BackgroundCommunity engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation.MethodsIn this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.Results and conclusionsDrawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research. (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)

This open access casebook addresses complex and important ethical challenges arising when health-related research in conducted in the context of epidemics and pandemics. This book provides contextually-rich real-world case studies illustrating research ethics issues encountered by researchers, ethics reviewers and regulators around the globe during the COVID-19 pandemic. The accompanying commentaries outline relevant conceptual approaches and ethical considerations. These promote understanding and reflection on relevant ethical issues, ethical approaches and competing considerations in a manner supporting thoughtful evaluation of their implications (...) for practice. As such the casebook is relevant to academic and professional audiences with an interest in global health, research ethics, and outbreaks and epidemics. (shrink)

BackgroundObtaining consent has become a standard way of respecting the patient’s rights and autonomy in clinical research. Ethical guidelines recommend that the child’s parent/s or authorised legal guardian provides informed consent for their child’s participation. However, obtaining informed consent in paediatric research is challenging. Parents become vulnerable because of stress related to their child’s illness. Understanding the views held by guardians and researchers about the consent process in Malawi, where there are limitations in health care access and research literacy will (...) assist in developing appropriate consent guidelines.MethodsWe conducted 20 in-depth interviews with guardians of children and research staff who had participated in paediatric clinical trial and observational studies in acute and non-acute settings in the Southern Region of Malawi. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. Interviews were compared across studies and settings to identify differences and similarities in participants’ views about informed consent processes. Data analysis was facilitated by NVIVO 11 software.ResultsAll participants across study types and settings reported that they associated participating in research with therapeutic benefits. Substantial differences were noted in the decision-making process across study settings. Guardians from acute studies felt that the role of their spouses was neglected during consenting, while staff reported that they had problems obtaining consent from guardians when their partners were not present. Across all study types and settings, research staff reported that they emphasised the benefits more than the risks of the study to participants, due to pressure to recruit. Participants from non-acute settings were more likely to recall information shared during the consent process than participants in the acute setting.ConclusionThe health care context, culture and research process influenced participants’ understanding of study information across study types and settings. We advise research managers or principal investigators to define minimum requirements that would not compromise the consent process and conduct study specific training for staff. The use of one size fits all consent process may not be ideal. More guidance is needed on how these differences can be incorporated during the consent process to improve understanding and delivery of consent.Trial registration Not applicable. (shrink)

During the WHO-GloPID COVID-19 Global Research and Innovation Forum meeting held in Geneva on the 11th and 12th of February 2020 a number of different ethical concepts were used. This paper briefly states what a number of these concepts mean and how they might be applied to discussions about research during the COVID-19 pandemic and related outbreaks. This paper does not seek to be exhaustive and other ethical concepts are, of course, relevant and important.

Four ethical values — maximizing benefits, treating equally, promoting and rewarding instrumental value, and giving priority to the worst off — yield six specific recommendations for allocating medical resources in the Covid-19 pandemic: maximize benefits; prioritize health workers; do not allocate on a first-come, first-served basis; be responsive to evidence; recognize research participation; and apply the same principles to all Covid-19 and non–Covid-19 patients.

BackgroundGenome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.DiscussionWe explore ethical (...) issues in three key areas: protecting the interests of research participants, regulation of international collaborative genomics research and protecting the interests of scientists in low income countries. With regard to participants, important challenges are raised about community consultation and consent. Genomics research raises ethical and governance issues about sample export and ownership, about the use of archived samples and about the complexity of reviewing such large international projects. In the context of protecting the interests of researchers in low income countries, we discuss aspects of data sharing and capacity building that need to be considered for sustainable and mutually beneficial collaborations.SummaryMany ethical issues are raised when genomics research is conducted on populations that are characterised by lower average income and literacy levels, such as the populations included in MalariaGEN. It is important that such issues are appropriately addressed in such research. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics is embedded in the design and implementation of such research projects. (shrink)

As the federal government distributed remdesivir to some of the states COVID-19 hit hardest, policymakers scrambled to develop criteria to allocate the drug to their hospitals. Our state, Michigan, was among those states to receive an initial quantity of the drug from the U.S. government. The disparities in burden of disease in Michigan are striking. Detroit has a death rate more than three times the state average. Our recommendation to the state was that it should prioritize the communities that bear (...) a disproportionate burden of suffering in the allocation of the new potential treatment. This recommendation is justified not only for new drugs with uncertain effects, but also for drugs of certain benefit or vaccines. For states with significant health disparities, such as Michigan, this allocation priority may help to repair them. In fact, any other allocation strategy may make them worse. (shrink)

Community engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation. (shrink)

Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent (...) to data sharing in January 2016. Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing. The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders’ perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context. Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants’ understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing. (shrink)

Since January 2016, the Mahidol Oxford Tropical Medicine Research Unit has trialled a data-sharing policy where requests to access research datasets are processed through a Data Access Committee. In this paper, we share our experiences establishing data management systems and data-sharing infrastructure including a data-sharing policy, data access committee and related procedures. We identified a number of practical and ethical challenges including requests for datasets collected without specific or broad consent to data sharing and requests from pharmaceutical companies for data (...) to support drug registration applications. We also encountered significant resource constraints which required the development of appropriate human resources and infrastructure. We suggest a research agenda to promote responsible and equitable data sharing while safeguarding the rights and interests of research participants and researchers. (shrink)

Drawing on the influence of primacy and recency effects in processing information about corporate social responsibility, the authors examine how internal and external factors impact the consumer-firm relationship in the presence of contradictory CSR information. Evaluating these factors provides a more comprehensive understanding of how consumers react to unethical and socially irresponsible actions. Contrary to recent research that suggests a reactive CSR communication strategy to be best due to recency effects, the present findings show that past customer experiences with the (...) firm facilitate a ‘primacy effect’. Thus, when corporate social irresponsibility occurs, a customer’s prior experiences mitigate negative consequences. Conversely, a firm’s positive CSR reputation may provide goodwill, although it does not guarantee that consumers will process CSR information differently. Therefore, firms cannot build a strong CSR reputation and expect to be immune from the consequences of CSI. Given these new findings of how consumers process contradictory CSR information, firms should implement a strategic and deliberate communication plan that delivers different messages to different stakeholders. Specifically, these findings suggest that firms benefit most from a proactive communication strategy with their current customers and a reactive communication strategy with the general public. (shrink)

This wide-ranging book reconstructs this debate and places within their contemporary contexts the rival claims concerning the nature of the cosmos and the ...

Realizing the benefits of translating psychiatric genomics research into mental health care is not straightforward. The translation process gives rise to ethical challenges that are distinctive from challenges posed within psychiatric genomics research itself, or that form part of the delivery of clinical psychiatric genetics services. This article outlines and considers three distinct ethical concerns posed by the process of translating genomic research into frontline psychiatric practice and policy making. First, the genetic essentialism that is commonly associated with the genomics (...) revolution in health care might inadvertently exacerbate stigma towards people with mental disorders. Secondly, the promises of genomic medicine advance a narrative of individual empowerment. This narrative could promote a fatalism towards patients' biology in ways that function in practice to undermine patients' agency and autonomy, or, alternatively, a heightened sense of subjective genetic responsibility could become embedded within mental health services that leads to psychosocial therapeutic approaches and the clinician-patient therapeutic alliance being undermined. Finally, adopting a genomics-focused approach to public mental health risks shifting attention away from the complex causal relationships between inequitable socio-economic, political, and cultural structures and negative mental health outcomes. The article concludes by outlining a number of potential pathways for future ethics research that emphasizes the importance of examining appropriate translation mechanisms, the complementarity between genetic and psychosocial models of mental disorder, the implications of genomic information for the clinician-patient relationship, and funding priorities and resource allocation decision making in mental health. (shrink)

Bringing together researchers from across the cognitive sciences, the book is valuable for philosophers of mind, developmental and comparative psychologists, and neuroscientists.

Global health emergencies such as the COVID-19 pandemic are contexts in which it is critical to draw upon learning from prior research and to conduct novel research to inform real-time decision-making and pandemic responses. While research is vitally important, however, emergencies are radically non-ideal contexts for its conduct, due to exceptional uncertainty, urgency, disruption, health needs, and strain on existing health systems, amongst other challenges. This generates novel ethical challenges and a broader conception of research ethics is necessary to effectively (...) address the complexity of pandemic research contexts. Going beyond traditional approaches to research ethics centring on the design of specific studies, this broader conception requires consideration of fundamental questions relating to the exercise of power and influence throughout research pathways, and a broader attention to both salient ethical issues, and the ethical responsibilities of stakeholders. These include important questions about responsibilities to gather evidence and generate knowledge systematically during emergencies, to implement policy responses in ways that are amenable to evaluation, and even potential moral obligations to participate in research. In situations of heightened uncertainty, additional questions arise about what constitutes sufficient evidence to justify the development and implementation of policy responses, and the responsibilities of scientific and social science researchers involved in policy-making processes. The four cases in this chapter prompt reflection on evolving and at times competing values and responsibilities of policy-makers, regulators, health authorities and researchers during the design and conduct of research, and proposed early implementation of research findings. These cases highlight issues arising when conducting research of national importance in a pandemic, where researchers are required to liaise with authorities responsible for pandemic responses and address complex ethical issues, including protecting the interests of participants and publics when tensions arise between prioritising the completion of research and accelerating the rollout of novel health interventions. This chapter invites reflection on the practical ethical implications of commitments to undertake research during emergencies, including the nature and scope of the relevant responsibilities of a range of stakeholders. (shrink)

In this essay I argue that Albert would reject the need for a separate fourth mode of common personal supposition, and that his view of merely confused supposition has not been fully explicated by modern scholars. I first examine the various examples of conjunct descent given by modern scholars from his Perutilis logica , and show that Albert clearly adopts it in resolving the sophistic examples involved. Second, I explicate the view of merely confused supposition that Albert defends in his (...) Sophismata , and then attempt to answer the question: which view of merely confused supposition was his final view, the view articulated in the Perutilis logica or the view in the Sophismata ? I conclude that based upon his Sophismata view of merely confused supposition, Albert came to realize the logical strength his revised theory of personal supposition afforded, and consequently, that he is one of the earliest 14th-century logicians to adopt conjunct terminal descent to resolve various sophisms, a move which gave his theory of personal supposition a logical symmetry having two sorts of propositional descents to singulars, and two sorts of terminal descents to singulars. (shrink)

Michael J. Loux here presents a fresh reading of two of the most important books of the Metaphysics, Books Z and H, in which Aristotle presents his mature theory of primary substances. Focusing on the interplay of Aristotle's early and late views, Loux maintans that the later concept of ousia should be understood in terms of a theory of predication that carries interesting implications for contemporary metaphysics. Loux argues that in his first attempt in identifying ousiai in the Categories, (...) Aristotle encountered a set of ontological problems which he wrestled with again in Metaphysics Z and H. In the Categories, where the primary realities are basic subjects of predication construed in essentialist terms as things falling under natural kinds, familiar particulars are the primary ousiai. In subsequent works, Aristotle holds that since familiar particulars come into being and pass away, they must be composites of matter and form; and in Metaphysics Z and H, he explores the implications of this insight for the search for ousia. Maintaining that the substantial forms of familiar particulars are the primary ousiai, the later Aristotle interprets forms as predicable universals rather than as particulars, each uniquely possessed by a single object. (shrink)

The social world contains institutions, groups, objects, and more. This essay explores a puzzle about the essences of social items. There is widespread consensus against social essences because of problematic presuppositions often made about them. But it is argued that essence can be freed from these presuppositions and their problems. Even so, a puzzle still arises. In a Platonic spirit, essences in general seem detached from the world. In an Aristotelian spirit, social essences in particular seem embedded in the world. (...) The puzzle is that these inclinations are individually plausible but jointly incompatible. The essay has four aims: to clarify and refine the puzzle; to explore the puzzle's implications for essence in general and for social essences in particular; to illustrate the fruitfulness of the general distinction between detached and embedded; and to develop this distinction to sketch a novel solution to the puzzle. (shrink)

In this paper significant challenges are raised with respect to the view that explanation essentially involves unification. These objections are raised specifically with respect to the well-known versions of unificationism developed and defended by Michael Friedman and Philip Kitcher. The objections involve the explanatory regress argument and the concepts of reduction and scientific understanding. Essentially, the contention made here is that these versions of unificationism wrongly assume that reduction secures understanding.

Philosophical discussions of the morality of suicide have tended to focus on its justifiability from an agent’s point of view rather than on the justifiability of attempts by others to intervene so as to prevent it. This paper addresses questions of suicide intervention within a broadly Kantian perspective. In such a perspective, a chief task is to determine the motives underlying most suicidal behaviour. Kant wrongly characterizes this motive as one of self-love or the pursuit of happiness. Psychiatric and scientific (...) evidence suggests that suicide is instead motivated by a nihilistic disenchantment with the possibility of happiness which, at its apex, results in the loss of the individual’s conception of her practical identity. Because of this, methods of intervention that appeal to agents’ happiness, while morally benign, will prove ineffective in forestalling suicide. At the same time, more aggressive methods violate the Kantian concern for autonomy. This apparent dilemma can be resolved by seeing suicide intervention as an action undertaken in non-ideal circumstances, where otherwise unjustified manipulation, coercion, or paternalism are morally permitted. (shrink)

An Essay on Human Action seeks to provide a comprehensive, detailed, enlightening, and (in its detail) original account of human action. This account presupposes a theory of events as abstract, proposition-like entities, a theory which is given in the first chapter of the book. The core-issues of action-theory are then treated: what acting in general is (a version of the traditional volitional theory is proposed and defended); how actions are to be individuated; how long actions last; what acting intentionally is; (...) what doing one thing by doing another is; what basic action is; and what omitting to do something is. Attention is also given to the concepts of causation, intention, volition, deciding, choosing, and trying. Finally, a libertarian account of free action is tentatively proposed and defended. (shrink)

Metaphysics: Contemporary Readings is a comprehensive anthology that draws together leading philosophers writing on the major themes in Metaphysics. Chapters appear under the headings: Universals Particulars Modality and Possible Worlds Causation Time Persistence Realism and Anti-Realism Each section is prefaced by an introductory essay by the editor which guides students gently into each topic. Articles by the following leading philosophers are included: Allaire, Anscombe, Armstrong, Black, Broad, Casullo, Dummett, Ewing, Heller, Hume, Kripke, Lewis, Mackie, McTaggart, Mellor, Merricks , Parfit, Plantinga, (...) Price, Prior, Putnam, Quine, Russell, Smart, Swinburne, Taylor , Van Cleve, van Inwagen, Williams Featuring a new section on causation, this new edition is highly accessible and provides a broad-ranging exploration of the subject. Ideal for any philosophy student, this reader will prove essential reading for any metaphysics course. The sections and selections of readings have been updated to complement Michael Loux's textbook Metaphysics: A Contemporary Introduction , third edition. (shrink)

Comparing my historical account of the early years of Laurent Schwartz’s theory of distributions with number theorist Michael Harris’s narrative of the early years of Peter Scholze’s perfectoid theory, I develop a perspective on change and temporality in mathematics that emphasizes the relationships between concepts, expectations, and communities of practice. Contemporary mathematics, understood as mathematics imbued with temporality, reflects the dynamic relationship between the people, ideas, pasts, and prospects of mathematical knowledge. Studying these historically may offer critical perspectives on (...) the social and political conditions and implications of mathematical research and the communities that practice it. (shrink)

This paper has three interdependent aims. The first is to make Reichenbach’s views on induction and probabilities clearer, especially as they pertain to his pragmatic justification of induction. The second aim is to show how his view of pragmatic justification arises out of his commitment to extensional empiricism and moots the possibility of a non-pragmatic justification of induction. Finally, and most importantly, a formal decision-theoretic account of Reichenbach’s pragmatic justification is offered in terms both of the minimax principle and the (...) dominance principle. (shrink)

We think about and refer to things that we’ve never perceived or experienced. This paper bears on how this could be. Someone is testimonially acquainted with something just in case the explanation of one’s ability to think de re thoughts about it essentially appeals to communication with others who already have that ability. The main motivation for the claim that testimonial acquaintance is possible is that it best explains how we can think de re about and refer to things we’ve (...) never perceived or experienced: we gain these abilities in part by communicating with those who already have them. The main point of this paper is negative: to argue that testimonial acquaintance, as we currently understand it, is impossible. Although one might take this to show that we cannot be acquainted with things we haven’t perceived or experienced, I prefer to think of it as motivation for rethinking the nature of acquaintance. (shrink)

Sociology originated in the mid-nineteenth century from a new confidence in the power of science to explain the world on a mathematical foundation. Both mathematics and sociology transformed over the ensuing century, inverting the hierarchical relationship from sociology as a mathematics-based science of complex human configurations to mathematics as a complex science based on social institutions. That is, where sociology began as the hard case for mathematics, it became possible to see mathematics as the hard case for sociology. In this (...) light, we examine a number of motivations and provocations for the sociology of mathematics, from language and social cognition to Marxist and materialist skepticism of ideology, and sample the evidence and arguments brought to bear on the sociology of mathematics at a range of scales. (shrink)

Much of the science and religion debate has focussed on statistics. The chapters in this section go beyond bare statistics by examining more nuanced studies of science, religion and education with the aim of developing a deeper understanding of the issues at play when attempting to deal with the issues of science and religion in the classroom.

Every choice we make is set against a background of massive ignorance about our past, our future, our circumstances, and ourselves. Philosophers are divided on the moral significance of such ignorance. Some say that it has a direct impact on how we ought to behave - the question of what our moral obligations are; others deny this, claiming that it only affects how we ought to be judged in light of the behaviour in which we choose to engage - the (...) question of what responsibility we bear for our choices. Michael Zimmerman claims that our ignorance has an important bearing on both questions, and offers an account of moral obligation and moral responsibility that is sharply at odds with the prevailing wisdom. His book will be of interest to a wide range of readers in ethics. (shrink)