Republished by the LSU Medical Reseach Law Project

The Birth of the Belmont Report

DR. JONSEN: Thank you very much, Dr. Shapiro. It's a great pleasure to meet with you, Commission. So many of you, my friends, and colleagues, and even some students in the past. Eric Meslin asked me to speak with you about the Belmont Report, where it came from, and where I think it ought to go. I have described the origins of the Belmont Report in my recent book, "The Birth of Bioethics," and you have a copy of that chapter devoted to that issue. That's based on my recollections and on the record, as best I could reconstruct them. I will today add to that account several comments about the influences that shaped my own approach to the writing of Belmont. And then we'll suggest some directions toward its revision for the next bioethical era. A Congressional mandate to the National Commission required us to "conduct a comprehensive investigation and study to identify the ethical principles which would underline the conduct of biomedical and behavioral research with human subjects." The Commission could have been flip about that mandate and simply pointed to the Nuremberg Code and the Declaration of Helsinki as the principles, but we were all sure that Congress wanted more. Indeed, they wanted a more principled approach. A comprehensive investigation and study obviously required a review of the history of the ethics of research. The Commissioners all had copies of Jay Katz and Alex Capron's monumental book on experimentation with human beings published in 1972, which led us into an calibration of that history. A comprehensive investigation also had to include inquiry into the thought of those familiar with the notion of ethical principles. Several Commissioners who had read the ethics literature of that era were aware that the notion of ethical principles was not a subtle and a simple one, easily transferred from the pages of philosophy books into our recommendations. So, we asked five working ethicists to educate us on the meaning and use of that complex notion, and Jim Childress was one of those five. We received from them an anthology of five excellent essays. Our comprehensive investigation also had to listen to the words of those ethicists who had made a serious effort to identify the ethical principles governing research. Fortunately, the era's most outstanding ethical scholars—one a philosopher, and the other a theologian—had made such an attempt and we had their work in our hands. Hans Jonas's tour de force entitled, "Philosophical Reflections on Experimentation with Human Subjects," which was written for the 1968 Academy of Arts and Sciences Symposium on Human Experimentation, and the first chapter of Paul Ramsey's "Patient as Person," devoted to research with children with discussing the ethical principles of research in general. One could not read all of this material without seeing one principle emerge dominant, the obligation to respect the autonomy of any person invited into research with its corollary moral rule of informed consent. The many scholars who informed our study unanimously repudiated a utilitarian approach to the subject. Jonas did so explicitly when he criticized the words of Dr. Walch McDermott, one of the nation's premiere physicians, who had said, "The core of this ethical issue is to ensure the rights of society, even if an arbitrary judgment must be made against an individual." When Steven Tillman presented a meta-analysis of the scholarly essays on the first night at Belmont, he echoed McDermott's words, saying in summary, "The central question is how to reconcile protection of individual rights with the fruitful pursuit of the collective enterprise." Yet, ironically, none of the scholars had done much reconciling at either the theoretical or practical level. They had come out loud and strong for the principle of autonomy and the protection of subjects. The dominance of that principle is very clearly expressed in some words of Jay Katz, written a few years after the Commission's report. I quote Dr. Katz: "Had the Nuremberg Tribunal been aware of the tensions that have always existed between the claims of science and individual in violability, it might have suggested that a balancing of these competing quests is necessary. Even if the Tribunal had been aware of the problem, I hope it would not have modified its first principle, namely, the voluntary consent of the human subject is absolutely essential. It is this assertion that constitutes the significance of the Nuremberg Code then and now. Only when that principle is firmly put into practice can one address the claims of science and the wishes of society to benefit from science. Only then can one avoid the dangers that accompany a balancing of one principle against the other that assigns equal weights to both. For only if one gives primacy to consent can one exercise the requisite portion in situations where one may wish to make an exception for clear and sufficient reasons." The Belmont Report affirms that view. It added to respect for persons two other principles: beneficence and justice. Beneficence and its correlate, nonmalefeasance, was an obvious addition, since all previous statements on the ethics of research from Claude Bernard to Pope Pius the 12th, from Nuremberg and Helsinki, admonished the researcher not to harm the subject. Justice was less obvious, but its importance was suggested by the common, but invidious practice of burdening the indigent sick with research, whose beneficial products flowed to the better off. Tuskegee was the shameful reminder of that practice. However, the larger question of the relationship between individuals and society raised by the words of McDermott and Tillman that I've quoted, which certainly can be framed as a question of justice, was not addressed either at Belmont or in Belmont. Three principles were stated; the Commission does not attempt to articulate the balancing or priorities between these three. Respect for persons, beneficence, and justice, are proclaimed the three formal principles, the pillars that uphold the ethics of research with human subjects. Indeed, it is clear that the first of these exercises dominance or a priority over the others. A careful reading of Belmont reveals that the manner in which beneficence and justice are discussed limits their meaning quite stringently to benefits and harms to individual subjects and to justice in selection of individual or classes of subjects. Neither of these two principles manifest the broader meanings of which they are susceptible. Beneficence does not here refer to utility or the production of social good. Justice does not extend to the claims of a community over individuals of which it is made up. Belmont then does what Katz imagines Nuremberg wished to do. It gives clear primacy to consent. The actual recommendations of the Commission in various areas of research, such as those involving children, the institutionalized, mentally infirm, and prisoners, are somewhat less adamantine. The Commissioners believed, as principalists, they worked as casuists. They saw all of the principles, as in the jargon of moral philosophy, prima facie principles, general ruling, but under rare and specific circumstances allowing for exception. This is a respectable doctrine in moral philosophy, but it is also a perilous one. Because both the circumstances cannot be clearly provisioned, and because unscrupulous persons are eager to discover exceptions to their own benefit. Still, even when exceptions are envisioned, as in the very difficult Recommendation Six of the Children's Report, where more than minimal risk is presented to children who will not benefit, and a serious public health problem, such as an epidemic, calls for research, the exceptions are built clearly on the principle of respect. Our social or scientific circumstances rendered the Belmont principles obsolete. Do the three principles need augmentation, reformulation? Should certain trends in moral philosophy, such as communitarianism, dictate a rewrite that would, for example, locate respect for autonomy within a theory of social responsibility? My answer to these questions is, yes and no. I believe that the three principles should stand. On the other hand, I believe that a new redaction of the text would be advisable. Allow me a metaphor to explain my ambiguous answer. Belmont was first discussed by the National Commission at Belmont House in Elkridge, Maryland, which is a fine old country mansion built around 1802. Now, you on this Commission have traveled to the Pacific to study and discuss the future of Belmont. Most of you flew over the entire route traveled by Lewis and Clark in 1804, 1805, just a few years after Belmont House was actually built. You have ended up about 150 miles from their final western outpost, Fort Clatsa, near the mouth of the Columbia. The Lewis and Clark expedition provides a metaphor for my suggested redaction of Belmont. The original report was drafted with an Eastern Seaboard perspective, a broad forested littoral sloping down to the Atlantic from the rugged but modest Appalachian range. Belmont's perspective on the social and scientific enterprise called "research," was similarly flat and unspectacular. As Lewis and Clark labored westward, they were constantly astonished by the seemingly endless breadth of open prairie, the width and turbulence of the rivers, and above all by the crowning heights of the Rockies. Twenty years of experience with the research enterprise has revealed similar dimensions of height, breadth, and width. We commonly refer to the AIDS experience. Only a few years after Belmont was issued, the nation encountered an epidemic of communicable disease which many experts had thought the civilized world would never see again. The epidemic conditions seem to demand research, perhaps, even at the price of individual autonomy. It also created a situation in which desperate persons demanded treatments as yet unproven and claimed a right to be research subjects. We've also seen changes. We have seen changes in the drug approval process to accommodate these demands. We've seen other epidemics, the appearance of other lethal viral diseases, and the recrudescence of resistant strains of tuberculosis and sexually transmitted diseases. Also, research itself has expanded vastly, as it has moved up. Methodologies have also expanded. A controlled clinical trial remains as it was when Belmont was written, the paradigm for research. But it has been crowded by all sorts of modifications to get at data difficult to enfold within classical protocols. The development of genetic diagnosis challenges common notions of test accuracy and enters personal privacy more deeply than most biomedical research. Research and research ethics now has its Rockies and its Columbia. I believe that a redaction of Belmont for the next generation should retain almost unchanged the current text what the Biblical scholars would call the ortext. But it should surround it with an appreciation of these broader, wider, perspectives. I would suggest that new frontiers can be delineated. The ortext contains three sections: A, entitled, "Boundaries"; B, entitled, "Basic Ethical Principles;" and, C, entitled, "Applications." We might now conceive of adding another section entitled, in accordance with the first section, which is entitled, "Boundaries," entitled, "Frontiers," showing how the simple and straightforward, or what I might call the Eastern Seaboard perspective, opens out into broader perspectives. First, the empirical frontiers, where classical scientific protocols meet other forms of investigation, should be described, and their implications for ethical evaluation sketched. Second, the ethical frontiers, where the three principles meet and challenge each other, how should we describe the frontier, for example, between personal autonomy and social justice? Third, the frontiers where scientific research enterprise encounters the demand of profit and of politics. Without attempting the gargantuan task of exploring these new territories beyond the frontiers, some acknowledgement of their presence and immensity is desirable. It is at the frontiers that serious ethical discourse and reasoning must be encouraged. Perhaps one of Belmont's adverse effects was the impression that the matters were settled. It came to be seen as the strict constructionists see the Constitution. I believe that a redaction should encourage the sense that once principles are stated and their applications noted, the discussion only has begun. Ethics of research is a dynamic, casuistic activity. It is often said today that the excellent system of research review has stalled. May this not be, in part, because it became too automatic, too much the application of principles to protocols, and too little the struggle with the frontiers when the principles confront previously unexpected challenges? In conclusion, I wish to affirm that in the view of this superannuated Commissioner, and I think in the view of my colleagues on the National Commission, the Ethical Advisory Board, which we recommended to be the living oracle of Belmont. Just as our Constitution requires a Supreme Court to interpret, as a writer in the last week's New York Times said, "Its majestically open-ended phrases." And if I may allude to my own Catholic heritage, as the Bible requires a living majestarium to interpret its mystic and metaphorical message, so, too, does Belmont, a much more modest document, that either Constitution or Bible granted, require a constantly moving and creative interpretation. It was in the EAB that we envisioned the debate at the frontiers. It was from the EAB that we expected constant refreshing of the perspectives of IRB members everywhere. It was to the EAB that we intended the apparently irreconcilable questions to go, if not for satisfactory resolution, at least for serious study and public exposition. This has not come about as you well know. The EAB languishes in ghostly form as an ignored imperative within 46.204 of Federal regulations 45 C.F.R. 46. I earnestly hope that any redaction of Belmont is matched by a revitalization of the EAB. So, then, in my view, Belmont is an essentially sound proclamation. Its three principles are the right ones, necessary and sufficient, for the ethics of research with human subjects. At the same time, those principles must illuminate wider territories, ethical and empirical, than they now do in the ortext. The written proclamation, what form it takes on paper, must be delivered to a body of responsible interpreters who can make its words come alive in the particular circumstances of particular protocols, public policy, and the changing research enterprise. Thank you.

DR. SHAPIRO: Al, thank you very much for those extremely thoughtful and provocative remarks. I know that our Commissioners might have some questions, if that's all right with you, and we can have some discussion. Let me turn first to Jim, and then to Alex next.

DR. CHILDRESS: Al, thank you very much for that powerful and moving presentation, which will really be very helpful to us as we try to think further today about how we might proceed. Let me raise one question, a question with two parts, perhaps. You mentioned traditions of interpretation of the primary text, and you focused on the absence of the EAB, which was presumably to have been a more or less authoritative body providing interpretation. But in the 20 years that Belmont has existed, there have been different traditions of interpretation. I guess one question would be whether there is any way in looking at other commissions—for example, the President's Commission— or at the way IRBs have used Belmont, that we could begin to see some things about these traditions of interpretation that might be helpful. Before you address that let me tag on a second part. If I understood you correctly, one might think about affirming the original principles, but then to use—partially my own language, but language I think is consistent with what you presented, we need to think further in the changed context of research about the meaning of those principles. We may have to think about justice, for instance, in terms of—as we've discussed on the Commission, in terms of access, not simply nonexploitation. But we also would have to think further, as you have emphasized today, about how we relate the principles to each other if they come into conflict, if they clash, which should have priority, and what kinds of settings? So the first part would be, could we learn something from the traditions of interpretation that were developed? And then the second part would be, would that be the—in terms of sort of the meaning and the weight of the principles, the primary way in which you would assist to supplement the original text?

DR. JONSEN: Jim, I don't think we know much about the interpretation of Belmont in the actual world of research, evaluation of research protocols. I'm certain that lots of IRBs have never read Belmont, don't know much about it, are surprised by it. In fact, I gave a talk in Portland last year to a group of people who were all IRB participants, and a large number of them knew nothing about Belmont. What they knew was the Federal regulations. They didn't know Belmont. So, they didn't know the higher level of principle. I suppose other IRBs do make an attempt to interpret. But I believe that my guess would be that their interpretation would be a fairly wooden one. And the text, in fact, supports a fairly wooden interpretation. It's not really terribly challenging in circumstances where there are problematic situations to be dealt with. So, I don't know that we know much about the — if you'll pardon again a reference to religious tradition. We don't know much about the Protestant interpretation of Belmont, that is, the believer's own reading of the text. And we don't have any example of the Catholic interpretation, because we don't have any authoritative body doing it. The second question was?

DR. CHILDRESS: The meaning of respective weights of the principles.


DR. CHILDRESS: Those would be the two major areas you think we ought to focus on, in terms of amplifying the original?

DR. JONSEN: My belief is, and to some extent this is reflected in my remarks, that people who have thought about Belmont in current circumstance might like to reformulate it much more as a document about social responsibility. I think that might be the primary push for reinterpretation. I don't think that's a good idea. Because I think it would be important for people to go back to Hans Jonas' article to see why that's not a good idea. But I think it would be very valuable to raise the question of research within the context of social responsibility, not to redefine the ethics of research, but to put it up against issues of social responsibility, such as what one should — how one should view research activities in the context of epidemic diseases, which quite remarkably we didn't even think about at the time Belmont was written. We thought they had all gone away.

MR. CAPRON: I'm sure that I speak for all Commissioners in our pleasure in having that historical tour that you provided and the perspective on trying to understand if the gist of this, coming from a native Californian like yourself, in redressing the Eastern focus, and your choice to pick Lewis and Clark, rather than the Donner party, as a reference point, means that we should now refer to this as the Mount Hood Report in our new version. I was particularly struck by two of your recommendations: One which you made, more or less, in passing, and I'd like you to expand upon it slightly, if you have any particular concerns, and that was when you were describing the difficulties with casuistry. And you didn't say you were talking about casuistry then, but I believe that you were. You said that one was unscrupulous practitioners, one of the two dangers that I recall your mentioning—that is to say, people carving out exceptions to their own benefit. It seems to me that that is an underappreciated risk in this field, and is a matter of considerable concern as we look at both AIDS research and the like, and the project that has absorbed so much of our time with research with persons with decisional incapacity. So, I would like any further thoughts you have on that. The second one is your strong view that we don't really need to supplement the principles. And as you may be aware, one of the reasons we are talking about this as a topic was early in our work the question of revisiting Belmont came up mostly in the context of the argument that these were principles that had been inadequately attended to. I find myself actually fairly sympathetic with your view, because it seemed to me that the reason that the notion of community wasn't stated, and obligations to the community weren't stated as a principle there -- was that the driving force behind research itself was the notion of benefiting the community through the process of benefiting scientific knowledge, and everything else. The whole examination of Belmont, and so forth, is in effect providing the counterweight to that. We know that that impulse is there. Now are there any principles by which one would govern an ethical response to that impulse? And it is more in other areas, as the Belmont principles got applied to clinical medicine, that one might say, "Wait a second. Do we need a restraint here?" And it's at this point that I'd like your comment about whether we should be thinking about the Belmont Report as something that is more than just a set of principles for research, because Belmont has become more widely applied. And, of course, through the work of Professors Beauchamp and Childress, is addressing the same congeries of principles that has been addressed very broadly. And, secondly, to what extent do you think that the Belmont principles mostly speak, in terms of negative application? That is to say, this notion of protecting people from things, and that the duties that they establish on the correct behavior of researchers, and one might say correlatively the rights that they establish for potential subjects, were mostly the rights of protection against harm. And the difficulty that has been introduced as people have tried to look at the process, in terms of the choice of individuals to have access to, because that is very similar to the issue that arises on the clinical medicine side as people say, "Well, I want that respirator, even if you, doctor, say its use will be futile," a subject on which you have of course written. So, that's the two sets of issues — one around the casuistry and this risk of the unscrupulousness; and the second, reflecting on the community issue and the active rights versus negative rights aspect of Belmont. Thank you.

DR. JONSEN: Thanks very much, Alex. I didn't choose the Donner party, because at least Lewis and Clark got back home. And I hope you will get back home, too. On the first point, the unscrupulous practitioner—I use the term "unscrupulous" in a fairly—I don't mean it in a very negative pejorative sense in which we usually use it. I mean people who don't have a lot of scruples about sticking to the essence of the law, and so that they'll range far away from it. But I think that the problem with any document, any ethical document that is very—that sets out thematically to say, "This is a tough problem. There are a lot of principles involved, and we have to balance them." That's an invitation to this kind of unscrupulous casuistry. Say, "Well, we've got to balance them, so..." I think the challenge posed to a body like the EAB, if it existed, or if this body were to continue in this function of this is to be very careful about what it does when it balances, what balancing means when you face up to exception, to the question of should there be an exception. So in dealing with the institutionalized mentally infirm, or with children, we had to face that. It seems to me that that can't be done very well in a document. It has to be a living enterprise of people who criticize each other's readiness to make exception. And so, the casuistic enterprise is not very well carried out on paper. It's really carried out in a live-in setting where you have to argue pro and con. And so, that's why I wouldn't like to see the document rewritten in a way that says, "Well, we've got to balance principle." I'd like to see the principles adamantine, pretty firm. I think that the reason why principles that I have suggested, and that Belmont suggests, and that I affirm, calls for the task of a very careful examination of the ethical standing of the research enterprise. I think that that is what this unsurpassed analysis of Hans Jonas did. That's an article that we really have to go back to. In his affirmation way back in the beginning of these discussions, we were talking about research and the benefits of research. We were talking about what he called maleuristic goal. But it's very different from the kinds of obligations that we have to protect society against the various things that inferiorate it. And so, the danger of rewriting Belmont as a communitarian doctrine is that it begins to miss that. And you quite rightly suggest that Belmont came into being because that was the position that everybody in the research world was quite happy to accept. McDermott is a very good example of that. Research benefits the world. Therefore, we must have research subjects. And so, the trick of establishing principles that stand very firmly and clearly, and then leaving them open to debate by people who have a sense of the strictness with which you should deal with exceptions. And, finally, I think the very important point that you make, this Commission, unlike the National Commission, is not established just to deal with research. It was established to deal with a broader range of questions. And, therefore, you may want a document that does that. I would only say that let it not be Belmont. You may remember, Alex, that in the very beginning of the President's Commission, there were some brief discussions about whether the President's Commission should not issue a Belmont-like document about the broader range of issues that it had to deal with, and that didn't happen; perhaps, could not have happened given the range of things that we had to cover. What this Commission may wish to do, a Mount Hood Report, a report that deals with the kinds of issues that you have to face. In a sense, it's a reminder of Michael Walzer's approach to justice, saying that when we think about justice, we have to think about justice in terms of various different sorts of social enterprises, in which the concept has to be applied. And it seems to me that it probably is incorrect to think that there is a statement that can cover bioethics. There may be statements and principles that can cover certain segments of bioethics, or certain sorts of problems. And you may be able to find amidst the things that you have to do here some common thread that merits a report that states principles differently than Belmont, and one that does stress social responsibility. There may—you don't have to deal with managed care, I don't think anywhere. But, certainly, the issue of managed care and the provision of health care in the United States today raises very serious questions about social responsibility and justice in the broader sense.

DR. SHAPIRO: There are two Commissioners who want to speak, then I do want to get on to turn to Jim to tell us a little bit about our own project about Belmont. Alta, and then David.

MS. CHARO: I would like to keep you talking about what seems to be the central dilemma here about meeting the needs of the collective, at the same time respecting the individual. One of the experiences that we have had here on this Commission and many of us in our own work personally, has been to see a kind of "a wink and a nod" approach in the area of research ethics on the subject of personal autonomy. To enroll children in any research, no matter how minimally risky, without their ability to genuinely consent, is to wink and nod at the idea of personal autonomy. To enroll those people who are cognitively impaired in any fashion is to wink and nod. Because we know empirically that most people in the United States are not volunteers for research. So, we can guess with any particular person that the odds are that this person wouldn't volunteer. And anytime we volunteer them without getting their explicit consent under conditions where they can really give it with all of its flourishes, we are fooling ourselves. We build lots of protections in, and we try to make sure it's not expletive and we have lots of special rules about risk levels and review to make it tolerable. But I don't think we often face the fact that really we have simply come to a point at which notions of individual autonomy are just yielding. Now, sometimes I find that these fictions are helpful and it's better to slide by this way. Other times, sometimes, it seems more helpful to name the beast. And, although I'm not yet persuaded on this, I'm truly of no particular mind on this. I'm really interested in your reaction to what would happen if one were to try to make an argument more openly, that there really is a civic responsibility, and that the same kind of civic responsibility that underlies draft, however controversial, is the kind of civic responsibility that underlies this research enterprise, and that you try to minimize its exploitation by relying on volunteers until you're an extremist. But that kind of model, in some ways, more openly acknowledges the dilemma. Perhaps this is the communitarian style. I'm just beginning to get familiar with their work. But I'd like to hear your explanation of exactly how you all dealt with this, and how you came to a conclusion that whether based on principles of intergenerational justice, or notions of civic responsibility, it still wasn't something you'd want to argue as an affirmative obligation on the part of individuals.

DR. JONSEN: I think there are two things that you've mentioned that I would like to distinguish. First, the use of children and persons who are mentally incapacitated, I don't think that the National Commission's approach is a wink and a nod. A wink and a nod would be essentially to do what Helsinki does with children. Helsinki simply says, "You need consent. And if you can't give consent, consent can be given by a proxy." That's a wink and a nod. The National Commission, I think, very seriously tried to do what I referred to before. They tried to see what the grounds for a justifiable exception would be. And I think that, particularly, the papers in the Children's Report of the National Commission, where the matter—and, for example, the debate between Paul Ramsey and Richard McCormick is spelled out in some detail, is really an attempt to do the most serious sort of ethical work of justifying an exception. The second thing that you referred to is whether people actually do give consent, and whether we ever are able to live up to the principle of consent. I think that is another problem that I guess everybody who has to do with, ethics has to struggle with, that is, statements of principle versus empirical reality. If we build our statements of principles on the basis of empirical reality, we probably don't have statements of principle anymore, so that there is at some point a necessity of saying, "This is the way it ought to be." Even though it may never actually be that way, but you try, as you said, to build social structures that would help it to be that way, as opposed to kind of letting it drift into the empirical. And so, I simply suggest that that's the kind of argument that needs the closest sort of scrutiny. And again I say that I think it's Jonas more than anyone else that gave us that scrutiny and before anybody would buy into an argument like that, which do a lot of good things, I think go back and see what the old man said.

DR. SHAPIRO: Thank you. David?

DR. COX: I want to follow up on this point in a way because you mentioned that one of the things that might lead to an evaluation was new technologies, and this Commission is grappling with genetic information and genetics, certainly not the only important issue but one that's taken up a lot of our time. And it's troubling to me to see in the early part of this century that society was very keen on the social good of using genetics. And people could have as many principles as they wanted, and it was like an ant getting crushed by a steamroller. So that even if one upholds these principles, how, in the context of social and cultural steamrolling, does one maintain them? Because I think right now that we see more and more with genetic information that it's consumers that will have a say about it. We see books published pointing out that we can't stop it because people will do whatever they want to with it. And so one can have the Belmont Report and one can maintain this bastion, but how can one be effective? You mentioned perhaps one has this Board, but who's going to listen to it? So this goes one step further than sort of re-examining the points. But how can one think about protection so that society doesn't overrun the principles? Or is that even a worthwhile consideration?

DR. JONSEN: Oh, I think it's a very worthwhile consideration, and it's not something that I feel I could answer with much insight, except to say what I think used to be. What happened in National Commission days was that we had a fairly constrained enterprise. Basically we had the federal government giving money to quite specific institutions to do quite specific kinds of research in the 1970s. And, therefore, you could set up a system of control that was fairly modest that would pretty much do the job. The research enterprise was comprised within that. And you could build into it what most other ethical enterprises never have; namely, you could build in sanctions by taking away their money. And that was pretty neat. You could sanction an institution. Their research would go away, etc. etc., which has happened a few times. But that's gone, and what you're suggesting is that a new Belmont is going to go out into a world where research is being done by a lot of people outside that setting, over which there are very few sanctions. And that's a great challenge. I don't know what we say about that. That's a different thing than what we had in the past.

DR. SHAPIRO: Thank you very much. I know that there are others that want to raise some issues, but I think we're going to have to move to the next item on the agenda. Al, thank you very much once again. I hope you'll be able to stay with us if your time allows. But let me now turn to Jim to bring us up to date on one of our projects, which is the Belmont Report Revisited. Jim?