Responsible Research and Innovation in the context of human cognitive enhancement: some essential features

ABSTRACT

Human cognitive enhancement (HCE) is an area in which non-therapeutic enhancements have been widely debated. Some applications are already on the market and available for home use (e.g. non-invasive brain stimulation devices), while other forms of enhancement such as ‘smart drugs’ or pharmacological enhancers are readily available (albeit ‘off-label’ or illegally obtained). Private and public interest in HCE may well intensify as the field engages with broader societal trends such as an increasingly competitive work-life and greater demands for productivity, in addition to increased interest in cognitive enhancement more generally. There is thus a need for some dedicated and timely consideration of the area, particularly with regard to governance issues. Responsible Research and Innovation (RRI) offers one possible approach that aims to anticipate and reflect on potential implications and societal expectations with respect to research and innovation. This article takes up current work on the HCENAT (Naturalness in Human Cognitive Enhancement) project and offers some essential features of RRI for HCE.

KEYWORDS:

• Responsible Research and Innovation
• human cognitive enhancement
• pharmaceutical cognitive enhancement

1. Introduction

Human enhancement can be defined as ‘any modification aimed at improving individual human performance and brought about by science-based or technology-based interventions in the human body’ (Coenen et al. 2009, 6). Human enhancement is an umbrella term that encompasses a plethora of current, emerging and visionary technologies including reproductive technologies, nutritional supplements, cosmetic surgery, performance-enhancing drugs, non-invasive brain stimulation techniques and neural implants, to name just a few. These technologies are illustrative of the blurring of boundaries between therapy, which is frequently defined as an attempt to restore a certain condition, and enhancement, which is viewed as going beyond therapy to augment or improve capacities (Nuffield Council 2013).

Human cognitive enhancement (HCE) – the particular focus of this paper – is an area in which non-therapeutic enhancements have been widely discussed (Farah et al. 2004; Cakic 2009; Ferrari, Coenen, and Grunwald 2012; Forlini et al. 2013; Dresler et al. 2013; Davis 2014; Giubilini and Sanyal 2015). HCE can be defined as ‘the use of interventions to improve cognitive functioning and performance, where these are not impaired in clinically significant ways’ (Nuffield Council 2013, 164). Cognitive enhancement includes improvements in capacities including attention, understanding, reasoning, learning and memory (Nuffield Council 2013). A variety of means can be used to enhance cognitive performance, ranging from pharmaceutical cognitive enhancers (PCEs) (’smart drugs’) to brain stimulation techniques and smart glasses. Indeed, some applications are already on the market and available for home use. For example, non-invasive brain stimulation devices such as Trans Cranial Direct Current Stimulation can be used to enhance spatial learning and memory (De Jongh et al. 2008; Hamilton, Messing, and Chatterjee 2011; Kadosh et al. 2012; Fitz and Reiner 2013; Davis 2014). ‘Smart drugs’ or pharmacological enhancers are also readily available (albeit ‘off-label’ or illegally obtained) (Hall 2004; Cakic 2009; Sahakian and Morein-Zamir 2011; Farah et al. 2014). Smart glasses can be used to increase a wide range of capacities, such as information retrieval and processing, geographical orientation, and ability to handle tasks in a more efficient way (Hofmann, Haustein, and Landeweerd 2016).

The convergence of diverse areas such as biotechnology, nanotechnology and information technology has provided a new multidisciplinary knowledge base for the investigation of the complexity of the human brain. This new area has enabled new fields of research and innovation on cognitive enhancements (Roco et al. 2013) and may lead to an intensification of interest in the area. Indeed, private and public interest in HCE may well intensify as the field engages with broader societal trends such as an increasingly competitive work-life and greater demands for productivity, in addition to increased interest in cognitive enhancement more generally (Pustovrh and Mali 2014; Nicholson, Mayho, and Sharp 2015).

In addition to the range of cognitive improvements that cognitive technologies can bring (Nuffield Council 2013; Farah et al. 2004; Hamilton, Messing, and Chatterjee 2011), they also bring with them considerable ethical, legal, social and cultural issues including issues of social coercion, competitiveness in contemporary society and distributive justice. Indeed, the ethics of enhancement is a prominent topic in the area of neuroethics (Caplan 2003; Farah et al. 2004; Outram 2012; Mohamed 2014; Dubljević 2015; Farah 2015). There is an identified need for some dedicated and timely consideration of the area, particularly with regard to governance issues and policy-making (Farah et al. 2004; Coenen et al. 2009; Zwart 2015). Responsible Research and Innovation (RRI) is being increasingly mooted as one possible approach that aims to anticipate and assess potential implications and societal expectations with respect to research and innovation (Nuffield Council 2013; Ter Meulen 2013). RRI can be applied to the context of cognitive enhancement technologies and applications as a means of working towards ethically sound and societally desirable research and development (Ter Meulen 2013; Nuffield Council 2013). In addition, RRI offers an opportunity to assess the merits of new technologies and not only the possible negative impacts and risks.

This article takes up work on the Czech-Norwegian funded HCENAT (Naturalness in Human Cognitive Enhancement) project, which, amongst other objectives, aims to understand the opportunities and challenges of RRI as an approach that can contribute to the governance of HCE. Our paper contributes to this special issue on ‘Neurotechnology and Society: Towards Responsible Innovation’ by focusing in on a concrete example of HCE, namely PCEs, in order to establish what RRI might look like in the context of HCE. We want to make RRI for HCE concrete and of practical use to decision-makers to take a responsible approach to particular contexts involving HCE applications and technologies. Our aim is to facilitate the cultivation of societal capacity to monitor and govern HCE.

Our primary focus here concerns the relevance of the ethical debate on pharmaceutical cognitive enhancement to governance. This means that we emphasise ethics as a key orientation in the governance of HCE through the lens of an RRI approach. We acknowledge that ethics is just one driver of governance – issues of intellectual property, patents and risk and safety regulation are also, of course, key dimensions of governance. At the same time, we contend that the flourishing of ethical debate in this area underlines the importance of considering the ethical acceptability and societal desirability of cognitive enhancement applications.

In order to advance some essential features of RRI for HCE we will build on previous work, which mapped out ethically relevant concerns and arguments pertaining to PCEs (Forsberg et al. 2017). We focus on this particular case for two reasons. First, PCEs or ‘smart drugs’ are widely discussed in the literature on non-therapeutic enhancements and many issues discussed and deliberated for this case apply to the HCE field more generally. Second, smart drugs are readily available on the market, necessitating consideration of their uptake and use. Our focus is thus on what Schermer et al. (2009) call ‘enhancements with a small e’ – these refer to those forms of enhancement that are currently possible or available or will be in the short term. These often occur in the slipstream of medical innovations, as unintended and unexpected applications of medications developed for treatment and prevention in the medical domain.

Enhancements with a ‘small e’ (‘enhancements’) can be contrasted with enhancements that go beyond what we currently understand as being ‘human’ – enhancements with a ‘capital E’ (‘Enhancements’). These are the enhancements referred to in transhumanist discourse (cf. Bostrom 2003) which emphasise the opportunities for enhancing the human condition opened up by technological advances.¹ Transhumanist discourse tends to be characterised by inflated expectations about technological innovation. While many people associate human enhancement with transhumanism, the link between ‘enhancements’ (those that are available now or likely to be available in the short term) and ‘Enhancements’ (speculative technologies that reconfigure what we currently understand as being human) is rather weak. The debate over human ‘Enhancement’ is less relevant for governance of current research and innovation pathways, as the technologies and applications discussed are of a speculative nature. They concern topics such as mind uploading or extreme lifespan extension, neither of which is within the grasp of the current scientific state of the art. We contend that it is important to retain the distinction between enhancement with a small ‘e’ and enhancement with a big ‘E’ as a confusion of the two may lead to misinformed policy. Enhancements with a small ‘e’ are already being developed in practice, necessitating direct attention to policies regarding the ethical, legal and social issues involved.

The paper proceeds as follows. First, we set the scene by providing an overview of conceptual and ethical issues with respect to PCEs. Then we elaborate on the need for governance in the area of HCE, and specifically, PCE. Third, we offer a brief overview of the RRI discourse and discuss the value of RRI as an approach that can contribute to the governance of HCE. We then go on to propose and advance some essential features of RRI for HCE and for PCEs in particular. These essential RRI features are given shape through the identification of specific questions and issues relating to the particular RRI dimension. Finally, we reflect on the opportunities and challenges inherent in developing an RRI approach to HCE.

2. Pharmaceutical cognitive enhancers

In the following section, we provide a brief overview of the kinds of medications used for cognitive enhancement purposes and the current knowledge as to their effectiveness and use.

Prescription medications used to treat cognitive impairments and to improve the quality of life of sufferers of neurodegenerative diseases and individuals with brain injury (Sahakian and Morein-Zamir 2011) are also used by healthy individuals in an effort to achieve ‘better than normal’ cognitive ability (Hall 2004; Racine and Forlini 2010; Farah et al. 2014; Frati et al. 2015). Stimulants prescribed for the treatment of Attention Deficit Hyperactivity Disorder – Ritalin (methylphenidate) and Adderall (mixed amphetamine salts) – and for the treatment of fatigue caused by narcolepsy and other sleep disorders – Modafinil – are most commonly used for cognitive enhancement purposes (Greely et al. 2008). Smart drugs are reported to be used by specific groups including students and academics (Sahakian and Morein-Zamir 2007) for a number of enhancement purposes, ranging from increasing productivity to improving alertness (Castaldi et al. 2012) and enhancing concentration (Mache et al. 2012).

Evidence regarding the effectiveness of PCEs is scarce, and knowledge as to prevalence of use is lacking (Mache et al. 2012).² Primary studies are small, single dose studies, which are often of low quality and generate conflicting findings (British Medical Association [BMA] 2015). Moreover, there has been a dearth of studies outside the laboratory that investigate effects in occupational groups in normal working conditions (BMA 2015). Effect sizes are moderate and depend on individual and situation factors, in addition to the cognitive capacities that are investigated (Caviola and Faber 2015). The use of methylphenidate by healthy individuals appears to improve verbal learning but leaves visual learning unaffected, while small – but robust – positive effects on spatial working memory have been reported in multiple studies. Most studies on the effects of methylphenidate on attention have reported no significant improvements in attention (Caviola and Faber 2015). Indeed, it appears that most PCEs do not enhance cognitive ability beyond a person’s optimal level (e.g. in decreased conditions such as sleep deprivation) (Coenen et al. 2009). Farah et al. (2014) caution that the risk of dependence to individuals using PCEs is not known and highlight the potential habit-forming nature of such drugs, citing a study carried out in the United States by Kroutil et al. (2006) which estimated that ‘almost one in 20 non-medical users of prescription stimulants meets criteria for dependence or use’ (98).

With regard to the issue of the prevalence of use of PCEs, their use has been shown to be a group-specific phenomenon, as mentioned previously. However, as noted by Ferrari, Coenen, and Grunwald (2012), the social relevance of use of prescription drugs for cognitive enhancement is far from clear. Studies reveal problems in representativeness of the sample, and with respect to motives and the readiness of individuals to use these drugs. Morever, study results differ significantly depending on whether lifetime prevalence or last-year-prevalence is investigated. In addition, higher prevalence rates are found in studies of smaller, more specific groups of people than in broader, national studies (Ferrari, Coenen, and Grunwald 2012). Finally, very little is known about people’s attitudes towards cognitive enhancers. Such knowledge is necessary in order to formulate appropriate policy and practice recommendations in a range of contexts (e.g. general practitioners’ practices, schools, workplaces and universities) (Nadler and Reiner 2010; Lucke 2012).

3. Pharmaceutical cognitive enhancers: ethical issues

A number of ethical issues are regularly discussed in the literature with respect to the use of cognitive enhancers. However, debates on already existing forms of cognitive enhancement focus primarily on issues related to (1) fairness and personal achievement; (2) distributive justice and (3) coercion. Given our focus here on enhancements with a small ‘e’, we discuss these issues in the coming section.

Issues of fairness and personal achievement centre on whether the use of cognitive enhancers can be considered as cheating, extending an unfair advantage in particular competitive contexts such as college and school examinations (Cakic 2009; Sahakian and Morein-Zamir 2011). The idea of taking cognitive enhancers to concentrate or to stay awake for longer in order to meet a deadline or to study for an examination is perceived by some as unfair and inauthentic, undermining the hard work of those who do not take enhancers but pursue the effort naturally (Whetstine 2015). Related concerns revolve around whether achievements facilitated through the use of PCEs are devalued in some way because they do not entail sufficient personal sacrifice and perseverance (Maslen, Faulmüller, and Savulescu 2014; Whetstine 2015). A counter-argument to this cheating argument is advanced by Goodman (2010) who argues that the use of cognitive enhancers does not ‘unnaturally cheapen accomplishments’ (145); rather cognitive enhancement can be viewed as being ‘in line with well-established conceptions of collaborative authorship, which shift the locus of praise and blame from individual creators to the ultimate products of their efforts’ (145). In other words, cognitive enhancers represent another kind of influence, the use of which should be disclosed in the same way that collaboration with another author is acknowledged. Another counter-argument to the cheating concern refers to the possibility of cognitive trade-offs, that is, enhancements in one cognitive area which occur at the cost of diminishments in other areas. Such trade-offs, the argument goes, demonstrate that personal sacrifice is a factor in the use of PCEs (Maslen, Faulmüller, and Savulescu 2014).

Debates concerning the issue of distributive justice question whether PCEs will worsen socio-economic inequality, particularly if access to PCEs is only available to the wealthy (Maslen, Faulmüller, and Savulescu 2014). There are two counter-arguments to this argument (Hall 2004). Proponents of enhancement hold that such arguments do not comprise specific objections to enhancement per se but rather to existing inequalities and argue that facilitating equal access to such new technologies can work to address the problem (Bostrom and Roache 2008; Buchanan 2011; Caplan 2002, 2003). Another distributive justice issue concerns whether enhancement research takes resources away from therapeutic research (Giubilini and Sanyal 2015). This argument holds that therapy should be prioritised over enhancement so that all members of society can benefit from equality of opportunity (Daniels 1985; Buchanan et al. 2000; Daniels 2000; Savulescu 2006). Conversely, the cognitive liberty argument holds that it would be unethical to withhold cognitive enhancers shown to be safe and reliable from healthy individuals (Sahakian and Morein-Zamir 2011).

Coercion – the pressure to take cognitive enhancers – is another issue that regularly features in the ethical debate on PCEs. Coercion can be implicit or explicit.

Implicit coercion can take place in the pressure to maintain or improve one’s position in some perceived social order, such as in a professional environment or in education (Chatterjee 2004). Such coercion might arise in the cultivation of a work or learning environment in which competition and incentives for performance are key features (Sahakian and Morein-Zamir 2011). Children and students are of particular concern here, as children are unable to make their own decisions, while students may feel pressured to take PCEs to keep up with their peers (Cakic 2009).

Explicit coercion can be defined as an ‘explicit demand of superior performance by others’ (Chatterjee 2004, 971). Explicit coercion might occur if shift workers, for example, are required to take PCEs to improve their alertness levels (The Academy of Medical Sciences, the British Academy, the Royal Academy of Engineering and the Royal Society 2012). This may also happen in high-level professions. Santoni de Sio, Faulmüller, and Vincent (2014) argue that if cognitive enhancers were shown to be safe, reliable and effective, people in high-responsibility professions, for example, surgeons, may be required to use such enhancers in order to minimise risks or to enhance the likelihood of positive outcomes. They suggest that a duty to enhance may materialise in the future. First, scientific and technological progress has already had an impact on professional duties; surgeons, for instance, are required to undertake basic antiseptic procedures aimed at increasing safety. Second, specific groups of people – such as people with epilepsy and diabetes who wish to drive vehicles – are already required to take medical substances to prevent the negative effects of these conditions adversely affecting others. The authors argue that the fact that these examples centre on the use of medications used to treat rather than enhance makes little difference as people are still expected to take medications for the benefit of others.

Finally, another ‘coercion’ argument holds that prohibiting or curbing the use of PCEs in schools, universities and workplaces is also coercive as it ‘denies people the freedom to practice a safe means of self-improvement, just to eliminate any negative consequences of the (freely taken) choice not to enhance’ (Farah et al. 2004, 423).

3. The need for governance of HCE

Despite a lack of data regarding PCEs, their use and relevance, the phenomenon is attracting attention not only in the bioethics and neuroethics literature but also in discussions about policy (Outram and Racine 2011; Ter Meulen 2013; Blank 2016). Indeed, key scholars in the area have concluded, ‘the question is therefore not whether we need policies to govern neurocognitive enhancement, but rather what kind of policies we need’ (Farah et al. 2004, 424). While there is recognition of the lack of knowledge regarding PCE and the relatively limited use of such drugs, there is also concern that the rapid advance of enhancement technologies necessitates anticipatory policy-making (Blank 2016). A number of arguments are offered for this assertion. First, our dependence on technological solutions to health and social problems may make it difficult to curtail the diffusion of drugs or enhancement techniques (Blank 2016). Science and technology advance rapidly, while policy frameworks often lag behind. Second, media hype around PCEs promotes the use of PCEs before risks and issues of efficacy are fully understood (Blank 2016). Indeed, HCE has become a popular topic in science café meetings, popular press publications and public debates (Ter Meulen 2013). Third, professional associations such as the BMA (2015) and science academies in the United Kingdom (The Academy of Medical Sciences, the British Academy, the Royal Academy of Engineering and the Royal Society 2012) have undertaken policy-oriented work regarding the possible obligation of certain professionals to take cognitive enhancers (Goold and Maslen 2014). Finally, there have also been a few examples of efforts to apply RRI to the governance of HCE and to neurotechnologies more generally. In 2012, the Nuffield Council on Bioethics developed priorities for RRI for novel neurotechnologies (Nuffield Council 2013) with the aim of making RRI more concrete ‘and thus of practical use both to those conducting and funding research and to those involved in governing (…) by guiding the discharge of their responsibilities’ (119). The recently concluded European Commission (EC) funded NERRI (Neuro-Enhancement Responsible Research and Innovation) project³ was established in order to contribute to the introduction of RRI in neuroenhancement in the European Area and to shape a normative framework for the governance of neuroenhancement technologies.

In the following section, set out our understanding of the relevance of RRI to the governance of HCE.

4. RRI in the context of HCE

RRI has emerged as an approach that aims to enhance the integration of science in society, specifically with regard to the alignment of research processes and outcomes with the values, needs and expectations of society.⁴

The notion of RRI emerged as a policy discourse at European Union (EU) level around 2011, underpinning key policy strategies and cutting across the Horizon 2020 work programme, which defines tackling societal challenges as one of its main priorities.⁵ The EC’s RRI approach includes five policy agendas or keys including ethics, science education, gender, open access and public engagement.⁶

RRI quickly gained traction in the academic discourse, with the founding of this journal in 2014 an important development. A variety of definitions exist in the academic discourse on RRI, however, they do share a number of threads including an emphasis on the dimensions of anticipation, inclusion, reflexivity and responsiveness (Stilgoe, Owen, and Macnaghten 2013). Drawing on this research and on a study of a variety of definitions of RRI, Wickson and Forsberg (2015) have developed a description of the central characteristics of RRI. RRI can be characterised as

1. a specific focus on addressing societal needs and challenges;

2. a research and development process that actively engages and responds to a range of stakeholders;

3. a concerted effort to anticipate potential problems, identify alternatives, and reflect on underlying values and

4. a willingness from relevant actors to act and adapt according to 1–3.

Notwithstanding the variety of priorities and definitions put forward for RRI, the concept of RRI remains quite generic and its application to specific technologies and concrete cases is still in its infancy. In this paper, we think through how to concretise RRI for HCE and offer some essential features of RRI for HCE.⁷ First, we specify and elaborate on the value of RRI as a concept for thinking about the current and prospective embedding of HCE in society.

RRI seeks to highlight issues in research and innovation (R&I), to anticipate their consequences and to engage societal stakeholders in discussing the alignment of the outcomes of R&I with the values and needs of society.⁸ We contend that RRI is particularly important in the case of HCE for a number of reasons.

First, as mentioned previously, scientific and sociological evidence underpinning claims regarding the use, safety and efficacy of existing HCE technologies is lacking. Data concerning the social relevance of PCEs outside specific groups (i.e. students, academics and employees) are lacking in statistical robustness (see Section 2) (Ferrari, Coenen, and Grunwald 2012). At the same time, the number of potential users for non-therapeutic applications of novel neurotechnologies is inevitably much greater and more diverse than that for specialised medical applications (Nuffield Council 2013). This warrants serious consideration of the need for and potential embedding of HCE in society, in addition to the ways in which HCE may change social reasoning, norms and values. Furthermore, bringing an RRI lens to the context of use of prescription drugs for cognitive enhancement can contribute to raising the level of discussion from individual level to collective or societal level to consider both societal needs and expectations and implications for society.

Second and related to the previous point, the application of RRI questions and issues to HCE may shed light on whether and how HCE might contribute to addressing societal challenges such as ageing, well-being, economic competitiveness, distributive justice and so on.

Third, RRI enables us to think about how and whom we might engage in addressing the area from multiple angles – this is particularly important in a situation characterised by a lack of clarity but potentially affecting a diverse group of stakeholders, ranging from health practitioners and employers to schools and parents. Fourth, RRI allows us to take a step back to elucidate and reflect on the underlying values driving discourses around and about HCE (e.g. notions of competitiveness, self-improvement and so on). Indeed, RRI aims to cultivate skills and capacities among stakeholders to identify, assess and deliberate on issues that need to be reflected upon.

5. RRI for HCE: some essential features and issues

In the coming section, we advance some essential features of RRI for HCE, building on the key characteristics of RRI as described by Wickson and Forsberg (2015). We align our approach with the practical approach of the Nuffield Council (2013) which sets out specific elements as priorities for the RRI of novel neurotechnologies.

Drawing on the overview of conceptual and ethical issues – as set out in Sections 2 and 3 – we offer some guiding questions and specific issues as means of elaborating on the respective features of RRI for HCE that we present here. The questions and issues developed here take into account the current empirical context for PCEs (both in terms of the science and in terms of sociological insights regarding use and other issues), as described in the previous sections, while foregrounding the societal context in which PCEs emerge. Where necessary, we draw on additional literature to further elaborate our points. Some of the questions are broad-based questions, which reflect our own insights and reflections. The questions are organised in bullet points for readability – they are not ordered according to importance. The questions and issues should be seen as a departure point from which decision-makers can start thinking systematically about taking a socially responsible approach to a HCE application, such as PCEs. Our target audience is decision-makers who are tasked with making decisions about cognitive enhancement technologies in a specific context. Mandates for decision-making will vary across occupational roles and contexts; such decision-makers might include health authorities (e.g. general practitioners and psychologists) and university rectors, school management and education authorities, for example. In order to practically do something about these issues, decision-makers would need to avail themselves of specific methods or tools available elsewhere. For example, the RRI-Tools project (https://www.rri-tools.eu/) offers resources tailored to the needs and interests of specific stakeholders. Such tools can be used in conjunction with our guiding questions and issues to formulate a comprehensive and practical approach to addressing the particular issue in question.

5.1. Openness and transparency

Openness and transparency are crucial elements of RRI, requiring balanced and meaningful communication of research and its implications in order to facilitate public understanding and scrutiny of research and innovation.⁹ A ‘commitment to candour’ (cf. Hartley et al. 2016) here implies a variety of stakeholders candidly recognising and truthfully representing uncertainties and a lack of knowledge about the off-label use of prescription medications (Coenen and Ferrari 2012). These stakeholders include neuroscientists, psychiatrists, other medical experts, philosophers, social scientists and journalists (Coenen and Ferrari 2012). Such candour requires openness and humility regarding a number of factors. These factors include the complexity of brain function and issues regarding the effectiveness of interventions and unintended side effects. Additional factors include substantial information gaps regarding scientific and sociological claims about the efficiency and use of existing technologies.

These factors are further unpacked under the headings below.

5.2. Generating knowledge of the situation

As described in Section 2, there are many unknowns regarding the off-license use of drugs for cognitive enhancement. This uncertainty is particularly problematic outside the therapeutic context, given that the question of ‘need’ has less applicability with respect to non-therapeutic applications (Nuffield Council 2013). In a therapeutic context, one can speak of a need to alleviate the suffering of those living with neurological or mental health conditions, although there may be enduring uncertainties and risks regarding the particular therapeutic intervention. This need is absent in the case of the use of drugs for enhancement purposes; in this situation the intervention is non-essential, that is, it is for enhancement rather than therapeutic purposes. It is thus unclear how benefits should be assessed and what constitutes proportionate risk (Nuffield Council 2013). Moreover, further research is needed regarding the motivation for use of PCEs and prevalence of use in various groups, in addition to data regarding individuals’ attitudes towards and willingness to use the drugs (Ferrari, Coenen, and Grunwald 2012). Generating knowledge of the situation here involves highlighting those issues and questions that need to be addressed with respect to risk and efficacy and context of use of prescription medications in a non-therapeutic context.

5.2.1. Context of use

• How prevalent is the use of smart drugs in the student and academic populations (across multiple jurisdictions)? Are there particular areas of study that reflect particularly high rates of drug use (e.g. medicine, law, etc.)?

• What kinds of expectations do people have of drugs (regarding efficacy and duration of effect)?

• Are people aware of the risks of using the drug outside of its intended use?

• Are there legal consequences of the off-license supply and/or acquisition and use of the drug?

• Do universities, schools and workplaces have any policies in place regarding the use of drugs for enhancement purposes?¹⁰

5.2.2. Risk and efficacy

Based on the data on ‘known unknowns’ with respect to the use, safety and efficacy of prescription medications for cognitive enhancement purposes, the following questions can be formulated:

• What kind of data regarding the safety and efficacy of drugs for non-therapeutic purposes are required?

  • o Is there a potential risk of dependence on such drugs?

  • o Is there a potential for adverse effects?

• Do such drugs enable improvements in cognition? If so, what kinds of improvements? How might be the specific improvements be defined? Do improvements in one area of cognition lead to diminishment in other areas?

5.2.3. Fairness and personal achievement

• See context of use – What are students’, academics’ and workers’ views and attitudes to the use of the drug for enhancement purposes (not only those who use the drug but also those who do not use it)?

• Societal issues (see section on anticipation and reflection)

5.2.4. Coercion

• Do students/academics/workers report feeling pressured or coerced – either implicitly or explicitly – to take the drug?

5.3. Engagement of stakeholders

Anyone can be a user of cognitive enhancement technologies.¹¹ Moreover, the off-label use of drugs implicates the involvement of a variety of stakeholders, ranging from health authorities, including general practitioners, medicines regulators and neuroscientists, to university management, parents and the media. For these reasons, the engagement of stakeholders is an important item here. Policy for cognitive enhancement should not only be based on risk and benefit analyses but also be informed by evidence and insights regarding the perceptions and views of groups affected by cognitive enhancement (Forlini et al. 2013; Zwart 2015). In order to ensure that the uptake and embedding of cognitive enhancement applications in society take place in an ethically acceptable and socially desirable way, a diversity of views should be taken into account.¹² In the coming section, we offer a ‘snapshot’ into stakeholder perspectives reported in the literature on cognitive enhancement, underlining their importance for policy development. We conclude the section by focusing in on various stakeholders and/or decision-makers and highlighting why they might usefully be engaged in discussions about cognitive enhancement.

Many of the ethical issues addressed in the scientific literature reflect concerns expressed by ethicists, neuroscientists, policy-makers and politicians, thus limiting the debate to these actors (Dijkstra and Schuijff 2016 ). Several authors have argued for the opening of up of the debate around HCE to include the opinions of a wider public including the medical profession and, specifically physicians, particularly in primary care, paediatrics and psychiatry, in addition to educators and human resource professionals, to name just a few (Hall 2004; Greely et al. 2008).

Systematic literature reviews have shed some light on public opinions and attitudes to cognitive enhancement (Fitz et al. 2014; Schelle et al. 2014; Dijkstra and Schuijff 2016). For example, the overall conclusions reached in Dijkstra and Schuijff’s (2016) literature review of 38 articles addressing public perceptions and attitudes towards technologies for human enhancement suggest that the vast majority of respondents hold a moderate to sometimes strong negative attitude towards enhancement technologies for non-medical applications.

Fitz and Reiner (2013) gathered quantitative data from 4011 participants who were presented with a single vignette in one of four experiments revolving around safety, pressure, fairness and authenticity. They found that the public is aware of and understands the four issues identified by neuroethicists. Furthermore, the public in Fitz et al’s study were shown to be ‘biopolitically moderate’ (as was also found in Dijsktra and Schuijff’s study) suggesting that the public appears to be cautiously accepting of cognitive enhancement, while also recognising potential dangers (2014, 184). Fitz et al. conclude that the public appears ‘morally reasonable’ and suggest that ‘empirical data demonstrating that the public’s judgements are sensitive to the reasons commonly discussed by experts provides compelling evidence that public attitudes, or even the public themselves, should be included in the development of future policy’ (2014, 185).

The role of healthcare professionals in cognitive enhancement has also been considered by a number of commentators (Farah et al. 2004; Hamilton, Messing, and Chatterjee 2011; Muhammed 2014). Hamilton, Messing, and Chatterjee (2011) and Farah et al. (2004) suggest that the ‘cosmetic application’ (Hamilton, Messing, and Chatterjee 2011) of non-invasive brain stimulation may challenge the traditional role of physicians, particularly neurologists and psychiatrists. Physicians will have to clarify their relationships with patients and consumers, particularly when their fiduciary and financial interests are at odds (Hamilton, Messing, and Chatterjee 2011). Moreover, ‘as novel approaches for enhancing cognition develop, accurate dissemination of information from the scientific and medical world to the public will call for the responsible actions of clinicians and neuroscientists alike’ (Hamilton, Messing, and Chatterjee 2011, 191). Muhammed (2014) argues that, if complications arise in the use of PCEs, healthcare professionals will most likely have to get involved. For this reason, he argues for the participation of specialists from the outset in regulating and ensuring that PCEs are not abused by people and are only used by those for whom it is judged appropriate.

The following stakeholders might also usefully be engaged in order to help elucidate the social and ethical issues associated with a particular technology or application, in addition to views and concerns regarding its uptake, and potential future impacts, both desired and undesired:

• Student unions: to advise and counsel student communities with regard to the use of drugs for enhancement and, particularly, with regard to alternatives to this particular form of enhancement

• University rectors, school management and education authorities: to advise regarding any particular policies that may be in place regarding the use of drugs and to elicit their views on exam and other pressures

• Employers: see previous point

• Labour unions: to advise on the concerns and needs of groups of workers functioning in high performance, highly competitive or high pressure employment situations in which off-label use of drugs may occur or be tacitly encouraged

• Parents: to elicit their views regarding students’ use of the drug and to discuss practical ways of supporting their children at stressful times

• Media: to establish good relations with the media and to encourage the media to pursue responsible reporting. The media plays a central role in the hype phenomenon regarding HCE (Blank 2016). Studies of news articles have found that while material to ‘balance out’ the story is included; such articles still tend towards an optimistic view of HCE. Such distorted reports lacking ethical and technical details raise social and ethical concerns, given the lack of critical analysis regarding the neuroscience and their digestion by a public that is limited in its knowledge of neuroscience (Blank 2016).

5.4. Anticipation and reflection

Anticipation involves asking ‘what if … ?’ questions to ‘consider contingency, what is known, what is likely, what is plausible and what is possible’ (Stilgoe, Owen, and Macnaghten 2013, 1570). Reflection involves reflecting on underlying values, assumptions and values underpinning research and innovation. Anticipation and reflection can provide valuable insights and enhance our capacity to act according to what we know.¹³ Wickson and Forsberg’s definition informs our particular approach to anticipation and reflection in this section.

Anticipating potential problems might involve:

• the investigation of unexpected and unwanted side effects and the potential for addiction;

• thinking about how to deal with increasing study, academic and work pressures;

• considering the impact of smart drugs on young adults and children with respect to their self-perception, such as the kinds of psychological and social consequences the systematic use of such drugs among vulnerable groups may have on notions of self-worth, identity and pressure to conform to higher standards of performance (Hagger and Johnson 2011);

• reflecting on the potential societal (e.g. economic, ethical and cultural) effects of mass enhancement in work or education, such as

  • ○ the potential increased productivity, effectiveness and precision that the use of smart drugs may facilitate in various work situations (Mann and Sahakian 2015), and particularly in high-risk occupations (Franke et al. 2013) and

  • ○ the unknown and unanticipated long-term effects of smart drugs such as psychiatric disorders (Sharp 2016) or other side effects in younger subjects (Partridge et al. 2011) and how these may impact subjects’ decision-making capacity, social functioning and quality of life (Hagger and Johnson 2011).

Identifying alternatives might involve:

• thinking through non-technical sources of enhancement as a means of achieving the same desired purposes (this also depends on the context of use). Guiding questions might include:

  • ○ What other means are available to students and other groups to enhance their performance (e.g. exercise, diet, sleep, realistic time schedules for exam preparation, reduction of unrealistic expectations regarding exams and grades, stress management techniques, etc.)?

  • ○ Are students/academics/workers aware of these means and methods? Is there somewhere they can access information and support?

Reflecting on underlying values might involve the consideration of the following questions and issues:

• What does the use of smart drugs for enhancement purposes tell us about our society, competitiveness, work-life, etc.? With fewer jobs available and fierce competition for good jobs, smart drugs may be used by individuals to give them a boost (TA Swiss 2011). On the other hand, the social circumstances that cultivate the use of enhancers can be criticised: ‘the criticism is that economic rationality and competitive logic are gradually infiltrating all areas of life’ (TA Swiss 2011, 39). Given the prevailing trend towards a ‘performance society’ (TA Swiss 2011), the question as to the kind of society we want vis-à-vis competitive study and work environments and other social pressures becomes more pressing.

• Do such drugs expand our conceptions of health? The World Health Organization’s definition of health as ‘ … a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity’,¹⁴ for example, could be used to argue for a duty to make people ‘better than well’ with cognitive enhancers.

• The ‘social value’ of a drug has been established for therapy purposes and is justified on the basis that it advances progress in medicine and may offer some medical benefit (TAB 2011); however, it is unclear as to the form of social legitimisation drugs for cognitive enhancement might receive (TAB 2011). This requires some reflection about the specific social benefit cognitive enhancers might offer, and how such a benefit might align or conflict with other social values (Nuffield Council 2013).

• The use of drugs for cognitive enhancement will most likely lead to the increased medicalisation and pharmacologisation of society whereby societies view and define cognition as a medical matter (Nicholson, Mayho, and Sharp 2015). Moreover, it may make individuals conceive of their challenges in medical terms and look first to pharmacological and medical solutions to their problems rather than other means of addressing them – such as lifestyle changes, etc. – which may have fewer side effects, and be more effective.

As the issues above illustrate, reflecting on underlying values can contribute to raising the level of discussion from the level of the individual to the societal consequences and impacts of the use of drugs for cognitive enhancement.

5.5. Responsiveness

Arguably, the one characteristic that informs all RRI-informed approaches to emerging science and technology is their sensitivity to the unfolding of a multitude of value positions, the entanglement of policy and politics, and the absence of a consolidated knowledge base from which to build a governance approach. Ultimately, this sensitivity entails having ‘a capacity to change shape or direction in response to stakeholders and public values and changing circumstances’ (Stilgoe, Owen, and Macnaghten 2013, 1573). Responsive governance of research and innovation within such emerging areas like HCE entails building institutional awareness and capacity to adequately adapt and respond to changing circumstances, in which both ignorance of effects and uncertainty of outcomes are a continuous concern. Given the lack of knowledge regarding both the efficacy and societal implications of PCEs (Ferrari, Coenen, and Grunwald 2012), responsiveness in the context of this area of HCE entails building a capacity to adapt both to rapidly shifting knowledge and to normative assumptions held by a range of stakeholders. A given governance situation thus would take into account upstream, midstream and downstream considerations depending on the context in which these shifting normative, ethical and scientific dimensions are addressed. For reasons of space, we only consider one question or issue per stream:

• Upstream considerations

  • ○ What kind of social good can be served by such research and technologies?

• Midstream considerations

  • ○ In what way could researchers and developers in the field of PCE be engaged in a reflexive process regarding the societal implications of their research as it progresses so as to foster a ‘responsive’ tailoring of RRI for PCE research? (Stahl, Eden, and Jirotka 2013).

• Downstream considerations

  • ○ In what way could the impact of current off-label uses of PCEs be monitored in relevant contexts, such as among employers or schools, so as to provide a sufficient foundation for responsive governance?

5.6. Solution to societal challenges?

An important issue at societal level centres on the link to societal challenges and the ways in which pharmaceutical cognitive enhancement might contribute to addressing such challenges. Other areas of science and technology such as renewable energies, information and communication technologies and bio-based products have clear links to societal challenges and deliver on societal needs (van den Hoven 2013). On the face of it, human enhancement technologies – and pharmacological cognitive enhancement, in particular – offer a potential solution to the societal challenges of ageing societies and the drive for enhanced economic competitiveness.¹⁵ The European Brain Council, for example, stated the following at a working breakfast entitled ‘A European Approach to Human Enhancement’,¹⁶ organised by the European Parliament’s Science and Technology Options Assessment (STOA) body :

Only with the best outputs of healthy brains will we solve many of the challenges that face modern societies. Advancing understanding and improving the health of the brain has a positive ripple effect as it leads to better overall health, which leads to better productivity among the working population, which in turn contributes to increasing Europe’s competitiveness. (9)

In order to investigate how PCEs may contribute to addressing societal challenges, a distinction may be drawn between existing challenges such as public safety, health and well-being, and the ways in which HCE may play a role in new challenges that may arise as a consequence of rapidly shifting social, cultural and technological contexts. In the former context, HCEs may potentially contribute to safer and more effective decision-making in high-risk and high-stake situations, such as among surgeons or health workers (Goold and Maslen 2014). In the latter context, PCEs may emerge as a solution to the increased cognitive demands of new work situations.

6. Discussion and conclusion

Some HCE applications are already available on the market, while interest in cognitive enhancement more generally continues to grow. The governance of HCE requires an emphasis not only on possible negative impacts of technologies but also on their ethical acceptability and social desirability. The essential features of RRI presented here reflect an attempt to flesh out those issues and items that warrant attention and consideration in the governance of HCE, emphasising both the scientific context and the societal context in which these technologies may be taken up. Our aim is to make the concept of RRI practically useful to decision-makers tasked with taking a socially responsible approach to HCE in a particular context. While the questions and issues we present here may have their limitations and possible critiques, we nonetheless view them as a foundation from which to think concretely about how to govern PCE and HCE in specific decision-making contexts.

We share others’ concerns that governance and governance activities for HCE should remain true to the scientific realities of the current context of cognitive enhancement (Schermer et al. 2009; Outram and Racine 2011; Ferrari, Coenen, and Grunwald 2012). In other words, the problematic features of the discourse on PCEs, for example, the lack of data regarding the social relevance of PCEs and the efficacy and safety of drugs used for the purposes of cognitive enhancement (Ferrari, Coenen, and Grunwald 2012) should be taken into account in thinking through governance needs and concrete governance activities for HCE. Moreover, we are acutely aware of the risk of reifying the area of HCE as a concrete area when it can be viewed as a goal rather than a particular set of technologies (Ferrari, Coenen, and Grunwald 2012). We have chosen to zone in on a specific application by addressing an enhancement – with a small ‘e’ – that is already available. Nonetheless, given significant gaps in knowledge regarding the use and efficacy of PCEs, the reader might question whether we are also giving fuel to a phenomenon about which so little is known. We have clearly acknowledged such gaps and taken them into account both in our overall perspective regarding the value of RRI for HCE and in the formulation of the essential features. As described previously, RRI seeks to facilitate socially desirable and ethically acceptable science and innovation. Thinking concretely about this ambition for the case of PCEs – and HCE more generally – allows us to identify those elements that warrant consideration in the governance of HCE, that is, acknowledging known unknowns; considering the role of HCE in delivering on societal challenges; describing and reflecting on underlying values driving the phenomenon; and thinking through alternative means of framing the issues at stake and alternatives to the technology/application itself. Thus, our aim was to stay true to the scientific realities of PCE while considering questions of desirability and acceptability of HCE technologies in society (cf. Ferrari, Coenen, and Grunwald 2012). Indeed, remaining true to the realities of PCE has meant that our discussion of PCEs may fall more on the side of the negative aspects of PCE, with less of an emphasis on the possible merits of PCE. This emphasis in our approach reflects a trend in the discourse on PCE – led by neuroscientists, social scientists and researchers in technology assessment – towards challenging central assumptions frequently visible in the discourse (Ferrari, Coenen, and Grunwald 2012).

The essential features we propose here are not freestanding but link up as an integrated whole. Indeed, as Stilgoe, Owen, and Macnaghten (2013) note about the RRI dimensions, ‘responsible innovation demands their integration and embedding in governance’ (1573). However, while the features we present here are interdependent, we hold that the dimensions of ‘openness and transparency’ and ‘responsiveness’ are of particular importance in the development of a HCE governance approach. Knowledge of the scientific context and real-world complexities is crucial in order to be able to devise an approach that can point to the ‘right impacts’ or alternatively, to less positive or even undesired impacts. Having a concrete handle on what these impacts might be will allow us to be genuinely responsive and take the next step either to call for dedicated funding for the HCE area or to question the relevance and societal desirability of HCE technologies and applications. The features we propose here encompass concrete questions and issues that can be used as a departure point for decision-makers to generate knowledge about and understand the application of RRI to the particular context of PCEs and HCE, more generally.

Acknowledgements

We gratefully acknowledge important suggestions for the paper from Ellen-Marie Forsberg and Erik Thorstensen. We are also grateful to the editors of this special issue for their consideration and to the anonymous reviewers for their constructive feedback.

Disclosure statement

No potential conflict of interest was reported by the authors.

Notes on contributors

Clare Shelley-Egan is a senior researcher at the Research Group on Responsible Innovation at Oslo and Akershus University College of Applied Sciences. She holds a PhD in Science and Technology Studies. Her research interests include Responsible Research and Innovation (RRI), ethics and governance of new and emerging technologies, technology assessment, applied ethics, nanoscience and nanotechnology and regulation of new technologies.

Anders Braarud Hanssen is a PhD candidate at the Research Group on Responsible Innovation at Oslo and Akershus University College of Applied Sciences. His PhD thesis is part of the Patent Ethics project, emphasising ethical and societal aspects of patenting in non-human biotechnology in Norway and Europe.

Laurens Landeweerd holds a position as assistant professor at Radboud University Nijmegen’s Institute for Science Innovation and as a senior researcher at the Research Group on Responsible Innovation at Oslo and Akershus University College of Applied Sciences. His research areas include RRI in industrial biotechnology and continental philosophy of science.

Bjørn Hofmann is a professor at the Norwegian University of Science and Technology (NTNU) at Gjøvik and an adjunct professor at the Centre for Medical Ethics at the University of Oslo. He holds a PhD in philosophy of medicine. His main research interests are philosophy of medicine, philosophy of science, technology assessment and bioethics.

ORCID

Bjørn Hofmann http://orcid.org/0000-0001-6709-4265

Additional information

Funding

The research leading to these results was carried out as part of the project Naturalness in Human Cognitive Enhancement, led by the University of Bohemia, and has received funding from the Norwegian Financial Mechanism 2009–2014 (Norway/EEA Grants) under Project Contract n° 7F14236.

Notes

1 http://www.nickbostrom.com/ethics/values.html.

2 It is important to note that these drugs are widely used therapeutically and their safety profiles in the therapeutic context are well documented (Farah et al. 2014).

3 http://www.nerri.eu/eng/about.aspx.

4 https://ec.europa.eu/programmes/horizon2020/en/h2020-section/responsible-research-innovation.

5 https://ec.europa.eu/programmes/horizon2020/en/h2020-section/responsible-research-innovation.

6 https://ec.europa.eu/programmes/horizon2020/en/h2020-section/responsible-research-innovation.

7 Here we focus only on the academic discourse, as the RRI dimensions propagated in this discourse tend to be the ones taken up in scholarly studies of RRI in various contexts. There is, of course, overlap between the academic and policy discourses but they do reflect different priorities.

8 https://www.rri-tools.eu/about-rri.

9 http://www.rri-tools.eu/about-rri.

10 Duke University in the United States includes ‘the unauthorized use of prescription medication to enhance academic performance’ as part of its policy on academic conduct (see https://studentaffairs.duke.edu/conduct/z-policies/academic-dishonesty).

11 http://www.nerri.eu/eng/definitions.aspx.

12 http://www.nerri.eu/eng/about.aspx.

13 http://www.rri-tools.eu/about-rri.

14 http://www.who.int/about/definition/en/print.html.

15 Given the potential of some HCEs to bring about a societally significant change in the interrelations between humans and technology (Deans, Hammond-Browning, and ter Meulen 2010), one could imagine that HCEs could also potentially represent a societal challenge. However, since we are dealing with comparatively more ‘mundane’ issues, we will not address this here.

16 http://www.braincouncil.eu/wp-content/uploads/2016/02/Booklet.pdf.