How is the public systematically excluded from discussions about genetic engineering technologies? What strategies might scientists employ to include public opinions within their governance structure?
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To date, deliberation and decisions about genome editing have occurred in a narrow variety of venues. Most of them look either like conferences or panel-based workshops. At the larger end of the scale, the National Academies of Science, Engineering and Medicine (NASEM), the Royal Society of the United Kingdom, the Chinese Academy of Science and the Hong Kong Academy of Science have organized two international summits. Hundreds attend and thousands live-stream these conferences where experts go on stage to present their ideas. At smaller scales, scientists have held information-gathering sessions with local community members for specific projects, like releasing genetically engineered mice on Nantucket island to curb the spread of Lyme disease. While these stages vary in the breadth of both audience and expertise, in the United States they continue to reproduce the dynamics of the Asilomar model. On stage, academic experts present information, typically via powerpoint slides or prepared remarks, and audience members are, at best, given a brief period of Q&A or placed into breakout sessions.
Despite the growth of the public interest in emerging genetic technology, publics remain in a reactive position rather than offered opportunities to be proactive. Deliberation about the social and ethical dimensions of genome editing lags behind the science. In this post, we will examine the formation of committees in charge of international summits and the outcomes of these gatherings to identify ways that different publics can be more proactive in the backstage decisions that have dominated decision-making in genetic engineering so far.
Committee Formation at The National Academies
NASEM is a non-governmental association of academics in the United States created in 1863 to provide science and technology advice for the nation by bringing together experts from a vast array of scientific specialties. Expert committees are formed to organize events and consensus studies to inform white papers and reports drawn from symposia, conferences, and workshops that discuss specific issues related to science policy. These committees are typically a group of between 10-20 people with “a diverse range of expertise and perspectives.”  But who is actually invited to participate? Who is considered an expert? According to current formal organizational procedures, NASEM staff first reviews the scholarly literature and then “consults widely with the institution’s members and volunteers, knowledgeable authorities, and professional associations.” Individuals are chosen based on the Academies’ assessment of their knowledge and experience with the topic being investigated. When selecting candidates, one dimension of focus is the balance and disclosure of conflicts of interest (COI). To do this, the academies require selected participants to fill out a series of forms disclosing any potential conflicts of interests.
This is important to unpack because the NASEM acts as a quasi-governmental agency, allowing political interests to leverage the allure of scientific authority in their favor.  We took a look at the most recent forms available on the NAS website to get an idea for what this process looks like. A conflict of interest is defined as “any financial or other interest which conflicts with the service of the individual because it (1) could significantly impair the individual’s objectivity or (2) could create an unfair competitive advantage for any person or organization.”  Typically, this means that the individual must disclose if they or anyone close to them (e.g., a spouse, employer, or family member) is either employed by or owns part of a company that might benefit from the decision-making. A conflict could also include holding patents that relate to the science being discussed. The NAS acknowledges that in some cases, conflicts of interest are unavoidable, but at least tries to be transparent.
Despite this process, the selection of individuals for NAS committee members has recently come under scrutiny. Two salient weaknesses of this policy is that financial interests valued less than $10,000 are not considered conflicts of interest, and the selection criteria only focuses on “current” conflicts, ignoring the possibility that past engagements may influence committee members’ views. In part because partnerships between scientists in academia and industry are now commonplace, the variety of ways in which any individual can have a conflict of interest has ballooned. Since committee members are asked to voluntarily describe conflicts of interests, assessing the extent to which financial connections have been disclosed by the NASEM is difficult. For example, one study found that six out of 20 committee members from a genetically engineered crop consensus study had financial COIs that went undisclosed. 
In addition to financial COIs, there are other ways a potential committee member might demonstrate conflict. One group of scholars characterizes non-financial interests as interests related to (1) the individual through personal beliefs, (2) other people through personal relationships and (3) the organization through organizational relationships.   Another group describes non-financial conflicts more narrowly as intellectual conflicts of interests in which an academic activity creates the potential to develop a strong attachment to a specific point of view that could affect an individual’s judgment.  Unfortunately, one of the problems with identifying non-financial conflicts is that they may not fit any definition of conflict of interest.  In addition to these steps, the NASEM sometimes opens up the selection of prospective committees for public commentary during a period of time. For a month or so, individuals, companies, or interest groups may submit letters of concern and suggestions for the formation of the committee. These comments are then considered by the organizers of the committee and changes may be made to the final slate. Given these limitations to the COI process, it is unclear what mechanisms exist to ensure accountability and that the widest possible set of stakeholders are represented on committees.
Science is a value-laden field where judgments are made based on researchers’ values and preferences. Researchers’ preferences and values can form via personal beliefs, scientific training, and research settings. In the context of making big decisions, there is a clear need for various values and preferences to be present, as well as vigilance for an awareness of when one type of value is dominant.
In response to the publication in Science after the Napa Valley meeting (discussed in Post 4), an initiative was formed at NASEM to address the need for broader scientific and societal consensus on genome editing. From our interviews, we became aware that it was unclear to genome editing scientists which organization should host such an effort–the Howard Hughes Medical Institute, scientists at UC Berkeley, and the American Society of Human Genetics all vied to be the stage for these discussions. Because of its expertise, legitimacy and perceived neutrality, the Academies arose as the central host. The explicit aim of the initiative was to “provide researchers, clinicians, policymakers, and societies around the world with a comprehensive understanding of human gene editing to help inform decision-making about this research and its application.”  As such, the initiative acted as if it was an information funnel and filter with the task of producing reports.
In pursuing this aim, the NASEM identified what areas of genome editing are controversial, which ones are settled, and what the technical limitations of the technology are. NASEM has been given such authority in the conversation about genome editing technology because its committees are made up of scientists, who are perceived as neutral, objective and able to analyze data and make decisions using unbiased processes. But as we have been learning in previous posts, science is always political and value-laden.
One of the first outcomes of this initiative was the organization of the first International Summit on Human Genome Editing. Held in Washington, DC, at the Academies in December 2015, it was the first large public stage that fostered dialogue among the international scientific community and included presentations and deliberations around the scientific, ethical, legal, social and governance issues associated with human gene editing. The organizing committee included David Baltimore (as chair), Paul Berg, George Daley and Jennifer Doudna, all of whom played central roles in the Napa Valley meeting. The committee also included expert representatives from the Chinese National Academy of Science and the Royal Society of the UK. This summit invited US and non-US researchers to serve as speakers and discussants on the emerging societal implications of new genetic technologies.
David Baltimore, an organizing committee member of both the 1975 Asilomar Conference and 2015 Napa Valley Meeting, stated in DC, “We are taking on a heavy responsibility for our society because we understand that we could be on the cusp of a new era in human history.” Rather than an exaggeration, this statement is a reflection of the role the scientific community has written for itself as the main arbiter of what should happen next regarding human genome editing. It is reminiscent of narrow arguments for technocratic governance in which only the experts hold decision-making power. This sense of duty and the weight of lone responsibility inhibits collaborative processes that actively include the ideas and knowledge of individuals not professionally trained in molecular biology, but who will still be impacted by the products of this research.
After the meeting, the NASEM released a set of guidelines for oversight systems to govern the research on and clinical uses of human genome editing. While these guidelines pay lip service to some of the concerns voiced by social scientists and disability justice advocates at the Washington meeting, they actively neutralize any argument for establishing a more socially just science or preventing applications of genome editing that are racist or ableist.
For example, in response to concerns voiced by some disability justice advocates that the biomedical expansion of genome editing could exacerbate stigma towards people with disabilities or parents of children who are born with disabilities, the guidelines argue that “Public policy has shifted toward eliminating discrimination in employment or public services, and public investment in changing the social, physical, and employment environment to achieve this goal has increased, with measures ranging from accessible buildings to sign language presentations to aural signals for street crossings. The range of measures remains insufficient, however, and one cannot know whether this shift in attitude would have been even more dramatic if genetic screening and abortion laws had not made it easier to reduce the prevalence of birth defects. Nonetheless, this progress does to some extent address the concern that reducing the prevalence of disabilities will necessarily decrease empathy, acceptance, or integration of those who have them.”  Opting instead for a permissive framework and minimizing concerns about the use of genome editing for enhancement and germline modification on technical grounds, these guidelines have had a lasting effect on how applications of genome editing are governed.
The Second International Summit on Human Genome Editing was held in 2018 to discuss a broad range of issues pertaining to biomedical uses of genome editing. While the vast majority of the agenda was made up of a carefully curated set of lectures and panels, the second summit hosted a three-hour event called “Let’s Talk About Genomics and Genome Editing” that was intended to provide members of the public with an introduction to genomics and genome editing, and an opportunity to engage with experts on these topics. These types of events are regular practices of what is seen as public “engagement.” At best, this form of engagement is designed as a listening session where scientists can hear public concerns and answer questions; at worst they devolve into smaller dissemination sessions. Other public events, such as CRISPRcon, have attempted to develop avenues for conversation with audience members, but similarly devote most of their time to dissemination and panel discussions between experts. What we want to underscore about these efforts at deliberation is that they are seen as orthogonal to the process of decision-making and formal governance. They are highly valued by scientists as an opportunity to learn what the concerns and interests are of different stakeholders, but are not a venue for collective action. Instead, decisions about setting research agendas, technical standards and policy articulation occurs in closed-door committees largely made up of technical experts in government offices—such as at the National Institute of Standards and Technology, The National Institutes of Health, the Food and Drug Administration, or at professional associations of scientists.
In these formal venues, concerned and curious publics made up of patients, their advocates, citizen scientists, religious leaders, scientists in training and nurses are replaced by patent lawyers, biotech startup reps, industry scientists, and PIs from high profile academic labs. As a result, claims about equity of access, disability justice and ethics that are voiced by participants in public conferences are largely absent. This arrangement effectively de-centers concerns about, for example, CRISPR-based sickle-cell therapeutics being too expensive, disabilities such as deafness being “corrected” without input from the Deaf community, the environmental effects of genome editing in non-human animals, or about profit driven in-vitro fertilization clinics adopting genome editing to sell “designer genes.”
Policy debates must consider these and other concerns voiced at public venues and learn to wrestle with complex issues. At stake in these conferences, meetings, guidelines and informal discussions are the values that undergird genome editing. This means bridging, on the one hand, broad discussions about how health and wellness are defined, how to protect the environment, how to advance social justice and racial equity, with, on the other hand, practical discussions about technical limitations, uncertainty and clinical risk.
What about International Cooperation and Consensus Building?
Globalization and the interconnected nature of research communities have aided in the spread of genome-editing technologies across national borders. Irrespective of nationality or social identities, we all have a version of the human genome. So what does this mean for how the regulation of genome editing looks? This question becomes even more pressing when we expand outward from our individual agency to engage with the application of gene editing on ourselves or future children, to questions of state and military interest, as different countries can have real interest in seeing these technologies deployed in the name of public health or in military defense.
Each country has distinct regulatory standards as well as ethical, political, cultural, and social norms. For international consensus to be developed, these norms would either need to be compressed into a single set of norms for every country, or expanded to work with multiple governance structures. Two of the few examples of an international consensus that have been operationalized as bilateral treaties and agreements, effectively serving as a sort of law, include the Cartagena Protocol on Biosafety and the Nagoya Protocol on Access and Benefit-sharing. These are examples of laws that are legally enforceable. International summits and symposiums on human genome editing would be considered agents that can wield “soft power.” This would include a list of guidelines that are not legally enforceable, and instead are voluntary, require cooperation, and can be adopted and revised quickly. Both of these forms of governance would require thoughtful, deliberative conversation across countries about the accountability of science to the people, social justice, and confronting the vast differences in governance across countries. Despite being in the interest of constituent publics, as a matter of public policy, international competitiveness in science can inhibit the formation of such agreements. Finally, existing efforts to regulate scientific research internationally must overcome pressures from private firms and large pharmaceutical conglomerates who may lobby for specific outcomes in each county.
Decision-making meetings and conferences about genetic engineering technologies continue to mimic the Asilomar model, which excludes the public from holding meaningful decision-making power with how the technology should be used. Organizing committee members for these meetings are selectively screened, and it remains unclear how accountable these committees are to public comment and outside stakeholders. This is especially important because science is value-laden and largely shaped by the interests and preferences of those in power. Global initiatives similarly place scientists as the arbiter of what happens next with genetic engineering technologies, effectively removing key perspectives that would challenge systemic and structural issues related to the production, access and use of genetic technologies. Accessible and deliberative conversations about the accountability of science to the public—with an emphasis on the role of social justice within genetic engineering technology governance—will be an essential step towards creating equitable global standards for the use of these new technologies.
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