Team:Virginia/Interviews/Policy Ethics Interviews

• PROJECT
  • DESIGN
  • MODELING
  • EXPERIMENTS
  • PARTS
  • SUMMARY
• HUMAN PRACTICES
  • INTERVIEWS
  • SURVEY
  • SAFETY GUIDELINES
  • POLICY PROPOSAL
  • PUBLIC EDUCATION
  • iGEM OUTREACH
  • BUSINESS
• TEAM
  • TEAM MEMBERS
  • COLLABORATIONS
  • ATTRIBUTIONS
• DOCUMENTATION
  • NOTEBOOK
  • SAFETY
  • REFERENCES

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Initially, the goal of our policy interviews were to understand how our biocontainment method might fit into the current framework of legislation and regulation. However, we soon discovered that the current institutions and policy did not allow for a comprehensive regulation of synthetic biology, using biocontainment, decreasing the barriers to implementation. Many of these interviews inspired, informed, and refined many of our deliverables, including the iGEM pamphlet, policy proposal, and the Open Bio Labs safety guidelines. Many of the concerns expressed by these individuals, both scientific and ethical, also affected the design of our biocontainment method and the experiments we decided to run. Lastly, many of these experts cited an expressed need for effective and cheap biocontainment in order to further advance the field through policy.

Hank Greely

We interviewed Hank Greely, Professor of Genetics at Stanford School of Medicine, early on in our summer of research. As our first interview, we didn’t have a clear or succinct idea of what we wanted to take away from talking to professionals about our project, but we did know we wanted to make a difference in the area of synthetic biology policy. More specifically, we wanted biological containment to be a topic that was discussed more frequently in the scientific community because we believe that a lack of clear biocontainment guidelines and regulations hinders the expansion of the field. We also wanted to gain feedback on our project while we were still in the early stages of planning our experimental design.

During the interview, we asked him several questions about his opinions on the Presidential Commission for the Study of Bioethical Issues and its relevance to modern synthetic biology.  He believes that changes will need to be made in the near future, but he does not believe that change will occur to the coordinated framework until the first large problem occurs. With this approach, the government is avoiding exactly what they started the Presidential Commission for: to prevent problems from occurring by addressing possible concerns before the technology is actually accessible. The idea was to stay ahead of the new biotechnology, but he was led to believe that this would not be the case.

Next, we asked him about biocontainment policy in broad terms to get a better idea of what it is like for policymakers that do not understand the technology to also make regulations for it. He used the example of a different new technology, drones, to explain the importance of scientists and policymakers to interact, educate each other, and collaborate on regulations that both parties can agree on. He mentioned that it is most important, and most difficult, to make policy in such a way that does not inhibit future progress, but also protects those who do and do not use the technology.

Along with this long discussion on biological policy, he asked us many questions about our project. He had several concerns that we were able to address on the spot, but a number of other ones that we did not have an answer for. This was not only good practice for the iGEM presentation, but also a new way of gathering information on our project. By asking experts about their concerns or recommendations for our project, we could cater to the needs of the people that would actually use our technology one day. Additionally, we discussed his major concerns and, in some cases, implemented them into the design of our project.

Overall, we gained a lot of insight on how we wanted to direct our interviews in the future. We used all the information that Professor Greely provided us with and used it to further inform our research. Some of this information can also be found in our biological containment pamphlet that we constructed specifically for iGEM teams to use so that they can have access to the same information and resources that we collected and used throughout the summer.

Lisa Lee

We spoke to Dr. Lisa Lee, the current Executive Director of the Presidential Commission for the Study of Bioethical Issues (PCSBI), this summer. During our conversation, we discussed the role of the Commission and compared it to the ethic committees of other countries. Dr. Lee explained how PCSBI is given a subject to review by the President of the United States, and upon completion of the review, the Commission moves on to the next project. The Commission has no regulatory power so it can only make recommendations that is then up to other agencies to follow through on. Dr. Lee also said many countries have a standing ethics committee, whereas the establishment of PCSBI and the appointment of its members are dependent on the President of the United States; in other words, PCSBI disbands at the end of the President’s term and whether or not the United States continues to have a bioethics commission is at the discretion of the next President.

We discussed the pros and cons of having a standing ethics committee versus having a temporary one. On one hand, a standing ethics committee is not limited by time. They are able to carry out long term projects that span throughout the terms of multiple Presidents. However, a standing committee would likely have elected members, or members appointed by Presidents from different parties. As a result, the committee would likely face the same type of gridlock that we often see in politics today. A temporary committee with appointed members, on the other hand, does not have to deal with standstills and can sometimes get more accomplished even when limited by time. Our conversation with Dr. Lee was very informative. We learned a lot about how PCSBI and other ethics committees work. Dr. Lee also gave us a lot to consider about whether it is better to have a standing ethics committee or a temporary committee, and she provided us insight into the political facet of science and ethics, something that we had never thought about before. Additionally, she recommended we contact the Woodrow Wilson International Center for Scholars for more information regarding follow-ups to the recommendations made in New Directions: the Ethics of Synthetic Biology and Emerging Technologies.

James Wagner

In 2010, the Presidential Commission for the Study of Bioethical Issues (PCSBI) issued a report titled New Directions: the Ethics of Synthetic Biology and Emerging Technologies providing recommendations for the responsible and ethical use of synthetic biology. We had the pleasure of speaking to Dr. James Wagner, former Vice Chair of PCSBI, to better understand the reasoning behind the Commission’s recommendations in New Directions.

In our conversation with Dr. Wagner, we were interested in learning whether his views on the Commission’s recommendations have changed in the six years since they were issued, especially given the rapid developments in synthetic biology in recent years. Dr. Wagner explained to us that the Commission was pro-science and recognized the potential benefits of science for society. However, they wanted to ensure any risks to society are also minimized. Thus, the Commission recommended broad principles such as public beneficence and responsible stewardship to provide flexibility in the document while simultaneously investing in science. Furthermore, Dr. Wagner emphasized the Commission wanted to “leave the longest legs possible” and were satisfied with the timeless nature of the final recommendations. He firmly believes that the recommendations still hold and provide a good compromise between allowing scientific advancement and minimizing risk.

In regards to biocontainment, the New Directions report only mentions suitable containment methods should be used on synthetic biology materials to prevent unintended consequences to the environment. When asked why the Commission did not recommend a specific biocontainment method for researchers to use, Dr. Wagner expressed that a recommendation of that nature was beyond the scope of the Commission and needed scientific expert decision. It was also premature to select a biocontainment method when all of the existing methods exhibited rates of failure. Consequently, the Commission simply recommended a review be conducted to identify suitable containment methods for synthetic biology materials. However, to the best of his knowledge, Dr. Wagner does not believe the reviews were conducted after New Directions was issued.

Our conversation with Dr. Wagner allowed us to gain a more comprehensive understanding of the broad role of the Presidential Commission as setting the framework for progress. However, this discussion also exposed the lack of regulatory policy pertaining to synthetic biology and biocontainment. Additionally, it was also brought to our attention that much of the information on biocontainment was inaccessible and not comprehensive. In response to both of these concerns, we utilized existing data from research papers to create a side-by- side comparison of different characteristics, such as effectiveness and ease of use, of current biocontainment methods. This conversation, in conjuction with others, inspired our team to create the policy proposal. Additionally, Dr. Wagner suggested we rebrand our project as an advancement of potential applications of synthetic biology rather than the prevention of consequences. Since then, we have determined many areas where the barrier to implementation of synthetic biology technology can be overcome with our biocontainment device. Additionally, we have used this advice to modify the language we used in the discussion of our project on this Wiki and other materials generated.

Nick Evans

Dr. Nicholas Evans, an assistant professor of Philosophy at the University of Massachusetts, Lowell. He was an excellent source of information on bioethics, as his dissertation was on dual-use research of concern in the life sciences and his current research is on the ethics of dual-use research in synthetic biology. He expressed that conducting good scientific work should be both balanced against and driven by the concern of public health. Although he believed that the 2010 report by the Presidential Commission was useful advice, he thought that certain ideas, such as periodic reassessment and prudent stewardship, were not clear. Additionally, due to the structure of the Presidential Commission and their relative lack of enforcing power, none of the recommendations were carried out. When asked about the ideal system for enforcement of synthetic biology regulations, Dr. Evans preferred an international organization funded by the government. This organization would be independent, serving the states, and able to hire scientific experts to review technology. His recommendation is a standing body that has the sole role of reviewing and regulating technology rather than a committee that meets to discuss a topic once and generate recommendations based on a specific time point. Additionally, he believes that this type of review can alter the behavior of scientists, who, currently, are not incentivized or paid to look at the larger impacts of their research. The regulation of technology that may not fully be understood, in his opinion, warrants policy that is responsive without being too particular: in other words, it must work decently in most situations rather than excellently in only one situation. He believes that there should be an international biocontainment standard of success that allows implementation of synthetic organisms into the environment, because diseases and ill consequences aren’t restricted to borders. These insights truly helped to shape our approach to generating the policy proposal.

Dr. Evans discussed the ethical concerns of biocontainment with us as well. The ideal system, in his perspective, should be cheap, effective, and easy for labs in all countries to use. In his words, it is worse to tell people that a faulty system works than it is to provide no system or be transparent about weaknesses. Additionally, he spoke about the importance of considering vulnerable populations in implementation of synthetic biology. Dr. Evans inspired and was the primary source for the “Ethics” page in our pamphlet.

With regards to our project, Dr. Evans prompted us to consider the consequences if our system was hacked, how likely it would be for our system to be hacked, and the potentials for dual use. However, he admitted that the potential for dual use of our project is not great. He also expressed that there was a large market for an inexpensive reliable biocontainment method in the implementation of synthetic biology products.

Charles Green

We spoke with Deputy Commissioner Charles Green of Virginia’s Department of Agriculture and Consumer Services to discuss the effect of GMO’s on Virginia’s economic and social policy. Within iGEM, many teams develop projects that solve key problems in society, but fail to establish methods in which their project can fit into policy. It was our hope that, through discussion with Deputy Commissioner Green, we could find a niche within state legislation that would benefit from our technology, or in some way be improved by opening up the floor for discussion.

Deputy Commissioner Green spoke toward the differences between state and federal legislation toward synthetic biology. The issues of development and deployment of synthetically modified crops has been dealt with as an economic issue within the state. As such, most focus has been focused on the import and export of GMO’s, as well as local labeling regulations to deal with growing social movements within the state and country. According to Deputy Commissioner Green, regulation is performed on a federal level by agencies such as the EPA and USDA, depending on the product being produced.

An interesting point brought up in our discussion with Deputy Commissioner Green was that of international standards. A major issue facing synthetic biology legislation is that of maintaining a reasonable and internationally accepted standard. Two major roadblocks exist, that of varying levels of regulation, and different paces of countrywide legislation. The first point details cases in which a GMO is accepted in one country but not another, leading to difficulties with trade and commerce. To address this point, we hoped that opening the floor for discussion of a global standard for GMO’s would help facilitate trade and partially eliminate this issue. The second problem exists between countries with different methods of regulation, such as China and the United States. A product in the U.S can pass through regulations quicker than in China due to a well-established infrastructure. This delay in approval sometimes results in large losses to exports, slowing down trade and causing additional issues between countries.

Overall, our discussion with Deputy Commissioner Green gave us a greater insight into the interplay between federal and state law. We learned more about the depth of the legislative issues surrounding synthetic biology, including economic, social, and international considerations. This interview helped us to consider the importance of an internationally accepted standard for synthetic biology. His insights greatly informed the creation of the policy proposal.

Jessica Tucker

We spoke with Jessica Tucker, the Director of Office of Biotechnology Activity at the NIH, to discuss our proposed policy and to learn more about the NIH as an institution. From our conversation, we learned that the NIH is not a regulatory agency, so it would be unable to enact our proposed policy. She expressed that while the ideas in our proposal were well thought-out and valid, it served more as a tool to enable discussion and conversation rather than a full-fledged policy. In response to this point, we decided to shift our focus away from submitting our proposal to a department for approval. Rather, we redefined the goal of the proposal as fostering discussion about synthetic biology regulation and biocontainment legislation.

While guidelines for genetic engineering do exist, they are at least forty years old and do not fully account for new developments or issues in the field. The guidelines are set in place to manage all laboratory practices regarding synthetic biology. With that in mind, any change that would incorporate environmental release of an organism would be drastic and unlikely.

After discussing our proposal and the NIH, Jessica Tucker offered some possible organizations that we could contact to initiate discussions. Those organizations included regulatory agencies such as the EPA and FDA, and while we had already considered contacting them, Mrs. Tucker’s feedback encouraged us to pursue additional contacts.

Alan Pearson

To reinforce our policy proposal further, we contacted a member of the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS), Alan Pearson. We sent him our policy proposal for his review and he offered us corrections and suggestions. The most significant advice he gave us was to avoid assuming that a biocontainment device can be evaluated independently of the organism in which it is instantiated because it can be caused by the organism itself or the environment. We took this recommendation into consideration while making revisions to our proposal.

Todd Kuiken

Earlier in the summer, we spoke to Dr. Lisa Lee, who suggested we contact the Woodrow Wilson International Center for Scholars to learn more about how the recommendations in the New Directions: the Ethics of Synthetic Biology and Emerging Technologies report were carried out. We were fortunate enough to speak to Dr. Todd Kuiken, then an investigator at the Wilson Center and current co-chair of iGEM Human Practices. Dr. Kuiken also works closely with community biolabs to ensure safety protocols are followed within these labs, which aligns with our own work with the local community biolab, Charlottesville Open Bio Labs, to create safety guidelines for them to follow.

We first asked Dr. Kuiken about New Directions: the Ethics of Synthetic Biology and Emerging Technologies and his opinion on the recommendations made in the report. Dr. Kuiken said the recommendations were good, but there was no real authority to ensure the recommendations were followed so many, if not all of them, were never implemented. Therefore, it left open the question of who would claim responsibility in a synthetic biology accident. Dr. Kuiken believes the more foresight you have in the matter, the better. This led us to consider how we, as an iGEM team, could influence policy and patch the gap in safety, so we decided to try our hand composing a policy proposal to address regulatory agency authority on biocontainment. Dr. Kuiken recommended we start by talking to the Environmental Protection Agency, the U.S. Food and Drug Administration, and the U.S. Department of Agriculture.

We then talked to Dr. Kuiken about his work with community biolabs. Dr. Kuiken told us how community biolabs on DIYbio.org have an agreed upon set of safety principles and how he works to ensure people in these labs are properly trained in safety protocols. Additionally, DIYbio.org has a biosafety portal where a panel of biosafety professionals review and respond to any safety quesitons you may have. We explained how we were working with Charlottesville Open Bio Labs to rewrite their lab safety guidelines and asked for advice on what areas of safety to emphasize more heavily when it comes to community biolabs. Dr. Kuiken said community biolabs are often limited by the safety equipment they have. For instance, fume hoods are costly, both in terms of money and space, so labs often go without one. This exposes researchers to noxious chemicals and poses health risks to everyone in the lab. Thus, we added a section to our safety guidelines that explains alternative methods for achieving comparable results with cheaper equipment.

In summary, Dr. Kuiken gave us great insight to both the New Directions: the Ethics of Synthetic Biology and Emerging Technologies report and community biolabs. He helped shape our Human Practices by pointing out areas that needed policy change, resulting in the development of a biocontainment policy proposal and a more comprehensive safety guideline for Charlottesville Open Bio Labs.

Jason Shwartz

Dr. Jason Schwartz is an Assistant Professor of Health Policy and Management at Yale University. His research focuses on the translation of data into regulation and policy in medicine and public health. His expertise was very useful to our team in shaping the way that we thought about the role of public discussion in informing policy. He expressed that extension of the conversation about synthetic biology into the broader community would reverberate, causing elected officials to discuss and implement policy related to synthetic biology and biocontainment. He also talked about the importance of including scientists in the discussion on regulation policy. Like Dr. Nick Evans, he expressed the concern that a false sense of security is worse than not implementing a security method at all and, as a result, decreasing implementation. Biocontainment, in his view, must be part of a comprehensive biosecurity standard. This viewpoint, in addition to Dr. Todd Kuiken, inspired the creation of Open Bio Labs Biosafety Guidelines, a all-purpose and all-inclusive biosafety guideline for a narrow population with specific needs. His thoughts on this subject also informed the public outreach activities that we conducted, including the Building with Biology event and pamphlet.

His perspectives on the current policy also helped us in refining our policy proposal. Due to the lack of progress made on the recommendations, he suggested, like other interviewees, that a standing body in government on synthetic biology should exist to continuously monitor and regulate the field. He also expressed that the government should be sensitive to the balance of risks and benefits in the regulation of the field. Dr. Schwartz’s insights helped inspire several deliverables, while confirming the need for better biocontainment.