[MUSIC] In the last week of the course, we will be talking about two topics, governance and synthetic Biology, and public engagement. So governance is a word that is intended to capture a range of modes of oversight and regulation of an activity by a range of different actors. Everything from traditional laws and regulations coming from governments, through non-governmental organizations, institutions, professions, and others. And it's not the case that for any given technology or across technologies, that one particular mode of governance or regime, collection of government's approaches is going to be appropriate. There are important and substantive differences between technologies and between different applications of a particular technology. So the technologies and the applications will vary. There will be a different constellation of moral concerns raised by a technology or by a particular application of a technology. There are different stakeholders, different groups of folks stand to benefit or bear the burdens of a particular technology or application, and different backgrounds constraints. So the existing for example, regulatory landscape, or intellectual property landscape, will vary across technologies or applications in ways that impact how we think about governing that technology or application. But I do think that sort each new technology or each new application is sort of an opportunity to try to get it right again. Because these are all quickly evolving, sort of cutting edge technologies, and they can be hard to govern effectively. And ideally you would want your governance to be flexible and responsive to changing technologies. In SynBio there exists a number of different kinds of governance, of both the science and the applications. And there have been a series of recommendations for how we might think about governing this technology. Governance can happen at many different levels. As I said in the definition on the first slide, a whole range of actors might engage in governance. This can go from something as sort of informal as norms, so how one is expected to behave as a member of a particular field or profession. Self-governance, wherein people within a field take it upon themselves to place limits or provide guidance for how to engage in research or deploy technology. The institution at which you work engages in governance of science. Funders, through their decisions about what they will and won't fund, or what can and cannot be done with funding, engages in governance. Journals, in academia, publication is along with grants, are the coin of the realm, it's a key point for governance within science. States and nations of course, engage in governance all the time and in science that is increasingly global. There's also interest in global governance of the science. So just provide a few examples of each of these levels of governance, some of which you've already seen in this course. So with regard to norms, in the first week on recombinant DNA technology, I talked about Andrew Lewis who was working with hybrid adenoviruses. And made a decision that he would only share these viruses with people that he thought would handle them carefully and appropriately, and understood the danger associated with them. The SB2.0 resolutions, which I'll talk about later this week, was an attempt by the synthetic biology community itself, to engage in or to define norms of behavior within the field. Self governance, the first week again with recombinant DNA technology and the moratorium on recombinant DNA research. Followed by a seminar and a more, those early steps in self governance lead to more formal governance at the level of funders. And the government through NIH and the recombinant DNA advisory committee. Also, self governance at the commercial or industrial level, and I'll talk about this later this week as well with regard. To DNA synthesis companies screening orders that are coming through their doors. And self governance can happen by individuals, or at the level of professional society, for example, as well. At the level of institutions, your research university engages in governance all the time. We have institutional biosafety committees. We have material transfer agreements that regulate how research resources move within and out of the university. And how research institutions deal with intellectual property. What kind of licensing agreements they write for technologies developed at their institutes. Funders, both public and private, again, the examples that you have already seen in weeks one and two of the rack, here in the US to govern recombinant DNA research. And the NIH gain a function funding clause, would also fall into this category. Journals, as I mentioned before, are very important in particular in academic science, we have to publish. Journals are uniquely situated to exert influence on academic scientists. In the case of synthetic biology, a case that I'll talk about later this week. There was a statement from a large number of journals about the publication of dual use research of concern. And how they were going to monitor and make decisions about the publication of potentially concerning research. Journals also have requirements about data sharing and data deposition in public databases. In the US, states do sometimes make research policy, both with regard to what kinds of research activities can take place within their borders. And the funding of research, in particular in the case of the use of certain human tissues. So for example, newborn blood spot DNA, and the sale or transfer of human eggs, and funding of stem cell research. Nations, of course, make laws, have regulations, develop federal funding priorities. And in some jurisdictions there are QUANGOs, or Quasi Autonomous Non Governmental Organizations, hence QUANGOs. An example of sort of national regulations affecting synthetic biology, came in week two in the discussion of the H5N1 case, and the Dutch export control rules that were evoked in that case. And then finally governance at the global level. This is trickier because nations have different background constraints, have different regulatory tools available to them, limits on power, etc. But there are examples of course, out of the United Nations, UN declarations, global agreements, etc, that can have some effect. And an example there is the convention on biological diversity that you heard about in the week on biofuels. And then of course there can be combinations across all of these levels of governance. It's also the case that governance can be approached from different perspectives, right, and I'm just going to talk about three of these. One, the first one, is the precautionary principle, which is most closely associated with the EU. A definition of the precautionary principle out of the Rio Declaration 1992, is that where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing efforts to mitigate the damage. The Rio Declaration out of the Rio Summit of course, was related specifically to the environment and development, and so the focus was on environmental degradation. The precautionary principle is often now framed around protecting the environment, human, animal and plant health. So again, the idea here is that you don't have to have all the scientific data in to take precautions against potential harm. Another approach that is gaining in prominence right now, not just in the EU but internationally, is responsible innovation. We talk a bit about that with Jane Calvert in my interview with her. As defined by the European Commission, responsible innovation is an approach that anticipates and assesses potential implications and societal expectations with regard to research and innovation. So it's the idea that research and innovation should take place with a broad lens with regard to the impact of that research or innovation. And then the third approach that I'm going to talk about is prudent vigilance, which came out of the Presidential Commission for the Study of Bioethical Issues here in the United States, in their report on synthetic biology and emerging technologies. And in contrast to the precautionary principle, prudent vigilance is the idea that you establish processes for assessing risks and benefits, sort of both before and after projects are undertaken. So it's sort of a watch and wait approach. You're going to let the technology move forward, but you're going to keep a close eye on it. And the orientation or the approach that one takes to government. The orientation or approach that one takes to governance, influences what that governance is going to look like. So another important aspect of governance that we're going to talk about this week is the role of various stakeholders. You've done some stakeholder mapping now. And that includes of course, the public in many or most cases. So one example here from the National Coordinating Center for Public Engagement is that it describes sort of The various ways in which activity and benefits of higher ed and research can be shared with the public. And importantly, engagement is viewed as a two-way process. It's not just the scientists communicating, it's the scientists listening as well. And public engagement has evolved over time from sort of basic science communication or outreach. Basically the scientific community telling the general public, here's what we're doing. Through a long period of functioning within sort of the deficit model, meaning the general public does not understand this stuff. They have a deficit, they don't get it, they don't have the knowledge, they don't have the understanding. And the scientific community needs to sort of fill that gap. They need to educate the public about what it is science does, what are scientific values, and what science is doing at any given time. And this really now has transitioned into the model of engagement, which is more along the lines of the definition I just showed you. Engagement really is about that two way street and importantly, and I think Tanya Bubula captured it well in her 2009 paper. Public deliberations or engagement should be an honest effort at relationship and trust building rather than persuasion. With mechanisms for actively incorporating the input of lay participants into decision-making. So the scientific community really does have a lot to learn from the general public. And that's what engagement is supposed to be about as well. Public engagement is not only important but it's also I think, a duty of the scientific community. Often, public funds are being used to conduct research and to develop, for example, intellectual property. And that comes with duties for transparency and accountability to the people who are paying the bills. The public ultimately are likely to bear the burdens and reap the benefits of these technologies. Science, in theory, should be done in the service of improving human well being. So it's important to talk to the public and to learn from them what in fact would be nurturing of that well being, and what would harm that well being. In addition, there are values as I've talked about earlier in the course that are important, that are not scientific values. The general public holds values that come from a different place and that are valuable as well, and ought to be incorporated into our thinking about research and innovation. It's also important to understand those values, given that oftentimes this governance is being developed in democratic pluralistic societies, right? There are lots of different people who live in society, and again, are going to bear the burdens and reap the benefits of science and technology. And their voices need to be heard. Then finally, science in particular, publically funded science, but science generally does best when there is as Tanya Bubula noted, a trusting relationship between the scientific community and the broader public. Neither can thrive without the trust of the other.
