In face of the multiple controversies surrounding the DSM process in general and the development of DSM-5 in particular, we have organized a discussion around what we consider six essential questions in further work on the DSM. The six questions involve: 1) the nature of a mental disorder; 2) the definition of mental disorder; 3) the issue of whether, in the current state of psychiatric science, DSM-5 should assume a cautious, conservative posture or an assertive, transformative posture; 4) the role (...) of pragmatic considerations in the construction of DSM-5; 5) the issue of utility of the DSM - whether DSM-III and IV have been designed more for clinicians or researchers, and how this conflict should be dealt with in the new manual; and 6) the possibility and advisability, given all the problems with DSM-III and IV, of designing a different diagnostic system. Part I of this article took up the first two questions. Part II will take up the second two questions. Question 3 deals with the question as to whether DSM-V should assume a conservative or assertive posture in making changes from DSM-IV. That question in turn breaks down into discussion of diagnoses that depend on, and aim toward, empirical, scientific validation, and diagnoses that are more value-laden and less amenable to scientific validation. Question 4 takes up the role of pragmatic consideration in a psychiatric nosology, whether the purely empirical considerations need to be tempered by considerations of practical consequence. As in Part 1 of this article, the general introduction, as well as the introductions and conclusions for the specific questions, are written by James Phillips, and the responses to commentaries are written by Allen Frances. (shrink)

The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a duty to participate. The (...) current social norm is that individuals participate only if they have a good reason to do so. The public goods argument implies that individuals should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making society significantly healthier and longer lived. (shrink)

The “best-medical-interests” standard for reporting findings does not go far enough. Research subjects have a right to know about any comprehensible piece of information about them that is generated by research in which they are participating. An even broader standard may sometimes be appropriate: if subjects agree to accept information that they may not understand, then all information may be disclosed.

With the recent report of a live birth after use of Mitochondrial replacement therapy, sometimes called ‘Three-parent IVF’, the clinical application of the technique is fast becoming a reality. While the United Kingdom allows the procedure under regulatory scrutiny, it remains effectively outlawed in many other countries. We argue that such prohibitions may violate individuals’ procreative rights, grounded in individuals’ interest in genetic affinity. The interest in genetic affinity was recently endorsed by Singapore’s highest court, reflecting an emphasis on the (...) importance of biological ties found across the globe. We apply that reasoning to make the case for a right to ‘Three-parent IVF’. (shrink)

The success of digital COVID-19 contact tracing requires a strategy that successfully addresses the digital divide—inequitable access to technology such as smartphones. Lack of access both undermines the degree of social benefit achieved by the use of tracing apps, and exacerbates existing social and health inequities because those who lack access are likely to already be disadvantaged. Recently, Singapore has introduced portable tracing wearables (with the same functionality as a contact tracing app) to address the equity gap and promote public (...) health. We argue that governments have an ethical obligation to ensure fair access to the protective benefits of contract tracing during the pandemic and that wearables are an effective way of addressing some important equity issues. The most contentious issues about contact tracing apps have been the potential infringements of privacy and individual liberty, especially where the use of apps or other technology (such as wearables or QR codes) is required for access to certain spaces. Here we argue that wearables, as opposed to apps alone, will make a digital contact tracing mandate more practical and explain some conditions under which such a mandate would be justified. We focus on Singapore as a case study that has recently deployed contact tracing wearables nationally, but also reference debate about wearables in Australia and New Zealand. Our analysis will be relevant to counties trialling similar portable tracing wearables. (shrink)

In this chapter, it is argued that the Mind-Body Powers model of neural correlates of consciousness provides a metaphysical framework that yields the theoretical possibility of empirically detecting consciousness. Since the model is informed by an Aristotelian-Thomistic hylomorphic ontology rather than a physicalist ontology, it provides a philosophical foundation for the science of consciousness that is an alternative to physicalism. Our claim is not that the Mind-Body Powers model provides the only alternative, but rather that it provides a sufficient framework (...) for empirically detecting and scientifically studying consciousness. Elsewhere, the integrated information theory’s prediction about the neural correlate of being conscious has been used to illustrate how the Mind-Body Powers model grounds the possibility of empirically detecting consciousness (see M. Owen, 2021, ch. 8). The theory’s prediction was used as one plausible example of a hypothesis about the nature and location of the neural correlate that can be combined with the model. However, there is no settled conclusion about which neurobiological theory of consciousness accurately identifies the neural mechanisms corresponding to being conscious (NAS, 2021, p. 39; Sattin et al., 2021; Seth, 2017; Seth & Bayne, 2022). Therefore, this work will employ another plausible neurobiological prediction provided by the Temporal Circuit Hypothesis. The hypothesis is combined with the Mind-Body Powers model to demonstrate that empirically detecting consciousness is metaphysically plausible wholly apart from a physicalist framework. (shrink)

It has recently been argued that reproductive genetic manipulation technologies like mitochondrial replacement and germline CRISPR modifications cannot be said to save anyone’s life because, counterfactually, no one would suffer more or die sooner absent the intervention. The present article argues that, on the contrary, reproductive genetic manipulations may be life-saving (and, from this, have therapeutic value) under an appropriate population health perspective. As such, popular reports of reproductive genetic manipulations potentially saving lives or preventing disease are not necessarily mistaken, (...) though such terminology still requires further empirical validation. (shrink)

The Symposia Aristotelica were inaugurated at Oxford in 1957. They are conferences of select groups of Aristotelian scholars from the UK, USA and Europe, and are held every three years. In 1975 the meeting was held in Cambridge and was devoted to Aristotle's psychological treatises, the De anima and the Parva uaturalia. The members of the conference discussed some of the much debated problems of Aristotle's psychology and broached important new topics such as his ideas on imagination. Dr Lloyd and (...) Professor Owen have collected and edited the papers presented to the Symposium and provided an analytical index. (shrink)

Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is an ethical framework developed by the WHO for using unproven interventions in public health emergencies outside the context of medical research. It is mainly intended for use when medical research would be impracticable, but there is still a need to systematically gather data about unproven interventions. As such, it is designed as something of a middle ground between clinical and research ethical frameworks. However, I argue that MEURI does not truly (...) lie at the intersection of clinical care and research. Due to its intent, structure and oversight requirements, it takes on most of the crucial features of research, to the point that it is best understood as a form of research. As a result, cases where MEURI could practicably be applied should instead make use of existing research frameworks. For those circumstances where research is truly impracticable, a more straightforward oversight system than MEURI is needed. While existing practices of compassionate use have some applicability, proposals to make use of clinical ethics committees to oversee unproven interventions may help achieve the right balance in acting in a patient’s best interests when the relevant evidence base is weak. (shrink)

Superoxide is produced by a NADPH oxidase of phagocytic cells and contributes to their microbicidal activities. The oxidase is activated when receptors in the neutrophil plasma membrane bind to the target microbe. These receptors recognise antibodies and complement fragments which coat the target cell. The oxidase electron transport chain, located in the plasma membrane, comprises a low potential cytochrome b heterodimer (gp 91‐phox and p22‐phox) associated with FAD. It is non‐functional until at least three proteins, p67‐phox, p47‐phox and p21rac (and (...) possibly others), move from the cytosol to dock on the cytochrome b. The docking involves the interaction of SH3 domains may become exposed follwoing phosphorylation of p47‐phox by protein kinase C or, in model systems, by addition of arachidonic acid to reconstitution mixtures. Following the docking process the electron‐transporting component is able to transfer electrons from NADPH to oxygen. This electrogenic event is charge‐compensated by the opening of a prton channel. Components of the oxidase are expressed in non‐phagocytes, where their function is uncretain but could be related to some signal function of superoxide. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical issues relating to (...) the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (shrink)

The Symposia Aristotelica were inaugurated at Oxford in 1957. They are conferences of select groups of Aristotelian scholars from the UK, USA and Europe, and are held every three years. In 1975 the meeting was held in Cambridge and was devoted to Aristotle's psychological treatises, the De anima and the Parva uaturalia. The members of the conference discussed some of the much debated problems of Aristotle's psychology and broached important new topics such as his ideas on imagination. Dr Lloyd and (...) Professor Owen have collected and edited the papers presented to the Symposium and provided an analytical index. (shrink)

We live in the Information Age. Advances over the past 50 years in computing technology have enabled ever-expanding capacity to generate, store, transfer, process and analyse information about people, societies, products, services, the environment—nearly every aspect of the world. In parallel, concerns over how such data is being used have emerged, focusing especially on issues of privacy and confidentiality. Yet as technological capabilities continue to expand, the debate over ethical uses of data inevitably has evolved as well. Whereas we used (...) to just talk about data, now there is great concern over Big Data. This chapter explores what, exactly, Big Data is; the ethical ramifications of its emergence, particularly for consent and anonymization; and what sorts of policy solutions are being proposed to address these emerging challenges. We will not defend one particular approach, but hope this chapter can be a useful reference for those who are contemplating difficult questions surrounding responsible management of Big Data. (shrink)

Some have objected to human enhancement on the grounds that it violates the autonomy of the enhanced. These objections, however, overlook the interesting possibility that autonomy itself could be enhanced. How, exactly, to enhance autonomy is a difficult problem due to the numerous and diverse accounts of autonomy in the literature. Existing accounts of autonomy enhancement rely on narrow and controversial conceptions of autonomy. However, we identify one feature of autonomy common to many mainstream accounts: reasoning ability. Autonomy can then (...) be enhanced by improving people’s reasoning ability, in particular through cognitive enhancement; given how valuable autonomy is usually taken to be, this gives us extra reason to pursue such cognitive enhancements. Moreover, autonomy-based objections will be especially weak against such enhancements. As we will argue, those who are worried that enhancements will inhibit people’s autonomy should actually embrace those enhancements that will improve autonomy. (shrink)

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest (...) treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical—they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles. (shrink)

Studies have shown that some covertly conscious brain-injured patients, who are behaviorally unresponsive, can reply to simple questions via neuronal responses. Given the possibility of such neuronal responses, Andrew Peterson et al. have argued that there is warrant for some covertly conscious patients being included in low-stakes medical decisions using neuronal responses, which could protect and enhance their autonomy. The justification for giving credence to alleged neuronal responses must be analyzed from various perspectives, including neurology, bioethics, law, and as we (...) suggest, philosophy of mind. In this article, we analyze the warrant for giving credence to neuronal responses from two different views in philosophy of mind. We consider how nonreductive physicalism’s causal exclusion problem elicits doubt about interpreting neural activity as indicating a conscious response. By contrast, such an interpretation is supported by the mind-body powers model of neural correlates of consciousness inspired by hylomorphism. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 31-33, May–June 2022.

Like all research, embryo research can take a variety of forms, some posing substantially more risks to persons than others. Savulescu et al argue persuasively that regulatory regimes specially designed for sensitive embryo research should differentiate between person-affecting and non-person-affecting embryo research, with substantial scrutiny only warranted for the former.1 Yet if we find Savulescu et al ’s argument persuasive, what practical implications would it have? In this commentary, we focus in particular on how such an argument might apply in (...) Singapore, one of the jurisdictions with special regulations for embryo research. We will summarise the way in which approval for oocyte and embryonic research operates in Singapore, and suggest that Savulesc et al ’s distinction requires specification to be useful in such contexts. We propose adopting a risk-stratified framework similar to that employed with Institutional Review Boards. This requires a wider view of risks than the focus by Savulescu et al on future persons. We then illustrate how such a framework would apply in five scenarios discussed in Savulescu et al. Research with embryos and oocytes is regulated in Singapore under the Human Biomedical Research Act.2 Enacted in 2015, this law sets out requirements for consent, IRB review and research oversight. By definition, all research involving gametes and embryos fall within the remit of the Act. Moreover, such research is defined as ‘restricted’; besides the Act, research involving oocytes and embryos is also subject to control under the Human Biomedical Research …. (shrink)

Mitochondrial replacement therapy requires oocytes of women whose mitochondrial DNA will be transmitted to resultant children. These techniques are scientifically, ethically and socially controversial; it is likely that some women who donate their oocytes for general in vitro fertilisation usage would nevertheless oppose their genetic material being used in MRT. The possibility of oocytes being used in MRT is therefore relevant to oocyte donation and should be included in the consent process when applicable. In present circumstances, specific consent should be (...) obtained. However, once MRT becomes more routine, such consent could be incorporated into the general consent process for oocyte donation. The reported lack of proper consent for MRT from the oocyte donor in the first baby born via the technique is an ethical failing and should be corrected in any future practice of MRT. (shrink)

Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the (...) ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment. (shrink)

It is generally unquestioned that human subjects research review boards should assess the ethical acceptability of protocols. It says so right on the tin, after all: they are explicitly called research ethics committees in the UK. But it is precisely those sorts of unchallenged assumptions that should, from time to time, be assessed and critiqued, in case they are in fact unfounded. John Stuart Mill's objection to suppressers of dissent is instructive here: “If the opinion is right, they are deprived (...) of the opportunity of exchanging error for truth: if wrong, they lose, what is almost as great a benefit, the clearer perception and livelier impression of truth, produced by its collision with error”.1 Andrew Moore and Andrew Donnelly's compelling article, “The job of ‘ethics committees’”, is just this sort of challenge to conventional wisdom, a rejection of the notion that review boards should be considering ethical matters at all.2 If true, we should be substantially reforming our research ethics policies. And if false, rebuttals would help strengthen and ground the otherwise unquestioned assumption of the role of ethics committees. As it happens, I will argue that their critiques fall into the second category. While mistaken, they present a valuable opportunity to clarify the role of ethics committees and their relationship to relevant codes. In particular, I will defend a hybrid account where codes have strict primacy, but leave significant room for review boards …. (shrink)

Individual health assessments (IHAs) for asymptomatic individuals provide a challenge to traditional distinctions between patient care and non-medical practice. They may involve undue radiation exposure, lead to false positives, and involve high out-of-pocket costs for recipients. A recent paper (Journal of the American College of Radiology 13(12): 1447–1457.e1, 2016) has criticised the use of IHAs and argued that recipients should be classified as ‘presenters’, not ‘patients’, to distinguish it from regular medical care. I critique this classificatory move, on two grounds: (...) one, it is conceptually suspect. Two, it obviates the medical ethics framework for IHAs, potentially exposing recipients of IHAs to lower standards of oversight and protection. Responsible regulation of IHAs will be easier to ethically justify if those seeking IHAs are considered patients and not merely presenters. (shrink)

Volume 19, Issue 7, July 2019, Page 28-30.

G. E. L. Owen; VIII*—Aristotelian Pleasures, Proceedings of the Aristotelian Society, Volume 72, Issue 1, 1 June 1972, Pages 135–152, https://doi.org/10.1093/ar.

Moral enhancement is an ostensibly laudable project. Who wouldn’t want people to become more moral? Still, the project’s approach is crucial. We can distinguish between two approaches for moral enhancement: direct and indirect. Direct moral enhancements aim at bringing about particular ideas, motives or behaviors. Indirect moral enhancements, by contrast, aim at making people more reliably produce the morally correct ideas, motives or behaviors without committing to the content of those ideas, motives and/or actions. I will argue, on Millian grounds, (...) that the value of disagreement puts serious pressure on proposals for relatively widespread direct moral enhancement. A more acceptable path would be to focus instead on indirect moral enhancements while staying neutral, for the most part, on a wide range of substantive moral claims. I will outline what such indirect moral enhancement might look like, and why we should expect it to lead to general moral improvement. (shrink)

In “Assessing the Remedy: The Case for Contracts in Clinical Trials,” Sarah Edwards (2011) proposes that research participants acquire contractual obligations to investigators, thus opening the doo...