THE USE OF HUMAN BIOLOGICAL MATERIALS IN RESEARCH

DR. SHAPIRO: Thank you. Anything else on this? If not, I want to go back, to use what few minutes we have left to decide just what next steps we should take with respect to the Human Biological Materials Report. And since I want to work on this letter, I'm going to turn this over to you, Eric and Tom, to take the last few steps there.

DR. MURRAY: Right. Our numbers are dwindling, and I think they are likely to dwindle further rapidly. Is that a fair assumption? Okay, so let me get your advice then, rather than try to engage in a more substantive deliberation. What's the next step? Now, Kathi, you have certain ideas about when you'd like feedback from us on the report. Why don't you tell us that, and then I want to convey what I thought were some very good observations by Mark Sobel about our request for turnaround for public comment. Kathi, tell us when you'd like to hear from us.

DR. HANNA: Tomorrow. No, actually, as soon as you can get your comments to me the better. At some point we're going to just have to stop the discussion and get the report out for public comment. If you can get comments on Chapters 1 through 5 back to me by no later than Wednesday of next week, that would be most useful. If things come in after that, we will do our best to accommodate them.

DR. MURRAY: When are we going to try to post a draft of this?

DR. HANNA: We would like to get this ready to go out for public comment by December 1st.

DR. MURRAY: All right, so next Wednesday is the Wednesday before the Thanksgiving holiday, and December 1st, I think, is the following Tuesday. Will that be enough time?

DR. HANNA: Yes.

DR. MURRAY: You're planning not to have a Thanksgiving holiday, is that it?

DR. HANNA: No, I just know from the patterns of this Commission that I'm not going to be inundated with a lot of comments by next Wednesday.

DR. GREIDER: You may be surprised.

DR. MURRAY: Eric has asked me to ask the commissioners the following question: is it reasonable at this point to say that whatever we put on the Web in early December, and we'll try to do it by the 1st, could properly be labeled a Commission draft? Should we vote on that? Let's vote on that. All those who think it should at this point be labeled a Commission draft, please raise your hands. All those opposed to doing that at this point, please raise your hands. We have no objections on the record to that.

MR. HOLTZMAN: Will you respect or heed that?

DR. MURRAY: Someone please remove Mr. Holtzman from the room. Mark Sobel's comment was this: if we permit 45 days for commentary and public response to what we post, and we post on or around December 1st, that's a very busy and distracted time of year for many people. It could be difficult for professional groups, for example, to organize and get comments to us in 45 days, which would be roughly January 15. So do we want....

DR. MESLIN: When's our next meeting?

MS. KRAMER: January--it's the 16th or 17th.

DR. MESLIN: 19, 20? After the 15th.

DR. MURRAY: Okay, the next meeting, I'm hearing, is about the 19th or 20th of January. My concern is, Kathi, that between the 15th and the 19th is probably not sufficient time to incorporate all the public responses.

DR. HANNA: Well, the process is as public comments come in, staff process them and try to collate and present them in a way that's useful. So that's an ongoing process. Certainly there are two considerations. One is that we are trying to avoid the practice of discussing and meeting on a report that is out for public comment, just because procedurally it gets complicated for those who are commenting when they feel that the draft is still being revised. It would be nice to have most of the public comments in by the time you have your next meeting. We can present to you, if only in a verbal format, the nature of the public comments. Some of them you will actually be able to see in a collated fashion. The second set of issues has to do with just the mechanics of staffing, which is that we need to schedule. We now have a new report that we have to contend with on top of the other reports that we haven't discussed today, which are the Comprehensive Report and the International Report, and I'll let Eric talk about the staffing issue. But we really need to get the HBM Report progressing rapidly.

DR. SHAPIRO: I think 45 days is more than enough time, and I understand it's an unusual period, but nevertheless I think it's more than enough time. And in any case, it's the time we have. And so we ought to just make it happen in that time.

MR. HOLTZMAN: Is there a formal way we can get out to the professional societies tomorrow that we will be posting this on thus and such a day, so that they can put in place whatever is their process?

DR. MURRAY: The comment by Eric is, we'll do our best. Please, most members of professional associations who are here, interested associations, please notify your respective organizations that we will be posting it by, we hope, December 1st. We would hope to get your comments by January 15. That doesn't mean that you can't continue to give us comments, but we would very much like to have whatever you can do available to staff as early as possible so that we can consider it during the meeting in January. I think we should simply heed our chair's advice about this.

DR. SHAPIRO: Are there any other issues about compiling or process for the Human Biological Materials Report that commissioners wish to raise at this time?

DR. HANNA: That's what I said....

DR. SHAPIRO: Okay, David?

DR. COX: I would just like a clarification. Kathi had three questions for us, and when we leave here today I'd just like to know what our conclusions were concerning those three questions.

DR. MURRAY: Yes, no, maybe, and on alternate Thursdays, those were the answers. No--Kathi, what was your understanding of the answers?

DR. HANNA: My understanding is that for question number one, we will take up Dr. Shapiro's suggestion, which is that in the recommendations when we refer to what we are now calling "unidentifiable" we make it clear that we're talking about "unidentified" and "unlinked"; even though we are treating those the same, we will keep the distinction in the text so that investigators understand that within this category that's being treated the same way there are subcategories that might deserve special attention in the way they design a study or whatever. That's one. Number two is, I think I have a sense from the Commission that the big picture is that you see this research by and large as about minimal risk; however, there are significant types of research in this area that are above minimal risk, and we need to focus more specifically on what we're saying about those. So that just really is trying to reconceptualize the way that the report is introduced and the recommendations are introduced. On the third, we're going to go ahead and test the waiver or the dropping of the practicability requirement. We're just going to put that in the draft--and the opt-out--and see how public comment responds. And then on the fourth, having to do with saying more about future consents, staff will try to work with commissioners who have indicated that they would like to help. Dr. Lo indicated he would like us to think through that a bit with him. So the only thing we didn't address in there was my question about redefining what we call consent in the clinical context, and if you want to just respond to me by e-mail or whatever, it's not a significant issue. I don't think we need to take up any time on it.

DR. MURRAY: If there are no other specific clarifications or comments about the process and timing of the Human Biological Materials Report, I'd like to turn it over to Eric Meslin.

DR. MESLIN: For those who are keeping track of the agenda, I just wanted to mention for the record that there were two items we did not have an opportunity to discuss at this meeting. The first was the Comprehensive Human Subjects Project, for which an update was going to be provided. We will circulate materials to the Commission on that; you already have some from discussions with Kathi and Alta. Second, and with some regret, I did want to report--the report is I didn't have enough time to do it--report on two activities on the international side of our work. One was a very successful meeting that was held in Tokyo when Dr. Shapiro and his colleagues Jean-Pierre Charchew (phonetic) and Hiro Imura (phonetic), the respective chairs of the French and Japanese National Bioethics Commissions, cochaired the single largest collection of National Bioethics Commissions in history in Tokyo for two days. It was a very successful meeting, with membership from our Commission represented by Alex Capron, Tom Murray, and Alta Charo. The resulting product of that second international summit of National Bioethics Commissions was a two-page communiqué that is now in the process of obtaining final signatures. There are 35 signatures from National Bioethics Commissions and seven international agencies that pledge continuing commitment to work together to look at international issues, to share resources, to work together, and to develop further research opportunities. And I think that's in no small part due to the leadership of Dr. Shapiro and his colleagues in France and Japan, as well as to the tireless work of Alex Capron, who isn't here today but who worked extremely hard in helping to convene that meeting and to prepare the communiqué. We will circulate it to all commissioners because it is a very nice document. And second, just to report very briefly, we have now under way, despite the fact that our research agenda is rather fungible at this point and moving in different directions, continuing our work on the international project with three Commission activities looking at empirical work both here and abroad. I won't take up all of your time now, but we'll send materials around to commissioners, both by e-mail and hard copy, and it will be available to the public if they so desire, which describes the work in progress. I'm hoping that at our January meeting, then, there will be a more full discussion of the progress that we're making on the International Report.

DR. SHAPIRO: Thank you very much. Any other business to come before the.... Bernie?

DR. LO: I think this is sort of a good opportunity for us to pause and take a big deep breath. I mean we've got our second report almost out the door; we've made, I think, good progress on the Biological Materials Report, and we've gotten this big, new assignment. And I guess I'd like to think through a couple of issues: one, given the importance and the short time course of the President's request, how are we going to set priorities to make it realistic for the staff and everybody? And then second, could we reflect a little bit on how we've worked on these two reports? I understand it's very tough doing two reports at once, but in looking back I think a lot of us are frustrated that we somehow took this long to get to where we are. And if we're going to be entering a phase of having potentially three new projects getting off the ground while we're finishing the Human Biological Materials one, can we think a little bit about how we can make our deliberations more productive? On the one hand, I think sometimes--like perhaps this morning with the Human Biological Materials--we seem to get a lot done and really make progress. And at other times I think there's a sense that we're going back to issues that we had talked about before and going in circles. And given what we're asking ourselves to do, it might be a good time for us to reflect a bit on how we can do our job even better.

DR. SHAPIRO: I think that is always an appropriate thing to do, and maybe an especially appropriate moment now. I want to make a couple of comments. I don't think we can easily carry on that discussion today, we don't have time, but I think it's a very important discussion to have. And so I appreciate you raising it. First, it will not be possible for us to proceed on anything like this agenda if we don't have a new understanding regarding the resources available to the Commission. That's just not going to be possible any other way. And that's something we're going to have to talk about and report back to the Commission about it. A second issue is not only how we organize our meetings and our staff and so on, but how responsive the commissioners are to requests that we send out. Now the frank truth is that sometimes we hear nothing, sometimes we hear a lot, sometimes it's all up and down. And we're going to have to ask ourselves, those of us who are members of the Commission, how much, given the fact that all of us have so many different commitments, whether it's realistic to give the commitment that's necessary to get this going at a faster pace. And other staffing issues also need to be addressed. So I'm very appreciative and embrace the issue. We should have at our next meeting some time to discuss explicitly these issues, and by that time we'll have more information. Other issues to come before the Commission? Once again, excuse me, Bette.

MS. KRAMER: I want to thank, on behalf of all the commissioners, I'm sure, thank Arturo for the arrangements for this meeting. It's going to be hard to go back to Crystal City.

DR. SHAPIRO: That's right, it'll be hard to go back to our normal venues. We may never go back; you'll never see us again.

DR. MURRAY: It's no Cleveland, but it's nice.

DR. SHAPIRO: Where is the Rock and Roll Hall of Fame, anyhow? But anyway, thank you, Arturo, very much. I'm very glad to have been here. Enjoyable for all of us. We are adjourned. Thank you.