7

Engaging Communities, Stakeholders, and Publics

Rapidly advancing areas of research, like gene drives and their related applications, often are the subjects of multifaceted public discussion and debate. Some conversations will focus on scientific questions: Does the use of CRISPR/Cas9 to create a gene-drive modified organism cause unintended effects on the organism? How quickly will a gene drive spread throughout a population of mosquitoes or weeds or rodents? Some discussion will revolve around complex questions of ethics and values (see Chapter 4) and governance (see Chapter 8): Should gene-drive modified organisms be released into the environment? How do we decide where gene-drive modified organisms might get released? Who gets to decide? Not surprisingly, media attention to questions about gene drive research has risen sharply since the first proof-of-concept studies were demonstrated in fruit flies, yeast, and mosquitoes (see Chapter 2). Some gene drive researchers have shown an early interest in fostering broader conversations about gene drives (Esvelt et al., 2014; Oye et al., 2014), while some existing policy mechanisms, such as the National Environmental Protection Act, will require public consideration and input before a gene-drive modified organism could be released into the environment. Importantly, organized interests are likely to demand public engagement as innovation proceeds. This chapter focuses on challenges related to engagement and offers evidence-based frameworks for researchers, biotech companies, and policy makers to use to engage with public audiences about the science, ethics, and governance of gene drive research and its potential applications. We draw evidence from theoretical and empirical work in social science disciplines, including science communication, public relations, political science, psychology, sociology, and science, technology, and society, as well as the experiences of practitioners in public health to outline best practices for engagement across the diversity of potential gene drive applications and contexts.

COMMUNITIES, STAKEHOLDERS, AND PUBLICS

For the purposes of this report, we define engagement as follows:

Engagement is not just one activity (WHO, 2014) and it requires attention to multiple types of communication, deliberation, relationship building, reflection, and empowerment (e.g., Lavery et al., 2010). It is an ongoing and iterative process that does not stop at the conclusion of a research project. Neglecting engagement also undermines the important connections among values, responsible scientific practices, risk assessments, and governance.

Engaging communities, stakeholders, and publics is critical for successful decision making regarding the research, development, and potential release of gene drive technologies. These audiences for engagement exist on a continuum that relates to geographic proximity and interests (see Figure 7-1). In the context of this report, we define communities as groups of people who live near enough to a potential field trial or release site that they have a tangible and immediate interest in the project. While some scholarship identifies a community as “at least those individuals who share identified risks associated with the proposed research” (Lavery et al., 2010, p. 280), an emphasis on

shared, identified risks leaves open the possibility of excluding key, proximate groups, depending upon how risks are defined. While public health interventions to use gene-drive modified mosquitoes to control vector-borne diseases clearly implicate “communities” of people who live near a proposed release site, other possible gene drive projects may cast doubt on the standing of nearby communities that cannot prove a shared, identified risk. For example, if the gene-drive modified mouse in Case Study 4 were released in an area near residences on an inhabited island, the inhabitants may not constitute a community for purposes of engagement based on the definition in Lavery et al. (2010). Instead, the more common definition adopted by the committee errs on the side of inclusion. Stakeholders have professional or personal interests sufficient to justify engagement, but may not have geographic proximity to a potential release site for a gene drive technology. Publics—which we use in the plural as a reminder that public audiences are almost always subsets of the population as a whole—represent groups who lack the direct connection to a project that stakeholders and communities have but nonetheless have interests, concerns, hopes, fears, and values that can contribute to democratic decision making. Importantly, individuals may belong to more than one of these groups, suggesting that identifying who is a community member and who is “just” a member of the public will be less important than remembering that different groups may require different kinds of engagement.

MOTIVATIONS FOR ENGAGEMENT

Many factors motivate scientists, regulators, and other experts to engage with communities, stakeholders, and publics in the oversight of gene drive research. First, communities and stakeholders have knowledge that is essential to understanding the complex and variable social, political, economic, and ecological contexts in which gene drives will operate. Second, principles of justice demand both transparency in and well-informed consent to any future (experimental) trials that may affect communities of people and landscapes. Third, engagement creates opportunities for mutual learning that foster forward thinking, reflective deliberation, and the building of trust among diverse groups. Engagement thus presents challenges that must be recognized and addressed throughout the development of gene-drive modified organisms.

Integrating Practical, Experiential Knowledge

Communities have practical knowledge, insights into problems, and wisdom born of experience that may contribute pragmatically to more robust approaches to the development and governance of gene drives. Technologies exist within sociotechnical systems (Johnson and Wetmore, 2009), which means that technologies always operate in ways that connect to institutions, human beings, and social structures. For example, a gene drive for eradicating rodents on islands (Case Study 4) will not exist in a vacuum. Research and development of gene-drive modified mice will require funding from institutions, environmental release will be subject to regulatory oversight by various agencies, and diverse labor will be needed to design a release strategy and care for the rodents. Given this complexity, the “success” of gene drive technology will depend on the interaction of many parts of systems—social and technical.

Scholars of innovation have identified the importance of understanding and integrating multiple forms of knowledge—scientific, local or indigenous, and broader public preferences to the successful adoption of new ideas and technologies (Ascher et al., 2010). Recognizing the contributions of local understandings to the practice of science (Epstein, 1996; Wynne, 1996), and the ways that multiple forms of expertise interact and complement one another (Collins and Evans, 2002; Collins, 2004; Pielke, 2007; Suryanarayanan and Kleinman, 2013) is also crucial to the success of innovation. These diverse forms of knowledge and experience are often undervalued by experts, but they are essential to a complete understanding of complex phenomena and are especially important in the context of scientific uncertainty. Put another way, technical expertise is insufficient for ensuring good governance and responsible conduct in science; making decisions when gaps in knowledge exist requires multiple forms of judgment and strong attention to values (Sarewitz, 2015).

As just one example, Chuma et al. (2010) describe how an initial distribution in Kenya of insecticide-treated bed nets to protect people from malaria-infected mosquitoes was a disappointing failure. The technology and distribution plan were sound, but the white-colored bed nets mimicked the burial shrouds used by the local population, who thus did not adopt them (Chuma et al., 2010). When new bed nets were manufactured in a different color, adoption rates—and thus the impact of the technology—increased dramatically (Gore-Langton et al., 2015). The engagement of community members in the development of the technology would have quite likely avoided this mistake. Such stories are common in the arenas of international public health and development, suggesting that gene drive technologies designed for similar purposes and contexts could be subject to the same pitfalls. In addition, the need for ongoing monitoring for the long-term success of gene drives dictates the importance of creating partnerships with local community members—who not only might conduct the monitoring but also might suggest ways to adapt standard monitoring protocols to local conditions (Lavery et al., 2010; McNaughton, 2012). This exemplifies the importance of ongoing and iterative engagement.

Democracy and Justice

Moving from pragmatic considerations that motivate the integration of multiple types of knowledge to a more normative perspective raises important questions about engagement that relate to democracy and justice. What should we do because it aligns with our values? The National Research Council (NRC) weighed in on this theme with particular attention to decisions about risk:

As such, engagement enhances transparency and ensures some level of meaningful participation and consent. While engagement does not guarantee an outcome that will be celebrated by all, procedures that demonstrate good-faith efforts toward respectful listening, creative compromise, and flexible practice contribute to a sense of “procedural justice.” According to Ottinger (2013), “procedural justice, or the ability of people affected by decisions to participate in making them, is widely recognized as an important aspect of environmental justice” (p. 250), demanding that we foster “ongoing opportunities for communities to consent to the presence of hazards as local knowledge emerges and scientific knowledge changes” (p. 251). Regulatory frameworks may provide convening authority for engagement (see Chapter 8), but are often insufficient to achieve procedural justice. Where such laws are not in place, which may be a common context for field trials of gene drives in low-income countries, decision making processes may need to be developed to fit the political and cultural context—a lack of regulatory requirements demanding engagement does not relieve developers and scientists from the ethical obligation to engage public audiences. Examples might include ad hoc community meetings led by village elders or consultation with organized constituencies—furthering democratic goals regardless of the broader political context associated with the field trial’s location.

Case Study 2, a gene drive in Anopheles gambiae to reduce the spread of malaria, for example, involves communities of people who live near the release site, and depending on the social and political infrastructure of the locale, may also involve health institutions, environmental protection frameworks, and mosquito-control agencies. Precisely because many proposed gene drives aim to solve environmental and public health problems, the severity and priority of such problems cannot be determined a priori, or by experts alone. Severe and high-priority problems may justify attempting solutions with the potential for negative outcomes, but such determinations must be made in contexts that go beyond technical analyses. For example, communities of people suffering from high rates of malaria may be willing to accept greater uncertainties about the safety and efficacy of a gene-drive modified organism, especially if other control measures have failed or are unavailable. Such decisions may represent cultural differences in the perception and tolerance of risk, but they may also emerge from stark differences in living conditions, public health infrastructure, and access to resources. Thus, political decision making is required, and the engagement of stakeholders, community members, and publics is consonant with democratic visions of the governance of emerging technologies.

Relatedly, gene drives (as sociotechnical systems) connect with many existing ethical and social issues, in which public audiences, stakeholders, and communities are already engaged. Examples include: the proper regulation of genetically engineered organisms in food and the environment; strategies for managing biodiversity that identify and eradicate “undesirable” species; policies related to the patenting of organisms and genetic constructs, public health practices that involve the transfer of technologies globally; and definitions of and metrics for sustainability in agriculture and other production systems. Without exception, every imagined application of gene drive technology would occur in a context already embroiled in important social debates and ethical discussions that reflect different values and priorities. Gene drives may offer new solutions that resolve the concerns of some publics; for example, as a method of eradicating rodents that has fewer non-target effects and limits animals’ suffering (Case Study 4). Gene drives may also provoke new dimensions of concern; for instance, whether the combination of gene drive and patent protections lead to forms of ownership that span an entire species. The burst of media coverage surrounding advances in gene drive research (e.g., DeFrancesco, 2015; Wade, 2015; Webber et al., 2015) provide evidence of the degree to which innovation in this field connects to issues that are highly relevant to diverse stakeholders and communities.

The diversity of gene drive applications and contexts suggests that their applications may be unevenly distributed, highlighting the importance of justice considerations. For example, if a gene

drive is developed to combat dengue (Case Study 1), who will benefit most from gene drive applications? Who will bear the anticipated and unanticipated negative impacts? In the context of engagement, these questions motivate attention to the voices and preferences of different communities. At present, gene drive research occurs unevenly across social and geographic landscapes, with important decisions to be made regarding which human and ecological communities may experience the first field trials of gene drive technologies. For the foreseeable future, gene drives are envisioned to be developed predominantly in countries that already conduct gene-editing research and related product development. However, applications of gene drives will surely focus on geographies (human, political, and ecological) with less-established infrastructures. Such contrasts imply a need for engagement across such boundaries to ensure that developments are appropriate to context.

Mutual Learning

In the field of gene drive research, public engagement creates opportunities for knowledge exchange and mutual learning. For example, scientists developing a gene-drive modified mouse for release on an island (Case Study 4) will need to engage with local experts on the biodiversity, geography, and climate of the island ecosystem. Through such interactions, and especially if a field trial is designed and implemented as a partnership, significant learning would occur among the diverse experts. Irrespective of whether the trial is judged as a success or failure, all partners would be in a better position to work together effectively in the future.

As such, engagement activities are a key part of capacity building in a triple sense. First, the capacity of stakeholders and community members to understand relevant expert knowledge and partner with scientists can be enhanced. Simultaneously, technical experts increase their own capacity to understand and connect with stakeholders and community members—a skill seldom emphasized in standard training programs for scientists and engineers. Third, those who organize engagement activities build their own capacity to facilitate and organize meaningful deliberation, an especially challenging goal in political or cultural contexts in which civic engagement is not the norm. Furthermore, these interactions, if managed well, and if conducted in the absence of fundamental value conflicts, build trust among diverse groups, which creates a positive feedback loop for future engagement efforts (King et al., 2014; see Box 7-1). These views contrast sharply with the so-called knowledge-deficit model, which presumes that one-way instruction of laypersons by experts will result in public support (Sturgis and Allum et al., 2004; Bucchi and Neresini, 2008). While information is important, and learning is important to forming opinions and decision making, research shows that it is not deterministic in the way that the deficit model assumes.

Finally, research on deliberation suggests that engagement can foster “reflexivity” among participants, in the sense of creating opportunities for reflexive thinking to clarify one’s beliefs and understandings, reflect upon and revise one’s opinions, and gain insight into how different interests and values are situated in conversations about how to proceed (Dryzek, 2011; Dietz, 2013; Jasanoff et al., 2015). For example, stakeholders who have historically supported conservation of biodiversity and are affiliated with environmental groups that have opposed the release of genetically engineered organisms may experience tension as they confront the possibility of using a gene-drive modified mosquito to save Hawaiian bird populations (Case Study 3). Other stakeholders may have a more ambivalent initial position and perspective on gene drive applications, but engaging them may foster reflexive thinking about basic requirements of respectful and fair treatment of communities. Thus, engagement with stakeholders, experts, and community members may help clarify existing tensions that surround gene drive research and applications and offer ways forward for decision making under conditions of value uncertainty.

CHALLENGES OF ENGAGEMENT

While this report makes the case for stakeholder, community, and public engagement in the area of gene drive research and innovation, there are a number of important challenges and obstacles to effective engagement (see Box 7-2). Many of these have been articulated by social scientists who study engagement processes empirically and with an eye toward experimenting with new formats and procedures. These insights largely come from the fields of communication, political science, sociology, and science, technology, and society. These well-documented obstacles can be addressed directly in practice through the consideration of a set of questions that can also help guide the development of efficient engagement strategies.

The first challenge is determining who should be engaged among the many possible experts, stakeholders, community members, and publics. Drawing such boundaries—which include and exclude certain people—and motivating their participation are not trivial tasks. While it may be obvious to engage residents of an island on which a gene-drive modified mouse may be released to protect the eggs of native birds from being eaten, less clear-cut are questions about the need to engage residents of a neighboring island or the mainland, tourists, conservation volunteers, citizens whose taxes contribute to the science foundation that makes the research possible, or individuals with moral or religious objections to modern methods of genetic engineering?

At the broadest level, scientists often speak of “public engagement,” but a public audience is always just a slice or a portion of the population as a whole. Publics do not just exist; they are constructed through procedures of engagement that range from public opinion polls (with complex algorithms to achieve representative sampling, as defined by the polling agency), to public hearings (that tend to attract the most interested and organized citizens), to community meetings (that occur in particular locations and rely upon certain methods of advertisement and recruitment), to door-to-door surveys (which prioritize geography over other criteria that might define a community). Importantly, these constructions have implications not only for who has access to relevant discussions, but also the content, significance, and impacts of such engagements (Delborne and Galusky, 2011; Delborne et al., 2011).

Decisions about inclusion and exclusion raise a set of crucial questions that must be considered explicitly in any engagement effort (for a complementary perspective, see Kaebnick et al., 2014):

• What groups have sufficient “stake” to be considered stakeholders? Must they be impacted directly? Must they already be involved in the problem? Must they have a financial stake? Do stakeholders change with the phase of gene drive development and deployment? Do gene-drive modified organisms that are meant to spread geographically implicate ever more numerous communities?
• What knowledge or capacity is required to participate? What level of scientific literacy is expected? Who has the authority to convene an engagement activity?
• If representativeness is sought, what characteristics will be prioritized (e.g., demographic variables, political affiliations, cultural identities, interests)? What are the criteria to validate claims of legitimate representation of such characteristics?
• Do some kinds of expertise justify excluding some would-be participants? While this may appear nonsensical, deliberations including a mix of experts and laypersons can stifle the participation of those who defer to the “experts” in the room (Joss, 1998).
• How can procedural justice be established? How should conflicts of interest be managed? Does a financial stake in the technology’s success (or failure) exclude someone from participating in an engagement process? What disclosure or degree of transparency of value commitments, experience, and affiliation is required?

These questions, which are by no means exhaustive, hint at the complicated decisions that precede the recruitment of actual participants for engagement. Ignoring such questions, or lacking clear answers, can lead to conflict, breakdown, or the undermining of the credibility of the engagement effort at later stages. And regrettably, despite the best efforts of all concerned, it is impossible to control for all the factors that may affect communities and disrupt even the best planned engagement process.

Given that engagement is not just one type of practice or activity, a second primary question is what are the goals of engagement? Answering this question relates to questions of inclusion/exclusion discussed above, but goes further to consider the relationship between procedures and outcomes. The purposes of engagement range from assessing lay knowledge about a technical issue to integrating public values into decision making. Rowe and Frewer’s (2005) highly cited typology for engagement mechanisms focuses on the desired flows of information: public communication, from experts to publics (e.g., outreach or educational initiatives); public consultation, from publics to experts (e.g., surveys or opinion polls); or public participation, which denotes information flowing in both directions (e.g., consensus conferences, task forces). King et al. (2014), note that there is no agreement about what community engagement contributes to the ethics of research, but that the relationships established in the course of engagement allow re-

searchers to meet three ethical goals: (1) identifying and managing risks and benefits; (2) demonstrating respect to the community; and (3) building legitimacy for the research project.

Sophisticated procedures exist for a full range of engagement activities (Rowe and Frewer, 2005; Bucchi and Neresini, 2008; Irwin et al., 2013). This diversity of procedures serves as a reminder that engagement activities are not easily interchangeable, and each has its own limitations and challenges. For example, public opinion polls to measure the level of support for a new technology are frequently cited in political debates about governing emerging technologies. While such strategies have the advantage of accessing high levels of demographic diversity among respondents, opinion polls offer respondents little opportunity for learning and deliberation that might lead to more informed and thoughtful opinions (Sclove, 2010a). On the opposite extreme, consensus conferences, which do provide such opportunities, are vulnerable to critiques of a lack of representativeness (Schneider and Delborne, 2012). Even more broadly, engagement may have different meanings and significance in different contexts, although experiments in engagement suggest that deliberative forums can be successfully implemented in cultural contexts that lack such traditions (Rask et al., 2012; Rask and Worthington, 2015).

A third area of challenge emerges from the complexity of organizing people—whose behaviors are unpredictable—to discuss complicated issues—that involve a mix of facts and values—within institutional contexts that have political, economic, and cultural relevance. In other words, doing engagement well is difficult. Logistical challenges include:

• Obtaining adequate resources to organize the activity and incentivize participation (Kleinman et al., 2011);
• Training facilitators—who may be more likely to come with expertise in communication or social science rather than the laboratory-based skills that undergird gene drive technologies (Mansbridge et al., 2006);
• Scaling up existing models to larger national or international contexts (Cobb and Hamlett, 2008; Rask et al., 2012);
• Managing access to high quality information (Anderson et al., 2013);
• Coordinating media coverage (Schneider and Delborne, 2012);
• Balancing the benefits and drawbacks of virtual tools (Delborne et al., 2011); and
• Communicating the outputs effectively to decision makers (Delborne et al., 2013).

Research into effective community engagement strategies for the introduction of new technologies is promising, but a universal method that can be applied to the area of gene drives, or any other emerging technologies is unlikely (Guston, 1999; Kleinman et al., 2007; Nisbet et al., 2009; Phil-brick and Barandiaran, 2009; Sclove et al., 2010b; Rask et al., 2012; Rask and Worthington, 2015; Tomblin et al., 2015). Just as risk assessments represent a model that is highly adapted to each particular case, so also must engagement models serve as guidelines for flexible design. McNaughton has found that the range of people and issues that must be recognized, understood, and accounted for in any individual engagement process warrants long-term social research in order to develop engagement strategies that can be effectively integrated into a research program’s operations (McNaughton, 2012).

Kolopack et al. (2015) conducted a qualitative case study on how community engagement activities were integrated into the day-to-day management practices of the Eliminate Dengue Program in Australia. The authors found that critical features of the Eliminate Dengue Program that contributed to meaningful engagement included funding agencies’ sustained support for community engagement; core commitments and guiding values associated with community engagement, and formative social science research (Kolopak et al., 2015).

A fourth challenge is determining when to conduct engagement. Much attention has been given to the pitfalls of engaging public audiences late in the innovation process, which may either make the engagement irrelevant or force opinions into binary “pro” or “anti” positions. Some scholars have thus emphasized the benefits of “real-time technology assessment” (Guston

and Sarewitz, 2002), “anticipatory governance” (Sarewitz et al., 2011; Guston, 2014), and upstream engagement (Wilsdon and Willis et al., 2004; Kuzma et al., 2008), which implies engagement “upstream” during the development of technology, when feedback might shape design choices made during the innovation process. In tension with this view, premature engagement with community and public audiences can present a range of other challenges. For example, in the early stages of research it is difficult, if not impossible, to predict whether experiments will lead to the development of future technologies or what the potential benefits and harms of those technologies might be (Tait, 2009; McNaughton, 2012).

Fifth, cultural differences between groups with different kinds of expertise make engagement across those groups difficult. Research has shown that scientific and public audiences often have different attitudes toward technological risks (Kahan, 2012; Mielby et al., 2013; Su et al., 2015). In the case of gene drive research for the control of vector-borne diseases, cultural nuances can make engagement challenging across all communities. Differences in knowledge, values, language, social status, and communication styles all combine to stress any attempt at engagement. Careful facilitation and thoughtful design are required to minimize the likelihood of frustration among participants or breakdown in good-faith deliberation.

Sixth, engagement may not always lead to consensus—especially as efforts are scaled up to include more diverse publics. When there is a lack of consensus, it can be difficult to discern whether disagreements stem from disputes about evidence or differences in values. Evidence disputes suggest that further research to reduce uncertainty may resolve disagreements among stakeholders. Yet much decision making surrounding the governance of science and technology involves an “excess of objectivity” (Sarewitz, 1996), meaning that different experts can be found to “objectively” defend various political or other stances. Furthermore, incentives exist to frame disputes over values as factual disputes (Pielke et al., 2007). Pielke’s solution is to encourage more teams of experts to operate as “honest brokers of policy alternatives,” expanding and clarifying the range of policy options available to decision makers, but his framework does not make clear the available roles for communities, publics, and stakeholders with non-certified expertise. Therefore, managing participants’ expectations of an engagement process will be important, particularly in regard to stakeholders’ expectations that any decisions made will reflect their preferences, which is not possible where there is no consensus.

If engagement does not lead to consensus, how does one confirm that an engagement process is effective, or that a community is truly engaged? Standardized approaches and metrics to address this question are elusive and a topic of discussion (Alderman et al., 2013). However, community scorecards and other social auditing tools have been successfully used to capture public feedback and guide health priority settings in some contexts (World Bank, 2015). Similar tools could be applied to engagement processes in research with gene drives. Regardless of the approach, it is generally acknowledged that indicators of success will vary with context (Sibbald et al., 2009).

Seventh, social science research has described problems such as polarization cascades, particularly when there are divisive political or ideological perspectives that can undermine engagement (Tait, 2001; Sunstein, 2009). Relatedly, social amplification of concerns may occur when, for example, an over-emphasis on uncertainty is used as a political tool to reinforce negative or positive framings of science and technology (Stirling, 2014; Tait, 2014).

FRAMEWORKS TO GUIDE ENGAGEMENT

From these challenges, it is clear that public engagement is dynamic and context-specific. There is not a standard approach that can or should be used across all scientific research and related applications. Engagement is challenging for many scientific communities, and so lessons

can be drawn from prior efforts to design and evaluate engagement (Mazerick and Rejeski, 2014; NASEM, 2016). For example, Effective Chemistry Communication in Informal Environments, presents a five-part communication framework “based on the best available empirical evidence from the research literature in informal learning, science communication, and chemistry education” (see Box 7-3). Each element of the framework is based on the notion that engagement and evaluation processes should be designed in advance. The framework emphasizes that targeted goals should take into consideration the interests, values, and perspectives of communities, stakeholders, or publics. Equal emphasis is also given to the need for evaluation to occur throughout the engagement process, not just at the end. Although this framework was developed to guide scientists in the design of engagement activities about chemistry, it is broadly applicable to other engagement contexts and areas of science and technology, including gene drives.

Public engagement experiences on issues related to gene drives, such as the release of genetically modified mosquitos, can also inform engagement efforts for gene drives. Lavery et al. (2010) summarized key points to consider for effective community engagement in global health research in Mexico that was developed as part of a field study involving genetically engineered mosquitoes. To ensure that community members can be active participants from the outset, Lavery et al.’s framework begins with site-selection criteria that call for the capacity to be active participants in research and engagement. It is imperative to characterize the community and build trust with relevant authorities early to ensure that the goals of the research are clearly articulated and that investigators are afforded the opportunity to understand the community’s perceptions of and attitudes toward the research. Awareness of those persons and groups that will integrate the cultural background is also a critical component of their engagement framework; therefore, tailored practices of engagement may be required in developing countries (Tindana et al., 2007). Lastly, continual review of the outcomes of and additional need for engagement is essential to strengthening the process as the research program progresses.

The World Health Organization, in partnership with the Foundation for the National Institutes of Health (FNIH) and the Special Programme for Research and Training in Tropical Diseases (TDR), has also proposed a framework for community engagement specific for testing genetically modified mosquitoes (WHO, 2014). The framework gives special attention to the communities for whom the engagement is intended. For example, engagement at the community level will focus on those persons within the primary area where genetically modified mosquitoes will be released, such as a village in Africa, whereas engagement with stakeholders will focus on broader groups and organizations with environmental concerns about the release of the modified mosquitoes. The expertise required for effective engagement will therefore be unique to each level. Related to levels, the phase of testing, which dictates the scale of study, will also require investigators to identify appropriate engagement facilitators. Investigators can outline levels of engagement by phase of evaluation to guide them with identifying the appropriate stakeholders for engagement and the type of expertise that will be required in order for the effort to be effective.

CONCLUSIONS AND RECOMMENDATIONS

The committee did not attempt to prescribe a single method of engagement for gene drive applications, but rather, aimed to provide considerations for responsible practices through the following conclusions and recommendations.

Engagement with communities, stakeholders, and publics is an essential part of research on and development of emerging technologies, including gene drives. Engagement can facilitate mutual learning and shared decision making, support democracy and justice, help identify and assess potential benefits and harms, and provide a mechanism to explore difficult-to-articulate questions, such as the human relationship to nature. Engagement is also important as a matter of respect for and empowerment of the people likely to be most closely affected by the potential use of gene-drive modified organisms. The question is not whether to engage communities, stakeholders, and publics in decisions about gene drive technologies, but how best to do so.

The outcomes of engagement may be as crucial as the scientific outcomes to decisions about whether to release of a gene-drive modified organism into the environment. Thus, engagement cannot be an afterthought; it requires effort, attention, resources, and advanced planning. Those who organize and facilitate engagement about gene drive research need to explicitly consider who is to engage with whom, along with when, how, and for what purpose the engagement will occur. If engagement efforts are meant to have impact beyond mutual learning, it will be important those goals and plans are transparent to participants.

Engagement won’t happen all at once; it can and often occurs in stages and iteratively. One stage of engagement can inform the next phase of research and the next phase of engagement.

Short-term or online training of scientists is unlikely to build sufficient capacity to design and implement engagement activities without drawing upon additional expertise—especially because each engagement effort must be tailored to a specific context and purpose. Strategies will be needed to study, develop, and foster meaningful community engagement for specific research endeavors, as well as broader public engagement about the overall goals and consequences of gene drive technologies. These efforts will likely need to draw upon a wide diversity of examples and instructive scholarship, as well identify facilitators with a measure of distance from the technological research and development. Such experiences will build the capacity of gene drive researchers to participate and play increasingly important roles in future engagements.

Strategies will also be needed to evaluate engagement efforts to determine if they are working as intended. Such evaluations need not overwhelm a project’s financial or human resources in order to contribute meaningfully to tacit and formal knowledge about the success of engagement efforts. In addition, interdisciplinary efforts could also enable the convening of a new formal consortium on engagement on gene drive research that would communicate “lessons learned” among scholars, scientists, practitioners, stakeholders, and communities.

Engagement is not a one-size-fits-all endeavor. Engagement strategies will need to adapt and remain sensitive to cultural, social, and political contexts. The diverse proposed environments for gene drive research and potential release suggest that attention to this principle will take time, sensitivity, and a commitment to listening and learning. It is important to recognize that engagement practices always include some members of communities, stakeholders, and publics and exclude others, and that engagement sponsors (e.g., companies, government agencies, non-governmental organizations), participants, and broader publics may have different expectations of and goals for engagement. In addition, disagreements over values, standards of evidence, or preferences for desired outcomes may remain even after fruitful deliberation. Because of these complexities, efforts to build mutual trust and maintain procedural justice will be paramount. Such efforts could include:

• Transparency from organizers about their decisions on who is or is not included in engagement and the basis on which those decisions are made.
• Open acknowledgement from all parties of the diversity of goals that people may have and how specific procedures aim to fulfill those participants’ expectations.
• Open acknowledgement from all parties that successful engagement may not always—or even often—result in consensus.

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