Jonathan Lewis

Neural organoids derived from pluripotent stem cells have sparked ethical debate because, it is claimed, they could be sentient, or could develop sentience. We critically assess three routes for defending such a possibility: analogy with known sentient organisms, inference from neural function using leading theories of consciousness, and foundational philosophical commitments. Current cortical organoids lack nociceptors, sensory integration, and behavioral repertoires necessary for analogical arguments; they also fall short of the structural differentiation presupposed by most empirically grounded consciousness theories, rendering existing neural metrics unreliable. Even if constitutive panpsychism were accepted, the moral relevance of any putative micro experiences would remain undetermined. Precautionary appeals, therefore, hinge on how the term “possible” is interpreted. We argue that regulatory or experimental restrictions are warranted only once there is a non-trivial empirical likelihood that a given organoid type can generate valenced experience. Given present technological limits on size, complexity, and vascularization, that threshold has not been reached, nor is it likely to be met in the near to medium term. This claim is contingent on the current state of research, but we believe it to be justified. Our analysis clarifies conceptual ambiguities surrounding organoid sentience and offers a principled framework for proportionate precaution.

Human brain organoids (HBOs) are three-dimensional structures derived from human stem cells that model aspects of brain development and function, offering potentially unprecedented opportunities for studying neurological disorders and for developing treatments. This consensus paper presents recommendations from the Asia Pacific Neuroethics Working Group, developed through interdisciplinary collaboration among scientists, bioethicists, philosophers, and legal scholars who convened in Singapore in November 2024. We provide a comprehensive analysis of the ethical, legal, and sociocultural dimensions of HBO research, addressing both current realities and future possibilities. The paper examines key ethical considerations, including the potential moral status of HBOs, particularly regarding sentience and consciousness, while identifying and dispelling common misconceptions and “ethical red herrings” arising from sensationalized portrayals. We analyze consent frameworks for cell donation, privacy concerns, dual-use risks, and questions of distributive justice. Legal challenges are explored, including the categorical ambiguity of HBOs within existing regulatory frameworks, intellectual property issues, and cross-border inconsistencies in standards. Sociocultural perspectives emphasize the importance of public understanding, cross-cultural engagement, and empirical research on diverse community attitudes toward HBO research. In our recommendations, we advocate for evidence-based ethical discussions, anticipatory frameworks addressing potential future developments, contextualized analysis comparing HBOs to related experimental models, robust informed consent processes, proportionate responses to consciousness concerns, development of adaptive regulatory frameworks, responsible science communication to manage public expectations, and sustained interdisciplinary collaboration. We emphasize a balanced approach that promotes scientific innovation while maintaining rigorous ethical oversight, recognizing HBOs’ significant potential for advancing neuroscience and medicine. This represents the first comprehensive ethical framework for HBO research from the Asia Pacific region, helping to establish foundational principles for responsible development of this rapidly advancing field.

Human brain organoids (HBOs) are three-dimensional structures derived from human stem cells that model aspects of brain development and function, offering potentially unprecedented opportunities for studying neurological disorders and for developing treatments. This consensus paper presents recommendations from the Asia Pacific Neuroethics Working Group, developed through interdisciplinary collaboration among scientists, bioethicists, philosophers, and legal scholars who convened in Singapore in November 2024. We provide a comprehensive analysis of the ethical, legal, and sociocultural dimensions of HBO research, addressing both current realities and future possibilities. The paper examines key ethical considerations, including the potential moral status of HBOs, particularly regarding sentience and consciousness, while identifying and dispelling common misconceptions and “ethical red herrings” arising from sensationalized portrayals. We analyze consent frameworks for cell donation, privacy concerns, dual-use risks, and questions of distributive justice. Legal challenges are explored, including the categorical ambiguity of HBOs within existing regulatory frameworks, intellectual property issues, and cross-border inconsistencies in standards. Sociocultural perspectives emphasize the importance of public understanding, cross-cultural engagement, and empirical research on diverse community attitudes toward HBO research. In our recommendations, we advocate for evidence-based ethical discussions, anticipatory frameworks addressing potential future developments, contextualized analysis comparing HBOs to related experimental models, robust informed consent processes, proportionate responses to consciousness concerns, development of adaptive regulatory frameworks, responsible science communication to manage public expectations, and sustained interdisciplinary collaboration. We emphasize a balanced approach that promotes scientific innovation while maintaining rigorous ethical oversight, recognizing HBOs’ significant potential for advancing neuroscience and medicine. This represents the first comprehensive ethical framework for HBO research from the Asia Pacific region, helping to establish foundational principles for responsible development of this rapidly advancing field.

This paper seeks to address the challenges with applying a right to withdraw to pluripotent stem cell (PSC) research. PSC lines are unique in that they can be expanded indefinitely, disseminated globally, transformed into multiple derivatives, and employed as therapeutic products, rendering withdrawal not only logistically unfeasible, but also a substantive risk to research stability. Following an analysis of whether the classical right to withdraw can be suitably modified to address the tensions between donor freedoms and transformative biomedical research, we argue for a recalibration of donor control. Specifically, we present a hybrid model that combines up-front broad consent (including an expression of initial preferences for currently known ethically contentious areas of stem cell research), ongoing dynamic consent, and robust governance. While the paper reviews existing consent and withdrawal models, its primary contribution is to show why these models fail to adequately address the PSC-specific tension between respect for donor autonomy and provision of research certainty and to propose a hybrid, autonomy-preserving alternative that is designed to deliver greater research stability than a modified right to withdraw.

Stem cell-based human embryo models (SCBEMs), generated in vitro from stem cells, currently exist outside the scope of regulatory frameworks that govern in vitro embryo research in most jurisdictions. A widely discussed proposal suggests using a "Turing test" framework, whereby regulatory oversight is triggered if a SCBEM is found to be “equivalent” to a human embryo. In this paper, we argue that such a proposal faces two major complications. First, sophisticated laboratory techniques such as trophoblast replacement allow researchers to manipulate normal embryogenesis, obscuring whether a given SCBEM meets embryo-like regulatory thresholds. Second, attempts to assess SCBEMs’ developmental potential—especially through non-human analogues—rest on tenuous epistemic assumptions that may not align with human-specific developmental trajectories. Given SCBEMs’ potential manipulability and uncertain biological and potentiality benchmarks, we argue that reliance on equivalence-based frameworks alone is highly problematic. We conclude by urging a cautious, flexible approach that recognizes both the scientific promise of SCBEMs and the normative need to prevent the circumvention of regulatory safeguards.

Background Toomey et al (2024) found that US participants were more likely to follow a medical treatment preference—expressed after substantial cognitive decline—of a third person rather than their own future self. This correlated with a greater tendency to see the third person as still their true self. We hypothesised that the greater epistemic access one has to one’s own true self as opposed to others might drive this difference. Methods A codebook designed to capture different kinds of evidence and reasoning was developed, and participants’ explanations for their treatment decisions in Toomey et al’s study were coded and qualitatively analysed. Results In first-person cases, participants were more likely to explain their treatment decision with reference to perceived direct access to their own true self. In contrast, in third-person cases, participants more often relied on proxies or heuristics, such as the presumption that an expressed preference is an authentic one or that preferences expressed with greater cognition tend to better reflect the true self. Conclusions These findings support the hypothesis that differential epistemic access to the true self in first- and third-person cases may drive different medical treatment decisions. Participants may be trying to follow the patient’s ‘true’ or ‘authentic’ preference in all cases, but relying on different kinds of evidence in so doing.

Neural organoids derived from pluripotent stem cells have sparked ethical debate because, it is claimed, they could be sentient, or could develop sentience. We critically assess three routes for defending such a possibility: analogy with known sentient organisms, inference from neural function using leading theories of consciousness, and foundational philosophical commitments. Current cortical organoids lack nociceptors, sensory integration, and behavioral repertoires necessary for analogical arguments; they also fall short of the structural differentiation presupposed by most empirically grounded consciousness theories, rendering existing neural metrics unreliable. Even if constitutive panpsychism were accepted, the moral relevance of any putative micro experiences would remain undetermined. Precautionary appeals, therefore, hinge on how the term “possible” is interpreted. We argue that regulatory or experimental restrictions are warranted only once there is a non-trivial empirical likelihood that a given organoid type can generate valenced experience. Given present technological limits on size, complexity, and vascularization, that threshold has not been reached, nor is it likely to be met in the near to medium term. This claim is contingent on the current state of research, but we believe it to be justified. Our analysis clarifies conceptual ambiguities surrounding organoid sentience and offers a principled framework for proportionate precaution.

Concern for vulnerable people is a crucial issue when considering the legalisation of assisted dying (AD), but the meaning and normative significance of vulnerability in this context is under-explored. We examine vulnerability and the protective obligation through the lens of vulnerability theory to improve understanding of vulnerability in the context of AD. By appealing to a more nuanced account of vulnerability, we argue that the current ban on AD in England and Wales is a blunt tool that lacks compassion and fails to recognise the importance of personal autonomy as well as the relationship between vulnerability and autonomy. Recently, some emerging lawful models of AD purport to better protect the vulnerable via prospective legal authorisation. This is also a feature of recent English Assisted Dying bills, with proposals for judicial or quasi-judicial authorisation, and so we consider the potential value of prospective judicial authorisation. Although this approach risks being burdensome for applicants, we suggest that it could, in principle, not only safeguard vulnerable individuals, but also enhance end-of-life autonomy thereby offering support for a restrictive approach to lawful AD.

Jennifer Hawkins (2024) offers two cases that challenge traditional accounts of decision-making capacity, according to which respect for a medical decision turns on an individual’s cognitive capacities at the time the decision is made (Hawkins 2024; Appelbaum and Grisso 1988). In each of her described cases (involving anorexia nervosa and grief, respectively), a patient makes a decision that—although instrumentally rational at the time—does not reflect the patient’s longer-term values due to being in a particular psychological state. Importantly, this state does not impair the patient’s cognition, but rather predisposes them to make a decision that conflicts with their own broader values, beliefs, or desires.

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. Methods A vignette-based survey was conducted (N = 1445 US Americans; gender-balanced sample), in a 3 (relationship: self, best friend, stranger) × 2 (T1 preference: treat, do not treat) × 2 (T2 contrary preference: ambiguous, unambiguous) design. Results Participants were more likely to defer to the incapacitated T2 preference of a third-party, while being more likely to insist on following their own T1 capacitated preference. Further, participants were more likely to conclude that others with substantial cognitive decline were still their “true selves,” which correlated with increased deference to their T2 preferences. Conclusions These findings add to the growing evidence that lay intuitions concerning the ethical entitlement to have decisions respected are not only a function of cognition, as would be expected under many traditional bioethical accounts, but also depend on the relationship of the decision to the decision-maker’s true self.

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.