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Thursday, March 12, 2009

Session 4: National Ethics Commissions:
Looking Back and Looking Forward

Alexander M. Capron, L.L.B., Scott H. Bice Chair in Healthcare Law, Policy and Ethics
Co-Director, Pacific Center for Health Policy and Ethics, University of Southern California

Ruth Faden, Ph.D., M.P.H., Professor and Executive Director, Berman Institute of Bioethics, Johns Hopkins University

Yuval Levin, Hertog Fellow, Ethics and Public Policy Center, Washington, D.C.

Eric Meslin, Ph.D., Director, Indiana University Center for Bioethics


CHAIRMAN PELLEGRINO: We're going this afternoon to take advantage of the fact that some people who have been in the trenches have decided that they'd be willing to help us a little bit by reflecting on what they've heard during the day. And this means a limitation on time. We've agreed that each would have the same amount of time, ten minutes, and that should get us over the major issues, I would hope. And I hope that there'll be some chance for you to query them.

These are all experienced people who have lived through working with a council or a committee or commission or whatever you want to call it. So I'm going to stop talking. They're looking at me and saying "What he's talking about?" the time is so short. And I'm going to start with the person from the first commission.

MR. CAPRON: Thank you. It is a pleasure to be here. Ed and I have in common that we were the chair, myself, and the vice chair, Ed, of one of those commissions that Cynthia Cohen said did nothing because we were the frozen embryo caught up in the abortion politics of the Congress of the United States. So I'm here because I was the executive director of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. You see I'm going to go very quickly.

My assigned task was to be here for the three preceding sessions, to reflect on the exchanges, to use my commission experience as a touchstone, and to stimulate—these are not my words, these are your director's words—stimulate the Council to grapple critically with differing conceptions of the missions and functions of national bioethics commissions and the working philosophies of such commissions.

So I reached a few general conclusions based on what I heard today. There is a wide range of views on what constitutes bioethics. I heard—I think Alfonso suggested it is a subfield of philosophy and therefore proceeds according to a certain type of philosophical reasoning. Other people suggest it's a multidisciplinary field.

There seemed to me in the exchanges from this commission, from our guests from France and England, who I think may have departed now. No, they're still there. No, there's Hugh . There seemed to be actually a great deal of satisfaction of each with their own way of doing work, and I think that is a natural human tendency. It also perhaps suggests that if there are successes and failures in each, there's nothing about the methodology that absolutely assures success or failure.

Skepticism was expressed in some quarters on whether it is useful to have governmental commissions and whether they have raised the right questions, but confidence was expressed in other quarters that they have. There is clearly, as the last panel showed us, a rich variety of issues on the cutting edge of science, health care, clinical medicine, public health, and environment that still need to be addressed, so that it's not going to be for want of issues that we would not have a future commission.

And throughout the day, the commission, the Council members and your guests spoke of the need to find ways to work and think internationally. So the major topics raised I've dissected under six headings. These are probably rather tentative and arbitrary, but I have a slide for each, so don't worry that you didn't get to read that slide.

As to missions, there were a variety of missions. Some, like the French Commission, said that they were there to bridge the divide between science and society. Others said they were there to monitor scientific and medical developments—or a number of people said "advances," which doesn't seem to me a neutral word, so I tend to use the word developments instead—and identify the issues that they will raise for society. Particularly, Hugh described that as the Nuffield's operating mode, looking out on the horizon and seeing what needs attention and hasn't yet gotten it.

Your own council has the mission of articulating the range of views on controversial subjects. And those who defended this said this was the best way to inform the political process and policy making, with the suggestion that once these views are out there, the democratic process will operate. Others have said that the commissions worked well if they provided guidance at the individual level—that is to say, questions about how to live a good life, how to confront these difficult decisions—or, at the level of health care professionals, ethical standards that should guide practice. And, finally, clearly a number of the commissions were charged and did operate by way of providing recommendations to policy makers.

Now, under that, then, what are the functions or objectives of commissions? And I admit to drawing these categories from an article that you had that I wrote reflecting on the President's Commission, but they were all brought up today. Some of the issues, Carl Schneider suggested, all you're doing is solidifying the emerging consensus or, as he put it, the conventional wisdom.

You may in the process, if you do it well enough, lay the issue to rest. That is to say, it stops being a major issue of controversy and people say we have an idea of how we're supposed to be handling that. But I don't think anyone thinks that that will quiet all the ethical concerns, and you would certainly not write the final commentary. Indeed, one of the areas in which the President's Commission I have always thought did that was in our report on defining death. And yet, as your own report on that indicates, twenty-some years on it is worth looking at it, addressing the remaining or the revived ethical concerns, the analytic and philosophical concerns, and providing a new analysis of what's at stake and how it's resolved.

There is a watchdog function. And not very much of this came up today, but there was a suggestion by several people of this role, particularly I think in the French Commission, and the President's Commission was given that responsibility as to the federal execution of the rules about research.

And to take small issue with Carl Schneider, I think a number of the commissions, including the President's Commission, did examine and did publish reports on the degree of research risk, what harms. The major such report done by the National Commission actually concluded that most risks of research were like risks of ordinary life.

The President's Commission, taking on the regulatory framework, said it is very difficult for researchers and research ethics committees to operate with 28 different sets of rules from different departments and agencies. We recommended successfully that they all be put together, and we have the common rule. I suggest that that has lessened the administrative burden and made analysis at least somewhat more sensible.

Then there is a function, a crucible, in which issues come in and boil up, and that process can identify the underlying disparate views, sometimes offer some correctives for obvious defects in reasoning or lack of communication, and articulate the implications of policy and ethical behavior. And sometimes, as I think it was Cynthia said, issues end up going to the commission as a dumping ground.

They take difficult issues out of the political arena, off the back of the President, out of the Congressional committees where they are a lightening rod causing problems, and they put them with a commission which will have time; and maybe in that time the issue will become less controverted. If it doesn't, at least the commission absorbs the controversy instead of whoever else had it before.

The question was raised throughout the day: Can these functions be better served by other means? And I think we have to take note of points that were made, such as using National Academy of Sciences committees (much more focused membership, much expertise there) and a few bioethicists.

You look at organ donation? Have Jim Childress there. He's the bioethicist. But then you have a lot of people who know about organ donation as well. Also, Hugh mentioned in Britain with their separated or spread-apart forms of ethical review, a lot of reliance on the BMA's ethics committee. And for professional ethical norms, why not have it with that committee rather than with a governmental body?

Then the question was raised — might we need coordination across the topics? And again, the Nuffield achieves some of that by having specialized working groups but having members of the council on those groups and having the chairman of the working group on the council.

Question of influence. How is influence measured, a number of people asked. Is it press coverage? Some people mentioned that. The Nuffield mentioned the number of the web downloads. Or is it only through adoption of policies?

A number of factors were cited as relevant to measuring the commission's impact: its connection with policy makers; will you have more interest from the chief executive and from agencies if you have liaisons appointed? And the President has actually been involved in the process of getting the commission started. Does the commission have action-forcing power.

Both the National Commission and the President's Commission had action-forcing power, saying they could say to an agency this is what you should do. The agency had to publish the recommendations and respond within a given amount of time either accepting or rejecting. They don't always do it, but that impetus is there, and there are others with real power who can then say to them, "You're not following your mandate." That, however, usually requires legislation.

And connection to legislators. That can be either because they are authorizing agents for the commission or they're the objects of the reports and hold hearings on them.

Another way of having influence is to have continuity. Both the national French committee and the Nuffield have existed for decades, and they developed a reputation by the quality of the work that they do. And the quality in and of itself of any commission gets to be a basis for having influence if you get respectful comments from the chattering classes.

Clarity of presentation, including presentation which is intended to reach the educated public — to take people who have an interest in something and express things in a way which is sophisticated enough to satisfy the experts but is clear enough to be comprehended by the public.

And finally, influence will certainly be more likely to come about if there is relevance of the reports to practical problems facing society as patients, professionals, and citizens. And a number of people suggested that while you may be advisory, you're not academic. That is to say, you should be policy relevant and not purely philosophical.

Questions of organization as they affect commissions came up: the members and chairs, who appoints them? A department, the way the National Commission was? The president, like a number of the successive commissions? Or the Congress, like Ed 's and my experience with the Biomedical Ethics Advisory Committee.

Are there categories of membership? Yes. In most of these to try to get breadth of scope of knowledge. But that does not mean that they are representatives of particular constituencies. They don't have reporting-back mechanisms to those constituencies. And there was some challenge to the notion that people are unaligned. Can they ever be unaligned from the views that they hold? Would you expect anybody to be able to operate that way? And there was some exchange over the difference between that and representativeness.

This question of independence and connection: Obviously connection is good because it gives you influence, but then does it lose you the necessary distance to be able to disagree with the people who appointed you? And a little bit of exchange about commission and staff relations, the relative expertise of each group and who produces the reports, the staff or the members.

Method of working: Here questions came up about agenda setting. Who sets the agenda? Is it the appointing body? Is it policymakers? Is it the commission itself? Is it somebody else? Are there criteria that are used, certain topics that are within our remit and others aren't? This question of duplication. Rebecca just mentioned the issue of ripeness. Is something now ready either to come back to or for the first time? Is it ready for discussion or is it still too new?

Deductive versus inductive and the—many of the commissions—there was a quotation about the work of the National Commission—I think it was also true with the President's Commission—were fairly pragmatic bodies. They try to engage in defensible reasoning from which principles could be derived rather than setting it out as a deductive model.

In any case, the obligation to articulate ethical reasoning was mentioned, and I've already mentioned the question of what is the field. Likewise, in terms of the method of working, are you aiming for, a consensus or just a range of opinions?

In terms of dissemination of results, what are the appropriate mode and timing of distribution? It seems to me—and here I'm drawing on my work with the President's Commission: It is important to complete work early enough to allow for follow-up with these commissions that end up being time limited. We had success, for example, with Splicing Life because it came out a year and a half before we were done. There was a series of congressional hearings, and in the end the recombinant DNA advisory committee was broadened to include human genetic transfer.

We did not have the same success with Securing Access to Health Care, an important report which contradicts several people who said commissions never look at issues of health care and access. You all are looking at some of these issues yourselves now. But we did that. Unfortunately, it was done toward the end of our time, and the same set of hearings could not be held.

Obviously, you have done a great job in publishing your reports in print and electronically and you've done a nice job of having an ongoing web presence for previous commissions.

It's also possible to work with congressional committees, federal agencies and law reform bodies. For example, Defining Death, obviously done by the President Commission with the National Conference on Commissioners on Uniform State Laws; Protecting Human Subjects, done by working with the Department of Health and Human Services; and likewise Splicing Life, with the hearings before then Representative Gore's committee.

My own sense listening to things is that follow-up may be more important than dissemination, and that means that follow-through planning has to begin when the commission's agenda is established and amended. And I've developed what I call the HEARD model. That is to the say that there's a Heritage, what issues you inherit and are you bequeathed; the Environment, how familiar the issue is or how novel; the urgency and the controversy; the Audience, let us say professionals, public, peers, public officials and the press; Response, what is your response? Do you give information, standards, programs, regulations; and the Dissemination, the question of the mode and timing.

Could commissions do better? Yes. They certainly can, and there's a lot to critique. I think that they have had some success. And if they want to be heard, I think they have to avoid being too academic. They have to—they work best when they see their own work as part of this continuing chain. Nuffield is an unbroken chain. The French committee is an unbroken chain.

The American chain, we didn't hear here today from the National Commission, although they're not all dead, so I wondered why they weren't here. But there's a chain going back to 1974 in the National Research Act which established the Commission.

They have to understand the topical setting of the subjects that are chosen, be clear about who is expected to read the reports and about what responses or reactions you want from them; and when and how to distribute is determined by the foregoing: what's the audience? What do you want them to do?

And so I think the follow-up has to begin at the start, not the end. You all are perhaps reaching the end of your work with your charter expiring in six months. But I hope you will have some of these things to pass on to others. Thank you all very much.

CHAIRMAN PELLEGRINO: Thank you very much, Alex . Ruth? Yes. Fire away.

DR. FADEN: I have the advantage in some respect in following Alex because some of what he said I was going to say, and he'll never know how brilliantly I was going to say it.

MR. CAPRON: In comparison to.

DR. FADEN: In comparison to. No, actually it's because Alex said it so well that I'm just going to quickly edit as I go by.

Part of our remit was, obviously as Alex pointed out, to stay all day, to listen and to respond, but also to give a little bit of history in terms of looking back. So I'm going to do one minute on the Advisory Committee on Human Radiation Experiments, which Cynthia didn't talk about.

But as a segue into what I want to talk about, the first thing I want to talk about in terms of reflecting on the day's experience has to do with the social functions or types of commissions, and Alex has already addressed that.

I'm going to do a slightly [expanded] type of topography, but I think it is helpful to think about this council and other commissions in some sort of a wider context. I then want to say a few words about government structure and the architecture of commissions, particularly ones that are government commissions, unlike the Nuffield Council, which as you pointed out, doesn't have to locate itself in any kind of democratic or government structure that relates to the larger legal context in which the commission is situated.

And then if I have time, a couple of words on structuring commissions for success, which I think is an underexamined question and I think has something to do with what you were saying, Alex, about from the beginning thinking about how you're going to orchestrate the response and what counts.

So first of all, in terms of the different functions or structures of commissions, the commission that I chaired was in 1994-1995. It was created by President Clinton, and it was very different from the other commissions in following respect: It was created in response to what looked like the brewing of a major national scandal, and the scandal had to do with increasing allegations in the press that Americans had been used without their knowledge, without their consent in secret human radiation experiments from the 1940s through the 1970s. That was the allegation.

Now, at the time I didn't do this, because that's what you do. You just go to work and you don't think about it. But in retrospect and sort of almost to the end of this, I started looking at the political science literature on presidential commissions, which are a particular beast somewhat different from congressional commissions and so on.

And what I learned was that we were in part a species of commission that is sometimes called the "disaster" or "scandal" commission. So this is a commission that's created when something terrible has happened and there is a determination that a credible sort of arm's-length entity needs to be created, credible with the public, to discern, to establish, to investigate what actually happened, report back to the general public.

And so the examples of this, the commission that was set up after the Challenger disaster, after Three Mile Island, the Kerner Commission perhaps in some respects, the most dramatic, and then most recently the 9/11 Commission. These are all commissions that are set up because something terrible has happened or it is suspected that something terrible has happened and there's a view that the government can't investigate itself at least directly, and so you set up this arm's-length commission.

Always linked into these commissions, however, is a never-again function. So there's a piece that says go and find out what terrible—if something terrible happened, tell us what in fact happened, tell the story, make recommendations about what response there should be if, in fact, something bad happened in terms of compensation looking backwards.

But looking forward, there's always that line that says "and then make recommendations so that whatever terrible things you discovered won't happen again." And that was the structure of the commission that I chaired that we participated in and that took us in directions that I think the administration and, frankly, we did not foresee both with regard to oversight research involving human subjects about which I might say something later and also about the relationship between science and the state, a territory that had been relatively underexplored and still is to some extent in bioethics.

So that's one type of commission and that was the type of commission that we were. By definition, those commissions are very time limited. There's a need on the part of the public to get the answer quickly. You've got a month. You've got 18 months. You've got what looks like initially one subject and one subject only. It, of course, expanded. 9/11 ends up looking—the 9/11 Commission essentially takes our whole national security establishment to task and so on, but it starts out as a very particular thing.

Other kinds of commissions that—the way I would structure it and the way I've come to view it very similar to the way Alex put it forward. There are commissions that are set up in response to contentious or challenging issues, often challenging social, moral, or political issues, often longstanding ones, and they're usually of two types. One is the type in which there is an earnest desire to get back recommendations and findings based on which there will be action or response. The other is what Cynthia and now Alex have used again to be the dumping ground. We will take that contentious, challenging social, political, or ethical issue, and we'll get rid of it by giving it to a commission that will deal with it in some responsible way that we can ignore.

Okay. Generally speaking in terms of both of these two types of commissions and the first type as well, there is an expectation that there will be findings and that there will be recommendations. That's the structure of a scandal or disaster commission. We are supposed to come back with findings and then come back with recommendations. But also it is the structure of commissions that are being tasked to address particular contentious issues or challenging issues that when it's set up that way the intent is to get back responses that could be presumably useful from the standpoint of moving the public policy issues forward.

Some political scientists take it that the mark of success or the gold standard of success for those kinds of commissions if they're presidentially appointed is the extent to which the president pays attention to the recommendations of the commission. And there are many, many things we can talk about as to what would constitute paying attention by the president.

Now, there's a fourth function. There are four types of commissions and I would—I think very much of great interest to me in terms of this particular council. I remember an exchange I had with Leon when it was first set up, which is one that from the very beginning has as its remit—say the first two of the three remits that Hugh was describing the Nuffield Council committees and working parties have.

And that is the function is to identify and to articulate moral concerns or social concerns in this case around science and medicine and then to promote public discussion and reflection. So this is a commission whose intent is not to come up with recommendations, not to come up with findings as much as to come up with an analysis of the issues that can serve to elevate public debate and deliberation.

I want to get back to what that exactly would mean if I have time. So what does it mean to say that you work towards the end of elevating public conversation and improving the deliberative process for society as a whole? How would be know that?

It has a lot to do, it seems to me, with some of the things that Nancy mentioned about the role of community and public engagement. Are we talking about one-way education? Are we talking about an analysis structure that allows informed—the informed public to better debate and reflect on the issues? Are we talking about ways of—that extend to eliciting the public's views about concerns? And are we talking about public engagement, which is a much more aggressive way of attempting to elevate public conversation. So that's—in terms of the typology—I'm sorry. I wasn't as technically adept and don't have a slide to show you that. I was doing it as we were talking.

A couple of comments on governance and architecture issues. I don't think you can separate identifying the most appropriate governance and architecture for a presidential or national commission from the commission's remit in social function. So I think it's terribly important to get a good fit. And the question is, do you really know at the outset what kind of commission you are or are supposed to be?

I think some of the problems, not just in the context of bioethics commissions but commissions generally, is that there's ambiguity about exactly how you're supposed to understand your remit and, of course, you can have multiple remits. So some issues to think about also have come up in the course of the conversation today and that Alex mentioned that I think bear repeating.

One is to think about the difference between standing committees that have continuity and time-limited committees and commissions. And there is a lot to be said—we heard from the French experience but also the Nuffield, which is a very different way of thinking about a structure that extends over time across political administrations, although you had that experience a little bit and could talk about it.

But just in general, what are the differences in terms of what is possible or not, what is appropriate or not, what is the right remit or not for commissions that come and go versus the notion that we might have a standing commission of some sort and what would be the right role for a standing commission.

So, for example, insofar as there is a watchdog function, insofar as there is an oversight function, one would think that that kind of function for a national commission—maybe it isn't even a national commission—really belongs in something that extends over time.

We're having conversations just beginning in this country about creating a federal reserve board for health modeled after the Federal–a federal health board modeled after the Federal Reserve Board and the notion that this sort of a structure, which would deal with some extraordinarily difficult moral issues with regard to coverage decisions and finance decisions, would need to be insulated from the political process.

It would need to have a structure that would allow it to continue over time and to not suffer from the interruptions and the vagaries that come as political parties rise or fall in their control of Congress or the administration.

There's the issue that has already been discussed here a lot about representativeness and whether members of commissions are thought to be representative of groups or entities. The language that I had preferred to use for this would—is to establish stakeholder committees. That is, commissions or committees that are put together to represent particular stakeholders in whatever the territory is that is at issue for this commission or committee versus expert committees where you put people together because you have a view about a certain range of expertise that needs to be present to advance the issues further versus committees that are generally put together with no forethought at all. Right?

So we are very fortunate because the architects, as it were, of the Advisory Committee on Human Radiation Experiments in the Clinton administration at that time had come recently from the experience of OTA, the Office of Technology Assessment, where there had been a lot of lived history and thinking about how to put together diverse expert committees. That was the model of which it operated.

That said, we had a public member. I'm looking at Jonathan in the back. We had this great—we had one woman who was appointed to the committee to represent the American public, which is like saying the remit to educate 300 [million] Americans is a little daunting. The notion that one woman should represent—one person should represent 300 [million] Americans, but that was her role. She was the designated representative for the general public.

Fortunately, she was a woman who had a great sense of humor and bore her responsibility with equanimity and, in fact, she did basically what Hugh was describing. She functioned within her judgment and she responded to the issues before us as we all did: with our own values, our own judgments, and our own good or bad sense, our own practical reasoning.

There were the issues of resources. I just want to say two more things and then I think I need to stop. Resources are key. I don't really know what the resources were for the President's Council. I don't know how your funding—how much funding you had and whether you were satisfied with your funding in the early years or later years or not. But resources—

MR. CAPRON: No comment.

DR. FADEN: No comment. All right. Funding can make a tremendous amount of difference. And, again, this good fit in terms of structuring of commissions for success, if you give a remit to a commission that doesn't have the resources to responsibly pursue that remit. So let's say that eliciting the public's views and engaging the public on issues before you is part of your remit. Well, if you don't have the resources to do serious systematic public engagement, you won't be successful in regard to that part of your remit.

Also, if you've got diverse enough topics and issues, the working party's model that the Nuffield Council uses makes a lot of sense, and again that is like the model, as Alex points out, the IOM [Institute of Medicine] and NAS [National Academy of Sciences] and other groups use. You put together committees that—where the expertise is appropriate to the particular issue at hand.

When you have standing commissions and councils, resources become a real issue in terms of getting the right people around the table. And although you can take testimony and can hear from the best, you're not deliberating with them in a regular, ongoing fashion, the best in that particular area. It's a problem.

Should commissions and committees have the resources to conduct empirical research? A very important question. To do fact finding of its own? Depending on your remit, you really can't pursue what you need to pursue unless you have those resources. So I will stop here with—I want to go back to that in just a minute and tie it back to Carl 's comment.

But with two other things, independence is key. Right? And this has been mentioned several times. The independence of the committee and the commission is key. But the question is independence from what? So the obvious one is independence from influence from government. If in fact you're a presidential commission or a congressional commission, independence from Congress or independence from the White House.

But really, how independent are you? If you're a commission that wants to live to see another year, another two years, another three years, the issue emerges how do you negotiate your relationship with the White House or Congress. How contentious can your reports or conclusions or findings be? All kinds of issue of that sort. And then there's also issues of independence from other stakeholders besides the government agency to which you're accountable.

Finally, in line with that, accountability, impact, and relevance. I won't say anything more about that. We've got Alex 's wonderful HEARD out there to think about it and discuss further and I want to leave time for Eric .

One thing about being able to conduct empirical research, however. Carl, you really threw down a gauntlet in terms of your analysis of the failure of commissions with regard to human subjects research, and I think that your analysis needs to be sort of disaggregated. The critique about the failure of the current oversight system with respect to human subjects, I would completely share. [I would] not necessarily explicate it the way you do, but I think the time is right to recognize that we need to rethink how we do things in very foundational ways.

But I don't accept the part of your critique that says that national commissions or presidential commissions have not been helpful in pointing out that problem and I would argue they could be even more helpful. One of the issues we have, the point you make, is that we don't have data. We don't have data about how well the system functions.

It's extremely difficult—I've tried to do this through a presidential commission. I've tried to do it outside of government. When you're within a presidential commission, you have authority and power that you can use to get information that you cannot get otherwise.

It's just extremely difficult. So I was part of an enterprise with the advisory committee. We were able to compel, essentially, funding agencies within government and essentially manipulate universities to give us data information that they would not otherwise have given us. And that's a whole other story.

Separately, I was part of a consortium that tried to do a cost study, tried to figure out how much the IRB system actually costs academic and non-academic research institutions. I can tell you we struggled. It was a horrible experience. We got the roughest possible estimates, and it was in large part because nobody had to tell us anything, and very quickly universities and private research IRB kinds of places figured out that they might have some interest in the findings and not want to know or, you know, be part of a process that showed how much, in fact, it did or didn't cost them.

So there's a place for an empirical and fact-finding and investigative role. Whether it should sit with national, presidential, or congressional commissions, I don't know, but it needs to sit some place. And I'll stop there.

CHAIRMAN PELLEGRINO: Thank you very, very much, Ruth . Eric?

DR. MESLIN: Dr. Pellegrino and Dr. Davis, thank you very much for the invitation. I'm going to do three things in ten minutes. I want to give you my take on the issues addressed today, many of which will be similar to what Ruth and Alex have done. Secondly, I'm going to describe how the National Bioethics Advisory Commission addressed those same issues of which I was the executive director. And then third, I do want to put out a little bit of a list of issues that weren't addressed or at least weren't explicitly addressed today that are sort of my free offer to you to take on.

There are three categories of issues that I think were addressed today. The first were methods, models, and approaches; the second one, clustered under a topic that I'd call public representation or engagement; and then the third one is impact. Each of those have subcategories.

With respect to each of them, I'll just go through them relatively quickly and not dawdle on the ones that have already been commented on by others. Of the many issues that I heard today discussed around the topic of methods of work, the consensus issue was most frequently offered. If we were keeping track, I sort of took about 25 different notes that that issue of consensus versus rich diversity versus some other method of approach was discussed quite often.

I've got to tell you that—and I've published on this, so my views are widely known. I think the critique of consensus on commissions has a bit of work to do in part because there are claims made on both sides of this debate that are on the one hand quite helpful because we can't just throw out a word like "consensus" and yet on the other hand might often rise to the level of being pejorative as in, "Oh, you're just doing consensus, whereas we're just doing . . ." something else.

I'm actually—and I'm going to make a little attempt at achieving consensus and see if it works. I don't think that consensus is either a destination or a required mode of transportation. In some instances consensus happens, not because it's a goal to be strived for or because it is an agreed upon method by which agreement is reached, but it occurs.

And I'll give you a couple of examples of that from NBAC using the example of another methodologic dispute that I think has been discussed here between whether we do bottom-up or top-down bioethics. And you might call that the principles versus practice or cases versus theory. It goes by many different names.

Harold Shapiro, who is the chair of NBAC, and I outlined our views on some of NBAC's early work, sort of two or three years into it, in a paper that we wrote for the 20th anniversary of the Belmont Report Conference that was held in Charlottesville. Some of you were there.

And we carried out a little report-by-report assessment. You can read the paper if you're interested. But what we basically concluded was that some of the NBAC reports more easily identified with one approach starting with principles and moving down to something else. In fact, the best example of that was our report on research involving persons with mental disorders. In fact, we wrote early in that paper that "NBAC's views about respect for persons, beneficence, and justice are squarely in the tradition established by the National Commission nearly 20 years ago." Those words were published words.

So we went to great lengths to sort of talk about principles. Contrast that with the report on cloning, NBAC's very first report in which the commission reviewed the various philosophical approaches around the topic but learned very quickly, not surprisingly because of time constraints, that they weren't able to arrive at a set of recommendations solely through a process of philosophical reasoning and deliberation. In fact, if you were to interrogate two or three of the commissioners, including perhaps Professor Capron, I suspect you would get different reasons in their mind for why they came to the conclusions that they did that resulted in recommendations to President Clinton .

A second methodologic distinction that I heard discussed today was the role of education versus policy advice. And I think everyone could identify with this dilemma of whether one can do both things well within the ambit of one group. I'm going to mention later on how to assess impact, but suffice it to say the ongoing educative value of commission transcripts, working papers, commission papers, draft reports that had yet to be finalized, and final reports provides a voluminous literature from which many can and still do learn today.

If you think that education is simply unidirectional from here to someone in Congress, then we're obviously not thinking about what education means, let alone training, an entirely separate but related feature. I've actually had the pleasure of teaching about stem cell research ethics to high school students in the United States using the President's Council on Bioethics literature and NBAC as a compare and contrast. It's a fascinating pedagogical strategy, and I would submit that the results of both of those commissions are very valuable from an educational perspective.

With respect—and this is different from the policy advice function that Alex has referred to and I'm not going to replicate for reasons of time. With respect to a selection of topics, NBAC lived this dichotomy of being assigned a set of topics generically in its executive order and charter and then actually being given topics when a version of Ruth 's—what did you call it? It's a great name for— disaster planning. I don't know if Dolly was a disaster, but I can tell you that in private conversations with Harold Shapiro —

DR. FADEN: Crisis.

DR. MESLIN: Crisis. With Harold Shapiro, it's no longer a private matter. He related to me that he agreed to become chair of NBAC when he discussed this with the president on one condition, and that there would be no emergent issues for the commission to address within the first year. He wanted the commission to start to get its feel and understand how to work. Well, that was thrown out the door in— when Dolly was announced to the world.

So this distinction between responding to issues that you have been given versus identifying those on your own is actually a delicate balance that I think all commissions from the National Commission on have had to address. I actually have just figured out that NBAC equally divided its six major reports between those that it had been assigned to undertake. Those were cloning, stem cell research, and research involving human participants, the latter being within its initial charter. And a second set of three reports, the Report on Human Biological Materials, the one on mental disorders and the report on international research, which arose from the commission's own priority setting activity.

Now, this priority setting exercise, which took seriously the commission's charter, made it clear— and I think this was a question asked of Nancy Kass when she was here and she was politely trying to deflect it, but I thought her answer was quite nice-how do we decide what's important? Or as Professor Dresser has now been attributed to calling this—I like this version of "ripe." It sort of has a fruitiness to it or a wine bit to it. And I would encourage wine at commission meetings, Dr. Davis, if you could discuss with those who are revising the Federal Advisory Committee Act.

Now, we—I suspect you do too. You, the President's Council, received many e-mails, letters, and telephone calls asking for particular topics to be placed on your agenda, some by people who had longstanding interest in a topic, some by people who are very serious commentators and wished finally that a presidential commissions would look at this. We could only address a certain number of issues for reasons very similar to what Marie-Hélène indicated and also Hugh indicated. There's only so much time, only so much staff work, and only so much money.

With respect to public representation, and we don't even have a good language yet for talking about this issue. I've just divided it into two different categories, which is inelegant to say the least. One is the commission membership version of the public representation topic and the other is the actual public participation in the process itself.

With respect to membership, much has been made, including by me in a Hastings Center quickie, about this council before—as it was starting about the difference between NBAC's charter and the President's Council charter with respect to public membership on it. We explicitly included public members. This one did not. And a lot of to-ing and fro-ing and puffing of chests occurred as a result.

Well, I'm here to tell you if you didn't already know that the two designated public members on NBAC were first the president of an advocacy organization and the second was a principle in a biotechnology firm, neither of which I think a reasonable person, including the one that Ruth was mentioning that represents 300 million Americans, could sensibly be considered the, you know, the gentle person on the Clapham omnibus, so to speak.

I suppose a good argument for reproductive cloning would be to clone that reasonable person that we're all looking for and place her on every one of the 900 federal advisory committees, and we'd be done with it.

Public participation. I'm not going to pull one of those critiques that will come back to haunt me like Al Gore inventing the Internet, but I do think that NBAC was the among the first commissions that took seriously its obligation to use the Web and to use the Internet.

We had long discussions with general counsel at HHS on such things as when we would put our transcripts—you never thought "transcript" would be in the transcript of a meeting, but there it is—on the Web. That was sort of like genome sequence discussions. Would it be within 24 hours? Would it be within 72 hours? Would it be within, you know, a month? These were difficult decisions that I'm sure only maybe Dan and Yuval can appreciate, those of us who are executive directors or staff directors of commissions, the nuances. But it was very important, putting something on the web immediately gave it a gravitas that having to wait for something published later on in the federal register didn't.

Let me conclude with my—the biggest list of all, and that's impact because I think the elephant in the room today is claims about how to assess and evaluate the impact of these groups. Again, I've tried to do a very rough subdividing. Like Ruth, I was typing furiously in the back of the room and couldn't pull off the slide show that Alex did.

But I've divided my categories of impact into three different ones, all of which recognize that impact comes in different forms, involves different time horizons and involves different types of metrics, some of which, like the instruments that didn't exist when we said we'd map and sequence the human genome, weren't present to us then and probably still aren't present to us now. We're going to have to invent them.

The first set of impacts—sorry about the word—are what I might call stimulus or push impacts in the interest of the current administration. When NBAC wrote its report on human biological materials, the fact that it wrote that report stimulated a very active discussion on such issues as the identifiability of genetic tissues—of genetic information in human tissues. That was not a robust discussion in the bioethics literature, the FDA, or anywhere else. It elicited a response from the FDA, the NCI, and lots of public and private organizations.

Our stem cell recommendation that's already been eluded to generated a lot of reaction, some of which we didn't anticipate. Like the president issuing a press release on July the 14th saying that he rejected the recommendations that we hadn't submitted yet. This was an interesting form of impact and caused—I can't—I mean, I'm still going through therapy because of it—a lot of hand wringing on behalf of commissioners and the staff.

Again, not taking credit, but I do think that in some small way NBAC's discussion about the oversight of the human subjects system led to or contributed to the transition of OPRR to OHRP. We had very long discussions about this and it happened during our watch, so there's at least an associative impact as a result of that. Our discussion led by Alex Capron in our report on international research led to an important debate about the equivalent protection provision of 45-CFR-46, which gives the secretary particular powers to talk about other country's guidelines.

And I think our work on international research stimulated discussion and action by many around two of the most controversial provisions of the Declaration of Helsinki at that time. Indeed there was some discussion that many groups wanted to wait for NBAC to complete its work before they weighed in on the issue. There was a kind of timing phenomenon. I had long discussions with Sandy Thomas, Hugh Whittle 's predecessor at Nuffield, who was pleased to have us finish our reports that they could then take up their report. This is an important type of impact. WHO, CIOMS [Council For International Organizations of Medical Sciences], and many other organizations, including Public Citizen, weighed in on NBAC's work.

A second category of impact is what I call the reminder or "nag" kind of impact. The report on mental disorders which I had mentioned earlier had an impact for a different reason. And it had the effect of reminding the federal government that the subparts that existed, only four of them, one of which was the basic rules and three of which referred to special or vulnerable populations, did not have any coherence to them.

Why those three? We know that there's a history to them, but why not others? Why isn't there a provision for the aging patient, the young patient, the economically disadvantaged patient, or the patient who is lacking capacity? Compensation for research injury, privacy, harmonized research policy.

Let me just close, Dr. Pellegrino, with these two remarks on areas that I don't think are discussed by commissions or has not been discussed today. The first is the importance of a commission's convening power. Like it or not, although you're all members of a presidentially appointed commission and the staff have senior executive service status, I suspect that Yuval will mention Dan understands that when you make a phone call from a place that has a presidential seal on the letterhead, people return the phone calls an awful lot faster than they do normally. People don't return my phone calls as much now, and it's kind of sad. But it was an important point about convening power.

Reporting relationships. Ruth has spoken about and Alex has spoken about staff- and commissioner-led roles. I do want to mention one thing, which might be a very appropriate transition to the last speaker. You should know that Yuval and I have had some very nice and enjoyable conversations over the last five or six months about the transition from one commission to another. We sort of lived in both eras. I congratulate you, Dr. Pellegrino and Dr. Davis, for having some of us on who worked for previous commissions come to you because this is a mini type of transitional activity from one to another.

No one gave me any materials from prior commissions. Were it not for Ruth Faden's commission's work, NBAC would not have known what the history of some of those issues were. But there was no formal debriefing, no formal transition, and I very much appreciate the opportunity that Yuval and I had just to sort of—you know, guys sitting around and talking about the good old days. But I think this is a topic that you need not let go unnoticed.

Last, and then I'll sit down. Bioethics commissions now seem to be as much an instrument of science policy advice as they are about bioethics policy. If that's the case, then you need look no further than a memorandum that President Obama signed earlier this week that talks about science and science policy and science integrity as an instrument of national and domestic policy. So bioethics commissions are going to have to think a little bit more about those as well. Thanks very much.

CHAIRMAN PELLEGRINO: Thank you very much, Eric . Yuval?

MR. LEVIN: Thank you very much. It's a great pleasure to be here and I appreciate very much the invitation, and it's wonderful to be on such a distinguished panel. Eric is too modest to say so, but he was in a way an exception to the rule he laid out at the end. We didn't have a formal transition, but he was immensely helpful to us in the transition. And, as he says, we've continued to talk about these issues since.

In a way I want to pick up on where he ended, which is on the way in which bioethics issues—what we think of as bioethics issues have changed over the years and what that has meant to the work of bioethics commissions. This invitation gave me an excuse to look again through some of the wonderful work of the early commissions of the National Commission and the President's Commission, extremely valuable work and we all ought to recognize how much there is to appreciate.

And one of the things you notice is that what they were called to do was rather different than what we were called to do and in a way what NBAC was called to do and had to do. Bioethics does a lot of things, but I think that from the point of view of public bioethics commissions there are two things we can focus on in particular.

One is to act as a mediator between science or medicine and society. To mediate between medicine and society is a lot of what bioethics did at the beginning. It emerged from concerns about medical paternalism, about the treatment of patients, about the place of physicians in society, and saw its role correctly, I think, as fixing the relationship between medicine and society.

A lot of what bioethics does now—and again, it's a matter of what's emphasized. Both of these elements were present in the beginning and both are present now. But a lot of what's emphasized now, especially in public bioethics, has to do not with mediating between medicine and society but with clarifying a debate or a dispute within the larger society about medicine or science.

And these, in fact, turn out to be very different. And in defining the role and the work of a bioethics commission or a public commission, they mean very different things. And I think that has to do with the subject that kept coming up today, the question of whether you seek consensus or not, the question of just what it is you see as your role.

There is a way in which this moment for bioethics commissions or maybe we can say the last decade or so has called for a lot more of the kind of work that tries to clarify a dispute that exists within society to help society think through a set of developments in science or medicine that raises tensions, that creates problems, that creates disputes that draw on existing differences in our political culture but that require an understanding of science and an understanding of what the question is we're called to deal with that experts can help to deal with.

Many of the most difficult bioethical questions that become policy or political questions now are not at their core technical or regulatory matters but truly moral questions. They're questions about what kind of being the human being is, what kind of a life that being should pursue. Certain kinds of developments in biology and biotechnology and medicine raise really complicated challenges to our sense of ourselves.

And one crucial goal, as I say, of bioethics is to help the public understand these question as they arise in their native, social, and cultural and political settings, not to translate them into a foreign language that only experts understand or to dispense with them like a kind of geometry problem. But to help the public understand what the issue is, what the arguments are, and to help people come to conclusions rather than to take over the debate.

The problems that these questions raise for our society are genuine problems. They have to be worked out by the larger society through its social and its cultural and its political institutions. And they have to be digested by people of very different world views who are going to come to very different conclusions.

And one role of the bioethics council in this view is to clarify and elevate the questions rather than simply to dispose of them. It's a view, I think, that draws on a particular understanding of politics in a democracy, on a sense that political, what me might think of as partisan differences, while they can easily get very carried away are fundamentally legitimate differences. They're not failures of understanding.

To approach this kind of genuine disputed public question with an eye only to a kind of expert consensus I think can easily disparage the question and disparage the people asking it and end up arguing that this kind of disagreement is just a function of ignorance or blindness. But that's simply not so—or at least it's not exactly so.

It's true, of course, that political disagreement, any political disagreement, is a function of our imperfect knowledge in part. We never see the whole truth all at once. We see only parts of it, and different people are inclined for a variety of reasons to emphasize with good reasons and good intentions different parts. That's what makes parties and partisanship.

The disputes between them are finally disputes about what parts of the truth ought to be emphasized. And these are serious disputes that deserve the aid of thoughtful and learned people. They speak to the question of the public good. No one has a grasp of the whole all at once and everyone has a case to make for why the part they think is most important really is. Why liberty might matter more than equality in some instance or why the family might matter more than the individual or why the health or some might matter even more than the lives of others or vice versa.

In any serious public dispute, each of these kinds of views will have a very serious case to make. And as I say, each will benefit from the work of intelligent and educated advocates to help to clarify it and to argue it out. Instead, too often thoughtful and learned people, public philosophers, and intellectuals seek not to inform these debates but to overcome them by reaching for a language in which they are rendered essentially meaningless.

In practice, I think that what this really does is render that work meaningless, is render the work of these public philosophers meaningless since it doesn't speak to the way in which these questions emerged, and especially if you do this in a public body that's answerable to the political society that has asked you for help to say that—to say essentially that the reason this has all come up is pointless isn't going to be very helpful and for the most part isn't going to be very true.

I think it's clear the design and the scope of this council that it is moved by this kind of understanding of the nature of politics and of the nature of the most prominent bioethical questions of the day and of the role of intellectuals like these members of the council in the public sphere.

It's very evident in the charter of the council, the executive order that created it. The order says that the council is to advise the president but not by transforming the bioethical questions that emerge before the country into technical or academic questions, but by helping the president and the country better understand these questions and the various answers that have emerged to them and their implications.

The charter of this council really is a kind of explication of this view of politics, I think. It describes a very broad scope, but it does not say that the purpose of the council is to resolve these issues. Its purpose is to clarify them for policy makers and for the public so that they can be argued and decided in the proper venues.

The council was certainly empowered to make recommendations and to have the members or the body as a whole express particular views. But the point was always the argument for those views. The point was laying out the positions so that policymakers and the public might understand them better. And the hope was that council members would help people understand their own views by taking these views seriously, by as Diana Schaub said earlier paraphrasing Alexis de Tocqueville, I think, by seeing further than the partisans but not looking in a different direction, looking at public questions as serious questions.

This approach obviously has its benefits and its drawbacks. but I think as a descriptive matter this is certainly the approach behind the design of this council and behind the selection of the members who were chosen to disagree, as they often did, much to the chagrin of the staff...

And the hope was to provide a forum in which that disagreement could be had among people who thought about these questions, that thought through the issues and can articulate the competing position with knowledge and with depth. It's an approach to public bioethics that makes for a very different flavor in the council's report than what you would normally find in such bodies around the world and some of the prior American councils but that if done properly offers a way of taking politics seriously and respecting the character of our democracy and the difficulty of these questions.

It's not easy to do this well, but I think that on the whole, this council has done it very well, which is a testament above all to it's chairmen, past and present, to its members, past and present, and I'll close by thanking the chairman and the members not only for having me today but for giving me the opportunity to serve this council in the past and benefiting from its work as a consumer of its work later on in the White House. Thank you very much.

CHAIRMAN PELLEGRINO: Thank you very much, Yuval. And thank you to all of my colleagues and friends who were kind enough to do a terrific job, honestly, in a few minutes summarizing so much of what went on today and embellishing it in a way that I think is extraordinarily helpful. We're deeply indebted to you, especially for your patience and putting up with this particularly rigorous way of doing it. Thank you so much.

Well, it looks like someone wants to ask a question. Yes, Dr. Gómez-Lobo?

PROF. GÓMEZ-LOBO: This is really my question from the morning that's transported to the afternoon.

CHAIRMAN PELLEGRINO: We failed to forget.

PROF. GÓMEZ-LOBO: I really enjoyed all four of the expositions. I really learned a lot. I was unprepared for so much information and so much insight into—particularly into the positive aspects of all of these devoted public bodies.

Now, I want to address my question to Eric. In reality, it's a question that I had planned to address to Cynthia Cohen, but I saw her leaving so I said I'll hit Eric in the afternoon.

But let me preface the question, because in a way it's going to sound like a very narrow question. It's going to sound narrow, but I trust that everybody in the room will realize that it has broader implications. It has implications, I take it, for this idea of consensus. In fact, the—I'm been personally puzzled all day today about this idea. I mean, how do you reach consensus when you have convictions that are so different and opposed and contradictory on many of the issues?

One way to go about it would be to distinguish levels where, of course, you can compromise. You can go into a consensus and then say, well, but at Level C it's impossible. It would logically inconsistent on my part if I did. And the specific question is this: Last night I was reading Cynthia's Kennedy Institute of Ethics Journal article from 2005 that we got in our briefing book. And I thought it was fascinating whenever Leo Strauss appears on the horizon. That gives me shivers because I'm not very partial to his views.

But I thought that simplifying a lot, in a way meant to present the NBAC people like the good guys the President's Council people like the bad guys in a way. Why? Because there's an argument there that the first council went for this idea of overlapping consensus, and that just sounds great. I mean, why should we as civilized and educated human beings not go for overlapping consensus?

In fact, I would say we do that all the time. I mean, we couldn't live with each other if we didn't do that. But then I took a closer look at the specific point in the report on stem cell research and how that consensus was reached. And the consensus was reached–and I better quote because it's almost unbelievable. The consensus was reached by adopting an argument by Ronald Dworkin to the effect that people who hold inviolability of a human embryo do admit exceptions.

Now, that's the premise. The conclusion is therefore these people don't believe in that inviolability or that a fetus is a person or whatever formulation you like. Now, that's an non sequitur any way you look at it. I mean, it's an incredible argument after people who have been holding the inviolability of early human life have been discussing direct and indirect killing for what? Eight centuries?

So to conclude that the report had reached on the basis of that argument the required overlapping consensus to agree—and I quote: "It also is permissible to destroy embryos when it is necessary to save lives or prevent extreme suffering," taking that as a basis for the recommendation. And here's the question, the real question. Wasn't there anyone in the NBAC who stood up and said, "Wait a minute. This is really a very fallacious argument. It really doesn't work. It's simply not true that you can infer the mental states of people who would go on holding that inviolability simply because of alleged exceptions."

I mean, traditionally anyone holding—anyone who has some sense of the principle of double effect would say, no, they're not exceptions at all. So the question is very specific. Wasn't there anyone who stood up and said, "Wait a minute, this argument just doesn't work?"

DR. MESLIN: Yes. Do you want to hear more? Consensus is not unanimity. And in fact—I mean, it's great that you asked the question. I'm smiling for two reasons. One, this is, as physicians often swear by Apollo to their—those who help them along the way, Professor Gómez-Lobo helped me as a young graduate student at Georgetown, so I thank you. And now you're putting me through the wringer again. I thought we were already over that.

Yeah. I'll tell you two things about that discussion. And Professor Capron can also weigh in, being a member of the group that actually came—I was merely an executive director. But the answer to the question is yes. And there are two ways that I could describe it. One is I could encourage you to read the transcript again so you could see just who those commissioners were, what they said, what their level of comfort and disagreement was not only with the argument but with the final recommendations.

I don't treat this answer lightly because, in fact, there—it was among the most difficult of the reports that I was involved in. I was not involved in the cloning report; I came on after that. To talk to individual commissioners on their own about these issues and one—I'm thinking of one commissioner in particular who I think was the most troubled by the direction of this argument.

So the answer to the question is yes. Was there anyone? Of course there was. There was, in fact, more than one. I think the question you're also asking is, if that's the case, how is it that they could sign on to a recommendation like this or an argument that goes like this?

You know, the quick answer would be they felt comfortable enough—I can't go into their mind anymore than you would like us to be able to—to come to that conclusion and did so in several ways. And here I'm going to extrapolate a bit and again, Alex, if you want to jump in, you're welcome to.

One is I think that as a procedural matter, the meeting that we held in the Riggs Library at Georgetown where we invited 12 scholars from different faith traditions to speak about their views. In fact, I think—is Professor Meilaender still here? Yes, he is—who helped us greatly at that—at that meeting and in prior documents.

Provided a certain degree—and I'm reluctant to use this word, but I'll say it anyway—degree of comfort in the minds of the one or two commissioners that I'm thinking of. It's not that I'm trying to protect their identity. I'm just simply—the point is not naming names; it's answering the question. But to hear this discussion at the level of clarity and commitment to these very questions that you're asking, Alfonso, I think gave a certain degree of assurance that the commission had weighed, considered not so much the Dworkin argument.

This wasn't take argument, take stem cells, stick stem cell to argument, and get conclusion. In no way, shape, or form is that the process. But, yes, there was an awful lot of deliberation. There was an awful lot of discomfort. I well remember an interaction between one or two commissioners and Father Demetri Demopolis, a Greek Orthodox theologian, who came to that Riggs Library meeting— I remember it like it was yesterday—who went on at quite some length expressing his own reservations and discomforts.

So whether or not there is a relationship between hearing the arguments of others and the level of comfort that provided these one or two commissioners with the assurance that they felt that their fellow commissioners needed in order to sign on, I don't know.

I'll say one other quick thing. In no way, shape or form was there any effort at arm twisting, at driving to consensus at all costs. There are several examples in many NBAC reports, including ones written by my colleague to my left, who wrote personal statements not at the end, not in an appendix, on the very page where the debated issue was raised in order for their views and their view or views or multiple views could be—could be reflected.

So I don't know if you want to add to it, Alex, but that's a quick answer for you, Alfonso.

CHAIRMAN PELLEGRINO: I will call on you, Bill, for one second. Eric, you may not remember. I was at that meeting. And I think if you look at the record, I stated unequivocally that there was no compromise on this issue so far as I was concerned, and I'd like to go on the record stating that clearly because some of my compatriots of the same persuasion—

DR. MESLIN: At that same meeting—

CHAIRMAN PELLEGRINO: —disagreed with me.

DR. MESLIN: At that same meeting.

CHAIRMAN PELLEGRINO: So I was, I think, the only one who held to that strictly and without compromise, and I think it's important to know that. Now, I'll ask for Bill Hurlbut, who wants to comment.

DR. HURLBUT: I really want to just extend what's being said here with an analogy, as I was thinking about it ever since the presentation this morning that if we look at the meaning of diversity or a variation of views, we have a really good analogy from the—from the basic biochemistry of our being, namely the diversity of our gene pool, which although we're not all identical it's a tremendous resource of variation for our species.

And yet it has to work as a unit. It has to have a kind of diversity of parts that's compatible with the survival of the whole. And that seems to me the key here. Somebody—one of my friends at Stanford said about the genome that we're packed for all kinds of weather. In other words, we survive as a species partly by generating diversity. Species have always done that from the beginning. Bacteria would produce thousands of slight variations, and one or another would survive. We've distilled it down into a more enduring individual who can think with a diversity of thoughts and a community that has a diversity of individuals with diverse thoughts of their own.

If life started out by surviving by mutation, it ended up by permutations of mind. And this strikes me as absolutely crucial in a body such as a bioethics council, where there is a combination of defense of a stable core of our humanity but the creative power that diversity brings that allows the transformations that are necessary for the changing weather of social realities and different circumstances.

And it strikes me if we look back with a thoughtful reflection of what ethics is, we would realize more deeply that the word gives us a clue. That—ethics, of course, comes from the fundamental Greek—you better correct me if I'm wrong on all this, Alfonso. But the Greek root is having custom or character, and it's tied deeply with the—even further with the Indo-European root with the word "ethnic." So it was something that sort of flowed up by its nature from who you were and what you were.

Ethical positions feel so fundamentally real to us. That's why they work in individual life and sustaining communities. But it also makes it so we can't understand easily why somebody else wouldn't agree. It's like—it goes all the way to bottom of us. "Why can't they see that it's true?" And it ends up, then, that we unfortunately misjudge one another, sometimes label each other's views as intentionally obfuscating truth or as ideology or as unscientific or something that doesn't bespeak respect to the diversity of views that are being expressed.

And so what I really want to say about this, there are two fundamental things that I think are extremely important in future councils. I feel like one of the best things we did in this council—have done and continue to do—is to respectfully seek what is common behind our diversity of views. And one of the things that I think we did best in the past in our work in this council was our white paper for alternative sources of pluripotent stem cells, because that was where we both understood there were irresolvable differences. Maybe if we'd had more time or something else, we could have resolved them, and maybe societies in the future will resolve them. But we couldn't.

So finally what we did was we understood that even within that diversity there was perhaps a space where they could be a creative third option, a solution that was at the core of our common concerns. And I think it's that which is the strength that we need to seek, a kind of creative, constructive resolution of some of this. Otherwise, we're just headed for an infinite playing out of the culture wars.

And I would wish bioethics could be a more constructive process. It's not that we should seek lowest common denominator ethics. It's that we should seek a kind of unity and multiplicity, and that means understanding the role and the purpose and the strength and the vitality in variation and diversity. There's an old saying the first principle of intelligent tinkering is never throw away any of the parts. It's a mechanical metaphor, but I think in a good society there will always be a diversity that's crucial to the survival of the society itself.

It's—the way you find that common ground that we did in the white paper was to take each other's views seriously, respectfully, and also acknowledge from the beginning the deep seriousness of the deliberations, how much they transcend any one generation. That's the way all future bioethics commissions should sit. They should realize that they're speaking about issues that transcend any politics or immediate purposes. That they have to be very, very serious. They have to seek that locus of consensus that is—preserves our diversity within our common humanity.


DR. ROWLEY: Well, I'd like to come back to the question that Alfonso raised and actually ask him in his concerns about the dilemma of how to view and treat embryos, pointing out that at least in Europe, because the number of embryos that are implanted is limited and yet the number of embryos that are formed are often in excessive of the two, I believe, that at least some countries limit implantation.

All the excess embryos are destroyed. And so that's part of the way that they operate. In the United States, excess embryos are frozen and either used subsequently if needed for a pregnancy or else they are excess. And then different IVF facilities thaw those embryos or would—it kills them or makes them available for others if a donor approves, makes them available to other couples who have not been so fortunate as to have their families complete.

So the question is, if you thaw the embryo or if you don't freeze it and just let it die, that's—that's the current practice. And why is it so different? And why is it so immoral to then say that parents or donors have the option of using those embryos for research that may lead to information that ultimately benefits individuals who need that information available scientifically?

CHAIRMAN PELLEGRINO: Professor Gómez-Lobo and then Peter.

PROF. GÓMEZ-LOBO: I had inadvertently become part of the panel, I guess. Let me take it from a little bit from further back, if I may. It's a little bit of a follow-up on the previous reply. I am familiar with Volume 3 of the report and—of your report, of the impact report. And, you know, I think it's a very important document. [Available at]

On the other hand, when I go through those religious testimonies in Volume 3, with the golden exception of our chairman, Professor Pellegrino, I find that most of them are pre-1827. You know what I mean by that?

PROF. LAWLER:   [Inaudible].

PROF. GÓMEZ-LOBO: No. I was—I was not around at the time, but 1827 is, if I'm well informed, the date in which Baird discovered the female ovum. The vast majority—I don't remember the names. Abdulaziz Sachedina was one of the persons testifying, and there were a number of religious authorities testifying. And they were testifying on the basis of sacred scriptures that all—I can guarantee that—all were pre-1827.

And I thought that in a community that should discuss these things on the basis of science and reason—it was totally unreasonable to accept those testimonies as important. And one of the things that I think is very important about our council is that we have not invited those kinds of testimonies, and the few times that I've been consulted on that I've been firmly against it—firmly against it.

No, I have nothing against religion. I hope you trust me on that one. But I do—I do want to discuss this on the basis of the scientific evidence and the philosophical conceptual convictions that we have reached.

And now I'm going to address your question, Janet . Basically, for me the key thing is that there is a good way of showing that there is identity through time between the embryonic stage and the later stages. Hopefully I won't need to develop the whole argument. You know, I've published papers on this.

But twinning is not an interruption of identity. To be an embryo is not to be a being of a separate class. "Embryo" is a word that designates a stage, so what matters is whether you're a human embryo or a feline embryo. And last but not least, everybody in this room was an embryo some years ago, some of us many years ago, some less.

So I would be ready to develop that argument, and therefore I see—and, again, I could argue at length on this—I see it as important to hold the inviolability of every human being, every human being, and that means every human being of any age. I would be adverse to discriminate on the basis of age. We care about children. We care about the youth. We should care about all human beings of—throughout their lives.

Now, on that basis, on that basis—on the basis of the profound respect, the dignity that leads to inviolability, I would argue that to freeze human embryos in the first place is wrong. That would be my first claim. I think that having children is a great human good. I've enjoyed it, thank God, and that one should strive, of course, to have children. But it's—it seems to me inconsistent, then, to freeze a human child at a given point just for later use. So my first claim would be that we should not freeze human beings.

Now, the second point is, well, if they're going to die anyway—because that's part of the argument—why not use them? Well, again, I find that morally troubling because all of in this room are going to die anyway too. But that does not justify our dismemberment. We could use, you know, the organs of some people, perhaps some of the younger people in the audience, to provide transplant organs, organs for transplantation, but it would be wrong to do it.

So what I see is that frozen embryos create a moral quandary of which there's no way out. I don't see honestly—I think there may be adoption possibilities given the numbers of frozen embryos in the United States, I think it's unrealistic that many of them will be adopted.

But still, that does not—does not justify in my view intentional dismemberment just for the benefit of the rest of us, particularly now with the reprogramming of cells and all of the progress that has been made in that direction. So that's the way I would personally go on this issue.

DR. ROWLEY: So it seems to me that this—this raises additional problems. So it's the European way, which is not to freeze embryos and therefore to kill them immediately, is in some way more morally justified than to freeze and then thaw and kill. And you know, I'm—in this area of ethics and philosophy, I'm just an ignorant scientist, and so I have difficulty in appreciating the nuances of some of these discussions. But I have to say I don't find the distinction personally terribly convincing.


PROF. LAWLER: All right. There they go again. And I'm glad they're going over this material, because I wasn't here when they went over it the first time. But what have you got here? You've got two very, hugely reasonable people having a scientific argument over the facts. Alfonso says an embryo is a who, finally has to be treated like a who. Janet, in the final analysis, an embryo is a what. You know, like our great president says, it might even be above my pay grade to resolve this in a simply scientific way. It's a great dispute.

But I notice it is a scientific discussion between two most able people. I predict even if we extend this far beyond dinner, we will not reach consensus on this important issue tonight because I read the transcripts the first time. There was no consensus, and some members of the Council, making simply scientific arguments with nary an Archbishop being brought in, could not reach a consensus because of reasonable people disagreeing.

Now, you've all made the good point if they— either of these two people — were simply wise, not like Socrates on the way to wisdom, but if we had philosopher kings on this Council, then they would resolve this. Maybe it's true, as you've all said. Alfonso is emphasizing some facts. Janet 's emphasizing other facts. And if we had Rush Limbaugh on here making our—and Fox News making us all fair and balanced, we could work this out.

But in fact, it's not going to happen. So very reasonable people are disagreeing on the most elementary facts. These are tough facts, right? So on this council, you know, through discussion you always attempt to research consensus but you fall short. And so when recommendations were made, they fell back on the political method of compromise.

Now, you might want to say it's almost horrible to compromise on this issue, but it seems to be you're stuck with it. Like we're stuck in actually making public policy with compromise on abortion, not because objectively a compromise is what's called for, but because such reasonable people are disagreeing on the most elementary facts.

So in the previous council and commission and the article, quoting Dworkin and all this, it made it—it seemed like to me the proposition was this: reasonable people, if they really thought about their opinions, would reach this conclusion that it's okay to kill embryos if you're going to save lives because you make exceptions with respect to abortion. As Alfonso pointed out, that's not self evidently true.

And so the idea that that consensus is based in reason through the quoting of professors of philosophy actually is quite tyrannical, because if you're outside of that you're like not a reasonable person. You're merely a religious person or merely an archbishop or something or merely Dr. Pellegrino, who is a fake philosopher and a real MD or something.

So it seems to me our council had the advantage of not being tyrannical, of allowing the free play of ideas on this, showing that reasonable people with high level of scientific and philosophical knowledge could not reach agreement, mirroring what's going on in the country.

And I'm not saying objectively there wouldn't be a way of working this out. It just happened that when you picked from the best and the brightest they didn't work this thing out. So it seems like finding consensus on an issue like this really does not reflect what the country actually thinks and really marginalizes quite unreasonably people who don't fall within the consensus.

CHAIRMAN PELLEGRINO: I have Dr. Meilaender and Bill, who want to comment. I just want two minutes in between just because my presence at this meeting was mentioned. My argument, the record will show, was not based on quotation of scripture. My argument was a scientific argument, and I will be glad to take anyone on on that basis. That's number one, what was recorded.

The second point is, I think these two ideas are incommensurable and are not going to be a compromise. I think we should comment and begin to think about how do we live together with this difference. Now, you spoke about the process of dialectic. One aspect of the process of dialectic is recognizing when you're at the point that you're starting from two different propositions, and Aristotle pointed this out in the "Posterior Analytics." At the beginning of every argument, there is a non-provable assumption. We're at that point in this particular discussion.

And so I would say let's comment on how we as a civilized society live together with this issue. If you'll forgive me for that clarification on my part. Now, you have the day and then Bill and then I think I'm going to have to ask for a cessation of the discussion lest we be here ad aeternitatem.

PROF. MEILAENDER: Well, I don't know how we got back to here. But I want to say—I wanted to say a word in response to Janet 's question because I don't think—it's a little different, Peter, from the way you put it. I don't think she was disagreeing with Alfonso about the status of the human embryo, though I'm sure they do disagree about that question.

I think she was for the moment granting his position and saying given that it's what you think it is, wouldn't it be better to at least get some use out of it in a process that destroys it than to simply thaw it and let it die. That's what I think.

And Alfonso gave a very complicated answer. I think the simple answer which will not necessarily persuade you, but I don think there's a difference, Janet, is the difference between letting someone die and wanting to get in on the kill. Those are two quite different things. Allowing to someone to die or aiming at their death and that I think is the distinction.


DR. ROWLEY: But I don't—I don't think that's so at all. I think that—I was very persuaded at the first meeting by Michael Sandel talking about competing goods. And I have no idea—and this is where I pleaded ignorance as to whether that's a philosophically generally accepted point of view or whether it's simply Michael Sandel .

But when you have competing human goods, then I think it's possible to say that in my view this competing human good takes precedence of that competing human good. And so getting in on the kill is something I find quite—I won't accept that as a— you know, as a possibility.


DR. HURLBUT: Well, just to underscore what I said earlier and to give our predecessors a little credit for some of this, the greatest human good in the face of an irresolvable problem is to seek another kind of solution. And let me underscore that NBAC actually acknowledged this in their work, and I've got a quote for you.

They saw this difficult debate. They knew they weren't going to solve it, and they probably knew we weren't going to solve it. And so they wrote "In our judgment the derivation of stem cells from embryos remaining following infertility treatments is justifiable only if no less problematic alternatives are available for advancing the research."

Now, if the put research ahead of human inviolability, that Alfonso will see it as an error. But they did propose a solution that was respectful of a diversity views. And with those solutions at hand, let's try our best not to keep fighting about things we don't have to fight about. Otherwise, our society is going to be torn apart. I mean, serving on this council for eight years, I've felt the depth of the differences in our culture, and it's time for us to truly seek some kind of ways forward with unity in this civilization.

DR. ROWLEY: Yeah, but I want to come back because he's referring to IPS cells or induced pluripotent cells. And even people like Jamie Thompson and Yamanaka, who were at the president's signing of the executive order on Monday, they both say that IPS cells are no substitute for human embryonic cells. So to say that there are other ways and you just don't need these cells is not true right now.

Now, it may well be–and one hopes and I've got —I do sincerely hope that with continued research that IPS cells—and I have to say that that Bill Hurlbut proposed an example of this in the white paper that I was skeptical of and I was wrong that we do—I've sort of lost my train of thought. But I think that it is important that both options be available until we know that one is better than the other.

DR. HURLBUT: Or at least we should—whatever we do, we should work for the positive. That's the point. I mean, let's be clear about it. We're only going to deepen our cultural divide if we don't respectfully proceed with a diversity views. Instead of shutting down the processes that can resolve these things, we truly need to say yes we can. Work for solutions, not keep fighting battles.

CHAIRMAN PELLEGRINO: And in the mean —

DR. ROWLEY: We don't know what the end is.

CHAIRMAN PELLEGRINO: We need to work on how do we live together with something which is incommensurable at this moment. That would be my next step. I want to call—I don't mean to cut you short, but I do need to cut you short.

DR. HURLBUT: Don't forget about Robby.

CHAIRMAN PELLEGRINO: Yeah. That's what I'm about to do. Robby, I'm about to pull you up from wherever you are. De profundis are the words.

DR. GEORGE: Thank you very much, Dr. Pellegrino . I'm sorry not to be able to be there with you. I'm rather deeply under the weather.

First, I want to make a general point about ethics, just a warning that we should be careful not to oversimplify what ethical analysis is. It's very complex. Rarely is it the case that when we actually have competing human goods we can rightly resolve the question just with a consideration or a judgment of which is the most important, and you can see that very clearly just through a thought experiment, a kind of extreme case.

Imagine that there are seven people are waiting for organ transplants, vital organ transplants. One guy's waiting for a heart, a couple guys are waiting for kidneys, and so forth. And then there's one person who's in good health, but perhaps good physical but not good mental health, or someone who's mentally disabled or something like that. You could say, well, look. We could save the lives of the seven people by taking the organs at the cost of killing him of the one individual.

Now, you could say that there are competing goods here. Obviously one person's life is a good even though it's a physically or mentally disabled person for the lives of the other seven. When we say to ourselves, well, no, it would always be wrong to kill one individual even to save seven, we're not thereby saying that the lives of the seven are not important. We're not making the judgment that the life of the one is more important than the life of the seven. It's not the kind of judgment it is. So it's not simply a matter of declaring which side you're on when there are competing goods and judging one to be more important than the other.

Then I wanted to respond to Janet's point, and I appreciate Janet's sincere effort to understand why those of us who are on the other side on the embryo question from the side she finds herself on, why we come down the way we do. There was a premise to her question, though, and if I understand her correctly she was suggesting that in European practice the number of embryos created is typically the same as the number or roughly the same as the number created in the American practice.

The difference being the number—pardon me—that are implanted and with the Europeans simply destroying those immediately that are not used and the Americans are freezing them away. That was not my understanding of what happens in Europe, but perhaps my understanding is wrong. I thought that in the European situation, at least in many European jurisdictions, you do not have a large number of excess embryos produced, or at least as large a number as we typically have in reproductive practice in the United States .

So I would be grateful if Dan or someone on Dan 's staff could look into that and just let us know if the practice is, in fact, as Janet described it or as I thought it was. But either way, Janet leaves us with the question. If you're—if you have embryos that, quote, are going to be discarded anyway why not use them to advance science if you can dot hat.

And here there are really two reasons. If you consider, as those on our side do—and it's Janet 's granting here for the sake of argument, but not conceding. It's not her own view, but she's just assuming for the sake of argument that we're right about this and then asking us a question about its implications or consequences.

But assuming that we're right that human embryos are human beings who have an inherent and equal right to life, if they're going to be discarded anyway what would be the problem with using them to advance science. Two problems. One is, when someone has been a victim of injustice, then to benefit—to allow ourselves to benefit, to use the injustice committed against them to benefit ourselves, obviously raises ethical questions.

It can be very complicated. There are some circumstances in which most ethicists say that, well, if the injustice is remote enough from the benefit that you're now seeking perhaps it would be okay. But if not, then you should forego the benefit because of the injustice. So that's number one.

And then the second thing would be the concern about incentivizing people to create excess embryos or incentivizing people to not take steps that would reduce the number of embryos who are created, the assumption being here creating excess embryos when you know that they're going to be lost one way or another or destroyed justice in itself an injustice.

So Janet, just to explain at least my own position, those are the two reasons that I would cite in response to your question.

DR. ROWLEY: Well, just as Dr. Pellegrino was worried about lunch, I realize that there may well people now who are worried about dinner. But my understanding–and I think facts would certainly would be helpful here—is that part of the difference in Europe and the United States is, as I've described it before, our appalling health system, such that women and families get paid or pay an amount for the developing of the embryos, some of which sometimes is covered by insurance.

And if you have excess embryos that are frozen and if the first time implantation is not successful, you can go back to frozen embryos and use them to implant a second time at either no additional cost or a very reduced cost. Whereas the Europeans who pay for this, they can just keep going back again and again at no individual cost or minimal individual cost. And therefore, there isn't the same financial incentive as we force in the United States .

So that's—my understanding is, part of the reason for having increased numbers of embryos is driven strictly by differences in the health care systems.

DR. GEORGE: Well, Janet, then perhaps I misunderstood you because I thought the premise of your question would be that a roughly equal number of embryos would typically be created in either of the two systems and then the only question is what happens to them. Are they simply discarded as is the European model, you said, I thought, or are they frozen for possible use in the future or to be thawed and used for research in the future. Is that not right?

DR. ROWLEY: Well, this is where I said some facts would helpful because–

DR. GEORGE: Okay. Well, then it would be [inaudible]—

DR. ROWLEY: —it's my impression from reading that, in fact, fewer embryos are produced in the Europe because they're only going to implant at the most two embryos. All of this says that the embryos have to be cultured for a bit of time so that somebody using some very imprecise criteria decide which two embryos look as though they are most viable, and it's those embryos that are used in Europe .

Certainly the same criteria or similar analogous criteria are used in the United States for implantation. But there is, as far as I understand, no statutory limitation on the number that you can implant, which is why we're having an increased number of triplets, quadruplets, quintuplets and beyond.

DR. GEORGE: Yeah. Well, there are two distinct questions. One, are there limitations on the number of embryos that can be implanted, and then the second is, is there a limitation on the numbers that can be created? My understanding was there was a limitation in Europe on the number that could be created. And perhaps, Janet, if I understood now this last time, we're on the same wave length there and we think that actually fewer are created in Europe . But either way, it would be good the staff could get us the answer.

CHAIRMAN PELLEGRINO: Could I—could I have an additional minute? We had Madame Mouneyrat with us who was here this afternoon, and she's concerned about the comments re: European storage, destruction, et cetera. And I think we have a source of facts here—


CHAIRMAN PELLEGRINO: —and we should ask her if she's be kind enough to enlighten us.

SECRETARY GENERAL MOUNEYRAT: I'm very sorry to be again in your debates. But I just would like to tell you the exact situation in France about the [French] embryo. The situation in France is defined by law, the law of 2004. So in France when you do an IVF you have to obtain approximately ten embryos. The good practice is to transfer three, no more than three. So you have approximately—it's not exact numbers, but approximately you have seven or eight embryos left.

They are frozen. And when they are frozen, the law says that the parents have three possibilities. First, they keep it for a second IVF operation to have a second child. The second possibility is to ask the destruction of the embryos after—not immediately but after—I don't remember exactly the number of months to have a reflection about the decision.

And the third possibility which has been offered by the law is to—the word is very difficult to find because it raises an ethical problem—is to "give" an embryo to another couple so this couple is able to adopt it. The problem is that the French law didn't say to "give" an embryo because you immediately see the ethical problem because you can only give an object, and as embryo is not rather an object it's difficult to say that you can give your embryo to another couple.

So you have—we have a [word] in French —my vocabulary is bad—not the word to "give" but to "receive" by the other couple... And the law in France now limits the authorization of research on [word garbled] embryos four years—five years. Sorry. After five years, the law will be recommend and we have to take a decision. And I can say that nowadays in France approximately 12 researchers have obtained the authorization to do research on the [garbled] embryo by biomedicine agency which has been created in France for giving these authorizations.

Thank you. It was only what I wanted to say.

CHAIRMAN PELLEGRINO: Thank you very, very much. Very relevant.

DR. HURLBUT: Can I get clarification? Are you saying you don't currently allow the research on them and you will in five years or are you saying they do now and don't?

SECRETARY GENERAL MOUNEYRAT: No. This is precisely in debate. The state of the French law is very complicated and ambiguous because the French law from 2004 says that research on embryo is forbidden. It's a principle. But just after, you find an exception to the principle, and by derogation and only during five years certain types of research [are] regulated by the law and with authorization by biomedicine agency are possible. But it's a temporary solution. So as I said this morning, we are in a period of re-examination of these laws, and the parliament will have to pronounce to say if we continue to forbid, strictly forbid, the research on embryo or [French] to authorize or to continue to have this very difficult situation which forbids but immediately after by derogation must arise which is not very clear and very easy.

So it's a—it's the main crucial issue of the general state of bioethics which will take place in the future months in France .

DR. HURLBUT: So it's not just the United States that has controversies and which are also labeled from the "religious right." It's a real human issue recognized internationally as a serious issue. And when Janet says it seems obvious to her and Alfonso says it isn't obvious to him, they are the two sides that are represented also in France?


MR. CAPRON: Now, Mr. Chairman, you have the former deputy director of the human embryology—fertilization embryology authority here. You might hear what they've done in Britain .

CHAIRMAN PELLEGRINO: Well, thank you. Let me remind everybody there is a time limit here. This could go on ad infinitum. We'd be delighted to hear from you but choice words.

MR. WHITTALL: I remember being involved with this discussion about 20 years ago. If we start again now, this will take me way past my retirement date. Can I just say first of all, I think it would be a mistake to try and characterize Europe as having one policy. It is far, far, far from the case. There are many, many different policies across different countries in Europe, and that's why we've been talking about it for 20 years in Europe .

It may be true that more embryos are created in a single cycle in the States than on average in Europe . It may not be true in all parts of Europe . There may be reasons for that, and I wouldn't want to go into them. They may be to do with commercial pressures, but it is not the case that in Europe all countries provide state funding for IVF treatments. That is not the case at all.

There is, in many countries, a limit on the number of embryos to be transferred per cycle, mostly for reasons of the health of the woman and of the fetus because of the risk of multiple pregnancy and a wish to avoid fetal reduction, a reduction of the number of fetuses being carried in a pregnancy, which has been a hidden problem in a lot of countries. So I think one needs to be careful.

There is also—while there is an insistence on a reduction on the number of embryos per cycle, that doesn't mean to say that fewer embryos are produced unless they're frozen because there is also again as a matter of good practice a desire to limit the number of times a woman is stimulated through drug cycles. So actually freezing supernumerary embryos and using frozen embryos in subsequent cycles is actually clinically regarded to be good practice.

So this is a really rather more complicated question than I think that you've got here at the moment. And if Dan and his people want to look up the situation across Europe, that material is easy to get. I mean, we can help you out providing the reviews of the laws and practices across Europe . But I can assure you, you'll find all kinds of different customs and practices in many different countries. I don't think I need to go into the UK 's position because I don't think it would help to learn of one other one.

DR. ROWLEY: It would help.

CHAIRMAN PELLEGRINO: Janet said she might like to hear the British approach.

MR. WHITTALL: I'll be very, very brief about that. This has been established for some considerable time, since the law that was implemented in 1990. Embryos are created in the course of IVF treatment. They can be used for treatment. If any are left over, it is a question of consent of the individuals who provided the eggs and the sperm as to whether they will be frozen or whether they will be destroyed, whether they will be donated to another couple or whether they will be used for research. They have all of those options.

It is also the case that they can agree that embryos can be created purely for the purpose of research, so we're not only talking about supernumerary embryos and research in the UK . This is all framed within legislation that specifies the conditions under which they can be created, the purpose for which the research can be carried out, and that it can only be carried out under a license that surveys those conditions and that they comply with all those requirements.

CHAIRMAN PELLEGRINO: Thank you very much. I believe we've reached the end of useful discussion unless, Robby, do you want to come up with an additional point? We're about to close the meeting. Robby, I think, has gone to dinner. Thank you all very much. This has been a very good meeting.

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