Governing the Global Antimicrobial Commons: Introduction to Special Issue.

Antimicrobial resistance is one of the greatest public health crises of our time. The natural biological process that causes microbes to become resistant to antimicrobial drugs presents a complex social challenge requiring more effective and sustainable management of the global antimicrobial commons-the common pool of effective antimicrobials. This special issue of Health Care Analysis explores the potential of two legal approaches-one long-term and one short-term-for managing the antimicrobial commons. The first article explores the lessons for antimicrobial resistance that can be learned from recent climate change agreements, and the second article explores how existing international laws can be adapted to better support global action in the short-term.

An empirical bioethical examination of Norwegian and British doctors' views of responsibility and (de)prioritization in healthcare.

In a world with limited resources, allocation of resources to certain individuals and conditions inevitably means fewer resources allocated to other individuals and conditions. Should a patient's personal responsibility be relevant to decisions regarding allocation? In this project we combine the normative and the descriptive, conducting an empirical bioethical examination of how both Norwegian and British doctors think about principles of responsibility in allocating scarce healthcare resources. A large proportion of doctors in both countries supported including responsibility for illness in prioritization decisions. This finding was more prominent in zero-sum scenarios where allocation to one patient means that another patient is denied treatment. There was most support for incorporating prospective responsibility (through patient contracts), and low support for integrating responsibility into co-payments (i.e. through requiring responsible patients to pay part of the costs of treatment). Finally, some behaviours were considered more appropriate grounds for deprioritization (smoking, alcohol, drug use)-potentially because of the certainty of impact and direct link to ill health. In zero-sum situations, prognosis also influenced prioritization (but did not outweigh responsibility). Ethical implications are discussed. We argue that the role that responsibility constructs appear to play in doctors' decisions indicates a needs for more nuanced-and clear-policy. Such policy should account for the distinctions we draw between responsibility-sensitive and prognostic justifications for deprioritization.

Prospective Intention-Based Lifestyle Contracts: mHealth Technology and Responsibility in Healthcare.

As the rising costs of lifestyle-related diseases place increasing strain on public healthcare systems, the individual's role in disease may be proposed as a healthcare rationing criterion. Literature thus far has largely focused on retrospective responsibility in healthcare. The concept of prospective responsibility, in the form of a lifestyle contract, warrants further investigation. The responsibilisation in healthcare debate also needs to take into account innovative developments in mobile health technology, such as wearable biometric devices and mobile apps, which may change how we hold others accountable for their lifestyles. Little is known about public attitudes towards lifestyle contracts and the use of mobile health technology to hold people responsible in the context of healthcare. This paper has two components. Firstly, it details empirical findings from a survey of 81 members of the United Kingdom general public on public attitudes towards individual responsibility and rationing healthcare, prospective and retrospective responsibility, and the acceptability of lifestyle contracts in the context of mobile health technology. Secondly, we draw on the empirical findings and propose a model of prospective intention-based lifestyle contracts, which is both more aligned with public intuitions and less ethically objectionable than more traditional, retrospective models of responsibility in healthcare.

Neuroprosthetic Speech: The Ethical Significance of Accuracy, Control and Pragmatics.

Neuroprosthetic speech devices are an emerging technology that can offer the possibility of communication to those who are unable to speak. Patients with 'locked in syndrome,' aphasia, or other such pathologies can use covert speech-vividly imagining saying something without actual vocalization-to trigger neural controlled systems capable of synthesizing the speech they would have spoken, but for their impairment.We provide an analysis of the mechanisms and outputs involved in speech mediated by neuroprosthetic devices. This analysis provides a framework for accounting for the ethical significance of accuracy, control, and pragmatic dimensions of prosthesis-mediated speech. We first examine what it means for the output of the device to be accurate, drawing a distinction between technical accuracy on the one hand and semantic accuracy on the other. These are conceptual notions of accuracy.Both technical and semantic accuracy of the device will be necessary (but not yet sufficient) for the user to have sufficient control over the device. Sufficient control is an ethical consideration: we place high value on being able to express ourselves when we want and how we want. Sufficient control of a neural speech prosthesis requires that a speaker can reliably use their speech apparatus as they want to, and can expect their speech to authentically represent them. We draw a distinction between two relevant features which bear on the question of whether the user has sufficient control: voluntariness of the speech and the authenticity of the speech. These can come apart: the user might involuntarily produce an authentic output (perhaps revealing private thoughts) or might voluntarily produce an inauthentic output (e.g., when the output is not semantically accurate). Finally, we consider the role of the interlocutor in interpreting the content and purpose of the communication.These three ethical dimensions raise philosophical questions about the nature of speech, the level of control required for communicative accuracy, and the nature of 'accuracy' with respect to both natural and prosthesis-mediated speech.

Responsible Use of Machine Learning Classifiers in Clinical Practice.

Machine learning models are increasingly being used in clinical settings for diagnostic and treatment recommendations, across a variety of diseases and diagnostic methods. To conceptualise how physicians can use them responsibly, and what the standard of care should be, there needs to be discussion beyond model accuracy levels and the types of explanation provided by such classifiers. There needs to be consideration of how the explanations are provided and how historical accuracy rates can together constitute the overall epistemic status of the model, and how models with different epistemic statuses should subsequently be deferred to by medical practitioners. Answering this will require a multi-disciplinary consideration of the literature on automation bias in human factors and ergonomics to higher-order evidence in social epistemology. Adjudicating physician responsibility will also require assessing when a physician's ignorance of the appropriate ways to engage with such classifiers, as outlined above, will be culpable and when not.

Nudging Immunity: The Case for Vaccinating Children in School and Day Care by Default.

Many parents are hesitant about, or face motivational barriers to, vaccinating their children. In this paper, we propose a type of vaccination policy that could be implemented either in addition to coercive vaccination or as an alternative to it in order to increase paediatric vaccination uptake in a non-coercive way. We propose the use of vaccination nudges that exploit the very same decision biases that often undermine vaccination uptake. In particular, we propose a policy under which children would be vaccinated at school or day-care by default, without requiring parental authorization, but with parents retaining the right to opt their children out of vaccination. We show that such a policy is (1) likely to be effective, at least in cases in which non-vaccination is due to practical obstacles, rather than to strong beliefs about vaccines, (2) ethically acceptable and less controversial than some alternatives because it is not coercive and affects individual autonomy only in a morally unproblematic way, and (3) likely to receive support from the UK public, on the basis of original empirical research we have conducted on the lay public.

Rationing elective surgery for smokers and obese patients: responsibility or prognosis?

BACKGROUND: In the United Kingdom (UK), a number of National Health Service (NHS) Clinical Commissioning Groups (CCG) have proposed controversial measures to restrict elective surgery for patients who either smoke or are obese. Whilst the nature of these measures varies between NHS authorities, typically, patients above a certain Body Mass Index (BMI) and smokers are required to lose weight and quit smoking prior to being considered eligible for elective surgery. Patients will be supported and monitored throughout this mandatory period to ensure their clinical needs are appropriately met. Controversy regarding such measures has primarily centred on the perceived unfairness of targeting certain health states and lifestyle choices to save public money. Concerns have also been raised in response to rhetoric from certain NHS authorities, which may be taken to imply that such measures punitively hold people responsible for behaviours affecting their health states, or simply for being in a particular health state. MAIN BODY: In this paper, we examine the various elective surgery rationing measures presented by NHS authorities. We argue that, where obesity and smoking have significant implications for elective surgical outcomes, bearing on effectiveness, the rationing of this surgery can be justified on prognostic grounds. It is permissible to aim to maximise the benefit provided by limited resources, especially for interventions that are not urgently required. However, we identify gaps in the empirical evidence needed to conclusively demonstrate these prognostic grounds, particularly for obese patients. Furthermore, we argue that appeals to personal responsibility, both in the prospective and retrospective sense, are insufficient in justifying this particular policy. CONCLUSION: Given the strength of an alternative justification grounded in clinical effectiveness, rhetoric from NHS authorities should avoid explicit statements, which suggest that personal responsibility is the key justificatory basis of proposed rationing measures.

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

BACKGROUND: 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. OBJECTIVE: This paper aims to discuss and provide concrete procedural guidance on the ethical issues raised by serious unexpected complications of novel deep brain stimulation treatments. APPROACH: We illustrate our analysis using a case study of the unexpected development of recurrent stereotyped events in patients following the use of deep brain stimulation (DBS) to treat severe chronic pain. Examining these unexpected complications in light of medical ethical principles, we argue that serious complications of novel DBS treatments do not necessarily make it unethical to offer the intervention to eligible patients. However, the difficulty the clinician faces in determining whether the intervention is in the patient's best interests generates reasons to take extra steps to promote the autonomous decision making of these patients. CONCLUSION AND RECOMMENDATIONS: We conclude with clinical recommendations, including details of an augmented consent process for novel DBS treatment.

Quarantine, isolation and the duty of easy rescue in public health.

We address the issue of whether, why and under what conditions, quarantine and isolation are morally justified, with a particular focus on measures implemented in the developing world. We argue that the benefits of quarantine and isolation justify some level of coercion or compulsion by the state, but that the state should be able to provide the strongest justification possible for implementing such measures. While a constrained form of consequentialism might provide a justification for such public health interventions, we argue that a stronger justification is provided by a principle of State Enforced Easy Rescue: a state may permissibly compel individuals to engage in activities that entail a small cost to them but a large benefit to others, because individuals have a moral duty of easy rescue to engage in those activities. The principle of State Enforced Easy Rescue gives rise to an Obligation Enforcement Requirement: the state should create the conditions such that submitting to coercive or compulsive measures becomes a fundamental moral duty of individuals, i.e. a duty of easy rescue. When the state can create such conditions, it has the strongest justification possible for implementing coercive or compulsive measures, because individuals have a moral duty to temporarily relinquish the rights that such measures would infringe. Our argument has significant implications for how public health emergencies in the developing world should be tackled. Where isolation and quarantine measures are necessary, states or the international community have a moral obligation to provide certain benefits to those quarantined or isolated.

"A Steadying Hand": Ascribing Speech Acts to Users of Predictive Speech Assistive Technologies.

Neuroprosthetic speech technologies are in development for patients suffering profound paralysis, such as can result from amyotrophic lateral sclerosis. These patients would be unable to speak without intervention, but with neurotechnology can be offered the chance to communicate. The nature of the technology introduces a neuroprosthesis that mediates neural activity to generate synthesised speech. How word prediction coheres with speaker intentions requires scrutiny. Some future forms of prostheses, using statistical language models to predict word patterns, could be thought of as participating with communicative intent - not merely channelling it. Concepts relating to vicarious liability, may serve to clarify these issues. This column shows how technology might interact with speaker intent in cases of delegated action, and how it should be seen as participating in the implementation of user "instructions".

Taxing Meat: Taking Responsibility for One's Contribution to Antibiotic Resistance.

Antibiotic use in animal farming is one of the main drivers of antibiotic resistance both in animals and in humans. In this paper we propose that one feasible and fair way to address this problem is to tax animal products obtained with the use of antibiotics. We argue that such tax is supported both by (a) deontological arguments, which are based on the duty individuals have to compensate society for the antibiotic resistance to which they are contributing through consumption of animal products obtained with the use of antibiotics; and (b) a cost-benefit analysis of taxing such animal products and of using revenue from the tax to fund alternatives to use of antibiotics in animal farming. Finally, we argue that such a tax would be fair because individuals who consume animal products obtained with the use of antibiotics can be held morally responsible, i.e. blameworthy, for their contribution to antibiotic resistance, in spite of the fact that each individual contribution is imperceptible.

Deep Brain Stimulation, Authenticity and Value.

Deep brain stimulation has been of considerable interest to bioethicists, in large part because of the effects that the intervention can occasionally have on central features of the recipient's personality. These effects raise questions regarding the philosophical concept of authenticity. In this article, we expand on our earlier work on the concept of authenticity in the context of deep brain stimulation by developing a diachronic, value-based account of authenticity. Our account draws on both existentialist and essentialist approaches to authenticity, and Laura Waddell Ekstrom's coherentist approach to personal autonomy. In developing our account, we respond to Sven Nyholm and Elizabeth O'Neill's synchronic approach to authenticity, and explain how the diachronic approach we defend can have practical utility, contrary to Alexandre Erler and Tony Hope's criticism of autonomy-based approaches to authenticity. Having drawn a distinction between the authenticity of an individual's traits and the authenticity of that person's values, we consider how our conception of authenticity applies to the context of anorexia nervosa in comparison to other prominent accounts of authenticity. We conclude with some reflections on the prudential value of authenticity, and by highlighting how the language of authenticity can be invoked to justify covert forms of paternalism that run contrary to the value of individuality that seems to be at the heart of authenticity.

OBLIGING SURGEONS TO ENHANCE: NEGLIGENCE LIABILITY FOR UNCORRECTED FATIGUE AND PROBLEMS WITH PROVING CAUSATION.

Increasing interest in the use of cognitive enhancing pharmaceuticals, such as modafinil, has led to considerable ethical debate about issues around authenticity, fairness and even whether there is a moral obligation to enhance. This latter question has raised questions as to whether there might be a legal obligation to enhance. We have argued elsewhere that the law will not oblige a professional to self-enhance. In this article, we explore a second reason why a claim of negligence for a failure to enhance would be unlikely to succeed: the problem of establishing causation. As the science on enhancers and what they are capable of currently stands, it would be almost invariably impossible to establish a causal link between failure to enhance to redress fatigue, and the harm that allegedly resulted. Even where a link between fatigue and harm can be established, it will be extremely difficult to show that taking an enhancer would have averted the harm. We focus on the most likely context in which such claims might arise--clinical negligence--and on the most efficacious enhancing drug currently available-modafinil.

Control and Ownership of Neuroprosthetic Speech.

Implantable brain-computer interfaces (BCIs) are being developed to restore speech capacity for those who are unable to speak. Patients with locked-in syndrome or amyotrophic lateral sclerosis could be able to use covert speech - vividly imagining saying something without actual vocalisation - to trigger neural controlled systems capable of synthesising speech. User control has been identified as particularly pressing for this type of BCI. The incorporation of machine learning and statistical language models into the decoding process introduces a contribution to (or 'shaping of') the output that is beyond the user's control. Whilst this type of 'shared control' of BCI action is not unique to speech BCIs, the automated shaping of what a user 'says' has a particularly acute ethical dimension, which may differ from parallel concerns surrounding automation in movement BCIs. This paper provides an analysis of the control afforded to the user of a speech BCI of the sort under development, as well as the relationships between accuracy, control, and the user's ownership of the speech produced. Through comparing speech BCIs with BCIs for movement, we argue that, whilst goal selection is the more significant locus of control for the user of a movement BCI, control over process will be more significant for the user of the speech BCI. The design of the speech BCI may therefore have to trade off some possible efficiency gains afforded by automation in order to preserve sufficient guidance control necessary for users to express themselves in ways they prefer. We consider the implications for the speech BCI user's responsibility for produced outputs and their ownership of token outputs. We argue that these are distinct assessments. Ownership of synthetic speech concerns whether the content of the output sufficiently represents the user, rather than their morally relevant, causal role in producing that output.

Evidence-Based Neuroethics, Deep Brain Stimulation and Personality - Deflating, but not Bursting, the Bubble.

Gilbert et al. have raised important questions about the empirical grounding of neuroethical analyses of the apparent phenomenon of Deep Brain Stimulation 'causing' personality changes. In this paper, we consider how to make neuroethical claims appropriately calibrated to existing evidence, and the role that philosophical neuroethics has to play in this enterprise of 'evidence-based neuroethics'. In the first half of the paper, we begin by highlighting the challenges we face in investigating changes to PIAAAS following DBS, explaining how different trial designs may be of different degrees of utility, depending on how changes to PIAAAS following DBS are manifested. In particular, we suggest that the trial designs Gilbert et al. call for may not be able to tell us whether or not DBS directly causes changes to personality. However, we suggest that this is not the most significant question about this phenomenon; the most significant question is whether these changes should matter morally, however they are caused. We go on to suggest that neuroethical analyses of novel neuro-interventions should be carried out in accordance with the levels of evidence hierarchy outlined by the Centre for Evidence-Based Medicine (CEBM), and explain different ways in which neuroethical analyses of changes to PIAAAS can be evidence-based on this framework. In the second half of the paper, we explain how philosophical neuroethics can play an important role in contributing to mechanism-based reasoning about potential effects on PIAAAS following DBS, a form of evidence that is also incorporated into the CEBM levels of evidence hierarchy.

Praiseworthiness and Motivational Enhancement: 'No Pain, No Praise'?

The view that exertion of effort determines praiseworthiness for an achievement is implicit in 'no pain, no praise'-style objections to biomedical enhancement. On such views, if enhancements were to reduce the need for effort, agents would be less praiseworthy. Motivational enhancement would appear to be the most problematic in this respect, given that increased motivation reduces the need for agents to rally themselves and to exert effort in activity. We use the prospect of motivational enhancement to re-examine the grounds of praiseworthiness for achievements. We consider the place of effort amongst the grounds for praise, whether effort exhausts these grounds, and how they can be better specified. We argue that praiseworthiness depends on (i) the voluntariness and strength of the agent's committed pursuit of a valuable end (E), (ii) the costliness of the committed pursuit of E, and (iii) the value of E. Effort is just one cost amongst many, and costs of activities can be traded-off. Motivational enhancement reduces the praise due to an agent only when it reduces the net cost to the agent (without strengthening the voluntary commitment). We emphasize the importance of a diachronic perspective on active agency for praiseworthiness, to include training, prior planning, and deliberate strategies to overcome weakness of will, even where this reduces the need for effort.

When Thinking is Doing: Responsibility for BCI-Mediated Action.

Technologies controlled directly by the brain are being developed, evolving based on insights gained from neuroscience, and rehabilitative medicine. Besides neuro-controlled prosthetics aimed at restoring function lost somehow, technologies controlled via brain-computer interfaces (BCIs) may also extend a user's horizon of action, freed from the need for bodily movement. Whilst BCI-mediated action ought to be, on the whole, treated as conventional action, law and policy ought to be amended to accommodate BCI action by broadening the definition of action as "willed bodily movement". Moreover, there are some dimensions of BCI mediated action that are significantly different to conventional cases. These relate to control. Specifically, to limits in both controllability of BCIs via neural states, and in foreseeability of outcomes from such actions. In some specific type of case, BCI-mediated action may be due to different ethical evaluation from conventional action.