With the increasing use of algorithms in high-stakes areas such as criminal justice and health has come a significant concern about the fairness of prediction-based decision procedures. In this article I argue that a prominent class of mathematically incompatible performance parity criteria can all be understood as applications of John Broome’s account of fairness as the proportional satisfaction of claims. On this interpretation these criteria do not disagree on what it means for an algorithm to be _fair_. Rather they express (...) different understandings of what grounds a claim to a good being allocated by an algorithmic decision procedure. I then argue that an important implication of the Broomean interpretation is that it strengthens the case for outcome-based criteria. Finally, I consider how a version of the levelling-down objection to performance parity criteria arises within the Broomean account. (shrink)

The Principles of Biomedical Ethics by Tom L Beauchamp and James F Childress which is now in its fourth edition has had a great influence on the development of bioethics through its exposition of a theory based on the four principles: respect for autonomy; non-maleficence; beneficence, and justice (1). The theory is developed as a common-morality theory, and the present paper attempts to show how this approach, starting from American common-morality, leads to an underdevelopment of beneficence and justice, and that (...) the methods offered for specification and balancing of principles are inadequate. (shrink)

This paper develops a general approach to how society should compensate for losses that individuals incur due to public health interventions aimed at controlling the spread of infectious diseases. The paper falls in three parts. The first part provides an initial introduction to the issues and briefly outlines five different kinds of public health interventions that will be used as test cases. They are all directed at individuals and aimed at controlling the spread of infectious diseases (1) isolation, (2) quarantine, (...) (3) recommended voluntary social distancing, (4) changes in health care provision for asymptomatic carriers of multi-resistant microorganisms, and (5) vaccination. The interventions will be briefly described including the various risks, burdens and harms individuals who are subject to these interventions may incur. The second part briefly surveys current compensation mechanisms as far as any exist and argue that even where they exist they are clearly insufficient and do not provide adequate compensation. The third part will then develop a general framework for compensation for losses incurred due to public health interventions in the infectious disease context. This is the major analytical and constructive part of the paper. It first analyses pragmatic and ethical arguments supporting the existence of an obligation on the part of the state to compensate for such losses, and then considers whether this obligation can be defeated by (1) resource considerations, or (2) issues relating to personal responsibility. (shrink)

This paper considers the relation between medical ethics (ME) and common morality (CM), professional norms, and moral philosophy. It proceeds by analyzing two recent book-length critical analyses of this relationship by Bob Baker in “The Structure of Moral Revolutions—Studies of Changes in the Morality of Abortion, Death, and the Bioethics Revolution” and Rosamond Rhodes in “The Trusted Doctor—Medical Ethics and Professionalism.” It argues that despite the strengths of these critical arguments, there is nevertheless a relationship between ME, understood as the (...) professional ethics of the healthcare professions, and both CM and moral philosophy. It also argues that ME cannot and should not be understood purely as the internally developed professional norms of the medical or healthcare professions. (shrink)

The purpose of this paper is to describe the scientific background to the current ethical and legislative debates about the generation and use of human stem cells, and to give an overview of the ethical issues underlying these debates. The ethical issues discussed are 1) stem cells and the status of the embryo, 2) women as the sources of ova for stem cell production, 3) the use of ova from other species, 4) slippery slopes towards reproductive cloning, 5) the public (...) presentation of stem cell research and 6) the evaluation of scientific uncertainty and its implications for public policy. (shrink)

This paper discusses a recent solution to the problem of artifact phantom functions by Beth Preston. A phantom function is a function associated with a kind of artifact that it is structurally incapable of performing. Preston proposes a criterion of artifact proper function according to which phantom functions can be proper functions. This paper argues that Preston’s criterion cannot ground the teleological and normative aspects definitive of proper functions and that the proposed criterion is not consistent with Preston’s account of (...) how copies of novel prototypes acquire proper functions. The paper defends an understanding of phantom functions suggested in earlier work by Preston. (shrink)

Background There has been debate on whether a global or unified field of bioethics exists. If bioethics is a unified global field, or at the very least a closely shared way of thinking, then we should expect bioethicists to behave the same way in their academic activities anywhere in the world. This paper investigates whether there is a 'global bioethics' in the sense of a unified academic community. Methods To address this question, we study the web-linking patterns of bioethics institutions, (...) the citation patterns of bioethics papers and the buying patterns of bioethics books. Results All three analyses indicate that there are geographical and institutional differences in the academic behavior of bioethicists and bioethics institutions. Conclusion These exploratory studies support the position that there is no unified global field of bioethics. This is a problem if the only reason is parochialism. But these regional differences are probably of less concern if one notices that bioethics comes in many not always mutually understandable dialects. (shrink)

Non-compliance is a label often used about patients who do not follow therapeutic advice. This paper analyses the notion of compliance, and tries to show that this notion is inextricably bound to a paternalistic conception of the doctor-patient relationship. It is proposed that we should perhaps not talk so much about the non-compliant patient, but instead shift the focus towards the non-compliant doctor.

The relationship between first and second language literacy was examined by identifying the skills and processes developed in the first language that were transferred to the second language. The performance of 40 university students from The People's Republic of China, Hong Kong, Vietnam and Australia were compared on a series of tasks that assessed phonological awareness and reading and spelling skills in English. The results indicated that the Hong Kong students (with non-alphabetic first language literacy) had limited phonological awareness compared (...) to those students with alphabetic first language literacy. The reading and spelling tasks showed no differences between the groups on real word processing. However, the students from Hong Kong had difficulty processing nonwords because of their poor phonological awareness. The results supported the hypothesis that people learning English as a second language (ESL) transfer their literacy processing skills from their first language to English. When the phonological awareness required in English had not been developed in the first language, ESL students were limited to a whole-word, visual strategy. The findings indicate that students from non-alphabetic written language backgrounds might have difficulties with new, or unfamiliar words when attending universities where English is the medium of instruction. (shrink)

Theorists analyzing the concept of disease on the basis of the notion of dysfunction consider disease to be dysfunction requiring. More specifically, dysfunction-requiring theories of disease claim that for an individual to be diseased certain biological facts about it must be the case. Disease is not wholly a matter of evaluative attitudes. In this paper, I consider the dysfunction-requiring component of Wakefield’s hybrid account of disease in light of the artifactual organisms envisioned by current research in synthetic biology. In particular, (...) I argue that the possibility of artifactual organisms and the case of oncomice and other bred or genetically modified strains of organism constitute a significant objection to Wakefield’s etiological account of the dysfunction requirement. I then develop a new alternative understanding of the dysfunction requirement that builds on the organizational theory of function. I conclude that my suggestion is superior to Wakefield’s theory because it (a) can accommodate both artifactual and naturally evolved organisms, (b) avoids the possibility of there being a conflict between what an organismic part is supposed to do and the health of the organism, and (c) provides a nonarbitrary and practical way of determining whether dysfunction occurs. (shrink)

In this issue of the Hastings Center Report, Moti Gorin, Steven Joffe, Neal Dickert, and Scott Halpern offer a comprehensive defense of the use of nudging techniques in the clinical context, with the aim of promoting the best interests of patients. Their argument is built on three important claims: Nudging is ubiquitous and inescapable in clinical choice situations, and there is no neutral way of informing patients about their treatment choices; many patients do not have authentic preferences concerning their treatment (...) choices, and those that do can easily resist nudging; and, finally, since many people lack authentic preferences and those that do can still act on their preferences, nudging in the patients’ best interest is justified. I agree with the authors that if these three claims stand up to scrutiny, then they will provide a justification for many types of clinical nudging. I am, however, skeptical as to whether the claims can be sustained, despite the valiant efforts of Gorin and colleagues. (shrink)

A widespread and influential characterization of synthetic biology emphasizes that synthetic biology is the application of engineering principles to living systems. Furthermore, there is a strong tendency to express the engineering approach to organisms in terms of what seems to be an ontological claim: organisms are machines. In the paper I investigate the ontological and heuristic significance of the machine analogy in synthetic biology. I argue that the use of the machine analogy and the aim of producing rationally designed organisms (...) does not necessarily imply a commitment to mechanical biology. The ideal of applying engineering principles to biology is best understood as expressing recognition of the machine-unlikeness of natural organisms and the limits of human cognition. The paper suggests an interpretation of the identification of organisms with machines in synthetic biology according to which it expresses a strategy for representing, understanding, and constructing living systems that are more machine-like than natural organisms. (shrink)

In this paper I assess the explanatory powers of theories of function in the context of products that may result from synthetic biology. The aim is not to develop a new theory of functions, but to assess existing theories of function in relation to a new kind of biological and artifactual entity that might be produced in the not-too-distant future by means of synthetic biology. The paper thus investigates how to conceive of the functional nature of living systems that are (...) not the result of evolution by natural selection, or instantly generated by cosmic coincidence, but which are products of intelligent design. The paper argues that the aetiological theory of proper functions in organisms and artifacts is inadequate as an account of proper functions in such ‘Paley organisms’ and defends an alternative organisational approach. The paper ends by considering the implications of the discussion of biological function for questions about the interests and moral status of non-sentient organisms. (shrink)

OBJECTIVES: To study the ethical reasoning of nurses and physicians, and to assess whether or not modified focus groups are a valuable tool for this purpose. DESIGN: Discussion of cases in modified focus groups, each consisting of three physicians and three nurses. The discussion was taped and analysed by content analysis. SETTING: Five departments of internal medicine at Danish hospitals. SAMPLE: Seven discussion groups. MAIN MEASUREMENTS: Ethical content of statements, style of statements, time used by each participant. RESULTS: Danish physicians (...) and nurses do not differ in the kind of ethical reasoning they use, but physicians use more of the discussion time than nurses, they use a more assertive style of argumentation, and the solutions chosen are usually first put forward by physicians. CONCLUSION: The results and informal comparisons with similar data from long qualitative interviews indicate that groups of this kind are a useful tool for gathering data on ethical reasoning. (shrink)

It is generally accepted that we need more research into concussions and other injuries with potential long-term effects in sport because such research underpins effective, evidence-based prevention, management, support, and treatment. This paper provides an analysis of the obligations of sports federations to support and facilitate such research, as well as an analysis of the role active participants in the sport should have in the research process. The paper focuses on concussion and concussion research, though very similar arguments apply to (...) other common sports injuries with potential long-term effects. The paper argues that sports federations have a moral obligation and a prudential interest in initiating, facilitating, and funding concussion research. This follows from their duty of care towards active participants and from considerations of reciprocity. The ability to discharge these research obligations depends on the resources available to a particular federation, but those who can discharge them should do so. The paper further argues that athletes and other active participants in sport should be involved in all aspects of the concussion research process from conception to design, i.e. that Active Participant Involvement and Engagement (APIE) should be a non-negotiable element of concussion research projects. This is supported by instrumental reasons, but also by philosophical argument based on standpoint epistemology and on ethical arguments related to the interests of active participants. Standpoint epistemology is the epistemological position that the knowledge a person has and can have depends on that person’s standpoint in the world. Keywords: Concussion, funding, participant involvement, sport, sport association, sport federation. (shrink)

Synthetic biology is an emerging discipline that aims to apply rational engineering principles in the design and creation of organisms that are exquisitely tailored to human ends. The creation of artificial life raises conceptual, methodological and normative challenges that are ripe for philosophical investigation. This special issue examines the defining concepts and methods of synthetic biology, details the contours of the organism–artifact distinction, situates the products of synthetic biology vis-à-vis this conceptual typology and against historical human manipulation of the living (...) world, and explores the normative implications of these conclusions. In addressing the challenges posed by emerging biotechnologies, new light can be thrown on old problems in the philosophy of biology, such as the nature of the organism, the structure of biological teleology, the utility of engineering metaphors and methods in biological science, and humankind’s relationship to nature. (shrink)

OBJECTIVES: To study the ethical reasoning of nurses and physicians, and to assess whether or not modified focus groups are a valuable tool for this purpose. DESIGN: Discussion of cases in modified focus groups, each consisting of three physicians and three nurses. The discussion was taped and analysed by content analysis. SETTING: Five departments of internal medicine at Danish hospitals. SAMPLE: Seven discussion groups. MAIN MEASUREMENTS: Ethical content of statements, style of statements, time used by each participant. RESULTS: Danish physicians (...) and nurses do not differ in the kind of ethical reasoning they use, but physicians use more of the discussion time than nurses, they use a more assertive style of argumentation, and the solutions chosen are usually first put forward by physicians. CONCLUSION: The results and informal comparisons with similar data from long qualitative interviews indicate that groups of this kind are a useful tool for gathering data on ethical reasoning. (shrink)

This paper considers the argument that if the ban on doping in sports was abolished it would be possible to have doping under medical control, i.e. open doping, prescribed by doctors with collection of reliable information about effects and side-effects. A game-theoretic argument is developed showing that this positive scenario is very unlikely to be instantiated given reasonable assumptions about the motivation of sportspersons and sports doctors. It is furthermore shown that the standard arguments against the current ban on doping (...) also entail that if doping was made legal any requirements that it should be open doping could not be justified. (shrink)

Recent technical developments in genetictesting has led to a situation where the DNA inpreviously stored tissue samples can beextracted and used for genetic analysis. Thisraises the question of how to decide whether aspecific use of such samples should be allowed.Using the genetic testing of ancient DNA ingeneral, and the DNA of the pharaoh Tutankhamenin particular as examples this paper analysesthe question. It investigates whether ethicalframeworks based on proxy consent, culturalaffiliation, ownership, or the privacy rightsof the dead are appropriate and justifiable (...) inthis context. The conclusion is that frameworksbased on proxy consent, cultural affiliation,and ownership are not very useful. (shrink)

Artificial intelligence systems advising healthcare professionals will be widely introduced into healthcare settings within the next 5–10 years. This paper considers how this will sit with tort/negligence based legal approaches to compensation for medical error. It argues that the introduction of AI systems will provide an additional argument pointing towards no-fault compensation as the better legal solution to compensation for medical error in modern health care systems. The paper falls into four parts. The first part rehearses the main arguments for (...) and against no-fault compensation. The second explains why it is likely that AI systems will be widely introduced. The third part analyses why it is difficult to fit AI systems into fault-based compensation systems while the final part suggests how no-fault compensation could provide a possible solution to such challenges. (shrink)

In the paper ‘Genetic information, insurance, and a pluralistic approach to justice’, Jonathan Pugh1 develops an argument from unresolved pluralism in our theories of justice, via the pluralism this occasions in relation to the specific question of the use of genetic test results in insurance underwriting, to the conclusion that the UK regulatory approach in relation to the use of GTRs in insurance is broadly correct.1 Pugh’s argument is wide-ranging and I cannot provide a complete critique of it in this (...) short comment, but I will gesture towards some strands of the argument that are potentially problematic. The first potential problem in the argument is that Pugh bases his argument on a very extensive range of accounts of justice, including pure maximising consequentialism, strict egalitarianism and libertarianism, among many others. If these are all accounts of justice, it is not strange that there is pluralism of conclusions in relation to a specific question of justice or discrimination, such as the use of GTRs in the underwriting of specific kinds of insurance contracts. Pugh’s range, for instance, includes accounts of justice that deny the direct importance of distributive concerns as well as accounts that see distributive concerns as crucial. These accounts disagree not only about the answer to Pugh’s question but also about …. (shrink)

The paper by Lynch et al. argues that payments to research participants in biomedical research can be divided into three different categories, reimbursement, compensation, and incentive and...

This paper considers the ethical issues raised by biobanking of material from children who are not mature enough to give ethically valid consent. The first part considers consent requirements for entry of such materials in the biobank, whereas the second part looks at the issues that arise when a competent child later wants to withdraw previously sored materials, and at the issues that arise when there is informational entanglement between information about a parent and information about a child. The paper (...) argues for three main conclusions:That it is in most cases acceptable for parents to give proxy consent to entry of material from their children ino biobanks, even though this is not strictly speaking in the best interest of the child;that a right to withdraw from the biobank is more important when material has been entered with proxy consent; andthat disputes about the withdrawal of entangled information, i.e. information that is both about a parent and a child, should be resolved in favour of the child. (shrink)

This article considers naturalistic analyses of the concepts of health and disease in light of the possibility of constructing novel living systems. The article begins by introducing the vision of synthetic biology as the application of engineering principles to the construction of biological systems, the main analyses of the concepts of health and disease, and the standard theories of function in artefacts and organisms. The article then suggests that reflection on the possibility of artefactual organisms amounts to a challenge to (...) the functional theories of health and disease proposed by Wakefield and Boorse. More specifically, Wakefield and Boorse's theories are reconstructed as responses to a dilemma concerning how to allow for the ascription of health and disease to artefactual organisms without at the same time opening up the possibility of diseased nonliving artefacts such as cars and computers. It is argued that neither response will enable us to ascribe health and disease to artefactual organisms, because both theories, in order to rule out the possibility of ascribing health and disease to nonliving artefacts, make such ascriptions conditional on having a natural-selection history or being part of a species which has been designed by evolution. (shrink)

We propose the FoodSmart City framework as a transdisciplinary avenue to promote sustainable seafood consumption. We argue that a change in human seafood consumption towards eating at lower trophic levels may be helped by discovering forgotten cultural practices and tapping into locally-sourced marine resources. We set out a framework of knowledge exchange and production between academia, businesses, and civil society to promote and assist healthy and ecologically sustainable living using digital tools and intangible cultural heritage while engaging with innovative chefs (...) and educationalists. The framework targets Dublin City, Ireland, but may potentially be replicated in other contexts. (shrink)

In this paper, it is argued that even though the concept of community does not play a significant role in Marxist theory, Marxism needs a notion of community, and the paper sets out to theorize how to make sense of this concept in a Marxist theoretical setting. The paper claims that Althusser’s philosophy, especially his elaboration of the concept of practice, may assist us in this task, and it sets out to explore what can be gained by redefining community in (...) terms of practice. In Althusser’s theory, practice and ideology are very closely linked. While recognizing the importance of Althusser’s theory of ideology, the paper then subsequently explores an alternative configuration of the concepts community and ideology. Finally, it is claimed that this analysis may help us to better understand ideologies such as racism and nationalism. (shrink)

This paper gives a presentation and critical assessment of the phenomenological philosophy and ethics of the Danish theologian and philosopher K. E. Løgstrup (1905–1981). It is argued that although the ethics of Løgstrup contain valuable insights, an uncritical appropriation as the main source for a health care ethics or a philosophy of caring, is problematic. Løgstrup's philosophy contains a number of internal problems, and does not adequately deal with some problems raised by work in the modern health care setting.

Whenever embryo experimentation is discussed the question of whether it is preferable to use spare or specifically produced (‘research’) embryos for destructive embryo experimentation always enters the debate at some stage. This question is analysed, and it is suggested that the distinction is morally uninteresting, but rhetorically useful for both sides in the debate. It is further suggested that part of the force of this distinction is caused by the fact that it is parasitic on a real moral distinction based (...) on the degree to which the gametes used in the experiment are obtained by explicit or implicit coercion. (shrink)

In this introduction to The Journal of Aesthetics and Art Criticism special issue on the aesthetics of creative activism, we canvas influential scholarship of political aesthetics to sculpt a broad typology of six interconnected mechanisms by which art might intervene in the world. We label these: Documentation, Disruption, Recognition, Participation, Imagination, and Beauty. Each has a compelling tradition of theory and application, augmented, extended, and sometimes challenged by the thirteen fresh and provocative contributions in the special issue. Yet, we ask, (...) if both politically minded artists and culturally minded activists are convinced of the power of art to provoke social change, and if we live a world that by almost all measures is now saturated with politically inclined, aesthetically informed practices, interfaces, objects, and texts, why does art not seem to be making a difference? Clearly, we need to think harder about the relationships between art and action, a task the articles assembled here call upon us to take seriously. (shrink)

Machine learning algorithms are expected to improve referral decisions. In this article I discuss the legitimacy of deferring referral decisions in primary care to recommendations from such algorithms. The standard justification for introducing algorithmic decision procedures to make referral decisions is that they are more accurate than the available practitioners. The improvement in accuracy will ensure more efficient use of scarce health resources and improve patient care. In this article I introduce a proceduralist framework for discussing the legitimacy of algorithmic (...) referral decisions and I argue that in the context of referral decisions the legitimacy of an algorithmic decision procedure can be fully accounted for in terms of the instrumental values of accuracy and fairness. I end by considering how my discussion of procedural algorithmic legitimacy relates to the debate on algorithmic fairness. (shrink)

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. (shrink)

This chapter examines Soren Kierkegaard's views and relationship with the Church, explaining that while Kierkegaard was a frequent churchgoer, he also considered the Church a corrupt and disgraceful business enterprise. It discusses Kierkegaard's criticism on the development of the Church as an institution and analyses various aspects of his ecclesiastical conception of the Church. The chapter also considers Kierkegaard's own experiences in writing and delivering sermons.

A significant portion of newborns cared for in the neonatal intensive care unit or other ICUs, such as the cardiac ICU, have a medical condition with a genetic component, including congenital malformations, the leading cause of death in the NICU. In many cases, however, it is not clear which condition the child has or what can be done to help him or her. Genomic sequencing of sick newborns has the potential to bypass the prolonged journey to a diagnosis, improving the (...) medical care of individual infants. Sequencing also has the potential to benefit others beyond the child whose genome is sequenced and his or her immediate family. Sequence data from sick newborns will expand medicine's understanding of genetic diseases, leading to improvements in clinicians’ ability to counsel family and to provide even more targeted care. Not only will more frequent use of sequencing lead to discovery of new genes; it will also provide unique insights into the full spectrum of known Mendelian genetic diseases, so‐called phenotypic expansion, when a gene previously recognized as associated with a phenotype is found to be associated with an expanded set of clinical features. Genetic and environmental changes that modify the expression of a genetic disease may also be elucidated. (shrink)

This paper demonstrates how ideology plays a major, but previously neglected role in Rousseau's treatment of politics in the Social Contract. Specifically, it shows how a number of key elements in his line of argument come close to ideology criticism as it is conceived in Louis Althusser's theory of ideological state apparatuses. This is the case not just in relation to the distinction between general will and particular will, but also in relation to such concepts as property and social contract. (...) However, the paper also demonstrates how this pre-Marxist understanding of ideology co-exists in the text with a different and more primitive understanding of ideology which is incompatible with Marxism and which points back to Rousseau's previous discourse on the origins of inequality. The paper concludes that while there are definitely elements in Rousseau's text which point toward a future development of the theme of ideology in Marxist theory, the Social Contract on the whole is characterized by heterogeneity on this topic. (shrink)

In his recent book The Foundation of Bioethics , H. Tristam Engelhardt Jr. advances the idea of a peaceable pluralist moral society based on principles of autonomy, beneficience, and ownership. This paper tries to show that unless there is one and only one rationally sustainable definition of "a person", then the peaceable society cannot remain peaceable, but will be stirred up by groups with different and equally rational definitions. The paper further tries to show that Engelhardt's own definition of "a (...) persons in the strict sense" is an unsatisfactory solution to the problem, and the same is true for any of the possible compromises. Keywords: medical ethics, persons, autonomy CiteULike Connotea Del.icio.us What's this? (shrink)

In this paper we analyse the degree to which a distinction between social science and public health research and other non-research activities can account for differences between a number of large scale social surveys performed at the national and European level. The differences we will focus on are differences in how participation is elicited and how data are used for government, research and other purposes. We will argue that the research / non-research distinction does not account for the identified differences (...) in recruitment or use and that there are no other convincing justifications. We argue that this entails that eliciting participation by coercion or manipulation becomes very difficult to justify. (shrink)

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...) a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas. (shrink)

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. (shrink)