NEXT STEPS THOMAS MURRAY, Ph.D. DR. MURRAY: Yes. We have a bit under 25 minutes left and we have-- We are at the point of the agenda where we were going to talk about next steps. I hesitate to cut off the discussion about the boxes, but I think we do need to talk about next steps now. Can I ask one quick thing? Tell me if I am way off line about this. My sense is that we just sort of talked about 1a through f; that 2 and 3a-f are all going to include basically the same thing as 1a-f, with the possible addition of some community consultation. Do I misunderstand it, or is that the likely direction we are headed? So it is going to be that, plus, in each? DR. GREIDER: Well, we already discussed all the 1 issues, so I think the discussion would be-- DR. MURRAY: Right. So 2 and 3 is that, plus whatever we said about community. So, in way, filling in the remaining dozen blanks shouldn't be a back-breaker. DR. EMANUEL: Well, we still have to decide whether it is going to be two or three categories. We haven't discussed that. DR. MURRAY: We have to decide that. And my sense-- What I want to say then is do you think it would be appropriate to put that high on the agenda for our half-day in January? Remember, we have a half-day as a subcommittee and then a full day as a full commission, then the human subjects-- DR. MIIKE: I think it will take the whole half-day to discuss it. DR. MURRAY: It may. It may. Except I have a feeling we-- We have a lot of clean up of stuff to do from today even, but I have a feeling that we are fairly close on the community consultation issue. Would that be appropriate? Okay. Let us make that an agenda item. In that case I have several other things I would like you to--the staff and I--would like you to please help us with. The first thing is, in your packets, you should have received a draft outline of the report. It says "Draft -- December 7." We have Kathi Hanna to thank for this. I suppose I will ask you to do two things. One is to take a quick look at it, if you haven't already. If you know immediately of anything that needs to be changed-- I think changing the order is the least important thing. It has more to do with are we covering the right issues? Is there anything of significance being left out? Is this complete? Now, if you don't see anything today, you should please take this with you, make it the first thing you study when you get home, or on the way home, and get in touch with Kathi, the NBAC staff, and actually the rest of the subcommittee, myself included. DR. GREIDER: Can we ask questions now? DR. MURRAY: Yes, absolutely. DR. GREIDER: The two first points, "medical" versus "genetic" information. What does that mean? MS. HANNA: Well, I was hoping you would all let me know today what that means. I think I need some input on that. I keep hearing that, by and large, it is not different, but I think there is two reasons why you are going to have to be very explicit about why you are saying that. One is just from the point from which you are arguing your recommendations; you have to be clear about that. But also because this is the Genetic Subcommittee and I think you need to make it clear to the readers of the report why, right up front, you chose to really not make a very clear distinction. So I would like perhaps a few volunteers that I can pick your brains a little bit, either through e-mail or over the phone, and help me develop the explanation of that whole argument. DR. MURRAY: It is actually I think a good idea to have us each take some responsibility for pieces of the report. You can take responsibility for more than one piece. I would like to have everybody involved in at least one piece. What does it mean to take responsibility? It means to be a primary reader of drafts, whoever generates the draft. In some cases, depending on your wants and abilities, it may mean helping to draft bits of it. I mean, a paragraph here, et cetera. But I would like to see some specific assigned responsibility, self-assigned, so I am going to volunteer to help with that one. Anybody else? MR. HOLTZMAN: I will help on that one. DR. MURRAY: Steve is going to help with that. DR. EMANUEL: Our understanding there is that we anticipate that our recommendations are going to apply beyond genetic tests; that it really-- It is really any research on stored tissues. DR. MURRAY: Right. DR. EMANUEL: And as to whether that applies beyond that to stored information, medical information, I think is also important because the appropriate section in the regs is broad. Let me just quickly remind people it says, "Existing data, documents, records, pathological specimens or diagnostic specimens." Okay. That is what the current and existing regs apply to. DR. MURRAY: Right. MS. HANNA: I think this has to be considered in the light of the fact that there are a lot of definitions of genetic information that are being floated around right now, both in the pending legislation and in existing legislation. And so, to the extent that the subcommittee can either concur or refute those, I think it would be useful. DR. GREIDER: So we need to cite some of the things that are already out there and say, "It has been said that there is a distinction and we think that there is not because..." DR. EMANUEL: Or it is not relevant in this category. DR. MURRAY: I think that is right. DR. GREIDER: Yes. We just have to be explicit. DR. MURRAY: That is right. Who would like to help with III, Public Knowledge and Beliefs? Remember, we are not going to ask you to do things you are uncomfortable with. At a minimum though, it would be someone that Kathi could talk to and share drafts with for comment. DR. MIIKE: Okay. I will volunteer. DR. MURRAY: Larry, thank you. If you don't volunteer I may twist your arm in private later. I don't know if that is informed consent. It is a warning though. Human Tissue Samples in Research? Carol. We may, since David is not here, we are going to assign him to that section. DR. MIIKE: You know, on that one, there seems to be--the last dash of the second bullet--everything else seems to be very scientific, but then the uses that such information might be put seems out of-- It doesn't match the rest of that. It gets into the social implications type area. So maybe-- So I was thinking maybe that should not be part of that section but-- DR. MURRAY: Part of the Overview? DR. MIIKE: Yes. Part of the Overview. DR. MURRAY: Okay. I tentatively put it up there. DR. MIIKE: And obviously diagnosis and treatment stays in there, but the public health planning, managed care decisions kinds of things should really go up there. DR. EMANUEL: I would also recommend it is not clear to me that existing scientific medical policies/directives/guidance, i.e., the current debate, appropriately goes under that. I mean, what I took this section to be is what are the samples we have and how are they used? What are the sort of kind of paradigmatic cases? Whereas the recommendations floating out there might be more appropriate to either Status of Current Policies, VI. DR. MURRAY: Okay, V, Principal Issues to Consider. DR. GREIDER: The volunteer's name is right in the front there. DR. EMANUEL: Thank you, Carol. MS. HANNA: I have kind of an operational question on this section because obviously Section V and Section VII are linked. V is really the discussion I think of the issues and then presumably, if today is any evidence, then VII is kind of your walk through the boxes. So, Zeke, maybe we can talk at some point about how to separate out the kind of discussion versus the recommendations. DR. EMANUEL: Or one question is whether-- I mean, the way you have structured it here, I think either V goes after VI--that was going to be my next recommendation--or V goes after II. That was, you know, you have got to have the framework either right up at front, or right before your recommendations. Now, I think there is a reason-- There might be a good argument to have V after VI because we are, in some sense, re-writing the kind of presumptions. You know, we are no longer interested in anonymous tissue. We are combining research and clinical in many categories. DR. MURRAY: I think that is right. I think that is a tentative reorganization, so we are basically switching V and VI. DR. EMANUEL: So then what we have is, I would estimate, a very brief paragraph, a brief chapter--sorry--outlining the sort of framework we are adopting and the justification for that framework, and then a much more detailed, "This is what we mean in each one of those boxes," which would be VII. DR. MURRAY: Yes. One thing I don't think I see here is the sort of fully fleshed out discussion of the ethical, ethics and values issues. MS. HANNA: Right. And, I mean, they are kind of lumped under Section II right now. DR. MURRAY: Right. MS. HANNA: And we, Tom, we had talked about this a little bit; that I felt like we were still missing that piece that would talk more generally, not from a religious perspective, but from a more ethical perspective on things having to do with harm to individuals, privacy, wrongs. DR. MURRAY: Yes. Yes. MS. HANNA: Group harm. DR. MURRAY: What is the sense here of the commission? Should we-- Has that become a separate chapter? Does it become a separate chapter? DR. EMANUEL: Yes. It should be IIA there. MS. KRAMER: IIA? DR. MURRAY: Okay. DR. EMANUEL: That is where I would put it. DR. MURRAY: Yes. DR. MIIKE: Then should religious perspectives go in there rather than Public Knowledge? DR. : I think so. DR. MIIKE: I am just trying to see-- MS. BACKLAR: And I would wonder if you would like Public Knowledge and Beliefs before that. It seems odd to do the ethics first-- REPORTER: Could you use your microphone, please? MS. BACKLAR: --and then Public Knowledge and Beliefs. REPORTER: Use your microphone, please. MS. BACKLAR: Oh, I am sorry. It seems odd to do ethics before Public Knowledge and Beliefs. DR. MURRAY: I actually agree with that. DR. EMANUEL: Really? DR. MURRAY: Yes. DR. MIIKE: Well, except that the ethics part is included in the current debate. The public perception is not. I mean, what has brought this issue to the fore and what are the kinds of things that are being discussed? MS. BACKLAR: That is true. DR. EMANUEL: My own view is that I would have moved the public perception after the Status of Current Policies because, in some sense, the public perception, you know-- Here is my line. We have an introduction to the problem, an overview of the current debate, the ethical and religious values at stake, the kind of samples we have, and research that we are likely to use them for, the kind of rules and regs we have, and where the public weighs in, or might not weigh in. And then we talk about our framework. DR. MURRAY: I am easy, Zeke. That sounds fine. DR. MIIKE: So that goes after the current VI. DR. EMANUEL: Yes. DR. MIIKE: And then your V goes after the current III. DR. EMANUEL: Right. Is that clear, Kathi? MS. HANNA: Yes. Now, the one thing that doesn't really-- I mean, if you look under Section VII, what I have kind of loosely called "security mechanisms," which is the more procedural handling of the tissues and the encrypting and all of that, at the last meeting we talked about it a little bit more extensively that, you know, the wall, the fire wall. We didn't really talk about it today. But at some point I think that has to be more. People have to agree really on what is being said there. So maybe at the next meeting. MR. HOLTZMAN: Could we get a hold of Klausner at the NCI because I was talking to Eric Lander last night and he Botstein(?) put together something they sent to Klausner on the one-way permeable membrane about a year and a half ago. DR. MURRAY: There is also a piece in the latest edition of The Journal of Law, Medicine and Ethics about medical records privacy, including various kinds of ways of protecting, and some of the dangers. So I will be happy to share those with you. Well, actually copies of the Journal are going to all the members of the commission. MS. HANNA: Right. DR. MURRAY: So you will be getting it. DR. EMANUEL: Kathi? Maybe we could go down VII for a second. I think this retrospective versus prospective, which we have renamed, really belongs in V, what will be future VI, or whatever. Sorry. DR. MURRAY: Let us use their names. DR. EMANUEL: Okay. The general framework that we are using. DR. MURRAY: Yes. DR. EMANUEL: Then I think we need to talk in general here about the kinds of protections we are interested in. The anonymity protections and, therefore, the one-way permeable membrane, the issue of trust, the kinds of levels of consent. And then I think we go, in this chapter, to the different boxes. You know, what is the judgement in each of those boxes? And actually, as we are talking, as we were-- DR. MURRAY: Except the boxes collapse. Some of them collapse. DR. EMANUEL: Right. DR. MURRAY: Say all research on identifiable tissues looks like-- DR. EMANUEL: Right. I would only raise a flag in people's mind. In what way now, on the samples to be collected in the future, is clinical research-- Is clinical-- How is the sample collected under the guise of clinical care, different from samples collected under the guise of research? Have we now collapsed, as we did previously, those two columns, if we are no longer making the presumed consent versus general consent? If we are making it all general consent, I submit to you we may, in fact, have collapsed the research and clinical care section. MR. HOLTZMAN: We have with respect to general consent to unspecified studies. DR. EMANUEL: Yes. I think people ought to think about that for the opening of the next meeting. DR. MURRAY: I didn't get-- DR. EMANUEL: Sorry to-- DR. MURRAY: I didn't get to-- That is okay. I didn't get to finish assigning sort of accountability for these sections. Steven and I are going to look at the Overview. We now have a chapter on Ethics. I am certainly going to stick my nose in that one. Who else would like to work on that one in particular? (No response.) DR. MURRAY: Public Knowledge and Beliefs. Larry. Human Tissue Samples in Research. Carol and perhaps David. Principal Issues to Consider. We have nominated Zeke. DR. EMANUEL: Right. DR. MURRAY: Anyone else? (No response.) DR. MURRAY: Status of Current Policies. Who would like to help with that? DR. EMANUEL: I certainly could. DR. MURRAY: Yes. Well, some of us haven't-- MS. BACKLAR: I haven't volunteered for anything. DR. MURRAY: Policy Options and Recommendations. DR. LO: I was going to volunteer for that. DR. MURRAY: Bernie is volunteering for the Policy Options chapter. Zeke is volunteering for the Status of Current Policies. There are a few of us who have been relatively quiet. MS. KRAMER: Noticeably. Where would you like me to go? DR. MURRAY: Bette, since you were so involved in the Public Knowledge and Belief piece and helping to put the idea of the mini-hearings together, would you be willing to work on that one? MS. KRAMER: Uh-huh. DR. MURRAY: Thank you. Now, we don't have anybody-- Well, no, that is a sub-issue. And, Trish, did you have anything in particular you wanted to work on? MS. BACKLAR: No. I mean, I was interested in the section for the discussion groups and also the ethics. We already have been discussing these. DR. MURRAY: Okay. So I am going to put Trish down for the Ethics chapter and for the old III. MS. BACKLAR: But I am concerned-- (Technical difficulties.) DR. MURRAY: Okay. Any-- I need this. Any further thoughts on that, let us share it with each other. Do we have any pieces that we need to get written that we need to hire somebody for? We will-- We thought that there might be a good role for, say, a 2,500 word piece to summarize the ethical issues on both sides, which we thought one of the contractor's paper would do, and it did some other very useful things, but not exactly that, and so if you have any thoughts about who might do that, we do have some thoughts about trying to get that done rapidly. MS. KRAMER: Tom? DR. MURRAY: Yes, Bette? MS. KRAMER: Would it be possible for us to get a new chart of the boxes with a synopsis of what we have done? DR. EMANUEL: What we have agreed to? MS. KRAMER: Uh-huh. DR. MURRAY: Yes. DR. EMANUEL: You mean just 1a-f? MS. KRAMER: Uh-huh. DR. EMANUEL: Yes. DR. MURRAY: Zeke, the offer is that, if you even just want to mark it up by hand, the staff will produce it, or if you want to do it-- DR. EMANUEL: All right. I have it on diskette and I will e-mail a thing to you, Henrietta. DR. MURRAY: Thank you. I should note that we want to think about the meeting in January; about the issues that we just want to deal with. We know we are going to talk about the community consultation piece on the first half-day. But the things that we really would like to see brought up for the full commission, possibilities. And there are things that the full commission, the other half of our commission, has been working on, including issues about informed consent, you know, the composition, behavior, et cetera, of IRBs, the idea of the community consultation research, et cetera. So I don't think we need to make a decision at this moment, but please think about which issues you would like to see us most especially focus on in our joint meeting. DR. EMANUEL: Tom, I think, you know, we have had a number of meetings without them. If we don't, in some sense-- I mean, one of the big things that we have to go through to get them up to speed and understand, we need some brief overview of the current debate. DR. MURRAY: Yes. DR. EMANUEL: We need some summary of the available human samples. I think we need to remind them about the current policies. They haven't focused in on it. And then talk about our framework and where we come out. I mean, it seems to me that, until they get all those pieces in place, they can't even, in an educated way, participate in the discussion and, you know, that is frustrating for them and it is frustrating for us. DR. MURRAY: Well, our hope and expectation is that they will have at least a draft of major sections, drafts of major sections of the report by then. That is our hope. DR. : By January 9th? DR. MURRAY: Before January 9th. DR. EMANUEL: But I think-- DR. MURRAY: The meeting is January 9th? MS. HYATT-KNORR: It is the 7th. It is the 6th and 7th. DR. EMANUEL: Yes. It is the 7th. But I think much more realistically we should plan for maybe either a half-hour or hour dog and pony show, frankly. DR. MURRAY: No. I think that is right. By the way, I have put in a bid, because I think our report is closer to fruition than what is going on in the Human Subjects Committee, for us to have more time to present our report than if we just split the meeting 50/50, which means we would have to then say, at another future full meeting, that we give them more than half the time. But I think that is utterly appropriate and it is in the commission's interest and in the researcher's and subject's interest to get this thing done as quickly as possible. So I will put that-- I will continue to press that bid. I think Zeke is right. We will have to take a half an hour, or an hour to just sort of lay it out for them, and then we should have just the issues that we think are crucial to discuss before them. It has been pointed out to me that it would be useful to involve-- There have been voices that have been present pretty continually, continuously in our deliberations, and there are other voices that haven't been so present, other perspectives. It would be helpful for us to identify other groups, individuals, who we ought to be showing the report to, talking to--whatever--so that we make sure we are not, you know, that we haven't ignored significant perspectives. So if you would think about that, that is another thing which you could communicate by e-mail to the rest of us and to staff. That would be very helpful. Bernie? DR. LO: A question about potential other bits of information you want to gather; to go back to what we were talking about right before we talked about next steps. Do we want to try and compile some compendium or article on what is being done to improve informed consent to these types of studies, and where we stand, and what the likely time-table is? I mean, what some of the sample documents are? DR. EMANUEL: An appendix, you mean? DR. LO: Well, just so we could gather all that so we know, you know, against what moving target are we taking our-- DR. MURRAY: Yes. What is the best way to accomplish that, Bernie? I think it is a good idea. DR. LO: I don't know if staff can do it. If there is someone we could contract to do it who is-- MS. HYATT-KNORR: I think we ought to give it some thought and get back to it. Let us say tomorrow. DR. LO: I know. But people in-- MS. HYATT-KNORR: I think it is a two-pronged effort. I think you want to do a literature search and you want to write something up. So let us give that some thought and get back to you tomorrow. DR. MURRAY: And it may be that the other half of the commission has already done some of this, so I will count on staff to brief us on that and communicate with us all soon. Any other urgent items? We are approaching 3:30 p.m. Bette? MS. KRAMER: Is this on? Is there any information out there that we could have at our disposal to help us as we are thinking about community issues? DR. LO: We are going to try to ask Jack Killen. DR. MURRAY: We are asking-- Yes. As Bernie said, Bernie and I approached Jack Killen. We thought what he had to say was very interesting and we encouraged him to write it up, and he had the same idea. I hope we will have something from him. I don't-- I am not aware of a sort of really good evaluation of scholarly resource on this. In fact, I think we have identified a lacunae in the literature, which ought to be filled as rapidly as possible, but probably it won't be filled rapidly enough to be part of our deliberations. It will take a while. DR. EMANUEL: I forget whether we have seen Charles Beers'(?)-- DR. MURRAY: No. I have not. DR. EMANUEL: We haven't shared it yet. I have seen a prior draft. DR. MURRAY: I have not seen it. Could you share-- Can we see that? MS. KRAMER: That is the paper you said that was coming. DR. MIIKE: You know, maybe over two years ago, Gary Ellis and OPRR was very interested in the issue about communities and community's responses and information in terms of our research projects. Remember, when we first started as a commission, there was the Canadian report that talked about collectivities and things like that? DR. EMANUEL: That report is reviewed by Charles and sort of-- And that actually turns out to be a derivative report of something that went on in Australia, but it has got some, you know-- I mean, part of the virtues of his paper is he outlines the pluses and minuses, but doesn't lay out sort of prospective positive this is where we ought to go. DR. MURRAY: In case this is mysterious, as I understand it, this is a paper commissioned by the other half of the commission, the Human Subjects group, so that paper, as soon as it is in a suitable form, which may be already for all I know, ought to be circulated to all of us.