TRANSCRIPT: Meeting 3, Session 4

Commission Deliberations and Public Comment

Date

November 16, 2010

Location

Atlanta, Ga.

Transcript

Amy Gutmann:
We will begin with the first principle of Democratic Deliberation and Dan.
 
Dan Sulmasy:
Thanks. I’ve been a fan of Democratic Deliberation and a proponent of its applicability to bioethics for some time, so it’s lucky for me that I got to work on a commission that is chaired by one of the leading lights in the field, Dr. Gutmann.
 
I think it’s important as a way to engage contentious issues, asking for public deliberation and engagement by wide sectors of the public, more than just the powerful, more than just interest groups, and particularly for something like synthetic biology or any topic in biotechnology. Part of the reason it’s important to engage the public is that, in fact, an issue like this affects everybody in the long run.
 
Quoting from our report, at the core of Deliberative Democracy is an ongoing public exchange of ideas. Particularly regarding many topics in science and elsewhere, in which competing views are advocated, often passionately. The process of democratic deliberation is guided by principles of reciprocity and respect of publicity, transparency and of accountability for those who make the decisions.
 
In some ways, this is, of all the principles we have, more a process than a content principle. Obviously, there’s some content that informs the process, but in the end, for our purposes, it’s probably more a process for engaging in questions like this. I think we’ve tried, as a commission, to live that out in what we’ve done so far about synthetic biology. We sought out input from scientists and, we can tell — Tom Murray — engineers, as well, who spoke to us. People who are both in the scientific community inside synthetic biology and outside of synthetic biology, voices from business, from ecology, those who poll the public, they are general ideas on a topic like this. From people who oppose synthetic biology on various grounds and those who are wildly enthusiastic. A wide variety of religious and philosophical points of view and we also read the think books we were given on the topic, and we sought public comment. Since, in some ways, the medium is the message, I’ll go to reading the recommendation.
 
We encourage religious, secular and civil society groups to maintain an ongoing exchange regarding views on synthetic biology and related emerging technologies sharing their perspective with the public and with policy makers. Scientists and policy makers in turn should respectively take account all perspectives relevant to biology.
 
We may want to say that’s motherhood and apple pie, but I think in many ways it’s critical that it be stated and stated clearly and critical that the process continue. Our deliberations should not exhaust public debate about synthetic biology or any other aspect of biotechnology and public engagement should continue. Science is developing. What seem innocuous to the views to some now may later not be. We need to hear about that if there are significant developments and significant objections to those views later. Just as we had said before, yesterday, the Responsible Stewardship demands an iterative evaluation of the risks and benefits, so I think Deliberative Democracy is ongoing and iterative, and so I think that this recommendation is actually quite important.
 
Amy Gutmann:
Thank you, Dan. For the next recommendation, John Arras.
 
John Arras:
Thank you. Within the context of this section on Democratic Deliberation, we have nested a very apt case study dealing with what are often called intrinsic or intrinsically moral objectives to synthetic biology.
 
I’m going to start by reading our recommendation and then comment on it. The recommendation reads, “Intrinsic objections to synthetic biology are best addressed when carefully described and evaluated, both logically and in light of the best available knowledge about the state of the science and its capabilities. These discussions should be revisited periodically in light of future scientific and technological advances in novel research directions.” I think that this is a good case study for any process of Democratic Deliberation, and I think that this particular recommendation is totally unobjectionable.
 
I do, however, have some reservation about the way in which our report has, so far, dealt with these intrinsic objections and I just wanted to share those concerns with my fellow commissioners, as well as the public.
 
Now, by intrinsic objections, we mean a loosely connected set of worries about syn-bio, which refer either to the crossing of morally salient boundaries here and now. For example, we hear claims about playing God, or creating life, substituting the manufacture of artificial organisms for the processes of evolution and so on. Or, to threats of undermining over the longer term our understanding of, or relationship to, nature and the environment. That theme is played out in some of the environmental literature that we have been looking at.
 
Now, many reports and papers on synthetic biology that belong in the same genre as our project, will often divide up the worries or objections to this emerging technology into separate discussions of first risks and benefits, namely the terrain covered, I think, very well by our principle of prudent vigilance. And secondly, this catch-all collection of so-called ‘intrinsic objections’. That’s not a very good name for it, but I’ll just use it as a term of art.
 
My question for the Commission is this: have we done justice to these so-call intrinsic worries in our working draft? Compared to our minutely entailed sections on risk assessment and oversight, I think it’s fair to say that these intrinsic objectives get relatively short shifts, so far, in our report. Although, I think we are making progress on this front over the last couple of drafts. We conclude that, “we are not persuaded by concerns that synthetic biology fails to respect the proper relationship between humans and nature.” But, at least as I read our work so far, we don’t really explain in any detail exactly why we reached this conclusion.
 
There are two ways of looking at this question that yield very different answers corresponding to two different conceptions of the function of such reports. First of all, one could take a bottom-line approach and here the question that we pose in our report is the following, and this is a really important question. The question relevant to our present review of synthetic biology is whether this field brings unique concerns that are so novel or serious that special restrictions are warranted at this time. I think that we all agree that the answer to this question is no, we don’t believe that such special restrictions are warranted at this time. So, one perfectly reasonable conclusion would be to focus as we have done on questions of risk and oversight given these intrinsic objections a respectful mention, as we do here, but little more. The worry here is that by concentrating on the so-called intrinsic objections, we would complicate the policy narrative with too much philosophy.
 
There is an alternative approach. One which understands presidential commission reports as state of the art repositories of important or influential arguments intend to not only give policy guidance, but also to help educate the nation about the moral dimensions of key public debates. I think, for me, the best example of this is from the original Presidential Commission back in 1983, in a report on forgoing life-sustaining treatment. This Commission devoted an entire chapter to a cluster of influential distinctions in ways of speaking about forgoing treatments. For example, between omissions and commissions, or between ordinary and extraordinary treatment that were quite common in the literature and the way people talked about these things. These were distinctions that the Commission considered to be both partially illuminating but also partially confused, unhelpful and misleading. This chapter turned out, in my opinion, to be one of the best of many good things that that initial Commission accomplished.
 
The report was both a very helpful guide of future policy in the death and dying area, but also an invaluable educational resource for all of us in what was then a relatively new field. It gave us a state of the art discussion that all of us; students, professors, journalists, judges, doctors, lawyers and members of the public could draw upon as we enter those momentous debates.
 
This alternative understanding of the function of commission reports would have us expand our discussion of internal objections to synthetic bio and move it some distance from the margins of our report to a more prominent place, perhaps to its own short chapter. I hasten to add, but I say this as a philosopher who is not personally persuaded by these intrinsic arguments, in so far as I’ve recently come to be acquainted with some of them, but who never the less, thinks that they deserve a more robust treatment and detailed critical response than we afford them here. Thank you.
 
Amy Gutmann:
Next is Dan — back to Dan — for the next recommendation.
 
Daniel Sulmasy:
This follows on John’s, but at least in some ways, it will differ as well. It’s talking more about the language that’s used in public deliberations about contentious issues like this. I think we all recognize the irresponsible use of language can distort public opinions, obscure the truth, and suppress or even poison public debate. We have no better recent example, I think, than the use of the phrase, “death panels” in discourse about health reform. Democratic Deliberation, I think, seeks a reasoned public debate in which the public is educated as well as engaged. Sometimes this language engages people, but I’m not sure that it actually serves the purpose of educating. Euphemisms either linguistically soften reality, or sensationalisms that linguistically amplify reality are equally, I think, to be avoided in a good public debate. This is especially true regarding scientific developments of which the public may have really very little initial understanding at the outset of the societal evaluation and discussion.
 
For the press, as well as for interest groups, there are temptations, of course. Not only can these linguistic distortions serve to get your way by the press, they’re pressured, of course, to sell newspapers and advertisements. There’s also another difficult line to walk, and that’s in the use of metaphor. It’s often useful to use metaphors to simplify complex ideas in order to educate people, but sometimes the metaphors can seriously distort popular perceptions at the same time.
 
Synthetic biology is exactly the kind of topic that’s ripe for this kind of linguistic abuse. Scientist can use metaphors about nucleic acids and sequences that, for instance, often draw in computer terms; DNA is the source code and we’re going to “boot up” an organism. Maybe that helps to educate people at some level, but it has adverse effects attributing to the scientists greater power than they actually have and then suddenly frightening people into thinking that they might be subjects eventually that will be booted up. We have to be careful about those things.
 
News media can report that scientists have “created life” in a test tube. Then when the dust settles, we find that this really means that an oblate intracellular parasitical bacterium has been transpeciated using a synthetic chromosome that was made using the code of another species of the same genous. The sensationalist description causes needless fear and anxiety. Phrases — maybe a little bit of a difference with John — phrases like “playing God,” turn out to actually be used much more by the media and by secular commentators than by the scholars and religious leaders of the world’s great religions, who are to be sure and anxious to warn us against the contestant temptation we have to hubris. I think that maybe that’s what’s behind some of this. They continue none-the-less to recognize the sovereignty of their deity is not threatened by the ingenuity of the scientists.
 
So, with that in mind, our next recommendation is that when discussing synthetic biology, deliberate forums should strive to offer clear and accurate language. The use of sensationalist buzz words and phrases, such as “creating life” or “playing God” may initially increase attention to the underlying science and its implications for society, but ultimately such words impede ongoing understanding of both the scientific and the ethical issues of the core of public debate on these topics.
 
Amy Gutmann:
Thank you. The next recommendation, Steve.
 
Stephen Hauser:
Thank you. For all of us, meaningful participation and deliberations involving synthetic biology or any other emerging technology obviously requires useful levels of familiarity with context in science and particular aspects of the developing field. We have spent quite a bit of time thinking about promotion of scientific literacy. There’s a wonderful definition by the National Academy of Sciences for Scientific Literacy, which they describe as the knowledge and understanding of scientific concepts and prophecies required for personal decision-making, participation in civic and cultural affairs, and economic productivity.
 
Now, this scientific literacy involves two related skills. It is understanding both the general nature of scientific advances as well as their implications, and the ability to formulate reasonable ideas about its appropriate use in specific situations. For example, in genetics and in personalized medicine, an area that is high on many people’s list of important emerging technologies. Not only understanding how variance in our genetic structure are identified as important, but having some level of comfort with the mathematical concepts that are needed to interpret these results is equally important. Ideas such as sensitivity, how do you know whether this finding will predict an outcome.
 
Another is specificity — how do you interpret the people, who may be many people who will have the change you can measure, but not develop the outcome of interest? Concepts such as this are critical for interpreting scientific information. Making science accessible to the public requires creativity and innovation. We spoke yesterday about the importance of making ethics important to scientists and making that an interesting part of our education and similarly, we need to find better ways to make science interesting to the general public.
 
A few years back, I had the pleasure to accompany a friend who was awarded the Nobel Prize. What was so impressive to me about that trip to Stockholm is that during the week when the Nobel Prizes are given, the entire nation is transfixed on science. People are stopped in the streets and asked, “Which party are you with?” I know that Discovery Television is full of discussions about the nature of these prizes. It would be just wonderful if a similar period in time could be developed in the United States where we were equally interested as a community in scientific discovery. Public education efforts are clearly central. It needs to be made as exciting and important and as relevant to our present and our future as the science itself.
 
Our next recommendation is as follows: Educational activities related to synthetic biology should be expanded and directed to diverse populations of students at all levels, civil society, organizations, communities, and other groups. These activities are best encouraged and supported, not only by public sources, but also by private foundations and grass roots scientific and civic organizations. The EOP, through an interagency process and with input from the scientific community, the public, relevant federal agencies, and private organizations should identify strategies to promote scientific and ethical literacy. This group should consider the feasibility of including public education modules in research funding agreements, either linked to specific projects or organized at the institutional level among recipients of federal research support. The results of this review should be made public.
 
Amy Gutmann:
Thank you. We added one recommendation to these, not as a separate recommendation, but as an addendum in a discussion that we had most recently. It reads as follows, and then I’ll do a brief explanation of it: “To further promote public education and discourse, we recommend that an online mechanism be created ideally overseen by a private organization to fact check the variety of claims relevant to advances to synthetic biology and other biotechnological innovations.”
 
What we have in mind is the bioscience analogy to factcheck.org, so if you will, ‘biofactcheck.org’, which would be run by a nonprofit, nonpartisan group. Like factcheck.org, it would be the go-to place. When there were new innovations that came out with claims flying, whether by the innovators themselves, or by the media, or by critics of them, which even the educated public and journalists who are covering this, really don’t have at their fingertips whether these claims are factual. You could go to an online resource and check it out. The same way you can in politics with factcheck.org. We’re recommending, and I’ll just repeat it, to further promote public education and discourse, an online mechanism ideally overseen by a private organization to fact check the variety of claims relevant to advances in synthetic biology and other new advances in the field of biology and technology.
 
To give one example of how that might have worked in this case, the phrase that The Wilson Center and others who have done reviews of publicity that came out after The Venter Institute announcement was made, the phrase that was most used was “creating life.” If there were the biofactcheck equivalent to factcheck.org, you could have gone online and simply found out that what The Venter Institute did was not create life. The life of the cell — there was a living cell in which the genome was injected and the genome self-replicated. Therefore, the cell was taken over by a new genome, but the life existed prior to that experiment. The experiment center institute itself did not say anything to the contrary. Although, as the rhetoric escalated, the notion of creating life took over.
 
With that said, I will open it up to any Commission members, floor comments and questions about these recommendations under Democratic Deliberation. Anybody in the public who wishes to make a comment or a question, please just stand up behind the mic and I will recognize you. Who would like to begin? Dan.
 
Daniel Sulmasy:
I would like to respond a little bit to John Arras, because I’m sort of two minds on this, John. I recognize that it is important to acknowledge different views and, you know I have a PhD in philosophy and I would like to have a long section that sort of unpacks what’s wrong with some of these kinds of arguments. I think that against that we’ve been giving a fairly short turnaround time for this particular report. I don’t think we actually have the kind of staff that was around in terms of PhD’s in philosophy at the time of the previous President’s Commission that you were talking about. I think that also, the kinds of arguments that they were making were against pretty prevalent views and I do think that the kind of intrinsic objections here, from what we’ve heard, are not very prevalent within the public.
 
I could make a long argument about why it is that the playing God argument reduces to a claim that one is usurping prerogatives which ought to be reserved to God. Which turns out to be kind of the elementary sin, because ‘Do Not Kill’ is also — For instance, usurping prerogatives that only belong to God, who is the Lord of life, so therefore this reduces to only saying that it’s wrong. Therefore, you still have to give explanation as to why that’s the case, but I’m afraid that in the context of this kind of a report would be distracting. Just as it would if we went into a very complex analysis of the concepts of risk that we were talking about yesterday and trying to get out handle on those as well. Maybe we want to do supplementary work on these kinds of topics, which are very important, but I don’t think that they fit well into this genre.
 
Amy Gutmann:
Anita.
 
Anita Allen:
Thank you. I have a lot of empathy for the kinds of remarks that John Arras was making about the intrinsic values section of our report. Just a couple of things. I think that the earlier report that you referenced was different from ours in that, I believe it was addressing a very distinct clinical practice or clinical issue, is that right?
 
Amy Gutmann:
Yes.
 
Anita Allen:
Yes. We have a very distinct clinical practice issue on the table. I think you can do a much more refined, detailed, philosophical analysis of the concepts and issues at stake. I think because we’re really talking about something much less formed at this point, that maybe our discussion of intrinsic value would naturally be a little less refined. On the other hand, I do think that we can say more in the report about the ethical aspects of impact on biodiversity, ecosystems, food, and energy supplies. We have a one-liner in our pending draft report that we say a lot more about why these things — why do we care about biodiversity? Who cares if they are fewer forms of life and some of them are manmade? What are these impacts on the ecosystem that we care about intrinsically as opposed to by virtue of consequential concerns? What are the food and energy supply implications and why do they matter in intrinsic manner as opposed to extrinsic manner. That’s the particular part I agree really needs to have a lot more said about in our report.
 
Amy Gutmann:
Good. I think it’s clear we will say more in our report. One of the challenges, I think, of doing this has nothing to do with whether we’re philosophical or practical because we really aim to be both. I’ve been on record to saying, and I think this Commission illustrates, it’s really a false dichotomy here. We want to bring good theoretical reasoning to bear on practical issues. Really, the challenge here for us has a lot to do with the fact — and it is a fact — that synthetic biology is in a very early stage of development. Right now, the threat to biodiversity is — we have to project it way into the future at this point. Therefore, our discussion turns out to be more theoretical than self-theoretical, because we don’t have really any ability to know where synthetic biology is going or whether it’s even going in the direction, at this point, that will, in fact, produce this threat.
 
With that said, we have some discussion in our report and I think I can speak for Jim and myself, and I’ll let Jim speak for himself, as well, but he and I just spoke moments before we convened and said that we want to give as robust of a discussion in this report as is suitable to the topic. We’ve moved in that direction, we’ll have to move a little bit, or substantially further. Whether it’s a separate chapter, I think, John, by your gesture, that’s not really what’s important — right? We really just need to make sure that the issues... Biodiversity is an issue, which there is a significant link to synthetic biology, unlike what Dan said, and I think you’ll also agree the charge of playing God has no hook in synthetic biology at this point. Everybody we consulted with, and we really did not only consult in bringing people here, but we got lots of letters. There’s no major religious constituency that said they were fearful of the playing God, with regard to synthetic biology at this point.
 
Dan, go ahead.
 
Dan Sulmasy:
Just to say, I think John said, and I did as well, the caution against hubris, which I think underlies that. Maybe we need to amplify what we said about that just a little bit within the text.
 
Amy Gutmann:
One other thing which we say in the text, but we may also want to amplify, there was a sense among...it wasn’t really simply religious groups, I think it wasn’t mainly religious groups... Its just people who think you don’t have to be religious to think life is special. That language of bio-bricks is a reduction of language, if it’s used other than to describe the fact that there are component parts that are being put together, but if it’s used to characterize life itself. Life is a sum of a bunch of bio-bricks. We’ve said something, but we probably should say some more about that.
 
Jim Wagner:
Can I jump in — since my name was invoked here? Two or three points.
 
Amy Gutmann:
I always recognize you after put your light on.
 
Jim Wagner:
It’s my claim to a slot. Two or three points. I think I’ll start with specific and go to general. We should, when we talk about diversity, and we should, perhaps talk a little more about biodiversity, we should take Tom Murray’s caution to heart. We’re talking about genomic genetic diversity, because again, way down the line one can imagine or fear, if you will, manipulation of the human genome and it would diversity within the human genome that we would also want to preserve as well, so that’s point one.
 
Point two; I’ll remind the Commission that the only objection that we heard for moratorium on all activity and in our prior presentations was not based on religious grounds. I’ll remind you of that. It was fairly intransigent. I remember Nelson asking, “Under what conditions would you raise the moratorium?” It seemed to be it was Armageddon or something, I can’t recall, but it was way down the line.
 
I do think, to John’s point, it would be wrong if a reader of our report were left with the impression that we were not aware of these intrinsic concerns. It would be wrong if the reader imagined that we did not take them into account to the extent that they’re applicable. To the degree that they can be listed and you can help, John, if there’s ways we can expand that in order that the reader is certain that when we come up with nineteen or twenty recommendations that these recommendations were based on a totality of information and we didn’t just ignore it as irrelevant some aspect. It would be, in fact, counter to our recommendation that says we encourage religious, secular, and civil society groups to maintain an ongoing exchange. Having said that, everything else that Amy just reflected on, is reflective of our conversation earlier. I don’t know one needs a small chapter to do that, but I think it is important that the reader feel as though we touched every base when we came up with twenty recommendations.
 
Amy Gutmann:
Christine.
 
Christine Grady:
I was wondering if this is an area where we might emphasize a sort of concept, like the prudent vigilance, because it is true that at the moment, the concerns that we heard about and read about, we don’t think are major concerns. But this is something that we do want to encourage people to watch and look at and talk about and dial on about, and so maybe that’s the point that we want to strengthen, the continued attention to these issues over time as the technologies change.
 
Amy Gutmann:
Exactly. I think that’s very important. Nita.
 
Nita Farahany:
Thank you all for an incredibly thoughtful discussion on this. I agree, I think that we need to flesh out the intrinsic concerns. I’m going to talk about a slightly different direction of these recommendations that I think we should focus on as well. We had incredibly helpful testimony yesterday from Tom Murray about thinking carefully about to whom our recommendations are directed and also when our recommendations are suggested. The way that we currently have the chapter framed, as well as the recommendations frame, I’m not sure we’re making it quite as clear as we should to whom we are directing the call for Democratic Deliberation. So, I take it that we are making this call, not just to a particular government agency or to the government, but as a call to the public generally.
 
I think in order to make sure that that happens there needs to be a clear leadership role as well. I would suggest that we make clear that this a call — both to the government to potentially take a lead and to ensure that in any conversations going forward that the public is actively involved, but also a call to the public and to scientists and those working in the field to actively engage. So, another area that I’m particularly interested in, which is biological predisposition evidence and how it’s being used in law, I’ve sought to engage scientists and to informing a lot of the legal debates that are happening and they’ve shied away from doing so for fear of misrepresentation of the science. I think that fear is one that should really be a catalyst for scientists and for other engaged in it to actually be engaged in the conversations and to ensure that they’re shaping the debate going forward.
 
Which brings me to that second concern, which is not just to whom, but when this is happening: we are of great fortune to be dealing with an issue that is emerging. Synthetic biology is an incredibly new field and we received significant public commentary on this point as well. On the point of Democratic Deliberation, we had a thoughtful commentary by Dan Kahan and Don Braman at our first meeting, who also submitted an additional letter as well as some additional thoughtful research for us to consider, where they likewise make a call for public commentary. To think about shaping that debate by taking into account things like intrinsic concerns and making clear, both where our positions are currently, but also to help frame that debate so that it isn’t one that is framed by these catch phrases like “playing God,” etc. They emphasize that these are not just ongoing conversations, but ones that really need to happen now, while the field is still young. So, for scientists, and for the policy makers and for the public, the time to engage in that debate and shape that debate is now and going forward, rather than waiting before the field is already shaped with significant cultural terms and significant terms that color and shape public view. I would suggest that we make clear we mean to whom and when these recommendations should apply.
 
Then just on a side note, I am incredibly supportive of our new recommendation of having an online forum. And I mentioned that there is a neuroscience one that has developed as well called Neuroskeptic [neuroskeptic.blogspot.com] where a neuroscientist from the UK has been taking each of the major FMRI studies that come out and has been analyzing what those studies say and kind of debunking different myths and different applications of those types of science. I admire that effort of that particular neuroscientist and think that a broader effort that could be funded by a large private organization or could be funded by a group of organizations and bring together more than just one scientist leading the charge would be a really terrific way to try to shape this debate.
 
Amy Gutmann:
Terrific. Let me just summarize some of the specific feedback from the Commission that I’m sure we’re going to integrate into the report. We’re going to give a more robust review of objections, not just intrinsic objections, but the whole range of objections to synthetic biology, too. We’re going to call for deliberation now when the science is still young. Let me just say that for the President’s Commission we have, perhaps, a historically unprecedented opportunity here. In cases in the past, the cat was out of the bag, Dolly was already cloned when the National Bioethics Advisory Commission (NBAC) was called by President Clinton to issue a report. Synthetic biology, as I said, is in its infancy or maybe adolescence, so calling for deliberation now will make a difference in the public perception of science and this field. Third, I think it’s really important to call for scientists as well as civil society associations as well as the government, to enter into this kind of deliberative effort. We heard from a group of scientists who are truly extraordinary in their ability to communicate publicly. One only had to listen to Drew Endy speak about synthetic biology — and we sort of wanted to clone him, but I know that is ethically wrong — that’s just a joke, for the record. I think these are a good set of additional recommendations for how we should write the report.
Jim Wagner:
I want to add, quickly, an amendment, or a suggestion, for the consideration of the group. I was thinking about Steve’s mention of the period of in Sweden of such excitement about science, and I was looking at these recommendations as a whole. It seems to me number fourteen, the first one that we heard saying that we want to encourage ongoing exchange and number seventeen, the one about education. I would like to suggest that we at least slip the word in there — and this is coming off Nita’s comment about targets — something about the media and the fourth estate. The last time I can recall a vivid period of scientific focus, one of those would have been around the earlier days of the space program. I would think that you would agree that one of the key players in that was the media, was Walter Cronkite giving us language at the dinner table that “bladed heat shield” and “lunar excursion module” language, that wouldn’t otherwise come to our tongue that I think is encouraging, and I think there are a couple of foundations trying to do this as well, literate open science reporting, could be a good recommendation out of here. Simply slipping the word “media” or “journalism” into the targets, I would like to see us… would be a good step.
 
Amy Gutmann:
Are there any comments or questions? Yes.
 
April Dworetz:
I have a question about emerging technologies, emerging behaviors. Was that discussed with the religious contingent looking at some of the intrinsic concerns? Because I would imagine there might be more concerns with emerging behaviors than there would be with the rest of synthetic biology.
 
Jim Wagner:
Give me a quick example. Do you mean just with what the unknown is?
 
April Dworetz:
No, there’s a subset of synthetic biology that has to do with taking stem cells, putting them into a Petri dish, and letting them populate, letting them emerge into organs on their own within their own cellular matrix, so that it’s not actually taking them out of their environment and hoping that they develop and form organs in vitro.
 
Jim Wagner:
The regenerative medicine dimension of synthetic biology, is that — ?
 
April Dworetz:
I’m not sure.
 
Amy Gutmann:
I think we heard, and it’s too bad Raju isn’t here because he’s a very eloquent spokesperson for this. There is a part, in this part of synthetic biology, which is very closely related to recombinant DNA and regenerative medicine. Indeed, we recognize in the report that synthetic biology would be impossible, it would not have existed, were it not for everything that was done with the mapping of the human genome and the really well-developed field now of genetic biology and molecular biology and genetic engineering. This is a preface to say that the issues that are attached to genetic engineering flow over into synthetic biology as it may develop. All the synthetic biologists that we heard from believe, as does the community of molecular biology, that there would be serious objections in their own mind, ethical objections, to extending this to the cloning of a human being or to changing human genetics in the way, that wasn’t directed towards addressing disease, per se.
 
April Dworetz:
Thank you.
 
Amy Gutmann:
There are earlier presidential commissions —
 
Jim Wagner:
You said “thank you,” but I’m not sure — did we cover what your concern was or did we let you know that we have had conversation and thought about that?
 
April Dworetz:
Well, MIT, Georgia Tech, and Illinois have a program that’s working on the grant that funded synthetic biology, which has one subsection that is being done at Georgia Tech, which is basically defined as using the stem cells to form by themselves organs, so that it is developing into an organ. If you want to extend it out, you think about whether it eventually could develop into multiple organs systems and then into a human being. Now, they’re not close to that, and they don’t think that will ever happen, but at the same time, because people think that way — I did, at least, when I first heard about it. I was wondering if some of the religious spokespeople thought about that, or were concerned about that.
 
Jim Wagner:
We did not hear that addressed directly as you’re posing. In fact, most of the focus of our deliberation has been on the genetic side as opposed to the somatic side. You make a very good point. All of the genetic synthetic biology activities are principally around putting the genome in an existing chassis. You’re talking about the issue of potentially generating a chassis, which could also ultimately evolve. We didn’t have a direct discussion on that. I think we should let the group respond. I think the sense of the group is that the first issues to be addressed are those around the genomic-genetic dimensions of synthetic biology and those will be very domain of these other technologies such as the ones you’re talking about, which I think we believe, are even further in the future obtained. Bear in mind that the kind of recommendations we’re making are for essentially a living activity around guiding the ethics of synthetic biology. We do not speak in hubris, we do not imagine that this is the definitive work that will never be rewritten, but in fact the recommendations themselves call for continuing dialogue in order that we can address these sorts of issues as they might arise. Is that helpful?
 
April Dworetz:
Yes.
 
Amy Gutmann:
I think we should move on to Justice and Fairness. Christine.
 
Christine Grady:
Thank you. I want to start by recognizing, which Tom Murray reminded us yesterday, that any technological advance brings both the promise of benefits and possible risks. We’ve seen and discussed the exciting potential of synthetic biology to address major challenges and global health and welfare, but also bring a possible spectrum of risks to house other species, ecosystems, national security, etc., and around the globe. As we’ve said, many of these risks are largely unknown and even the promise of benefit, and there’s a need for caring and ongoing attention in risk assessment along the way. But in addition to the principles that we’ve already discussed in Public Beneficence, Responsible Stewardship, Intellectual Freedom and Responsibility, and Democratic Deliberation, we as a Commission want to also promote the fair distribution of the burdens and benefits of synthetic biology. So, we have as one of our principles, Justice and Fairness and are committed to sharing the burdens and benefits across society of this technology. This includes thinking about the distribution of burdens and benefits to people who work in laboratories and personnel who are associated with developing the technology as well as research subjects that might be involved in the studies that we do to develop the technologies and test them. Then the public, once the technologies are adopted, whether they’re adopted intentionally or not.
 
For research subjects, there are mechanisms in place to assess risks and benefits before somebody is involved in a research study and also requirements and regulations that require research subjects be fully informed about what they’re being asked to participate in. We wanted to look at whether or not the evaluation for research proposals for synthetic biology allows consideration for environmental exposures, social disruption, and other kinds of risks to groups or communities or future and long term effects and impacts and consequences of the research on synthetic biology.
 
Currently, the federal regulations instruct IRBs not to address these issues. In fact, the wording exactly is under the regulations and both the common rule and the FDA regulation say: IRBs in this context of considering risks and benefits for research subjects, the IRB is instructed to look at risks to the research subjects in relation to benefits to the research subject, if any, and the importance of the knowledge. They are also instructed only to consider the risk and benefits that may result from the research. Then they are instructed not to consider possible long range effects of applying knowledge generated in research as among the research risks that are under their purview.
 
Given that, we thought that in order to attend to these issues of fairness and distribution of risks and benefits across society from synthetic biology research that there needs to be some attention to the issue of thinking about the distribution of risks that affect more than just the individuals in the studies.
 
With that in mind, the provisional recommendation is: The Department of Health and Human Services, in conjunction with other relevant federal agencies, should evaluate different models and make recommendations to ensure that appropriate consideration is given to the distribution of risks, both short and long term, in research and the development activities in synthetic biology. Specifically, DHHS should reexamine existing regulations for the protection of human subjects found in the common rule and the FDA regs to examine how they do — or might — guard against the possibility that risks are disproportionately borne by certain individuals or population.
 
Amy Gutmann:
Excellent. Thank you. We are now at the nineteenth and last provisional recommendation. Barbara.
 
Barbara Atkins:
This is a direct extension of what you just heard in the last one, but what it does is extend the same thinking about risks and population to the manufacturer in the commercialization of products that would be developed from synthetic biology. So, the real issue here is that there are underrepresented populations, cultures, economic status, nationality, political power, and things like that, that are often used to determine where testing will be done and what kinds of populations testing will be done on, and then, even what kind of areas might be used to manufacture synthetic biology and biology products. I just mentioned some of the most egregious episodes in the past that had to do with just this very thing with African-Americans, with American Indians in Arizona, and most recently with the finding of the study from Guatemala. So, it has cultural aspects, it has population aspects, it has disadvantaged population aspects, and it has international aspects, particularly as it relates to under-developed or developing nations.
 
The nineteenth recommendation looks more broadly then at the manufacturing and commercialization. We want to be sure that there is protection and consideration of the risks, the long-term risks and the short-term risks, of using particular populations and that any population that is considered, or any areas, can be a geographic area that is going to be considered. If you think about what synthetic biology products must do, there are some that may be algae growing in giant lakes making biofuels and what are those lakes going to be, where are the lakes going to be, what are the risks to the communities in those areas? It might be a vaccine; it might be a vaccine for malaria or a treatment for malaria. That isn’t going to be tested on people in the United States, because that’s not where the at-risk populations for malaria are — it’s going to be tested in underdeveloped countries.
 
The real issue in this one is how you use the communities to actually help you design the research activities, plan them, and help even to implement them, and be sure that they understand the risks and potential benefits at the same time as you’re doing this planning. I think that the community pieces are very essential in all of this.
 
Then there’s also the issue of how you can be sure that they get the benefits as well. Some of these things may be very expensive when they come out. You hope that a new drug for malaria will be cheaper than the old treatments for malaria, but say it turns out to be very expensive, these are the very populations that might not be able to afford it, or might not have access to the kind of care that could be given in this regard. I think there is a balancing then in being sure that the risks are understood, the populations are understood, and the benefits happen for everybody, particularly the people who were most involved in the development.
 
With that in mind, the actual recommendation says, manufacturers and others seeking to use synthetic biology for commercial activities, as well as those responsible for approving these efforts should ensure that community and environmental risk evaluations shows that the most serious risks, including long term impacts, are not disproportionately or unnecessarily borne by certain individuals or subgroups. The Executive Office of the President, as part of the review, described in recommendation five should consider developing guidance materials and voluntary recommendations in the absence of statutory change or regulatory requirements.
 
Amy Gutmann:
Thank you, Barbara. That concludes the presentation of our recommendations and I open it up to Commission members for discussion and again, if anyone in the public would like to make a comment or question, please stand up to the microphone. Nelson.
 
Nelson Michael:
I have just one small comment, which is, I think our recommendations, eighteen and nineteen, don’t reflect many of the comments that we just heard about also addressing the distribution of benefits. There’s language about the distribution of bearing risk, but not about accepting or benefitting from the positive results of this research.
 
Amy Gutmann:
Correct, and we need to revise this. There is symmetry actually between risks and benefits here, which we have — for those keen observers of yesterday’s recommendations — we have taken great care to indicate that the upside potential here is just as important to take into account as the downside risk. If a malaria drug has the potential for saving lives, which it does, we want to make sure that those benefits are fairly distributed as well, and our recommendations take account of that. These need to be reworded to take that into account.
 
Daniel Sulmasy:
Just in keeping with our general theme of regulatory parsimony, I have a worry that hadn’t struck me in until I just saw it now. The second sentence in number eighteen almost makes it seem that we’re suggesting IRBs be looking over bench work science to make sure that if somebody is working on a yeast in their laboratory, it doesn’t get out and disproportionately effect brewers and bakers or something. I think we have got to be very careful… I think the intention is to use that analogously of those sorts of protections, by putting that language in here and the numbers of the regs, it almost suggest that that’s what we’re doing, so we want to be very careful that we’re not suggesting to scientists that are doing bench work and that IRBs should now start reviewing their work.
 
John Arras:
In light of that comment, I want to ask Christine, what are we in fact urging here? You’re right; the burdens to the public are explicitly ruled out of the common rule, whereas benefits to the public are explicitly ruled in. I’ve always thought that to be a bizarre exclusion. This might be an opportunity to rethink that.
 
Christine Grady:
That is correct and I think it is problematic, especially when we start to think about group harms of various types from synthetic biology and other technologies. But I think there is a really interesting question here that Dan raised and that is, who should review it? Should it be the IRB? Should there be some other mechanism to look at long-range consequences of research? That’s why I like the first sentence of the recommendation as it’s currently worded--although it may have to be beefed up. And, on the second one, I changed — you may have noticed — but we may want to change it certainly from how it’s currently worded. Maybe we might even want to strike it, but I think the first part is absolutely critical — that the DHHS and other relevant federal agencies evaluate different models and make recommendations to ensure that consideration is given to these long term impacts. People have been calling for that for a long time in other fields of science.
 
Amy Gutmann:
That first sentence is precisely right. Were going to need to either strike or revise the second sentence, because we certainly don’t intend to recommend that IRBs take over this task of overseeing the long-term benefits and risks of bench science. We have to beware of the unintended consequences of your wording and in this case, we will work on that. We’ll initially strike it and see if we need anything more than the first sentence. We may, in which case, we’ll get a better specification.
 
Nita Farahany:
I agree strongly with the sentiments of both of these recommendations, if I understand them, to be as characterizing it, which is we don’t wish to have any group disproportionately bear the risk without also realizing the benefits of that research. My only caution is, it is the case given some of the conditions that we would be setting, like malaria, for example. There are certain populations who will disproportionately bear the most serious risk. I guess I’m just pushing a little bit on the language that we’re using. I think the second part of number nineteen where we say that it’s not unnecessarily borne by certain individuals or sub groups is absolutely right, but that they are not disproportionately borne, I think is perhaps just inaccurate. It is the case that some will bear it. What we are asking for is that it not be unnecessarily borne disproportionately by certain groups, and recognizing that certain groups may face the disproportionate risk. We want to insure, particularly given that many of the medicines as Barbara said, may become expensive or inaccessible to those very same populations, that they realize the benefits when they are subject to bearing the risks. It’s simply a matter of how we’re wording this and understanding the realities of science —
 
Amy Gutmann:
Let me make a distinction here between the disproportionate bearing of risks by populations given the status quo that exists — and no work on synthetic biology is going to change that — and the disproportionate risks borne through the activities of synthetic biology, and that we can recommend again.
 
Nita Farahany:
Maybe it’s just my reading that’s unclear, but since I am a learned reader of our own recommendations, I suggest that we clarify what we mean by the different risk, which is there is a disproportionate bearing of risk by the activities versus being the subject for population of research studies, both of which we believe need to be addressed. One of which is unfortunately harder to address, we’re simply not able to say certain populations cannot be research populations, nor as we suggesting against it. We’re simply recognizing that certain populations will be researched; populations we wish those people to also receive the benefits of that research.
 
Amy Gutmann:
Although, there are existing regulations, which I, for one, strongly approve of and disapprove of the violations of it, which require human subject research in clinical trials to make sure that when you’re using people in clinical trials, they stand to gain and not to lose by the trials relative to the status quo. We may need to say that here to remind people of that existing set of regulations — and those are very important.
 
Christine Grady:
I was just going to reemphasize that I agree with what you said, Amy, about the emphasizing that the individuals in the research study. I think the missing link in research considerations it everybody else might be affected by the research.
 
Amy Gutmann:
Please introduce yourself.
 
Felix Khin-Maung-Gyi:
Good morning, Felix Gyi, Chesapeake Research Review. I want to thank you for a very thoughtful discussion and many very thoughtful recommendations. I want to tie some of the discussions from yesterday back to thoughts that have been put out today. Dr. Sulmasy, thank you for recalibrating the role of the IRB, because that is a perspective that I want to speak to. I want to speak from the perspective of a recovering federal advisory committee member. I was on the Secretary Advisory Committee since its inception and served on various subcommittees and co-chaired a few and have come off it in 2007.
 
Many of you know that SACHRP still exists and continues to work and advise the Secretary of Health and Human Services on human subject protection issues. One of the things that SACHRP has been wrestling with is the notion of helping the agencies come to terms and harmonize some of the interpretations, regulations, and the application of those interpretations. As I sit and listen to the thoughtful deliberation here, I wanted to ask the group to at least be mindful of the fact that having those agencies talk to each other is like herding flying cats — it’s not just butterflies or cats — it’s just a daunting task that has taken a long time for folks to try and do something.
 
Yesterday, Dr. Murray thoughtfully reminded us that there ought to be clarity and consistency in the types of information that you give, especially in the agencies. I would add one other perspective to that. I would ask that you think about precision in terms of the types of recommendations that you make. Somebody, I’m not sure who it was, just recently recommended that there be better clarity on the types of things that you recommend to the agencies, and I would simply echo that, because in the absence of your specific recommendations, I fear that there will be lapse in time that’s going to be unforgiving. Research is going to continue, the agencies are going to continue to deliberate, and I think we, as both a general population and a scientific population, will suffer from the agencies discussing issues that you put out without the precision that you’ve given them. They will make interpretations and fill that void on their own; resulting in the FDA asking the IRBs to do certain things and OHRP asking the institutions to provide a level of oversight that you may not have intended.
 
Amy Gutmann:
That’s a wonderful suggestion and it provokes in me the thought that just as we were given six months to issue this report, we may want to suggest some time frame in which those specific recommendations should be addressed.
 
We will take a break. We are a little past our time. We are scheduled to reconvene at 10:30, let’s say 10:35. Thank you.

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