Jonathan Lewis

Background: Advance healthcare decision-making presumes that a prior treatment preference expressed with sufficient mental capacity ("T1 preference") should trump a contrary preference expressed after significant cognitive decline ("T2 preference"). This assumption is much debated in normative bioethics, but little is known about lay judgments in this domain. This study investigated participants' judgments about which preference should be followed, and whether these judgments differed depending on a first-person (deciding for one's future self) versus third-person (deciding for a friend or stranger) perspective.

Research ethics committees and institutional review boards spend considerable time developing, scrutinising, and revising specific consent processes and materials for survey-based studies conducted on crowdsourcing and online recruitment platforms such as MTurk and Prolific. However, there is evidence to suggest that many users of ICT services do not read the information provided as part of the consent process and they habitually provide or refuse their consent without adequate reflection. In principle, these practices call into question the validity of their consent. In this paper we argue that although the ‘no read problem’ and the routinisation of consent may apply to research participants’ consent practices for studies on crowdsourcing platforms, this is not a serious problem. Furthermore, given that the informational requirements for informed consent in these contexts are minimal, we argue that these participants are, nevertheless, sufficiently informed to give valid consent. We conclude that research ethics committees and institutional review boards should only agonise over the precise details of the informed consent process and materials in those rare cases where appreciable risks to research participants need to be managed.

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of molnupiravir, a novel antiviral medicine aimed at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of molnupiravir through the large-scale Platform Adaptive trial of Novel antiviRals for eArly treatMent of COVID-19 In the Community randomised control trial. By analysing the ways in which the authorisation and clinical use of molnupiravir complicate standard approaches to clinical equipoise, standard of care and participant consent in the PANORAMIC randomised control trial, we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers.

“Bodily autonomy” has received significant attention in bioethics, medical ethics, and medical law in terms of the general inviolability of a patient’s bodily sovereignty and the rights of patients to make choices (e.g., reproductive choices) that concern their own body. However, the role of the body in terms of how it can or does contribute to a patient’s capacity for, or exercises of their autonomy in clinical decision-making situations has not been explicitly addressed. The approach to autonomy in this paper is aligned with traditional theories that conceive autonomy in terms of an individual’s capacities for, and exercises of rational reflection. However, at the same time, this paper extends these accounts by arguing that autonomy is, in part, embodied. Specifically, by drawing on phenomenological conceptions of the experience of autonomy, we argue that, in principle, the body is a necessary component of the capacity for autonomy. Secondly, through the presentation of two different cases, we highlight ways in which a patient’s body can contribute to the autonomy of treatment choices. Ultimately, we hope to encourage others to explore additional conditions under which a concept of embodied autonomy should be employed in medical decision making, how its underlying principles might be operationalised in clinical situations, and its consequences for approaches to patient autonomy in healthcare practice, policy, and law.

Smajdor argues that “recognition” is the solution to the “reifying attitude” that results from “the urge to protect ‘vulnerable’ people through exclusion from research”. Drawing on theories of reification, we argue that it is the concepts of autonomy and vulnerability themselves that have been reified, resulting in the impoverishment of approaches to autonomy at law and in research ethics. Overcoming such reification demands a deeper consideration of the grounds on which vulnerable individuals are owed recognition and thereby the forms such recognition should take. Smajdor argues for a recognition that appeals to autonomy and that manifests in providing vulnerable individuals with the opportunity to assent. The problem is that this kind of recognition is dependent on a more fundamental kind. It is this second form of recognition that would need to do the heavy lifting for assent-based frameworks to avoid the same problems we find with consent.

Abortion remains a highly controversial issue in many countries and subject to intense public debate. The aim of this chapter is to summarize the most prominent assumptions and arguments concerning the moral and legal dimensions of abortion on which this debate rests. Where the moral justifiability of abortion is concerned, this chapter focuses on arguments relating to the moral status of the fetus or embryo, the notion of personhood, the biological development of the embryo or fetus, and the moral relevance of specific points in the developmental process. In terms of the legal aspects, we consider concepts and principles invoked at law, principally, the rights of pregnant women and the medical concept of viability. For each moral and legal position in the abortion debate, we provide an overview of the principal assumptions and arguments and acknowledge the main criticisms.

Legal concepts can sometimes be unclear, leading to disagreements concerning their contents and inconsistencies in their application. At other times, the legal application of a concept can be entirely clear, sharp, and free of confusions, yet conflict with the ways in which ordinary people or other relevant stakeholders think about the concept. The aim of this chapter is to investigate the role of experimental jurisprudence in articulating and, ultimately, dealing with competing conceptual inferences either within a specific domain (e.g., legal practice) or between, for example, ordinary people and legal practitioners. Although this chapter affirms the widespread assumption that experimental jurisprudence cannot, in and of itself, tell us which concepts should be applied at law, it highlights some of the contributions that experimental jurisprudence can, in principle, make to normative projects that seek to prescribe, reform, or otherwise engineer legal concepts. Thus, there is more that experimental jurisprudence can normatively offer than has usually been claimed.

This entry summarizes an emerging subdiscipline of both empirical bioethics and experimental philosophy (“x-phi”) which has variously been referred to as experimental philosophical bioethics, experimental bioethics, or simply “bioxphi”. Like empirical bioethics, bioxphi uses data-driven research methods to capture what various stakeholders think (feel, judge, etc.) about moral issues of relevance to bioethics. However, like its other parent discipline of x-phi, bioxphi tends to favor experiment-based designs drawn from the cognitive sciences – including psychology, neuroscience, and behavioral economics – to tease out why and how stakeholders think as they do.

Phenomenology gives rise to certain ontological considerations that have far-reaching implications for standard conceptions of patient autonomy in medical ethics, and, as a result, the obligations of and to patients in clinical decision-making contexts. One such consideration is the phenomenological reduction in classical phenomenology, a core feature of which is the characterisation of our primary experiences as immediately and inherently meaningful. This paper builds on and extends the analyses of the phenomenological reduction in the works of Husserl, Heidegger, and Merleau-Ponty in order to identify and explain its implications for our current understanding of the principle of respect for patient autonomy and the norms of clinical decision making.

This article explores the impact of an Increase in the average Number of Authors per Publication on known ethical issues of authorship. For this purpose, the ten most common ethical issues associated with scholarly authorship are used to set up a taxonomy of existing issues and raise awareness among the community to take precautionary measures and adopt best practices to minimize the negative impact of INAP. We confirm that intense international, interdisciplinary and complex collaborations are necessary, and INAP is an expression of this trend. However, perverse incentives aimed to increase institutional and personal publication counts and egregious instances of guest or honorary authorship are problematic. We argue that whether INAP is due to increased complexity and scale of science, perverse incentives or undeserved authorship, it could negatively affect known ethical issues of authorship at some level. In the long run, INAP depreciates the value of authorship status and may disproportionately impact junior researchers and those who contribute to technical and routine tasks. We provide two suggestions that could reduce the long-term impact of INAP on the reward system of science. First, we suggest further refinement of the CRediT taxonomy including better integration into current systems of attribution and acknowledgement, and better harmony with major authorship guidelines such as those suggested by the ICMJE. Second, we propose adjustments to the academic recognition and promotion systems at an institutional level as well as the introduction of best practices.

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers.

In the debates regarding the ethics of human organoid biobanking, the locus of donor autonomy has been identified in processes of consent. The problem is that, by focusing on consent, biobanking processes preclude adequate engagement with donor autonomy because they are unable to adequately recognise or respond to factors that determine authentic choice. This is particularly problematic in biobanking contexts associated with organoid research or the clinical application of organoids because, given the probability of unforeseen and varying purposes for which a donor’s organoids could be employed and given the different ways in which a donor can relate to her biospecimens, a donor can value her organoids differently in different contexts and her reasons for autonomously permitting use of her cells and tissues in one case may not support an autonomous decision in another. In response, this paper has three aims: firstly, to make the case for why organoid biobanks ought to respect donor autonomy conceived as authentic choice; secondly, to explore the autonomy-respecting limits of established and widely prevalent models of biobank consent; and thirdly, to propose certain conditions that organoid biobanks ought to support or facilitate in order to respect donor autonomy.

The question of what makes someone the same person through time and change has long been a preoccupation of philosophers. In recent years, the question of what makes ordinary or lay people judge that someone is—or isn’t—the same person has caught the interest of experimental psychologists. These latter, empirically oriented researchers have sought to understand the cognitive processes and eliciting factors that shape ordinary people’s judgments about personal identity and the self. Still more recently, practitioners within an emerging discipline, experimental philosophical bioethics or “bioxphi”—the focus of this chapter—have adopted a similar aim and employed similar methodologies, but with two distinctive features: (a) a special concern for enhanced ecological validity in the examples and populations studied; and (b) an interest in contributing to substantive normative debates within the wider field of bioethics. Our aim in this chapter is to sample illustrative work on personal identity in bioxphi, explore how it relates to studies in psychology covering similar terrain, and draw out the implications of this work for matters of bioethical concern. In pursuing these issues, we highlight recent work in bioxphi that includes the perceived validity of advance directives following neurodegeneration, the right of psychologically altered study participants to withdraw from research, how drug addiction may cause one to be regarded by others as “a completely different person,” the effect of deep-brain stimulation on perceptions of the self, and the potential influence of moral enhancement interventions on intuitive impressions of a person’s character.

The COVID-19 pandemic has coincided with the proliferation of ethical guidance documents to assist public health authorities, health care providers, practitioners and staff with responding to ethical challenges posed by the pandemic. Like ethical guidelines relating to infectious disease that have preceded them, what unites many COVID-19 guidance documents is their dependency on an under-developed approach to bioethical principlism, a normative framework that attempts to guide actions based on a list of prima facie, unranked ethical principles. By situating them in relation to the key philosophical debates concerning bioethical principlism, we aim to explore the limits and limitations of pandemic ethical guidance documents as, specifically, ethics documents – documents that fulfil the functions of ethics as a fundamentally normative discipline. This means not only determining whether such ethical guidance documents can, in principle, provide adequate action guidance and action justification, but also, more importantly where pandemics are concerned, determining whether they support consistent decision making and transparent processes of justification. Having highlighted the problems with merely furnishing ethical guidelines with substantive ethical content in terms of principles and values, we argue that organizations that develop these documents should, instead, focus on the procedural dimensions of action guidance and action justification, which extend to questions regarding the make-up of the committees, panels and groups that develop such guidelines, the public transparency of justifications for specific pandemic-related advice or interventions and the development of explicit procedures for transparent and consistent decision making.

In our recent article, together with more than 60 of our colleagues, we outlined a proposal for drug policy reform consisting of four specific yet interrelated strategies: (1) de jure decriminalization of all psychoactive substances currently deemed illicit for personal use or possession (so-called “recreational” drugs), accompanied by harm reduction policies and initiatives akin to the Portugal model; (2) expunging criminal convictions for nonviolent offenses pertaining to the use or possession of small quantities of such drugs (and releasing those serving time for these offenses), while delivering retroactive ameliorative relief; (3) the ultimate legalization and careful regulation of currently illicit drugs; and (4) the delivery of a new “Marshall Plan” focused on community-building initiatives, expanded harm reduction programs, and social and health care support efforts (Earp et al. 2021). We were gratified to see so many thoughtful commentaries on our proposal, and we respond to them in part in this reply.

BackgroundThe areas of Research Ethics (RE) and Research Integrity (RI) are rapidly evolving. Cases of research misconduct, other transgressions related to RE and RI, and forms of ethically questionable behaviors have been frequently published. The objective of this scoping review was to collect RE and RI cases, analyze their main characteristics, and discuss how these cases are represented in the scientific literature.MethodsThe search included cases involving a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework. A search was conducted in PubMed, Web of Science, SCOPUS, JSTOR, Ovid, and Science Direct in March 2018, without language or date restriction. Data relating to the articles and the cases were extracted from case descriptions.ResultsA total of 14,719 records were identified, and 388 items were included in the qualitative synthesis. The papers contained 500 case descriptions. After applying the eligibility criteria, 238 cases were included in the analysis. In the case analysis, fabrication and falsification were the most frequently tagged violations (44.9%). The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation (15.7%), followed by patient safety issues (11.1%) and plagiarism (6.9%). 80.8% of cases were from the Medical and Health Sciences, 11.5% from the Natural Sciences, 4.3% from Social Sciences, 2.1% from Engineering and Technology, and 1.3% from Humanities. Paper retraction was the most prevalent sanction (45.4%), followed by exclusion from funding applications (35.5%).ConclusionsCase descriptions found in academic journals are dominated by discussions regarding prominent cases and are mainly published in the news section of journals. Our results show that there is an overrepresentation of biomedical research cases over other scientific fields compared to its proportion in scientific publications. The cases mostly involve fabrication, falsification, and patient safety issues. This finding could have a significant impact on the academic representation of misbehaviors. The predominance of fabrication and falsification cases might diverge the attention of the academic community from relevant but less visible violations, and from recently emerging forms of misbehaviors.

The High Court continues to exercise its inherent jurisdiction to make declarations about interventions into the lives of situationally vulnerable adults with mental capacity. In light of protective responses of health care providers and the courts to decision-making situations involving capacitous vulnerable adults, this paper has two aims. The first is diagnostic. The second is normative. The first aim is to identify the harms to a capacitous vulnerable adult’s autonomy that arise on the basis of the characterisation of situational vulnerability and autonomy as fundamentally opposed concepts or the failure to adequately acknowledge the conceptual relationship between them at common law. The second part of this aim is to draw upon developments in analytic feminist philosophy to illustrate how standard approaches to autonomy are ill-equipped to capture the autonomy issues of capacitous vulnerable adults when their decisions regarding care and treatment are at stake. The second (normative) aim is to develop an account of self-authorised, intersubjective autonomy on the basis of analytic feminist insights into the relational practices of recognition. This account not only attempts to capture the autonomy of capacitous vulnerable adults and account for the necessary harms to their autonomy that arise from standard common law responses to their situational vulnerability, it is also predicated on the distinctions between mental capacity, the satisfaction of conditions for informed consent and the exercise of autonomy, meaning that it is better placed to fulfil the primary aim of the inherent jurisdiction – to facilitate the autonomy of vulnerable adults with capacity.

Historically, laws and policies to criminalize drug use or possession were rooted in explicit racism, and they continue to wreak havoc on certain racialized communities. We are a group of bioethicists, drug experts, legal scholars, criminal justice researchers, sociologists, psychologists, and other allied professionals who have come together in support of a policy proposal that is evidence-based and ethically recommended. We call for the immediate decriminalization of all so-called recreational drugs and, ultimately, for their timely and appropriate legal regulation. We also call for criminal convictions for nonviolent offenses pertaining to the use or possession of small quantities of such drugs to be expunged, and for those currently serving time for these offenses to be released. In effect, we call for an end to the “war on drugs.”

This paper explores an emerging sub-field of both empirical bioethics and experimental philosophy, which has been called “experimental philosophical bioethics” (bioxphi). As an empirical discipline, bioxphi adopts the methods of experimental moral psychology and cognitive science; it does so to make sense of the eliciting factors and underlying cognitive processes that shape people’s moral judgments, particularly about real-world matters of bioethical concern. Yet, as a normative discipline situated within the broader field of bioethics, it also aims to contribute to substantive ethical questions about what should be done in a given context. What are some of the ways in which this aim has been pursued? In this paper, we employ a case study approach to examine and critically evaluate four strategies from the recent literature by which scholars in bioxphi have leveraged empirical data in the service of normative arguments.

The late Robert Veatch, one of the United States’ founders of bioethics, never tired of reminding us that the paradigm-shifting contribution that bioethics made to patient care was to liberate patients out of the hands of doctors, who were traditionally seen to know best, even when they decidedly did not know best. It seems to us that with the advent of COVID-19, health policy has come full-circle on this. COVID-19 gave rise to a large number of purportedly “ethical” guidance documents aiming to assist health care providers and practitioners with responding to the ethical challenges that might arise in their response to the pandemic. Ethics has two primary functions: provide clear action guidance, and provide clear action justification. The documents in question arguably reflect the ultimate policy triumph of bioethical “principlism”, and, perhaps surprisingly, as a corollary, the ultimate triumph of “doctor-knows-best”.

According to the High Court in England and Wales, the primary purpose of legal interventions into the lives of vulnerable adults with mental capacity should be to allow the individuals concerned to regain their autonomy of decision making. However, recent cases of clinical decision making involving capacitous vulnerable adults have shown that, when it comes to medical law, medical ethics and clinical practice, vulnerability is typically conceived as opposed to autonomy. The first aim of this paper is to detail the problems that arise when the courts and health care practitioners respond to the vulnerability of capacitous adults on the basis of such an opposition. It will be shown that not only does the common law approach to vulnerability fail to adequately capture the autonomy of capacitous vulnerable adults, the conception of vulnerability and autonomy in oppositional terms leads to objectionably paternalistic health care responses that undermine the autonomy of vulnerable patients as well as clinical and legal interventions that violate their autonomy. In response, the second aim of this paper is to show that the concepts of autonomy and vulnerability are necessarily entwined and, on that basis, the focus should be on promoting the autonomy of capacitous vulnerable adults where possible. In order to make this case, the paper explains the limitations of standard approaches to the autonomy of vulnerable adults and, in their place, offers a conception of legitimate, self-authorised autonomy that is fundamentally dependent on intersubjective practices of recognition.

In the debates regarding the ethics of human enhancement, proponents have found it difficult to refute the concern, voiced by certain bioconservatives, that cognitive enhancement violates the autonomy of the enhanced. However, G. Owen Schaefer, Guy Kahane and Julian Savulescu have attempted not only to avoid autonomy-based bioconservative objections, but to argue that cognition-enhancing biomedical interventions can actually enhance autonomy. In response, this paper has two aims: firstly, to explore the limits of their argument; secondly, and more importantly, to develop a more complete understanding of autonomy and its relation to cognitive enhancement. By drawing a distinction between the capacity for autonomy and the exercise and achievement of autonomy and by exploring the possible effects of cognitive enhancement on both competence and authenticity conditions for autonomy, the paper identifies and explains which dimensions of autonomy can and cannot, in principle, be enhanced via direct cognitive interventions. This allows us to draw conclusions regarding the limits of cognitive enhancement as a means for enhancing autonomy.

The practice of assigning authorship for a scientific publication tends to raise two normative questions: 1) ‘who should be credited as an author?’; 2) ‘who should not be credited as an author but should still be acknowledged?’. With the publication of the revised version of The European Code of Conduct for Research Integrity (ECCRI), standard answers to these questions have been called into question. This article examines the ways in which the ECCRI approaches these two questions and compares these approaches to standard definitions of ‘authorship’ and ‘acknowledgment’ in guidelines issued by the International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME). In light of two scenarios and the problems posed by these kinds of ‘real-world’ examples, we recommend specific revisions to the content of the ECCRI in order not only to provide a more detailed account of the tasks deserving of acknowledgment, but to improve the Code’s current definition of authorship.

Recent developments in experimental philosophy (‘x-phi’) suggest that there is a new way in which the empirical and normative dimensions of bioethics can be brought into successful dialogue with one another. It revolves around conceptual analysis – though not the kind of conceptual analysis one might perform in an armchair. Following Édouard Machery, this is Conceptual Analysis Rebooted. In short, morally-pertinent medical concepts like ‘treatment’, ‘euthanasia’ and ‘sanctity of life’ can each have several meanings that underwrite inferences with different moral implications. X-phi shows us that an experimental approach to conceptual analysis can make explicit the implicit structures that underpin our thinking about such concepts. By presenting concrete examples, I aim to offer a glimpse of an empirically-grounded, practically-normative 'bioxphi' that demystifies and distinguishes medical concepts, assesses the normative inferences these concepts dispose us to draw and revises those inferences that are deficient.

Shared Decision Making (‘SDM’) is one of the most significant developments in Western health care practices in recent years. Whereas traditional models of care operate on the basis of the physician as the primary medical decision maker, SDM requires patients to be supported to consider options in order to achieve informed preferences by mutually sharing the best available evidence. According to its proponents, SDM is the right way to interpret the clinician-patient relationship because it fulfils the ethical imperative of respecting patient autonomy. However, there is no consensus about how decisions in SDM contexts relate to the principle of respect for autonomy. In response, I demonstrate that in order to make decisions about what treatment they will or will not receive, patients will be required to meet different conditions depending on the approach proponents of SDM take to understanding personal autonomy. Due to the fact that different conceptions of autonomy yield different obligations, I argue that if physicians and patients satisfied all the conditions described in standard accounts of SDM, then SDM would undermine patient autonomy.