Hannah Maslen

The regulation of cognitive enhancement devices: extending the medical model.

This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions.

Brain stimulation for treatment and enhancement in children: an ethical analysis.

Davis (2014) called for “extreme caution” in the use of non-invasive brain stimulation (NIBS) to treat neurological disorders in children, due to gaps in scientific knowledge. We are sympathetic to his position. However, we must also address the ethical implications of applying this technology to minors. Compensatory trade-offs associated with NIBS present a challenge to its use in children, insofar as these trade-offs have the effect of limiting the child’s future options. The distinction between treatment and enhancement has some normative force here. As the intervention moves away from being a treatment toward being an enhancement—and thus toward a more uncertain weighing of the benefits, risks, and costs—considerations of the child’s best interests (as judged by the parents) diminish, and the need to protect the child’s (future) autonomy looms larger. NIBS for enhancement involving trade-offs should therefore be delayed, if possible, until the child reaches a state of maturity and can make an informed, personal decision. NIBS for treatment, by contrast, is permissible insofar as it can be shown to be at least as safe and effective as currently approved treatments, which are themselves justified on a best interests standard.

Pharmacological cognitive enhancement—how neuroscientific research could advance ethical debate

There are numerous ways people can improve their cognitive capacities: good nutrition and regular exercise can produce long-term improvements across many cognitive domains, whilst commonplace stimulants such as coffee temporarily boost levels of alertness and concentration. Effects like these have been well-documented in the medical literature and they raise few (if any) ethical issues. More recently, however, clinical research has shown that the off-label use of some pharmaceuticals can, under certain conditions, have modest cognition-improving effects. Substances such as methylphenidate and modafinil can improve capacities such as working memory and concentration in some healthy individuals. Unlike their more mundane predecessors, these methods of “cognitive enhancement” are thought to raise a multitude of ethical issues. This paper presents the six principal ethical issues raised in relation to pharmacological cognitive enhancers (PCEs)—issues such as whether: (1) the medical safety-profile of PCEs justifies restricting or permitting their elective or required use; (2) the enhanced mind can be an “authentic” mind; (3) individuals might be coerced into using PCEs; (4), there is a meaningful distinction to be made between the treatment vs. enhancement effect of the same PCE; (5) unequal access to PCEs would have implications for distributive justice; and (6) PCE use constitutes cheating in competitive contexts. In reviewing the six principal issues, the paper discusses how neuroscientific research might help advance the ethical debate. In particular, the paper presents new arguments about the contribution neuroscience could make to debates about justice, fairness, and cheating, ultimately concluding that neuroscientific research into “personalized enhancement” will be essential if policy is to be truly informed and ethical. We propose an “ethical agenda” for neuroscientific research into PCEs.

The ethics of deep brain stimulation for the treatment of anorexia nervosa

There is preliminary evidence, from case reports and investigational studies, to suggest that Deep Brain Stimulation (DBS) could be used to treat some patients with Anorexia Nervosa (AN). Although this research is at an early stage, the invasive nature of the intervention and the vulnerability of the potential patients are such that anticipatory ethical analysis is warranted. In this paper, we first show how different treatment mechanisms raise different philosophical and ethical questions. We distinguish three potential mechanisms alluded to in the neuroscientific literature, relating to desire, control, and emotion, respectively. We explain why the precise nature of the mechanism has important implications for the patient’s autonomy and personal identity. In the second part of the paper, we consider practical dimensions of offering DBS to patients with AN in certain cases. We first discuss some limited circumstances where the mere offering of the intervention might be perceived as exerting a degree of coercive pressure that could serve to undermine the validity of the patient’s consent. Finally, we consider the implications of potential effects of DBS for the authenticity of the patient’s choice to continue using stimulation to ameliorate their condition.

The Indirect Psychological Costs of Cognitive Enhancement

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Must the Surgeon Take the Pill? Negligence Duty in the Context of Cognitive Enhancement

Recently, attention has turned to the possibility of enhancing human cognitive abilities via pharmacological interventions. Known as ‘cognitive enhancers’, these drugs can alter human mental capacities, and in some cases can effect significant improvements. One prime example is modafinil, a drug used to treat narcolepsy, which can help combat decreases in wakefulness and cognitive capacity that arise due to fatigue in otherwise healthy individuals. In this paper, we respond to calls in the philosophical and ethical literature that surgeons and other medical professionals should be morally obliged to take cognitively enhancing drugs. We examine whether surgeons who make fatigue‐related errors during patient care might be considered legally obliged to enhance themselves. We focus on liability for a failure to medicate, and conclude that it is highly unlikely that surgeons will be legally obliged to address their fatigue through the use of cognitive enhancing drugs.

Do-it-yourself brain stimulation: a regulatory model

Fitz and Reiner describe the widespread appeal of transcranial direct current stimulation (tDCS) as an all-purpose cognitive enhancer.1 Relatively safe, cheap and effective, tDCS has been met with excitement by academics, journalists and private individuals hoping to purchase or construct equipment for home use. Devices can now easily be bought online without regulation or oversight.2 Urging a more cautious approach to claims about the safety of tDCS, Fitz and Reiner offer recommendations to guide balanced discourse and call on all stakeholders to contribute to policy debate. We respond to this call by proposing a model for the regulation of tDCS devices. We propose that cognitive enhancement devices (CEDs), such as tDCS and neurofeedback equipment, should be regulated in the same way as medical devices (MDs) with the further suggestion that a ‘low-risk exemption’ should be incorporated for MDs and CEDs alike. This model, we believe, is very much in the spirit of the ‘managed technological optimism’ Fitz and Reiner advocate. As Fitz and Reiner point out, devices marketed for cognitive enhancement are not covered by any existing legislation in either the EU or the USA, other than that which covers general product safety. The EUs General Product Safety Directive, for example, only sets general requirements and does not make provision for pre-market assessment.i Devices marketed for enhancement purposes are therefore not held to the rigorous standards set for MDs since they do not fall within the definition of an MD set out in the Medical Devices Directive (MDD)ii. Given the safety concerns Fitz and Reiner raise, and the emerging market for tDCS, we agree that maintaining the status quo is not a tenable option—some regulation is needed. However, we also share their view that the optimum regulatory framework would be one that acknowledges the potential …

Regulation of devices for cognitive enhancement.

938 www.thelancet.com Vol 382 September 14, 2013 World Health Assembly covers disparate agendas that do not always reflect the international burden of disease. Therefore, increasing the flexibility and predictability of funding has been identifi ed as one of the highest priorities of WHO reform. Currently, WHO is undergoing reform to better equip itself to address the increasingly complex health challenges of the 21st century. By establishing clear priorities and by improving the management and governance practices, WHO can better serve the global community, protect health, and save lives. The 66th World Health Assembly discussed the strategic allocation of the limited WHO resources, a n d p r o p o s e d a f i n a n c i n g dialogue between the WHO governing body and the member states. This aims to increase the predictability and transparency of WHO’s financing before the biennial budget implementation. If accurately implemented, it could allow contributors to improve the alignment of resources with the strategic plan for 2008–13, from the WHO website. The figure presents the total budgetary allocation trend according to various categories for both the western Pacific and African regions. During this period, it is evident that WHO’s budgetary allocations were heavily skewed towards control of infectious diseases in both regions. WHO itself has struggled with this mismatch between priorities, even though they have been agreed by all the member states, as well as the resources available to fi nance them. This probably resulted from an over-reliance on voluntary funds, because programmes that attract donor interest tend to be well financed, whereas programmes that do not can be under-resourced, despite offi cial designation as priority issues. Notably, 93% of the budget for infectious disease control in Africa for 2012–13 came from voluntary contributions, which donor countries often tightly earmark. Another issue, reported by Tomomi Kitamura and colleagues, is that the Figure: WHO’s budgetary allocation according to health category Allocations to SO1 (to reduce the burden of communicable diseases) and SO2 (to combat HIV/AIDS, malaria, and tuberculosis) were categorised as infectious disease control. Allocations to SO3 (to prevent and reduce premature death due to chronic non-communicable conditions) and SO6 (to promote health and reduce risk factors for health conditions such as use of tobacco, alcohol, and unhealthy diets) were categorised as non-communicable diseases. Allocations to SO4 (to improve health during the key stages of life, including pregnancy, childbirth, neonatal period, childhood, and adolescence) were categorised under maternal and child health. Allocations to SO5 (to reduce the health consequences of emergencies, disasters, crises, and confl icts) were categorised under emergency response. All allocations to the remaining SOs were categorised as others. SO=WHO strategic objective. Total

With cognitive enhancement comes great responsibility

Although drugs that enhance the cognition of ‘healthy’ individuals (e.g. methylphenidate and modafinil) have received attention from ethicists and philosophers, little research has focused on the concrete opportunities they present for particular groups in society. Recent policy discussion has gone as far as suggesting there may be a moral obligation for individuals in high-risk professions (e.g. surgeons, pilots) to take enhancers. This chapter outlines a theoretical framework and methodology for investigating the claims that some professionals: (a) might have a responsibility to enhance and (b) might acquire more responsibilities once enhanced. Our methodology is interdisciplinary—as we examine normative hypotheses alongside psychological data and legal precedent—and practice-oriented—as we ultimately aim to make recommendations for policy and the professionals within its remit. Philosophical analysis exposes the conceptual and normative questions involved in a discussion of enhancement in professional contexts, offering and refining definitions of concepts (capacity, responsibility) and theory about their relationship. Psychological inquiry uses surveys and experimental methods to collect data from lay people and professionals on attitudes and responsibility attributions associated with enhancement. Legal analysis examines the conditions under which professional duties to enhance might emerge and how the law might impose or limit liability.

Unexpected Complications of Novel Deep Brain Stimulation Treatments: Ethical Issues and Clinical Recommendations.

Innovative neurosurgical treatments present a number of known risks, the natures and probabilities of which can be adequately communicated to patients via the standard procedures governing obtaining informed consent. However, due to their novelty, these treatments also come with unknown risks, which require an augmented approach to obtaining informed consent.