The neurotechnology and society interface: responsible innovation in an international context

ABSTRACT

Advances in brain science and research tools promise to increase our understanding of the human brain, treat brain injury and mental illnesses, and enhance cognition, perception, mood, and alertness. Novel neurotechnologies present opportunities but also profound societal questions and require stakeholders to deeply consider ethical, legal, and medical challenges. The current Special Issue of Journal of Responsible Innovation explores the interface of neurotechnology and society in an international context, defining neurotechnology broadly as technical tools aimed at generating better knowledge of the brain and/or intervening in its function. The Issue features a unique and globally drawn group of authors from the public, private, philanthropic, and academic sectors. Together, and befitting the complex challenges of innovating responsibly in a social context, they explore neurotechnology as a simultaneously technical and social practice.

KEYWORDS:

• National brain initiatives
• neuroethics
• neurotechnology
• OECD
• responsible innovation

Part one: introduction

Mental illnesses are an enormous global public health burden. Data published by the Institute for Health Metrics and Evaluation (IHME) (2016), as part of the Global Burden of Disease Project, ranks Alzheimer’s disease and other dementias as the fifth leading cause of death (globally) in 2015. By some estimates, the total global cost (direct and indirect¹) of mental health conditions could increase from US$2.5 trillion in 2010 to US$6.05 trillion in 2030 (Bloom et al. 2011; see also Insel, Collins, and Hyman 2015).

For example, in 2015, depressive disorders ranked as the third leading cause of ‘years lived with disability’ (YLDs²) globally, up 12.9% from 1990 (IHME 2016).³ Or, the total estimated worldwide cost of dementia, with Alzheimer’s disease as the most common form of dementia, is US$818 billion (Alzheimer’s Disease International 2016). Of course these statistics fail to convey the very real human toll that these conditions have on individuals and their loved ones.

Recognizing the social and economic burden that mental illnesses place on society, a number of governments – often in conjunction with foundations, private companies, and other parties – have established multi-year human brain research initiatives (Grillner et al. 2016; Yuste and Bargmann 2017). Collectively, national brain research initiatives account for billions of dollars of investment by the public and private sectors (see, for example, Amunts et al. 2016; White House Office of Science and Technology Policy 2016). These include, for example, the China Brain Project, the European Union’s (EU) Human Brain Project (HBP), Israel Brain Technologies, Japan’s Brain Mapping by Integrated Neurotechnologies for Disease Studies (Brain/MINDS), and the US Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative (Amunts et al. 2016; Jeong et al. 2016; Martin and Chun 2016; Okano et al. 2016; Poo et al. 2016). These national projects each have a particular focus, for example, gaining a more integrated understanding of brain structure and function through information and communications technology, building models of neural circuitry, and developing new technologies to engage brain function.

Despite their differences, these projects share the goal of radically transforming the capacity of science and medicine to treat, cure and prevent brain-related conditions (see, for example, Australian Academy of Science 2016). But fostering new neurotechnology is also an explicit goal. The convergence of neuroscience with information and communication technologies (ICTs) is driving forward the development of fields such as brain imaging, neuromorphic computing, and artificial intelligence (AI). These efforts to develop neurotechnology are part of larger missions to improve public health, foster innovation, increase productivity, and promote economic growth.

At the same time there is broad agreement across national jurisdictions that innovation in brain science and neurotechnology raise a host of ethical, legal, and social issues (ELSI) and governance questions (Garden et al. 2016). Brain science and its applications carry unique power to engage with our identity, self- understanding, and the natural boundaries of cognition. The perception of a gap in thinking about the neurotechnology and society interface has given rise to new scholarly fields, including ‘neurolaw’ and ‘neuroethics’. The widely perceived need for better thinking on neurotechnology and society – and for better approaches to manage their interactions at an early stage (see, for example, Hauser 2014; Sullivan and Illes 2017) – is in no small part due to the long and complicated history of brain science and therapeutic interventions (see, for example, Gross 1999; Finger 2001) such as lobotomy, electroconvulsive therapy, and psychopharmaceuticals.⁴

It shall be of utmost importance for ELSI approaches associated with these advances to actively inform research, development, and technological diffusion (see, for example, Presidential Commission for the Study of Bioethical Issues 2014). Innovation in this space is likely to also give rise to philosophical and bioethical questions that go to the very heart of what it means to be human and what we mean – or seek to define – as a ‘healthy brain’. Questions over access and equity – who gets access, and at what cost – are likely to be central to the debate.

Many of the major brain projects have explicitly identified the need to consider uncertainties and opportunities in governance across the neuroscience research agenda and innovation process. Thus, it is clear that national brain research projects and their stakeholders recognize the need to bring society into the neurosciences (Greely, Ramos, and Grady 2016; Aicardi, Reinsborough, and Rose 2017). It is less clear, however, how they plan to do so. How is this occurring in practice, and what might be gained by comparing across initiatives, national contexts, and stakeholders?

Part two: themes from the 2016 OECD workshop and special issue

In fact, there remains a great need for international dialogue across national initiatives on issues of ethics and responsible research and innovation (RRI) in the arena of the human brain. Seeking to address this gap, the Organisation for Economic Co-operation and Development (OECD) – in partnership with the National Academies of Sciences, Engineering, and Medicine’s Forum on Neuroscience and Nervous System Disorders and Arizona State University – convened a day and a half workshop entitled ‘Neurotechnology and Society: Strengthening RRI in brain science’, held 15–16 September 2016 in Washington D.C. The workshop drew together experts from 16 countries, and included representatives from the major brain research initiatives, government agencies, philanthropic organizations, business and academia.

A primary objective of the workshop was to explore the key challenges and barriers of integrating ethical, legal and social concerns upstream in the neurosciences with comparative attention across national brain research initiatives. Discussion focused on how society and policy makers might better anticipate, before products hit the regulatory system or market, the governance challenges raised by technologies such as cognitive enhancement, non-therapeutic use of neuromodulation, and convergence of the human brain with AI systems. The meeting provided an opportunity for multi-stakeholder, cross-jurisdictions and cross-discipline dialogue on these issues.

While the event was multi-faceted, we wish to highlight four themes here because they lay an important foundation for the contributions in the Special Issue.

Cross-project learning

Engagements of brain science and society across different national and international contexts have to date taken diverse forms. This diversity might have been predicted, but it is still not well understood. The Washington, D.C. workshop sought to address this lacuna by drawing a landscape of different activities in neurotechnology and society across multiple arenas. The Special Issue further enables an examination of the diverse approaches being planned and in operation.

Learning across different governance frameworks

Different ethical frameworks are in operation to structure neurosciences and society in different contexts. The frameworks of ELSI and RRI were explored across the five workshop sessions. The ELSI framework emerged with the Human Genome Project and tends to emphasize the need for oversight structures and careful thought about the governance needs in anticipation of techno-scientific advances. Building on prior frameworks, RRI focuses on engaging the innovation process itself, opening the doors to more actors in order to help steer technology in socially desirable directions. Considering consistencies and differences across the ELSI approach and RRI framework provides an opportunity for mutual learning and enrichment.

Innovating governance

Developments in the brain science and associated social practices, such as self-experimentation with neuromodulation devices and the use of brain imaging in the courtroom, are raising new legal and regulatory questions. For example, whether fundamentally new forms of governance might be required that help anticipate and shape technology as it develops. ‘Anticipatory governance’ (Guston 2014) is just one example.

Facing the challenges of integrating society and science

While better integration of ethical and social values in the course of research is a common goal, mechanisms vary across jurisdictions. Success remains elusive is most contexts. Despite the frequently-stated desire for ELSI issues to be actively incorporated into all stages of the research programs for major brain research initiatives, and analogous neurotechnology innovation, leading commentators such as Greely, Ramos, and Grady (2016, 640) have argued that ‘none of these [ELSI issues] seems likely to be addressed any time soon by the ethics components of the brain projects’. A failure to adequately explore these difficult, yet pressing, questions may have a dampening effect on the research and the market’s response to products and treatments. Different approaches to integration that were explored resemble those seen in other emerging areas of science and technology that have sought to employ the tools and concepts of responsible innovation, and include embedding researchers (Fisher et al. 2015) and engaging stakeholders and publics in forms of dialogue (Blok 2014) that could inform agenda setting, innovation pathways, and governance.

Part three: this special issue

The following research articles, discussion section, and perspective pieces presented in this Special Issue provide an insight into a number of the questions explored during the course of the 2016 OECD workshop, and across institutions, stakeholder groups, and jurisdictions actively working within these areas on a daily basis. By bringing together a diverse set of insights and experiences, our aim here is to catalyze debate in and around the responsible development and use of neurotechnologies by society.

The Special Issue is structured in three parts. Part One consists of three research articles that, taken together, set the scene in, and around, one of three large-scale brain initiatives taken up in the Special Issue as a whole and discuss the orientation of such research and innovation endeavors in relation to the conceptual underpinnings of RRI.

In the opening piece, The integrated Ethics and Society Program of the Human Brain Project: Reflecting on an ongoing experience, Aicardi, Reinsborough, and Rose (2017) provide a ‘view from the trenches’ on the machinations and challenges of working on a subproject of the EU-funded HBP. HBP is, as the authors note, a large-scale brain initiative that draws together approximately 100 research institutions from across the EU. The objective of the HBP is to ‘create an ICT-based scientific research infrastructure for brain research, cognitive neuroscience, and brain-inspiring computing’. Its launch in 2013 was, however, met with intense criticism from a myriad of stakeholders, many of whom were concerned with the hype and over-promise of the program, concerns over scientific focus and, more generally, the governance structure. These concerns resulted in significant reform of the HBP; today’s HBP looks very different to that which was launched in 2013.

The HPB Ethics and Society Subproject (SP12), in which Aicardi et al. are actively involved, is charged with integrating RRI practices across the HBP, including the various research pathways. Given the scope of research and the number of entities involved, this is no small task. But SP12 also has a second key role – to ‘provide “ethics management”’, or to oversee the researchers so as to ensure that they are complying with all the relevant ethical and legal norms. This is no easy task, given the complex organizational structure of the HBP, and the fact that researchers are actively dealing with challenging ethical and social issues on an ongoing and dynamic basis. The authors ask whether RRI tools and methods can therefore provide a platform for the research community to, for the most part, do this themselves.

Part One continues by focusing in on RRI as a concept ‘to connect the practice of research and innovation in the present to the futures that it promises and helps bring about’ (Owen, Bessant, and Heintz 2013), and does so by narrowing its focus to RRI activities within the neuroscience landscape. Thus, the second piece, RRI as the Inheritor of Deliberative Democracy and the Precautionary Principle, by Reber (2017), traces the evolving history of RRI as a policy framework in the EU before setting out an agenda for the framework going forward. But, as the title suggests, an accurate historical account of RRI begins well before the term was first coined; Deliberative Democracy (DD) and the Precautionary Principle (PP) are both precursors to RRI. But they are more than just that. To Reber, ‘the three of them share the same concerns, even if the RRI analysis have not made these connections’. This intersection is important to Reber, and the future of RRI, as it provides a rational basis for drawing deliberation and precaution into the RRI approach. Both, according to Reber, require actors to be proactive especially when faced with uncertainties.

In the third and final research article, Responsible Research and Innovation in the context of human cognitive enhancement: some essential features, Shelley-Egan et al. (2017) consider how RRI could be used to help shape the governance landscape for pharmaceutical cognitive enhancement (PCEs), sometimes known as ‘smart drugs’. Such drugs are, as the authors note, already available in the market. But, rapid advances in the field of brain science and the convergence of neuroscience with other emerging technologies will, Shelley-Egan et al. argue, result in an explosion of new, and increasingly powerful, PCEs into the market. Such products,

often occur in the slipstream of medical innovations, as unintended and unexpected applications of medications developed for treatment and prevention in the medical domain.

While acknowledging that a number of authors have already begun to consider the ethical and policy issues raised by PCEs, Shelley-Egan et al. suggest that much more attention needs to be given to the governance of PCEs and human cognitive enhancements (HCEs) more generally. Here, they argue, RRI has an important role to play and should be employed as a way to address the collective and/or societal level issues associated with PCEs. Taking a pragmatic approach, Shelley-Egan et al. draw out a series of concrete questions and issues that they contend should be examined through the RRI lens ‘as a departure point for decision-makers to generate knowledge about, and understand, the application of RRI’ to PCEs’.

Part Two focuses on the controversial topic of do-it-yourself (DIY) transcranial direct current stimulation (tDCS). It opens with a discussion piece by Smith, The Electric Brain: Do-it-yourself healthcare with Transcranial Direct Current Stimulation. Smith introduces the reader to the practice of, as he puts it,

citizen scientists [who] are experimenting with their own brains and trading information with each other online on how to build, and use, these [tDCS] devices.

According to Smith, their interest in the tDCS devices is primarily for therapeutic purposes; evidence suggests, though, that some people may also be stimulating their brain for the purpose of enhancing their intelligence. And while there is a growing body of literature that supports the efficacy of the technology for treating certain health conditions in certain populations – when administered by a highly trained individual in a therapeutic setting – Smith suggests that the DIY approach brings with it a myriad of potential risks. In setting out these potential risks, some of which seem more plausible than others, Smith challenges the neuroscience community to help in the responsible development and deployment of the technology; he asserts that they have an ‘ethical or moral responsibility to get involved with’ citizen scientists who are actively experimenting on themselves with tDCS technologies, and calls upon them to do so. But what does this realistically look like? And how could this be done in an effective way?

Smith’s piece sets the stage for four responses, which seek to engage with the discussion piece in various ways. May, for example, challenges Smith’s assertion that the neuroscience community has an ethical obligation to engage, and inform, DIY tDCS users about the potential risks of their actions. May argues that, ‘neuroscience community can best serve the interests of the consuming public by conducing research on the safety and efficacy of tDCS technology’, the results of which could then inform regulatory policy.

Jwa, in contrast, focuses her response to Smith on the DIY user population itself, and what little we – as in the research community, regulators and industry – know about who is using DIY tDCS, and the ways in which they are using the technology. She notes, for example, ‘many people do not stay as committed users and move on after practicing tDCS for some time’. Without a more comprehensive understanding of who, how and why the community engages with the technology – and in the absence of sound scientific studies on efficacy – there are, in her words ‘practical barriers to coming up with safe and effective protocol guidelines from the neuroscience community’. In short, Jwa counters Colton’s call, suggesting that the development of any such guidance material at this time would be ill-advised. Investment in sound scientific studies which provide for a better understanding of the technology and its impact, in her view, would be a better use of resources at this time.

Conrad and Craig tackle Smith on the issue of risk and public perception of risks associated with DIY tDCS – or, in their view, lack thereof. Drawing upon Smith’s call for neuroscientists to inform the public about potential risks, Conrad and Craig note that such information is already available in the public domain; from a letter published in the Annals of Neurology through to a disclaimer statement published on the sub-reddit page for tDCS itself. Warnings like that published on the user forum, the authors argue, ‘demonstrate that, at the very least, some members of the tDCS community are more informed about tDCS’s potential risks than Smith gives them credit for’. The authors go on to compare DIY tDCS to other once hyped technologies or applications including shoe-fitting fluoroscope and copper bracelets which claim to give the wearer relief from various ills, making the point that the market is often able to sort out genuine solutions from more spurious (and/or unsafe) applications. In pointing to the individual user, and the market, to play the primarily role in governing DIY tDCS, the authors conclude by arguing that ‘smart DIYers should approach tDCS with skepticism and carefully consider the disclaimers made by the reddit posters’. Failure to do so may come at a price.

In the final response piece, McGurrin and Frow focus on the roles and the responsibilities of scientists with new and emerging technologies and applications. Such roles are found within the laboratory, the clinic, and the ways in which neuroscientists engage with the public more generally. They note, for example, that,

tDCS is not the only field currently suffering from the effects of enthusiastic promotion of research findings; the stem cell research community, for example, is increasingly concerned about the consequences of ‘overselling’ their science.

It is this hype, and overselling of technology – with tDCS just being another example – that is of greater concern to McGurrin and Frow. Accordingly, the authors propose a ‘call for action’ that could be applied to tDCS technologies, as well as a myriad of other emerging technologies and their applications. A fundamental tenant of any such action would be a duty on members of the scientific community to ‘resist the pressures to overstate conclusions and “spin” their work’. This alone, the authors argue, would help to dull hype, while also making it harder for others to extrapolate out ‘findings’ that were, simply put, not actually there. More modest presentation of one’s work tailors nicely, the authors suggest, to calls for greater accountability within the innovation and governance process. They go on to echo the calls of other authors for greater transparency within the governance process, including more opportunities, and more comprehensive, engagement activities.

Part Three consists of three perspectives that provide further indications of the variety of governmental and scholarly approaches to addressing responsibility in brain research. Thus, in Neuroethics and the NIH Brain Initiative, Ramos et al. (2017) set out the rationale that underpinned the establishment of the US BRAIN Initiative by the Obama administration in 2013. While much of the focus of the BRAIN Initiative is on decoding the physiology of the human brain and creating new tools and technologies, Ramos et al. speak to the central role that ethics – neuroethics – and ethicists (as well as other social scientists) are playing in the wide-ranging research agenda. This express inclusion of four ethical goals in the BRAIN 2025 roadmap, as discussed by Ramos et al., is suggestive of more than merely a passing thought of the potential ethical issues that such fundamental research and application could, and shall, give rise to. Importantly, as the authors themselves recognize, these questions cannot be left in the hands of only a few. Engagement with, and across, stakeholder groups and jurisdictions – including other large-scale brain initiatives – will be vital for their success, as too various forms of education. Only through such practices, which embrace a diversity of actors and voices, will we have, in the words of the authors, ‘the best chance of delivering on the promise of scientific advances to treat, and perhaps even cure or prevent, diseases and disorders of the brain’.

Part Three then shifts its focus to Australia and the push by some members of its scientific community for a RRI engagement program for neuroscience. In SWOT [Strengths, Weaknesses, Opportunities and Threats] Analysis of The Brain Dialogue, Nowak and Paton (2017) lament what they see as a failure in, and around, collaborative endeavors between industry and the research community, the result of which has been to hamper innovation. Noting that ‘poor information flow is a critical component of this lackluster performance’, the authors suggest that the RRI framework has the capacity to address this failure with its attention to stakeholder communication and collaboration throughout the innovation process. Nowak and Paton illustrate how, on this basis, the Australian Research Council Centre of Excellence for Integrative Brain Function came to establish The Brain Dialogue in 2014. The purpose of this effort is to actively engage – using a range of different engagement methods – with the public on brain science. But simply establishing and funding such an initiative doesn’t, by itself, guarantee success. With this in mind, Nowak and Paton employ a SWOT analysis to evaluate The Brain Dialogue against its singular goal: ‘improved knowledge exchange between neuroscientists for their mutual benefit’. While the SWOT tool allowed the authors to see the initiative in a new light – limitations and all – it is their finding that it is possible to actively engage with the public on complex and rapidly evolving technologies, and to increase their appetite for scientific information, that could provide the biggest lesson for us all.

In the third and final Perspective piece, Progressing the health agenda: responsibly innovating in health technology, Christie (2017) provides an industry perspective of what it means to do business in a rapidly evolving and highly complex field. Recent work in the social science and public policy suggests that rapid changes in the system of industrial production driven by new and converging technologies should be considered a ‘revolution,’ one that carries both many potential gains but also social uncertainties (OECD 2017). Christie frames her piece around the concept of the Fourth Industrial Revolution, a term coined by Professor Klaus Schwab, Founder and Executive Chairman of the World Economic Forum, and relates to the period in which we now live (Schwab 2016). This, to Christie, presents an opportunity to,

shape the innovation landscape—including the brain science landscape—of today. We can be proactive and not reactive. We can be thoughtful and deliberate, and not rash or irrational.

However, Christie recognizes that for society at large to benefit from this new wave of innovation, especially within the health field, industry must work collectively with stakeholders – including consumers – and do so in a way that recognizes, and responds to, broader societal concerns. By drawing upon her experiences with personalized health technologies, Christie provides insights and principles for how this can be achieved in the real world, and not at the expense of the shareholder.

Having summarized the contents of this Special Issue, several reflections are in order. One thing that the collection illustrates – as is particularly evident from contributions such as those of Aicardi, Reinsborough, and Rose (2017), Ramos et al. (2017), and Nowak and Paton (2017) – is the different ways that governments around the world are attempting to unravel the many mysteries of the human brain, and benefit therefrom. What is, arguably, most striking about these pieces, when placed side by side, is the divergence in research priorities, program structure, and scale. Despite all focusing on the same organ, these articles show that there is no ‘one size fits all’ approach when it comes to the design and implementation of a large-scale brain initiative. Moreover, as these and several other articles in the collection illustrate, the diversity of responses is especially evident when it comes to incorporating public engagement outreach to stakeholders into the initiatives, and/or managing the broader ethical and social dimensions of the projects. In many ways these dimensions are amongst the most challenging aspects to manage and ‘get right’ not only theoretically (Reber, 2017; Shelley-Egan et al., 2017) but also within scientific (Smith, 2017; McGurrin and Frow, 2017), user (Jwa, 2017), and industrial (Christie, 2017) communities and, no less importantly, in such large, multi-layered projects as the NIH Brain Initiative, the HBP, and The Brain Dialogue.

Collectively, the articles making up this Special Issue provide an insight into the breath and complexities associated with the rapidly advancing field of neurotechnologies. They touch upon the many issues and questions canvassed at the September 2016 workshop in Washington, D.C., while also posing many new questions to consider. By presenting these pieces together, side-by-side, we hope that a broader segment of the public will begin to engage with even small slithers of the issues and their intricacies. And that by doing so, help shape the course of research in brain science as it takes place around the globe.

Notes on contributors

Diana M. Bowman is the Associate Dean for International Engagement in the Sandra Day O'Connor College of Law and the Associate Director for Students, School for the Future of Innovation in Society, Arizona State University.

Hermann Garden is a Policy Analyst in the Working Party on Bio-, Nano- and Converging Technology at the Organization for Economic Cooperation and Development (OECD) in Paris.

Clare Stroud is an Independent Researcher.

David E. Winickoff is a Senior Policy Analyst and Secretary of the Working Party on Bio-, Nano- and Converging Technology at the Organization for Economic Cooperation and Development (OECD) in Paris.

Additional information

Funding

This work was supported by National Science Foundation [grant number 1632299].

Notes

1 In their calculations, Bloom et al. (2011) suggest that indirect costs will account for 67% of total spending. Direct costs, such as medical care, will account for only ∼33% of total spending.

2 IHME defined YLDs as follows: ‘Years lived in less than ideal health. This includes health loss that may last for only a few days or a lifetime’ (2016, 7). The authors go on to provide the following explanation of what YLDs means in relation to health: ‘YLDs measure years of life lived with any short- or long-term condition that prevents a person from living in full health. They are calculated by multiplying an amount of time (expressed in years) by a disability weight (a number between 0 and 1 that quantifies the severity of a disability). If a person lives one year with a disability, then, the YLD measure of that person’s disability would be less than one, while the YLL for a year not lived would be exactly one’ (IHME 2016, 12).

3 Other brain related diseases to feature in the top sixteen global leading causes of YLDs included: migraine (7), anxiety disorders (9), schizophrenia (12) and autistic spectrum disorders (16).

4 Lobotomies, once heralded as being revolutionary in terms of their treatment of mental illness (see Kucharski 1984; Valenstein 1986) have subsequently been described ‘as one of the most spectacular failures in the history of medicine’ (Johnson 2009, 367). Electroconvulsive therapy (ECT) has a similarly marred history (Abrams 1979; Lauber et al. 2005), although recent evidence now shows efficacy as a treatment for depression (National Institutes of Health 1985; UK ECT Review Group 2003) and acute mania (Mukherjee, Sackeim, and Schnur 1994). So-called ‘first generation’ antidepressants were first used for treating depression in the 1950s (Sapolsky 2001). While effective, neither class of drug was considered safe, with adverse side effects linked to both types of classes (Coccaro and Siever 1985). Evidence of their effectiveness did, however, act as a catalyst for researchers within the field of neuropyschopharmacology, with advances in efficiency and safety being made with each successive generation and classes of drugs (Schwartz 2016). While questions remain over their (potential over) use and efficacy (see, for example, Ioannidis 2008; Lenzer 2004) Judd has nevertheless argued that, ‘nowhere in neuropsychopharmacology has the scientific progress been more palpable in the lives of so many patients with mental disorders, than the development of antidepressant medications’ (1998, 211).