TRANSCRIPT: Meeting 2, Session 1

Amy Gutmann:

Good morning, and I’m Amy Gutmann. I’m president of the University of Pennsylvania and I’m chair of the Presidential Commission for the Study of Bioethical Issues. On behalf of myself and my vice chair, Jim Wagner, who is president of Emory University, I’d like to say welcome to everybody and welcome to day one of our second public meeting.

 

I’d also like to note the presence of our designated federal officer, our newly appointed commission executive director, Valerie Bonham. Valerie, we’re happy to have you as executive director, not the least because you make this meeting official but you also do many other things to help us move forward.

 

I’m especially pleased to welcome all of you to the University of Pennsylvania. It is our intention to move our Presidential Commission meetings around the country. They’re all open to the public, and this second — the first one was in Washington, D.C., the second one at the University of Pennsylvania. We will move to Atlanta to Emory University next and then around the country to places where commission members reside but many other centers of population reside. As you may know, Penn was founded by one of this country’s most celebrated citizens, Benjamin Franklin, and Franklin was a polymath. He was a brilliant inventor, a renowned statesman, and he helped to bring a new nation into being. Though not known for his modesty, Franklin wisely recognized that however masterful the Constitution that he had helped to create, the new nation would depend upon the ongoing efforts of its citizens to survive. After the final session of the Constitutional Convention, Franklin was asked by a woman standing outside the door, “What have we got?” And he responded, “A republic, if you can keep it.” That is one of my favorite of Franklin’s responses.

 

The Presidential Commission meets today at Franklin’s university dedicated to ensuring that our country remains a robust democratic republic and committed to providing President Barak Obama with recommendations about any actions the Federal Government should take to ensure that America reaps the benefits of synthetic biology while minimizing its risks.

 

Over the next day-and-a-half, we will hear from leading experts in science and medicine and engineering and theology and in ethics. We will consider lessons learned by previous advisory committees. We will hear more about the prospects of translating synthetic biology into useful discoveries. We will also delve more deeply into ethical and theological perspectives as well as our social responsibility as it relates to synthetic biology.

 

By taking a deliberative and open-to-the-public approach, by sharing well- reasoned perspectives, and robustly deliberating about matters of public importance, the Presidential Commission is using these meetings to move us closer to our recommendations that we hope will serve the public good and also to strengthen the fabric of our democracy by demonstrating that open-to-the-public deliberations on tough issues, complex issues — and certainly synthetic biology figures is not something that rolls off the tongue of anybody, but is really a very important part of the future of our life — can be subject to public, open, reasoned discussion, and we hope our recommendations will serve this nation well.

 

The commission also has formally requested public input through a notice published in the Federal Register. We will read all of the public comments. We have gotten many to date, and we will continue to read as we prepare our recommendations. For more information, please visit www.bioethics.gov. And now I will turn it over to Jim for a few welcoming remarks.

 

Jim Wagner:

Very few, Amy. Thank you. I know I speak for all of the commissioners in thanking you and the University of Pennsylvania for your hospitality and for the efficiency with which all of this is coming together. It’s probably worth repeating the charge, or at least a portion of the charge, that we received from the White House. It was to ensure that America reaps the benefits of this developing field, speaking specifically this time of synthetic biology, this developing field of science, while identifying appropriate ethical boundaries for minimizing identified risks. While we spent much of our last meeting together looking at the science, the balance that Dr. Gutmann has referred to in today’s program of looking at how the applications are evolving and discussing the ethics really starts to put the commission in a place where we will move from listeners and learners toward a report asserting some recommendations.

 

We know we are working in a very exciting space, when you think about it. It’s a space that’s bound on the one hand by concerns that inappropriate communications or over-regulation or resource restrictions or perverse incentives could prevent the science from manifesting itself in technologies that help enhance and unlock human potential on the one hand, and on the other hand we’re bounded by concerns that unwise and unbridled applications of science could do just the opposite: could damage and even narrow the diversity of human possibility.

 

Our job, of course, is to define the boundaries of that space in order to be responsive to the President’s charge to the Commission. Welcome to everyone and please do get started today.

 

Amy Gutmann:

Thank you. We are blessed by having some of the world’s greatest experts on this topic broadly understood as the space that Jim has just outlined in which synthetic biology operates for, we hope — and against we hope to prevent — the public good.

 

So, let me begin. Here’s the way we operate, just for those of you who are new to being at a commission meeting. By the way, we invite you to all of our meetings, if you would like to tour the country with us over the next several years. We’ll begin with Dr. Faden, who I will introduce in a moment, and she will speak for 15 minutes. I will open the floor to questions from commission members, and then I will leave time for questions from the public.

 

You are our public, and there is a microphone up there. And we have found from our first meeting that we had a tremendously informative, indeed educational, give and take with those experts who came and presented, and we intend to do the same this time.

 

So, let’s begin.

 

Ruth Faden is Professor of Biomedical Ethics, and she is the Director of the Johns Hopkins Berman Institute of Bioethics. Dr. Faden has authored and edited books and articles on biomedical bioethics and health policy. She is a member of the Institute of Medicine and a fellow of both the Hastings Center and the American Psychological Association. She has served on many national advisory committees and commissions, including the President’s Advisory Committee on Human Radiation Experiments, which she chaired in the 1990s. Welcome, Dr. Faden.

 

Ruth Faden:

Thank you. Thank you. It’s my pleasure. Thank you for inviting me. I want to say at the outset that the cumulative talent and wisdom among the leaders and members of this commission gives me and I know others committed to public bioethics great optimism that you will be an extraordinarily successful commission whose reports and recommendations will be of real and lasting value to this country. So we’re just delighted.

 

Another reason why I’m optimistic is Val’s appointment. I’m delighted to hear that. I know Val either has or will distribute to you remarks that Alex and I made last March at one of the last meetings of the President’s Council on Bioethics, where we were asked to address among other things our views about the missions and functions of national bioethics commissions and the different substantive and practical ways in which commissions can best (and not so best) approach their remits.

 

I’m very happy to discuss the views about presidential commissions that I expressed there, for that matter where I have expressed in many places. But this morning I have been asked to be more specific and concentrate in particular on what this commission could do that would be most helpful with regard to your initial synthetic biology charge. So I’m going to refrain from talking about, as Jim and I had mentioned, war stories from the past commissions, the one I served on and others, and instead look forward and opine a little bit here, if you will indulge me, on what you might do that could be of great use broadly.

 

And I’m going to keep it simple. I have only one such suggestion. How’s that? You do this one thing, and it will be a wonderful thing.

 

I don’t know how many of your experts in synthetic biology are already here and sitting behind me. With all due respect to the extraordinary work now being done in synthetic biology, synthetic biology joins what is likely a never-ending stream of rapidly developing areas of science that raise challenging societal issues. One of the most important things that your commission could do would be to put forward a general framework for the moral and policy assessment not only of synthetic biology but of emerging technologies more broadly.

 

When I look back at previous bioethics commissions, I see many important, enduring contributions, including in particular the commission for which Alex was the executive director and, I would say humbly, the one that I chaired. Arguably, however, none of these contributions has been more important than the moral framework for research with human subjects put forward by the national commission of the 1970s.

 

Whatever we may think today about the limitations of that framework and the oversight system that was developed around it, it has served this country, and arguably the global community, very well for decades. Now, I do not??not — I want to emphasize??here mean to suggest that you should identify a set of moral principles for the assessment of emerging technologies that would be some sort of direct analog to the Belmont report, which is generally referred to as sort of instantiating that framework that the national commission put forward. Far from it.

 

The times are different, and this challenge is different. A framework for assessing emerging technologies will likely look very different from the framework that was put forward for research involving human subjects by that much earlier commission. Although you can build on existing technology assessment platforms, developing a framework for evaluating emerging biotechnologies broadly understood that in today’s world — and here I’m going to invert in D.C. adage — “good enough for government work” will not be easy. Getting something good enough for government work these days is almost impossible.

 

Among other things, in developing that framework you will have to address what has been a central question with the emergence of every new development in the biological and related sciences. Is there something about this new development or this new area of science — in this case synthetic biology — that poses unique or singular moral or policy challenges? Your framework will have to find a way to substantively address that recurring challenge. And I can’t think of a better case example for doing that than synthetic biology.

 

Let me also suggest five other criteria for such a framework. First — in addition to taking care of the challenge or claim that somehow this area is unique — first, the framework will have to be robust enough to provide actionable guidance to policymakers. By that I mean robust enough to ground the development of appropriate policy responses to and appropriate oversight mechanisms for emerging technologies. You need to provide the platform on which policy responses can rest. Secondly, that framework has to be flexible enough to accommodate the often unpredictable, sometimes rapid, pace at which science and emerging technologies both lose ground and progress.

 

Third, the framework has to be specific enough to provide clear and practical guidance to scientists as they conduct their work, and also to provide clear and practical guidance to the private sector and institutional sponsors of that work.

 

Fourth, the framework has to be plain spoken enough to be able to help the public as well as those with technical and policy backgrounds to assess emerging technologies. And, finally, the framework has to be global enough to work in the international, borderless world in which emerging technologies evolve.

 

In order to demonstrate the utility of your framework, assuming you decide to go in that direction, it will also be important for to you be clear about what the framework has to say with regard to the emerging technology that set you off on this inquiry, namely synthetic biology. You will need to show what it would mean for synthetic biology and perhaps for other areas of science if this framework is adopted.

 

Now, in the process of developing this framework iteratively with your analysis of synthetic biology, you may identify what I have called in other contexts some low-hanging policy fruit. These would be salutary changes in public policy or practice, generally small-scale fixes — but sometimes they’re not so small scale — that are politically and administratively easy to implement. Now, if you do identify such low-hanging fruit, then of course by all means specific, immediately actionable recommendations would be welcome, would be wonderful.

 

But let me close where I began. If you can put forward a general framework — a general framework — for assessing emerging technologies that meet the criteria that I have enumerated this morning as well as others that I am sure you will want to add to the list, then that would be beyond wonderful. Thank you.

 

Amy Gutmann:

Thank you. Thank you very much. Our next speaker is Alex Capron. Dr. Capron is a professor of law and medicine at the University of Southern California, where he co-directs the Pacific Center for Health Policy and Ethics.

 

Professor Capron is a widely published and globally recognized expert in health policy and medical ethics. Has served on two former national bioethics commissions, as the executive director of the former President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in the 1980s and as a member of the National Bioethics Advisory Commission in the late 1990s.

 

Professor Capron is a past president of the International Association of Bioethics and of the American Society of Law, Medicine and Ethics, and he has also served as the first director of Ethics, Trade, Human Rights and Health Law at the World Health Organization in Geneva. Thank you for being with us, Professor Capron, and I know you made a lot of special concessions to join us today in between some world travels. So, welcome.

 

Alexander Capron:

Thank you very much, Amy. I am going to use some slides which are intended more or less as a — sort of aid memoir for you in reviewing. I can begin by saying that I agree with just about everything that Ruth just said. I’m going to put one slight difference on something.

 

When we were — 18 months ago to the day, I think, or almost to the day in March of 2009 — before the President’s Council, I preceded her and she said that I had just said everything that she was going to say, and we would never know how brilliantly she was going to say it.

 

[AUDIENCE LAUGHTER]

 

And I suppose I thought as compared to the way I just said it. So this time you had the brilliance first and a more pedestrian approach that I will give you.

 

Thirty-one years ago I was sitting in an office at the corner of 34th and Chestnut, two blocks from here, when Morris Abram, who had just been appointed the chair of the President’s Commission called and asked me if I could come to New York and talk to him about becoming the director of that commission. And I have been asked today in a letter last month from Valerie Bonham to, quote, discuss your experience generally with regard to public policymaking for new scientific advances and specifically with the President’s Commission some of the tools and strategies that made the group successful. And on the slide that you’re now seeing, I have used the word, “developments” rather than “advances.” It’s a small matter, but I think one of the questions you will be asking yourself is to what extent is the topic with which you are dealing or future topics with which you deal an advance.

 

You also notice there that you are at a distinct advantage because we had a title that was much longer than yours. More or less to the same effect but quite a mouthful, and I used to think it was a test of the ability to say something without breathing to be able to say the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. And I just didn’t do it, actually. It’s like blowing out birthday candles.

 

I’m going to give you a comparative perspective, and I thought you I would tell you a little bit about the basis for the comparison, because there are differences between the commissions that may turn out to be somewhat relevant. First, we were created by a statute, and we were given what’s called action-forcing power. That is to say, our recommendations to federal agencies had to be published by them in the federal register, and then they had to either act to adopt them or to explain why they weren’t adopting them.

 

Now, that action-forcing power was not accompanied by an army, and neither we nor our predecessor, the National Commission, was in any position other than hectoring people to say why haven’t you acted within 90 days, much less some longer period of time, on our recommendations. And one of the things we ended up having to do, in fact, was to beat the drum for several of the recommendations that the national commission had made before us to get those acted on by HHS, which they were.

 

We were about your size. We had eleven commissioners. All of them came from outside government, and I think it’s going to be an interesting experiment here. We had liaisons with government agencies, so we had very active involvement of the federal agencies, but none of them were members. None of the particularly departments were privileged by having a member or burdened by having a member. And we also are the only commission to have bridged two administrations. I would love it if we could finally get back to the point — the French have now done this. After the President’s Commission, the French set up their national consultative committee on ethics of health care and medicine in the life sciences, and they have succeeded president after president in having an ongoing commission. And there are some real value in terms of credibility and kind of moderating some of the ideological problems.

 

We had at the end of the commission’s life eight commissioners appointed by president Reagan and three of the original Carter commissioners, including the chair, and we had unanimity on all of our reports, and most of the reports were actually issued after the new Reagan commissioners had been appointed in 1982.

 

And so they came in, immersed themselves with our help in the work that had already gone on, and they didn’t throw any of it out. They just marched on with it. And if there was any divide at the time that the commission was appointed, there was criticism from some non-physicians and non-scientists that we were too heavily weighted to science and medicine. We had three scientists and three physicians and five people from all of the other fields and the public. And that was sort of the C.P. Snow-like issue of was there a balance. It wasn’t left and right. That’s changed in the intervening years, so that’s a struggle that you have that we didn’t have.

 

We reported both to the president and to Congress directly. Our reports went to the Speaker of the House and the President of the Senate. We had a life which was extended by three years. Our original statute ran out in December of ’82. There was an attempt to have a two-year extension. That got attached to a proposal to create a National Institute of Aging, which was very controversial in the Senate. So our one little one-line bill got a 20-page amendment, and the amendment killed the — the tail killed the dog.

 

We produced in that time period eleven reports and the IRB guidebook, and one of the things about that process was that we were working simultaneously on numerous topics. So each meeting, one or two topics would be up, and then the next meeting other ones. And so we had these ongoing tracks, which is important, I think, for something I want to come back to in a moment. Six of the reports were on health care and five were in research. I asked Val to distribute to you this report called “summing up,” which is also our discussion of the privacy and confidentiality, a very brief discussion of that. Six of them were reports mandated by the statute. One we inherited from the ethics advisory board, which had been bumped off when we were created. One we took on on our own initiative, and one, like your report on synthetic biology, was on a request from the President, and I’ll come back to that in a moment.

 

Let me quickly say, one might think that the main purpose of bioethics commissions is to provide recommendations to policymakers. But I think that there are a number of other purposes that almost come first. One is to look at advances and identify the issues that they’ll raise for society. As I say, I use the word advances in quotes. The second is to provide the bridge between science and society. One of the things that we certainly found is, in a number of areas there was simply a lot of public distrust. We did a big public opinion study on informed consent, for example, and found that the public — the overwhelming view of the public was that informed consent existed just to protect doctors against lawsuits. The higher bioethical aspirations for that process were doubted by the public. Some of those same issues came up around the genetic engineering topic in terms of doubts about scientists.

 

Obviously it’s important to articulate the range of views. The previous president’s council, I think, put a great emphasis on wanting to lay out all of the views and say nothing about necessarily one being better than another. They obviously came to some conclusions, but they began by saying, well, we’ll just lay it out and the policymakers can make up their own mind. My sense is, the policymakers want more help than that.

 

And finally, there are some subjects on which one can even provide guidance to individuals and health care professionals. We did a lot of things in health care. I don’t know if you will end up in the same way, but in looking at end-of-life treatment decisions and informed consent, we were basically talking about the physician-patient relationship. We weren’t talking about what the federal government should be doing or anything like that.

 

So in shorthand, when I went — when I was thinking of taking this job, someone handed me the book Good as Gold, Joseph Heller’s book, because the main character goes to Washington to go on a commission. He says, “We go, we have meetings, we talk, we socialize, and then we go home and everybody knows nothing will happen, and that’s the way they want it.” And that’s the view, the cynical view, about why people have commissions like this. It’s handy for the president. He’s handed the difficult issue of synthetic biology — thanks to Craig Venter, it’s on the front page. It’s been around for quite a while in one way or another, as you know, but now it’s suddenly the front page of everything. He throws it to Amy. He throws it to Jim and says, you guys do it, in hopes it will go away. Well, I don’t think that’s going to be an accurate description, but some people can cynically say that.

 

Then there are a lot of other commissions that exist as watchdogs. To a certain extent we had function vis-à-vis the rules for research. Very explicitly in our statute, we were supposed to find out were they being implemented correctly.

 

But I think that in terms of the bioethics commissions, successful bioethics commissions have done other things. There are some areas in which there is kind of an emerging consensus. It’s not a matter of inventing the thinking but pulling it together and being a presidential commission, having a platform from which it can be explained to people in a way that it will really kind of put the issue into a situation where people think this is understood; it’s in good shape if we do the following things.

 

In the end, you’re not going to quiet all of the ethical concerns. It won’t be the final word. Nor will you be able to avoid unintended results. You won’t even — the fact they’re unintended, they’re probably also unanticipated. Let me give you an example from our work.

 

The main things we did was to recommend that the 26 or 28 — whatever it was then — separate rules on research with human subjects, which were very similar but different in small ways, be brought together in the common rule. And then if a particular department, the Department of Defense or something, had some reason why it needed some special rules it could just spell out those, and researchers and institutional review boards wouldn’t have to worry every time they’re looking at a research project, is it going to be submitted to different agencies? Do they have different rules? Do we have to know these rules? and so forth.

 

Well, it took ten years after our recommendation in 1981 for the common rule to be promulgated. The unintended consequence of that is, it can’t be amended because — and so when I was on the National Bioethics Advisory Commission, when we were confronting issues where the right thing would have been to say this or that part of the common rule should be changed, everybody in the federal government said, “Don’t make us do that. We can’t do it. It will be ten years to change that comma because of getting people all to that process.” So instead, we ended up recommending, I think with some reluctance, kind of a process of, well, let’s make interpretations of this and explain it.

 

You may end up with some things like that. You do a good, and it has this unintended consequence. A lot of what you are going do is what I think of as a crucible. Things come together. They’re disparate elements. You work them through, you offer some correctives, you give clarity of reason. And then you say, what are the implications of this for policy and practice?

 

Now, let me go through six modes of work for you that — the main point I want to make if I can get this to go. Your work has to be open and visible, and actually one of the expectations of that would be that you have public comments at your meeting. And I know we now have this elaborate process. People can send in comments. I didn’t notice that you had a public comment time. We always scheduled one because there are people who want to come and speak and it seems to me a reasonable thing. You will find that particularly in Washington because there are a lot of people there whose job who it is to go and talk on things. But people have things to say.

 

It’s infinitely easier, it seems to me, for you now than it used to be for us. We had to send out physical mailings to people. Now everything is quite instantaneous and easy. We had these agency liaisons, and I gather that you have them, too. It’s very important.

 

I don’t know if you’re allowed to communicate directly with Congress. Since we were a creature of Congress, we had close relations with the relevant committees, and we briefed their staff on what we were doing.

 

Congress had wisely denied itself the power to give us assignments. Only the president could give us assignments. So we didn’t get stuck with anything they wanted to, but we did keep them informed of what we were doing.

 

Second important thing is knowing the audience, and that will vary from topic to topic as to whether it’s mostly public officials, professionals. By peers I mean peers in bioethics, the people who are going to evaluate your work as to whether or not it passes bioethics muster. John Arras’ colleagues, Anita Allen’s colleagues, and so forth, and then the public and the press. Broad, well-informed, and a sensitive consultation. And that means you are not only going to convene expert panels, not just bring people as witnesses, but you can work with your experts and get them to develop papers for you. And as I have already talked to Valerie, I think the power of working for the president on this means you can draw people to Washington as staff members and get fairly high level people to come and give a year’s time or two years’ time.

 

Now, the main thing I want to emphasize, and this is where I slightly differ with Ruth, is about using an inductive method. Now, obviously that’s much easier when the cases are real, and we had that in a number of our reports. For example, looking at counseling — we were asked to look at genetic counseling and screening. And we took the emerging likelihood of screening for cystic fibrosis as a case study and developed our ideas out of that.

 

Likewise, in looking at end-of-life care we looked at the major cases that had come up and what were the implications for the development of, for example, advance directives, which we did a lot to promote. Sometimes people think the inductive method is kind of just pragmatic. You’re just sort of figuring out answers and its casuistry and so forth, and they think that’s pragmatic. I think being pragmatic is not pejorative.

 

Now, that doesn’t mean that you don’t have an obligation to articulate coherent reasoning, but I would say that you let the principles emerge from that process. And what that means is, it’s not just one report; it’s the process of several reports on different but in some sense overlapping issues. And even the most famous instance that Ruth has already mentioned, the Belmont report, came at the end of the national commission’s work in 1978. And, of course, the national commission had a specific charge from Congress that they were supposed to issue a report explaining these principles. And I agree with Ruth that I don’t think you would do the similar work, but I am not sure that that kind of articulation of principles, as opposed to their emerging from your work should be your goal.

 

It’s important that you’re not, of course, asked to invent knew philosophical theories.

 

Another question comes up, are you aiming for consensus? I would say you should as a methodology, but not as a goal. Leon Cass was very negative on the notion of consensus. I think that the struggle within your commission to reach agreement is useful because by looking at those things about which you can agree, if you start with something and move outwards to the boundaries of agreement, you’re likely to come up with conclusions which are also broadly agreeable to the public. So your process will help you to do something useful.

 

You also have to end up speaking, I think, with one voice if you want to be persuasive. The Supreme Court speaks with many voices, and what it really does, it’s particularly problematic.

 

Finally, work products. I guess it was Einstein who said be as specific as possible but no more. But — precise as possible. Was that his —

 

Jim Wagner:

Simple, I think.

 

Alexander Capron:

Simple? Simple is good, too. But no more. Also, it’s necessary to give simple recommendations and conclusions, but give your full reasoning. One of the values of these reports — and by the way, the only influence that I had on the President’s Council is it returned to issuing reports — this is the size of the President’s Commission reports. This is a book size. People look at this and say, “I’m going to read it.” When you get these eight-and-a-half-by-eleven things, they’re government reports. It’s a tiny issue, but I would urge you to make it look like something people want to read as well as the content being something they will find readable.

 

It seems to me, to make an analogy, when I was beginning law school, I remember watching classmates who I thought were brilliant in moot court because they were such good debaters. And then the judges afterwards — I remember one of the judges saying clearly, if I’m on the bench I don’t want to hear cleverness. I want you to answer the question. If I’m asking a question, as the president has asked you, it’s because I want help in understanding it, and there are difficulties. I wouldn’t ask you if the answer were easy. So help me. Don’t be clever about it. Don’t try to cover up things by changing the names of things.

 

There’s a lot of concern around cloning for example. And the people doing stem cell research who wanted to create embryos kept saying, oh, we’re going to do somatic cell nuclear transfer, as though that would make the issue go away. That is cloning. Now, if cloning is a problem, calling it something else is not going to make it go away. Likewise, if people are concerned about euthanasia, if you’re telling them it’s allowing to die, it won’t make a difference. You have to tell them why it’s all right for it to happen, not why it has a nicer name.

 

Just to finish up, our request from the president was like yours. It was the prospect of human application, in that case, of genetic engineering. It had been brought to the president by the National Council of Churches, the Synagogue Council, and the Catholic Conference together saying, “Alarming prospects. What’s going on? There’s nobody doing anything.” And they were partly right. We went out and looked. We mapped the terrain. We found out that there was a mechanism that really wasn’t in use on an interagency level. We convened the leading experts, did a workshop. We tried to clarify and provide rationality for the field. We addressed “what does genetic engineering mean” technically and so forth. Let’s not worry about the scary term.

 

What would it mean to play god? What would it make — because those are the terms. Is this the Frankenstein’s monster? Are we distrusting science and so forth? And finally we ended up weighing the potential risks and benefits and talked about the social context.

 

In the end, what works is having reports that are highly relevant to the practical questions facing society, whether it’s the professions, the patients, or the citizenry. And you aren’t going to end up doing a philosophical work. That’s not what you are about. It’s not academic. It’s practical. But it has to be clearly reasoned and respectable. With that, I endorse what Ruth has already said about the specific objectives that you would face here. Thank you.

 

Amy Gutmann:

Thank you, Ruth and Alex. I will ask Jim to ask the lead-off question.

 

Jim Wagner:

First of all, thanks to both of you. Your wealth of experience is very helpful. And I agree with the observations you made. Myself excepted, the capability and experience that we have on this panel is impressive and does give us an opportunity to articulate what the issues are, to catalyze this formation toward a consensus, as you have said. And for those reasons and the fact that we have been given a case study, if you will, out of which we can develop principle, I think everybody here wants our work to have impact, wants our work to be influential. And so I want to ask a question that both — a point that both of you made. You said we need to be addressing policymakers, we need to be addressing scientists, we need to be addressing the public. Ruth, I think that was in your list of — I know that was in your list of five and, by the way, on a global scale. And the only thing left was flexibility. Is that the reason that neither of you would point to the kinds of principles in the Belmont report? Why did both of you say the Belmont report is lacking or that it’s??

 

Alexander Capron:

Oh, I didn’t say the Belmont report was lacking. Ruth, as you may know, is in a peculiar circumstance because she gets into bed every night with one of the authors of the Belmont report.

 

Ruth Faden:

Legitimately, I might add.

 

Amy Gutmann:

So much for private lives.

 

Alexander Capron:

This is a public meeting.

 

Ruth Faden:

What I want to be careful about in —

 

Amy Gutmann:

Be close to the mic, Ruth. Thanks.

 

Ruth Faden:

There were two pieces to this. First of all, the remit to the national commission was in the 1970s in a territory that is, I think, substantively different from the territory that you are facing with regard to synthetic biology or emerging technologies more broadly.

 

Jim Wagner:

That’s certainly true.

 

Ruth Faden:

So that’s one thing. And different times demand different kinds of responses. Also with the Belmont report I take as only a piece of the framework that the national commission put together. It was not only that. It was a broader way of structuring and thinking about how to organize and also how to oversee research involving human subjects. They had multiple case examples with which to work. Alex is right: children, prisoners, people with mental disabilities, and so on. That gave them a platform for thinking through what they wanted to say with different fact situations, which was, I think, very helpful to their work. And I don’t think — and this is, of course, where I’m conflicted. But I think — I can do this — that it is overstating to say that what was given to our country as a consequence of the work of that commission was quite significant. With the test of time, it stood well for decades. We started to see fraying. We could see a whole deconstruction of what needs to happen now in today’s world, but it stood us well for a long time. And if you could do something like that for emerging technologies, and it’s — the “something like that” is not “find the right four principles.” There are different ones or whatever. But rather to say, look, here is a way from now on forward, regardless of what the technology is that’s at issue, for vetting that technology. And we have models for that but the models also are reified and are not —

 

Jim Wagner:

Ruth, I think I’m starting to get the foundational piece of this. They espoused, what, five —

 

Ruth Faden:

Four principles.

 

Jim Wagner:

Three.

 

Amy Gutmann:

Three principles, actually.

 

Ruth Faden:

Well, three principles —

 

Jim Wagner:

And they added three more.

 

Ruth Faden:

And then they added the three more. Yeah.

 

Jim Wagner:

Fidelity, non-malfeasance, and veracity were added.

 

Ruth Faden:

What’s more —

 

Jim Wagner:

What’s wrong with building on a foundation?

 

Ruth Faden:

Nothing, if that’s where you go. The other thing I would emphasize, though, it was not the enumeration of, in that case, those three principles, thank you, but also the implication: what it would mean to live by those principles? They worked it together. And they talked about respect for autonomy. They then elaborated at great length what that would mean with regard to obligations to obtain informed consent. You have to link it with something that gives it practical guidance. So identifying three principles doesn’t do it.

 

Jim Wagner:

If I could just — Amy began by invoking Benjamin Franklin, and the school that he founded, he said, was for practical reason. I think that was his phrase. And that’s what we’re talking about here. We’re not talking about taking some abstract principles. The national commission began, as you did, with a 90-day gun to its head to come up with a report on fetal research, and it did it. And they didn’t have the Belmont principles then. They reasoned their way through to a set of conclusions about what to do about fetal research because that, along with the Tuskegee experiment, were two of the driving things that led to the formation of that commission. And so once they were up and running —

 

Amy Gutmann:

Let me just put what Ruth and Alex have said together, because I don’t think it is at all in contrast. I think they’re actually in quite eloquent and heated agreement with one another. We could have a set of principles which the public could understand, which policymakers could refer to and guide them. But and and at the same time connect those principles to recommendations that illustrate them coming out of a very large case study of synthetic biology that are not simply relevant to synthetic biology but could be applied to genetic experimentation and genomics moving forward, to nanoscience and technology and other emerging biotechnologies. And if we go back and forth between principles and this case study, we’re more likely to have some lasting impact on thinking because we are not a policymaking — we can recommend policies, but we can’t twist anybody’s arm on them. And that’s what I??just a summary of??

 

Jim Wagner:

Right.

 

Amy Gutmann:

Of how — what you are together recommending. Nelson Michael. And then I’m going to go to members of the public, so you can come to the microphone if you have a question.

 

Nelson Michael:

Both of you have worked and continue to work in the international sector. What’s the way forward to socialize, to embrace those outside of this country, in the important products that will flow from commissions that will actually have relevance to the global community? Obviously it’s more important than ever in terms of putting all of the frameworks that both of you eloquently described. How does that have a voice overseas when inevitably this commission is tied to the U.S. government?

 

Alexander Capron:

You know, I almost feel as though this question was set up. What I can say is that your chair has already taken an important step in that direction by re-engaging the United States in something called the Global Summit of National Bioethics Advisory Bodies. She attended the meeting in August in Singapore, and one of the topics there was synthetic biology. It’s a summit of these commissions that was begun in 1996 by the National Bioethics Advisory Commission. It is usually connected to the World Congress of Bioethics so that people could come and benefit from that as well. But it’s a meeting of the commission representatives. And in your book, for example, is an interesting report going into some of the metaphysical sorts of issues from the Swiss commission. I doubt that that’s what you’re going to do, but it’s interesting to have that, particularly on the scientific issues more than on things like clinical practice or??we had a report on access to health care, which for most of the Europeans they say, well, of course you have access. We have national health insurance. We didn’t at the time, and so those are parochial sorts of issues. But scientific issues, absolutely. The science is global. The scientists move globally. And so those reports — there has to be some dialogue. And your chair has already set that up, and I’m sure through the staff will continue to correspond with other groups around the world that are doing this and bring the results.

 

Of course, she had to be very circumspect, and you will be happy to know that she was. She, in her presentation, could only describe the charge and the makeup of the commission and so forth and couldn’t yet say what you had decided since you haven’t decided.

 

One other note on this issue of principles, if I could come back to that. When the National Bioethics Advisory Commission began its work, we thought, oh, well, maybe it’s time to look at the Belmont principles. Aren’t there principles that are missing? And we spent a fairly useless meeting or two talking about what should be added. Should community be one of the principles and so forth, and solidarity, and so forth.

 

Then along came Dolly, and suddenly our work became much more highly charged and focused, and we didn’t — of course, you can read the report on Dolly and say, well, here are principles that are guiding. But it was really practical reasoning about that set of things. And there are principled issues. For example, the precautionary principle, which is very prevalent in Europe about — when you have a risk, it is on those who want to do things to bear rather than the other way around. Now, you can sort of think, where do you come out on that? And that might influence you, but I don’t think you’re going to write a treatise on the precautionary principle.

 

Amy Gutmann:

Just on the international, I think it’s really important what Nelson is pointing to, which didn’t exist — correct me if I’m wrong — 30 years ago. There is an international network now that meets, communicates on issues of bioethics. And we have established ourselves now as part of that network and not an unimportant part of it, just an emerging part — a newly emerging part — and we have a group of reports that are accessible to all commission members from many different bodies in Asia, Europe, and around the world, and they will be very helpful to us.

 

Are there any — is there any question out there? Because otherwise I’m going to ask another commission member, but if I see anyone standing up. I know we’re already late for the next one, but we’ll take another five minutes. Nita?

 

Nita Farahany:

Thank you both. These presentations are quite helpful in thinking about the process and methodology of the commission. But it seems to me that there’s potentially a tension between the methodology that you are proposing of going back and forth between case-specific and general principles and your argument, a persuasive one, that consensus is really important for these reports. So to the extent that we have an individual case study, it seems like you both agree that it’s much easier to come to agreement about recommendations for a case study as opposed to building up to more general principles or agreement that you might get from more general principles. Of course, there’s different methodologies that you could go between, whether it’s using the individual case study as the opportunity for consensus and recommendation or trying to start with general principles and then derive what the individual case study would be. So I wonder if you could comment about the interaction between consensus and methodology and general principles versus individual case studies.

 

Ruth Faden:

I just want to reiterate that — or explicate — a little bit that a framework is not necessarily synonymous with a set of principles. So you may conclude that you want to identify a set of underlying foundational principles and still have a framework of relevant policy or moral considerations or both that is more practical or pragmatic as well. So I just want to be clear that what I meant, you may not want exactly the same thing as the Belmont report. I meant literally, you may not want exactly the same thing. There may be, from the standpoint of technology assessment, ways to structure a framework that are at an intermediary level that may be especially helpful, still at a structure that allows for consistent standards against which technologies now are assessed and where you identify the moral principles potentially that stand behind those more specified considerations.

 

So that’s just by way of clarification. I’m not sure, and I wouldn’t want to begin to prescribe, what the right framework would be. That’s the work that you all will be engaged in or have already started to engage in. On the methodology, I think your point is important. To me, it’s entirely and always has been an iterative process. I’m going to be very surprised, at least in your own deliberations and discussions, if you don’t pull in other examples in addition to synthetic biology just to test your intuitions. And you’ve got people with a range of expertise across other areas. It’s going to happen naturally.

 

Consensus, I couldn’t agree more with Alex and especially the way he described it as a methodology and not necessarily a goal. If you don’t reach it, you don’t reach it. But if you can reach it, it’s enormous. And it’s, I believe, rather the reverse. I think it’s actually easier to achieve consensus around mid-level frameworks and even underlying moral principles than it is necessarily with regard to how they specifically apply to particular cases. I think you will have more difficulty there. And the challenge is to show that your framework has power that can actually help narrow the range of relevant considerations and the spaces for disagreement. If it can’t do that, it really won’t help your audiences going forward. So I would kind of invert it just a little bit.

 

Amy Gutmann:

Thank you. I don’t know whether to??we have John and Anita, and they’re going to have to be very quick questions. They have to be quick. Because —

 

John Arras:

I had a Hegelian question for you, but I’ll have to pass. So we’re charged with providing a policy framework for biotechnology. One of the persistent questions in this area is the problem of uncertainty. All of the people who came trooping before us at the last meeting and experts in the area were saying “It’s a moving target. We don’t exactly know where it’s going.” So in your experience, you know, what would you recommend as the best ways to grapple or cope or manage that kind of uncertainty?

 

Amy Gutmann:

We’re going to take two questions and then you’re going to have to the wrap-up answers.

 

Anita Allen:

Well, my question was remarkably similar. It was going to be a question about: if we take your advice, what would you expect to be some of these general frameworks or principles that would emerge, and is uncertainty, you know, one of the things which you think is going to be common across emerging technologies? What else besides uncertainty might we expect to find as a common thread among emerging technologies?

 

Ruth Faden:

Well, hopefully you’ll figure this out. I think Alex is — I don’t mean to be flip about it, but I think that’s really the work of this commission and your staff over the next months that you take this on, is trying to identify what those relevant considerations will be. As I started to say, there is a tradition — I don’t need to tell many of the people in the room as we already know — of technology assessment and different ways in which people have proposed to do it across multiple fields in engineering and the life sciences and operations research. And there’s a whole emerging — I know other branches of government like to use the word decision science and policy science increasingly. I’m not sure, again, if getting labels helps, but people who are struggling to identify more systematic ways in which you can vet new technologies more broadly.

 

If you could do one thing — I will echo Alex on this, on doing, simple, one thing. Very simple: come up with a framework; another thing, really simple, is figure out where you stand on the precautionary principle. If there’s one really divisive and contested response to uncertainty, it’s been the way in which the precautionary principle has been interpreted and applied, which is a very conservative response to the anticipated downside of technologies. Right there, a clarification of that would be of huge help.

 

Amy Gutmann:

Ruth, for the sake of people in the audience, would you give just a very brief definition of the precautionary principle? I understand it’s a??even a definition is contested, but just give us a flavor of it.

 

Ruth Faden:

Rather than attempt, Amy, a definition, one way to think about it, which will be a way that people will reject depending on your standpoint, is if there is a question the burden of proof is on the person who wants to promote the technology or the group or the agent. The burden of proof is that it’s safe??to use a term I don’t like. But the burden of proof is that it’s safe and acceptable and good for society rather than the other way around. So the burden??it’s where you shift the burden.

 

Amy Gutmann:

Right. Alex?

 

Alexander Capron:

I think I took — when I was agreeing with Ruth earlier, her idea of a framework was precisely the idea of how these issues are going to be dealt with. And to me that means both intellectually dealt with and some suggestion of the mechanisms. Because, John, of the continuing uncertainty — the “evolving” thing — this is exactly what we did in the report on so-called splicing life, the human applications of genetic engineering. Kind of cleared away a lot of the hype and the confusion, said “Here are what the real issues are going to be” and “Here are some mechanisms.” And we set forth several alternative ideas about mechanisms that could be used on an ongoing basis, recognizing that the questions would be of a certain nature, but they couldn’t be resolved until the technology had moved forward.

 

People weren’t putting genes in human beings at that time. It was on the horizon. It could come in different ways. Those would have different implications for the risks affecting other people. Were these going to be genes that could recombine? Were they going to affect inheritable traits and so forth and so on?

 

So that’s was what I understood Ruth to be talking about with the framework. And I think starting with cases — I guess I slightly disagree with Ruth. I think it’s actually easier to get agreement on case solutions, by which I mean this kind of a framework. This is the way of dealing with it. Some people are going to say, it’s for one principle. I believe that that’s right. Someone else for another principle. But they can agree on the common way forward, and then the principles will grow out.

 

Amy Gutmann:

We will test your competing hypotheses, but right now I have to thank Professors Faden and Capron. Let’s thank them for a wonderful —

 

[AUDIENCE APPLAUSE]

 

Jim Wagner:

And let’s invite Professors Collins and Weiss to the table.