Event Started: 7/1/2005
Good morning. I want to briefly mention how strongly I feel that yesterday's session went very well. and I'm looking forward to the presentations and discussions that we had scheduled for today. Once again, I'd like to welcome the board members. Those in attendance in the audience and those watching this on the webcast. So let's get started. One of the charges of the board is to provide recommendations for a code of conduct for scientists and laboratory workers that can be adopted by a professional organization and institution engaged in the performance of life science research. In this next session, we'll touch onish b shoes related to the benefits of a code of conduct as well as complexities in establishing such a code. We'll hear from three distinguished speakers, after which we'll have a general discussion and questions from the board. So our first questioner will be Dr. Phillip ap Sharp. Dr. Sharp is currently at M.I. T. He is a member of the national academy of sciences and recipient of Nobel prize of physiology and medicine. Dr. sharp will speak on the sporns of guidelines and responsibilities in the life sciences. Dr. Sharp?
Thank you. It's a pleasure to have the opportunity to speak here this morning before the national sigh "Eyewitness News" -- before the NSABB NSABB. I am impressed that you are engaged in this activity the Friday afternoon before the fourth of July weekend. I think about half of Washington was in the airport yesterday as I was coming through. The yeft of it will probably be in today as I leave. I look forward to getting back to Boston to listening to the 1812 over chore and seeing the fireworks on the esplenade. I've been talkingked to talk about life sciences and there are many codes. What I want to give you as a message is that codes of conduct have been taken seriously. It's part of what we teach it's part of what we do. The reason that these codes are so widely used and effective is that there are ethical and pragmatic reasons for them, and when viewed from the perspective of the active sciences which is the perspective I'm talking from today, they are essential for our work. The many codes come from the activities of buy yo medical research and are taken that were developed as buy yo medical research community has developed. We'll try it the other way then. The buy yo medical research community is a culture of responsibility, and I believe this science community, the buy yo medical research or life science community is the one that's most involved in codes of conduct. That probably comes from the fact that this community developed after World War II mostly with the discovery of recombinant dna and scmajs expansion of life science after the war. It also developed because it engages humans in part of the research activity so as we have advanced life sciences and been involved in the medical aspects of translation of life science, we have engaged in more and more regulation as a community vis-a-vis, the use of humans and animals as subjects for experimentation are or being involved in experimentation. And then theres with the second event or the other event that I will talk about today that also broke many codes of conduct and a formalism to it into the community, and that was the discovery of recombinant dna, the whole genetic engineering that occurred in the '70s which I'll comment directly on and that also brought codes of conduct into the community and brought us a formalism related to guidelines and BRAC and other nih activities. The culture is shared by both the scientists, institutes and federal agencies because we as a team in many cases have found it necessary to work together to implement these codes of conduct and to translate our science and advance our science in research. And some of the shared facts, very pragmatic facts that have generated this code of conduct or culture of responsibility is listed here on this slide. That's the continued advancement of buy yo medical research very much depends on the public funding. The nih is the major funder of this research in the country its support by the public and Congress and others is essential for that research activity. That research activity underwrites the whole medical care system in this country. The pharmaceutical industry, it underwrites health care and academic hospitals. It underwrites the knowledge base in which a physician interacts with a patient in any part of the country. So we see as part of the buy yo medical community that we play a very fundamental part of the country's development of health and health code delivery. When you look at the public support, the private support in the country, the pharmaceutical and other activities that are privately funded, also depend upon this structure of the interaction between nih and scientists that is essential for the advancement of science in the country. Now, continued development of buy yo medical research is critical for health care and security in the country, and every scientist who works in this field understands this today. If you think about that the issue, 15% of the gross national product depends upon health care or involved in health care in some aspect in this country. That number is growing to 20% of the gross national product underwriting that total part of the economy in the basic research is the nih support and the activity of the pie yo medical research community. Security in the country both in the context of a vibrant economy, context of securing the health of soldiers, of buy yo security depends very much on this activity of the interaction between scientists and nih. Buy yo medical research must be done in a safe and transparent fashion with responsible use of human and animal subject. This is an integral part. When one begins to translate science into the involvement of humans as research subjects, then you become very involved in codes of conduct and that has risen to promote codes of conduct being widely taught and used in the country. Now, in addition to those pragmatic facts, the scientific community, the pie yo medical research community has a culture of responsibility that is driven primarily from a set of values, which are common of other sigh enter-- sciences. I think these values are important when you start thinking about codes of conduct and teaching codes of conduct. One of the most fundamental shared values among all sciences is the belief that new knowledge will ultimately lead to a higher level of humanity that as we understand the world about us, we will then elevate ourselves to a higher plane of understanding world and world about us. So whenever restrictions are placed upon the limitation of gaining new knowledge of exploring new realms of biological space or chemical space or other space, the scientific community is very unsure of accepting those types of limitations. So there is a commitment to advance societies who the gaining of new knowledge and commitment of advancing health care. The scientific community as well is committed to education in terms of both transmitting and developing our science as well as educating people as to how to operate doing science in this community. And then there's this validity of scientific data done openness to its questions and exchange they're a fundamental part of being a scientist. If you are involved in this very simple process, a process that has been taught to students in the eighth grade of scientific experimentation asking the question, getting an answer. Asking the question, getting an answer. A simple process as that has changed the world about us by creating all of the things, including the building we're standing in, that technical scientific advances is something that has to be dealt with in terms of open questioning its description and publication of details and how one does science. This process of forwarding science by question and debate. So these are values that are commonly shared. When those values are restricted, it's very complex for the scientific community to accept, particularly in the buy yo medical as other sciences. And then the last tradition of the field or value of the field is that this activity is international. We have over a long period of time benefited from learning from our international colleagues and as well share it. And in fact, if you think about it before World War II, every major scientist in the U.S. was trained in some part by some experiences in Europe. In fact, if you were a chemist, you travelled to Europe in terms of being trained at some stage and then after World War II, that process is mostly come to the U.S. These are shared values about restrictions in terms of or the culture of responsibility for buy yo medical research. I want to talk to one example of the development of codes of conduct. What I showed in the picture is a picture of Francis Kirk and Jim Watson. Watson was, as you well know in 1953 when the discovery of dna, was a young American scientist from Chicago who had been interested in watching birds, and then got his Ph.D and went to travel through Europe to see if he could disoiver the structure of dna because he believed it was the basis of genetic material. Francis Krick who just died a year or so ago is one of the most brilliant people I've ever met, was a physicist who had been involved in World War II, and this shows them in Cambridge. It was in Cambridge where the discovery of dna was made, and that set forth then the whole development of the molecular biology community and as well the recombinant dna activities that I will speak about now. Recombinant dna was not the first set of guidelines that actually was developed by the life science community. In fact, if you look at codes of conduct in life science, you have to go back to the Hippocratic oath in terms of do no harm as a code of conduct for scientists involved in biomedical research. Actually human experimentation as a code of conduct came out of the neuronberg trials -- niewr 'em trials in 1946 where the use of human experimentations during that period led to issues and codes of conducts were further developed through Helsinki declarations in '53 and '64 and then in this country by the Belmont report in 1979. This was some of the first codes of conducts of conduct developed. In the '70s, a new technology was developed through basec science in laboratories, really in many cases not so obviously related to biomedical research, the ability to seek one's senses and recombine dna. This all developed in the early '70s about 20 years after the discovery of the structure of dna and led to a whole new set of experiments that were possible but had not been possible before. Experiments of the type of being able to take a gene from one organism, combine it with the gene of another organism and then asked in the process of experimentation what you could learn about the function and activity of those of the genes. This led to a whole series of concern that arose among the scientific community and then rose among the public about this new technology and what it might mean for safety in doing research. Safety both to the people who are in the laboratory but as well safety in terms of creating possible novel infectious and new agents. In many cases, the safety issues rose in the following -- We were by recombining dna, violating boundaries of nature where boundaries of nature were genes from two organisms who had never mixed end quote, were now being mixed by scientists and could tree create pathogens that would become highly infectious -- inspect -- infectious agents and could discredit the whole bioresearch committee and public support. That led to a bunch of concerns and then in 19374 -- 1974, something happend that had never occurred before in.biomedical research community, and that was a moratorium was called by leading scientific figures and the national academy stating we should not do scare pnts -- experiments in this area until we have met, discussed these issues and come to some conclusions as to how as a community these issues should be addressed. That led to a conference in '75. Note, there's a six to nine-month period here in which no experimentation was occurring, which then was a very novel and interesting period in science in which possible experiments were not being done simply because there was this public concern in wanting to respond in a responsible way. In 1975, the conference then suggested or recommended that nih develop guidelines. Those guidelines were first issued in '76, again, another about year passed without a lot of advancement in this experimentation, and then in '76 with the nih guidelines and the foremaltties of the BRAC committee and institute biosafety committees, research experimentation began. I want you to note that in 1976, Genentec was first formed. Biogen was formed in 1978. It was in this period in which the whole genetic engineering biotechnology community began to develop in biological science then grew from it. Now guidelines in '76 were highly restrictive, and then were again revised in '79 to Swiss the knowledge in what had transpired in the laboratory since '76 suggesting that the concerns were not as great as perhaps they were originally articulated and the dpliens with are then reduced. As far as I'm aware, there wasn't a single or has not been a single example of an infection from a laboratory over the last 30 years being due to a recombinant dna organism having been created in the laboratory and then infecting either someone in the laboratory or someone in the public creating a diseased state. Just to give you that arrow points to myself attending the conference. It was one of the most interesting experiences of my scientific life. At this time, I was about 30 years old, and there wasn't anyone in the world more ambitious than I was, in terms of this sigh Epps. I was really -- in terms of this science. I was really excited about what this science could mean and this was a very interesting life experience in terms of it moving forward. the guidelines had been viewed and have been very successful in terms of retaining the confidence of the public, support for the national institute of health and regulatory agents that worked together and public support. Why was it so successful? I think they were successful because they were led by the scientific community, including the funding agencies working as a team to make these guidelines effective and for them to be respected by everyone in the community. They were international at the onset. It was an international process, though, there was some variation from country to country. In essence, the same moratoriums, the same guidelines, the same rule for science were being developed in all of these countries. The process from the day one was public. Compliance was almost universal. It was, as far as I know, there were only two major or as for as I know, noted violations of the guidelines. One was more bureaucratic. There was an announcement of a change in the rules and an experiment done before the rules were officially issued, and then another case there was what is apparently a violation, knowing violation and the individual had funding withdrawn from the national institute of health, had other issues in terms of use of Hume be subject -- human subjects. Whatshas made the guidelines so effective is built into the guidelines and anticipated in the administrative structure was a mechanism for change with the progress of science. So this process of being able to change the rules as we learn more is a very important part of why the guidelines have been so effective in terms of the community. Now, we teach codes of conduct, in fact, over the last several years, I was a senior faculty member at M.I.T. with Terry had been teaching codes of conduct as part of the process of educating graduate students and complying with some of the regulations of N.I.N. in terms of support of graduate students. The course that I will briefly summarize in the next two slides is the material we've taught in codes of conduct to all second-year graduate students in the department of biology at M.I. T. We teach these students codes of conduct from a departmentmental instruction because we thought we would have the most rapport with these students. There's also an M.I.T.-wide course for fiewnts that are in chemistry and engineering and other parts of the university. What I'll talk about is primarily our interactions in students teaching codes of conduct. This is part lecture, part discussion. We start each of these sessions with some topics that will be covered in the session and then we begin discussions and it goes on for four hours. These are the sessions that we teach in responsible conduct and research. You note at the top is scientific misconduct record keeping, reporting results, data selection. This is how you view and must make decisions in terms of being an active scientist, reporting your experimental results, dealing with data and retaining that data in case it needs to be surveyed. Session two deals with mentoring authorship, peer review and confidential information. Parts of processes, again, that active scientists have to be comfortable with in making decisions. Section three is intellectual patents, trade secrets and responsibility to the public. That latter issue is safety in terms of biorecombinant dna issues, guidelines and other issues. That perspective, in fact, a couple years ago or a year ago when professor Jerry Fink at M.I.T. suggested the establishment of this group. We invited Jerry to come over and talk to the graduate students about the process of biosecurity and bioagents. And in session four is the use of humans in biomedical experimentation where we talk about the ethical uses of humans as research subjects, the compliance issues, what types of experiments have to be covered by that process and session five is the use of animals. We talk about the issue that we thought was using animals and as well the regulation issues of using animals. So these are sessions that two senior faculty members and every graduate student in the department participates in, and have I found teaching them really quite interesting. Now, behind this interaction between students and faculty at M.I.T. in terms of codes of conduct is a number of institutional activities that are essential for our research programs and in compliance with federal regulations and nih regulations in terms of activities at M.I. T. You'll note that the top that these support activities and organizations for biomedical research report for the office of vice president and research and associate provost Allen Guess who holds that position now. Under that organization, there is a committee on the use of humans as an experimental subject. The institute review board. Every grant and activity we have that involves humans have to be reviewed either by a delegate authority from that board or by the board. There's a committee on animal use similar. There is the academic misconduct policy, which M.I.T. is responsible for and needs to report to nih about. That's the responsibility of this office. There is an office of intellectual property. The issues of intellectual property and handling confidential information. The office of sponsored research is engaged in or responsible for dealing with conflicts of interest. The issue of whether in the context of grants and other activities investigators have economic conflicts of interest that would compromise their independence and judgment. That reports into the office of sponsored programs, another code of conduct issue. And then reporting academically to this office but independently to the vice president of operations at M.I.T. are the environmental program offices. Under that is the committee for the assessment of biohazard. That's the institute biosafety committee equivalent. Also, so that's where recombinant dna guidelines are that's responsible for the implication at M.I. T. There is the shekt agent control that reports in the identification of agents who could be possibly used for infectious agent, known infectious agent that could be used for infection or pie yo terrorism. It's responsible for the retainment of those agents at M.I.T. is the responsibility of that office. And then chemical and radiation lab safety. So what I've tried to do in these short moments is give you an overview of what motivates codes of conduct in the community. It is this responsibility to the public and the understanding that the activities in pie yo medical research underwrite an enormous part of the country's health care delivery process or health care. Some of the values. I tried to give you an overview of the experiences in terms of developing the recombinant dna guidelines, and I tried to give you a feeling for the implication of those types of codes of conduct on the ground in a research university with students at M.I. T. Thank you.
Well, thank you, Dr. Sharp. I think there will probably be many questions, but we'll hold them until the other two speakers have had their chance to speak. Devising a successful code of conduct can really be a challenge. To discuss some of the challenges and recommending a new code of conduct, we have two experts from institutions in the united kingdom. I'd like to introduce Dr. Brian Rappert, from the uft of Exeter and Dr. Malcolm Dando, professor of international security at the university of Bradford. Thank you.
Many thanks for that, chair. Malcolm's been gracious enough to allow me to give this presentation on my own so I should start with a thanks to him. What we've been asked to do for this presentation is to examine some of the barriers to the outtake of codes of conducts in relation to biological weapons. Our reflect -- reflections are going to be based on a few different sources. One is an examination of various discussions over the last few years about codes of conduct that have been happening internationally, which I'll speak about. Another is some of the recent experiences that we have at the meeting of experts for the pie yoological weapons conviction -- convention just a couple weeks ago that was discussing codes of conduct for scientists. And third is the discussions that Malcolm and I have been having with life science -- life scientists. I said we were going to Faulk about some barriers, so it's going to have a sort of negative feel to it. I think there are various challenges that need to be faced when talking about codes of conduct, and I hope by examining some of the fal criewrs, some of the difficulties that I can help the board in its deliberations. It is going to speak of several challenges. a number of people began by talking about history. I'll begin with may own sort of historical reflections. I think it's important to note that not only as Phillip says is there a long tradition of discussions about codes of conduct for science and for medicine. This discussion has also taken place in relation to pie yoological weapons. Just to give you a couple of examples of that, something that came out of a paiper that came out of the world federation of scientific workers conference was talking about the idea of codes of conduct in 1968. In part in relation to questions about biological weapons and debates happening at the time about various disarmament treaties. This S. was on the back of the plans the international council unions had at the time. When they themselves with are tawing about introducing some sort of identity cards for scientists which is a long way from where they are today. Just to give you another example of that, it's not just if you like post 39/11, it's been arriving provocative editorial about biological weapons. This is just a short quote taken from one article that ends with the line that's not some principles of conduct established for men and women who manipulate the materials. With anarchy disaster. And that was in 1968. And it's not just recently as well that scientists have been writing codes for journals life sigh Epps. So here's a code that was offered in 1977. So with that, I just hope you can get a sense that this topic has been on the agenda for quite sometime. And yet despite that sort of attention, there hasn't really been a big uptake in relation to biological weapons, vis-a-vis codes of conduct. Let me try to give you more contempt pry -- contemporary examples, discussions about codes that taken place post 9/11 context. By doing this, I want to give you a sense of the diversity and thinking that's been out there about codes, and just give you a sort of illustration of maybe some of the frustrations that organizations have experienced trying to develop codes in this area. If you just scan the sort of writings that have taken place about codes of conduct and issues, you can see quickly people are thinking about different kinds of codes for different audiences that are meant to have different purposes. So just to list these three here, the working group of the united nations, terrorism has advocated the development of the code of conduct, really thinking here about defense scientists and thinking about what restrictions there had to be about wmd-related knowledge and expertise. In Britain, there's been qhiet a bit of discussion about codes of conduct because Britain has chaired this year's discussions under the biological weapons convention that are talking about codes. So in 2003, the -- one of the committees of the parl mment -- parliament advocated a sort of Hippocratic oath. This would be an idea of some sort of professional membership joining the sigh entifng -- scientific profession. You needed to take an oath as part of that. 2001, George Bush called for a code that would provide a solid framework and one with universal recognition. Now, from these initial statements, there's been quite a bit of development in recent years. So the working group of the united nations and terrorism gave a mandate to the international center for genetic engineering and biotechnology to develop this code they were referring to. Since then, however, the organization decided it wants to develop principles that will inform other organizations of the scientific organization to develop their own code. In the uk, I don't think there's as much discussion about Hippocratic oath kinds of codes anymore, but there is this sense of wrapping up the biological weapons issue within a wider discussion of professional responsibility. So that would be very much touching on some of the general remarks that Phillip spoke to in his presentation, but not cw-specific. And as well to the statement by President Bush about a code that has universe at -- universal recognition. I think there's been a movement away from a universal code a sort of one size fits all code. Ideas are developing in this area, and there's plenty of them of what needs doing. And all this, I think, is to point to the importance of a very sort of simple question. And that question is this. What is the problem to which these codes that we're talking about gives a solution? And a very general remitt in terms of the codes issue. And that doesn't specify the purpose the audience or what type of code is necessary. These are questions that have to be discussed. I produced a paper for the experts meeting of the pie yoological weapons convention, which I distributed here. I gave to the organizers that I didn't see in my folder, but that discusses various kinds of codes that could be developed in relation to these questions about dual use issues. I've listed some of the possibilities here that includes issues about awareness of Doyle use issues. And responsibility between individuals and collective organizations such as professional societies. It also speaks to the way in which I think a lot of the international agreements that we've talked about, the pie yoological weapons convention. These are really written for state parties. They're not written for individuals. And a code could try to translate those sort of international agreements that exist into something more specific for research. Then there are questions about biosafety and pie yo security divisions. We've already had some comments yesterday about whether codes were a good idea, and some people seem to support the idea of establishing a code. Others seem more skeptical. I suppose my response to hearing those sort of comments is what kind of code are you talking about, and what's it supposed to be doing? I just offer this apology up to just to provoke a sense of the range of the types of codes that encep might think about developing. You could talk about aspirational codes, codes meant to just to get people thinking about an issue. The American society of mike micro biology of dual use issues and calls on researchers no the to engage in activities contrary to the welfare of human kind. It's not a code that's dpee tailed in relation to biological weapons issues. It gets people to acknowledge there is an issue to develop with. It serves sort of if you like organizational functions about highlighting the importance of dual-use issues. That's a possibility. I think there's sort of aspirational codes more often than not called codes of ethics, but I'm not going to be precious about these meanings that are offered. Another type of code that the board might think about is something more educational, something meant to provide guidance to individual researchers to get them endpaiched in debates and to foster their thinking in this area. If I were to think of one code that does that, I would point to the world medical association's declaration of Geneva which is not a code itself but it does try to lay out some of these educational and advisory issues. One of the key recommendations that comes out of that declaration is the individual's personal benign attempts is not sufficient. There needs to be a greater debate than just trying to lay out who are the good guys and who are the bad guys. a code of conduct could be something that is much more about enforcing rules. We heard from Phillip Campbell speaking about nature and some of its code of practice in relation to what sort of materials others have to submit along with the publications or make available to other researchers. Some people yesterday were talking about codes in relation to select agent regulations. Now you are starting to shade into your legislation. But there are these range of codes that might be developed. Let me move on to some of the other barriers that we see in relation to dual use and biological weapons codes. As has been said many times, it's very important that what has been done is international, and I agree with that, but there are barriers to developing a code in the life sciences that is, let us not say universal but widespread. And I think that relates to the lack of sort of key organization that would be able to take that up. In chemistry there's the international union that apply chemists which has taken a lead role in relation to the chemical weapons relation. There's the wma as far as medicine goes, but I don't think there's an equivalent umbrella organization in the life sigh Eppss. That's going to make developing any international code. They are suggesting yesterday that put forward the national academies might be able to do this that's reflecting on the process that they've been engaged with, the collective process over the last couple of years. I think it's fair to say that pre2004, you've had different national academies coming out with different policies in relation to codes. The national academy's different in terms of their relation S. to government, what sort of advice they are supposed to apply. The international ca cadmy shall -- academy panel was charged to produce the code of conduct which was originally going to be done with the icgeb, who I mentioned earlier. And I think through that process it became clear that, you know, there are different time frames that national academies are working to. There are these different rationales. There are different mandates. There are different relations to government. And it does rather complicate devising a sort of single code that's going to be relevant for all organizations that all national academies could agree on. So what's happened is that the interacademy panel has done a bit like what the icgeb did. It came out with principles to inform codes that we'd be taken up by various individual national academies. That is the useful act in itself but it does speak to some of the difficulties of, if you like, sort of trying to devise a sort of single code internationally in a way that's been framed here so far. There have been a lot of organizations that have showt thought about developing codes. The international community of the red cross has thought about codes. Again, it's moved off from developing a code itself to thinking about principles that could inform other organizations to develop codes. The biological weapons convention this year is having its discussions about codes of conduct. I would be very surprised if If out of that process there cam an international proposal for a code of conduct. I think you are going to see lots of codes of conduct. I would predict that the bwc is again going to come out with something like principles that would inform other organizations to come out with codes. So the basic point here is that there isn't, if you like a sort of natural air in the life sigh Eppss that would take up some sort of universal or global code as far as I can see. I want to very quickly summarize some of the discussions that have taken place internationally and nationally about codes of conduct to build on the point I just made about fragmentation. I think in my experience, certainly this the experience of Malcolm and I, there's been a great reluctance in many governments to, if you like come up with a code of conduct to devise one and to suggest that for the life science community. As we've heard from the discussions yesterday, it's opinion said that it's very important for the life science community to come up with codes, with ideas without regulation or what have you for itself. So I think married with that, there's been a despite some notable exceptions, there's been a reluctance for the life science community to develop codes of conduct in relation to these issues about biological weapons and biewl use research. I think these last two points that have been raised, when you add those two together, what you get is where the current discussion about bw codes is which is in a sort of continuing state of prelude. Lots of discussions about building up to a code. Not a lot of if you like initiative in terms of actually developing one, and thinking about how it might be implemented. Certainly, I would agree with the comments that were said yesterday about the importance of international codes or international criteria about dual use issues and what have you. I think the key issue is one of initiative. It's one of who is going to take up this challenge of devising codes. And NSABB with its ability to influence nih with the sort of geo graphical spread in the U.S. certainly has within its ability to come up with something that could provide a lead in terms of international discussions in this area. Move on to another area. This question of what is it all supposed to mean? There was some discussion yesterday about, you know, getting a code that people would sign up to that would in some sense determine what constituted appropriate behavior. I think a lot of the people that have lookd into codes and practice at the social scientists have often come up with a critical comment about whether or not a code is simply something that people sign up to that almost in some sense dictates behavior. Often professional codes of conduct, particularly, I think in the science area are meant to be aspirational. They are often meant to be educational, and with that, they open up to forms of interpretation. If you take a classic example of that, you can go to the case of the whistle-blowers. A lot of the engineering codes, scientific codes speak to the need to think about the public interest, the public good and to speak out when individuals, engineers, scientists see something that's questionable. But as well, many codes will also speak to the importance of confidentiality when thinking about client relationships which then cut across this idea of blowing a whistle. And for individuals trying to think about well what does a code tell me in relation to such a topic. Very often, not very helpful. So the question here is, what is a code or a key question to consider for the board to consider is what is a code going to say to current debate nationally and internationally about dual use issues? There are issues about transparency, the questions about the dual use potential research if it's a question about some of the sort of mid spectrum Kamm chemical biological is it a about it. There's questions about where are our global discussions going, prohibition of pie yoological weapons. The key question to consider is whether or not the code that's going to be developed here is going to try to, if you like, resolve or further those discussions. Another way of sort of framing that is to ask whether codes, a code is going to be -- going to be developed here as a way to state an agreement that's going to be developed over time or if you like to defer disagreement or is it to set the parameters for the discussion? I think can you see codes along with other ngo's have come out with a code that's trying to move toward something like stake an agreement coming to some accepted conventions about some of these issues of controversy. But it may be that this boy wants to take a sort of path and wants to set some sort of parameters for thinking about the discussion. Either way it's going to be a key question to address. Just to briefly speak about some that we've been doing in the uk. We've done about 25 seminars now, about 600 life science researches in the biology department in the uk. We did this really to promote a kind of conversation about some of these questions about dual issues and some of the discussions that have taken place. And it would be easy to give us a glib summary of those Sam nares. I think it is fair to say that many of the researchers that we've spoken to just to simply haven't engaged with the kinds of dual use issues that have been discussed yesterday. The sort of debate that most people in this room would take for granted about what have you, knowledge of these sorts of debates is not something we found to be very widespread at all in the uk, nor was there widespread knowledge about the international convention dealing with biological weapons, and the main point is that people just aren't engaged in the kinds of discussions that are happening in this room. Another barrier certainly our experience in the uk would suggest a barrier of what are you talking about file to weapons and dual use is certainly going to be one of them that would be experienced in the uk and an experience would suggest that this is a case in the U.S. as well. On the basis of the seminars that Malcolm and I did, we came up with, if you like two types, two very simplified types of scientists and just tried to say, okay, well, which camp of the scientists that we spoke to in so one of those Ideal kind of types we developed with this security conscious researcher knew about some of the issues about biological weapons. Was very at least willing to engage in preproject review, prepublication oversight and so on. If you want to contrast that with a classic open science researcher who thought some of the issues were a bit croarver blown in relation to biological weapons or biological terrorism that the contributions into the event of the life sciences to this problem was negligible and that in many ways be the preproject oversight mechanisms were ill advised. I mean, certainly, if you want to compare those sort of two Ideal types, very sort of simple kind of analysis than most of the people we spoke to were overwhelmingly this sort of classic open science category. Well, all this speaks to the point that was raised several times yesterday about the importance of awareness raising and education. I would certainly concur with those sentiments. I think as well, though, this issue about raising awareness begs lots of questions. In some sense, that's a very easy answer to give. The important raising awareness. When Malcolm and I went around and spoke to researchers, we engaged them in this issue and having raised their awains -- aware bs of it, many were still very dismissive of the concerns being discussed here. So I think you have to go beyond this notion about just raising awareness and ask what is that going to mean in practice? Is that a matter of challenging people's -- challenging researchers' perspective? Is it a matter of just finding out what they are thinking? There are difficult issues that have to be addressed here that I think this consensus that quickly forms around the importance of raising awareness masks a lot of those much more difficult issues. Okay. So on to the last slide then. I've spoke ton some of the initial barriers about if you look a greener code of conduct but all of those initial .s if you like are just part of the first phase about what codes mean and practice. Phillip is in the previous presentation spoke about the importance about thinking about codes and the living document that changes that becomes part of the research community that's taken forward through teaching or what have you. There's all these sorts of issues about implementation, which are very important. In many ways, the conversation that's been had so far about codes internationally is very much in a kind of still a limb stage. So the key question to consider is, is this question about how codes will be taken forward? I think I put down here watch what the ama is doing. As I mentioned at the start of my presentation, the world medical association has come out with a declaration of Washington, which smoke to some of the dual use biological weapons issues. I'm not aware that that's really been taken up anywhere other than in the U.S. but in the U.S., the ama has come up with these declines to prevent the use of biomedical research. What I think is very important about that worveg is that you have an organization, the ama, which is very committed to thinking about codes of conduct in terms of the practice of medics. It has a review process in play to think about what the various guidelines mean for the practice of medics and others. And it speaks to a lot of the dual usage that's considered here. So just to conclude, if you're interested in more information about code, particularly following out some of the international discussions which are actually quite numerous about codes of conduct, there's a web site here for people to visit. But I think there's going to be some key challenges to face in thinking about codes. And just in conclusion, I would highlight the initial barrier I raised, which is what is the problem to which codes are being offered as a solution? And also the importance of this question about awareness and education. I think that should be a topic of considerable discussion. Thank you.
Thank you, Dr. Rappert. I want to thank both you and Dr. Dando for making the trip here for this presentation. I'd like to now ask the people in Dr. Sharp and Dr. Dando and Ron Atlas is also here, I believe. Yeah. To come up and have a panel discussion. I'm sure members of the board and ex officios have questions, which we'd like you to address. So when you ask your question, perhaps is would be aboutest to at least initially define who you're asking the question of. We're open.
Yes. I thank you for the excellent presentations this morning. I'm very much distressed by what appears to be a lack of Coe herance among universities in this country. I can't speak for the uk, as to how we should collectively approach codes of conduct and stimulate discussions and dissell night information about them. I'd like to ask the question of Phil. Phil, have you and/or your cleaves been approached by other universities asking to replicate or proximate the code that you've developed in the biology department at M.I.T.?
We, if you look at nih's guidelines for training graduate students now, those guidelines require a educational program that deals with the topics in many cases not all of the cases most of the topics that I mentioned. And in the last, I'd say, five to ten years, a course of this type has been developed, I believe, at most ufts. Sometimes -- at most universities. Sometimes it is institutionalized university wide. Sometimes it is more departmental specific. The specific contents of this course are available and I have sent them to several people who have asked about M.I.T.'s codes of conduct course, how we're dealing with it. I actually having participated in the course for several years found is T. a very useful thing to do for the students. I think students benefit by raising their awareness of these issues. It's a good practice.
What I was struck by is that it is nationwide. The degree of organization and comprehensiveness was impressive. I wond fer other analysts have experience in their respective institutions with doing this on a uferlt-wide basis and getting con sort yums to work together on thesish b shoes.
I'll make a statement, M.I.T. is an engineering institution and they engineer things.
Touche.
Dr. Sorensen.
Oh, sorry.
We both represent -- [ Inaudible ]
Phil this is a question more yen. The ethical sciences directed at students is a mandate, but I was wondering what's done at your institution to engage, for example, the senior faculty or perhaps what is done to educate incoming junior faculty about the very same issues that are there. You mentioned that you and or we would do the job of teaching this course to graduate students but is there anything else that engages everybody doing research in their department?
Not specifically but as an academic institution, you probably realize as well that once you engage in a given class that spreads through the whole department and he develops from that experience and a conversation that goes on in various laboratory settings. So there's no specific formal instruction offered to faculty at M.I.T., but you can create an environment just by creating the dialogue within the department.
Dr. Dando?
We wouldn't like to leave the impression that the uk is underregulated in the kind of areas that Phillip has been talking about. It's quite clear in fact that the uk life sciences is very heavily regulated and they would know and have to know about things like regulation of animal experimentation and so on. The point we were trying to make is that despite that, despite their knowledge of animal welfare, biosafety or those kinds of issues, they were not aware of the kinds offish b shoes that you have to grapple with. These issues concern with the potential dual use of the life sciences. And I think the same would apply in the U.S.
Dr. Cohen?
Thank you, Dennis. My first question will be directed to Brian but some of the other panelists may want to comment. The question's going to focus on your ideas of how we can bring clarity to this issue or at least shed light rather than more heat. I want to thank and congratulation both presenters this morning. Phil, I think you did a very cogent John of taking a historical basis and debting to the clear need for Brian your taxononmy. The snapshot is what various people are already doing is so we don't reinvent the wheel. My question, my concern is that we're charged with developing a code of some type. How do we make sure in your view that we look through the right end of the binoculars and that we don't get the problem smaller and farther away instead of closer up with greater clarity? There's so many people doing things. There's so much talk, so much history already in the last four or five years. How would you guide us?
Well, I think, I mean, I would have two comments to that. One is the question of where's the guidance going? We spoke yesterday about a lot of the difficulties associated with thinking about these questions about dual use, and there are certainly issues for this board to resort for some satisfaction before any sort of code is talked about elsewhere. What I would say in relation to not wanting to duplicate elsewhere. What I would say would be to reiterate what I said in my presentation. That is that despite the interest in codes out there and despite if you go to the web page and you can go through scores and page after page to biological weapons issues. Despite that, I do see a distinct lack of issues in this area. What is required? I say the thing that's required is leadership. If this panel thinks that a code is a way to go, thinks that it has something that it wants to say in particular about the dual use issues. Then I say take it up here and provide that sort of leadership and I think you would feel a lot of current interest and codes if you like sort of coming with that.
Dr. franz?
Yes, thank you. Brian and Malcolm, thank you for that, and I agree with regard to the point about the taxonomy, that's helpful for me. I haven't really worked with codes that much myself. Your spectrum from a sort of awareness codes to enforceable codes reminded me of areas I had worked in, and specifically in an international context. I find that if I'm involved with the security council resolution or treaty or agreement across a table, there's issues often become contentious whereas if I work on a common problem or public health and basic research we build collaborations and barriers are brought down. I'm just woner -- wondering, and I haven't been involved in Geneva at all this year. I'm wondering if you saw any of that across your spectrum of proposed codes if you are talking about awareness codes. Was it easier to find consensus versus if you talk about regulatory or enforcement -- enforceable codes if that changed sort of the feel in the room.
I think there were people more knowledgeable than me in the audience about what happened at Geneva this time. I think the atmosphere seemed to me to be much better than it had been on the previous two years. It was good, also, in that the structure had changed so that there were many more presentations and involvement from scientists and scientific organizations than as usual in the Geneva meetings. I came away with a feeling that there was a lot of information being put there, and it would take quite a lot of work between the meeting that's just taken place for that to be boiled down into something which is easily assimilated outside of the Geneva context.
Just to add to that to the point the tenor of the discussion for different kinds of codes. I suppose my answer would be not from what I saw. Malcolm and I had one of the other ngo participants aren't always allowed in the room to hear what's being said, so in some sense we have a limited perspective on that, but I think, you know frrks the meeting there was certainly much more common ground than I had originally thought there would be. There was agreement about the importance of various kinds of codes, and certainly one of my worries going in was that people would simply be talking past each other. People would be saying code's a good thing, code's a bad thing but without getting to the nitty-gritty of what they were talking about. That didn't happen. So I do see quite a bit of common basis internationally for the different types of codes. But a point that should be made is that the bwc for this year doesn't have as its mandate to negotiate a code. They are there to form a common agreement about theedz issues. So you know, that -- the development of something is not going to come out of that form this year.
Doctor, I have a related question which is do you have a sense for which type of code tends to be the most effective?
The follow-up question has to be effective of what? And so, if you are talking about questions about education or, you know, are you talking about questions about the regulation of materials in labs, you know, there is a great deal of current legislation in the uk, the U.S. in relation to some of those biosafety, pie yo security issues. Certainly that is there. So really, you know, are codes effective? Effective of what?
I guess I mean in terms of compliance.
I would say that you are talking about changing behavior. Then you are talking about some sort of code of practice. You are talking about wanting to have mechanisms of enforcement. I think if you look at the literature that comes out of engineering, that comes out of business ethics, what it says is that if you don't have the teeth in place and you want to change pee hairve your, you know, code of conduct is just not the way to go about it. If you with nt to engage in a discussion with the life science community or between the life science community and the security community about some of these issues, then, you know, you'd be looking much more something like some sort of code of conduct. It would just try to be used as a resource to promote discussion and debate. You know, organizations can quite usefully develop aspirational codes that at least raise within organizations whole questions about biological weapons or dual use issues. It is a horses of courses kind of issue for that.
I want to add one little question or comment on this, having been at a university and talked a little about this issue, I think there has to be an increase in the awareness of these questions among the students and scientific community as part of what you're doing in the code of conduct. I think you can also easily put in places where there's obvious issues, select agents as questions and control of them. But as T.'s stimulating a dialogue that increases awareness, creating a community where you understand these will get you 99% of the benefit of any code. I think it's a very important part of what needs to be done.
Dr. Dixon.
Yes, I have a question building on that. It's for Dr. Sharp. Thank you very much for your thoughtful, instructive summary. It gets us back to the culture of responsibility. So when you listed the topics of coverage, you included human subjects and animal use. Do you cover recombinant dna at present as an existing regulation or guideline to lead us? And how do you anticipate covering dual use select agents and so forth?
In the topic of responsibility to the public, we talk about recombinant dna ant issues of that type. I would anticipate one would discuss this that context the issue of, you know, biosecurity issues of being aware what dual use policies could possibly mean and how to view it if somebody come as cross it in their professional life. You're training students for, you know, decades of act sieve it -- activities in private sector, public sector as well. You want to give them a sort of fundamental grounding as well as specifics. So you would talk about it in that context.
Represent ofve from the department of state?
Thank you, Mr. chairman. I have, as you know, and has been mentioned by several of the speakers here working to increase the standard of dual use and is spe seeking to develop tools and strategies which will help promote discussion as several of the speakers have mentioned, this year in the pie yoological weapons convention experts meeting, the discussion was on codes of conduct. That was actually something that the U.S. suggested as a suggestion and was an active participate in those sets of discussions. If you had to prioritize where we should go in terms of either enhancing or promoting understanding of dual use and also then sharing it with the international community, what would that be? What would be the best starting point from all of your perspectives?
I'm not -- well, you first? Go ahead.
I guess the real starting point is the dialogue you're having and the dialogue that went on at the bwc and the dialogue that's going on internationally just as your group is being asked to address the questions of codes of conduct world health organizations and similar hold meetings, other groups. The term among ethicists is among ethics talks. What will come out of that will be raised awareness of the issues. That is unlikely to be one prescription for a code I think is clear. On the other hand, as the interacademy panel has suggested there may well be underlying principles which can can be accepted globally which would then allow one to move forward. I think the word that's resonating already in this group that's appropriate is not codes of conduct as much as cultural responsibility. What does it mean? I'm very much captured by that term. I'm also captured by Brian's question, what are you trying to accomplish? Margot summerdall and I stood on the railroad tracks abd put out a code from people to question a few weeks back in science. We began with the premise what we were trying to do is help prevent the life sciences from becoming the death science. That when we talk of dual use research and the potential from this use doing harm that as we see the advance of technology, we see real danger in there. That's the awareeness raising. What do you do in that act to protect the science. We find some very interesting interactions both at the bwc conference and others one group saying the only way this works is to have teeth. We really need it to be set in law and we need to regulate the community. I'd argue that's not the case. I'd argue we need this culture of responsibility when wr we agree and discuss what we collectively need to do to protect science. Again, it really is that fundamental conversation which will lead to the basis for awareness and protection.
Fundamentally, it seems to me that the problem we're facing is how do we prevent a militarization of the whole of biology? How do we prevent this revolution of biology being applied in a major way to warfare and other hostile purposes. You can see how in history how this could happen through the initiation of a series of new offensive state level programs. You can see how this implication spread of biotechnology must increase our concerns about substate groups. Undertaking hostile acts with these kinds of technologies. But underlying all of that, I think the concern that the committee was worrying about was the general advance in life sciences reading to inadvent eartly -- inadvertently giving assistance to pie yo terror or state programs. It seems to me that the code of conduct discussion is part of what the international committee of the red cross calls the web of prevention. That set of integrative policies that we would like to have in place to stop the militarization of biology. It's one small piece of that overall web that we're talking about here. It is necessary for us to understand that piece that we're talking about and to understand how that piece stits in with all of the other range of policies that we're trying to develop. And we have to remember always that this regime this prohibition regime we've got in regard to biological knowledge and materials being misused. This prohibition regime is the weakest by far of the regimes we have for dealing with materials and methods that could be used for production of weapons of mass destruction.
Dr. Osterholm?
Let me turn the question a bit. In the end, our job if we're successful is that it will be a very uneventful next to or 30 years. That to me would be a goal. If we could have that, we would be successful whether it was because of us or in spite of us if it happens and we have no biologic event, that's a successful outcome. Having said that, let me ask kind of a rhetorical but hopefully common sense question that I hope you have an answer that will turn Mae on my head but what I look back at the issue of what it is that codes are for or all about in the history of human kind, we didn't need a code or a set of commandments or cannon or some higher calling to Mack a mother Therese ta I -- Theresa a Mother Teresa. You might argue that a code is a guideline or a road map to help us should we start to stray a bit whether it's out of guilt or conformed compliance or whatever we don't do something. Then there is that group for which in the history of Hume human kind it didn't matter if there was a code. We're willing to do something in spite of or because of. They were governments, they were groups and individuals. I guess the question I have is, is how much are we going to put into this effort from the construct of what you have to argue is motherhood and apple pie. You used to be able to say Chevrolet. I don't think you can say that anymore about what is good and what is right and how much we have to acknowledge. It doesn't mat whear we do on a code. From are going to be those parties that may be the tail that wagged the world not the world in terms of what we do. Thfer, we have to acknowledge that and fipg out what to do with it. Are there examples somewhere whether it's warfare or human rights or other areas of science where there's some evidence that a code or some type of standard had an impact on rogue individuals, rogue groups, rogue countries? I mean, I continue to come back to the bwc and look at the former Soviet union program and realize the sham that that was for so many years even at a government level. Do we have any evidence that we had an impact? And I say that, I hope you tell me that we do because I want very much to find a way to embrace and work hard on this issue, but also, I don't want to do -- I don't want to do something that makes us all feel good. In the end, does it get us that goal of the 20 to 30-year freedom from some kind of attack? If you could enlighten me, I would walk away prt meeting feeling much, much better.
First of all, let's go back to the people who won't do any harm. That was the first group of people and said they don't need a code because they are reasonable people.
I would merely just say they are going to do whether whether coding exists or not. They might exemplify the code.
These are all of the members of the life science community who took such a huge interest in the developments, the state priorities working through the 1990s to streng strengthen the biological weapons convention and all of the good people were taking a great interest, watching what was going on putting information in, working hard to achieve success. Weren't they? They weren't? There was hardly any interest in the scientific community. One thing for the code might have even if it just raise as wareness is to actually engage people in looking at this whole issue and providing the expertise that only scientists can provide into doing something about this. In regard to the people who you worry about and I worry about who won't be restrained by a code, what we have to rely on then is the whole range of other aspects of the web of prevention. Within which the code fits. But the code won't address those people. But other aspects of the code will. Sorry, other aspects of the web seernlly will. If we have good intelligence, we may be able to deal with them in that way. If we have a very good export control system in place, we can prevent the materials and information that they require. If we've got a strong international legal system effectively and implemented in national legislation, universally, we're a good step forward. If we've got solid defense, reasonable, sensible biodefense, that makes it more difficult for them and the international communities absolutely determined to sit on a substate group or state that goes down this path. Then that will do a great deal to per persuade them.
There's other aspects that fit for the other part of the problem. That doesn't mean that the codes can't be a very useful aspect.
I just want to make one additional comment on that. The successful outcome you described I think is totally correct. Certainly that's it and what we were seeking but unless the biomedical community can remain a vibrant community and actually engage in research that will be able to control and influence a biodefense then that rolling possibility is always becomes a much more difficult thoing deal with. We had a responsibility of not only a successful outcome of not having any bioterrorism attack but also the responsibility of maintaining the community so that if that type of activity occurs, we are prepared for it, recognize it and control it.
We have time for two more questions. Dr. duval has been waiting and Dr. Wexroad. That will be all for this session.
I think he's right. There is a significant proportion of the people out there who are not going to be checked by any codes and also not going to be checked by any laws. However there is a large rest of the community can be greatly influenced by codes. That would give you my own experiences. As a physician, I remember taking the Hippocratic oath the day I graduated and I faced enumerable situations where there is no obvious right and wrong, nothing on the book. What do you do? And a lot of the discussions with my fellow fitions have always begun with the three words, do no harm. That provides a mechanism by which you can begin to discuss it within the context of something that has a long history in humanity and I will point out even the Hippocratic oath has been amended over and over again. So codes, in fact, have to be living documents. It can be amended to deal with new problems as they arise. But as someone who's been in the trenches and face difficult decisions, that sense of humanity, those three words do no harm has help immediate tremendously.
Thank you. Dr. Rexrove?
Yes, to Brian. It strikes me that a code of conduct is best when it's organic to the values of the humanities espousing that. My question is, from your point of view, is there a community that exists or many we need to speak to? What is the likelihood of the success of the code of conduct that comes out of a, you know, life sciences is very wrought. It comes out of a group such as this as opposed to the option of providing again as others have chose ton do principles so more readily identifiable communities can provide codes of conduct.
Your first point, this is the difficulty. We're not talking about a life science community. We're talking about lots of different communities. And of course relevant to this topic is not just the life sciences but a lot of other everything here toking professions that's been mentioned yesterday. It is a thorny issue that there's no way of getting around it, and as I said in my presentation, I can't see, you know, a single, if you like organization form, what have you that's stood up and said okay, we'll take this issue on or that if you like had the scope to cover the range of communities that need to be addressed. So in terms of your comment about, you know, what can NSABB do, well NSABB can do what it has power to do. I would just go back to the points I made that, you know, there needs to be that -- there needs to be a development of code. There needs to be an implementation if this is seen as a serious topic and a way for it. And there's no perfect sort of solution to what's going to do that. If you watch, you should do that.
Dr. Dando, you have the last word.
Just to say that you may have some very good allies very close to you in the American medical association, and some of the thinking they've been doing in regard to codes for physician researchers. Seems to me to get to some of the really interesting and awkward questions that you are going to have to confront.
I'd like to thank our panel for a very, very interesting and challenging discussion. We're going to mrve on to the fourth session. This is the session where we're going to discuss topics of international perspectives pertaining to dual use research, and the scientific community is truly an international body. NSABB is charged with recommending strategies for coordinated international oversite of dual use biologic research. Miss Shana Dale is here to provide us with a brief overview of some of the recent international discussions of dual use dilemma in which she has participated in the last several months. Miss Dale is the chief of staff and general counsel of the office of science and technology policy in the executive office of the President. Miss Dale?
Thank you for the opportunity to come and speak to you today. For today's discussion, I plan to put the balance between science and security in a historical context leading up to today's development. In 1947, a report from the President's scientific research board emphasized the need to maintain an environment of free inquiry. And that security regulations should not attempt to cover basic principles of fundamental knowledge. Similar statements continued in 1949 in a report from the triple as committee on civil lifls for scientists. In 1950, saw the house on American activities committee, the McCarthy era and also the period known as duck and cover drills in schools. In the 19380s -- 1980s, the U.S. continued to be concerned about the Soviet threat and fears included loss of militarily significant technology, loss of technological leadership and know how and loss of industrial competitiveness. Universities were seen as targets and points of leakage of technology. In 1982, the Corson panel issued the report scientific communication and national security. Noting in particular that restricting international scientific commune caights would necessarily disrupt domestic scientific communication. In 1984, ostp convened a dod working group to grapple with thish b shoes flowing from the recent climate that seemed to inhibit the free flow of science and the group laid out principles to guide us toward a more open scientific environment, including the fourth bullet here, benefits of open publications far outweigh the risks. And 1985, nsdd189 was issued by Ronald Reagan. It states it's the policy of this administration but to the maximum extent possible, the products of fundamental research remain unrestricted and that if there is a need for control that it would be classification. Each federal government agency is charged with determining whether classification is appropriate prior to at ward and also periodically reviewing all research grants, contracts or cooperative agreements for proper classification. This leaves it up to the concerns today post 9/11. National security advisor rice reaffirmed fdd189 in November of 2001, explicitly stating in her letter, the policy on the transfer of scientific, technical and engineering information set forth in nsdd189 shall remain in effect. Dr. Marburger has sense reaffirmed nsdd189. The policy laid out in nsdd189 is extremely important especially in the context of post 9/11. As you know, dual use research refers to the potential of certain life sciences research to be used for both positive and negative purposes. For those of us who straddle both the homeland and national security sciences and communities, the goal is to enhance biosecurity while minimizing undue impact from the free flow of science. Since 9/11 and the Anthrax attacks upon the United States, many other countries have begun to examine the potential threats posed to their country by the use of pie yoological weapons. These discussions have all prompted the discussion of where dual use life sciences research fits into the discussion of international biosecurity efforts. Several organizations have sponsored conferences and symposium to address that surrounding the continuing advancements and dual use technologies. Just a few of those conference -- conferences are listed here and many reports are available on their individual web sites. These meetings have surfaced many of the same types of concerns and issues. The first being what is the threat to my country. Although not overtly articulated at some of the international meetings I've been to, there appears to be a feeling at least with some of the countries that this is a U.S. problem and not necessarily for them. All meetings are concurring with some basic themes. The support and cooperation of the international science is confirmed with being integral with the process of describing a path forward towards international bioscriewrt effort. Defining the risk associated with the dual use nature of bioscience was universally acknowledged as conceptually difficult and difficult to quantify. The availability of known dangerous pathogens has always been evident but in the age of genomic genetic engineering resources, the risk profile has become much more difficult to define. Restricting access to pie yo almost -- biological material is one solution. This creates new challenges in the form of possible impediments to the future advancement of science. Biotechnology per say does not prevent a risk with knowledge but that it presents a new potential for misuse of bioscience as evidence. Distinction was made between access to known harmful pathogens and access to other biological material, techniques and information. Many of which emerged from pie yo technology and have the potential to be used for harm. The value of having broad representation from the key communities was clear. And discussions characterizing the multifaceted threat drawn from different perspectives around the international community, including the threats of public health, plant and to animal, the food security and also economic stability. Discussions acknowledge that not only neck Nickally advances and also geo political changes. The global reach of the scientific community transcends national boundaries and wider availability has greatly diminished controls over the use of technology. And reconciling an open research environment with the threat of misuse of bioscience, a number of key concerns were identified. A need to understand the real as well as perceived threat to each nation and region, a need to establish a common international understanding of key terminology was emphasized. Participants had uses of the interprets of pie yo safety and pie yo security. It's been noted that in some languages there was a single word that encompasses French and Italian. Discussions also highlighted the need for increased awareness among researchers of both biosafety and pie yo security. In the context of encouraging responsible stewwardship and a security conscious among scientists. A need for increasing awareness raising was stressed. Discussions raised the need for codes of conduct and for registration and personnel. A need for a balanced approach was deemed essential and assuring public and political confidence that the risks were being correctly identified. The series of slides detailed some of the international pie yo security efforts underway. In September in 2004,55 aroundants were selected public research information, scientific publishing field and gathered from Italy for three days to discuss the promotion of responsible stewwardship for the pie yo sciences. Asking see here, these are the four sessions that we attended. To if a facilitate these types of actions, a small scale working group can be organized by oecd's international futures program, together key players in the stake holder communities. The general mandate of this working group could be to identify and document common concerns regarding the oversite of pie yo sciences research at its different stages. Develop a common vocabulary concerning the new securityish b shoes facing society, particularly in relation to biosciences research to help broker and integrate the concerns of the constituent stake holder communities into the development of codes of conduct and the mechanisms to ensure their operability. To facilitate the minimum standards for codes of conduct among the science communities. And to help develop criteria and relevant processes to render codes and other oversight tools particularly in the international context. A fist concrete step is the inven Torying of all efforts. Governments, associations or industry groups are discussing the formula and different approaches to biosecurity. It needs to include policy as well as legal approaches. The overview should detail specific tools being used to address problems. Ideally, a small working group could be formed to review and assess the inventory and provide guidance on further work. In particular, the group could focus on measures that have been implemented looking at what has worked and under what conditions. These first efforts would provide the basis for a gap analysis of current particularly at the international level. On the second point, there is ample scope to facilitate further action at the international level in the area of development scientific codes of conduct. Several codes are currently being developed at different levels with an industry at the scientific association level at the level of inner academy panel and even within some governments. These are being done independently and are in different time frames addressing different constituencies. This chart actually shows the web site from oecd that is now up and running. It allows you to click on different areas of the world and this is what you click on North America. And if you further click on the country say Canada, you can see who's working on the particular issues what conferences and other events are upcome tion and what type of legislation has either been passed or is pending. The academy panel on international issues, the interacademy and the national academy of sciences of the United States posted the inter-- hosted the international forum in march, 2005 in Italy. It seem tobz a recurring theme with these conferences occurring in Italy. It was by invitation only and the participants attended as individuals and not in their official capacity. People came from Senegal, Monday goal yarks uk, Brazil, Canada, Belgium, Australia, the U.S. and several other countries. The forum grew out of recommendations from a 2003 report in the age of terrorism research and the so called stink report. The recommendations called for Harmonized international oversight. Specifically the recommendation stated we recommend that the international policymaking and scientific communities create an international forum on biosecurity to develop and promote Harmonized national, regional and international measures that would provide a counterpart to the system we recommend for the United States. Upon the format of this particular -- I found the format to be very productive as we broke into small groups and conducted parallel sessions, the first being guidelines and prince principles for professional conduct including codes of conduct. The second, dissemination of research results including publication and the third oversight of research including formal regulation and self governance. As agreed upon in 200 2, there have been a series of expert beatings that you heard about in relation to bwc the last occurring June 24th of this year. The meetings have provided an opportunity for international experted on potential weapons of activity to meet and raise awareness about the need for each country to take steps to ensure pie yo security. The meetings also facilitated die yo logs. Participation included many agencies from the U.S. Government from the U.S. ngo community to many here as well as government participants. These are the countries that were listed on the program. Many more countries participated international foreign ngo's and also pharmaceutical representations. The issues agreed to were consensus issues include a need to heighten awareness and life sciences research and dual use applications. The codes are useful to educate and promote responsible bee haiive your that codes can facilitate compliance with the bwc and countries are already developing their own codes to advise regulatory bodies. A need to involve the scientific community and developing and implementing codes and the need to balance transPerrin si and security. Controversial issues discussed if he last minute include the idea of obligatory codes of conduct for all sciences. Mandatory and multi-chaired review of all dual use experiments including international review committee, codes of conduct applicable to industry, registration or licensing of scientists and universal codes verp sus national codes. In conclusion, I'd like to say that progress is being made. Oecd's web site will be very useful. As will efforts to analyze the data collected in order to make judgments about gaps and successes. The experts meeting of the bwc showed there's been significant progress in raising awareness of sharing information on individual countries, activities. The need continues for more dialogue, awareness of the issues and sharing of ideas of how individual countries are dealing with these issues. Obstacles remain. Many countries believe that these activities are a waste of money that does not encampus a -- encompass a substantial threat. Why invest in security at securities containing bioagents. Many countries have expressed resistance to a concept of code of conduct and other countries expressed resistance to any type of oversight over scientific publication. The goal should be encouragement of national, regional codes of conduct and approaches to review of scientific publication. On a parting note, I would like to thank this board, the work is incredibly important. These are difficult issues that you need to provide guidance on. The time is now and I hope that you share our urgency in getting the work done within the ns -- within the NSABB. Good luck and we think you for your willingness to serve on this board.
Thank you, miss Dale. If you want to stay there just a minute or two. There may be some questions. We have a few minutes if there are questions for you from the board.
Shana, on the last conference you had in Italy, with were there findings in that? Was it published? Is there information available?
I don't think we actually published this pause the people that came to the Cuomo, Italy meeting were there this their personal capacity and it was not -- we were not there as official representatives. I think for the people that went to this meeting, I know particular people sitting in the audience today, and I was in the first session, and we have a couple people in the audience that were this the second and third session. You know, we'd be happy to detail some of the discussions that went on in the individual sessions.
Dr. Ruben?
Miss Dale, it seems like you have a daunting job being the chief counsel in the White House on these scientific issues. Not speaking for the entire scientific community, but it's very clear there are a number of very divisive issues where the scientific community has one set of thoughts, you know, stem cells, global warming, nuclear ground penetrating devices, all sorts of qowt unquote scientific issues that members of the scientific community have very strong feelings about yet there seems to be some disconnect at the higher levels of government. I was hoping could you understand some of the processes that the White House uses to adjudicate some of the more contentious issues. If we do make some recommendations as a board representing some of the scientific community, how will that be processed?
Well, I can tell you the way that we engage in policymaking process in the White House is typically through policy coordinating committees. Majerle for ostp through our national science and technology council. That is a cabinet level council chaired by the President. Historically, we don't call meetings at that level. The President's science advisor actually manages the date to day operations of nstc through the ostp and we are broken out into four different committees, science, technology, environment and also homeland and national security. Within those committees, we have various subcommittees that grap well sigh en-- grapple with scientific communities throughout the government. That's the way in which we actually deal with issues, science and technology throughout the federal government that bubble up. A lot of the shoes that -- a lot of the issues that withwill be discussing touch upon the processes of the homeland security council. We are very closely linked with the homeland security council as well as the national security council. Being completely involved in their policymaking processes. So that's the way that it moves up through the system. Assistant secretary levels usually rising up to the deputies committee level and principles committee with the President. Or the President's science advisor for issues that touch upon science and technology, he is usually at the meetings with the President, and that's his opportunity to provide factual information on science and technology. Wetry to shy away from getting into any other areas beyond just what is factually correct because we want to maintain our -- maintain our credibility both within the White House to be honest brokers and also within the outside community. For the work that you are doing, as I said, it's critically, critically important, and we are very interested to see the nsabb move out expeditiously because we have all been waiting for guidance from the body on what we should be pursuing in terms of codes of conduct and what should be set up in terms of actually expanding committees, et cetera. So we're very receptive to the work of this board and we're very excited that this is the first meeting and very enthusiastic about the progress ses that you will be able to make.
Shana, over the course of these international meetings, have you sensed any Ken netic change in overseas beliefs in awareness of the dual use issue?
I would say in the meetings that I have attended, I felt a certain amount of frustration that were not moving a little bit quicker than I would like to see, and that's, you know how we like to move out quickly in the United States. The meeting I attended in September of 23004 and then the meeting that I attended in march of 2005, there are individual countries that are very interested in these issues and they are moving forward and doing their own work. There are other countries as I expressed that have reservations about what the real threat is. They have concerns that the United States is spending way too much money and is overblown the proportion of this problem. I am heartened by the discussions that I have heard coming out of bwc. It sounds like a very good dialogue and interested in tracking efforts in terms of developmental codes of conduct. Obviously, I wasn't there but that sounds like it was more promising.
Thank you, miss Dale. We're go fog take a 20-minute break. When we return, our final session will begin which will cover biosecurity issues surrounding chemical synthesis of bacterial and viral genomes. [ Break taken for 230 minutes -- for 20 minutes .] this is a test. .
Before we start the session, I wanted to take the opportunity to Dr. Ann vit var who is president of at the university of Nebraska she is joining us as a member of the committee.Welcome, Dr. Vit var.We going to begin the session.This is rapidly an accelerated technology in the area of recombinant DNA and and has applications are enormous and because of the applications, it really has raised all the issues that this committee is facing.These advances in the field though, we have had tremendous benefit to Life Sciences, medicine and industry and will continue to do so.There is, however, a that technology could be used in the synthesis of pathogens or genes from pathogens which are toxins and could be used for malevolent purposes.We are pleased to have an outstanding panel of speakers to update us on what the state of the art of what this field is.And the be Dr. Craig Venter, and he is going to speak on the state of gene synthesis technology.He is founder of the J. Venter institute and science foundation and founder of the infie tiewt for genomic and also a member of the academy of sciences.Welcome, Dr. Venter.
Thank you very much, Mr. Chairman.Pleased to be asked to give an update on science.I going to talk about reading and writing for genetic code and one of the key messages as we wouldn't begin to be able to write it without all the information we are getting from reading it.So 10 years ago this month when we published the first genome of influenza and seen a tremendous escalation in just a short period of 10 years of literally hundreds of microbial genomes and plants and animals and insects and humans etcetera and this is growing exponentially as we go forward.As we look at the my crow beel world--microbial world, it is each million low liter has a million bacteria in over 10 viruses some of you heard about the expedition or tour he expedition where we are taking samples and and our initial data was out at sea published one out of 3 new genes last April and maybe the 40,000 new microbial species.These are bacterial we we haven't dealt with the populations yet.Soon the next ib stallment will be up to the gallon lap ghost and I will show you the data.It is changed quite dramatically.The first funded genomes project took over 13 years to do at tiger and we reduced that to four months.We now reduced it to two hours and that is still changing dramatically as we get new D M A sequencing technologies using the four X four systems which is the applied bio systems genomes.So this is some of the data off of this where from a single machine get 200 base pairs a day with 37, 30s we have 100 of those and they do a lot of accumulation.Gordon and betfy Moore foundation gave us a $9 grant to sequence 130 microbial genomes so gone from one genomes in 13 years to 130 in one year as a side project to our main efforts of sequencing.These samples are from around the globe and follow a lot of the tracks that we are doing on the expedition.We have also with a from the Sloan foundation started the aero genomes project where we seeing and viruses captured from the top of a building in York City and Washington and we are treating them the same way.What you are breathing right now, lot of micro organisms.We don't think any of them are synthetic yet. through the GALAPOGOS, we have 3 new genes from some untold maybe over 100,000 bacterial species and maybe 10 times that we are starting to look at.We try to get a comprehensive view of whole earth gene catalog and look into 29 O RPHS.There are between 40 and 50,000.But the most important message here is if we take a new sample from the environment from soil or from the ocean, the number of new gene families is growing at a linear weight.There is no saturation confirming that know a small portion of biology.Namely microbial biology.Synthetic genomes is the construction of genomes from chemical components.We are more cop copying biology right now than new biology.In this project originated from the second genomes that was sequenced.And the second speakers are for more on the topic.We are consumers and suppliers but DNA synthesis has grown to the same pace that the ability to read the genetic the following speakers are two of the leaders who make it grow quite substantially.It is a difference between making a sin these sized and nuke lied in larger units that is changing quite dramatically.This is micro plaza again tall and it is one that grows by itself in culture.We have now since 1997 been trying to work out a minimal gene set.This came from simple questions in biology.It had genes.Micro plas Mchad 500.We asked the question can a species survive with a smaller number of genes.We spent lots of name on insertions and knocking genes out but they knocked them out one at a time.It became clear as far back as '97 and '98.That probably the only way to understand a minimal genomes is to synthesize one because we couldn't do knockouts.We got a different set of answers when we did this, it is with different genes knocked out can survive in populations.When we clone them out as individual cells with a gene knockout.We get a different answer of which genes are actually essential for life.So with all these conflicting answers we decided the only way to is actually go forward and build the genomes and we have sequenced or accumulated the genomes from 1300 micro plasmas and compared them and looking at how they overlap we have come up with a corset of genes.There is a roughly 173 common to all these species.We are absolutely certain they will not sustain life.If we eliminate one parasite goes up to 220 and the expanded set is on the order of -- 310 genes of the 36, they are nonessential as single geeps and we are able to knock them out.But what we don't know is whether something can compensate for nungs and also the definition of essential is very circumstantial.For example, there is genes that code for trance porters for glucose and truck toast in this organism.If you only have glucose, it makes it look like a nonexception.If look at glucose and friewk TOSE, you would knockout and conclude it was an essential gene.So we decided all of biology at the gene level is context tour ral based on what we have the environment so it is not sufficient to define any species or any genomes.In view of how we construct things we would build things I would view how they were built in nature and that we put the cast sets together so we can vary them and the challenge to even make them accurate cassette early on.This is worked on with my colleagues ham Smith and Mr. Hutchinson that enabled us to rapidly synthesize a K five B or so cassette which we tested with the 174 genome.It was excited taking the DNA and injecting it into chole and watch it make parl caves.This is a cartoon of the structural of fie X fie X and it builds its own.It has lots of implications if we could the operating systems in cell to design and build a hardware.So where are we as we switch from read tog writing?And this is the same information I gave before a senate testimony a couple of weeks ago.It is actually clear to me that any sequence viral genome including any genomes can be made today.If we don't treat that as a scientific fact we are making a grave error.It important to keep in mind though that the DNA from a large number of seesh shes such as E bowl la pox is not ineffective and won't buy anybody anything. The fear of new designer viruses is at least a decade away if it will ever come to pass.Because understanding the first principles of viral ineffectiveity is such a long way away and it is only through state sponsorship in the U.S. and former Soviet union where there are massive programs to design and develop new agents so it is unlikely the field will continue to develop.We are certain procure yacht genomes will be sizeable in two years and possibly genomes within a decade.We are building things in cassette basis but how do you put all the fragments together are building a system of rebottom bin nation based on the organism that can take millions of rads of radiation.Its chromosomes get blown apart and stitches them back together in 24 hours.If you look at the top part of this, is at 1.75 million-rads of radiation.The bottom is 24 hours later, the chromosome is back together again.Our genomes in our systems don't work that way but there is a very large number of species resistant to radiation because have this capability.We are isolating all the come components for this and trying to do it in vitro and and we think this will yield a new field that we are calling common tutorial genomics.We think thousands of cast sets and genomes could potentially be made per day.This would allow for selection by screening basically what ever question you ask, you could screen for.Whether it is producing a specific chemical or just cellular viability, what leads to life and hydrogen production and etcetera.Right now we are starting with genomes plantation and putting new chromosomes into those to see if the new operating system will support life and I said I expect that is within a couple of years.Well, some people like to take their imaginations in dangerous directions.We like to take ours in constructive roots and we think synthetic cells have the power to transform the world's industries.Do something as C.O. two capture and look at the third genome it was lieu that, which lives in boiling water temperatures.It captures C.O. two from the environment and that C.O. 2 is the carbon.There is probable tens thousands or more organisms the that have those type of capabilities.We can combine synthetic cells or mixed cultures to produce things like polymer sugar or proteins or infect C.O. 2.They capture and off carbon Monday and water producing hydrogen and okz oxygen so there is a variety of things in terms of the environment and energy that we think tremendous capability, ham Smith and I have a grant from the Department of Energy to take the energy from sunlight and switch it directly into hydrogen production and we hope to have progress over the next or that area.We trying to modify cell lieu lace sis and confirm them with fermentation and modify genomes and they could have potential for the he have fan knoll production.These are benefits of the synthetic genomics.Understanding the first principles of biology are going to try on come from sign they size cells.We didn't truly under dem mystery until we went to building the molecules.This is the next face in understanding biology.We talk about energy production, vaccine production, new materials, etcetera.I think these species could potentially replace much of what we call the petrol chemical industry and maybe sources of food.Hopefully a source of energy and bio remadeiation and the question is how to proceed with this area.Back in 1998 before proceeding with any experiments over than the knockout experiments we paid out of the foundation an ethical policy review at the university of Pennsylvania and trying to review whether it was reasonable for us to proceed with making the first synthetic spesh shes, results of that were published in science in 1999 along with the first genome paper and I think it to the scientific community and I hate to see them set by a regulatory agency and I think the recent announcement we had of a policy group published supported by the Sloan foundation is a step for the scientific community to move in this direction.We trying to lead the way as we go forward by good stewardship in the laboratory.We are taking to we don't think are necessary or should required but we have a P three that be building any genomes in.We don't think human pathogens should be taking place at this stage.Organisms with recombinant DNA so they can't survive outside the laboratory much we know from every goaj we have done how to do self evolution in the and think this session, this community is important in terms of open communication both with science and nonscience communities and I think we have tremendous opportunity for doing good.I mention the medical ba toast study in 1999 and the ongoing study with the Homeland Security program at the center for strategic studies the biology group at M I T and possible agreed man's program at your institute.Thank you much.
Thank you, Dr. Venter.Next we are going to hear from another pioneer in genetic research.I am pleased to introduce Dr. George church.He is professor of genetics at Harvard School and Lipper center for computational genetics.He will speak of risks and benefits of synthetic biology.
Have the first slide, please.So, thank you, what I am hoping to present as tech knowledge cal view is a small piece of the problem here.And also the social fabric that we have been about bit.Where the rewards might actually address partially the risk as well.And I think to do this, we need to consider sequencing synthesis in systems and I have just where I have been to get to here is in 1974, the code.This is not a conduct code.But the computer code meaning jet net particular -- genetic code.It is responsible for decoding R.N. A and proteins.In 84, I have made acquaintance with the Department of Energy which was a wonderful paper on again Nome Mcsecond quebsing and early genomes project grant and some of the companies have been a very good experience.H pie lore rye was commercial later and fused part of the fuse with adjunct court and they are part of the team for human and subsequent genomes.It is an exercise in cooperation with the government and then more recently synthetic biology which is what I will mainly talk about.My group and many others have been at the intersection of these three exponential technologies is computational and analytic.And this is a plot.You can see the slope might be changing.Recently upward and this is the reason we worry about, we call the destructive technologies for more reasons than one.And what is, how does this play in terms of we can see examples where code of ethics may not have had a big impact.Where the roads we were talking about in previous sessions will do this and can we minimize this sort of risk and below it are the things we discover and engineer in the laboratory.Presumably following the code of ethics but are enabling and we need to deal with those as well.It will suggest in ways of dealing with it.Some of it various representatives of synthetic biology community and I have conferred and there is this link down at the bottom down at the slide for a particular proposal for monitoring synthetic and I think John Mulligan who will be next will talk about this some more.But in particular, we need to extend the very good recombinant DNA starts and need to extend them so we have code of ethics and surveillance and ideally automated surveillance.They can monitor things that will be more comprehensive.It is a piece of the puzzle but very important one.The instruments, even though they seem to be getting cheaper and pro pro live prolific.-- this is something feasible to more tralized and more suitable for surveillance and if it becomes uneconomical then this might be beneficial.Sort of he had cition educational is our control in the lower right, you see, news item in 1977 on a recipe literally for weaponization of botulism and you can see innocent competitions if they are given war like attitude for the younger generation, this is certainly not what we are trying to encourage for synthetic biology where the stakes are higher and we talked about the code of ethics in engineering societies which doesn't necessarily effect the rogues if have a way of providing for the meetings with past treen knees and this is suggested to me by a number of people.And I think it is really code of he ethics to monitoring where people are going with their research.Our weather map in the upper right, this is literally a satellite image monitoring one of our organisms for what we the funding to study.But we also as with Craig, our interest in developing technology to monitor airborne and medical fluids as broadly as the technology cost will allow.We are heavily focused on bringing down the cost of analysis and I just the previous slide was about licensing and monitoring the supply chain while synthetic nuclear tides have become fewer and fewer manufacturerss of instruments are actually going into the business.Some are leaving the business like ADI which is one the first ones for having low impact on research but still high surveillance.I think that's a win-win situation.We would like to be able, we are, our team is working on improving vaccines and bio synthetic drugs and I will give you examples in a moment and this is going in increasing level of difficulty as we go down set of bullets.It is possible to imagine making cells resist at resistant to most viruses getting back to that genetic code.I give an example of that that is fairly near at hand for the case.So safer biology versus synthetic biology, computation Al systems biology can be increasingly invoked especially if people writing grants and papers phrase their proposals and their success stories in terms that are machine readable.Not human readable.That is a profound change that will be occurring and hopefully help some of the outcomes of this committee to model.In the future.Inthet particular biology is increasing capable of making sensors by protein design has gotten much better and our colleagues Dave and so forth and regulators are straightforward.We we would like to have higher fidelity gene replacement.I give you example.Metabolic dependencies is used in recombinant DNA and it will be even more valuable as we go into synthetic genomics and codes or methods can be and are being engineered into some of our cells.Here is some examples. The top one, we are in the process of implementing and second one is more speculative.So the idea is to change the genetic code.First change the 313 U A G stop code which is a favorite for a variety variety of purposes for Amber suppression and then that will allow us to delete the R F 1 which competes with good for amino acid and Peter Schultz and a.m. bricks company used to modify human growth hormone.It is a $2 so it has a higher survival but in order to produce the large quantities it is to get rid of the factor and stop code on.And then you can, there are other plans down below actually remove some of the code ons or switch them.Important thing being, these have positive uses.One is for engineering proteins and the other is for making isolating genomes so that nothing can go, no piece of DNA can go in or come out in a functional way.We want to be able to engineer these DNA and R.N. A elements.This is an antimal layerial drug which they think can be made more officially than E.coli and harvesting plants and many other examples like that.Many of our drugs can come and motfied sin thetally and we would like to be able to go in and change code-ons.Genomes wide is one example but do it gene by gene and move it between organisms and very important to adapt them for high level and making model mouse models that are closer to human reactions as might be of importance to this committee.So, it is wide change TKPW*DZ, we are not going to take this lightly.But the genetic code arguments I have been making already in safety. We make the genome more stable.Less likely to evolve and enhance recome bin nation.How do we do this.Make up to 10 mega pairs on a dollars chip by a varietyive of methods which we had wonderful interaction with most of these companies.The idea is that you get an image on to a glass or micro chip fabricated.Just like this project tore is projecting on the screen. You can project it on to a chip and make it.You can have the equivalent of two genomes or plasma genomes on a dollars chip.This is thousand dollars cheaper than any other way currently available.There are three papers that, Joe Jacobsen's group and Paul's group joined together with us in improving the accuracy from sort of on chips.It is about 1% and you can get this back up that is better than the P C R sort of error rates of one in 100,000.We have not put every piece of this together and assemble it pipeline yet, from the chips in the previous slides but we have greatly improved by of magnitude the aerate and we arle continuing to do that.
This carries to 1986 up with a PCR paper and other progress in 199 and all we did was add some computer design and multi flexing but the idea is to extend a nuclear type of the chips on to each other, eventually extending in vitro to 15 K B range which we published in nature and those you can trim back the end and have them up to the K B rank which is a relatively small piece of DNA to introduce into E.coli and people put in more than 300 basis.E.coli genomes is 500 pairs on the right there and the last steps because it is hard to handle large DNA on the five mega baits scale.We do the last steps and that's an automated process that they have done in the group and we start with one pool which is of a chip.And that goes into 480 pools and then it drops down to 48 48 which drops down to one.And the three ways that we are pursuing putting these together are fairly early technology development stages here.We can put in the 48 constructs serially one at a which takes a statement or higher ark cal stage where we can put them in using two and then four and it is dropping it from 48 strains from 24 to 12 and down to one. There is a highly multi flex possibility for which one stage. is the, not data.Just, you know, I am, where we made a 14 killly base construct of 21 genes from E.coli and we in the process we did them both in the orm form and by code on remapping where they could express on higher levels where they could change the usage.We quite enamored with all the things you could do with code on remapping and we wanted to make them safer not only by changing but metabolic dependency.We made metabolic dependencies and determine thousand they could cooperate with one another and rescue one another and how they would evolve and then monitoring possible escape mes.Here is one where we evolved them from one hour doubling time and two hour.And with the yellow arrow, it is one the points we have been anal loizing in great detail.Where we could involve the strains that have escaped.It is a selection or resistance and this new sequencing method is intended to be easily distributed using standard equipment, using a standard microscope.Albeit automated with computer read out and it is standard equipment and many laboratories will ride now and it can be done in vitro so it doesn't have the problems with cloning and so forth.And so it is also capable of doing single molecule detection which you see in a moment.We have seen already a 30 fold improvement in cost.It is a greater improvement than in speed and the important thing is cost not speed.And the accuracies are extremely high and there is the hundred thousand fold improvement that I think is fairly easy to imagine without any real changes in technology.Just use tg more effectively in how the camera is pictures.Things like that.So this is important.Because not only do we use sequencing for the synthetic to determine what we did sin thetally.For the strain how it evolved and monitoring the environment for viruses and bacteria such as Craig has mentioned, this is just kind of an academic summary slide of how we have been sequencing strain of E.coli we engineered and how it evolved showing that we discovered things and we have a very high accuracy on the order of better than 10 to the minus 6.This is very important for many applications for sequencing and sequencing humans and the last slide that we it single molecules.It is very sensitive.You want to do environmental monitoring.You want every molecule and there are many possibilities here because of T R's molecule is in its P C R tube without competing with the other ones and there are no crossovers and it is as large as 100 megabaits where we are sampling the points along them.In this is the slide I earlier have these options where we can do, I would love see us doing more bio weather map, our citizens should be interested in what biology is swirling around them as low pressure fronts are swirling in and that could be done with both airborne fluids with very low cost and low impact on researchers any way and even impact if by surveying the bio chain supply.For example nuclear tides and the machines and chemicals that are required to do that.You get idea of intent.If somebody tries to hide the synthetic research, then you have some indication of intent and you just code of ethics and combined with surveillance can help reveal the attempts to be surrepetitious and I mentioned bio synthetic drugs and how many vaccines can an handle at one time is a very interesting immune logical one with the code on changes in E E.coli and other species of agricultural whereby yo terrorists could act or possiblebly to human stem cells in the future.But we could test out these ideas in E.coli.So, I that's it.Thank you.
Thanks, Dr. Church.The next speaker is Dr. John Mulligan is president and CEO of Blue Biotechnology.He is going to share his perspective on the issue of potential misuse of genome, synthetic genomics and how it impacts on the science industry.
Okay.Well, thanks for inviting me today.So, I wanted to make really three main points about the regulation of DNA synthesis.Some these have been covered clearly by earlier speakers.DNA manipulations the heart of modern biology. that impacts the ability to impact DNA impacts all the R&D capacity.Our view is that the current regulations that involve select agents and sequences select agents some improvement that is lack of clarity and specificity and the other main point I wanted to make today, I believe the good choice insist regulation can enhance the retionlation of knew diseases by strengthening our and maintaining our R&D capacity and the other point is that I think good regulatory choices in this country are likely to be followed by other countries.So, our company Blue Biotechnology is a synthesis company.We give the customers a website.They pace into the website and we clone it and verify the sequence and ship the clone and in a few weeks back to the customer.Today, almost all of our customers are conventional bio medical researchers and pharmaceutical companies, biotech Nick Al company, universities and government labs and one of the key points is that they are using this technology to substitute for other standard techniques.Not using it because it is faster and cheaper.Gene access to gene synthesis activity increases the R&D process. Saves researchers and money and the cost to decline.In farther to technology like George described and having complete control the DNA sequence.Having to be able to design the sequence and improve and experimental design and allow experimental approaches and we believe synthesis can help to speed the responses to new diseases and one of the perspectives that I have been thinking about.Regulation of the technology.By way, I wanted to say myself a traditional open source biologist but feel like one who is interested in the biowarfare and knowledgeable about the you know, dangerous potentials.There is not necessarily a complete contrast being interested in open standard bio science approaches ignore yant -- ignorant to the dangers.Why is the range of the technology important.Molecular and disbret net particular is and this is iewb bik quit tus and billions of dollars are spend on DNA each year.There is close to a dollars spent on the reagents that are used directly to manipulate DNA.Enzymes.Cells the direct cost annoying are in NIH are in the spending and probably represents three to five cost.So there are huge efforts spent and tools to improve the speed of R&D could be critical to responses to new diseases.We see that increasing our ability and this disbursed ability to create the DNA molecules we need for research is important.I believe that serious incompetence affecttious diseases, pandemics are likely to rise from nature.Regardless of the efforts, from they have efforts.There is an ekeial and perhaps threat in the decade.So it is important, even if we stopped all biological R&D we are still going to have dangerous new diseases arise in the next few decades.The technology that we provide does have a direct impact op infectious disease research.They need the research from pathogen to develop knew therapeutics and some and perhaps most pathogens, all viral pathogens within the range of today's technology and maybe not completely unaltered but they could be made and we expect that one or more genomes will be synthesized so they have fairous uses are possible.And am many people pointed out.Direct isolation is of the same pathogens and easier to acquire them today.Our company is focused with the regulations.As government approval is required to possess or distribute certain pathogens and pathogen genes.What we do to comply with the regulation assist to screen all orders we receive from database from select agents and then we review every sequence that resembles a select gene and do a detailed analysis of genes to determine if they are covered by the regulations.So the current regulations, the select agent regulations require some interpretation.Many genes from select agents are not dangerous and are not controlled.Many genes from Seth agents resemble harmless genes and use nonfunctional parts of the genes.Viral proteins, fragments of tokz toxins and things like that.To give you an example, to see what we see when we anal loiz analyze the sequences.It matches about 30% of the toxin protein.If it matched the whole it would be covered by the rules.We found the suggested that this domain was very useful vaccine development and that was consistent with the group that ordered it.We decided to build that chain and we find geeps that are many of the sequences like agent pathogens are bacteria so any metabolic gene will come up as a positive.And many of the select agents viruses are similar to nonselect agent viruses.So each of the examples required input from a Ph.D biologist as to whether we should pre void the gene.Regulatory clarity in the area of select agent would be very helpful for our business ap the industry as a whole and the goals should be to restrain and monitor access to dangerous DNA fragments but to retain the ability to carry out rapid bio medical research and R&D.So the other points I want to make is known regulatory scheme can block the arrival of pathogen.National scheme won't control activities in other countries and even if you could regulate all the activities in the world.There is still going to be natural pathogens arising in the next few years.We believe poorly conceived regulations could impede whether they are from natural looking causes.So, I just want to give you our perspective on one small aspect of the whole regulatory thing which is that if are going to regulatory DNA sequences they should be expressed in the in terms of the sequence information.And define the sequences that are covered and they require somber pretation and define the actions you need to take.If we see an order that matches those sequences.So, one would be rather than or in addition to regulation that is are focused on the control of specific organisms would be regulation focused on specific sequences so the select agent rule already cover specific sequences and so what we propose is a of with a we call select DNA sequences that could be used to bill pathogens or build path general sayity and these would be in reference to a percent identity so you could tell whether not the sequence you have violates the law.And that you know, in order to be able to have the reference sequenced you need an reference of the database by an oversight panel and it would updated a regular basis.One possibility would be to have for the select second Queenies three clies of sequences.The classes that exist now.The specific genes from select agencies that require a permit to them another class might be a set of related genes or other pathogen genes that would require reporting but not necessarily any other controls on their possession by scientists and then all other geeps where we would not support a reporting requirement.This would allow you control of the high threat sequences.Tracking that could be incorporated into new pathogens.It is the select agent rules you to order a fragment of a toxin for instance in three different gene synthesis groups are not violating the rules until you assemble those together until you do a complete toxin.It would be useful to crack those and related sequences and no reporting requirement from those sequences.In terms of operational considerations for this kind of regulation.We would support a positive requirement to check orders against the select sequence database.The current rules make it illegal to provide certain sequences but they do not provide for them to check the sequences.Clear procedures to check the organizations and people that authorize them are in place today.And affordable sequences.And as I said, it is currently possible to buy the parts of from several different providers until you at sem believe a complete virus.-- assemble a complete virus.That is an idea of how to deal with a regulation.I wanted to make other points.One synthesis is an International industry.One is in Germany, United States and one is in China.Researchers that use this technology are located all over the world and gene synthesis companies exist all over the world.Dozen or so in U.S. and Europe and in Asia.Ad hoc so noncommercial occurs all over the world.There are tens thousands of people that are cape capable of carrying out gene synthesis and they can't block the impact and it can with new pathogens.
another point is the choice of regulations can impact the choice of technology.It is our view that our customers will not out source gene synthesis if regulations disclose all sequence of orders.So the sequence data is highly confidential and this regulation, regulations that required us to report every sequence we drive an order for gene synthesis into a more disperse technology.The technology we use is perfectly amenable to building a box of this podium that would allow you to assemble genes and if our customers decided that they didn't want to order from us the alternate is to provide them the capability to do it themselves. Regulations which push towards the dispersion of the technology will loosen the control rather than tighten it.So I think rapid effective R&D is the solution.Our response to new pathogens depends on basic research and immediate application of today today's best technology and it could play a role in the response to new pathogens.I believe regulations could specifically and it would be counter productive and they will increase the risk of pathogens by limiting lemg it Nate researchers and they limb the access to the technology.So, I think another really important point to think about in considering regulation is that scientists working for the good of society have a many thousand or million fold advantage of resources over the small nongovernmental organizations that might use the technology in they have fairous ways.The people who are unscrupulous and willing to kill innocent bystanders, I believe is very small to the vast people will good ways.So, balanced regulations that discourage the have fairous will preserve this advantage.I think it is critical to preserve that advantage of the good buys over the bad guys.I think we have opportunity and policy decisions that will improve the lives by retaining this capacity.So, in summary, gene synthesis and molecular biology the technology is iewb bik quit tus and control within the U.S. is not possible.The current regulations need some improvement and that poor regulatory choices could significantly reduce the risk to respond to pandemics whether it is natural or manmade.That's all I have to say.
Thank you, Dr. Mulligan.If Dr. Venter and Dr. Church wouldn't mind joining Dr. Mulligan on the podium.We can open for general discussion and questions.
Questions,.
Dr. Rubin.
This is a question for Dr. Church and this returns to an issue we talked about yesterday and that is, that gets back to where the boundaries of dual use start and stop and a lot of your words, George, and your work and a lot of the people have been working out mathematical models and the question I have in terms of dual use is where would it start and in your mind.So a computer science company wouldn't give you the source code.They would give you the disk at the end of the day or something.What, where do you see our group getting together see dual use actually starts?Especially as you go toward math met thighsing biology.Can you give us parameters on that score?
I think you know, one of the speakers yesterday pointed out how there is, you can weaponize about anything.The main way of determining intent that I can think of and I am not looking at it, but every possible way, if they are trying to hide it, that is an indication they are trying to weaponize it.You need to make it clear who is trying to hide it or not.The adding math mat particulars math mat if it is done in the open will tend to reveal how we it and it will drive, make the currently blurred distinction between the two uses sharper.Because as you engineer, you can make it very, very hard to weaponize and those that do try to keep the blurring going on will try to do it surreptitiously and everything you can do to expose that would be a good thing.
Dr. Franz?A question for any of the panel.What are the sort of International demographics of these capabilities in this technology area and what are the trends in that regard? U.S., China, Indian?
India?
I believe the vast majority of the capacity is in the last west and North America and Europe.But the trend is very rapid expansion in China and India and throughout the rest of the world.As I said one of our main competitors is in Shanghai.
To follow up on the earlier question to help guide us, you know, just before 9/11 we had a terrorist in Minnesota who went to flight school there who alerted authorities on his intent on using the airplane when he wanted to learn how to take off and he didn't care if he landed or not.That is a high technology device that alerted authorities to something bad.On the other hand, you have the guy that goes into the local car dealership here and want to say buy a tire Jack.You assume the buy in a suit has a flat tire and needs it and he walking down the street to bop them over the head and rob the cash register, that one you could not have anticipated that that was the intent of using the tire Jack.Where in your world would you see us trying to focus on the obvious care of 747, don't care if I land it versus if we try to this, we would largely be screening someone who had no ill intent in mind and how shall we start to focus on the technologies you are presenting to even say, what would be the yellow lights and obvious green light.You have shown us this morning is the future.This is where we are going to struggle on what advice we give where we consider something even potentially that 747 versus the tire Jack?
Let me take a at this.From Blue Heron or George Church 's company.It is well over 50,000 DNA synthesizers out there in the world.There is blue prints for making them on the internet.I looked a couple of days ago.There are several for sale on E bay for $5,000.What happens in a few reputable businesses isn't going to tell you anything.I think maybe tracking what we are doing with airborne samples and water sample and kind of surveillance church suggested is George suggested is maybe a wise thing to do and it as telling piece of information and it is everything going on out there.Locking for simplistic methods for fragments and the sequence would tell us instantly whether it was an engineered piece of DNA but I think if we are not concentrating.100% of the efforts on providing defensive counter measures.We are missing the big picture here.And we should assume that as said, Dr. Mulligan countered that any viral agent can be produced today.We should just assume that's possible and make sure we have good vaccines and new vaccine development procedures to work against anything.Whether they are natural occurring or manmade.But I think surveillance of the air, water testimonies systems is feasible and is being being ignored.
You believe will is nothing to monitor in the industrial process.I thought that's what you might say.But potentially monitoring the first potential attempt or leakage of what ever work is going on out there and that basically the real key issue for us is to always stay step of some on a defensive basis.Is that a fair assessment, would you say?
I would say that's a very accurate assessment.What we doing with the DNA sampling around the planet we think we could tell as more data is added on exactly what part of the world, perhaps even what port the ship's ballast water came from and what issue it came from and the bacteria and elements there of you know, the codes that as we modify things and synthetic biology, we are all altering those and tell tale signs and they would show up in a monitoring system.Detection and defense is what I choose had choices.
They were going to answer.
I agree with that perspective.Trying to monitor sequences in the environment is a great idea.It is very difficult to work with DNA particularly if you are trying to do it in a mearp without releasing sm in the process.Another thing would like see is an effort to try to detect.This is something that won't be buildable in the next decade but about do you recognize sequences that are nullly designed pathogens.Is it a way to analyze sequences to try to recognize something that is created fully.For the decade or two people will be working with existing pathogens but it is a potential.
was just going answer the question to the inevitable trade secret issue with pharmaceutical companies and others. Do you denote any push back in terms of this overwhelming ability to interrogate systems and it might be that there are some quote unquote trade secrets that they would not want to let lose and this gives you the -- let loose and this gives you the ability to give you recognition of what might be an early process leading to a patented element.
Referring to the element of the sequences.
That and the fundamental capability itself.To just capture a particular product and be able to quickly interrogate it.
I am sure that would worry people and in the pharmaceutical companies are more capable of keeping it internal than your you know, they have fairous actor.
share the skepticism that is about the feasibility of control and regulation and in part because of the dissemination or iewb bik quitty today of the pieces of technology and for the reasons that have not been, I think adequately he can plod and that and explored and that is insufficient understanding of the meaning of sequences.If we could in fact recognize all of those sequences that contribute to or are necessary for virulence we would be in a wonderful place today and every issue of every journal brings about another surprise and consequence of knocking something out that has the opposite results.As well as the comment at that toreial issues that Craig alerted to and between necessary and sufficient.But I am struck by something that John said which is really interesting.If in fact you push at some point in the process thinking it is a critical point.You may in fact cause an unintended disproportionate flourishing some other part of the process to circumvent.Can you identify specific actions that might want to most avoid for just that purpose?
I would like to push back a little bit on why it might not be so hard or have some impact by looking at knew clear advertise nuclearized second Queens and the objective here is to find intent.So if people are making.It is cheaper to make a nuclear advertise and and John and his three competitors and they insist on make tg higher cost in the basement.That is intent to do something.No matter what it is.It answers your question, David, of you know, whether this particular thing is a tok inch toxin or not.And there is a trail that they will leave behind like drug manufacturers leave a trail.The chemicals.Instruments they buy.E bay, all of these things are, that wouldn't drive people away the way people described.What will drive them away is if you publish the pharmaceutical company's sequences but if you have a black box that checks them for select agents and no one knows what is in the box but for people. will drive people who have only nefarious things underground and they are convinced it is safe.
I deally ideally I would rather not know what the sequences were.You could give me a black box that I could keep in my building and screen all the orders against and said make it or dope make it.I would be a man.But, most of customers are not going to buy from me if I ship it off to somebody that they don't know and they are doing analysis on it.So, I mean, they are just not going to.
Actually I was going to ask David a question back.What do you think our knowledge of pathogens is thus far in the world?If we are going to bill the magical boxes?
Yeah, I mean, the answer is a bit iffy and certainly fought with major voids.I think right now it would be very hard to have a sufficiently robust black box data set with which to screen. So for example, I think it might be hazardous to venture down this line that select agents are a dem on strabl concern and concrete set of concerns therefore, their sequences are those things we ought to monitor for.I and many other people come up with go arounds for most of the sequences for a select agent using similar sequences of like function.From elsewhere.
I am sure you could do it but you are not going to do it and it would be a whole lot easier.There are many easier ways to get and lower tech ways to get a pathogen than designing a new one that doesn't the published sequences.
If people don't know what is in the block box, they are not going to know what to work it around and they going to play it safe and do it in the basement.But it won't be safe because they won't be taking the best price and cheapest way available.They will self define what they consider nefarious and hazardous.We are not going to be able to make an agent list.But if all the creative red team guides are put into the box, they are the best guess and the people trying to do bad things will have sufficient doubt they won't use the cheapest and most services.
I would disagree with the contentious that they will use he and accurate sequence.
They may, they won't choose the worse.
Craig, I would like to ask you, I was very impressed by the comment at that toreial again Nome Mcs approached coupled with selection.It is to imagine someone would want to develop an infishtious disease model using this approach.Could you imagine where you would cross the line with dual use in this type of ep differ and imagine any type of line where you should say there would be a moratorium on such experiments.
I would crossed when you in an unregulated fashion worked on an infectious agent period.
So you allow any on infectious agents in the common genomics.
Without regulatory review.I think meaningful research to under pathogen I sayity is, I think as with the early stages of recombinant DNA research and gene therapy having a discussion and review of the approaches before they are approved before they are undertaken is an useful exercise.These are tools in an early stages that are forward-looking but things are changing rapidly so we need to be forward-looking and unless people are directly in the area of developing vaccines understanding path general I sayity for that purpose, I would be uncomfortable with someone randomly doing the experiment.
That is what I was thinking.Some tie of a shotgun approach.Using an animal.And.
selection is a very powerful tool.That's the problem.The easier thing to do is to select for ineffectiveity.
When would you, how feasible is it also for something more insidious or dangerous to be constructed in this fashion than what we have already which is pretty bad?In words, what is the time line for concern where is going to create something more dangerous than something we have already.
I think only if it was a dedicated program to do that.Which I can't imagine any reap reputable nation or government wanting to undertake.We have seen that in some of the former Soviet union of the programs when we were there.If they applied these to a known human pathogen, you could try and for something with greater pathogen I sayity but those would be experiments to undertake and do it.
And to make it work in people, you would have to test it in people.Which would allow to you detect it with the detection most likely.
Last question from Dr. Dr. Klein.
I have a question for Dr. Venter.He had commented we should assume people could create the pathogens and we should have vaccines to respond.As one who spends a of time and money on protecting our men and women in uniform.It takes eight years to get a vaccine licensed so the challenge seems there is a disconnect in time but takes a quicker time to create some of these pathogens than it does to get a licensed vaccine through our system.Any comments on how we can shorten that time constant.
I agree, 100% with what you said and I on a committee along with others for deputy secretary defense looking at the year 2025 to deal with some of the issues.That is one of the promises of the technologies is and was on, I think all three of our slide that rapid vaccine production is potential outcome of synthetic again Nome Mcs but -- again Nome Mcagain Nomics and they could synthesize one the smaller viruses in a week or two getting good vaccines take dedicated programs but this is an area of research.Some of our major pharmaceutical companies have shut off all their microbial teams because they can't make money on treating infectious diseases and that is something we need to change pretty radically.
Thank you much.This will conclude our final speaker session for the morning.We will now have a discussion about the next steps for the inincrep committee -- INSAB committee and open the floor for public comments.During this next step session, I would like to ask Dr. Paul Kind to join me and as we mentioned earlier we will establish working groups to maintain the momentum on particular issues that INSAB is engaged.These groups will be composed of board members, ex-officios and invited outside experts. The established in particular groups and their schedules will vary depending on the current mission of the board.Once delegated a task by the board, they will research, deliberate and provide information back to the board.I want to emphasize only the entire board reaches a conclusion any be issued.The entire board, not part of the board.I emphasize that again.So initially we will be forming working groups to focus on the topics we covered in this meeting.Dual use research.Communications, codes of conduct, International collaborations and synthetic again ves. genomes and we will give a charge and focus for these groups.I will ask board members as we go through who will be trrd in interested in serving on the groups and someone from the support group will who that interest.You can volunteer for more than one group.But of the, I will reserve the prerogative to reassign people as we see a in a specific area.So, there will be some flexibility needed in developing these groups.I think one the main charges for the groups will be to quickly define their goals and this will have to be in a time line to achieve the goals.It seems the charges are rather broad and we will really need to focus in and on each group with what we want to accomplish and the time line to get there.So, with that, we can now want to put that first slide.We only the set slides.The first committee will be that developing and defining the criteria for identifying dual use research.The next steps that we think need to be accomplished in that committee are to define criteria for identifying dual use research and research results and secondly to consider the flexibility needed in the criteria by assuming that potential for harm may evolve in this area.So that is the major charge for that committee.Now, I going to ask for a show of hands for board or an ex-officio members who will be interested in serving on that subcommittee.And who is recording it?
Dennis, would it work if we puferlg the buttons and they read the light.
If that will work.
don't know if it will.
I have a light.That would be good..
Do we have those recorded?Yes, no?
Sorry.We have everyone?Okay.Thank you.Dr. CASAdell VALcould be added to the group as well.The next group would be a communications group.To develop method and technologies for communicating results. The steps that this group will be involved with, would be to advise on policies and practices to communicate findings and technologies from dual use research and facilitate application from well considered principles to decisions about communication about information about the implications.Can I see a show of hands of members who would be interested in the communications group.
Starting with board members, Lynn, Sorenson; other board members?Coke Kay? okay.Ex-officios.Caramel la.Brenda, Terry low max, Stuart nighing nighing Gail.Dale parker.Er that's it.
Thank you.The next committee is the codes of conduct.For the Life Sciences.The topic we heard about this morning.The steps are to support recommendations for a code to address dual use research and provide recommendations that maybe adopted by the Life Science to say address dual use concerns.Show a hand please of people interested in working on this area.
Board members.Murray Cohen.Mark nans, Diane ware., John lump Ken, ex-officios.
Stuart nighing Gail.Scott steel, lawyer represents K*ER and Rex, okay.
you.The next committee is the enter fashion Al collaboration committee.The charge for the International working is recommend strategies for cooperation in the development of appropriate Biosecurity policies and this will be to gather information and develop out reach networks.Promote exchange of information ap develop strategies for engaging in the International community.
Board members.David Franz, Stuart Levy.Harvey Rubin.Stay Levin, Ann, Murray.Andrew Sorensen, ex-officios.
Terri low max.Peter, Stuart nighinggail.Dale Klein.
you.The final working group will be on synthetic genomes and this is dual use ceshs with advanced technologies and develop potential strategies working with the scientific and genomes and develop best practices in this area. show of hands please.
Paul, Harvey Rubin.General Gordon, ex-officios please.
Rex, one more board member?David Roman.Back to ex-officios.Ronald Walters.Scott steel.Vincent vil Kerr.David Thompson, NIH, and Rick.That's it.
That's it.Okay. Well, thank you.That gives us a good start.The plan now is to open the floor for discussion I ask that members wait to be recognized by the chair before answering questions.The list have an updated list of people who have asked to speak.And the first is from the Triple A Sand policy fellow.
you, very much.It was a very interesting discussion for the last two days that I have been hearing.My comment is regarding the much discussed subject of instilling a sense of cultural responsibility.And while I was listening, I was thinking how do we go go about around the world.We heard about graduate and under graduate students and bringing them same culture and I was thinking how do we accomplish think this and one idea I wanted to share with you is perhaps it is hard for a scientist.Especially for a young scientist to listen to a whole bunch of ethics and codes because that is probably the most boring thing to them when they are doing laboratory research.What if we started something like a reward system.Maybe that could be a certification like in to getting your degree, also get a certification through some professional society or an international organization where you know, I taken an on line course and become certified for Biosecurity and taking responsible egg cal conduct in scientific behavior.If something like that could be instituted.That would be encouraging to young scientists.Maybe something they could put on their resume and add value.As long as it is recognized by the people on the receiving end that they would take well.Thank you.
Thank you, for your suggestion.We will consider that.Are there any specific members of the board who would like to comment on that.Okay.Thank you.The next speaker will be Brian hand hf aflt N L E Y.
There is a statement made this morning regarding designer organ organisms that they are 10 years away and everyone is wear of genomes therapy and I would point out that there is at least one book,.
Dr. HANLY, can you into the Mike.
Should I restart?
There has been a statement made here this morning to the effect that designer organisms are 10 years away and that has been accepted.And everyone here, I think, is wear of human genomes therapy and I would refer you to a book which is an undergraduate text.Genomes sectors for genomes therapy which discusses how to modify and what to modify in terms of attachment to improve the attachment capability of viruses which would apply to other organisms.It talks about the attachment sites or receptor sites on membranes.It discusses how to bypass the immune system.Discusses the structure of the viral genes and where to insert novel genes to maintain the effective passages of the organism.It also discusses well, the basic point is, designer organisms are they have been here for awhile.And with all of the information that is out there, it is basically a cookbook now for somebody who wants to do it as to okay.You stick something else in there and you have something that is really nasty.It is the same book discusses how to recombine with animal virus to say produce new viruses which do not to which human are not yet have a natural immunity, so can use these types of techniques as base for constructing a new pathogen.So wanted to make sure that point was really clear to a grup like this.I found it a little alarming that that kind of a statement would go unchallenged by, you know, a group that has got this kind of a charge.
you, for your comments.The next speenger is Allan peer son, center for arms control and nonproliferation.
Good morning, thank you for the opportunity to address you today oon behalf of the arms control and nonpro liver ration and scientists working group on biological weapons which has over 15 years of working on the national or International level.We would be happy to provide you with the recommendations by one of speakers earlier today.We often heard in the last couple of days that the concept of dual use has multiple meanings.At least such meanings have been offered to you.It is military applications broadly defined.Second for legitimate research for misuse.What is misuse.The answer to that question maybe found in the third meaning.Research that can support both personaled and prohibited activities under the biological weapons convention and the BWC prohibits the stock buying of biological weapons and agents or toxins that have no justification for prof fill lack particular or other useful purposes and categoryally prohibits work on the design systems to use biological agents for hostile purposes for a nonconflict.This raises additional questions.Can we draw clear lines for research and or basic research and applied research.Most importantly, between those permitted and prohibited active tis.Can guidelines be developed you anyone that actually help keep research projects from crossing whether inadvertently or deliberately.The thip line between permitted and prohibited activities.The importance considering how intent is perceived was raised yesterday and today the test was offered for determining intenth.Their actions may decrease or increase the problems we are facing.What then about governmental compartment Alization about intentions.Isn't that enough to meet the intent or is that as peculiar of the dual use problem illustrate one more reason why transparency and oversight are critical.In considering the questions, you might look for questions and I will suggest four possibilities.First research which aims to develop more stable forms of tok in.Recently funded by NIAD and given a paper that was just published.
New therapies based on the modulelation of immune responses to infection.Three, research on biochemical on exas taiting agents.Like used in Moscow and in current interest of many, many governments including ourFour, research that explores the potential of various agent, genetic and physical and mechanisms.Having given examples, I will note that while we have often heard in the last couple days, the dual use problem in the abstract, we often have great difficulty in pointing to more than a few concrete individual examples in practice.Why?Is the problem any one experiment in say the field of sin thet cake biology or the direction of the entire field.I end by reminding you that prior to the BWC, it is Internationally acceptable.They still set the boundaries of and provide the justification of by those they find and especially ploy and employ and they are worth your serious consideration.Thank you.
you for your comments.The next speaker is from CSC, National Security program in Alexandria, Virginia.
Good morning.At the out set, I would like to thank the N S A.A. B in taking the leading roll in what could be the mess instraktable challenges facing the Life Sciences and bio medical research programs.For the sequence operated -- this is philosophical practical.Not only the and pursuit of bio medical research but the national security challenges of the United States and the rest of the world.We are the computer sciences corporation, work on the C B R and counter production and biological arms control program and counter measures department.Issues relating to bio ciewrt by the board are critical to the engagement with the federal government agencies.-- Biosecurity by the board are critical to the federal government.Nuclear security versus Biosecurity biosafety versus Biosecurity.Security of research at the individual scientist level which is institutional controls and human creative censorship.These are most from external forces.What we have on hand, is an assortment of partial solutions to a very complex problem.No matter how we interpret the effectiveness and vigor of the solution, there is no clear solution at this time.With limited base level assessment of the existing conditions.And south Florida veilable options we ought to be prepared for modest proposed partial solution.However, it is gd to have a partial solution than no solution.In my assessment, biosafety and bio assurance and Biosecurity are the three legs of this challenge where laboratory worker role is key at the institutional level.At some point yesterday, biosafety guidance and biosafety offered a tested and verified framework to incorporate Biosecurity and practice.Just as the food and drug administration requirement for good manufacturing practices and laboratory practices the biosafety requirement, Biosecurity requirements must be tied within the biosafety framework.Such that institutions, institutions need not have to meet multiple requirements but one of internally consistent rules covering all as peculiars.The different agents join with the assessment offer a practical item.For development of institutional level.Central to Biosecurity.In my opinion, threat assessment and risk assessment are, and risk benefit analysis are noting.And the board must ensure that these fundamentals are clearly laid out as part of guidance.And if at the publication level are too late.As a pointed out yesterday and if one general refuse to say publish.Authors will find Aller nat journals and other web based media.So the application review ward stage is more preferable.If it is developed a review and making process.Finally, I conclude stating that as part of guidance to the government the board should consider a case study base investigation for a variety of potential threats and scenarios in academia private sector and the government supported major programs that involve Biosecurity components.This will allow participation of key stakeholders communities and the development of very, very necessary Biosecurity guidance.Thank you again.
you, the next speaker is David silverman from stand Ford university.
I like to add my to the work that the committee will be doing.I think critical and important.And my remarks today really it is kind of for me a summation of what I have learned and maybe one whole, that I have seen hasn't addressed.We focused in the last couple days on education creating a culture of responsibility and particularly getting by from International colleagues. The prime focus of our effort have been directed at the roles of isn't tiss and their host institutions.There are however, other vibt tores -- contributors that play roles in a workable scenario.They are represented by the ex-officio members insab.These are the people who promise mull gate regulations and policies under we all work.And so, I would like to offer this case study or hypo thet cal case study or example that touches on one aspect where the back side is also important as well as the scientific side.That has to do with the fundamental research exemption in say that a post doctoral has finally been accepted by a laboratory in France after mch delay of bureaucratic red tape and gets the work done.Completes the post fellowship and publishes papers with the senior author and then is told, gee, when you go back, before you can do any work in your home country, you need to get, we need get an export license so you can do that.Now, this kind of thing would be kind of unacceptable, I would think.We would say, bon jour, you know how the french are.And now it is the reverse.There are challenges to the fundamental research exemption that are trouble some and so I one of which would be if you accept one restriction on publication.You kind of restricted it all it can compromise a source of funding.But I think if we are looking for enter national corporation, we have to look at our own policies as well and maybe offer some modifications.International corporation cooperation is critical.We heard earlier this morning.He along with max as most of you know, are kind of the father's of the cop temporary thought of genetics and as serve as monitor to Jim Watson.Yet both came from countries that were either fashist fastist or were to arrive.But it is the climate of change that is troubling to me where in the past we were more accepting and now we are more restrictive. We are preventing people from coming in.I believe M I T rejected an 1 million D.O. D grant because of foreign nationals and the last thing I have to comment on is what does one do with the research that cannot be published.Something that could not have been for seen by an IBC or anyone else review tg.It is one the wonderful things in science that comes up unexpectedly but it does have a truly negative effect.It could be something as simple as disdiscover discovering how a preteen unfolds.Do you put it in a special journal.Restricted website?Assemble a quarterly meeting of people o who are in this cat gore youry so they can talk to each other?How is that this shared?
Not quite sure.So, within your charge, you are given, you are charged with providing advice, guidelines and leadership.So my hope is that you will do it for both the scientific and both policy setting committees.
Thank you much.
Thank you.
The floor is open.For a few comments from people who didn't sign up if would like to say something.Now is the time.Please identify yourself.And if you represent some university or agency or industry, please identify that.
Thank you, drew, professor of biologic engineering at M II wanted to make remarks the panelings ploring the top pick of synthetic genomics.With regard to the idea that anybody building a gene in their base men or garage must be up to something no good would ask you to consider why somebody might build a radio in their garage.Why somebody might educate their children at home and the complexity of the reaps for taking such an approach.Are impressive and I am concerned at the we might simply try and presume that regulation, we should consider for synthetic again Nomes is so freight forward.I am extremely uncomfortable by the idea that we are going to think through how to regulate the technology absent a decent consideration of the facts on the ground with respect to the of the technology agents and knowledge by which people would do this and why they maybe motivated to do that.That said, in general, there are two things that the board might be well suited to consider at the out set before we understand all of facts on ground.The first is, with respect to the question when does dual use start.Especially with biological engineering and synthetic engineering.It starts in the mind of the designer or the individual.It gets back to the remarks of Dr. Sharp and others with a cultural responsibility.One the most important things I ask the board to consider is how we foster constructive culture within the development of next generation biological technologies.Second point not too early to is foster a transition with respect to the strategy by which we address current and risks.At are a where by we are concerned about specific threats.We develop the fences that are fixed fences specific to the stress.On time scale whether it is emerging infectious diseases or engineered diseases and wanting to consider how we go from threat to general capabilities where we can quickly identify, analyze and respond to new agents as they arise or if God forbid they emerge and they are engineered in our release.Thank you.
Thank you.Other comments from people in the audience?
Okay.This is the conclusion of the first meeting of insab.On behalf of the speakers and panelists I would like to thank them for coming and sharing their ien sights with us.Thank you for attending the proceedings.Either in person or webcast and express our gratitude for your comments.I believe the inaugural meeting of inINSAB was productive and laying out the ground work for the working groups.We established a solid base for the future of insab.Over the coming months, there is sure to be the cause of working group and items as we track the current issues at hand regarding Biosecurity and public health.These working groups will provide us with the flexibility that this board will need in responding to the dynamics of Life Sciences research.There is undoubtedly very important work ahead of us.The fact that the top picks discussed topics are to all Life Sciences speaks to the importance of continued contributions from academia, government and industry and the general public in order to achieve the balance necessary for effective Biosecurity without unduly encumbering research efforts.To conclude, I would once again like to thank the insab board members and staff.The meeting is adjourned.Thank you.