Abstract

The present paper aims to inform the bioethical debate on the regulation of human genome editing technologies with a specific focus on the role of scientific experts and their interactions with the general public in the formulation of policy. It reviews and compares two of the major contributions to this debate in the U.K. and in the U.S.A., comparing expert approaches towards regulation on genome editing technologies. The results of this analysis offer important lessons that should be appreciated in building an international regulatory framework. On the basis of these results, I conclude that the experts should embrace a socially responsible approach and encourage active public engagement.

Introduction

The rapid emergence of new genome editing technologies, such as CRISPR/Cas9 and their potential human applications, has presented society and scientific experts with two pressing challenges: the first is the ethical question regarding the moral acceptability of such interventions [1], and the second is the political discussion surrounding who should regulate this emerging biotechnology, and in what manner [2].

However, while there is persistent disagreement surrounding the moral status of genome editing's applications (especially in the case of uses other than treating or preventing serious conditions), some progress has been made concerning policy recommendations and practice [3].

In this paper, I will review and compare two of the major international contributions to the regulation debate: the report of the UK Nuffield Council on Bioethics released in 2018, Genome Editing and Human Reproduction: Social and Ethical Issues [4], and the report of the US National Academies of Science and of Medicine (NAS/NAM) released in 2016, Human Genome Editing: Science, Ethics, and Governance [5].

The results of this comparative study contribute to the regulation debate in two main ways. First, understanding the strengths and weaknesses of the experts’ recommendations at a national level establishes foundations for a more international and interdisciplinary consideration of the diversity of views on the global stage. This is particularly important since the institution of an international forum of discussion has recently been demanded by some scholars [6,7].

Second, a better definition of the respective roles and influence of experts, the public and stakeholders is required. This relates to a wider debate concerning the regulation of science in democratic societies, which has paved the way for a more consultative and socially engaged approach to the governance of genetic technologies [8].

In this paper, I will compare the British and American reports on three different levels: their statements of task, the founding principles underlying their analysis, and their consequent recommendations. This approach enables a comparison of the expectations and results of each report, and the identification of common threads between them.

Statements of task

A ‘statement of task’ is the manner in which a report explains how it has framed the challenge of drawing guidelines for human genome editing regulation, and what kind of questions it aims to address with its contribution. In what follows I will suggest that the ways of grounding the two inquiries differ, since the U.K. report, at least in its declaration of intents, seems to be more committed to the ethical and moral context of the emerging biotechnology, whereas the U.S. report presents a more technical approach, apparently divorced from its moral context.

Beginning with the British Nuffield Council report, the intention to ‘start with reality’ is clearly stated as a founding maxim of the report (p. 1) [4]. This has led to the identification of prospective parents as the benchmark of the work, since ‘in reality’ they would be, along with their offspring, the first beneficiaries of human genome editing. Consequently, the whole inquiry aims to address the following question(s): ‘In what circumstances, in what ways, and to what extent, should people be permitted, enabled or assisted to pursue their reproductive goals?’ (p. 155) [4].

A different approach emerges in the statement of task which introduces the American NAS/NAM report. Thus, its inquiry is framed around seven questions which aim to cover the state of science in human genome editing, and all the clinical, legal and societal issues potentially at stake, to gather all the information required to decide how to regulate this powerful biotechnology. Therefore, the U.S. inquiry is based on a specific and technical account of the facts in response to the task of ‘examin[ing] the scientific underpinnings’ (p. 17) [5]. It offers little appreciation of the flesh-and-blood subjects and situations potentially affected by the application of genome editing technology.

Thus, it can be argued that in grounding their inquiry, the Nuffield Council report is committed to a context-based exploration of the issue, starting from a consideration of the human subjects who would be potentially affected by the new technology (in the first instance, prospective parents) — not the technology itself — to understand the challenges presented by this technology.

In contrast, the American report offers a more detailed research structure supported by a close inspection of the scientific and technical aspects identified as important, at the expense of a human consideration of the scenarios made possible by the application of human genome editing.

Principles

The role of the principles in the reports is to ground the experts’ assessment of genome editing technology in shared ethical concerns and, in turn, to ensure a fair application in respect of people's well-being and rights.

Starting from the Nuffield Council report, the U.K. working party — in accordance with the maxim to ‘start with reality’ — has drawn their principles from a rigorous exploration of three sets of considerations relating to the interests of individuals who would be directly affected by the technology, namely the prospective parents, their future children and humanity in general. Hence, the group articulates that the use of heritable genome editing technologies must not fail to respect the principles of ‘the welfare of the future person’ and of ‘social justice and solidarity’ if it is to be morally acceptable. Specifically, the first principle is meant to address an inherent set of asymmetries that characterise any reproductive project that involves gene editing interventions: ‘the asymmetry of agency and responsibilities’ between the prospective parents and their offspring and ‘the asymmetry between knowledge of the present [states] and the future [consequences]’ (p. 74) [4]. The second principle, instead, is intended to account and respect ‘the way in which the pursuit of individual interests shapes the context in which others also pursue their own interests’ (p. 78) [4].

Similarly, the American NAS/NAM report carefully considers the importance of balancing individual benefits that might ensue for prospective parents and future children against potential risks and harms, not only at the individual level but also at societal and humanity-wide level. In contrast with the British report, it provides a more detailed list of seven principles: ‘promoting well-being’, ‘transparency’, ‘due care’, ‘responsible science’, ‘respect for persons’, ‘fairness’ and ‘transnational cooperation’ (p. 33) [5].

Consequently, the U.S. committee concludes that heritable genome editing clinical trials would be permissible only if conducted within a regulatory framework which follows strict criteria of restriction and allowance drawn from the principles. For instance, in respect of the responsible science and respect for person principles, they recommend ‘comprehensive plans for long-term, multigenerational follow-up that still respect personal autonomy’ (p. 135) [5].

Overall, there are two main differences in the way in which the reports have constructed and employed their principles in shaping their positions towards human genome editing technology. First, the Nuffield Council report seems to be more committed to a broader social consideration as it recognises that the attempts to influence inherited traits of a future person can have indirect effects on others and, in a broader sense, on our moral and social assessment. This commitment is reflected in how the principle of ‘social justice and solidarity’ is defined by the U.K. report. Moreover, it can be argued that in shaping the principle of the ‘welfare of the future family’ there was a precise rationale behind the choice of the word ‘welfare’ instead of ‘well-being’ because the concept of welfare was deemed to indicate a broader meaning beyond specific reference to a person's medical state (p. 76) [4]. Adopting as a principle, the ‘welfare’ of a person acknowledges that one's health is also highly dependent on psychological factors, environmental inputs and social context.

On the contrary, the American report promotes ‘well-being’ understood as the duty to provide benefits and avoid harms at the level of individual health. This focus on the physical aspect of individual health aims to ensure a balance of risks and benefits for any future human applications of genome editing, but does not acknowledge other important factors that could affect future users.

Regarding the second difference, in the NAS/NAM report the detailed list of principles is meant to offer a robust framework from which responsibilities and recommendations can easily be drawn. Indeed, for each principle, there is a detailed description of the responsibilities that flow from adherence to the principle. For instance, the ‘respect for persons’ principle embraces four responsibilities which, in turn, aim to protect four different areas of life that might be challenged by genome editing technology: equality between individuals, respect for individual decisions, prevention of ethically unacceptable uses of biotechnology, and respect for diversity and disability.

This level of detail is something that the Nuffield Council report misses since it suggests only two overarching principles. Therefore, the continuum between the principles and the recommendations may not seem obvious. However, the broad approach undertaken by the British experts in drawing up their principles has the great advantage of communicating a conceptual framework rather than a mere set of rules.

How these differences have shaped experts’ recommendations will be considered more fully in the next section.

Recommendations

In the following comparative analysis of British and American experts’ recommendations, I will consider the extent to which they differ, in an effort to draw two main lessons. Both have the potential to expand our understanding of how the debate on the applications and regulation of human genome editing technologies can be implemented.

Starting from the British recommendations, it clearly emerges that the British experts (in contrast with their American counterparts) are more committed to the social context and to the real-world circumstances of the potential applications. This means that their analysis starts from and constantly involves a consideration of values, beliefs and expectations that the society attaches to the technology and to its uses. Specifically, they recognise — as a matter of primary importance — the challenges that human societies might face in the event of widespread use of gene editing, rather than limiting their consideration to a narrow evaluation of the risks and benefits of the technology assessed only in terms of safety. Therefore, to transmit this mindset to policy-makers and institutions, in writing their recommendations they opted to provide a ‘conceptual significance concerning how we should think about the prospect of heritable genome editing interventions, what they will mean for people and societies, and in what context question about them should be posed’ (p. 154) [4].

Moving to the American context, it can be argued that the NAS/NAM report provides an accurate account of the significance, the aims and the means of the public engagement in the regulation debate, whereas the Nuffield Council report remains vague in explaining the terms, despite a formal promise of a broad and inclusive public debate.

Indeed, in drafting Recommendation 7, the American experts affirm that any public engagement should be informed by technical experts and social scientists, and they carefully articulate a participatory framework (pp. 178–179) [5]. In particular, they seem aware that the efforts that have already been made to establish engagement (e.g. meetings open to the public, information available for public posting, and the inclusion of a public representative on the advisory committee roster) only allow for limited and passive participation, since they only reach that subset of the public that has an existing interest in a specific issue (p. 171) [5].

Conclusion

In this paper, I have analysed expert recommendations on human genome editing regulation in the U.K. and in the U.S.A. through the review and comparison of two recent contributions to the policy-making process.

I have carried out the inquiry at three levels — namely, to investigate how they have framed the issue, the ethical frameworks upon which the recommendations are built, and the sensitive aspects and fields affected by human genome editing technologies (Figure 1).

Visual illustration of differences between reports.

At the first level (i.e. statements of task), I have concluded that the British report seems more committed to a context-based exploration of the issue, whereas the American report presents a very technical and scientific approach. At the level of moral and ethical principles, it has emerged that the Nuffield Council report suggests a moral approach committed to a broad societal consideration, as its principles are meant to protect individual and society and to respect the specific circumstances of its applications. Meanwhile, the NAS/NAM report provides a very accurate list of principles which are more committed to the technical aspects of the procedures than to the subjects and the contexts of application.

Finally, at the level of recommendations, we can learn two lessons from our comparison of different approaches of British and American experts. First, from the American experience, we should appreciate the efforts to encourage an active and well-structured public engagement. Second, from the British report, we should acknowledge the turn towards a socially responsible approach, namely the way in which the recommendations have been made to integrate perspectives from science and society.

Competing Interests

The Author declares that there are no competing interests associated with this manuscript.

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