ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a (...) waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research. (shrink)

Researchers have frequently complained that the NHS ethical review system stifles good research. At last measures are being put in place to address this criticism, but will they undermine the protection of research participants? The Declaration of Helsinki recognizes that medicine will not progress without good quality research, but also demands that the well-being of research participants takes precedence over the interests of science and society. This article examines the implications of the ongoing reform of the NHS research ethics review (...) system for researchers, ethics committees and research participants. (shrink)

This study explored the influence of the COVID-19 pandemic on perceived health behaviors; physical activity, sleep, and diet behaviors, alongside associations with wellbeing. Participants were 1,140 individuals residing in the United Kingdom, South Korea, Finland, Philippines, Latin America, Spain, North America, and Italy. They completed an online survey reporting possible changes in the targeted behaviors as well as perceived changes in their physical and mental health. Multivariate analyses of covariance on the final sample revealed significant mean differences regarding perceived physical (...) and mental health “over the last week,” as well as changes in health behaviors during the pandemic by levels of physical activity and country of residence. Follow up analyses indicated that individuals with highest decrease in physical activity reported significantly lower physical and mental health, while those with highest increase in physical activity reported significantly higher increase in sleep and lower weight gain. United Kingdom participants reported lowest levels of physical health and highest increase in weight while Latin American participants reported being most affected by emotional problems. Finnish participants reported significantly higher ratings for physical health. The physical activity by country interaction was significant for wellbeing. MANCOVA also revealed significant differences across physical activity levels and four established age categories. Participants in the oldest category reported being significantly least affected by personal and emotional problems; youngest participants reported significantly more sleep. The age by physical activity interaction was significant for eating. Discussed in light of Hobfoll conservation of resources theory, findings endorse the policy of advocating physical activity as a means of generating and maintaining resources combative of stress and protective of health. (shrink)

One of the perplexing features of an infectious disease is the damage it causes, not only to physical health, but to mental health and to social relationships. This tension between the separation that is required for safety and the human need for contact is especially felt by institutions of higher education. Many such institutions not only educate students but seek to foster the kinds of communities which have thrived on personal interaction and shared physical space. Different institutions have responded to (...) COVID-19 and its impacts on their members differently. Given that the spring semester will begin months before COVID-19 vaccines are widely available, we offer seven recommendations and argue that for a university, college, or other similarly situated educational institution to ethically respond to the pandemic, it must follow these recommendations. These recommendations are grounded in both scientific research and ethical analysis. Proper ethical analysis, which is necessary for the implementation of good policies, cannot be accomplished without an evidence-based grounding. After describing features of the virus and the situation that faces higher education institutions, in general, we turn to a detailed discussion of transmission. We discuss interventions available to institutions, including masking, hygiene, barriers, and testing and surveillance. Our recommendations are supported by an ethical analysis reliant on four themes: expertise, planning, stewardship, and dignity. (shrink)

Drawing on their extensive research, Nichols and Berliner document and categorize the ways that high-stakes testing threatens the purposes and ideals of the American education system. For more than a decade, the debate over high-stakes testing has dominated the field of education. This passionate and provocative book provides a fresh perspective on the issue and powerful ammunition for opponents of high-stakes tests. Their analysis is grounded in the application of Campbell’s Law, which posits that the greater the social consequences (...) associated with a quantitative indicator, the more likely it is that the indicator itself will become corrupted—and the more likely it is that the use of the indicator will corrupt the social processes it was intended to monitor. Nichols and Berliner illustrate both aspects of this “corruption,” showing how the pressures of high-stakes testing erode the validity of test scores and distort the integrity of the education system. Their analysis provides a coherent and comprehensive intellectual framework for the wide-ranging arguments against high-stakes testing, while putting a compelling human face on the data marshalled in support of those arguments. (shrink)

The sequencing of the human genome and decreasing costs of sequencing technology have led to the notion of ‘personalized medicine’. This has been taken by some authors to indicate that personalized medicine will provide individualized treatments solely based on one’s DNA sequence. We argue this is overly optimistic and misconstrues the notion of personalization. Such interpretations fail to account for economic, policy and structural constraints on the delivery of healthcare. Furthermore, notions of individualization based on genomic data potentially take us (...) down the road of genetic reductionism obscuring the role of environmental factors in disease and ill health. We propose that one should see personalized medicine as a way of using personal genomic information to stratify individuals into subpopulations and suggest that personalized medicine be seen within a broader idea of personalized healthcare, reflecting healthcare that integrates personal genomic data into cultural, environmental and personal contexts. (shrink)

There is an international consensus that medical research involving humans should only be undertaken in accordance with ethical principles. Paradoxically though, there is no consensus over the kinds of activities that constitute research and should be subject to review. In the UK and elsewhere, research requiring review is distinguished from clinical audit. Unfortunately the two activities are not always easy to differentiate from one another. Moreover, as the volume of audit increases and becomes more formal in response to the demand (...) for evidence-based practice in medicine, the overlap between research and audit grows more acute. Arguably, similar ethical standards and systems for ensuring that those standards are met should be applied regardless of whether or not a project is classified as research or audit. At a time when the research ethics review system in the UK is undergoing significant reform it is important that the opportunity is not missed to address the longstanding research-audit problem. We discuss suggestions for further reform that addresses this issue. (shrink)

Newborn bloodspot screening programs are some of the longest running population screening programs internationally. Debate continues regarding the need for parents to give consent to having their child screened. Little attention has been paid to how meanings of consent-related terminology vary among stakeholders and the implications of this for practice. We undertook semi-structured interviews with parents, healthcare professionals and policy decision makers in two Canadian provinces. Conceptions of consent-related terms revolved around seven factors within two broad domains, decision-making and information (...) attainment. Decision-making comprised: parent decision authority; voluntariness; parent engagement with decision-making; and the process of enacting choice. Information ascertainment comprised: professional responsibilities ; parent responsibilities; and the need for discussion and understanding prior to a decision. Our findings indicate that consent-related terms are variously understood, with substantive implications for practice. We suggest that consent procedures should be explained descriptively, regardless of approach, so there are clear indications of what is expected of parents and healthcare professionals. Support systems are required both to meet the educational needs of parents and families and to support healthcare professionals in delivering information in a manner in keeping with parent needs. (shrink)

Online medical reference websites are utilized by health care providers to enhance their education and decision making. However, these resources may not adequately reveal pharmaceutical-author interactions and their potential conflicts of interest. This investigation: evaluates the correspondence of two well-utilized CoI databases: the Centers for Medicare and Medicaid Services Open Payments and ProPublica’s Dollars for Docs and quantifies CoIs among authors of a publicly available point of care clinical support website which is used to inform evidence-based medicine decisions. Two data (...) sources were used: the hundred most common drugs and the top fifty causes of death. These topics were entered into a freely available database. The authors were then input into CMSOP and PDD and compensation and number of payments were determined for 2013–2015. The subset of highly compensated authors that also reported “Nothing to disclose” were further examined. There was a high degree of similarity between CMSOP and PDD for compensation and payment number. The amount received was 1.4% higher in CMSOP than in PDD. The articles where the authors had received the greatest compensation were in neurology, oncology, and endocrinology. Two authors reporting “Nothing to disclose” received appreciable and potentially relevant compensation. CMSOP and PDD produced almost identical results. CoIs were common among authors but self-reporting may be an inadequate reporting mechanism. Recommendations are offered for improving the CoI transparency of pharmaceutical-author interactions in point-of-care electronic resources. (shrink)

Online medical reference websites are utilized by health care providers to enhance their education and decision making. However, these resources may not adequately reveal pharmaceutical-author interactions and their potential conflicts of interest. This investigation: evaluates the correspondence of two well-utilized CoI databases: the Centers for Medicare and Medicaid Services Open Payments and ProPublica’s Dollars for Docs and quantifies CoIs among authors of a publicly available point of care clinical support website which is used to inform evidence-based medicine decisions. Two data (...) sources were used: the hundred most common drugs and the top fifty causes of death. These topics were entered into a freely available database. The authors were then input into CMSOP and PDD and compensation and number of payments were determined for 2013–2015. The subset of highly compensated authors that also reported “Nothing to disclose” were further examined. There was a high degree of similarity between CMSOP and PDD for compensation and payment number. The amount received was 1.4% higher in CMSOP than in PDD. The articles where the authors had received the greatest compensation were in neurology, oncology, and endocrinology. Two authors reporting “Nothing to disclose” received appreciable and potentially relevant compensation. CMSOP and PDD produced almost identical results. CoIs were common among authors but self-reporting may be an inadequate reporting mechanism. Recommendations are offered for improving the CoI transparency of pharmaceutical-author interactions in point-of-care electronic resources. (shrink)

Online medical reference websites are utilized by health care providers to enhance their education and decision making. However, these resources may not adequately reveal pharmaceutical-author interactions and their potential conflicts of interest. This investigation: evaluates the correspondence of two well-utilized CoI databases: the Centers for Medicare and Medicaid Services Open Payments and ProPublica’s Dollars for Docs and quantifies CoIs among authors of a publicly available point of care clinical support website which is used to inform evidence-based medicine decisions. Two data (...) sources were used: the hundred most common drugs and the top fifty causes of death. These topics were entered into a freely available database. The authors were then input into CMSOP and PDD and compensation and number of payments were determined for 2013–2015. The subset of highly compensated authors that also reported “Nothing to disclose” were further examined. There was a high degree of similarity between CMSOP and PDD for compensation and payment number. The amount received was 1.4% higher in CMSOP than in PDD. The articles where the authors had received the greatest compensation were in neurology, oncology, and endocrinology. Two authors reporting “Nothing to disclose” received appreciable and potentially relevant compensation. CMSOP and PDD produced almost identical results. CoIs were common among authors but self-reporting may be an inadequate reporting mechanism. Recommendations are offered for improving the CoI transparency of pharmaceutical-author interactions in point-of-care electronic resources. (shrink)

What were Shakespeare's final thoughts on history, tragedy, and comedy? Shakespeare's Last Plays focuses much needed scholarly attention on Shakespeare's "Late Romances." The work--a collection of newly commissioned essays by leading scholars of classical political philosophy and literature--offers careful textual analysis of Pericles, Prince of Tyre, Cymbeline, The Winter's Tale, The Tempest, All is True, and The Two Noble Kinsmen. The essays reveal how Shakespeare's thought in these final works compliments, challenges, fulfills, or transforms previously held conceptions of the playwright (...) and his political-philosophical views. (shrink)

In The Ethics of Food, Gregory E. Pence brings together a collection of voices who share the view that the ethics of genetically modified food is among the most pressing societal questions of our time. This comprehensive collection addresses a broad range of subjects, including the meaning of food, moral analyses of vegetarianism and starvation, the safety and environmental risks of genetically modified food, issues of global food politics and the food industry, and the relationships among food, evolution, and human (...) history. (shrink)

As a result of the COVID-19 pandemic people have endured potentially stressful challenges which have influenced behaviors such as eating. This pilot study examined the effectiveness of two brief interventions aimed to help individuals deal with food cravings and associated emotional experiences. Participants were 165 individuals residing in United Kingdom, Finland, Philippines, Spain, Italy, Brazil, North America, South Korea, and China. The study was implemented remotely, thus without any contact with researchers, and involved two groups. Group one participants were requested (...) to use daily diaries for seven consecutive days to assess the frequency of experience of their food cravings, frequency of giving in to cravings, and difficulty resisting cravings, as well as emotional states associated with their cravings. In addition to completing daily food diaries, participants in group two were asked to engage in mindful eating practice and forming implementation intentions. Participants assessed their perceived changes in eating, wellbeing, and health at the beginning and end of the intervention. Repeated measures MANOVAs indicated that participants experienced significantly less food cravings, as well as lower intensities of unpleasant states associated with cravings across time. In contrast to our hypothesis, the main effects of the group were not significant. Participants reported less eating and enhanced wellbeing at the end of the study. Our findings can be used to inform future remote interventions to manage food cravings and associated emotions and highlight the need for alternative solutions to increase participant engagement. (shrink)

We present a one per cent measurement of the cosmic distance scale from the detections of the baryon acoustic oscillations in the clustering of galaxies from the Baryon Oscillation Spectroscopic Survey, which is part of the Sloan Digital Sky Survey III. Our results come from the Data Release 11 sample, containing nearly one million galaxies and covering approximately 8500 square degrees and the redshift range 0.2 < z < 0.7. We also compare these results with those from the publicly released (...) DR9 and DR10 samples. Assuming a concordance Λ cold dark matter cosmological model, the DR11 sample covers a volume of 13 Gpc3 and is the largest region of the Universe ever surveyed at this density. We measure the correlation function and power spectrum, including density-field reconstruction of the BAO feature. The acoustic features are detected at a significance of over 7σ in both the correlation function and power spectrum. Fitting for the position of the acoustic features measures the distance relative to the sound horizon at the drag epoch, rd, which has a value of rd,fid = 149.28 Mpc in our fiducial cosmology. We find DV = at z = 0.32 and DV = at z = 0.57. At 1.0 per cent, this latter measure is the most precise distance constraint ever obtained from a galaxy survey. Separating the clustering along and transverse to the line of sight yields measurements at z = 0.57 of DA = and H =. Our measurements of the distance scale are in good agreement with previous BAO measurements and with the predictions from cosmic microwave background data for a spatially flat CDM model with a cosmological constant. © 2014 The Author Published by Oxford University Press on behalf of the Royal Astronomical Society. (shrink)

The ‘community of inquiry’ as formulated by C. S. Peirce is grounded in the notion of communities of discipline-based inquiry engaged in the construction of knowledge. The phrase ‘transforming the classroom into a community of inquiry’ is commonly understood as a pedagogical activity with a philosophical focus to guide classroom discussion. But it has a broader application. Integral to the method of the community of inquiry is the ability of the classroom teacher to actively engage in the theories and practices (...) of discipline-based communities of inquiry so as to become informed by the norms of the disciplines, not only to aspire to competence within the disciplines, but also to develop habits of self-correction for reconstructing those same norms when faced with novel problems and solutions, including those in the classroom. This has implications for science education and the role of educational philosophy in developing students' ability to think scientifically. But it also has broader implications for thinking critically within all key learning areas. Here we concentrate on science education. We present the parallels between philosophical inquiry and scientific inquiry that need to be realised to promote and engage with scientific inquiry in the classroom. We also discuss the conflicts between philosophical inquiry and the way inquiry science in the classroom is portrayed in the education literature. Based on philosophical and historical perceptions of science as inquiry, a practical approach to implementation of scientific inquiry in the science classroom is presented. (shrink)

Fanon and the Decolonization of Philosophy explores the range of ways in which Frantz Fanon's decolonization theory can reveal new answers to perennial philosophical questions and new paths to social justice. The aim is to show not just that Fanon's thought remains philosophically relevant, but that it is relevant to an even wider range of philosophical issues than has previously been realized. The essays in this book are written by both renowned Fanon scholars and new scholars who are emerging as (...) experts in aspects of Fanonian thought as diverse as humanistic psychiatry, the colonial roots of racial violence and marginalization, and decolonizing possibilities in law, academia, and tourism. In addition to examining philosophical concerns that arise from political decolonization movements, many of the essays turn to the discipline of philosophy itself and take up the challenge of suggesting ways that philosophy might liberate itself from colonial—and colonizing—assumptions. -/- This collection will be useful to those interested in political theory, feminist theory, existentialism, phenomenology, Africana studies, and Caribbean philosophy. Its Fanon-inspired vision of social justice is endorsed in the foreword by his daughter, Mireille Fanon-Mendès France, a noted human rights defender in the French-speaking world. -/- Contributions by Anna Carastathis; Nigel C. Gibson; Lewis R. Gordon; Peter Gratton; Ferit Güven; Mireille Fanon Mendès-France; Marilyn Nissim-Sabat; Olúfémi Táíwò; Mohammad H. Tamdgidi; Chloë Taylor and Sokthan Yeng. (shrink)

The ‘community of inquiry’ as formulated by C. S. Peirce is grounded in the notion of communities of discipline‐based inquiry engaged in the construction of knowledge. The phrase ‘transforming the classroom into a community of inquiry’ is commonly understood as a pedagogical activity with a philosophical focus to guide classroom discussion. But it has a broader application. Integral to the method of the community of inquiry is the ability of the classroom teacher to actively engage in the theories and practices (...) of discipline‐based communities of inquiry so as to become informed by the norms of the disciplines, not only to aspire to competence within the disciplines, but also to develop habits of self‐correction for reconstructing those same norms when faced with novel problems and solutions, including those in the classroom. This has implications for science education and the role of educational philosophy in developing students' ability to think scientifically. But it also has broader implications for thinking critically within all key learning areas. Here we concentrate on science education. We present the parallels between philosophical inquiry and scientific inquiry that need to be realised to promote and engage with scientific inquiry in the classroom. We also discuss the conflicts between philosophical inquiry and the way inquiry science in the classroom is portrayed in the education literature. Based on philosophical and historical perceptions of science as inquiry, a practical approach to implementation of scientific inquiry in the science classroom is presented. (shrink)

The last several decades of research on counterfactual conditionals in the fields of philosophy and linguistics have yielded a predominant paradigm according to which the notion of similarity plays the starring role. Roughly, a counterfactual of the form A > C is true iff the closest A-worlds are all C-worlds, where the closeness of a world is a function of its similarity, in a certain sense, to the actual world. I argue that this is deeply misguided. In some cases we (...) may only care about the closest A-worlds, but quite often we care about some broader variety of A-worlds varying in closeness. After presenting several problem cases for the similarity-based paradigm, some new and some known, I propose an alternative paradigm for the semantics of counterfactuals, which introduces the notion of A-scenarios, understood roughly as different ways of making A true. According to this view, A > C is true iff all the contextually relevant ways of making A true also make C true. I then more carefully spell out a working view that formalizes this idea with greater precision, and explore the consequences of that version of the view. (shrink)

The seminal works of Jean Bodin (c.1530–96) and François Hotman (c.1524–90), the Six livres de la République, and the Francogallia, were written and re-written over the turbulent course of the French wars of religion (1562–1629). Whilst conventionally these works are understood to represent fixed, and opposing, theories of monarchy (absolutist versus constitutionalist), this article explores them as they transformed in response to the changing circumstances of French politics, and especially the succession crisis of 1584. Theories of monarchy were in flux (...) in this period, and so the political thought of the late sixteenth century in France was in a constant state of mutation. This raises questions about the ways in which intellectual historians read ideas ‘in context’, even as those ideas, and those contexts, shift. What did it mean, to have a theory of monarchy in the French sixteenth century? (shrink)

Recent research has begun treating the perennial philosophical question, “what makes a person the same over time?” as an empirical question. A long tradition in philosophy holds that psychological continuity and connectedness of memories are at the heart of personal identity. More recent experimental work, following Strohminger & Nichols (2014), has suggested that persistence of moral character, more than memories, is perceived as essential for personal identity. While there is a growing body of evidence supporting these findings, a critique (...) by Starmans & Bloom (2018) suggests that this research program conflates personal identity with mere similarity. To address this criticism, we explore how loss of someone’s morality or memories influence perceptions of identity change, and perceptions of moral duties towards the target of the change. We present participants with a classic ‘body switch’ thought experiment and after assessing perceptions of identity persistence, we present a moral dilemma, asking participants to imagine that one of the patients must die (Study 1) or be left alone in a care home for the rest of their life (Study 2). Our results highlight the importance of the continuity of moral character, suggesting lay intuitions are tracking (something like) personal identity, not just mere similarity. (shrink)

According to Paul Draper and Ryan Nichols the practice of philosophy of religion—and especially its theistically committed practitioners—regularly violate norms of rationality, objectivity, and impartiality in the review, assessment, and weighing of evidence. (Draper and Nichols, 2013). We consider the charge of epistemic partisanship and show that the observational data does not illustrate a norm-violating form of inquiry. The major oversight in the charge of epistemic partiality is the epistemically central role of prior probabilities in determining the significance (...) of incongruent evidence. We argue that reasonably divergent views on the likelihood of theism on incongruent evidence can also account for differences in significance. We conclude that it is an epistemic requirement that committed theists regard incongruent evils as much less significant evidence against theism than do lukewarm theists, agnostics, or atheists. Differences in the significance of evidence quite properly reflect differences in commitments to theism. (shrink)

Williams (1970) argues that our intuitions about personal identity vary depending on how a given thought experiment is framed. Some frames lead us to think that persistence of self requires persistence of one's psychological characteristics; other frames lead us to think that the self persists even after the loss of one's distinctive psychological characteristics. The current paper takes an empirical approach to these issues. We find that framing does affect whether or not people judge that persistence of psychological characteristics is (...) required for persistence of self. Open-ended, abstract questions about what is required for survival tend to elicit responses that appeal to the importance of psychological characteristics. This emphasis on psychological characteristics is largely preserved even when participants are exposed to a concrete case that yields conflicting intuitions over whether memory must be preserved in order for a person to persist. Insofar as our philosophical theory of personal identity should be based on our intuitions, the results provide some support for the view that psychological characteristics really are critical for persistence of self. (shrink)

De Interpretatione is among Aristotle's most influential and widely read writings; C. W. A. Whitaker presents the first systematic study of this work, and offers a radical new view of its aims, its structure, and its place in Aristotle's system. He shows that De Interpretatione is not a disjointed essay on ill-connected subjects, as traditionally thought, but a highly organized and systematic treatise on logic, argument, and dialectic.

Philosophical theorizing is often, either tacitly or explicitly, guided by intuitions about cases. Theories that accord with our intuitions are generally considered to be prima facie better than those that do not. However, recent empirical work has suggested that philosophically significant intuitions are variable and unstable in a number of ways. This variability of intuitions has led naturalistically inclined philosophers to disparage the practice of relying on intuitions for doing philosophy in general (e.g. Stich & Weinberg 2001) and for doing (...) moral philosophy in particular (Appiah 2008; Doris & Stich 2005; Horowitz 1998; Nadelhoffer & Feltz 2008; Sinnott Armstrong 2008). In this paper, we will draw on naturalistic considerations to offer some solace to philosophers who rely on intuitions. We wouldn’t call this a defense of intuitions, exactly, since we are sympathetic with much of the naturalists’ critique. But we want to introduce into the debate some neglected naturalistic reasons to be optimistic about intuitions, focusing especially on ethical intuitions. (shrink)

According to recent accounts of the imagination, mental mechanisms that can take input from both imagining and from believing will process imagination‐based inputs (pretense representations) and isomorphic beliefs in much the same way. That is, such a mechanism should produce similar outputs whether its input is the belief that p or the pretense representation that p. Unfortunately, there seem to be clear counterexamples to this hypothesis, for in many cases, imagining that p and believing that p have quite different psychological (...) consequences. This paper sets out some central problem cases and argues that the cases might be accommodated by adverting to the role of desires concerning real and imaginary situations. (shrink)

The precautionary principle has been widely discussed in the academic, legal, and policy arenas. This paper argues, however, that there is no single precautionary principle and we should stop referring to ?the? precautionary principle. Instead, we should talk about ?precaution? and ?precautionary approaches? more generally and identify and defend distinct precautionary principles of limited scope. Drawing on the vast literature on ?the? precautionary principle, this paper further argues that the challenges of decision making under conditions of uncertainty necessitate taking a (...) precautionary approach to decision making that will enable us to understand what particular precautionary principles require of us on a case-by-case basis. (shrink)