Proposed Future Project: The Belmont Report Revisited

DR. CHILDRESS: Thank you, and if Al can stay around a few minutes, it would be useful also to get your input at some point in our discussion of Belmont Revisited. In your mailing you received, we're focusing on Tab 4C, where there are a couple of pages headed "Belmont Revisited." The Belmont Report was approved in 1978 but was published in the Federal Register on April 18, 1979. And as we're coming up on the 20th anniversary of the publication of the Federal Register, Harold had asked Eric Cassell and me to draft a proposal for NBAC to consider how we might revisit Belmont. And Eric Cassell and I did that with substantial and regular input from—and very important input—from Eric Meslin; and then at Cleveland, an opportunity to get Alex Capron's input over dinner. That was very important as well and relates especially, but not only, to the second part of the proposal. So you have here a two-part proposal, and the first one is an attempt to get at what Harold had suggested might be particularly useful, and that was to have a conference sponsored by NBAC, along with other groups, to look back at Belmont but also to look forward regarding Belmont's future. And so the proposal will be to have a conference in the Spring of 1999 with substantial funding from outside groups—and I've already explored some possibilities there, if there is a fair amount of interest in seeing such a conference occur—and if NBAC agrees that it would be useful to go that direction, one proposal we have would be to think about revisiting Belmont in a conference, followed by a publication that would look at three major general areas. The first would be in part for historical purposes, but also to eliminate the present and the future, to cover some of the ground that Al covered today and look at the background, the development, and the content of the Belmont Report; that is, especially the three principles. What was the nature of the report as a product of public policy deliberation, as an exercise in public philosophy? Those principles, why those principles, etc., and a lot of questions have been raised on the material you received under 1B about those principles and how they related to existing documents and discussions. We'd be interested in hearing the kind of story, a version of which Al presented from his own experience today of those who were involved. And we'd be thinking about contributors from those on the Commission, from on the staff of the Commission, as well as from outsiders who have a variety of perspectives on the background, development, and content of the report. But then, as you've already heard today, Belmont has been around and traditions and interpretations have developed. How has the report been used? How has it been interpreted? How has it been incorporated into regulations, guidelines, IRB decisions—and we heard from Al that we'd probably have to have a lot of information there—over the last 20 years? And some examples of the kinds of ways in which we might look at this—particularly, for instance, getting chairs or staff members of other major commissions to reflect on the extent to which, if any, Belmont or Belmont-like considerations entered into their deliberations and recommendations. We've already heard some discussion today about the institutionalization of Belmont in modern bioethics. What role does it have there? What role does it have in clinical medicine? What role in international discussions? And that would be looking at the way in which Belmont has been used, interpreted over the last 20 years. The third part would look at the future of the Belmont principles. What is their promise? What problems do they appear to have as we move into the 21st century? And a few examples of the kinds of questions that might be raised here under three. Some of these have to do with the possibilities and limitations of the principles as such. Some have to do, as we've already discussed today, with the possibilities and limitations of these three principles and where there's a need for additional principles, such as a principled community, principles that were called to our attention at the very first invite meeting, or for reinterpretation of the principles as received. As we think about cross-cultural and international issues, are these principles relative to particular sociocultural groups or are they universal? What's the relevance to the different areas of research like public health, epidemiology, genetics, and so forth that have emerged, particularly over the last 20 years? Those are some of the kinds of issues that came to our attention as we tried to think about a possible conference. So I think if I may share with folks on just the first part of this before turning to the second, that one question is whether you think it will be fruitful for NBAC, in collaboration with other groups, to revisit Belmont. And then, second, whether you think doing so along the lines that have been suggested here might be useful. And obviously, though we have already begun to develop a list of possible contributors, at some point—I don't have time today—but it would be useful to get your views about possible contributors to such an enterprise, which again would occur in a conference format with the goal of publishing the proceedings.

DR. SHAPIRO: Thank you very much. There are a number of views on these issues, but let me turn to the commissioners first.

MS. BACKLAR: I want to put another question to your question. Something that you said, Al—I'm really delighted that you are here and, yes, I am one of your students, as you know. It's a great honor to have you with us. You said something at the beginning that really does concern me and that I don't think that we can address this without thinking very seriously about it. And that is the relevance of Belmont today and how it is used and who is reading it and who is thinking about it. And if we're going to start on an enterprise like this, which I endorse, I think we have to think very carefully before we spend a great deal of time and energy and thought and bring other people in to give us their time, energy, and thought, about how we're going to frame this, how we're going to make certain that perhaps by updating Belmont, revisiting it, that we will draw attention to the significance of the issues that we wish to address. And in that, I think that David and Alta said something that was extremely important. I'm very concerned, Alex knows, about the "wink and nod," how we look at consent and how we bring subjects into research protocols, and also that this research industrial complex has its own pressures, as David points out, so that these are issues I think we have to think about very carefully before we start this enterprise.

DR. CHILDRESS: Let me respond in part because it seems to me that, while I appreciate the concerns you're raising, they are particularly relevant to the second proposal, not as much for the first. That is, to have a conference that we co-sponsor in which we deal with a variety of these questions. The questions you are raising are not as critical to that as they are to the second one. And that is, if we as a Commission, decide to go and revisit Belmont in terms of trying to come up with our own Commission statement—the other is not a Commission statement. The other is the Commission co-sponsoring a conference that would address a variety of these issues. And Alex and Eric Cassell in particular thought that this was something the Commission and NBAC could and should do. I'm a little less sanguine about the prospects there, but that's something we need to turn our attention to as well. It's not necessarily something we need to resolve because it will require—we have our table full—and we are already getting criticisms from a variety of federal agencies and departments, as well as members of the public, about the tardiness with which we produce reports, so I would hesitate to say that we ought to put something as important as Belmont on the table until we get some other stuff out. However, this is the sort of thing that could be pursued, number two of the second page of Tab-4C. That's something that could be pursued by individual Commissioners or a subcommittee to see whether it might be possible to revisit it. So I want to distinguish the two projects. One is a conference—some of your questions are relevant to that. But they are particularly relevant to the second; that is, whether we as a Commission want to go that direction.

DR. LO: I wanted to follow that line of thinking. I must say, as I try and explain to my colleagues what I'm doing, the question I keep hearing over and over again is "So, what have you done since the cloning report?" And I think I would view this as a matter of what are the opportunity costs. I mean, these are fascinating issues. I would love to go to a conference where people like Al think about these issues in depth. I'm just concerned that . . . our real charge, it seems to me, is to address the issues that really make a difference to the IRBs and the investigators and subjects, and we've tackled two big topics and we haven't really finished them yet. I think there are a host of other issues. Alex has started us thinking about international ethics. There's an incredible controversy going on about whether IRBs are doing anything other than just sort of soaking time and resources. And I think, unless we can sort of address some of these topics on a level of practical solutions to problems that IRBs and investigators and subjects face every day, I think we're getting off track. It would be nice to have this done. I would like to encourage some other organization to lead and for us to attend and to participate and to learn from it. I'm just concerned that this . . . I'm questioning whether this should be a major focus, given that we really haven't yet produced some of the documents that many in the country are waiting for.

MR. CAPRON: I share some of Bernie Lo's concern, and I wanted to put Jim's comment on the relationship between what he's calling sort of Part 1 and Part 2 of the proposal in a different light. If other people around the country, Bernie, are interested in doing the Part 1 part of the document, of the proposal rather, which is principally an historical piece with some attempt at reinterpretation or understanding the place of the report in today's world but not addressing the report in either a highly worked out, Protestant fashion, where people tell us everything and how they've interpreted it and we get sort of a common-law buildup of understanding, or the magisterial Catholic fashion. I think that that might be, as you say, a worthwhile enterprise, but it doesn't seem to me it's for this Commission to do right now given its time constraints. And I think the notion that it would go on and we would be involved in some way, we would be fooling ourselves if we didn't think both in terms of Commissioners' time in terms of thinking about and reading all that material that would be produced and going to the conference, it would still be substantial if we have a backlog of other things. I thought it was relevant to think about that, however, if we were going to do the Part 2 part. I mean, in other words, if we're going to say, just as the National Commission found it useful—and Al describes in his book how—I think he quotes Pat King as saying this—that once they'd had a chance to talk about those principles, it was then easier for her to understand what her fellow Commissioners were saying substantively on a lot of other specific reports, not that they had to have agreed on all of them, but that it helped to draw things together and it made the work go better. And then we get to the question that Patricia has raised, which is "Is the report then going to be a document which has some life in the world after the Commission?" And I want to tie this in with something which is on our plate already, and that is the notion of an ongoing governmental process that is at a higher level than the present OPRR process and that involves outsiders from the government similar to ourselves in that process, which is one of the proposals that we have discussed for recommendation on our general oversight function and how the government should handle this. We might think that if that project is really likely to come to fruition, if we think it is possible to generate the will, either in the Legislative or the Executive Branch or both, for that kind of move, that that project, that organization, that that ongoing entity would be ideally suited to actually take this task on because it could use this task as a springboard for its interaction with the actual process that IRBs and others are going to carry out. And so the timing is bad, Jim, I realize, because we kind of have to make a decision about this sooner rather than later. So to summarize, I would actually prefer, if I thought that that process was going to be forward, to put this on their plate and say, "This really ought to be your high agenda item to get your ball rolling." If we think that's too problematic and we feel we have to make a decision now, I'm really only interested in Part 1 as a Commission activity if we're going to do Part 2, which I guess I'm in exactly the opposite position as you. You think Part 2 is maybe too much for us and drag us down. I think Part 1 is a nice academic exercise but not for this Commission, hard-pressed for time and resources, unless we're going to really make use of it as the springboard for our own work.

DR. SHAPIRO: Okay. Thank you. There are a lot of people that want to talk, but we're going to make, if you'll permit me, a change in the agenda. I've just been told that a few of our guests who are here need to leave by 3:30 for the airport, so I want to just hold this in abeyance and turn to them right now because I appreciate very much the time and effort they have given us. So let me . . . our agenda, of course, calls for us to hear from Allen Buchanan about the work he's done for us as well as other work he's done in this area, and Frank Dukepoo, also from Northern Arizona University, wants to address us on issues. So let me turn to them right now, if the Commission doesn't mind. We'll come back to the issues that pick up this discussion a little later on. Professor Buchanan, let me turn to you. Thank you very much for being here. Hello. Dr. Murray, we have you on the conference call now. Okay, Tom. Welcome. We're about to hear from Allen.

DR. MURRAY: Thanks very much. It's good to be here even if it's only in voice.

DR. SHAPIRO: Okay. Thank you. Professor Buchanan.