Regulating Genome Editing: Integrating Ethics and Values
Society generates, accepts and endorses rules and regulation laid out by government. However, as the issues become less practical and more intangible, widespread social acceptance of certain ideologies and behaviours is harder to achieve. Approaches to moral reasoning, ethical action and personal acceptance of standards of right and wrong are embedded in human value creation and evidenced in adherence to religious and philosophical belief systems. When scientific technologies as potentially revolutionary as CRISPR-Cas9 emerge, it challenges our systems of thinking and arbitration, our balancing of future hopes and current fears (Carroll and Charo, 2015).
Legislation is a social instrument that facilitates the creation, dissemination and enforcement of a set of rules (Koop and Lodge, 2017). It is the product of the policy making process, designed through consultation to have largely beneficial outcomes for the wider community (Salter and Jones, 2002). Broadly speaking, regulation of biotechnological processes is focused on public health and safety and environmental protection (Nuffield, 2016).
When considering science policy, the UK regulatory system is particularly advantageous. It allows greater flexibility and facilitates prompt changes in the face of new evidence or developments (Bangay, 2017). This in-built flexibility can then be used by regulators to assess applications of new technologies such as CRISPR-Cas9 on a case-by-case basis. For example, last year the Human Fertilisation and Embryo Authority (HFEA) granted permission to researchers at the Francis Crick Institute in London to use genome editing techniques on human embryos (Callaway, 2016). The decision was guided by the Human Fertilisation and Embryology Act 2008, though the legislation does not explicitly mention “genome editing” (Bangay, 2017).
Regulations will have other objectives that often reflect the cultural values of society. In the United States a huge emphasis is placed on free markets and innovation, creating inherent conflicts in public policy between society and corporations (Koehler, 1996). Biotechnological regulations are required to be sufficiently permissive that they do not unduly stifle innovation or prevent trade (Federal Drug Administration, 2016), but this may come at the expense of proper stakeholder discourse. Additionally, the emphasis placed on corporate interests in the US – a matter which arises again later – may have fuelled public opposition to GM crops, cultivating mistrust.
By requiring regulation to be governed by the best scientific knowledge to date, the concept of “evidence-based policy” is introduced. In the United Kingdom, the idea was introduced by the Blair government to end policies led by ideologies (Staley, 2008). Yet research shows that individuals may reject scientifically-sound evidence in favour of ideas that support their own tenets or world-view (Sheehy and Feaver, 2015). As genome editing can challenge moral beliefs, this research has strong implications for the field, particularly when considering contentious issues such as germline editing.
Regulations cannot incorporate ethical judgements or values without inputs from the individuals, groups and communities affected – the stakeholders. Thus, a wide range of physical and organisational processes to achieve appropriate consultations are used.
Studies have found that, whilst agencies attempt to consult the public such that it can align its regulations with their values, the process may be confusing, biased and superficial (Sampson et al., 2004). These impediments may foster mistrust and discourage public engagement with regulatory processes. Such considerations must be included when future regulatory decisions are being made with regard to genome-editing technologies. Already, funders of U.K. research in the field have called for discussions amongst experts and non-experts concerning the application of these technologies with particular emphasis on their clinical applications (The Wellcome Trust, 2015).
This stakeholder consultation and promotion of public confidence introduces the complexity of views and values of individuals, groups and society at large. Ethics are essentially moral principles that govern a person’s behaviour, whilst ethical standards represent what is believed to be “good” by the majority, and once these are accepted they become the norms of behaviour (von der Pfordten, 2012). These norms then lay the foundations for cultures, which constitute a set of shared customs, values, beliefs and attitudes (Morris, 2014). As evidenced in the US’s emphasis on innovation policy, culture has important influences over policy decisions.
The coalescence of “normative” ethical considerations and inputs from disparate sources can be near-intractable: normative debate is based upon innate and deeply-held values and beliefs, and is consequently emotive (Croley, 2007). Science cannot resolve such disputes.
Established principles may also be used in policy decisions and include justice (no one stakeholder should be unfairly at risk) or autonomy (individual stakeholders may make their own choices) (Coughlin, 2008).
However, regarding CRISPR-Cas9, the interpretation and evaluation of established principles such as justice (no one stakeholder should be unfairly at risk) and autonomy (individual stakeholders may make their own choices) may vary contextually: in the case of somatic gene therapy, it is reasonable for individuals to make their own decisions regarding treatments. For gene drives, multiple communities are usually involved and compromises may be necessary. Additionally, the capabilities of new technologies such as CRISPR-Cas9 destabilise social norms and force reconsideration of what is deemed “right” and “wrong”.
Germline gene therapy is a key example of the difficulties regulators of technologies such as CRISPR-Cas9 face. Germline therapies, unlike somatic gene therapies, are heritable: any changes introduced into one embryo will then be inherited by that individual’s offspring. It can thus be used to spread a trait throughout a population.
In instances of non-fatal disability, the use of such genome editing technologies may threaten human dignity. By defining what is “normal”, such as having the ability to hear or to walk, already-negative views of disabled people would be reinforced. In some cases – such as deafness – those living with the condition do not see it as a disability (Check Hayden, 2016). As such, editing genomes to prevent deafness in future generations is akin to eugenics. There are additional concerns about availability and widening already-expansive inequalities, as the treatments are likely to be expensive and only available in countries with adequate infrastructure and expertise. Even within countries, without government subsidies genome therapies may become a preserve of the rich.
The threat of eugenics extends beyond medical treatments to alteration of other, benign traits. Some argue that this is a natural extension of the technology (Baylis and Robert, 2004), framed in terms of humans shaping their own evolutionary trajectory and “enhancing” certain traits (Baumann, 2016). Yet many faith groups argue it is against their central tenets, whilst others believe that to endow future generations with a genetic burden based on contemporary values is unfair and potentially dangerous (Carroll and Charo, 2015). The previous case studies have established that values are highly contextual: they change from society to society and they change with time. If future freedom of choice is limited by today’s decisions, rights of future generations are infringed as imposing traits that are only currently of normative or practical values can ultimately result in negative consequences, ethically or otherwise.
In light of these issues, there is near-unanimity in the scientific community against germline editing (Reardon, 2015) and many calls have been made for a voluntary moratorium on researching the use of genome editing technologies on human germ cells (Ishii, 2015).
CRISPR-Cas9 genome editing is a potentially revolutionary technique, though its introduction to laboratories across the world is not without issue. Concerns remain over safety, particularly in applications that directly impact human wellbeing, and how some uses of the technique fit in with existing ethical standards is debated. Integrating the value systems of stakeholders is a continuous challenge to policymakers, so the processes of consultation need constant renewal as incremental technological advances change our ability to evaluate risks. International differences in regulatory approaches reflect different cultural weightings given to ethical values, risk and economic factors, but both caution and scientific advancement can be accommodated by flexible regulations.
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