CRISPR Consensus? Session 2 – Governance and Its Gaps

CRISPR Consensus? Session 2 – Governance and Its Gaps

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Can. You hear me or see me because I thank. You but I cannot see anything. Alright. So we. Are on to session 2 which is titled, governance, and it's gaps so. We heard about the stakes in the stakeholders, certainly, it was not everybody. There are many people that were not here. In that conversation. So we think it's important also to start thinking about who, was missing from that stakes and stakeholder conversation, and keep that in your mind now. We're moving on to the governance and its gaps and to, kick this off we'll do some more. Pull. Every we're pulling in room and I'm sorry again panelists. Were blinding. You that was not the plan and, so. The, first question yeah. What. Quote no not, that one here, we go what. Mechanisms, of public engagement have, you found to be most useful. So. Engagement, you. Know as a form of. Input. For governance, we're. Going to start there so we've. Got options polling. Town, Hall open house citizen. Dialogue forum, citizen. Advisory groups, public. Comments, social, media. D'azyr. By a no means, all. Of the options these. Are some. So, the most useful one is starting to look like citizen dialogue. Forum people, think that's the most useful. With. Social, media citizen. Advisory groups and town halls as close, seconds. Right. Right yeah online polling in room, interactive. Pulling is not. Represented. That's. Me. Alright. So the next question what, mechanisms, of public engagement have, you found to be least, useful, so, these are the same options. What, isn't working. Social. Media is both most useful. And least useful so, far. Probably. Right. Polling. Is looking like it's a close second for least useful. Give, it a couple, more seconds. All right let's. Go to the next question. So. Do. You feel that public input, affects governance. Outcomes, in human, genetics in particular, why. Or why not. And. It's, trying, to connect to the internet. Okay we got a couple input, so no, current mechanisms, for a responsive, science. No. Consent, is impossible. Ah. Maybe. A and dear in response, to the options for the previous one yeah. Very. Smart. Public. Input barely, affects governance, in any area. Yes. But maybe, more than it should. It. Should but, the system does not always. Allow it we. See, signs of it in limited ways in the UK but. Broadly public, debate doesn't, affect. Governance, outcomes, in human genetics. Yes, government, officials want to get reelected. Yes. For, fear, of GMO. Yes. But decisions are ultimately political. No. Because, the decision-making, and organizing, committees are still made up of white senior, experts. Not. Wholly due to pharma companies, looking to, profit. Alright, I'm gonna stop reading, them there and we'll. Be collecting, more. Of these later, too. Many voices is, an interesting one, yes. Legislators, are accountable to the public I said I would stop so I'm gonna move on um. All. Right so, that's. Not the one, I'm looking for. Right. Alright, so I turn it over to Ben Hobart, who will be moderating session, two okay thanks thanks Lee. So. So. We've. Been talking about large issues, that that, you. Know as we've already seen from our first panel which I thought was really excellent they're they're large and complex issues, both. About the issues themselves and the question of who decides but, at the same time a, important. And significant, body of work has been done over the last several years since. This debate, has really gotten going but arguably stretching, back decades, and. We're privileged to have a group, of experts, who in various different ways have been involved. Very.

Significantly, With different dimensions of this work nationally. And internationally, and. One of the things that I think is especially important. Is. Recognizing. That there are a lot of different ways to do it that the what questions, are the right questions is not given in advance, and, that maybe we spend lot less, time than we should asking, what, questions need asking, and possibly. Learning, from from, different. Processes. Different communities, different institutions. That have asked different questions in, different ways and so, the aim of this panel is to explore. That what the what these processes, have been how. They have approached identified. And approached the problems, that they see as salient, and. Also the ways they, have, understood, their, work and their remit in relation. To each other and in relation, to. The. Broader public in, arguably. In relation to the humanity, whose future, they will in one way or another effect. So. I'm gonna give just very brief introductions, I would like to refer you to the BIOS the more extended BIOS that are on the website. First. I'll do this alphabetically, Dana Carol um who is a member of the innovative genomics, Institute and, distinguished, professor of biochemistry at, the Utah, School of Medicine, he is a pioneer, in development. And applications, of an earlier, version of genome editing namely. Programmable. Zinc, finger nucleases and, he, currently sits on the International, Commission on the clinical, use of human, germline genome, editing, which, was recently convened by the US. National, Academies. And the Royal Society of the UK. Ulta. Charro is the, warren p knowles professor, of law and bioethics at, the university of wisconsin she. Currently sits on the World Health Organization, Advisory, Committee on genome, editing, development. Of genome editing standards. And governance approaches, she. Also previously, co-chaired. The National, Academies, Committee. On human genome editing science, ethics governance, she. Was a member of the organizing, committee of the second summit not the first I think and. And, actually I mean ulties work stretches, back decades, in this domain in in salient, related, domains it's, it's, a sorry. But, you know it's it's actually hard to think of more than a couple of committees I'm, in the u.s. that have addressed salient, issues that she's not been on. Daphna. Fine Holtz who is, unfortunately. Was. Unable to come here at the last minute and so she's joining us remotely. Daphna. She. Is the chief of UNESCO, z-- bioethics. And ethics of science section which. Is UNESCO, this this structure, is one of the few formal, standing, intergovernmental. Organizations, for engagement with issues of bioethics, at the, international, level, before. Moving to UNESCO, she played a variety of high-level, roles in Mexican, biomedic, and and biomedicine. And bioethics, including. A director. For research and planning of the women and health, program of the Mexican Ministry of Health an executive. Director of the National Commission of bioethics. In Mexico, and. She was Mexico's representative, to the International, bioethics. Committee of UNESCO, during. The drafting, of the Universal, Declaration on, bioethics and human rights laurels. Lyubov is the head of bio at the bioethics unit, and. Secretary of the Committee on bioethics. Which. Is the Intergovernmental Committee, in charge of the activities, on. The protection of human rights in biomedicine, this, is at the Council of Europe she's. Been involved with a huge range of different issues in biomedicine, and biotechnology, and her work there at the Council of Europe including, in particular activities. On human genetics and on the protector of the human embryo and fetus and. Genetic testing for health purposes and, as, if her portfolio, of issues was not diverse, and complex enough she is responsible. For in effect convening, and. Managing, the conversations, of delegates, from a large. Number of European, and in actually other countries, around. These complex, issues. And. Finally Nora Schultz is research officer, with the German ethics Council and, she's also a freelance science writer and her. Work at the German ethics Council which is based in Berlin has. Covered topics from genetic diagnosis, and stem cell research to biosecurity, brain, death and big data she. Most, recently coordinated. The German Ethics Council's three-year, program on genome. Editing and Human Reproduction which, recently culminated. In the report, intervening, in the human germline, which was published last, May and I encourage, you all to take a look at so.

We Are gonna run this as a conversation. And. And I want to begin with by. Inviting our panelists, to say a few words first. Of all of introduction, about the organization. Or organizations they. Are sort of here speaking, about though I should say not, officially, representing, certainly, in daftness case and I think probably and all the rest of you are happy to have that disclaimer, as well. So. Speaking, about the the organization, or organizations that, they have been doing work in but, also but, also the. Way those organizations, have identified, the. Key questions, that they see as, needing, their attention, and understood, their remit and responsibility. Particularly, in relation, to the. Larger questions, of how, these how. This technology. Should. Be governed and by, whom so. Um, laronx, I'd, like to begin with you since, the framework. That you have been doing your recent work in it's arguably, the the, most long-standing of, the, of. Those that that the panelists, have been engagement. So, you asked me to say she words but was it a history of the Council of Europe maybe just to remind you, what this organization is. About Kia. Liu mentioned, about history, making, us I think Council of Europe is based on history, and. This, is an organization's, that is composed of 47. European. States so. The geographical, scope. Is quite large, it goes from include, Georgia, and Iceland, and. Russia. Ukraine, Turkey. Including, all the 28, or sorry, for those who are Brits maybe. 27. Soon member, of the European, Union. And. These. Organizations were, set up in 1949. With. A, mandate. Which is focusing on the promotion's of human rights and here, I think the most famous body, of the Council of Europe is the European Court of Human Rights, but. Also promoting, democracy and, the rule of law and it's. Within. This pillar and this missions, of protection of human right that the Council of Europe at the beginning of the 80s start looking more precisely, at, the, protection of human right in the field of biomedicine. And this, was very much linked, to the evolutions, of the. Practices. And technology, in this field which, together with being. Very promising, for. The. Health benefit, in particular we're. Also raising, concerns. Because. It enabled, to have a greater control on human life and the, concerns will linked to the possible misuse and abuses. Linked. To those possibilities, and, I. Think that's important, to underline that for the Council of Europe there was always the idea that, progress, and protection, of human rights were working in synergy. In. Other words progress, in the real sense of the words were closely linked to the fact that you could make sure that human rights are protected and you, are really promoting the applications. Of those. Development, are really beneficial for, individuals. Human. Individuals, but also our societies, and. It's with that kind. Of concerned, that, this work which started in the 80s ended up. With the adoptions, of what is currently the only legally. Binding instrument on international, level protecting. Human rights in biomedical, field which. Is the Convention, on Human Rights and bio medicines, very, often referred to as the OVA doe conventions, because it was open for signature in Oviedo in Spain in 1997.

And, These. Conventions, lay down fundamental. Principle, for the protection of human rights and bio medicines. Most. Of these applications are. Dealing with patient, rights issues but some are more targeting, a specific field of biomedicine, which is transplantation, genetics. And research, and I'm. Not gonna go further, into this but just to highlight that there are two provision, in this convention that are particularly, relevant for. The topics today one. Concerned. Intervention. On the human genome because as Kay Lu was mentioning, this, is not only with CRISPR that these questions came in, at. The time the Convention was elaborated, we had the talent and the same finger technology. Already and there. Were a certain concern, that led to the adoptions, of the provisions, that is. Limiting. The purposes, for which. Interventional. And human genomes could be possible, and prohibiting. Interventions. Aiming, at passing. On the, mutations, or the the, changes. To, future generations so, we could we could discuss that further and the second provision which to me is even more important, concerns. Public debate because. Twenty years ago already there. Was an analogy meant that all those issues concerned, the whole society, and it. Was particularly important, that not only states. And authority, promote, public debate but that they are also. Consulting, the, opinions, with, the view to make policy decisions and, I think that's particularly important, in current, context today so. Quickly, where we stand now we. Celebrated, two. Years ago the twentieth anniversary of, that convention, and, celebration. Is nice but have. A prospective approach, is even better just to assess, because, the drafter were very much aware that they were looking at a field that were constantly, evolving, and that. It was important, to regularly, re-examine. The evolution, of the, biomedical. Field to, assess whether the provision, laydown continued, to be irrelevant and the conclusions, of that examinations. Were indeed, they are relevance, and and and they are reference, we. Could again discuss further what. Being, a reference means but. These. Leads also to. Prospective. Work, which, led to the future, adoption of a strategic action plan on human rights and technologies. One. Pillar of which is focusing on governance, and two. Elements, came up as, an outcome of the discussion, on this governance issue first that we need new model of governance, where. Ethics and human rights are guiding, and the use of genome editing applications. So, we want to embed human rights in technology, and, that. In, the new model of governance, societal. Discussions, are key elements, and and. Here again I, guess we could discuss further what it means precisely so that's so, much for my introductions, so maybe, alter maybe I'll invite you to pick up there since you also you. Chaired an organization, or you chaired a body that offered. A set of principles for. How to think about governance. Particularly, at the international, level I wonder if you'd say a few words about those, principles, and how you approach them sure. So. Very. Briefly I want to walk through this chronologically, I think it may be easier. My. First introduction to the field was in 2015. When. Jennifer. Doudna organized. A very small group and it did not involve members of the public to, meet in Napa to. Discuss. The potential implications of her now emerging. Work in the area of CRISPR and notably. She invited. David Baltimore and, Paul Berg who had been part of what has now become a kind of famous event the Asilomar conference back, in the 70s, which, was a gathering primarily, of scientists, to discuss, what kind of self-regulation, they should engage in in the, earliest stages of recombinant, DNA work where there were a lot of concerns about potential, environmental effects, and, what's interesting about Asilomar, that you need to keep in mind is that those.

Approaches. Became. Influential. But, not determinative. Of what became the, approach in the United States at the policy and legislative level that, took place through, the NIH the National Institutes of Health and then through. The Congress, and so it was an example of watching how scientists. And their approaches, can influence but can't determine what will be the outcome because, by then you've actually got a much broader public, involvement when you get into legislation. And I was interested when you were talking in your questions, to people about. Forms. Of public engagement that. You didn't include voting, which. Would seem to be the most direct form however, frustrating. It may be. The. Next was then as a result of this particular small meeting the decision to have a broader, initiative the genome initiative at the National Academy of Sciences, National Academy of Medicine in the US, and. That was something. That was a, collaborative. Effort with the UK's, Royal Society. And the Chinese, Academy, of Sciences and. The genome initiative had two functions one was to create this international, summit which you had mentioned at, the end of 2015, where, we, really had the first kind of major international meeting to kind of look at where the science is and very briefly look at where the laws are and what, the societal implications might, be. Second. Part of that initiative was, this report, this consensus, study that took I don't, know 19 months no not quite it about. A year in two months to, get done, which, came out with. Recommendations and, I want to just say very briefly that, the. Report, was, done. By a committee that was multinational. We had people we've got French representatives, sitting in the audience here Jennifer merchants but. We had people from Egypt and Israel and, we had people who were originally, from Spain and from Italy, and from Germany. Who were sitting on the committee and other countries as well Canada, etc, but. We had two different tasks one was to make a set of recommendations to. The US government in particular and, so. In that sense those parts of our study were constrained, by US constitutional. Law and frankly by US politics and so, it focused on the role of the Food and Drug Administration and it looked primarily at the things the FDA is allowed to look at which is risks, and benefits they, are not supposed to look at whether, or not people think this is anti, religious, or otherwise immoral, they have a much more technical. Remit. The. Second was to outline these grand, Principi.

That, You know everybody, in the world could use and so, of course they become extremely general, and you, know very mom and apple pie but. Still the idea was any government, that's going to look at this whatever your policy turns out to be should answer to those principles and some, of them are very similar to what you saw earlier the idea of respect for persons responsible. Science. Do care for patients promoting. Well-being generally. Transparency. These, are the kinds of things that we, thought a wide variety of policies. Whether they are prohibitory. Or permissive, could, answer to but, you need to figure out how your policy is going to work within those approaches, and make sure that you're not being. Unduly, disrespectful. Of people's personal choices or unduly. Insensitive. To differential, access to technologies, and other kinds of things. These. Are, this. Was an expert committee that, did have somebody who represented, rare disease, groups but it did not attempt to involve the, general public, although anybody. Was welcome to send in comments and there were many people who came to speak to us including. People who represented. A wide variety of patient groups because. It, was understood that this was advisory, and it was only one step toward what would then become a more political, endeavor and so. There, was no sense, that every expert committee had to be one that answered to the entire public because it was only one piece of a, kind of multi sectoral. Approach. To these problems. The, Hong Kong summit, was another. Activity that, again. Used experts, for the organizing, committee and really again was not about, generating. Wide, public, engagement, for the sake of kind of deliberative, democracy it, was about getting an update on where the science is because it was moving so fast and where. Are the policy, and legal developments, around the world so. A kind of survey and some, amount of discussion about public attitudes. But not an attempt in any way to be representative, again. Nothing, out of these summits. Even with their statements, about societal, consensus, or the statement that came out of our second summit which, represented, only two views of the organizers, not of any agency or organization, which. Called for a responsible. Approach to this in particular for germline, to. Recognize that there's going to be different approaches. Countries will permit it or will fail to prohibit it and we. Need to have some. Guidance for the kind of preclinical research needed. To ever make this technically. Responsible. Even if you might still disagree, with its morality. And. Then, the last is this World Health Organization, committee, which is really, complementary, to the one that Dina Carroll is on one. Of the things that came out of the Hong Kong summit, was the recognition that there's really two interlocking. But distinct, issues one, is the technical, problems, how, do we know when we know enough to move on to the next step whether it's in laboratory, research or in clinical care inducing, a pregnancy, how, do regulators, get the information they need in order to know how to evaluate risks. And benefits and so, a committee that is primarily, been, guided by the US, and UK societies. And also the inter Academy partnership, is looking. At that certainly. There are ethical issues embedded, in that what. Is safe is really a relative question safe. Enough depending. On what you're trying to condition. You're trying to prevent so you, can't get away from ethics completely, but primarily we're hoping its technical world. Health organization, which, has representatives, from every continent. Was. Designed, to try and look at principles. For governance. The. First, thing that this committee has done is to call, for a registry, so, that we know what's being done around the world. The. Idea is good, ethics and good governance begins with good facts, and we had no idea who was doing what and where so. A registry, which has a million, little problems, in terms of influence. The. First the, second is going to be to try to be a little bit more precise, in some of the principles, for governance let's, say you've got a country that's going to prohibit something, what, should they be aware, of like what happens if one of their citizens goes to a country where it's permitted or their scientist, goes what happens when they come back if, you're going to permit it how do you make sure you don't become what some. People call a risk haven where, people. From less permissive countries, are flooding to you because you're simply allowing everything to happen so, there's kind of governance. Issues that, need some systemic attention, even, understanding, the different domestic governments. Are going to make their own choices I just. Want to conclude. With. One. Very, brief, anecdote it has to do with something I worked on before you made the point that I'm about 97, years old.

Yes. Nice. Catch. Human. Embryonic stem cell research and. I noticed that in one of the answers somebody took out you know took on Worf, and Jamie Thompson is in. Particular so. When you an embryonic stem cell research was, being debated in the US government it was very controversial, because of its interplay with the abortion debate. We, had an expert committee at the National Academies that I co-chaired, with the same co-chair ahead for the genome editing committee a wonderful, scientist. At MIT named Richard Hynes and. We came out with all kinds of recommendations, for what should be funded, and what kinds of experiments, were too dangerous to do. But. There were advisory and that that's all they were they were just advisory. What. Happened next we had hearings in Congress where, you now had a broader, set of people, offering. Up their voices Christopher, Reeve became, famous after, he was paralyzed, for supporting, this kind of work we also had people who were arguing against, it and. The. Most amazing thing though which really told me how the public, does in fact have an influence was. When I, was, sitting with Orrin Hatch who was the senator from Utah very, conservative, Republican, whom, you would expect to be opposed to anything that smacks. Of supporting, abortion rights or or, not. Acknowledging, the sacredness of the earliest forms of human life and. He said that he had been opposed to all of this kind of embryonic stem cell research because. It killed embryos. Except. That he, had a constituent who come into his office with her son who was in a wheelchair who. Said how can you vote. Against, research that might help my son walk one day now. Frankly the research was unlikely to let her son walk one day he probably had lost enough function. At this point that he was no longer really. Treatable, but. Nonetheless it, was so. Profoundly. Important. To hatch that he wound up changing, his vote and supporting, funding for this research and. Really. Began to bring along with him a whole host of people in the Republican Party so that we, now had bills that were co-sponsored, by Mike castle a Republican, and Dianne to, get from Colorado who the Democrat, and ultimately. Event, we did wind up with funding so I. See. Public participation, as coming, in from many different avenues, outside. Of expert committees which then are complementary, to public participation, and. It's why I feel comfortable serving on the expert committees without making them kind, of a the democracy, of the wolves and sheep that were mentioned earlier Thanks. Thanks Alton so so, that your comment raised you, know issues, of representation. I think which are very crucial, issues, so, the question of who stands in for whom on one, level but also who, represents. What's at stake and the ways in which those representations. Then maybe. Take on a life of their own and actually the the. The. Advice the advisory, statement, about stem, cell research governance, is instructive, in the sense that it has in fact been taken up and implemented, as a kind of as a, kind of quasi, codified, regulatory. Structure. Whether or not that was intended in its in the development, of that of those, recommendations or, guidelines, in the first place so it mean it's simply, worth noting. The ways in which. You. Know. Representations. Of issues that come out of. Even. Simply. Advisory, processes, do, have important, effects upon governance, and and so, with that in mind I'd like to turn to Daphna, who. Is. Responsible. For a division. Of a. International. Organization. In which questions of representation of course are key. Yet. Perhaps approached, in a somewhat different way than they were approached on for example in the expert committees. That that, alta, was part of so Daphne I wonder if you would just say a quick, word about the the. IBC. And also, about, how you have approached. Issues, in this domain and and in, particular what, prior work of the UNESCO of. UNESCO's they've, drawn upon visa vie, issues. Of human dignity and human rights. Thank. You very much for. This kind invitation. First. Of all even, if I'm not speaking officially. Now. On behalf of UNESCO, I would share and, all the all, the information, about what UNESCO.

Does And also, thank you very much for having me remotely. Because unfortunately. Last, time last, minute health. Issue. Was. The reason why I couldn't do it and I. Have to say that I'm also having a lot of problems and, I'm, not following you properly, what's discussed. In the room. So. Here. Your colleague has been very nice and, she has, transcribed. The chat, she says that. Which. Representation. Issues are key but approach differently, the next is. Please say something about IDC, and how you approach this and what prior UNESCO. Okay. Thank. You very much. Okay. So before. I, joined UNESCO, I was in, Mexico, I was in charge of the I was the executive director of the Mexican, national. Bioethics, committee and one, of the most important. Missions. That we decided, to have for the National by effects committee was ready to build, a culture of bioethics. Meaning that it was not, only in addition, of issuing. A. Advices. Of what, what. Was the right thing to do but for us it was really very much important, that everybody. Was because. For us bioethics. And and that's why I was. Very happy to join UNESCO, because the, division, of UNESCO, by exactly. The same is that all of the issues that are related to, health to disease to, cure to suffering, and human experiences. And therefore they, are everybody. Is concerned. And that's, why it's not an issue of experts. And such but. It is something that is somebody. That's not everybody has something to say, about and, they begin particularly. If we get, into. The UN, system where where we have the human rights framework. It's. Also something that nobody can be, left out of these, kind of decisions now, of course the great challenge, is how you make sure that everybody, is, the dress that everybody understands. That, everybody, can be engaged to what you what what, you have them but, what is the purpose of engaging the people, but. So, what, we try to do in, Mexico with, that that making. Sure that at least we. Produced, information, that. People different, audiences, would be familiar. With what was at stake particularly. When very hot range for sensitive, discussions, were taking place, now. UNESCO. In. A way continues. Today it's. That's why I was I was very happy to, participate. To. Join UNESCO. Because the idea of UNESCO, is also, to make sure one, of them coming as you know one, of the main because, many people are familiar with UNESCO, basically, because of the heritage, places, and, many, more do, not know that units because much, more than protecting. Cultural places, which is also very important, but is exactly the same principle for Sciences. For, example I, mean the reason. To establish, UNESCO. Was to foster international. Collaboration. And to, build peace and into, and, to make sure that they we erased that we achieve the well-being of people by, having. International. Collaboration, in science in education, and in culture and, in. That. Sense the idea of science, of Africa of looking at Sciences, to link it into, a set of values to, make sure but, this is that. These goals are achieved in the framework coverage of the human rights and. In. Particular, also making. Sure that this is a UN organization. So we are of a big variety of, countries, so, we have for, the moment 100, to 93, countries so, it is very important to make sure that you meet, the goals of all the nations and at the same time you take, into account the cultural variety which, is huge and we a little bit in the previous panel what, about for example indigenous. Populations. Or disabled, populations, or, whatever, so. What. Happened is that in. 1993. And. The director-general, of, UNESCO establish. International, biotics Committee and because. He realized, that. When. It was at the time when I went, I hold DNA, and once a, DNA. Project was finalized. And he realized, that he was going to be huge, huge. Challenges, becoming, in front of Member States and this technology will bring a lot of revolutions so. The. Idea of the Director, General at, the time was to have a body of experts. International. Experts, in their individual, capacities. They are not representing. Their governments, they are there because, in hindered individual, capacities. And the idea is that they are multidisciplinary, and. We. Really. Try to strike. A balance geographically. To, make sure that we have different.

Different. Ethical, positions different with. Different disciplines. And different cultures. Represented, in. The committee trying to kind of simulate, what. Is, the real world and, try. To have these. People to identify it what I'm not what what, are the challenges that, are. The. Most ethical challenges, that arriving, in, at that time particularly. Linked with with, genome, edit or with genomics, and then, try. To advise governments, on how to deal with this now. After that in, 1998. I'm not, a committee the commission of ethics. Of Science and Technology was established, it's also informed. By independent. Experts they. Are trying to track, to address more issues of more. General, not, only Life Sciences, and medical science and suddenly that happened a direct impact on human, health for, example but also in general in science. And technology, now the boundaries, as you know are getting, a bit blurred. So there is a lot of more communication. Among themselves they, have been doing, more much on or, for example on environmental. Ethics in, that in July and after, the last time look now they are working also a lot of IOT. And internal, I artificial. Intelligence, but also IPC. Has, been also working on. Latest. Technologies, so, I don't want to get very, much. To extend too much but just to say that these committees, have been the ones who have been paving, the way to another, very important, role of UNESCO, which is one, on one hand the laboratory, of ideas, through, the work of these committees, trying, to try, to find within, the diversity. Some, common, shared values, which. In, the framework of UNESCO, and particularly, in the whole declarations. That you can find in art. As I said already. Human. Rights, human. Dignity. Justice. Equity. Solidarity. The. The right to access to the fruits of science, that non-discrimination. And. Of course there is also always an issue of risk and benefits, and. So. These, committees. And try to find within the diversity. Some principles. And they, have been dug the driving, force to. The next. Work. Of UNESCO, which is a standard. Setting so, UNESCO, is the only UN. Body, that has. Adopted. Three. Declarations. Which are not legally. Binding but nonetheless have, been the ones who have paved the way to do, that to deliver national. And regional legislation. Related, to these topics so as you can imagine the, first, deadline. First declaration, was the one on human genome and human rights in 1997. The, second one is the International declaration on human genetic. Data in. 2003. The. Last one on this regard. Was larger, it's the universal declaration of ethics and human rights in 2005. And. We have another declaration of climate change and a recommendation on scientific, and scientific, researchers, I will. Speak later about, the public engagement, in the elaboration of these documents I just, wanted to make to refer, to this and, particularly, the, recommendations. That so, just one, one last word we, do the third pillar of the work is capacity, building the, idea of contained is normative instrument, and it Laboratory of ideas, is that they can have some, impact somehow. So, all if all of are linked to the possibility, building activities, which, are on one hand. Directed. To governments, today, institutional. Capacity, for example to establish, national politics committees, and. The other one is more, than academic. Which. In general the institutional, which is we. Have to develop for example, a lot of tools like a core curriculum on bioethics and, and. Teacher and and. Trainings. To teach teachers. How to teach bioethics. And we have also develop a lot of tools for national politics committee including. How to engage with public, and how to develop public policies. Which you can have those guidelines say, online. So. The what. Happened after the adoption of the Declaration and. This would be my last part. Is, that the IDC started, to write reports to. Try to flesh, out the principles. Of the declarations, because if you see of the principles, of the declarations, they are really shallow there, is there, is the, result of what is on a UN organization. It's a platform, where you can have all the academics. Try. And all the different cultures, bring in being together to try to explore. What values. They can have in common and at the same time they have, negotiation. About some political principles. That they can agree on so. They. Started, to prepare these reports, were that, are also using in the capacity-building, activities and, in, 2015. They, developed, one on updating. The reflection, of human, genome and Human Rights and there. They completely, call upon States and governments to produce internationally. Legal binding, instruments. To burn cloning. For Reproductive, purposes they. Agreed, to a moratorium on, geni on genomic, and gentling, at least as long as safely at the frequency, of the procedures, are not adequately, proven, and as Freedmen's to.

Renounce To the possibility, of acting, alone in relation, to engineering, the human genome and except. To cooperate, on establishing, shared global, standard, for these purposes, building. On the principle, set of the declarations. I thought I mentioned before and to, encourage to adopt, rules procedures. And some which, can be as non-controversial. As possible, especially with regards to the issue of modifying, human genome. Last. One last recommendation interventions. On the human genome should be admitted only for preventive, diagnostic, or therapeutic reasons. And, without enacting, modification. From the sentence. Thank. You very much Daphna, so, one, of the issues that has come out in all of the comments so far is the question, of shared. Values, of shared principles we might also say a sort of shared vocabulary or shared starting, point and you. Know I mean as we've seen there's as sort of a diversity, of what's. Shared and who it's shared among so, I asked Nora. - now speak from a particular national. Perspective, where. The. Altar. Made reference to the ways in which the work of her, committee was constrained, or configured, by an existing, regulatory, landscape in the US and the ways in which it asked questions and so forth its remit so, I wonder if you'd say something about. The. The, German ethics council, in Germany, its role, the way it sits within, the. The, kind, of larger landscape of how things are approached in Germany, and this sort of domain but also of its starting, points how are its questions. Framed. And what does that mean for how you approach those questions, particularly, if you if. You compare, that approach to approaches. Taken elsewhere for example in this country thank. You and, hello. So, the German ethics council in, some way goes, back to. 2001. When, there. Was a big debate in, German society about, whether or not to import, human. Embryonic stem cells that had been produced in, other. Countries, by destroying. Embryos. Destroy. Destruction, of embryos, for. Research is illegal. In Germany and. Has been since. 1991. But, the question arose whether. Scientists. In Germany should still be able to use the cell lines the, embryonic stem cell lines produced elsewhere. And. Back then the government. Created. This. Then. Called national ethics council to discuss this particular question, and, Parliament. Who. Weren't quite happy with. Leaving. All the initiative to the government, created. A sort of. Competing. Council. Made, up by members. Of parliament, and invited, experts, and both, these bodies deliberated, on this question and then because, the general, format, of having, these. Broad. Expert. Committee is discussing bioethical. Issues had. Turned out to be quite successful they both stayed. Active. For, several years after that and discussed other bio, ethical, and medical ethical topics but. At. Some point the. Wish. Arose, to, give, all this, bioethical. Advisory, business a more proper, Democratic. Foundation, and. Parliament. Then. Actually, created, its own separate, law to, form the. German ethics Council as it is now and. That replaced, post. Two. Previous bodies, so. In its current form the German ethics Council has been working, since, 2008. And. The. Law quite specifically. Tells. Us how we. Should work we have 26. Expert. Or. Otherwise. Represent. Members, who represent. With. Special. Expertise. Or. Interest. In bio ethical and medical, ethical. Topics. Half, of them get nominated by the government, half by Parliament and our. Role is to inform. Politics. To give advice to government and, Parliament. To. Work closely, with similar. Bodies from around the world and. Importantly. To further. Public. Discourse, as well and engage with relevant, target audiences. And. When. We embarked. On our. Project. On germline, editing. That's pretty, much what we did. So. We. Worked on this for three, years and, had. A, number. Of public. Meetings probably. If you count all of them and had some level of public participation about five or six different ones. Where. We talked about, the topic from all sorts of different angles not just including.

Reproductive Issues. But also in a broader context, and then. We. Also had, a number of exchanges. With, various, other partner. Councils. And other organizations. In. Contrast, to what my. The. Previous speakers have said. There, probably, has been a lot. More. Focus, on, the. Issues that, are. Facing. Researchers. Now in particular the use of. Human. Embryos again in the research that is needed to get, the. Reproductive. Genome, editing, to. The level where it would be considered, safe if you. Wanted to go down a droid. The. Other thing which. Is probably a bit different about. Our approach is that rather than trying, to come up with a series, of recommendations. About. What should or shouldn't be done although. We do have some of those as well is that we spend a significant. Amount of. Our. Energy, and efforts to flesh. Out the questions. That. People might want to ask along, the whole process of getting. To potential, applications, and, on. Really. Reflecting, on the arguments. That people. Might want to buy. Into when. Determining their own, positions. Most. Of this is available online, we've got our. Executive. Summary and the, graphic, that came out for like finding. Your own individual, path through these questions available. In English on our website so I won't go into detail, but, our, hope is really that by. Identifying. These questions, more closely and mapping, them quite explicitly. To both the possible, arguments, and the ethical, concepts. That, might come, into. Those. Arguments, the. Discourse. Speeds, at the public level or at the level of other expert, exchanges. Could. Be. Made. A bit more transparent. And also, help. People to find a common language even when backgrounds, are very different, buta. Just elaborates slightly, more on specifically. Ultimate, reference to the issue of, how. To what. Questions you would need to ask to make it technically, responsible. I wonder. How. Those. Stand in relation, to other sorts of questions ethical. Questions in your mapping of things and particularly. Given that the starting point is protection. Of human dignity, what. What does that mean for how you think about technical. Dimensions and its relationship, to other dimensions, of. This. Area I'm, not sure if, we. Answered that question. Explicitly, because, at the technical, level. We. Probably. Bought into a number. Of similar, conditions, that need, to be checked and, hopefully. Fulfilled, before people progress, to a, subsequent. Stage, but. What. We do is that we very clearly say that those cannot. Be the. Only, questions. Asked but they always need, to be seen in conjunction, with these. Other. Issues, at a societal level at.

The. Determination. Of general. Ethical. Or public political positions. And. That. They. Need to be certain checkpoints for both or all those, dimensions. Need, to be examined, before you. Consider progressing. Thanks. So. Tina I want to now turn to you last but not least to say something about a quite, new initiative, a quite new body. This. International. Commission on clinical. Applications, of germline editing or something like that of. Which you are a member, and I wonder if you'd say something about where. It came from what what has what, is the sort of sense of the need for this that, gave rise to it and and also its focus and the, rationale for its focus given that its focus is quite narrowly. Technical. If. It's alright then I will say. A little bit about myself. And these do and other. Things that I'm involved in because there's a reason that you're on this. So. I want to say first that, Altos. An. Anecdote, about Orrin, Hatch describes, one, of the only things he ever did that, I agreed, with and he thought and he was my senator, from Utah so. So. I am a genome editor and, until. I closed my lab last, year, I had worked with all of the platforms. The zinc finger nucleases the. Talons and the CRISPR platform, I started. Working on Geno net genome, editing almost, 24 years ago before. People, had defined really defined what it is and. I. Just. Have had a ball being, in, the. Whole history of this, technology and seeing. What it's able to do. And. Also mentioned, that I have, an affiliation with the IGI here. In Berkeley, I am. The, part-time. Interim, director of their Society program but, what that means is I spend a little bit of time here and I try to help lis Witkowski, any way I can. We're in a process of trying to expand, the efforts of the, society program in. A variety of areas including policy. And public engagement, and education and, a. Couple of the things that I'm particularly interested in are bi-directional. Conversations. Between, scientists. And non-scientists. As. A way of incorporating. Broad. Public opinion, into. Things that are happening both in the policy. Arena but, also in the research arena so. We're hoping to figure. Out ways to to. Have, impact. In those areas the, other thing that I'm quite interested in that it's. Been a little bit of discussion about in the previous panel is equitable, access to the, benefits of the technology and, I'm. Not going to. Elaborate, on that anymore. As. Part of my lightning campaign, to make Ulta feel good I'm. Gonna, mention, that I was at the Asilomar conference in, 19th. 1975. I. Was very young. But. But I was there and I. Think, arguably. There. Was public. Input into policies, around recombinant.

DNA The. The conference. Itself the Asilomar conference was. Attended, mostly. By scientists, and journalists, but. It. Was in response to a lot of public outcry. The. Public input into. The. Governance, of recombinant, DNA was chaotic it. Wasn't, organized. In any particular way but. It did have an impact and. Particularly. Because it. Was really easy for people to imagine horror. Scenarios. For, what, might happen with released, recombinant, DNA, and. So. You. May, know that the then, probably does maybe many, of you don't the city of Cambridge Massachusetts, banned. Recombinant. DNA research within, its borders for, six months. Forefront, of quickly did - anyway. We're. In a really different situation, now with CRISPR, and. With genome editing, in. 9 in the early. In mid-1970s, we really didn't know what the impact, of recombinant, DNA would be. For. Research, and for. Applications. Medical, applications, agricultural. Applications now. I think we can say with a lot more certainty both, what those applications, are going to look like and what the potential hazards, are so. Just to. Put that out there ok. The. International. Commission on, clinical. Uses of human, germline, genome. Editing, it's, a commission that was established last. Early. Summer I think it. Has 17, representatives. From a lot of different countries around the world. We've. Had one. Public. Meeting it was in Washington, in. August we. Have another one next month in, Londyn and. A final one will be in Washington in January and. At these meetings we're making. Progress toward, fulfilling, our tasks, and let, me just read you a couple of things from our statement, of tasks, this. Is, from. The National Academies, of Sciences, and medicine and the Royal Society who. Assembled. The committee the Commission an, International. Commission will be convened with the participation, of national academies of science and medicine throughout. The world to, develop a framework for considering. Technical, scientific. Medical. Regulatory. And ethical requirements. For, germline genome, editing should. Society conclude. That, such applications. Are acceptable, so, this, is a group, that's following on from altas, group that. Provided. That report. In, 2017. We're. Looking in even more depth at what would be the technical. Conditions, in particular that. Might. Make, human. Germline editing. Acceptable. This. The specifics. Refer. To scientific. Issues as well as societal, and ethical issues, were, inextricably. Linked. To research, and clinical practice that must be evaluated for. Various classes of possible applications. Identify. Appropriate protocols. For pre, clinical validation. Protocols. For assessing, and evaluating. Potential, mosaicism, and, long-term implications, and, some. Things that follow on from there so what, we what we've done so far has, been to. Get. Information. Testimony. We've had some webinars from. Experts, on the, technology, on, human, genetics, we've. Had some input from patient, advocates. We'll. Have more technical. Input. On. Human. Embryo but. Our understanding of human embryos and in, the in. The, London, meeting next. Month we'll also have more input from, people. Who are involved in ethics and governance and actually, we'll share a session, with the w-h-o. Committee on. That, session you've got all kinds of random people there so right yeah, supposed, to be a shared session I know yeah. So. Our our. Involvement of the public has been. Mostly. Like what happened with Altos. Commission which is that. We, invite public. The, public, anybody. At all to. Watch. And listen, to. Our public sessions. To. Listen and watch listen, to and watch our, webinars. To. Provide comment, but. We aren't specifically. Charged. With, involving. Broad. Ranges. Of the public in the discussions. Themselves. But, as I said we have a fairly narrow remit. To. Look, at you, know what standards, would have to be met before. A, public. That was comfortable. With going ahead with this might, think it was safe and effective. Do, you think that that remit can be met, through expert. Input do you see or do you have concerns about. Who. You are hearing from are not hearing from the. Waves the questions, that your you, have been handed as your as part of your statement of tasks are framed. Yeah.

So. Deciding. Who. We're going to hear, from is an, ongoing process, and we evaluate, it all. The way along we. Have phone. Calls. With. The full commission or subsets, of the Commission to. Decide what. Sorts of input do we need so what we're doing is we're looking at what's the state of the technology, right. Now and. What. Are. The things that are out there that are going to be developed, in the future that. You know there's sort of on the horizon, we can see them albeit. In the distance that. Would sort, of push us toward a situation. Where we would feel that, the technology. Can do the things that, people. In the public are. Hoping and actually thinking that it can do yeah. Though for, instance some of the questions Gregor brought up and the mornings in the previous, panel are. At. Once technical, and also sort. Of complex ly not well, what, is what are technically. Safe. Interventions. In two particular diseases. Also. Connects. With the question of how judgments. About what are diseases and what are diseases that warrant interventions, are made and what it would mean for those to be safe given. That those, can be understood, as he was pointing out as other kinds, of problems as problems of social context, as opposed to problems. Of DNA sequence. Are these questions. That that, the. Commission. Is contending. With or are they beyond. The remit. Because they are admittedly very difficult questions all right so. As. Altas group. Came. Up with and every. Pretty much everybody talks about in the same way you have a risk benefit analysis, that you need to do and depending. What the benefits might be the. Tolerable, risks, will be in a different category so. We are dealing with risk, benefit, analysis, that hasn't been a big part of the discussion so far we've been getting much more of the the, technical, input but it's it's coming. As. I, said we were, you. Only had one of the three public. Conferences. That we are going to have right it's a but the issue of sort of what counts as a risk as Daphna was pointing out you can see that as a as a risk to the common heritage of humankind, which is a very different way. Of thinking about risk than risk then then, you, know a, risk. At the sort of biochemical level to. A specific, individual did you ultimately. I. Wanted to say even more narrowly than that. Figuring. Out how to value the benefits is, one that is very different in each regulatory.

Context, I worked, at the FDA for a little while and, how. Do you put, a value on, a child, being able to sleep through the night because. An asthma medicine is helping, against. An extremely, remote risk of death because. You've got a million, kids that are gonna sleep better and do better in school etc these. Are things that are very difficult to evaluate and because, it's not apples and apples. And I think, that not, only is every regulatory agency, going to struggle with that but it's gonna vary from country to country so, here how, much value do you place on the ability to have a child who's genetically, related to you without the risk of the child having a disease, it's, going to vary depending on how important, is it in your country that people have kids that are genetically related to you so. I don't, know that any one body could answer this because it's going to be very context specific sure. Lawrence did you want to, know. Thank, you let. Me, let. Since, just in interest. Do. You guys can all see her waving at me. No. In the interest of time wit since we have reproduced. A. Problem. Not that's so much a deficiency, but it but it's a problem in these kinds of operations which is the, issues are immensely complex and can fill up the time for this small group of people who are commissioned, to deal with them and then there isn't room to bring in other voices so I want to I want to take, a few minutes to bring in some other voices from the audience. And. Ask. If anybody has, a question. Jennifer. So. Yes. So Jennifer asked how many how many people have now registered their, research, with the w-h-o. Right, now we're starting with somatic, research, not germline and, w-h-o. Already has a clinical, trials registry, which is the first step, finding. A way to get people to register research. Not clinical, but preclinical. Research is, the, next challenge and that we're still working on.

Other. Questions Santiago. Did you have a yes. How. Is meaningful this incorporated. Into the, communities that you're a part of and are there examples other. Than I guess the chaotic. Public. Backlash had a Sylmar or before asylum arm where. You could see that. Kind of playing, out in, in your cases. Opportunities. For dissent does anybody want to Nora, please so. This. Is the norm in, anything a German ethics council does we very rarely have consensus. On anything, and don't aim to. Publish. Just. Content. Consensus. So. We. Either. Directly. Set out as we have done in this project on germline. Editing, to. Fully. Develop the, dissenting. Paths. Or opinions. And, to, present. The arguments, that are in favor or against. Both sometimes. We then also include, how, many people voted for which but. Since we're not in, the first instance. A body. Who decides something but just sort of presents, the. Possible. Paths that's not the main thing sometimes. There is almost a consensus, but somebody, will still disagree, and for that we have, explicit, space for people to present dissenting, opinions, in their own separate space and that gets published together with the main opinion. We're. Not gonna put, the questions, up here because it will continue, to blind you all but they are active, so if you're if you're logging into the poll everywhere, it, will show you the what questions do you have for the panel and, Kevin back there is going to maybe, read one um if. That's all right yes. From. YouTube. So. From Alex and this, is a question I hear. A lot and it's kind of difficult asking, and I'm sure the, panel's hear, this a lot too. Do, they think that actors and such, countries and then list a bunch of countries that. There will ever be a way to regulate these or misuse of CRISPR worldwide. Particularly. For for enhancement, what. Do you say to the public that asks that a lot, the. Challenge, of global governance. Maybe. Lawrence do you want to start since you've got the largest number of cats to her. Knowledge. That it is a challenge. But. I think it's also a necessity, personally. In. The latest development, show the importance, of having that reflection, so, again. This notion of consensus, or agreeing.

Any. Steps is important. I think and and. It's. I do. Believe that it's possible to get agreement on a certain. Number. Of fundamental. Principles and then, on on the way to go, to our decisions, potentially. And I think that they the, approach of the German ethics committee is quite interesting, in that respect. If. I may take this opportunity, to make a comment I actually have a questions, to the panel to a certain point. I'm strike by the ID and you have in the title of this seminar CRISPR, consensus, with a question mark and I. Think that there is one area where there seems to be consensus, is a need for public debate, there's. None I mean we, we heard that. It's subject, to the society. Deciding and so on so this agreement, on public debate is necessary I, have to question on this is this. Are we are we all talking about the same things when we talk about public debate I have, a lot of data on this I have a lot of data in to respect the. Question. To answer and the modality, to it. And the. Second element is and, in. Here I can also address the questions to myself. There's. A lot of things going on on technology, technical, aspects we've heard that and it's always subject, to but, what about these, articulations. Between the work that is done on these technical, aspects and safety aspect and actually. The public. Opinions, collections. And how do we reconcile, this how do you articulate both because. There seems to be going quite fast on safety, risk technology, but. Is. That are, they going to be a possibility to wait for public opinion afterwards, because it seems to be the the key element at the end or, not I'm, sorry to put it that way but I think that's quite important, and an important issue here I think those are absolutely, excellent, and crucial questions, and and, actually. I'd like to close the panel by inviting everyone. To respond, to those questions not, in the fullness of the responses, you could give but by pointing, to in your, experience, in working in these contexts, what, are what, is a key, limitation. In. Capacity. Need. That. You feel is. It. Needs addressing, particularly. Visa vie the. Role, of public, debate and the, relationship, between processes, of technical, judgment and larger. Questions, that in effect belong to all of us maybe. We'll just go down the line beginning with uLTA I. Think. In an area in which a lot of the publicly expressed. Concerns, have to do with questions.

Of Morality and, religion and. Cultural. Values that it's, important, in every country and every jurisdiction, to really think hard about what is. The. Role of those attitudes, in terms, of governance are, those, sufficient, reasons, to. Prevent. Individuals from, acting, in a way that's contrary, to those larger, more commonly, shared values that, problem, of majoritarianism. But. Also wanting. To protect the interests, of dissenters. Runs. In every country and it's handled differently in every country and I think that that. Role of how what does public opinion really mean in your governance system I think is crucial. Garance. Well, that's a big question that's really challenging I. Think there are multiple aspects, that are really challenging even other regional. Level that is Europe, but. I also think that there's an issue of autonomy. In the sense of, recognizing. The ability, and the value, of the view of others as a, key element and, you can extrapolate that in many different levels and. Responsibilities. Responsibility. To be honnest transparent. And, objective. As, much as possible and there. Are share responsibilities, I think, we we were asking at the beginning who, is an expert who is not an expert so I think, III. Agree, with a question the world does expect mean I think, we could all have different, hats but. We have to be clear when we express ourself which had we are wearing. To. Voice our concerns and, that's quite important important. So. Transparency. Responsibility. Respect. Others. Including. It I. Agree. With all of that I. Do. Think there, always, is a challenge, and and will be throughout. The next steps of this particular discourse. To. Really. Think about how, all these different. Initiatives. And and approaches, to public discourse, are going to enter the, process at the decision, level. Making and I don't have a blanket, answer, to it nor do, I think there can be one, but. I think it's important that it happens at some level so, not that these, processes just happen and people can check the box and say oh we've done some discourse, now let's carry on with our usual processes. But that there is some. Reflection. On how this is going to be taken into account I, think. There have been instances in the past where this has worked, I think the UK's, process. In permitting. Mitochondrial. Replacement, therapies. Wasn't. A bad way to go about this but it was a very specific question and for genome editing, we. Are at a much earlier and broader. Stage. So. It. Will be interesting to see how it pans out. You. Know I agree with those comments from, a practical point of view I think, it's it's. Quite difficult to get a broad. Range of informed. Public, input and, I've had a few experiences where. I've. Gone into fairly. Small groups of people very. Little scientific background, and tried to give them a little primer on what. What. We're capable of doing what we're not capable of doing as. A, prelude, to getting, feedback from them. How. They feel about it and I think you, know the the GMO, example, is a good one where, without. Solid. Information. On what was actually happening with. These, modified, crops there were very loud voices that. Dominated, the conversation and. What I'd rather see happen is a lot of different voices that. Have, a better idea of what's actually underlying. The. Research and the applications. That are going on have a chance to to, chime. In and I've. Also in these. Opportunities. I've had answer. The question that asked, earlier tried to elicit. Dissent, and found. That. The. Sort. Of dominant, attitude of people is, if you've got a medical approach, that can help my family why. Aren't you doing it and so. I think we need we need to also. Be trying to put putting put the brakes on some. Of the. Exaggerated. Expectations. That, the public now has thank. You all, right definitely you've been very patient so you can have the last word. Thank. You so much in. Fact it's. Very complicated because many of the things have been said. So. Probably, what I would add, is, that is, the sum of what I, think we are facing a very crucial, a very. Difficult challenge first of all the technology, is very uncertain and it's, evolving, very quickly and we were all discussing CRISPR, cos 9 and now we have the new one which is supposed to be done better and we'll year so maybe you change, the title of the obsessing. Perfume second. We really don't know what's the. I also agree with who is the public, who, is the expert.

And What, what are the questions, who decides, and but. What. Is knowledge to. Begin with because I don't think the experts that what the sign tell them academicians. Of the scientific, the scientists, are the only ones who have knowledge they have a kind of knowledge that other people do not have but, there is knowledge although everywhere. And that's part of what we need to do

2019-10-31 10:28

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