going to have a useful discussion. So part of the agenda may be this report and part of the agenda may be the Tissues Report, and the Federal Agencies Report, and whatever. CHAIR CHILDRESS: I'm quite open on this. I understood from the discussion that evolved that the Genetics Subcommittee felt the need to meet in February to move their report. MR. CAPRON: I'm just saying, we shouldn't let them meet by themselves. PROFESSOR BACKLAR: Right. I second that. MR. MESLIN: Sounds like we're going to L.A. in February. You will be hounded for your calendar availability, since we are currently trying to secure two dates in February. The two dates being either February 5, 6 or 6, 7, and not everyone has responded to that yet. It would be very helpful, since the Genetics Subcommittee knows what it will be able to get accomplished within the next couple of weeks, i.e., within the next two weeks so that documents can be circulated in more than sufficient time for all commissioners to receive and think about them, it is not an entirely revised Stored Tissue Report, it is some specific aspects of that report that will be required for a focused discussion. It would be very helpful if this subcommittee could also make the same kind of request of staff, or of Jonathan with us, for what it specifically wants to have on the agenda for the February meeting. CHAIR CHILDRESS: Could I throw out some possibilities? MR. MESLIN: Please. CHAIR CHILDRESS: One, is we've had some things identified that we need to work through. Some of those having to do with minimal risk and benefit, for instance, can be -- the addition of -- materials that we've not talked about. Basically I would say our discussion with the whole Commission did not talk about the report. We only focused on a couple of recommendations. So I'm not at all concerned about not having something to do. I think we could have a very profitable discussion with the whole Commission about this report. That, at least, is my sense. I don't know what others feel. We should really go through it and think it through, with the changes that will be made also. But not that we have to have made every single change we think would be important at this point. DR. CASSELL: And in these two weeks we'll be doing back and forth. The two weeks before our document has to be produced we'll be going back and forth on e-mail. CHAIR CHILDRESS: I should hope so, if people are willing to commit to that. I think we could have a document that would be just a step or two short. But we have to obviously get the whole Commission's agreement on certain kinds of things, and some of that will come in February. DR. MORENO: I just need to be clear, Jim, on what we can do and what I can humanly do in the next two weeks. Is your theory that the whole Commission will be working from the current draft? CHAIR CHILDRESS: The current draft as modified, which would include any material -- any changes we can make in the discussion of minimal risk, et cetera -- the recommendations based on the discussion yesterday and today, doing the kinds of -- making the kinds of changes that we're committing ourselves to working on over the next several days and exchanging on e-mail. DR. MORENO: I can certainly make some headway in modifying the current draft. I am a little concerned, though, that there will be confusion if I make -- some of the modifications are substantive, quite substantive, and that the full committee will then be at a disadvantage in not being able to keep straight which is -- MR. CAPRON: Do a cover memo. Just do a -- DR. MORENO: Yes. What I've done, and so forth. MR. CAPRON: Read these pages for that, and this is new material and very -- and we're all -- discussing it for the first time. DR. SCOTT-JONES: Could I add to that that Jonathan already did some of that by noting points, like on page 143 and 144, issues we would need to discuss, things that are not in the draft. I think doing that type of thing, and also bolding the additions so we would know the things that had already been done in response to previous concerns. I think all those kinds of things helped us to be able to -- CHAIR CHILDRESS: I agree. And we are going to have to have a discussion with the whole Commission on this document. I should note that the outside critics have had less to say about--and internal critics--about the first several chapters. It's really only at the end where most of the problems have come, but we need to think about how all the things integrate. So I think we really need to have that study -- having that with these modifications in February, if that would be suitable for -- PROFESSOR BACKLAR: I think the Genetics Committee is going to be very interested and very involved in the discussion -- same issues. DR. SCOTT-JONES: I think, in addition to the cover memo, Jonathan, or I guess any one of us, perhaps you, Jim, could lay out for the whole Commission what these issues are -- in addition to their having them pointed out in the actual draft, because I think the discussion might be more productive now if it's really focused and not so wide-ranging. CHAIR CHILDRESS: I agree. Jonathan, Eric and I will take the lead on that, but we'll circulate materials to you to review, that is, what we are going to propose along these lines. DR. CASSELL: Just for clarification -- not making any changes in the hard copy before -- e-mail -- CHAIR CHILDRESS: We need to set a closing date for this. Let's look at the calendar and see exactly when NBAC needs to send out -- MR. MESLIN: May I make a suggestion, at the risk of helping Jonathan organize his work schedule. You all have his draft from today. I don't know whether everyone has given Jonathan any comments, written or otherwise, based on that text. If you are intending to do so, please do that as soon as possible. If you are also going to be providing additional materials based on the sort of homework assignments that seem to be coming out, please do that within the next week, i.e., within seven days. DR. CASSELL: We are using as our baseline draft of December 22, 1997. MR. MESLIN: Correct. DR. CASSELL: Unchanged, at least until that week is past. MR. MESLIN: Correct. It would be staff's hope -- DR. CASSELL: The baseline draft is this draft until seven more days. MR. MESLIN: Yes. Right. And it would be staff's hope that two weeks prior to the full Commission meeting, or sometime in the week of -- I'm just guessing here -- DR. CASSELL: The 19th. I believe the 19th. MR. MESLIN: Thank you. The 19th of January. We will be sending out the briefing books or have the briefing books being prepared with these revised materials, giving the full Commission at least, and hopefully, two weeks with directions for how to make their way through the materials, cover memos, et cetera, for what needs to be focused on. I mean, I'm pleased to say that with some of our additional staffing now that's something that we can do much more efficiently, and that you will come to the Los Angeles meeting prepared to discuss those items identified in that cover memo. The full Commission will receive all materials from this point forward. Is that what seems reasonable? CHAIR CHILDRESS: Any dissent to that? (No response) MR. MESLIN: This is a good time to talk about the dates. CHAIR CHILDRESS: Okay. MS. HYATT-KNORR: The only other issue I would like to raise is a very simple one, namely, which date would you like to pick. The 5th and 6th would be Thursday/Friday, the 6th and 7th would be Friday/Saturday. We have all agreed on the 6th already, the question is just, which day would you like to add at one end or the other for yourselves. DR. CASSELL: Would we have to start first thing in the morning on Thursday if we started on the 5th? CHAIR CHILDRESS: Could we start early afternoon? I think that would be helpful for -- DR. CASSELL: We can travel out. You want to use the Thursday to get out there anyway. It's just a question of getting an earlier flight. DR. SCOTT-JONES: I can't. I'd have to do it Friday and Saturday. I teach on Thursday. CHAIR CHILDRESS: Friday and Saturday. MS. HYATT-KNORR: Thursday and Friday. PROFESSOR BACKLAR: It doesn't matter to me either way. DR. CASSELL: Thursday/Friday. MR. MESLIN: What we will likely have to do, is we will have to take one final poll with the rest of the Genetics Subcommittee members as well, and we'll have to make a decision that allows everyone to obviously be there on the 6th, which will end up being a full day. Some will be able to come for the half day, which may turn out to be the way we do this, either on the 5th or on the 7th. So I hope you will appreciate that as we're moving into this new arrangement towards full Commission meetings with everyone participating, that every effort will be made to attend as much of the meeting as possible. We realize that this is difficult, and we're making these dates on the fly with previously existing commitments for your day jobs already in place. Hopefully by February forward, we will be able to schedule the rest of the Commission meetings along the lines that we had discussed in the planning bucket yesterday. So no one should take it personally if your preferred dates are not the dates that the Commission will be meeting in Los Angeles. CHAIR CHILDRESS: But it sounds as though everyone can make the date that had been previously scheduled, and that's very important. Okay. Any other discussion of what we need to do on the report, because it's almost 11:00. (No response) CHAIR CHILDRESS: We do have two people who have indicated that they would like to offer public testimony. If anyone else is interested in doing so, if you would indicate to a member of the staff. Jack Schwartz and Bill Freeman, could you wait until after the public testimony? We only have two people who are planning to testify, we can go ahead and do that since we planned to do that at 11:00, if that will be all right. Okay. First, is there anything else we need to say about how we're going to proceed on the draft report? I think we may have covered everything we need to. But let's plan to be active and revive the e-mail exchange program and move very quickly on this. All right. I know some are having to leave, Alex in particular. Let me just thank everyone at this point for being here and for a productive day and a half. The first person presenting in public testimony is Mr. John Cavanaugh-O'Keeffe, who needs no further introduction. He is with the American Bioethics Advisory Committee. And you know there's a five-minute rule, I'm sure.