Jonathan Pugh

This chapter reflects on the impact of brain stimulation on identity. Following substantial advances in our understanding of the brain, surgeons and neuroscientists have been able to develop powerful new medical interventions that aim to treat disease by modifying electrical activity in the brain. At present, Deep Brain Stimulation (DBS) is the most precise tool that we have at our disposal in this regard; it can target a cubic millimeter of brain tissue. In terms of precision, it stands in stark contrast to drugs that influence brain activity by affecting neurotransmitters across the brain. However, despite its precision, in some rare cases, DBS can have unintended side-effects, including behavioural and emotional changes. The possibility of controlling motivational and emotional states has intrigued scientists since the earliest days of invasive neurostimulation. This prospect raises profound ethical questions, regardless of whether such changes are intentional or an unintended side-effect of treatment. To what extent does it make sense to say that a medical intervention like DBS can change the recipient into “a different person”? The chapter then turns to concepts in moral philosophy, considering the nature of identity and the self.

Bioconservative opposition to enhancement often appeals to the value of preserving human nature as it is. But if human nature is the product of blind natural processes rather than divinely given, why shouldn’t we radically change it in beneficial ways? This chapter explores a different strategy for opposing enhancement: the thought that we should preserve human nature simply because it is our nature. A theoretical basis for this strategy can be found in Bernard Williams’ defence of what he calls the ‘human prejudice’ and Jerry Cohen’s defence of a ‘conservative bias’. Having identified some problems with their respective arguments, the chapter briefly sketches a potentially better approach that appeals to the idea of reasonable partiality. It suggests that reasonable partiality for humanity can ground an interesting—if limited—objection to enhancement that is in keeping with themes found in the work of Williams and Cohen.

A virologist recently made headlines after successfully using an experimental form of oncolytic virotherapy to treat her own recurrent breast cancer. This case has come at a time when regulators are increasingly having to grapple with the proliferation of self-experimentation outside of accredited research institutions. There is, therefore, a pressing need to outline the key ethical dimensions of self-experimentation and to develop ethical guidance for journals that may be faced with decisions about whether to publish research involving self-experimentation. In this paper, we aim to provide such guidance. We argue that while self-experimentation is not always ethically problematic, neither is there an in-principle moral reason for exempting it from ethical evaluation. After summarising the details of the recent case report of self-experimentation and briefly placing it in historical context, we suggest that it is possible to navigate the ethical issues raised in cases of self-experimentation by returning to fundamental values in research ethics, focusing on the implications of self-experimentation for respect for autonomy, reasonable risk, and preventing harm to others. We apply these principles to the case report and explain why the publication of this report can be morally justified. We ultimately advocate for a case-by-case assessment of studies involving self-experimentation submitted for publication by ethical review boards and journal editors, and we propose a decision-making algorithm to help guide such decisions.

Jurgen Habermas has argued that carrying out pre‐natal germline enhancements would be inimical to the future child's autonomy. In this article, I suggest that many of the objections that have been made against Habermas' arguments by liberals in the enhancement debate misconstrue his claims. To explain why, I begin by explaining how Habermas' view of personal autonomy confers particular importance to the agent's embodiment and social environment. In view of this, I explain that it is possible to draw two arguments against germline enhancements from Habermas' thought. I call these arguments ‘the argument from negative freedom’ and ‘the argument from natality’. Although I argue that many of the common liberal objections to Habermas are not applicable when his arguments are properly understood, I go on to suggest ways in which supporters of enhancement might appropriately respond to Habermas' arguments.

In this commentary on Joshua May's Neuroethics: Agency in the Age of Brain Science, I consider some of the implications of May's analysis for clinical neuroethics. In particular, in view of May's appeal to the power of valid consent to deal with some of the issues raised by neuro-interventions, I begin by highlighting that clinical neuroethicists often have to navigate a number of complexities in seeking to facilitate the valid consent of individuals who are potentially subject to various forms of vulnerability. I go on to consider whether May's claim that neuro-interventions can elicit transformative experiences raises any problems for his appeal to consent in this context. In the latter half of the commentary, I consider May's analysis of mental disorder and raise some potential areas of contrast between the concepts of responsibility in criminal justice and autonomy in the medical context. I conclude by suggesting that 'nuanced neuroethics' should not only be vigilant about the sources of empirical evidence it relies upon, it should also attend to the nuances of the particular contexts in which neuroethical arguments are made, and neuroethical concepts deployed.

There has been renewed interest in whether we should understand standards of decision-making capacity (DMC) to be risk-relative. Critics of risk-relative standards often highlight a puzzling asymmetry that they imply; a patient may have the requisite DMC to consent to a treatment that is in their best interests, whilst lacking the requisite DMC to refuse that same treatment, given the much higher risk that this would entail. Whilst some have argued that this asymmetry suggests that risk-relative standards are nonsensical, in this paper I defend a ‘quality of evidence’ view of such standards. I begin by outlining DMC’s purported gate-keeping role in medical ethics, and identifying three key normative claims that undergird this role. I then explain how two competing theories of risk-relative standards are incompatible with at least one of these claims. Drawing on Douglas’ distinction between standards of ‘true capacity’ and standards invoked in the ‘test’ for capacity, I then outline my ‘quality of evidence’ view. I explain how the view is compatible with the aforementioned normative claims, and outline the nature of the asymmetry it implies. I conclude by responding to the objection that there is no meaningful distinction between ‘true capacity’ and the ‘test’ for capacity.

It is often said that it is important for patients to possess hope that their treatment will be successful. We agree, but a widely appealed to type of hope—hope based on conviction (religious or otherwise), renders this assertion problematic. If conviction‐based hope influences patient decisions to undergo medical procedures, then questions are raised about the scope of patient autonomy. Libertarians permit patients to make decisions to undergo medical procedures on the basis of any considerations, including conviction‐based hopes, on grounds of respect for freedom of choice. Rational interventionists want to restrict choices made on the basis of conviction‐based hope on the grounds that choices based on hope incorporate irrationality of a sort incompatible with autonomous decision‐making. In this article, we navigate a middle path between these extremes, arguing that patient decision‐making based on conviction‐based hope ought to be acceptable and permitted in health care when it conforms to norms of practical rationality. These norms allow patients some room to make decisions to consent to undergo medical procedures informed by conviction‐based hope.

There has been renewed interest in whether we should understand standards of decision-making capacity (DMC) to be risk-relative. Critics of risk-relative standards often highlight a puzzling asymmetry that they imply; a patient may have the requisite DMC to consent to a treatment that is in their best interests, whilst lacking the requisite DMC to refuse that same treatment, given the much higher risk that this would entail. Whilst some have argued that this asymmetry suggests that risk-relative standards are nonsensical, in this paper I defend a ‘quality of evidence’ view of such standards. I begin by outlining DMC’s purported gate-keeping role in medical ethics, and identifying three key normative claims that undergird this role. I then explain how two competing theories of risk-relative standards are incompatible with at least one of these claims. Drawing on Douglas’ distinction between standards of ‘true capacity’ and standards invoked in the ‘test’ for capacity, I then outline my ‘quality of evidence’ view. I explain how the view is compatible with the aforementioned normative claims, and outline the nature of the asymmetry it implies. I conclude by responding to the objection that there is no meaningful distinction between ‘true capacity’ and the ‘test’ for capacity.

The Supreme Court of the United States has recently been petitioned to revisit legal issues pertaining to the lawfulness of imposing a vaccine mandate on individuals with proof of natural immunity during the COVID-19 pandemic. While the petition accepts that the protection of public health during COVID-19 was an important governmental interest, the petitioners maintain that the imposition of a vaccine mandate on individuals with natural immunity was not ‘substantially related’ to accomplishing that purpose. In this short report, we outline how some of the petition’s general arguments interact with points we raised in a 2022 article in this journal defending natural immunity exemptions, in light of new evidence. In particular, we reflect on new evidence pertaining to differences between vaccine-induced immunity, natural immunity, and so-called ‘hybrid’ immunity. We suggest that the nuanced nature of this evidence highlights the importance of making fine-grained judgements about proportionality and necessity when considering vaccine mandates. We conclude by claiming that if future pandemics necessitate the imposition of vaccine mandates, then those seeking to justify them should clearly articulate the relevance (and the evidence) for the comparative protection of vaccine-induced, natural, and hybrid immunity.

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.

Violence risk assessment tools are increasingly used within criminal justice and forensic psychiatry, however there is little relevant, reliable and unbiased data regarding their predictive accuracy. We argue that such data are needed to (i) prevent excessive reliance on risk assessment scores, (ii) allow matching of different risk assessment tools to different contexts of application, (iii) protect against problematic forms of discrimination and stigmatisation, and (iv) ensure that contentious demographic variables are not prematurely removed from risk assessment tools.

We extend recent conversation about the ethics of human challenge trials to tuberculosis (TB). TB challenge studies could accelerate vaccine development, but ethical concerns regarding risks to trial participants and third parties have been a limiting factor. We analyse the expected social value and risks of different challenge models, concluding that if a TB challenge trial has between a 10% and a 50% chance of leading to the authorisation and near-universal delivery of a more effective vaccine 3–5 years earlier, then the trial would save between 26 400 and 1 100 000 lives over the next 10 years. We also identify five important ethical considerations that differentiate TB from recent human challenge trials: an exceptionally high disease burden with no highly effective vaccine; heightened third party risk following the trial, and, partly for that reason, uniquely stringent biosafety requirements for the trial; risks associated with best available TB treatments; and difficulties with TB disease detection. We argue that there is good reason to consider conducting challenge trials with attenuated strains like Bacillus Calmette-Guérin or attenuated Mycobacterium tuberculosis.

Green bioethics is an area of research and scholarship that examines the impact of healthcare practices and policies on the environment and emphasises environmental values, such as ecological sustainability and stewardship. Some green bioethicists have argued that healthcare providers should inform patients about the environmental impacts of treatments and advocate for options that minimise adverse impacts. While disclosure of information pertaining to the environmental impacts of treatments could facilitate autonomous decision-making and strengthen the patient–provider relationship in situations where patients have clearly expressed environmental concerns, it may have the opposite effect in other situations if makes patients feel like they are being judged or manipulated. We argue, therefore, that there is not a generalisable duty to disclose environmental impact information to all patients during the consent process. Providers who practice green bioethics should focus on advocating for system-level changes in healthcare financing, organisation and delivery and use discretion when bringing up environmental concerns in their encounters with patients.

It is widely accepted that children enjoy some form of a right to bodily integrity. However, there is little agreement about the precise nature and scope of this right. This paper offers a conceptual analysis of the child's right to bodily integrity, in order to further elucidate the relationship between the child's right to bodily integrity and considerations of autonomy. Following a discussion of Leif Wenar's work on the structure and justification of rights, I first explain how the adult's right to bodily integrity can be distilled into separate elements that may plausibly be justified by different moral considerations. In particular, I claim that this analysis suggests that whilst the adult's right to bodily integrity is not wholly reducible to bodily autonomy, autonomy nonetheless remains entwined with our understanding of this right in a number of ways. On the basis of this discussion, I go on to outline three important complexities that arise when we consider the child's right to bodily integrity, before particularly focusing on the question of how third parties should determine whether or not to perform a physical interference upon a child who lacks decision-making capacity. Here, I raise some objections to Earp and Mazor's recent attempts to answer this question, before briefly defending an ‘autonomy-based interests’ account of permissible interference, an account that shares in what I take to be the spirit, if not the precise letter, of these earlier views.

Müller and colleagues (2015) address a range of ethical considerations associated with neurosurgical interventions for the treatment of anorexia nervosa (AN), arguing for several protective measures to safeguard clinical research and practice. This is an important article, which provides a thorough review of current neurosurgical research and presents key insights into challenges associated with compromised decision-making capacities in the context of AN and the early average age of onset. However, it is somewhat striking that they neither use nor examine the concept of authenticity. We describe the way this concept features in discussions of AN, and suggest that a deeper understanding of authenticity reveals further ethical problems that Müller and colleagues do not consider.

The National Health Service (NHS) in the UK is currently facing a significant waiting list backlog following the disruption of the COVID-19 pandemic, with millions of patients waiting for elective surgical procedures. Effective treatment prioritisation has been identified as a key element of addressing this backlog, with NHS England's delivery plan highlighting the importance of ensuring that those with ‘the clinically most urgent conditions are diagnosed and treated most rapidly’. Indeed, we describe how the current clinical guidance on prioritisation issued by The Federation of Surgical Specialty Associations serves this aim. However, whilst there are strong reasons to prioritise elective surgery in accordance with clinical need, we argue that it would be a mistake to assume that prioritisation in accordance with clinical need requires only a clinical or scientific judgement. The understanding of clinical need that we choose to employ in a prioritisation system will be grounded by some key ethical judgements. Moreover, we may also have to make trade-offs between addressing clinical need, safeguarding equality, and achieving other benefits. As the UK faces up to the backlog, it is important that surgical prioritisation guidelines enshrine a broad range of values that we believe ought to determine access to care in non-emergency circumstances. Our analysis suggests that the current approach to prioritisation is not a sufficiently nuanced way of balancing the different moral values that are operative in this context.

We provide ethical criteria to establish when vaccine mandates for healthcare workers are ethically justifiable. The relevant criteria are the utility of the vaccine for healthcare workers, the utility for patients (both in terms of prevention of transmission of infection and reduction in staff shortage), and the existence of less restrictive alternatives that can achieve comparable benefits. Healthcare workers have professional obligations to promote the interests of patients that entail exposure to greater risks or infringement of autonomy than ordinary members of the public. Thus, we argue that when vaccine mandates are justified on the basis of these criteria, they are not unfairly discriminatory and the level of coercion they involve is ethically acceptable—and indeed comparable to that already accepted in healthcare employment contracts. Such mandates might be justified even when general population mandates are not. Our conclusion is that, given current evidence, those ethical criteria justify mandates for influenza vaccination, but not COVID-19 vaccination, for healthcare workers. We extend our arguments to other vaccines.

In recent decades, researchers have attempted to prospectively identify individuals at high risk of developing psychosis in the hope of delaying or preventing psychosis onset. These psychosis risk individuals are identified as being in an ‘At-Risk Mental State’ (ARMS) through a standardised psychometric interview. However, disclosure of ARMS status has attracted criticism due to concerns about the risk–benefit ratio of disclosure to patients. Only approximately one quarter of ARMS patients develop psychosis after three years, raising concerns about the unnecessary harm associated with such ‘false-positive’ results. These harms are especially pertinent when identifying psychosis risk individuals due to potential stigma and discrimination in a young clinical population. A dearth of high-quality evidence supporting interventions for ARMS patients raises further doubts about the benefit accompanying an ARMS disclosure. Despite ongoing discussion in the bioethical literature, these concerns over the ethical justification of disclosure to ARMS patients are not directly addressed in clinical guidelines. In this paper, we aim to provide a unified disclosure strategy grounded in principle-based analysis for ARMS clinicians. After considering the ethical values at stake in ARMS disclosure, and their normative significance, we argue that full disclosure of the ARMS label is favoured in the vast majority of clinical situations due to the strong normative significance of enhancing patients' understanding. We then compare our framework with other approaches to ARMS disclosure and outline its limitations.

We would like to thank each of the commentators on our feature article for their thoughtful engagement with our arguments. All the commentaries raise important questions about our proposed justification for natural immunity exemptions to COVID-19 vaccine mandates. Thankfully, for some of the points raised, we can simply signal our agreement. For instance, Reiss is correct to highlight that our article did not address the important US-centric considerations she helpfully raises and fruitfully discusses. We also agree with Williams about the need to provide a clear rationale for mandates, and to obtain different kinds of data in support of possible policies.Unfortunately, we lack the space to engage with every one of the more critical comments raised in this rich set of commentaries; as such, in this response, we shall focus on a discussion of hybrid immunity, which underlies a number of different arguments evident in the commentaries, before concluding with some reflections responding to Lipsitch’s concern about the appropriate standard of proof in this context.

I would like to begin by thanking all of the commentators for their insightful analyses of ‘Genetic information, insurance and a pluralistic approach to justice’; I learnt a great deal from them all. Naturally, I cannot do justice to all of their criticisms in this brief response; instead, I shall use their remarks to prompt some clarificatory points about my arguments in the hope that this will help readers to draw their own conclusions about the various points of disagreement. My aim in the paper was modest; I aimed to argue that considerations of justice do not speak unequivocally against the use of Genetic Test Results (GTRs) in insurance, and that a pluralist approach may lend support to some limited uses. This represents a compromise position between outright prohibition, and using GTRs in an insurance market in accordance with purely commercial principles. Notably, this conclusion is compatible with the thought that there may be other very strong moral reasons in favour of prohibition. These include concerns about privacy, as well as the consequentialist and human rights considerations that Tiller and Delatycki rightly highlight.1 Of course, considerations of justice are not orthogonal to questions regarding the right against genetic discrimination, since such a right might plausibly be supported by appeal to broadly egalitarian considerations. Indeed, one important challenge for the rights-based argument for prohibition is to defend the strong degree of genetic exceptionalism it connotes. As I briefly suggested in the paper, broadly egalitarian arguments might be invoked in an attempt to justify at least some degree of genetic exceptionalism here. Notably though, in her commentary, Feiring expresses scepticism about the view of genetic exceptionalism that is implicit in my acceptance of the idea that the use of GTRs in insurance warrants its own specific guidance.2 Given the different …

COVID-19 vaccine requirements have generated significant debate. Here, we argue that, on the evidence available, such policies should have recognised proof of natural immunity as a sufficient basis for exemption to vaccination requirements. We begin by distinguishing our argument from two implausible claims about natural immunity: natural immunity is superior to ‘artificial’ vaccine-induced immunity simply because it is ‘natural’ and it is better to acquire immunity through natural infection than via vaccination. We then briefly survey the evidence base for the comparison between naturally acquired immunity and vaccine-induced immunity. While we clearly cannot settle the scientific debates on this point, we suggest that we lack clear and convincing scientific evidence that vaccine-induced immunity has a significantly higher protective effect than natural immunity. Since vaccine requirements represent a substantial infringement of individual liberty, as well as imposing other significant costs, they can only be justified if they are necessary for achieving a proportionate public health benefit. Without compelling evidence for the superiority of vaccine-induced immunity, it cannot be deemed necessary to require vaccination for those with natural immunity. Subjecting them to vaccine mandates is therefore not justified. We conclude by defending the standard of proof that this argument from necessity invokes, and address other pragmatic and practical considerations that may speak against natural immunity exemptions. There are no data in this work.

TB human challenge studies could accelerate TB vaccine development by reducing uncertainty in early-stage vaccine testing, selecting promising vaccine candidates for large-scale field trials, and identifying an immune correlate of protection. However, ethical concerns regarding the exposure of trial participants and bystanders to significant risk have been a limiting factor for TB human challenge models. We analyze the expected social value and risks of different types of TB human challenge models, and conclude that given the massive public health burden of TB, challenge models with even scant probabilities of expediting TB vaccine authorization have enormous expected humanitarian value, saving between 33,000 and 1,375,000 lives over the next ten years. We argue that attenuated M.tb challenge trials can be conducted ethically, and discuss the benefits and drawbacks of conducting virulent M.tb challenge trials.

In response to the COVID‐19 pandemic philosophers and governments have proposed scarce resource allocation guidelines. Their purpose is to advise healthcare professionals on how to ethically allocate scarce medical resources. One challenging feature of the pandemic has been the large numbers of patients needing mechanical ventilatory support. Guidelines have paradigmatically focused on the question of what doctors should do if they have fewer ventilators than patients who need respiratory support: which patient should get the ventilator? There is, however, an important higher level allocation problem. Namely, how are we to ethically distribute newly obtained ventilators across hospitals: which hospital should get the ventilator(s)? In this paper, we identify a set of principles for allocating newly obtained ventilators across hospitals. We focus particularly on low and middle income countries, who frequently have limited pre‐existing intensive care capacity, and have needed to source additional ventilators. We first provide some background. Second, we argue that the main population healthcare aim during the COVID‐19 pandemic should be to save the most lives. Next, we assess a series of potential heuristics or principles that could be used to guide allocation: allocation to the most densely populated cities, random allocation, allocation based on the ratio of patients to ICU personnel, prioritisation in terms of intrahospital mortality, prioritisation of younger populations, and prioritisation in terms of population mortality. We conclude by providing a plausible ranking of the principles, while noting a number of epistemological challenges, in terms of how they best further the aim of increasing the probability of saving the most lives.

The use of genetic testing has prompted the question of whether insurance companies should be able to use predictive genetic test results (GTRs) in their risk classification of clients. While some jurisdictions have passed legislation to prohibit this practice, the UK has instead adopted a voluntary code of practice that merely restricts the ways in which insurance companies may use GTRs. Critics have invoked various theories of justice to argue that this approach is unfair. However, as well as sometimes relying on somewhat idealised assumptions, these analyses have tended to invoke theories that have wide-ranging and highly revisionary implications for insurance. Moreover, they fail to adequately engage with a conception of justice that plausibly undergirds the status quo approach to insurance in the UK. I argue that it is a mistake to simply invoke a single contestable theory in seeking to develop sound policy on the use of GTRs in insurance. To that end, in this paper, I outline three plausible principles of justice that policy on this issue ought to balance: A principle of equity, a principle of equal access and a principle of need. In doing so, I shall offer a pluralist justice-based argument in support of the spirit, if not the precise letter, of the UK approach.

The UK government has put lateral flow antigen tests (LFATs) at the forefront of its strategy to scale-up testing in the coronavirus pandemic. However, evidence from a pilot trial using an LFAT to identify asymptomatic infections in the community suggested that the test missed over half of the positive cases in the tested population. This raises the question of whether it can be ethical to use an inaccurate test to guide public health measures. We begin by explicating different dimensions of test accuracy (sensitivity, specificity and predictive value), and why they matter morally, before highlighting key data from the Liverpool pilot. We argue that the poor sensitivity of the LFAT in this pilot trial suggests that there are important limitations to what we can expect these tests to achieve. A test with low sensitivity will provide false-negative results, and in doing so generate the risk of false assurance and its attendant moral costs. However, we also suggest that the deployment of an insensitive but specific test could identify many asymptomatic carriers of the virus who are currently being missed under existing arrangements. Having outlined ways in which the costs of false reassurance could potentially be mitigated, we conclude that the use of an insensitive LFAT in mass testing may be ethical if (1) it is used predominantly to identify positive cases, (2) it is a cost-effective method of achieving that goal and (3) if other public health tools can effectively prevent widespread false reassurance.