Social scientists have drawn attention to the role of hype and optimistic visions of the future in providing momentum to biomedical innovation projects by encouraging innovation alliances. In this article, we show how less optimistic, uncertain, and modest visions of the future can also provide innovation projects with momentum. Scholars have highlighted the need for clinicians to carefully manage the expectations of their prospective patients. Using the example of a pioneering clinical team providing deep brain stimulation to children and young (...) people with movement disorders, we show how clinicians confront this requirement by drawing on their professional knowledge and clinical expertise to construct visions of the future with their prospective patients; visions which are personalized, modest, and tainted with uncertainty. We refer to this vision-constructing work as recalibration, and we argue that recalibration enables clinicians to manage the tension between the highly optimistic and hyped visions of the future that surround novel biomedical interventions, and the exigencies of delivering those interventions in a clinical setting. Drawing on work from science and technology studies, we suggest that recalibration enrolls patients in an innovation alliance by creating a shared understanding of how the “effectiveness” of an innovation shall be judged. (shrink)

Deep brain stimulation (DBS), a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of psychosurgery (...) can help shed light on how to address the regulatory gaps that exist currently in DBS research. To show why it is important to address the current regulatory gaps within psychiatric DBS, we draw on the motivations underlying the regulation of earlier forms of psychosurgery in the US. We begin by providing a brief history of psychosurgery and electrical brain stimulation in the US. Against this backdrop, we introduce psychiatric DBS, exploring current research and ongoing clinical trials. We then draw out the ethical and regulatory similarities between earlier forms of psychosurgery and psychiatric DBS. As we will show, the factors that motivated strict regulation of earlier psychosurgical procedures mirror concerns with psychiatric DBS today. We offer three recommendations for psychiatric DBS regulation, which echo earlier motivations for regulating psychosurgery, along with new considerations that reflect the novel technologies used in DBS. (shrink)

Our think tank tasked by the Dutch Health Council, consisting of Radboud University Nijmegen Honours Academy students with various backgrounds, investigated the implications of Deep Brain Stimulation for psychiatric patients. During this investigation, a number of methodological, ethical and societal difficulties were identified. We consider these difficulties to be a reflection of a still fragmented field of research that can be overcome with improved organization and communication. To this effect, we suggest that it would be useful to found a centralized (...) DBS organization. Such an organization makes it possible to 1) set up and maintain a repository, 2) facilitate DBS studies with a larger sample size, 3) improve communication amongst researchers, clinicians and ethical committees, and 4) improve communication between DBS experts and the public at large. (shrink)

Since the 1960s, scientists, engineers, and healthcare professionals have developed brain–computer interface (BCI) technologies, connecting the user’s brain activity to communication or motor devices. This new technology has also captured the imagination of publics, industry, and ethicists. Academic ethics has highlighted the ethical challenges of BCIs, although these conclusions often rely on speculative or conceptual methods rather than empirical evidence or public engagement. From a social science or empirical ethics perspective, this tendency could be considered problematic and even technocratic because (...) of its disconnect from publics. In response, our trinational survey (Germany, Canada, and Spain) reports public attitudes toward BCIs (N = 1,403) on ethical issues that were carefully derived from academic ethics literature. The results show moderately high levels of concern toward agent-related issues (e.g., changing the user’s self) and consequence-related issues (e.g., new forms of hacking). Both facets of concern were higher among respondents who reported as female or as religious, while education, age, own and peer disability, and country of residence were associated with either agent-related or consequence-related concerns. These findings provide a first look at BCI attitudes across three national contexts, suggesting that the language and content of academic BCI ethics may resonate with some publics and their values. (shrink)

Brain-Computer Interface (BCI) research and (future) applications raise important ethical issues that need to be addressed to promote societal acceptance and adequate policies. Here we report on a survey we conducted among 145 BCI researchers at the 4th International BCI conference, which took place in May–June 2010 in Asilomar, California. We assessed respondents’ opinions about a number of topics. First, we investigated preferences for terminology and definitions relating to BCIs. Second, we assessed respondents’ expectations on the marketability of different BCI (...) applications (BCIs for healthy people, BCIs for assistive technology, BCIs-controlled neuroprostheses and BCIs as therapy tools). Third, we investigated opinions about ethical issues related to BCI research for the development of assistive technology: informed consent process with locked-in patients, risk-benefit analyses, team responsibility, consequences of BCI on patients’ and families’ lives, liability and personal identity and interaction with the media. Finally, we asked respondents which issues are urgent in BCI research. (shrink)

BackgroundNeuroethics describes several interdisciplinary topics exploring the application and implications of engaging neuroscience in societal contexts. To explore this topic, we present Part 3 of a four-part bibliography of neuroethics’ literature focusing on the “ethics of neuroscience.”MethodsTo complete a systematic survey of the neuroethics literature, 19 databases and 4 individual open-access journals were employed. Searches were conducted using the indexing language of the U.S. National Library of Medicine. A Python code was used to eliminate duplications in the final bibliography.ResultsThis bibliography (...) consists of 1137 papers, 56 books, and 134 book chapters published from 2002 through 2014, covering ethical issues in neuroimaging, neurogenetics, neurobiomarkers, neuro-psychopharmacology, brain stimulation, neural stem cells, neural tissue transplants, pediatric-specific issues, dual-use, and general neuroscience research issues. These works contain explanations of recent research regarding neurotechnology, while exploring ethical issues in future discoveries and use. (shrink)

Since the development of the first neural prosthesis, that is, the cochlear implant in 1957, neural prosthetics have been one of the highly promising, yet most challenging areas of medicine, while having become a clinically accepted form of invasiveness into the human body. Neural prosthetic devices, of which at least one part is inserted into the body, interact directly with the nervous system to restore or replace lost or damaged sensory, motor, or cognitive functions. This field is not homogenous and (...) encompasses a variety of technologies, which are in various stages of development. Some devices are well established in clinical practice and have become routine, such as cochlear implants. By comparison, other technologies are in experimental phases and still need to be further developed to achieve the desired results. (shrink)

The introduction of new medical treatments based on invasive technologies has often been surrounded by both hopes and fears. Hope, since a new intervention can create new opportunities either in terms of providing a cure for the disease or impairment at hand; or as alleviation of symptoms. Fear, since an invasive treatment involving implanting a medical device can result in unknown complications such as hardware failure and undesirable medical consequences. However, hopes and fears may also arise due to the cultural (...) embeddedness of technology, where a therapy due to ethical, social, political and religious concerns could be perceived as either a blessing or a threat. While Deep Brain Stimulation (DBS) for treatment resistant depression (TRD) is still in its cradle, it is important to be proactive and try to scrutinize both surfacing hopes and fears. Patients will not benefit if a promising treatment is banned or avoided due to unfounded fears, nor will they benefit if DBS is used without scrutinizing the arguments which call for caution. Hence blind optimism is equally troublesome. We suggest that specificity, both in terms of a detailed account of relevant scientific concerns as well as ethical considerations, could be a way to analyse expressed concerns regarding DBS for TRD. This approach is particularly fruitful when applied to hopes and fears evoked by DBS for TRD, since it can reveal if our comprehension of DBS for TRD suffer from various biases which may remain unnoticed at first glance. We suggest that such biases exist, albeit a further analysis is needed to explore this issue in full. (shrink)

Deep brain stimulation has been regarded as an efficient and safe treatment for Parkinson’s disease since being approved by the Food and Drug Administration in 1997. It is estimated that more than 150 000 patients have been implanted, with a forecasted rapid increase in uptake with population ageing. Recent longitudinal follow-up studies have reported a significant increase in postoperative survival rates of patients with PD implanted with DBS as compared with those not implanted with DBS. Although DBS tends to increase (...) life expectancy for most patients with PD, this medical benefit does not come without attendant negative consequences. For example, emerging forms of iatrogenic harms are sometimes induced—harms which were not initially expected when clinicians proposed neurosurgery and patients or their guardians consented to the treatment. We report and discuss the clinical case of a patient who was implanted with DBS more than 20 years ago and is now experiencing unexpected stages of PD. This case illustrates how extending the life span without improving quality of life may introduce a burden of harms for patients and families. As well, this case shows why we should prepare for the expanding numbers of PD-implanted patients experiencing a gain of longevity but with severe stages of disease leading to diminution in quality of life. This newly observed effect of DBS treatment requires us to explore ethical questions related to iatrogenic harms, informed consent, end of life and caregivers’ burden. (shrink)

The idea that deep brain stimulation (DBS) induces changes to personality, identity, agency, authenticity, autonomy and self (PIAAAS) is so deeply entrenched within neuroethics discourses that it has become an unchallenged narrative. In this article, we critically assess evidence about putative effects of DBS on PIAAAS. We conducted a literature review of more than 1535 articles to investigate the prevalence of scientific evidence regarding these potential DBS-induced changes. While we observed an increase in the number of publications in theoretical neuroethics (...) that mention putative DBS-induced changes to patients’ postoperative PIAAAS, we found a critical lack of primary empirical studies corroborating these claims. Our findings strongly suggest that the theoretical neuroethics debate on putative effects of DBS relies on very limited empirical evidence and is, instead, reliant on unsubstantiated speculative assumptions probablyin lieuof robust evidence. As such, this may reflect the likelihood of a speculative neuroethics bubble that may need to be deflated. Nevertheless, despite the low number of first-hand primary studies and large number of marginal and single case reports, potential postoperative DBS changes experienced by patients remain a critical ethical concern. We recommend further empirical research in order to enhance theoretical neuroethics work in the area. In particular, we call for the development of better instruments capable of capturing potential postoperative variations of PIAAAS. (shrink)

Owing to an oversight, we noted that the acknowledgement section was missing from the original published version of this paper.

The article Deflating the "DBS causes personality changes" bubble, written by Frederic Gilbert, J. N. M. Viaña and C. Ineichen, was originally published electronically on the publisher’s internet portal on 19 June 2018 without open access.

Deep brain stimulation (DBS) is an effective treatment for the debilitating motor symptoms of Parkinson’s disease and other neurological disorders. However, clinicians and commentators have noted that DBS recipients have not necessarily experienced the improvements in quality of life that would be expected, due in large part to what have been described as the ‘psychosocial’ impacts of DBS. The premise of this paper is that, in order to realise the full potential of DBS and similar interventions, clinical services need to (...) be arranged in such a way that these psychosocial dimensions are recognised and managed. Our starting point is that the psychosocial effects of DBS ‘in the field’ present us with analytically-useful disruptions: they disturb and foreground deeply held assumptions relating to the individual, health and its treatment, and which in a crude form manifest as the myth of technological solutionism within health care. Drawing on scholarship in medical sociology and science and technology studies (STS), we argue that DBS brings to the fore the relational dimensions of personhood, and demonstrates the emotional and social turmoil that can result if the relational dimensions of personhood are ignored by clinical services. In light of this, we argue that DBS should be implemented within a regime of care. Drawing on ethnographic research of a paediatric DBS clinical service, we provide an example of a regime of care, and conclude by reflecting on what other DBS services might learn from this paediatric service. (shrink)

Seven specific challenges in patient vulnerability related to neurosurgical advancement highlight needed augmentations for standards in innovation and research that do not unduly inhibit access to potential therapies while assuring just treatment of patients.

The vulnerability of patients receiving significantly innovative neurosurgical procedures, either as research or as non-standard therapy, presents particularly potent challenges for those attempting to substantially advance clinical Neurosurgical practice in the most ethically and efficacious manner. This beginning formulation has built into it several important notions about research participation, balancing values, and clinical advancement in the context of neurological illness. For the time being, allow vulnerability to act as a placeholder for circumstances or states of being wherein the established checks (...) and balances of power and interest are no longer sufficient in promoting the just treatment of persons. Further, the phrase to substantially advance Neurosurgical practice encompasses radical innovation as well as significant research into new procedures. Finally, few of these explorations involve true randomized placebo controlled trials, but rather they enroll patients rightfully hoping for some benefit by means of undergoing the procedure.When a neurosurgeon asks me, as an ethicist, to meet with a patient who has medically refractory disease and no good standard therapy options remaining, he is asking for help concerning whether to offer, as a last chance, an unproven therapy as either innovation or research. (shrink)

There is substantial evidence that methylphenidate (MPH; Ritalin), is being used by healthy university students for non-medical motives such as the improvement of concentration, alertness, and academic performance. The scope and potential consequences of the non-medical use of MPH upon healthcare and society bring about many points of view.

Deep brain stimulation (DBS) has been proposed as a potential treatment of drug addiction on the basis of its effects on drug self-administration in animals and on addictive behaviours in some humans treated with DBS for other psychiatric or neurological conditions. DBS is seen as a more reversible intervention than ablative neurosurgery but it is nonetheless a treatment that carries significant risks. A review of preclinical and clinical evidence for the use of DBS to treat addiction suggests that more animal (...) research is required to establish the safety and efficacy of the technology and to identify optimal treatment parameters before investigating its use in addicted persons. Severely addicted persons who try and fail to achieve abstinence may, however, be desperate enough to undergo such an invasive treatment if they believe that it will cure their addiction. History shows that the desperation for a cure of addiction can lead to the use of risky medical procedures before they have been rigorously tested. In the event that DBS is used in the treatment of addiction, we provide minimum ethical requirements for clinical trials of its use in the treatment of addiction. These include: restrictions of trials to severely intractable cases of addiction; independent oversight to ensure that patients have the capacity to consent and give that consent on the basis of a realistic appreciation of the potential benefits and risks of DBS; and rigorous assessments of the effectiveness and safety of this treatment compared to the best available treatments for addiction. (shrink)

Animal models are used in experiments in the behavioural neurosciences that aim to contribute to the prevention and treatment of cognitive and affective disorders in human beings, such as anxiety and depression. Ironically, those animals that are likely to be the best models for psychopathology are also likely to be considered the ones that are most morally problematic to use, if it seems probable that (and if indeed they are initially selected as models because) they have experiences that are similar (...) to human experiences that we have strong reasons to avoid causing, and indeed aim to alleviate (such as pain, anxiety or sadness). In this paper, against the background of contemporary discussions in animal ethics and the philosophy of animal minds, we discuss the views that it is morally permissible to use animals in these kinds of experiments, and that it is better to use less cognitively complex animals (such as zebrafish) than more complex animals (such as dogs). First, we criticise some justifications for the claim that human beings and more complex animals have higher moral status. We argue that contemporary approaches that attribute equal moral status to all beings that are capable of conscious strivings (e.g. avoiding pain and anxiety; aiming to eat and play) are based on more plausible assumptions. Second, we argue that it is problematic to assume that less cognitively complex animals have a lesser sensory and emotional experience than more complex beings across the board. In specific cases, there might be good reasons to assume that more complex beings would be harmed more by a specific physical or environmental intervention, but it might also be that they sometimes are harmed less because of a better ability to cope. Determining whether a specific experiment is justified is therefore a complex issue. Our aim in this chapter is to stimulate further reflection on these common assumptions behind the use of animal models for psychopathologies. In order to be able to draw more definite conclusions, more research will have to be done on the influence of cognitive complexity on the experience of (human and non-human) animals. (shrink)

Addiction is increasingly described as a “chronic and relapsing brain disease”. The potential impact of the brain disease model on the treatment of addiction or addicted individuals’ treatment behaviour remains uncertain. We conducted a qualitative study to examine: (i) the extent to which leading Australian addiction neuroscientists and clinicians accept the brain disease view of addiction; and (ii) their views on the likely impacts of this view on addicted individuals’ beliefs and behaviour. Thirty-one Australian addiction neuroscientists and clinicians (10 females (...) and 21 males; 16 with clinical experience and 15 with no clinical experience) took part in 1 h semi-structured interviews. Most addiction neuroscientists and clinicians did not uncritically support the use of brain disease model of addiction. Most were cautious about the potential for adverse impacts on individuals’ recovery and motivation to enter treatment. While some recognised the possibility that the brain disease model of addiction may provide a rationale for addicted persons to seek treatment and motivate behaviour change, Australian addiction neuroscientist and clinicians do not assume that messages about “diseased brains” will always lead to increased treatment-seeking and reduced drug use. Research is needed on how neuroscience research could be used in ways that optimise positive outcomes for addicted persons. (shrink)

In this chapter, I propose the mechanism of cognitive enhancement based on studies of cognitive-enhancing drugs and behavioral training. I argue that there are mechanistic differences between cognitive-enhancing drugs and behavioral training due to their different enhancing effects. I also suggest possible mechanisms for cognitive-enhancing drugs and behavioral training and for the synergistic effects of their simultaneous application.