[MUSIC] In this section, I'm going to talk about a number of different governance models. We've already run through some in the first section, where I highlighted governance models you've already seen, right? So recombinant DNA technology in week one, gain of function research and dual use research of concern in week two, biofuels in week three, and genome editing in week four. I'm going to talk about three specific examples in synthetic biology in a little bit more detail. So the first is from SB2.0, which is the Second International Meeting on Synthetic Biology, that took place in California here in the US in 2006. And day 3 of that meeting was intended to be devoted to thinking and talking about ethical issues raised by synthetic biology. In particular, biosecurity and risk, public understanding and perception, ownership, sharing and innovation, and community organization. And they really wanted everyone to be involved in these discussions. Because they had hoped to have a vote on a series of statements around developing norms, around some self regulation in synthetic biology, to develop norms of behavior in the field, particularly around biosecurity and safety. And those statements are listed here. Both ended up being scuttled before the meeting. But the points here that described norms nonetheless I think hold some sway in the field. So the first is to insist that all commercial gene synthesis companies adopt best practices around screening, and I'll talk a bit about that in my third example. To create and endorse watch lists to improve screening programs, to create a confidential hotline. This isn't a norm, it's a particular action. But B.2, affirm members' ethical obligation to investigate and report dangerous behavior. So the idea that we are all in this together and it's our responsibility to, Make sure, it's our responsibility to when we see dangerous behavior to report it. Here in the US, if you see something, say something. Create community wide clearing house for identifying and tracking these issues and endorsing biosecurity and biosafety research and development priorities. The second brief example is around dual use research of concern and the journals, which I mentioned briefly in the first section. So after the attacks here in the United States in September of 2001 and the anthrax attacks that followed very closely thereafter, concern about bioterrorism really was raised here in this country. And there were calls from the Bush administration at the time to the scientific community to address concerns related to the publication and broad dissemination of research that might reasonably be understood to pose a security threat. So, for example, the publication of the genetic sequence for anthrax or the reconstruction of the 1918 flu. And certainly the H5N1 example that we've talked about before would fall into this category as well. And out of this ultimately came a statement in 2003 that was published in science and elsewhere from a very large group of well regarded scientific journals and others that made some four brief statements. And these included sort of noting the unique status that research published in peer-reviewed journals has. Identifying the need to recognize an interest, safety and security issues raised by submitted manuscripts. An endorsement that processes should be in place to allow for the appropriate review of submissions that raised safety and security concerns. And then finally, the agreement that when potential harm from a particular paper outweighs the potential benefit, that that paper should be modified or not published at all. This agreement did absolutely lead to processes being put in place at a range of journals. Though it remains unclear whether this effort has actually led to papers not being published. They're being withheld. And then the third example, which I've also alluded to before, is sequence screening. So between 2008 and 2010, there were a range of codes published. A range of statements from a number of different organizations proposing standards that should be adopted by DNA synthesis companies. So these were from the International Association for Synthetic Biology, issued a Code of Conduct. The International Gene Synthesis Consortium published their Harmonized Protocol. And then, here in the United States the Department of Health and Human Services published their screening framework Guidance for providers of synthetic double-stranded DNA. There is some variation across these three documents, but generally, they all state that DNA synthesis companies should engage in the screening of incoming orders for synthesized DNA. In particular for regulated pathogens and other potentially dangerous sequences. In addition to sequencing the orders, the customer, the person placing that order should also be screened to ensure that they, for example, are associated with a legitimate research institution. There should be record keeping of orders and customers for up to eight years for example, and that that should include orders that were declined or findings of, Screening of orders and customers that in cases where there is a concern about the sequence being ordered or the customer that order can be refused. And that that should be reported to appropriate authorities depending on the jurisdiction. And that there should be, of course, regulatory compliance with the jurisdiction which one is operating. And these guidances are all voluntary but they have in fact had an impact and have influenced the behavior of DNA synthesis companies.
