Standard approaches to defining and evaluating environmental risk tend to reflect technocratic rather than democratic values. One consequence is that institutional mechanisms for achieving citizen participation in risk decisions rarely are studied or evaluated. This article presents a survey of five institutional mechanisms for allowing the lay public to influence environmental risk decisions: public hearings, initiatives, public surveys, negotiated rule making, and citizens review panels. It also defines democratic process criteria for assessing these and other participatory mechanisms.

While the demands for greater engagement in science in general and regulatory science in particular have been steadily increasing, we still face limited understanding of the empirical resonance of these demands. Against this context, this paper presents findings from a recent study of a potential participatory opening of the German Federal Institute for Risk Assessment, a prominent regulatory scientific organization in the field of risk governance. Drawing upon quantitative surveys of the public and selected professional experts as well as in-depth (...) qualitative expert interviews, we identify a general support for greater engagement in science-based risk assessment. However, we also find significant contestation concerning its potential enactment and its normative and strategic merit. Underlying these contestations, we identify the persistence of a normal view of science and decisionist understanding of risk assessment, which create conflicting legitimacy demands for BfR and other regulatory scientific organizations. Together with concerns about imbalances in the power to participate, especially in highly specialized engagement processes, these pose significant challenges for the institutionalization of more participatory practices. (shrink)

This book fills a gap in the literature on the Precautionary Principle by placing the principle within the wider context of precautionary reasoning and uses philosophical arguments and case studies to demonstrate when it does—and does not—apply. The book invites the reader to take a step back from the controversy surrounding the Precautionary Principle and consider the overarching rationales for responding to threats to the environment or public health. It provides practical guidance and probing insight for the intended audience, including (...) scholars, students, journalists, and policymakers. (shrink)

New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally—and has attempted to conduct field trials in the United States—of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito-borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. (...) Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what “engagement” means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals’ preferences. Community engagement foregrounds the community in our thinking about humans’ relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy-makers, private companies, research funders, or scientists alone. (shrink)

The lead article in this issue of the Hastings Center Report explores the ideas underpinning the Precision Medicine Initiative, the effort announced by President Obama in 2015 to promote the development of treatments adjusted to genetic and other variations. Authors Maya Sabatello and Paul Appelbaum hold that the effort works by appealing to a sense of collective identity and shared commitment—an understanding that they call the “PMI nation.” But what are the moral implications of this idea? Sabatello and Appelbaum's question (...) about the impact of an imagined community is an unusual way of exploring a set of values questions. In the second article, Johann Brännmark defends what is, at least in bioethics, an unusual philosophical framework for moral values. Brännmark starts by calling attention to large, never-quite-solved problems with the field's going way of understanding personhood and autonomy, and then argues that the body of tradition, law, and international governance known as the human-rights framework offers a solution to those problems. And a supplement to this issue offers a set of essays on a topic outside the usual range for bioethics: the prospect of “de-extinction”—that is, of using genetic and reproductive technologies to construct simulacra of extinct animals that might eventually be introduced into the wild. (shrink)

The release of genetically engineered organisms into the shared environment raises scientific, ethical, and societal issues. Using some form of democratic deliberation to provide the public with a voice on the policies that govern these technologies is important, but there has not been enough attention to how we should connect public deliberation to the existing regulatory process. Drawing on lessons from previous public deliberative efforts by U.S. federal agencies, we identify several practical issues that will need to be addressed if (...) relevant federal agencies are to undertake public deliberative activities to inform decision‐making about gene editing in the wild. We argue that, while agencies may have institutional capacity to undertake public deliberative activities, there may not be sufficient political support for them to do so. Advocates of public deliberation need to make a stronger case to Congress about why federal agencies should be encouraged and supported to conduct public deliberations. (shrink)

Participatory deliberation, whereby diverse experts and publics collectively engage in decision‐making, can ensure a more informed and just decision by centering historically marginalized perspectives and engaging a spectrum of value systems. Broad and diverse participation is crucial for the equitable distribution of risks and benefits resulting from complex and uncertain decisions such as environmental gene editing. From an ethical position that gives intrinsic value to the nonhuman and recognizes the interconnectedness of species across generations, we argue that deliberation over environmental (...) gene editing must include the voice of nature and the voice of future generations. Inclusion of these key participant groups can encourage reflection on the human relationship with nature and help safeguard intergenerational equity of decisions reached. By drawing from the legal rights of nature movement, the Boardman River Dams Project, and methods for representative participation, we offer strategies for inclusion of nonhuman nature and future generations in deliberative processes about environmental gene editing and other crucial decisions about our shared environments. (shrink)

Reply to a commentary by Joseph J. Fins on “Financial Side Effects: Why Patients Should Be Informed of Costs.”.

Imprecise definition of key terms in the “public participation” domain have hindered the conduct of good research and militated against the development and implementation of effective participation practices. In this article, we define key concepts in the domain: public communication, public consultation, and public participation. These concepts are differentiated according to the nature and flow of information between exercise sponsors and participants. According to such an information flow perspective, an exercise’s effectiveness may be ascertained by the efficiency with which full, (...) relevant information is elicited from all appropriate sources, transferred to all appropriate recipients, and combined to give an aggregate/consensual response. Key variables that may theoretically affect effectiveness—and on which engagement mechanisms differ—are identified and used to develop a typology of mechanisms. The resultant typology reveals four communication, six consultation, and four participation mechanism classes. Limitations to the typology are discussed, and future research needs identified. (shrink)

In my time at The Hastings Center, the projects I've worked on have intersected in fascinating ways, but one through line has impressed me as especially important: centering the experiences and needs of people and communities most affected by the issue at hand.

Environmental releases of gene edited (GEdOs) and gene drive organisms (GDOs) will likely occur under conditions of high uncertainty and in complex socioecological systems. Therefore, public deliberation is especially important to account for diverse interpretations of safety, risks, and benefits; to draw on experiential and public wisdom in areas of proposed release; to ameliorate dangers of technological optimism; and to increase the public legitimacy of decisions. Yet there is a “democratic deficit” in the United States' oversight system for GEdOs and (...) GDOs, as unconflicted experts, publics, and skeptical stakeholders are most often excluded from decision‐making and unavailable to critically examine potential risks and benefits or raise broader concerns about socioeconomic or cultural impacts. This article argues for the need to open up decision‐making for GEdOs and GDOs, discusses the challenges for doing so within the current oversight framework, and finally, proposes institutional, policy, and attitudinal changes that are likely important for overcoming barriers to public deliberation. (shrink)

Different applications of synthetic biology are alike in that their possible negative consequences are highly uncertain, potentially catastrophic, and perhaps irreversible; therefore, they are also alike in that public attitudes about them are fertile ground for behavioral economic phenomena. Findings from behavioral economics suggest that people may not respond to such applications according to the normal rules of economic evaluation, by which the value of an outcome is multiplied by the mathematical probability that the outcome will occur. Possibly, then, synthetic (...) biology applications challenge the normative postulates of the standard approach, too.I want to first consider how some of the phenomena described by behavioral economists—and behavioral scientists more broadly—might affect people's perceptions of the uncertainties associated with synthetic biology. My analysis will be far from complete, however, because behavioral economics is essentially the study of human behavior, and thus its reach is potentially vast and its development longstanding and ongoing. Nonetheless, I hope to give an indicative perspective on how some aspects of behavioral economics might affect the assessment and perceived acceptability of synthetic biology. I will then consider the issue of agency. Should policy‐makers respect people's reactions to synthetic biology when those reactions are known to be driven by behavioral economic phenomena rather than following the normative postulates of rational choice theory? Or should policy‐makers dismiss these reactions as inherently biased? I will argue that the normative force of these human reactions (probably) depends on phenomenon and context. (shrink)

Proposals to release genetically engineered organisms in the wild raise complex ethical issues related to their safe and equitable implementation. While there is broad agreement that community and public engagement is vital to decision‐making in this context, more discussion is needed about who should be engaged in such activities and in what ways. This article identifies Indigenous peoples as key stakeholders in decisions about gene‐editing in the wild and argues that engagement activities need not only include Indigenous peoples but also (...) be designed, conducted, and analyzed in ways that confront longstanding power imbalances that dismiss Indigenous expertise. We offer specific recommendations to guide deliberative activities to not only be inclusive of Indigenous peoples but also to empower their diverse, situated knowledges. We call on those committed to the inclusive design of broad public deliberation to pursue strategies that shift dominant power dynamics to include Indigenous communities in more meaningful ways. (shrink)

Gene editing in the environment must consider uncertainty about potential benefits and risks for different populations and under different conditions. There are disagreements about the weight and balance of harms and benefits. Deliberative and community‐led approaches offer the opportunity to engage and empower diverse publics to co‐create responses and solutions to controversial policy choices in a manner that is inclusive of diverse perspectives. Stories, understood as situated accounts that reflect a person's life experiences, can enable the articulation of nuanced perspectives, (...) diversify how perspectives are communicated, encourage wider participation, open dominant perspectives to challenge, and invite participants to assess appropriate empathy and precaution in collective positions. An emphasis on storytelling in deliberations on gene editing of organisms emphasizes carefully designed recruitment and facilitation to support hearing from a range of perspectives, including those that present a different set of assumptions than those that may be held by experts or other stakeholders, among these, consideration of how to understand our relationships to nature. (shrink)

Designing broad public deliberation is challenging. In addition, participants of public deliberation are guided by their cultural norms, values, and rules. This creates a tension between the goal of practical approaches to broad public deliberation and how individuals perceive issues and relate to others in the world. Despite such challenges, we must continue to create opportunities for the public to deliberate about and provide input into the regulation of emerging technologies. Therefore, previously imagined approaches to broad public deliberation should be (...) reevaluated to better utilize the information gained during the process and expand the range of ideas incorporated into decision‐making. To do this, institutions must consider how the public makes sense of complex issues concerning cultural conflict. This article introduces a framework that demonstrates how cultural theory can be used for rethinking previous approaches to public deliberation. In doing so, it offers guidelines for designing public deliberation involving distinct public participation venues based on different worldviews. (shrink)

The development of technologies for gene editing in the wild has the potential to generate tremendous benefit, but also raises important concerns. Using some form of public deliberation to inform decisions about the use of these technologies is appealing, but public deliberation about them will tend to fall back on various forms of heuristics to account for limited personal experience with these technologies. Deliberations are likely to involve narrative reasoning—or reasoning embedded within stories. These are used to help people discuss (...) risks, processes, and fears that are otherwise difficult to convey. In this article, we identify three forms of collective narrative that are particularly relevant to debates about modifying genes in the wild. Our purpose is not to privilege any particular narrative, but to encourage people involved in deliberations to make these narratives transparent. Doing so can help guard against the way some narratives—referred to here as “crafted narratives”—may be manipulated by powerful elites and concentrated economic interests for their own strategic ends. (shrink)

The emergence of de‐extinction is a study in technological optimism. What has already been accomplished in recovering ancient genomes, recreating them, and reproducing animals with engineered genomes is amazing but also has a long ways to go to achieve “de‐extinction” as most people would understand that term. Still, with some caveats in place, creating a functional replacement for an extinct species may sometimes be doable, and given the right goals, might sometimes make sense. The International Union for Conservation of Nature (...) guidelines for de‐extinction do a reasonable job of keeping the caveats in place and clarifying the goals. In fact, given the right caveats about what de‐extinction can accomplish, we should pay a lot of attention to the technology and should think carefully about the goals. Not only has the technology been advancing, but our environmental standards have been getting looser and more flexible, providing less guidance for implementing the technology. The guiding ideals for conservation are often explained as a choice between John Muir, founder of The Sierra Club, and Gifford Pinchot, who helped create the U.S. Forest Service. Muir argued for preserving some places in the world in their natural state because of their great value and beauty. Pinchot, by contrast, was bluntly utilitarian. He argued for trying to keep some natural places more or less undamaged so that we could use them later. There has long been dissatisfaction with this choice, and in the last couple of decades, a number of prominent voices have proposed a “gardening ethic” as a new standard that combines elements of Muir and Pinchot. A gardening ethic is supposed to both celebrate the land and declare that it must now be managed. But what would good gardening mean when it comes to de‐extinction? (shrink)

Can we make wise policy decisions about still‐emerging technologies—decisions that are grounded in facts yet anticipate unknowns and promote the public's preferences and values? There is a widespread feeling that we should try. There also seems to be widespread agreement that the central element in wise decisions is the assessment of benefits and costs, understood as a process that consists, at least in part, in measuring, tallying, and comparing how different outcomes would affect the public interest. But how benefits and (...) costs are best weighed when making decisions about whether to move forward with an emerging technology is not clear. Many commentators feel that the weighing is often inadequate or inappropriate. Those who argue for a “precautionary” approach to the weighing do so precisely because they feel the need for a restraint on the dominant decision‐making tools and processes for assessing outcomes.This Hastings Center special report examines those tools and processes, taking the method known as cost‐benefit analysis as a starting point. In U.S. governance, CBA, sometimes informed by risk assessment, is the most widely used and extensively studied method, and authoritative reports on genetic and reproductive technologies often use language suggestive of cost‐benefit analysis. There is also a long‐running debate about the role of values in CBA and other formal impact assessment mechanisms—and about how those mechanisms compare to the precautionary principle. The guiding idea in the report is to engage in a close examination of the strengths and limits of CBA for ensuring that emerging technologies are used in ways that square with the public's values, drawing on applications of synthetic biology to illustrate and sharpen the analysis and then considering corrections to CBA and some alternative methodologies that handle values differently. (shrink)

How strong is the argument for requiring public deliberation by very large publics—at national or even global levels—before moving forward with efforts to use gene editing on wild populations of plants or animals? Should there be a general moratorium on any such efforts until such broad public deliberation has been successfully carried out? This article works toward recommendations about the need for and general framing of broad public deliberation. It finds that broad public deliberation is highly desirable but not flatly (...) necessary before moving forward with any local cases of gene editing in the wild. It also finds that broad public deliberation would be most helpful in generating very general guidance and is unlikely to be appropriate for specific cases. Broad public deliberation is most helpful for cases that involve higher levels of uncertainty and moral ambiguity, but separating out a distinct class of cases for deliberation is not yet possible. (shrink)

Both articles in the November‐December 2021 issue of the Hastings Center Report reflect bioethics’ growing interest in questions of justice, or more generally, questions of how collective interests constrain individual interests. Hugh Desmond argues that human enhancement should be reconsidered in light of developments in the field of human evolution. Contemporary understandings in this area lead, he argues, to a new way of thinking about the ethics of enhancement—an approach that replaces personal autonomy with group benefit as the primary criterion (...) for deciding what enhancements are acceptable. In the second article, Johannes Kniess considers the many attempts within bioethics to draw on John Rawls's work to discuss health care access and social determinants of health, and he comes across as moderately optimistic that Rawls's theory of justice has ongoing relevance. (shrink)