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Human Genome Editing: Science, Ethics, and Governance (2017)

Chapter: 7 Public Engagement

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Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
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7

Public Engagement

The emergence of CRISPR/Cas9 as a research tool in the area of human genome editing has lent new urgency to calls for a broad public dialogue about these technologies and their applications. These calls have come from ethicists and social scientists (e.g., Jasanoff et al., 2015), as well as biomedical scientists (Bosley et al., 2015; Doudna, 2015) and multiple think tanks, bioethics groups, and scientific/professional societies, such as The Hinxton Group (Chan et al., 2015), the Nuffield Council (2016b), and the Center for Genetics and Society (2015).

The idea itself is not new. At the Asilomar Conference in February 1975, an international group of scientists discussed the use of recombinant DNA and decided strict controls should be placed on its use (Berg et al., 1975). The concerns expressed by that group are reflected in a report to the U.S. Senate Committee on Human Resources Subcommittee on Health and Scientific Research. That report argued that it was “increasingly important to society that the serious problems which arise at the interface between science and society be carefully identified, and that mechanisms and models be devised, for the solution of these problems” (Powledge and Dach, 1977, p. 1).

These early efforts have evolved into a “growing political commitment at the highest levels to giving citizens more of a voice in the decisions that affect their lives, and to engaging citizens in making government more responsive and accountable” (Cornwall, 2008, p. 11). In a 2000 report, the U.K. House of Lords recommended that dialogue with the public be a mandatory and integral part of policy processes, including the use of public

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

meetings as a tool for formal citizen engagement (U.K. House of Lords, 2000). Likewise, the 2003 U.S. Nanotechnology Research and Development Act mandated “convening of regular and ongoing public discussions, through mechanisms such as citizens’ panels, consensus conferences, and educational events.”1

These efforts have been motivated in part by the desire to anticipate the reactions of members of the public to potentially controversial technologies and to “avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers” (Holdren et al., 2011, p. 1). Research also has shown that engaging meaningfully with decision makers and public stakeholders “in processes . . . that incorporate diverse perspectives transparently” can increase public perceptions of the legitimacy of regulatory or policy decisions surrounding emerging technologies (Posner et al., 2016, p. 1760). These findings echo the conclusion of a 2008 National Research Council (NRC) consensus report that public participation in (environmental) assessment and decision making has the potential to improve not only perceptions of legitimacy but also the quality of decisions (Holdren et al., 2011, p. 1; NRC, 2008).

One could argue, for example, that a lack of meaningful engagement with different publics when genetically modified organisms (GMOs) were first introduced did irreparable damage to the emerging scientific field of genetic engineering. Public debates about harmful effects of Bt corn on the larvae of monarch butterflies, for instance, led to “a nearly 10% drop in the value of Monsanto stock, possible trade restrictions by Japan, freezes on the approval process for Bt-transgenic corn by the European Commission (Brussels), and calls for a moratorium on further planting of Bt-corn in the United States” (Shelton and Roush, 1999, p. 832). These debates have also slowed or halted the development and introduction of biofortification of some foods, such as golden rice, which has the potential to reduce disease caused by a vitamin A deficiency. The World Health Organization estimates that 250 million people suffer from vitamin A deficiency (nearly half of them children in the developing world), which is a leading cause of childhood blindness, affecting one-quarter to a half million children worldwide (Achenbach, 2016). A 2016 report from the National Academies argues that increasing micronutrients at appropriate levels in both conventional and genetically engineered crops “could have favorable effects on the health of millions of people” (NASEM, 2016c, p. 228).

Some scholars have argued that human genome editing has raised, and will continue to raise, ethical, regulatory, and sociopolitical questions that go well beyond discussions of technical risks and benefits identified by

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1 21st Century Nanotechnology Research and Development Act, Public Law 108-153 (December 3, 2003).

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
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biologists (Jasanoff et al., 2015) or even philosophical and sociopolitical concerns raised by social scientists and ethicists (Sarewitz, 2015). These scholars argue that the risks and benefits associated with human genome editing should not be defined solely by the scientific community, and that a comprehensive understanding of risks and benefits will require broad public debates that are highly inclusive with respect to the range of voices and how relevant concepts are defined. This argument suggests, as genome-editing technologies and applications develop, the need for ongoing public discussion about how regulatory bodies should draw distinctions between such concepts as therapy and enhancement or disability and disease.

There is considerable variation among countries, and even over time in the same country, with respect to the role of public opinion, world view, and religious affiliation in the formation of public policy. In theocracies, public policy concerning embryo research, germline genome editing, and even somatic therapy may be shaped by explicit reference to religious doctrine. Even in formally secular countries, religious belief may strongly influence individual morality, which in turn is expressed in personal opinions and political preferences. Other countries may have constitutional requirements for various degrees of separation between government programs or policies and religious institutions. For this reason, public engagement is part of public policy formation in a variety of ways across the globe (Pew Research Center, 2008).

In the United States, regulatory agencies such as the U.S. Food and Drug Administration (FDA) have statutory authority to permit or prohibit the marketing of medical products based on technical considerations of risk and benefit. There is no authority to refuse approval for a particular product that is intended for (or might be used for) a purpose that many view as immoral. If such a prohibition were to be enacted, it would emerge from the legislature, subject to limitation where the prohibition would abridge constitutionally protected rights. In matters such as these, public input is an important component of sound decision making.

This chapter begins by delineating the broad concepts encompassed by public engagement. It then reviews in turn U.S. and international public engagement practices. The chapter turns next to lessons learned from past public engagement efforts. The final section presents conclusions and recommendations.

PUBLIC ENGAGEMENT: BROAD CONCEPTS

The broad concepts that guide public engagement have been outlined by Alan Leshner, CEO Emeritus of the American Association for the Advancement of Science:

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
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We need to engage the public in a more open and honest bidirectional dialogue about science and technology and their products, including not only their benefits but also their limits, perils, and pitfalls. We need to respect the public’s perspective and concerns even when we do not fully share them, and we need to develop a partnership that can respond to them. (Leshner, 2003, p. 977)

In the same vein, an editorial in Nature called on scientists to participate in these public discussions and bring their expertise to the wider conversation, even when “such public discussions may take many researchers outside their comfort zone” (Nature, 2017, p. 5).

In practice, public engagement takes many different forms, and it is beyond the scope of this report to discuss the advantages and disadvantages of different modalities (NRC, 2008; Rowe and Frewer, 2005; Scheufele, 2011). Nonetheless, it is possible to articulate at least three broad principles of engagement that can be applied to guide any effort to broaden the discourse on human genome editing to include the maximum number of relevant viewpoints and stakeholders.

The first principle of public engagement relates to quality of outcomes. Previous National Academies reports have identified a host of factors that contribute to high-quality regulatory or policy decisions informed by engagement efforts (NASEM, 2016a; NRC, 1996, 2008). Four such factors are particularly noteworthy for engagement efforts surrounding human genome editing. First is considering and weighing systematically the widest possible range of effects, as well as the uncertainties surrounding them. This includes consideration of risks and benefits that go beyond technical, medical, or scientific questions and encompass the “perspectives and knowledge of [all] interested and affected parties” (NRC, 1996, p. 3). Second is identifying the full range of potential policy or regulatory options. Third is having quality public engagement mechanisms that “deal with both facts and values and in particular with how anticipated changes in the world will affect the things people value” (NRC, 2008, p. 235). And finally, members of the lay public are able to ask questions and suggest solutions that may not have been imagined by regulators or experts.

A second principle of public engagement is the legitimacy of outcomes. Legitimacy tends to be connected to a number of related factors. First, processes for public engagement are transparent and perceived by all participants as fair and competent (Hadden, 1995). Second, echoing some of the considerations outlined earlier, public engagement identifies the values, interests, and concerns of all interested or potentially affected parties. Finally, engagement is pursued in a manner consistent with relevant laws and regulations.

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
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These first two engagement principles, however, need to be balanced with a third—administrative efficiency. “The goal of full participation needs to be considered in light of the need for administrative efficiency to ensure that decisions are made in a timely manner” (NASEM, 2016c, p. 56), while also guarding against the risk that well-resourced or well-organized constituencies will dominate the public discourse and drown out other voices.

Based on these broad principles, public engagement efforts typically are built around one or more of the following processes (Rowe and Frewer, 2005):

  • Communication/information—ensuring that decision-relevant information (including ethical, regulatory, and political considerations) effectively reaches maximum cross sections of society. In other words, public engagement efforts—regardless of format—need to focus not only on easy-to-reach audiences (e.g., more educated segments of the population) or highly invested groups (e.g., patient advocacy groups, religious communities, groups concerned with women’s rights/gender issues, environmental activists).
  • Consultation—conveying decision-relevant information from the maximum number of relevant and affected public(s) to the sponsors of the initiative (e.g., regulatory agencies, policy makers at the federal and potentially even state levels). The process of structuring and soliciting this consultation typically is initiated by the sponsor. One possibility for more efficient consultation is to interact with interest and advocacy groups. These groups can be a vehicle for reaching large numbers of people who share a position or goal, although with the caveat that these groups vary widely in how democratically they arrive at their positions or how accurately they reflect the range of views of their members (Seifter, 2015).
  • Participation—exchanging all decision-relevant information and value considerations among the maximum number of relevant public(s) and policy actors. Dialogue and negotiation transform opinions and increase information and awareness among both sponsors and public participants. Many examples of participatory activities are based at least partially on formal deliberations among (policy) decision makers and members of the public, along the lines of Danish consensus conferences (discussed further below) that provide formal input into policy-making processes (Danish Board of Technology, 2006, 2010a,b).
Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
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Regardless of the process, the purpose of engagement efforts is not to create or increase public acceptance of emerging technologies. In this sense, public engagement is a direct response to what is known as the “knowledge deficit model” (Brossard and Lewenstein, 2009)—the notion that it is possible (or desirable) to increase public acceptance of new technologies by closing knowledge deficits and building relevant scientific literacy among nonexpert audiences. Public engagement models deviate from knowledge deficit models in two ways. First, they acknowledge that very limited empirical data support the assumption that more informed citizens will be more accepting of emerging technologies (Scheufele, 2013). Second, such models abandon the notions (1) that building public support for science is, in all cases, desirable; and (2) that public debate or even controversy is always undesirable. Instead, public engagement is designed to facilitate “the sharing and exchange of knowledge, perspectives, and preferences between or among groups who often have differences in expertise, power, and values” (NASEM, 2016b, p. 22). As a result, it “gives all stakeholders opportunities to discuss the potential risks, benefits, and consequences of a technology before it is developed or deployed; can motivate attention to issues important to the public good; and ideally encourages civic participation and expression of views by all the diverse groups that are concerned with an issue” (NASEM, 2016a, pp. 1-7).

Empirical evidence also is limited on how effective different models of public engagement are in achieving these goals, and the existing literature draws mainly on examples of engagement activities from the local and regional levels. As a result, it is difficult either to point to specific structures or processes for effective engagement that are applicable across contexts or to predict how they can be tailored to fit the wide diversity of participants, regulatory questions, and topics (NASEM, 2016a).

U.S. PRACTICES

Across different issues, countries, and jurisdictions, efforts to translate the principles discussed above into practice have varied widely. In the United States, the Obama administration codified the idea of public engagement under the label responsible development: “Innovation with respect to emerging technologies—such as nanotechnology, synthetic biology, and genetic engineering, among others—requires not only coordinated research and development but also appropriate and balanced oversight” (Holdren et al., 2011, p. 1). In practice, this concept involves communication and consultation, as described in the previous section, as two key processes:

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
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  • Communication: “The Federal Government should actively communicate information to the public regarding the potential benefits and risks associated with new technologies” (Holdren et al., 2011, p. 2).
  • Consultation: “To the extent feasible and subject to valid constraints (involving, for example, national security and confidential business information), relevant information should be developed with ample opportunities for stakeholder involvement and public participation. [This is] important for promoting accountability, for improving decisions, for increasing trust, and for ensuring that officials have access to widely dispersed information” (Holdren et al., 2011, p. 2).

In the United States, Congress enacts laws governing science, health care, and the like, all of which are influenced by democratic processes that bring public opinion and constituent interests to the attention of elected officials. Specialized agencies generally are empowered to implement law (subject in most cases to overall policy direction from the executive branch) through the use of regulations that are developed with public input.

The nature and extent of this public engagement vary to some degree with the overseeing agency, but all agencies are governed by a set of legal rules that have been outlined in the Administrative Procedures Act and subsequently interpreted by the courts. The engagement techniques include advance notice of proposed rulemaking, an opportunity to comment, and a requirement that the agency explain its rationale for a rule and why it adopted or rejected comments. These formal rulemaking processes include relatively straightforward rules regarding public engagement. Often in the case of a highly complex or rapidly evolving area (such as biotechnology or life sciences), subregulatory, legally nonbinding guidance or agency practices apply, some of which also are subject to formal public comment. Lastly, for new research such as genome editing, there can be additional nonbinding review by the National Institutes of Health’s (NIH’s) Recombinant DNA Advisory Committee (RAC) or by an expert advisory committee convened by the FDA.

Public engagement in science policy is a global affair. One example is the European Commission’s introduction of the concept of responsible research and innovation (RRI) in the Horizon 2020 funding program to increase stakeholder participation and influence in research directions. RRI is about “co-creating the future with citizens and civil society organisations, and also bringing on board the widest possible diversity of actors that would not normally interact with each other, on matters of science and technology” (European Commission, 2016b). It includes an effort to map the ethical issues relevant to innovation and, with the help of the public,

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

to identify the best options for governance, whether in formal law or in voluntary standards and practices (European Commission, 2016b). It also includes the VOICES (Views, Opinions, and Ideas of Citizens in Europe on Science) project, with its thousands of participants in focus groups and other exercises (European Commission, 2016c).

Existing Infrastructure for Public Involvement in Genome-Editing Policy

In addition to the general framework for public engagement in policy, there are some particularly relevant opportunities for public engagement in the current approval process for somatic gene therapy research. To the extent that some policy can be formulated at the state level, as has happened in some states with respect to embryo research, cloning, and funding for stem cell research, the states themselves can be stakeholders that engage with the federal agencies (albeit with complex goals that include concerns about state power and independence) (Seifter, 2014b). In federalist systems, such as those not only of the United States but also of Europe and Australia, it is important to include consideration of regional opportunities for public engagement and policy making as well. Beyond allowing for the possibility that policy making may well occur at the local level, doing so has the potential to increase the perceived legitimacy of centralized, federal policies adopted by administrative rule (Seifter, 2014a).

At the federal level in the United States, opportunities for public engagement exist but tend to be limited and passive, and not the type of fuller public engagement that may be appropriate for an important new technology such as human genome editing, especially as potentially applied to the germline. These opportunities are described below.

National Institutes of Health’s Recombinant DNA Advisory Committee

At present, the RAC provides the greatest opportunity for public involvement in the oversight of human gene-transfer or genome-editing protocols. Under the modified procedures enacted in April 2016, the RAC reviews only human gene-transfer protocols that present novel or significant scientific, societal, or ethical concerns. The RAC reviewed the first human CRISPR/Cas9 genome-editing trial in the United States pursuant to these criteria in June 2016. As described in greater detail in Chapter 2, the RAC’s process is transparent and provides opportunities for public involvement. RAC meetings are conducted in accordance with the Federal Advisory Committee Act, which requires public advance notice of meetings that are open to the public (unless certain exceptions apply) and in which time is made available for public comment. In addition, recent RAC meetings have been webcast for viewing in real time or from the archives after the meeting,

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

and NIH’s Office of Biotechnology Activities has created an email list for individuals who wish to be informed of new RAC meetings and activities.

Although these provisions allow for limited participation by interested members of the public, they are passive in that they apply primarily to a subset of the public that has an existing interest and that seeks out the meeting information. In its current form, the RAC lacks scholarly expertise in public opinion or public engagement research, and is therefore not as well positioned to spearhead efforts to seek input from, or dialogues with, different communities of people at large who have an interest in the issue at hand, often referred to as “publics.”

U.S. Food and Drug Administration

The FDA is the second major institutional player in gene therapy approvals in the United States, but as described in more detail in Chapter 2, the Investigational New Drug (IND) application contains confidential business information. Therefore, submissions are proprietary and not available for public review or comment. As noted earlier, however, the website ClinicalTrials.gov has now been amended to increase public access to data on trials and their results, and a product sponsor may elect to make some or all of the IND information publicly available. Furthermore, if a gene therapy or genome-editing protocol is reviewed by an FDA scientific advisory committee, that meeting is open to the public, and a public representative must be included on the advisory committee roster. Once a biological license is approved, additional information is available for public posting. Nonetheless, overall the FDA review process lacks the transparency associated with an advisory body such as the RAC.

The FDA periodically calls informational public meetings, as it did for genetically engineered salmon (FDA, 2010), or hosts a more general public discussion, such as that on how the regulatory system for biotechnology products should be modernized (FDA, 2015c). The FDA’s advisory committee meetings, as well as its more generalized meeting mechanisms, would be available for discussion of therapies that depend on genome editing, and they might be particularly useful for discussion of products aimed at or likely to be used off-label for “enhancement.”

National Bioethics Commissions

Many nations have bodies to provide advice to their governments or to provide venues for public conversation, and such entities exist on every continent except Antarctica. They are usually appointed by the executive or legislative branches, and offer analyses and policy recommendations on a range of topics in bioethics. In November 1996, a group of national

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

bioethics commissions met for a summit at the invitation of the American National Bioethics Advisory Commission and the French Comité Consultatif National d’Ethique pour les Sciences de la Vie et de la Santé.2 Since then, there have been a series of global summits of these bodies, the most recent in Germany and the next to take place in 2018 in Senegal.

Like many other countries, the United States has a long tradition of using bioethics commissions as a venue for both public participation and advice to the government on policy options (see Box 7-1). The tradition began in the 1970s with the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, whose work led to substantial changes in the management of clinical trials. The U.S. federal government has assembled many subsequent commissions to address bioethical issues. Common features of these commissions include opportunities for public testimony, open meetings, the availability of transcripts of commission discussions, and the evident effect of this public participation and observation on both the decisions made at the meetings and the implementation of the resulting recommendations. Although agencies often are restricted by law with regard to what they can consider in their decisions, these venues provide an important outlet for broader considerations that, if necessary, can lead to legislative changes in agency mandates or regulatory approaches.

Institutional Oversight

All gene therapy and genome-editing studies must be approved at the local level by a research institution’s institutional review board (IRB)

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2 See http://www.who.int/ethics/partnerships/globalsummit/en (accessed January 30, 2017).

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

and institutional biosafety committee (IBC), both of which are required to include public representatives in their membership. Under current U.S. regulations, an IRB must have at least one member “who is not otherwise affiliated with the institution,” and among the types of expertise its membership must represent is sensitivity to “community attitudes.”3 Likewise, an IBC must include at least two members not affiliated with the institution that “represent community attitudes.”

INTERNATIONAL PRACTICES

As noted above, in Europe, many of the efforts surrounding public engagement in science have been guided by the idea of responsible innovation, that is, a “transparent, interactive process by which societal actors and innovators become mutually responsive to each other with a view to the (ethical) acceptability, sustainability and societal desirability of the innovation process and its marketable products” (Schomberg, 2012, p. 50). This includes elements of information and consultation, as described above, but also a strong commitment to formal public participation in policy formation and decision making in many countries.

An overview of different non-U.S. efforts to engage with public stakeholders is provided in Table 7-1.

TABLE 7-1 Attributes of Public Engagement: Selected Examples

United Kingdom Denmark France
  • Solicits entities outside of the government, especially specialists in communication and Web resources, to create its public consultation structure
  • Single-issue focus in its consultation
  • Wide variety of ways citizens provide input, including workshops, meetings, online questionnaires, and interactive website forums
  • Longstanding experience in public consultation
  • Emergence of ethical issues raised by citizen groups that policy makers have not considered
  • Report content taken into consideration by policy decision makers via an independent agency that informs and advises the government
  • Citizen panels bring attention to new social demands and needs for new legal approaches to novel technologies
  • Widespread media dissemination of panel discussions
  • Proliferation of other forums for discussion subsequent to the public consultation

For example, Denmark has a longstanding tradition of consensus conferences for which broad representation is sought, and whose results are

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3 21 CFR § 56.107.

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

taken seriously in the policy-making process. To some extent, however, the emphasis on consensus constrains their ability to present dissenting views (see Table 7-2). Although no country can fully satisfy all the objectives of public engagement in the realm of human germline genome editing, one widely shared objective is to strive to “enrich and expand the scope of traditional debate between experts, politicians, and interested parties by communicating citizens’ views and attitudes on controversial technologies” (Scheufele, 2011, p. 11).

TABLE 7-2 Public Engagement in Denmark: Consensus Conferences

Modalities Strengths Weaknesses
  • These represent one of the earliest and most referenced of consensus conferences (late 1980s).
  • A representative sample is recruited; around 2,000 randomly selected citizens are invited to apply.
  • The Danish Board of Technology (DBoT, an independent body created by the Danish Parliament) then selects 14-16 panel members to participate in the conference.
  • These citizens are introduced to and briefed on the topic(s) at hand by an expert journalist.
  • They then meet for extensive discussion among themselves.
  • Finally, they draft a report that expresses their stance on a given issue.
  • The final report is taken seriously by the DBoT, which uses it to advise the Danish Parliament. Hence citizens’ voices are fully integrated into the debating chambers of the government.
  • This solicitation of input from selected Danish citizens prior to any form of legislative debate allows policy makers to identify ethical issues they may not even have considered, as well as gives them time to adjust policy proposals in light of the citizen report.
  • This in turn increases citizens’ levels of trust in government.
  • Many academics, and others as well, consider the Danish consensus conference to be a model unto itself.
  • The members of a citizen panel selected through such a top-down system can never be truly representative of the population at large.
  • The careful monitoring of citizen panel members to minimize imbalances due to age, geographic location, gender, socioeconomic status, and cognitive and personality differences, as well as level of interest in the topic(s), tends to create an “idealized” group of people meant to represent the real world, when such is not the case.
  • Hence, this highly selective procedure means that those selected already have a pronounced interest in the topic at hand. Thus, inclusion of those who need more exposure to and education on the topic under consideration is neglected.
  • The final citizens’ report must be a consensus; hence no dissension is either allowed or included in the document.
Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

In designing public engagement activities, there are lessons to be learned from previous national efforts. These include the need to avoid having a small or overly selective sample of citizens and viewpoints and having a structure that is overly centralized and controlled in a top-down fashion (a structure that may be difficult to avoid in large, centralized national systems). One way to address these potential pitfalls is to follow the U.K. approach of “outsourcing” many public engagement activities to independent and nongovernmental entities (Sciencewise, 2016; Wilsdon, 2015). However, independent data with which to evaluate the efficacy of these efforts in other countries and their applicability to the U.S. context are limited. Moreover, when the process involves formulating future public policy for a country at large, it may be advantageous to have a central organizer of these types of consultations.

LESSONS LEARNED FROM PUBLIC ENGAGEMENT ACTIVITIES

Public engagement efforts are crucially important for guiding societal and political debates about the social, ethical, legal, and political aspects of applications of human genome editing. Given the infrastructures already in place to engage the public, as well as the general principles for engagement discussed in this chapter, the committee sees particular value in an approach that uses different processes for engagement for different types of questions surrounding genome editing. At the same time, it is essential that all such efforts adhere to all the principles for effective public engagement outlined earlier and that they apply two additional engagement principles to help avoid potential pitfalls.

First, any effort to engage the public broadly needs to distinguish between systematic public opinion research and public engagement exercises. The former uses social scientific methods to measure public opinion in ways that allow for generalization from representative samples to larger populations. Such efforts include quantifiable indicators of how likely it is that certain characteristics observed in a sample occur in the general population (e.g., Dillman et al., 2014). Public opinion research is particularly useful for identifying informational needs, perceptions of risk and benefit, or other attitudinal variables among different publics (Scheufele, 2010). By contrast, public engagement exercises such as consensus conferences or public meetings typically rely on representatives of highly interested and knowledgeable groups that can help policy makers or the scientific community identify ethical, legal, or societal considerations early in the policy-making process. The specific populations on which most engagement exercises draw and the social dynamics that drive conversational settings—even with professional moderators—often limit the ability to generalize findings from such exercises to broader public opinion (Merkle, 1996; Scheufele, 2011). Parallel

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

efforts with focus groups and broad public surveys of more randomly selected samples may be needed.

A second important principle relates to communicating the specific types of science on which policy makers or other conveners of engagement exercises seek input. Human beings interpret new information by using existing frames of reference (Goffman, 1974; Kahneman and Tversky, 1984). Fairly minor differences in how scientific techniques are described in meeting materials or the examples that are chosen for particular applications can significantly alter initial attitudes among participants, as well as the overall nature of discussions (Anderson et al., 2013). Thus, it is important that written meeting materials or presentations by experts during public engagement exercises not be developed only by technical experts based on their perceptions of relevance or appropriateness. Instead, they need to be systematically pretested using empirical social science to ensure that they minimize a priori biases and allow for inclusive, broad discussions that are not constrained artificially to the technical or scientific aspects of the subject.

MOVING FORWARD

Current infrastructure in the United States adequately includes public input for current modes of gene therapy, including both commercially and publicly funded basic research involving human genome editing. As discussed earlier, science in the United States is subject to well-functioning quality controls, oversight mechanisms, and ethical controls. Many of these mechanisms, such as IRBs, already involve public input. Similarly, the public has a means of providing systematic input on funding priorities, regulations, and other aspects of basic research through electoral choices at the federal, state and local levels.

Engagement mechanisms built into current regulatory infrastructures in the United States are sufficient to address somatic applications of human genome-editing techniques, but this does not mean they cannot be improved. The engagement processes employed by groups such as the RAC are communication of relevant information and consultation with affected or interested parties. In rarer cases, efforts have also been undertaken to provide for true public participation in regulatory rulemaking. Ideally, all oversight bodies involved in human genome editing would expand their portfolio of engagement efforts to develop more systematic and sustainable modes of public participation. In particular, an expansion of current modes of public engagement will be necessary to help regulatory bodies define the definitions of and boundaries between such terms as “therapy” and “enhancement” or “disease” and “disability.” These efforts might be aided by regulatory agencies’ adding members with relevant expertise to

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

specific committees, such as FDA advisory committees that need to evaluate the benefits of an indication and the degree of unmet need for a new edited cell- or tissue-based product.

For any consideration of applications of genome editing of the human germline, extensive, inclusive, and meaningful public input consistent with the principles of engagement outlined in this chapter would be a necessary condition for moving forward. To this end, ongoing monitoring of public attitudes, information deficits, and emerging concerns would be essential. These public engagement efforts would allow agencies and other policy bodies to (1) communicate effectively by informing different publics and providing policy-relevant scientific information, and (2) identify areas requiring systematic efforts to create infrastructures for public engagement early in the process (NASEM, 2016a). The complex issues surrounding enhancement also would require an ongoing public debate to inform regulators and policy makers about the individual and societal values to be placed on the benefits and risks before clinical trials for such enhancement interventions could be authorized. These ongoing efforts to encourage public engagement would need to be tied directly to the policy-making process (NRC, 2008, p. 19).

To facilitate and monitor the effectiveness of such engagement efforts, federal agencies would need to consider funding programs for research to (1) promote understanding of the long- and short-term sociopolitical, ethical, and legal aspects of human genome editing; (2) evaluate the efficacy of various efforts to build public engagement (communication, consultation, and participation) into regulatory or policy-making infrastructures; and (3) assess how public engagement can and should influence different areas of policy making. Experiences with the genome initiative’s program for including consideration of “ethical, legal, and social issues” as part of its overall funding of scientific research, and experiences with the Centers for Nanotechnology in Society, funded by the National Science Foundation, might provide useful frameworks for structuring similar research agendas or funding programs for public engagement for genome editing.4

CONCLUSIONS AND RECOMMENDATIONS

Efforts to advance human medicine through genome editing will be strengthened by public engagement informed by technical experts and by social scientists who undertake systematic public opinion research, develop appropriate communication materials, and minimize artificial biases or constraints that would hinder discussion and debate.

___________________

4 See https://www.genome.gov/elsi (accessed January 30, 2017); https://www.nsf.gov/news/news_summ.jsp?cntn_id=117862 (accessed January 30, 2017).

Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Existing public communication and engagement infrastructures in the United States are sufficient to address oversight of basic science and laboratory research on human genome editing. Similarly, mechanisms for public communication and consultation that are part of the current U.S. regulatory infrastructures are also available to address public communication around the development of human somatic cell genome editing.

Weighing the technical and societal benefits and risks of applications of future uses of germline editing will require more formalized efforts to solicit broad public input and encourage public debate than are currently in place. Furthermore, the complex issues surrounding enhancement will require an ongoing public debate to inform regulators and policy makers about the individual and societal values to be placed on the benefits and risks before clinical trials for such enhancement interventions could be authorized.

The practices and principles developed for effective and inclusive public engagement in other emerging areas of science and technology provide a valuable base to inform public engagement on genome editing.

RECOMMENDATION 7-1. Extensive and inclusive public participation should precede clinical trials for any extension of human genome editing beyond treatment or prevention of disease or disability.

RECOMMENDATION 7-2. Ongoing reassessment of both health and societal benefits and risks, with broad ongoing participation and input by the public, should precede consideration of any clinical trials of heritable germline genome editing.

RECOMMENDATION 7-3. Public participation should be incorporated into the policy-making process for human genome editing and should include ongoing monitoring of public attitudes, informational deficits, and emerging concerns about issues surrounding “enhancement.”

RECOMMENDATION 7-4. When funding human genome-editing research, federal agencies should consider including funding to support near-term research and strategies for

  • identifying areas that require systematic and early efforts to solicit public participation,
  • developing the necessary content and communicating it effectively, and
  • improving public engagement within the context of existing infrastructure.
Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

RECOMMENDATION 7-5. When funding human genome-editing research, federal agencies should consider including funding for research aimed at

  • understanding the sociopolitical, ethical, and legal aspects of editing the human germline;
  • understanding the sociopolitical, ethical, and legal aspects of uses for genome editing that go beyond treatment or prevention of disease or disability; and
  • evaluating the efficacy of efforts to build public communication and engagement on these issues into regulatory or policy-making infrastructures.
Suggested Citation:"7 Public Engagement." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
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Genome editing is a powerful new tool for making precise alterations to an organism’s genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions.

Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

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